Single Copy Price ` 250 Vol. 52 No. 04 | April 2020 ISSN 0031-6849 Total Pages : 63

Indexed by Scopus & Embase Official Monthly Newsmagazine of Indian Pharmaceutical Association

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Commitment to Public Health and Science will go a long way in Defeating ‘Pandemics’ ... 22

Pharmaceutical Sector of India, Perspectives & its Journey During Covid-19: Recent Problems & Strategic Solutions –Ppp Mode...... 15 Pharma Times Pharmacist the ‘Apostrophe’ of the Health profession...... 20 Official Publication of: Covid-19: A Wake up Call for Pharma Stakeholders...... 25 The Indian Pharmaceutical Association, Safety of Pharmaceutical Employees in Covid-19 Kalina, Santacruz (E), Mumbai 400098. Pandemic...... 26 Pharma Times - Vol. 52 - No. 04 - April 2020 PB Pharma Times -- Vol.Vol. 5252 -- No.No. 0304 -- MarchApril 2020 2020 2 44 Pharma Pharma Times Times - Vol.- Vol. 52 52 - No.- No. 03 04 - March- April 20202020 453 COL

Pharma Times - Vol. 52 - No. 0403 - AprilMarch 2020 2020 2 2 Pharma Pharma Times Times - Vol.- Vol. 52 52 - No.- No. 03 04 - March- April 2020 3 Contents Novel Coronavirus Pandemic- Stark Realities & New Lessons for Science & Humanity: Dr. Jayant B Dave, Adjunct Professor, L M College of Pharmacy, Ahmedabad...... 9

Pharmaceutical Sector of India, Perspectives & its Journey During Covid-19 : Recent Problems & Strategic Solutions37 –Ppp Mode: 42 11 Dr. Dinesh Dua, Chief Executive Officer (CEO) & Whole Time Director, M/S Nectar Lifesciences Ltd. India & Chairman, Pharmexcil, Ministry of Commerce, Govt. of India...... 15 Pharmacist the ‘Apostrophe’ of the Health profession Dr B Suresh, President, Pharmacy Council of India, New Delhi Pro Chancellor, JSS Academy of Higher Education and Research, Mysuru...... 20 Commitment to Public Health and Science will go a 11long way in defeating ‘Pandemics’: 37 42 14 Dr. Krishna Ella,45 Chairman & Managing Director, Bharat53 Biotech...... 22

Contents Covid-19: A Wake up Call for Pharma Stakeholders: Lipid Excipients In Pharmaceutical Technologies ...... 11 Dr. Ajit Dangi, President & CEO, Danssen Consulting...... 25 Lipidic excipients in drug delivery for solubility and bioavailability enhancement ...... 14 Safety of Pharmaceutical Employees in Covid-19 Pandemic:14 45 53 S. G. Belapure, Senior Technical Advisor, Indian Pharmaceutical56 Alliance...... 26 From Exploration of Lipids to its Exploitation in Market: 54 Pharmaceuticals, Nutraceuticals and Herbal ...... 20 Contents A snapshot of lipid excipients for Topical Formulations...... 26 Pharmacy Experiences in India in Sars-Cov-2: Lipid ExcipientsRaj In Vaidya, Pharmaceutical Community Technologies Pharmacist, ...... Hindu Pharmacy, Panaji11 ...... 30 Processing technologies from Romaco Innojet GMP compliant Lipidic excipients in drug delivery for solubility and bioavailability hot melt device for applying pharmaceutical coatings ...... 29 enhancement ...... 14 Strategic Lipid-Based Delivery Interventions for Enhancing Oral Embracing 4.0 in Pharma Academics: Way Forward: 54 56 From ExplorationDr. Richaof Lipids Dayaramani, to its Exploitation Principal, in Khyati Market: College of Pharmacy...... 36 Bioavailability of BCS II/IV Drugs ...... 37 56 Pharmaceuticals, Nutraceuticals and Herbal ...... 20 Unleashing role of excipients in overcoming formulation challenges ....42 A snapshot ofAn lipid International excipients forCrisis: Topical Long Formulations Term Impact...... of Covid-19 Pandemic26 on Health Care Scenario, Role of lipid excipients in oral sustained release drug delivery systems ..45 Pharma Times ProcessingOfficial technologiesWorldwide Publication fromPharmaceutical ofRomaco The Indian Innojet Growth Pharmaceutical GMP and compliant Global Association Economy: hot melt deviceAnil for Kharia applying*, Sapna pharmaceutical Malviya1, Ankur coatings Joshi ...... 1, 29 Indexed by Scopus & Embase Regular Features Strategic Lipid-Based*President, Delivery IPA MP Interventions State Branch, for EnhancingIndore, 1Indian Oral Pharmaceutical Association, MP State Branch, Indore...... 39 From the Editor’s Desk ...... 5 EDITOR Dr. B. Suresh Dr. N. Shivaprasad BioavailabilityDr. Alka Mukne of BCS II/IVDr. Drugs C. Gopalakrishna ...... Murty Dr. P. Khadgapathi 37 56 President Speak ...... 7 EDITORIAL ASSISTANTS Dr. J. A. S. Giri Dr. Premnath Shenoy UnleashingArjun Jeswani role of excipientsKaushik in overcoming Desai formulationPuneet challenges Gupta ....42 Guest Editorial ...... 8,9 Regular FeaturesDr. Mukund Yelvigi Neha Dabholkar Dr. P.N. Murthy Role of lipid excipients in oralPrafull sustained Sheth release drug delivery systems ..45 Pharma Times Advertisement Tariff ...... 13 Pooja Kulthe Raj Vaidya FromRasika The R. Dharap Editor’s Desk...... Dr. Rao V.S.V. Vadlamudi 5 Official Publication of The Indian Pharmaceutical Association Book Review ...... 25 Shashikant Joag Rajesh Bhandari Rishab Babel Dr. R.N. Gupta Indexed by Scopus & Embase PresidentRegularSaee H. Misal Speak...... FeaturesSubodh Priolkar 7 Letter to Editor ...... 28 Sanjay Jain FromSakshi the Y. KasatEditor’s Desk ...... EDITORIAL BOARD 5 EDITOR Dr. B. Suresh Dr. N. Shivaprasad Announcement ...... 30,41,55,57 "IPASeline in Dantes the News!!" ...... Dr B.N. Sinha Dr. Shailendra Saraf 8 Dr. Alka Mukne Dr. C. Gopalakrishna Murty Dr. P. Khadgapathi PresidentShweta S.Shinde Speak ...... Dr. Divakar Goli Shyamal Kalani 7 EDITORIAL ASSISTANTS Dr. J. A. S. Giri Dr. Premnath Shenoy Kaushik Desai IPA Building Progress Report ...... 31 Tamanna Gidwani Hemanta Kr. Sharma Sripati Singh Arjun Jeswani Puneet Gupta ObituryGuest Editorial...... 14,218,9 Dr. Mukund Yelvigi Vibhusha Dube Dr. Subhash Mandal Neha Dabholkar Dr. P.N. Murthy Pharmexcil Updates ...... 44 Dr. Jayant Dave Prafull Sheth LetterAdvertisementADVISORY To Editor BOA TariffRD...... Kalhan Bazaz Dr. S.P. Manek 1333 Pooja Kulthe Raj Vaidya Advertisement Index ...... 47 Rasika R. Dharap Dr. Rao V.S.V. Vadlamudi BookDr. A. Review I. Mehta ...... M.P. George Prof. T.V. Narayana 25 Shashikant Joag Rajesh Bhandari Advertisement Tariff...... 42 Rishab Babel Dr. R.N. Gupta Minutes of CEC Meeting ...... 48 Copyright of Indian Pharmaceutical Association. All rights reserved throughout the world. Saee H. Misal Subodh Priolkar Letter to Editor ...... 28 Sanjay Jain Campus News ...... 53 Reproduction in any manner is prohibited. Sakshi Y. Kasat EDITORIAL BOARD AdvertisementAnnouncement Index...... Please...... send your communications to: 30,41,55,5742 Seline Dantes Dr B.N. Sinha Dr. Shailendra Saraf Association News ...... 56 The Editor, Pharma Times Dr. Divakar Goli Shyamal Kalani JumboIPA Building Covid Progress Crossword Report...... 3143 Shweta S.Shinde Advocacy Corner ...... 57 The Indian Pharmaceutical Association, Kalina, Santacruz (E), Mumbai 400098. Tamanna Gidwani Hemanta Kr. Sharma Sripati Singh Pharmexcil UpdatesTel: 91-22-2667 ...... 1072 E-mail: [email protected] 44 Vibhusha Dube Dr. Jayant Dave Dr. Subhash Mandal AssociationPrinted News by .Dr...... Alka Mukne, Published by Dr. Alka Mukne on behalf of 44 ADVISORY BOARD Kalhan Bazaz Dr. S.P. Manek Advertisement Index ...... 47 Prof. T.V. Narayana PharmasceneThe Indian .Pharmaceutical...... Association and printed at Ebenezer Printing House, 51 Dr. A. I. Mehta M.P. George MinutesUnit No. of5 & CEC 11, 2nd Meeting Floor, Hind ...... Services Industries, Veer Savarkar Marg, Dadar (West),48 Copyright of Indian Pharmaceutical Association. All rights reserved throughout the world. Mumbai 400 028 and published at The Indian Pharmaceutical Association, Reproduction in any manner is prohibited. Campus News ...... Kalina, Santacruz (E), Mumbai 400 098. 53 Please send your communications to: Association NewsFor ...... Pharma Times Advertisements please contact 56 The Editor, Pharma Times Tel. 022-26671072 / 26670744 The Indian Pharmaceutical Association, Kalina, Santacruz (E), Mumbai 400098. Advocacy [email protected] ...... / [email protected] 57 Tel: 91-22-2667 1072 E-mail: [email protected] Website: www.ipapharma.org Printed by Dr. Alka Mukne, Published by Dr. Alka Mukne on behalf of Designed, Typeset & Printed at Ebenezer Printing House The Indian Pharmaceutical Association and printed at Ebenezer Printing House, Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg, Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg, Dadar (West), Dadar (West), Mumbai 28. Tel.: 2446 2632 / 3872 Fax: 2444 9765 Mumbai 400 028 and published at The Indian Pharmaceutical Association, 20 26 E-mail: [email protected] Kalina, Santacruz (E), Mumbai 400 098. For Pharma Times Advertisements please contact Tel. 022-26671072 / 26670744 Pharma Times - Vol. 51 - No. 09 - September 2019 4 Pharma Times - Vol. 52 - No. 04 - April 2020 4 [email protected] / [email protected] Pharma Times - Vol. 51 - No. 09 - September 2019 5 Pharma Times - Vol. 52 - No. 04 - April 2020 5 Website: www.ipapharma.org Designed, Typeset & Printed at Ebenezer Printing House Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg, Dadar (West), Mumbai 28. Tel.: 2446 2632 / 3872 Fax: 2444 9765 20 26 E-mail: [email protected]

Pharma Times - Vol. 51 - No. 09 - September 2019 4 Pharma Times - Vol. 51 - No. 09 - September 2019 5 Contents Novel Coronavirus Pandemic- Stark Realities & New Lessons for Science & Humanity: Dr. Jayant B Dave, Adjunct Professor, L M College of Pharmacy, Ahmedabad...... 9 From the Editor’s Desk...

fatalities. The COVID-19 pandemic has their act to meet not just the domestic Pharmaceutical Sector of India, Perspectives & its Journey During Covid-19 : Recent Problems & caught the globe unawares and completely requirement but also grateful requests Strategic Solutions37 –Ppp Mode: 42 ill-equipped to tackle it. With no effective from neighbouring countries and all major 11 Dr. Dinesh Dua, Chief Executive Officer (CEO) & Whole Time Director, M/S Nectar Lifesciences Ltd. India drug and no signs of any vaccines for the nations of the world. Industry has been & Chairman, Pharmexcil, Ministry of Commerce, Govt. of India...... 15 next year or so, nations after nations have doing all of this, with skeletal work force, imposed stringent lockdowns of a nature serious supply chain disruptions and Pharmacist the ‘Apostrophe’ of the Health profession that none of us even remember hearing cash flow issues! The regulators have Dr B Suresh, President, Pharmacy Council of India, New Delhi of! The virus itself seems to be behaving responded with just as much alacrity; Pro Chancellor, JSS Academy of Higher Education and Research, Mysuru...... 20 strangely within the human host. Whereas the recent notification by Department of earlier, it was thought to be more lethal Pharmaceuticals, Government of India Commitment to Public Health and Science will go a 11long way in defeating ‘Pandemics’: 37 42 in older patients with pre-existing co- constituting a technical committee led by 14 Dr. Krishna Ella,45 Chairman & Managing Director, Bharat53 Biotech...... 22 morbidities, doctors are now increasingly Joint Drugs Controller (India) with industry revisiting this presumption. Just a few days representatives, for consolidating and back, Washington Post (22nd April 2020) recommending measures for revival of the Contents Covid-19: A Wake up Call for Pharma Stakeholders: reported American doctors observing fermentation industry and exploring latest Dr. Ajit Dangi, President & CEO, Danssen Consulting...... 25 a clear pattern of unexplainable blood technologies for API manufacture. It has Lipid Excipients In Pharmaceutical Technologies ...... 11 clotting, even in patients who were on been industry’s oft-repeated demand to Lipidic excipients in drug delivery for solubility and bioavailability anticoagulants. The post goes on to add incentivize API production in the country Safety of Pharmaceutical Employees in Covid-19 Pandemic: that autopsies have revealed patients’ lungs so that dependence on China for the vital enhancement ...... 14 14 45 53 filled with hundreds of microclots. So much starting materials, key intermediates and S. G. Belapure, Senior Technical Advisor, Indian Pharmaceutical56 Alliance...... 26 From Exploration of Lipids to its Exploitation in Market: 54 so that medicos are seriously considering many of the APIs is reduced. The hospital Pharmaceuticals, Nutraceuticals and Herbal ...... 20 giving preventive anticoagulants to all pharmacists have been on the go along Contents Indian pharma companies covid-19 patients. Young American patients with doctors and nurses and the community A snapshot of lipid excipients for Topical Formulations...... 26 Pharmacy Experiences in India in Sars-Cov-2: without any past medical history and pharmacists have also been doing their Lipid ExcipientsRaj In Vaidya, Pharmaceutical Community Technologies Pharmacist, ...... Hindu Pharmacy, Panaji11 ...... 30 have stepped up their act to Processing technologies from Romaco Innojet GMP compliant seemingly mild symptoms have had life- bit. Take a bow, all you fellow pharmacists, Lipidic excipients in drug delivery for solubility and bioavailability threatening strokes requiring immediate from the industry and other sectors! You are hot melt device for applying pharmaceutical coatings ...... 29 meet not just the domestic enhancement ...... 14 hospitalization. The sudden lethality with doing us all proud!!! Strategic Lipid-Based Delivery Interventions for Enhancing Oral Embracing 4.0 in Pharma Academics: Way Forward: 54 56 requirement but also grateful which the virus strikes; how patients with From ExplorationDr. Richaof Lipids Dayaramani, to its Exploitation Principal, in Khyati Market: College of Pharmacy...... 36 This special issue has leaders from the Bioavailability of BCS II/IV Drugs ...... 37 56 mild symptoms have suddenly deteriorated Pharmaceuticals, Nutraceuticals and Herbal ...... 20 requests from neighbouring and died, defying age and chronic industry, academia and practice sectors Unleashing role of excipients in overcoming formulation challenges ....42 writing for us, telling us about how the A snapshot of lipid excipients for Topical Formulations...... 26 countries and all major nations conditions, has stumped doctors. As of now, An International Crisis: Long Term Impact of Covid-19 Pandemic on Health Care Scenario, it appears that India, like most ‘developing’ pandemic has impacted their respective Role of lipid excipients in oral sustained release drug delivery systems ..45 Pharma Times fields and what long-term operational and ProcessingOfficial technologiesWorldwide Publication fromPharmaceutical ofRomaco The Indian Innojet Growth Pharmaceutical GMP and compliant Global Association Economy: of the world. All of this, with countries has had it slightly better; with * 1 1 all sorts of reasons being touted for this other changes can be expected! We are hot melt deviceAnil for Kharia applying, Sapna pharmaceutical Malviya , Ankur coatings Joshi ...... , 29 sure you will find it hard to put down this Indexed by Scopus & Embase skeletal work force, serious apparently greater resistance of its people Regular Features *President, IPA MP State Branch, Indore, 1Indian Pharmaceutical Association, MP State Branch, Indore...... 39 issue till you have read it all through. Do StrategicEDITOR Lipid-Based DeliveryDr. B. Interventions Suresh for EnhancingDr. N. Shivaprasad Oral to covid, right from genetic predisposition From the Editor’s Desk ...... 5 let us know what you think about the write- BioavailabilityDr. Alka Mukne of BCS II/IVDr. Drugs C. Gopalakrishna ...... Murty Dr. P. Khadgapathi 37 56 supply chain disruptions and to greater preponderance of malaria to Dr. J. A. S. Giri ups. You can write in to me at alkamukne@ President Speak ...... 7 EDITORIAL ASSISTANTS Dr. Premnath Shenoy the BCG vaccine that most Indians have UnleashingArjun Jeswani role of excipientsKaushik in overcoming Desai formulationPuneet challenges Gupta ....42 cash flow issues! ipapharma.org. Since this is going to be an Guest Editorial ...... 8,9 Regular FeaturesDr. Mukund Yelvigi been administered for protection against RoleNeha of Dabholkar lipid excipients in oral sustained release drug deliveryDr. P.N. Murthy systems ..45 Pharma Times e-issue, with no print copies being sent, we Pooja Kulthe Prafull Sheth tuberculosis. Advertisement Tariff ...... 13 Dr. Rao V.S.V. Vadlamudi Raj Vaidya Official Publication of The Indian Pharmaceutical Association request you to kindly forward the copy to all FromRasika The R. Dharap Editor’s Desk...... 5 Dear Readers, Book Review ...... 25 Shashikant Joag Rajesh Bhandari During this period, India has more pharma professionals in your circles. Rishab Babel Dr. R.N. Gupta Indexed by Scopus & Embase PresidentRegularSaee H. Misal Speak...... FeaturesSubodh Priolkar 7 These are difficult times! Mankind is than justified its position as ‘pharmacy of Letter to Editor ...... 28 EDITORIAL BOARD Sanjay Jain EDITOR Dr. B. Suresh Dr. N. Shivaprasad FromSakshi the Y. KasatEditor’s Desk ...... 5 in the grips of a pandemic that seems to the world’. Be it paracetamol tablets or Dr B.N. Sinha Dr. Shailendra Saraf Dr. Alka Mukne Dr. C. Gopalakrishna Murty Dr. P. Khadgapathi Announcement ...... 30,41,55,57 "IPASeline in Dantes the News!!" ...... 8 be like a never seen before! As per the last hydroxychloroquine of which 70% of the PresidentShweta S.Shinde Speak ...... Dr. Divakar Goli Shyamal Kalani 7 EDITORIAL ASSISTANTS Dr. J. A. S. Giri Dr. Premnath Shenoy Kaushik Desai IPA Building Progress Report ...... 31 Tamanna Gidwani Hemanta Kr. Sharma Sripati Singh Arjun Jeswani Puneet Gupta count, 2.76 million people were infected global supplies come from India, Indian ObituryGuest Editorial...... 14,218,9 Dr. Mukund Yelvigi Vibhusha Dube Dr. Subhash Mandal Neha Dabholkar Dr. P.N. Murthy worldwide, with 760K recovered and 194K pharma companies have stepped up Alka Mukne Pharmexcil Updates ...... 44 Dr. Jayant Dave Prafull Sheth LetterAdvertisementADVISORY To Editor BOA TariffRD...... Kalhan Bazaz Dr. S.P. Manek 1333 Pooja Kulthe Raj Vaidya Advertisement Index ...... 47 Rasika R. Dharap Dr. Rao V.S.V. Vadlamudi BookDr. A. Review I. Mehta ...... M.P. George Prof. T.V. Narayana 25 Shashikant Joag Rajesh Bhandari Advertisement Tariff...... 42 Rishab Babel Dr. R.N. Gupta Minutes of CEC Meeting ...... 48 Copyright of Indian Pharmaceutical Association. All rights reserved throughout the world. Saee H. Misal Subodh Priolkar Editorial Calendar for 2020 - 21 Letter to Editor ...... 28 Sanjay Jain Campus News ...... 53 Reproduction in any manner is prohibited. Sakshi Y. Kasat EDITORIAL BOARD Theme Based Special Issues Month AdvertisementAnnouncement Index...... Please...... send your communications to: 30,41,55,5742 Seline Dantes Dr B.N. Sinha Dr. Shailendra Saraf Association News ...... 56 The Editor, Pharma Times Dr. Divakar Goli Shyamal Kalani γ – scintigraphy in pharmaceuticals August ‘20 JumboIPA Building Covid Progress Crossword Report...... 3143 Shweta S.Shinde Advocacy Corner ...... 57 The Indian Pharmaceutical Association, Kalina, Santacruz (E), Mumbai 400098. Tamanna Gidwani Hemanta Kr. Sharma Sripati Singh Digitization in pharmaceutical industry November ‘20 Tel: 91-22-2667 1072 E-mail: [email protected] Vibhusha Dube Dr. Jayant Dave Dr. Subhash Mandal Pharmexcil Updates ...... 44 Nutraceuticals February ‘21 AssociationPrinted News by .Dr...... Alka Mukne, Published by Dr. Alka Mukne on behalf of 44 ADVISORY BOARD Kalhan Bazaz Dr. S.P. Manek Advertisement Index ...... 47 Prof. T.V. Narayana PharmasceneThe Indian .Pharmaceutical...... Association and printed at Ebenezer Printing House, 51 Dr. A. I. Mehta M.P. George MinutesUnit No. of5 & CEC 11, 2nd Meeting Floor, Hind ...... Services Industries, Veer Savarkar Marg, Dadar (West),48 Copyright of Indian Pharmaceutical Association. All rights reserved throughout the world. Mumbai 400 028 and published at The Indian Pharmaceutical Association, Reproduction in any manner is prohibited. Our Mission Campus News ...... Kalina, Santacruz (E), Mumbai 400 098. 53 Please send your communications to: The Indian Pharmaceutical Association (IPA) is the national professional body of pharmacists engaged in various facets of the profession of Pharmacy. The IPA Association NewsFor ...... Pharma Times Advertisements please contact 56 The Editor, Pharma Times is committed to promote the highest professional and ethical standards of pharmacy, focus the image of pharmacists as competent healthcare professionals, Tel. 022-26671072 / 26670744 The Indian Pharmaceutical Association, Kalina, Santacruz (E), Mumbai 400098. sensitize the community, government and other on vital professional issues and support pharmaceuticals education and sciences in all aspects. Advocacy [email protected] ...... / [email protected] 57 Tel: 91-22-2667 1072 E-mail: [email protected] Website: www.ipapharma.org Printed by Dr. Alka Mukne, Published by Dr. Alka Mukne on behalf of Designed, Typeset & Printed at Ebenezer Printing House The Indian Pharmaceutical Association and printed at Ebenezer Printing House, The information and opinions presented in the issue reflect the views of the authors and not of the Indian Pharmaceutical Association or the Editor Board. Publication Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg, Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg, Dadar (West), does not constitute endorsement by IPA or Pharma Times. IPA, Pharma Times and/or its publisher cannot be held responsible for errors of for any consequences Dadar (West), Mumbai 28. Tel.: 2446 2632 / 3872 Fax: 2444 9765 Mumbai 400 028 and published at The Indian Pharmaceutical Association, arising from the use of the information contained in this journal. The appearance of advertising or product information in the various section in the journal does not 20 26 E-mail: [email protected] Kalina, Santacruz (E), Mumbai 400 098. consitute an endorsement or approval by the Journal and/or its publisher of the quality or value of the said product or of claims made for it by its manufacturer. For Pharma Times Advertisements please contact Tel. 022-26671072 / 26670744 Pharma Times - Vol. 51 - No. 09 - September 2019 4 Pharma Times - Vol. 52 - No. 04 - April 2020 4 [email protected] / [email protected] Pharma Times - Vol. 51 - No. 09 - September 2019 5 Pharma Times - Vol. 52 - No. 04 - April 2020 5 Website: www.ipapharma.org Designed, Typeset & Printed at Ebenezer Printing House Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg, Dadar (West), Mumbai 28. Tel.: 2446 2632 / 3872 Fax: 2444 9765 20 26 E-mail: [email protected]

Pharma Times - Vol. 51 - No. 09 - September 2019 4 Pharma Times - Vol. 51 - No. 09 - September 2019 5 COL

Pharma Times - Vol. 52 - No. 0304 - MarchApril 2020 2020 6 6 Pharma Pharma Times Times - Vol.- Vol. 52 52 - No.- No. 03 04 - March- April 2020 7 President Speak...

health systems, particularly in rural areas, I feel privileged to share that all the which normally lack the resources of IPA State, local branches and Divisions are those in cities. Every single person has immensely contributing their services to a role to play in ending this pandemic. the public and to the society at large. The The outbreak affects all segments of the COVID-19 material and posters prepared population and is particularly detrimental by Community Pharmacy division has been to members of those social groups in the well received and my special appreciation most vulnerable situations, continues to to Manjiri Gharat for the contribution. My affect populations, including people living in appreciation to IPA-MSB particularly Mr. poverty situations, older persons, persons Nitin Maniar and team for their charitable with disabilities, youth, and indigenous and societal activities in the most affected peoples. The pandemic and consequent state of Maharashtra. My appreciation lockdown have hit various sectors, including to IPA local branches Enikepadu, MSME, hospitality, civil aviation, agriculture, Rajahmundry, Ananthapur, Warangal City business and allied sectors. Ultimately, for their initiatives in creating awareness the behavior of each of us will determine on COVID-19 with posters, other material. the behavior of the virus. This will take My compliments to Dr. G. Nagarjuna Reddy, perseverance and patience as there is no Dr. K. Padmalatha, Dr. Sumalatha, Dr. fast-track back to normal. It is imperative J.V. Suresh, for preparing the awareness that we do not let down our guard. Physical posters and also for distributing food distancing, lockdowns and other measures to the migrant workers and transport IPA has been recognised slow down and stop transmission though people carrying essential commodities in affecting lives and livelihoods. As we Rajahmundry high way area. My special at National level and got an consider transition, we must acknowledge appreciation to Dr. Rao Vadlamudi and opportunity to raise our voice there are no ‘quick wins’. Complexity and Dr. Ramalingam for sharing the COVID-19 updates of CPA and SEAR Pharm Forum through National TV channels uncertainty lie ahead, which means that we are entering a period where we may need regularly to IPA. and media. IPA has been to rapidly adjust measures, introduce and My compliments to Dr. Alka Mukne, contacted by various National remove restrictions, and ease restrictions Editor, Pharma Times for coming out with gradually, whilst constantly monitoring TV Channels and National COVID-19 special issue featuring messages the effectiveness of these actions and the on COVID-19 from stalwarts of Pharmacy Media to give our input in response of the public. 'Janata Curfew' Profession and also briefing us all with the various issues during COVID-19 is the beginning of a long battle against activities organised by state, local branches coronavirus outbreak and the countrymen and divisions of IPA. crisis. have proved that together they can defeat any challenge. We all showed our unity, My sincere appreciation to Mr. P. D. Sheth, Returning Officer of IPA Elections solidarity by lighting the lamps on 5th March Dear Readers, 2020-22 for his timely decision to at 9 pm for 9 minutes in response to the cancel the IPA elections due to COVID-19 “We must come to the aid of the call given by Prime Minister Narendra Modi ultra-vulnerable – millions upon millions Pandemic. My sincere thanks to all the CEC for the sake of the Nation. Let us all follow members for supporting the suggestion of people who are least able to protect the guidelines given by Modiji with effective themselves. This is a matter of basic human of Returning officer and consented to implementation of lockdown, the only solidarity. It is also crucial for combating the postpone the election process. alternative at present to prevent the COVID- COVID-19 virus. This is the moment to step 19 pandemic. My thoughts and deepest sympathy are up for the vulnerable.” with those grieving from the loss of loved The outbreak of coronavirus disease I am happy to share the news with ones or who are seriously ill themselves. I 2019 (COVID-19) has created a global members that, IPA has been recognised send my heartfelt gratitude to those on the health crisis that has had a deep impact on at National level and got an opportunity frontline - government Officials, in health the way we perceive our Nation, world and to raise our voice through National TV care services, Technicians, Pharmacists, our everyday lives. The COVID-19, which channels and media. IPA has been Pharma Industries, Police, Sanitary workers, has been characterized as a pandemic contacted by various National TV Channels Volunteers who are keeping services by the WHO, is attacking societies at their and National Media to give our input in operating, working relentlessly to save lives. various issues during COVID-19 crisis. I core. More than a health crisis, it is a “When all of us work together and feel privileged to participate in the Panel human, economic and social crisis. There start making our presence visible and are currently no approved treatments for discussion on “Challenges of Maintaining demonstrate the value addition to the COVID-19, the highly contagious respiratory supply of essential commodities including patients and community, the importance illness caused by the novel coronavirus medicines” conducted by Mirror Now on th th of the pharmacist in the society gets that has infected over 2.5 million people 25 and 26 March 2020 and also shared recognized by one and all. Let us make it worldwide with more than 1.5 lac deaths IPA views in the magazines: Out Look India, possible by proving that pharmacist can as on today. The alarming acceleration in BBC- Asia, India Today on issues related to contribute to a healthy society and thereby other countries with not only the rate of drugs used in Covid-19 and their exports. to “Swasth Bharat”. contagion and patterns of transmission, but IPA also appealed to the Government the safety measures put in place to contain and related agencies to engage PharmD the spread of the virus. We anticipate students in COVID-19 control measures to severe hardship for already overstretched reduce shortage of manpower. Dr. T. V. Narayana

Pharma Times - Vol. 52 - No. 04 - April 2020 6 Pharma Times - Vol. 52 - No. 04 - April 2020 7 "IPA in the News!!"

IPA President Dr. T. V. Narayana in a panel discussion on Mirror Now Television News Channel

IPA President Dr. T. V. Narayana's interview in India Today News

IPA President Dr. T. V. Narayana's interview in BBC- News

Pharma Times - Vol. 52 - No. 04 - April 2020 8 Pharma Times - Vol. 52 - No. 04 - April 2020 9 Article

Novel Coronavirus Pandemic- Stark Realities & New Lessons For Science & Humanity Dr. Jayant B. Dave Adjunct Professor, L M College of Pharmacy, Ahmedabad Abstract The article describes stark realities regarding origin and spread of novel Coronavirus SARS CoV-2 that has precipitated into global pandemic and most severe existential crisis since World War II. It touches upon scientific, sociological, international relations and philosophical aspects of the crisis. Due focus is laid on microbiology of virus, molecular basis of transmission and viral genome. The clinical presentation describes common symptoms, effects on lungs & cardiovascular outcomes. Importance of simple preventive measures is explained to ensure containment and prevention of mass communication. Diagnosis holds the key particularly in absence of any approved vaccine and drug therapy. ICMR has taken pragmatic stand on use of testing kits based on RT PCR for diagnosis and serological tests for surveillance. The article describes progress being made in development of vaccines, WHO global clinical trials and other evidence-based trials to find right therapeutic options. Last but not the least, authors delineate some ethical and innate lessons for science and humanity. Keywords: Coronaviruses, SARS CoV-2, COVID 19, Global Pandemic, Transmission, Viral Genome, Hand sanitizer, Testing kit, Vaccine, WHO Global Clinical Trials, Antivirals, Immunomodulators, Hydroxychloroquine, Remdesivir, Plasma therapy, Ethical lessons

Introduction its part. The contagion is spreading much faster and statistics of The world is facing severe existential challenge as novel infection & mortality worsening with every passing day. With 25.5 Coronavirus disease (Covid-19) has turned out to be a psycho- lakhs positive cases and 1.77 lakh deaths globally as on 22 April physical and social crisis of unprecedented magnitude. The novel 2020 the mortality rate has shot up to near 7 percent from initial Coronavirus (CoV) like any other virus is not a complete living being 1 percent worldwide. India on its part has done well in containing and depends on cell machinery of host for its survival and yet it positive cases to around 20,000 and mortality rate to 3.2 percent. has gripped the whole planet barring a few isolated islands. WHO Shall we call the pandemic a mystery of nature or some sort of declared this as global pandemic on 12 March 2020 and with rising retaliation by nature against some ills of mankind? toll of precious human lives, United Nations Secretary General Origin of Virus-Historical Background called this as humanity’s worst crisis since world war II. This is a new version of world war not among the nations but along the nations of Coronaviruses are a large family of viruses that are common in world. Among several measures adopted by WHO, it has launched animals. Coronaviruses are named so due to crown-like spikes on global mega trial of four most promising coronavirus treatment from their surface. There are four main sub-groupings known as alpha, existing drugs to find the right medicine.1 WHO Director General beta, gamma, and delta. Human coronaviruses were first identified Tedros Adhanom Ghebreyesus said that India being a highly in the mid-1960s. The coronaviruses that evolved and caused three st populous and responsible nation would determine trajectory of major epidemics of respiratory distress in humans in 21 century the disease and hoped that India would show the way to the world are- 1) Severe acute respiratory syndrome coronavirus (SARS‑CoV) as it had done in the past in eradicating two silent killer disease, in 2003 with epicentre in China 2) Middle East respiratory smallpox and polio.2 He recently hailed India’s collaboration with syndrome coronavirus (MERS‑CoV) in 2012 in Saudi Arabia and WHO in systematic engagement of Polio surveillance network 3) Epidemic of novel coronavirus (SARS CoV-2) or coronavirus across the country to fight against COVID. Ministry of Health official disease (COVID‑19) that started in Wuhan, China. Fatalities range 3 conveyed that its decision to join the global trial on 31 March to play from 10.35 & 5% respectively. Doctors in Wuhan noticed a surge in the number of pneumonia Dr. Jayant B. Dave cases in December when tests for flu and other pathogens returned Dr. Jayant B. Dave Adjunct Professor in negative. A Chinese doctor treating Covid-19 patient in Beijing L M College of Pharmacy, Ahmedabad. conveyed that numerous cases of mysterious pneumonia outbreaks Devoted to various facets of pharmacy had been reported by health professionals across several countries in profession, Jayant B Dave has gathered later part of last year. Italian professor Giuseppe Remuzzi had pointed over three decades of valued industrial at “strange pneumonias” in Italy since November 2019.This implies experience in several SMEs mainly in that virus could have reached Europe before anyone knew about it. areas of QC, QA, entrepreneurship and technical consul- tation services after distinguished academic career from While an unknown strain was isolated, a team from the Wuhan M S University of Baroda. Natural inclination for teaching Institute of Virology led by Shi Zhengli traced its origin to a bat virus drew him to academic career for the last 15 years where found in a mountain cave close to the China-Myanmar border. he excelled in teaching & research in the fields of Pharma- Shortly after the epidemic erupted, Chinese scientists sequenced ceutical quality assurance, Regulatory affairs and Clinical the genome of SARS-CoV-2 and made the data available to research. He was awarded Fellowship by IPA in 2012 and researchers worldwide. The genomic sequence data showed that is presently serving as Adjunct professor at L M College of Chinese authorities detected the epidemic and that the number of Pharmacy, Ahmedabad, partner of Apostle Remedies and cases were rising because of human to human transmission after as President of IPA Gujarat State Branch. introduction into the human population.

Pharma Times - Vol. 52 - No. 04 - April 2020 8 Pharma Times - Vol. 52 - No. 04 - April 2020 9 According to recent findings published in the journal Nature including the World Trade Organisation. Globalised world requires Medicine, the virus could have possibly been transmitted from global code of conduct to overcome the looming threat. animals to humans much before it was first detected in China. In All nations are isolating themselves from foreign nationals but fact, there are speculations that it could have been as long as a this is to ensure containment of the virus to so called hotspots decade. Dr Francis Collins, director of the US National Institute of with large outbreak/clusters and protection of locals and others Health has conveyed that due to gradual evolutionary changes at large. Each country has to put its house in order by further and over the years, the virus gained the ability to spread from human further subdividing the task within itself. Today one third of human to human and cause serious, often life-threatening disease. population is under lockdown in a desperate measure to contain the A study conducted by an international team of scientists from virus. All this is a part of united efforts to control the viral menace Australia, Britain and the US released on March 17, compared the until science and/or some natural phenomenon is poised to tame available genome sequence data for known coronavirus strains the highly infectious virus. and confirmed that SARS-CoV-2 has originated through natural processes.4 Indian Leaders show the way However, many Western countries, US in particular are holding The President of India, Ramnath Kovind conveyed in very early China guilty of negligence in proximately causing world pandemic phase that medically mandated and self-imposed quarantining is an and trying to demonstrate its prowess in identifying and combating opportunity for self-examination and evolution. He held sanitation the virus. Western countries and Japan are even accusing WHO and cleanliness personified by Mahatma Gandhi particularly DG guilty of going soft with China and not raising the alarm in a during plague outbreak as humblest of civic virtues. He also held timely manner. China on its part has replied that it is the victim that major crisis has reassured our cultural ethos of ‘world as one and not the culprit of the pandemic. It will take long time to reveal family’- Vasudhaiva kutumbakam and quintessential equality and various dimensions of the most unfortunate tragedy. Fortunately, all interdependence of mankind.6 The Prime Minister Narendra Modi nations are one in upholding the inevitable role of WHO as health initially gave mild exercise of Janata Curfew, mantra of resolve and keeper of the world. restraint and later clamped 21 plus 19 days nationwide lockdown to tackle social emergency. United international response is vital Pandemic & World’s Interconnectedness under guidance of WHO. Wisdom lies in expressing solidarity and A global pandemic calls for a global response, meaning, a working for collective good in and through individual good. There coordinated, multilateral response.5 India played a lead part in are several aberrations and exceptions in the collective fight by putting up a coordinated response by rejuvenated SAARC countries the nation. In a recent message posted on social media, Prime and made worthwhile contribution as seed money. The meeting Minister has brought out adaptability, inclusivity, opportunity and of G20 nations convened at the initiative of Indian PM voiced universalism as lessons emanating from COVID crisis. coordinated response. India has shown its scientific potential as pharmacy of the world by supplying hydroxychloroquine tablets Microbiology and Pathogenecity of Corona Viruses and supportive medication like paracetamol tablets to all in need Coronaviruses have a single-stranded RNA genome (size of them. When China was struggling to cope with the epidemic, range between 26.2 and 31.7 kb, positive sense), covered by most countries did not quite realise the potential threat and that an enveloped structure. The shape is either pleomorphic or microbes do not recognise national or any man-made borders. spherical, and it is characterized by bears club-shaped projections China’s initial response was secretive, but it acted smartly later of glycoproteins on its surface (diameter 80–120 nm).7 Among and earned both wrath & praise from WHO and some other all the RNA viruses, the RNA genome of CoV is one among the countries. The worst appears to be over for China and South Korea largest. The number of open reading frames (ORFs) in the CoV with reporting minimal new cases of infection. China admitted genome ranges from six to ten. CoV genetic material is susceptible to over 1000 deaths at a later date yielding to global pressure to frequent recombination process, which can give rise to new and attributed this to improper record keeping while it was busy strains with alteration in virulence.8 There are seven types of combating the novel infection. Today China has great experience human Coronaviruses- 229E, NL63, OC43, HKU1, Middle East to share with the rest of the world in combating the disease and respiratory syndrome (MERS)-CoV, severe acute respiratory has transformed a major national crisis into an opportunity, both syndrome (SARS) CoV, and 2019 novel coronavirus (SARS-CoV-2) in terms of scientific research and economics. The Chinese health which are responsible for the infection with special reference to experts in Italy conveyed that Italy should not repeat the mistake the involvement of the respiratory tract (both lower and upper made by China to advise home quarantine for patients exhibiting respiratory tract), e.g., common cold, pneumonia, bronchiolitis, mild symptoms as they could easily transmit the virus to nearby rhinitis, pharyngitis, sinusitis, and other system symptoms such people. Relatively small countries like Sudan & Turkey are extending as occasional watery diarrhea.9,10Among these seven types, three aid in different forms to highly developed countries as a pragmatic varieties (SARS-CoV, MERS-CoV, and 2019-nCoV) proved to be humanitarian gesture and this is being accepted not just as a token highly adaptive & pathogenic as described earlier and are classified of love but as much needed help. The global financial institutions as emerging viruses.10 The reservoir of SARS-CoV is unknown, like World Bank, IMF and RBI in India are playing their part to but bats and subsequent spread to Himalayan palm civets are contain the disease and impending damage to world economy. hypothesized. MERS-CoV also had a zoonotic origin in the Middle If the pandemic has a positive fallout, it is to underline the East, and the transmission was through camels.8. Knowledge about connected, interdependent nature of humanity today. Monitoring the structure, metabolic pathways of CoV, and pathophysiology of the pandemic’s progress, the search for vaccines and cures, the of CoV-associated disease is important to identify possible drug sharing of containment and treatment protocols and potentially, of targets. The most important structural proteins of CoV are spike medical supplies are all multilateral. It is time world leaders realised (S) protein (trimeric), membrane (M) protein, envelop (E) protein, this, and worked to reinforce weakened multilateral institutions, and the nucleocapsid (N) protein.

Pharma Times - Vol. 52 - No. 04 - April 2020 10 Pharma Times - Vol. 52 - No. 04 - April 2020 11 Transmission of Coronavirus and its molecular basis developed quality-controlled reference sequence data for the SARS- Transmission of virus occurs from persons who have the virus. CoV-2 reference strain for the United States. Availability of traceable The disease can spread from person to person through small droplets and quality-controlled data will help test developers and vaccine from the nose or mouth which are spread when a person with COVID- developers. The complete SARS-CoV-2 Reference Sequence Data 17 19 coughs or exhales. These droplets land on objects and surfaces is available on the FDA website. around the person. Other people then catch COVID-19 by touching Recent work on genome sequence of CoV by Gujarat these objects or surfaces, then touching their eyes, nose or mouth. Biotechnology Research Centre found total nine mutants of the People can also catch COVID-19 if they breathe in droplets from a virus out of which six have been reported earlier and three were person with COVID-19 who coughs out or exhales droplets. This is unique to sequencing here. This indicates that virus is mutating why it is important to stay more than 1 meter (3 feet) away from a fast contrary to reports earlier and that mutation depends on person who is sick. Studies to date suggest that the virus that causes several factors.18 COVID-19 is mainly transmitted through contact with respiratory droplets rather than through the air. Aerosolization procedures are Clinical presentation reported to enhance the spread of virus. The “incubation period” means the time between catching the When virus enters into the body, it binds to the primary target virus and beginning to have symptoms ranges from 1-14 days, most cells such as enterocytes and pneumocytes thereby establishing commonly around five days. a cycle of infection and replication. Other target cells of CoV are The most common symptoms of COVID-19 are fever, tiredness, epithelial renal tubules, tubular epithelial cells of kidney, immune and dry cough. Some patients may have aches and pains, nasal cells, and cerebral neuronal cells.11,12 congestion, runny nose, sore throat or diarrhoea. Some people CoV attaches to the target cells with the help of spike protein– become infected but remain asymptomatic and don’t feel unwell. host cell protein interaction (angiotensin converting enzyme-2 Most people (about 80%) recover from the disease without needing 13 [ACE-2] interaction in SARS-CoV 2 and dipeptidyl peptidase-4 special treatment.1 [DPP-4] in MERS-CoV14. After recognizing the receptor, the virus genome along with its nucleocapsid is released into the cytoplasm Most people infected with the COVID-19 virus will experience of the host cells. The virus produces two PPs- pp1a and pp1b due mild to moderate respiratory illness and recover without requiring to ORF1a and ORF1b genes in its genome which enables it to take special treatment. Patients with COVID-19 pneumonia may progress command over host ribosomes for their own translation process. to severe respiratory failure requiring supplemental oxygen and After going through a series of changes including formation of mechanical ventilation. One of the probable reasons is impaired mature viral particles called virions, form a vesicle, which fuses with surfactant production once virus enters via ACE2 on cells in the the plasma membrane and releases the virus into the extracellular lungs. This acute lung injury, known as acute respiratory distress region. This cause a surge of pro-inflammatory cytokines and syndrome (ARDS) is associated with significant morbidity, mortality 18 chemokines, which cause damage to lung tissue, deterioration and healthcare resource utilization 19 of lung function, and then finally lung failure in some cases.8 Older people, and those with underlying medical problems Virus Genome Sequence Data like cardiovascular disease, diabetes, chronic respiratory disease, The researchers across the world are working overtime to and cancer are more likely to develop serious illness Patients with understand evolution of the virus and they have identified eight underlying heart conditions are at even greater risk for death due strains of SARS-CoV-2 doing rounds globally. Over 2,000 genetic to COVID-19, and even those without underlying cardiac conditions sequences of the virus submitted from laboratories across the can experience cardiac injury. While COVID-19 is most known for world to the open-source project Nextstrain.org show how the virus affecting the lungs, underlying cardiovascular disease or cardiac is migrating into new subtypes. The report in National Geographic risk factors could worsen the outcomes. It was noted that the based on samples from all continents except Antarctica showed high inflammatory burden can induce severe cardiac-related that the virus is taking on an average 15 days for mutating. These problems such as vascular inflammation, myocarditis, and cardiac mutations are completely benign and useful as a puzzle piece to arrhythmias.20 Re-emergence of the disease in recovered patients uncover how the virus is spreading. Looking at the evolution of the reported in countries like South Korea, is a matter of great concern virus, scientists have debunked the conspiracy theory that the virus and investigation. might have originated in laboratories and concluded that the novel SARS-CoV-2 is a product of natural evolution.15 Persistence of Coronavirus on inanimate surface The two independent research teams from National Institute One meta-analysis comprising 22 studies revealed that human for Infectious Diseases in Rome after comparative study of genome coronaviruses can persist on inanimate surfaces like metal, concluded that SARS CoV2 is a relatively slow-mutating pathogen. glass or plastic for up to 9 days but can be efficiently inactivated The scientists held that they would generally expect dozens of new by surface disinfection procedures with 62-71% ethanol, 0.5% mutations after so many infectious cycles in patients. The initial hydrogen peroxide or 0.1% sodium hypochlorite within 1 minute. data showed that this is a very stable RNA virus, with only five novel Other biocidal agents such as 0.05-0.2% benzalkonium chloride variants. A virus with a stable genome is good news for vaccine or 0.02% chlorhexidine digluconate are less effective. The authors 21 development because it indicates that the effectiveness of vaccines expected similar effects against SARS-CoV-2 . could be more consistent, possibly over many years.16 Prevention, Diagnosis & Therapy Yet not in Sight FDA—in collaboration with the Centers for Disease Control and Currently, there are no specific vaccines or treatments Prevention (CDC) and several other lead scientific institutes have for COVID-19. However, there are many ongoing clinical trials

Pharma Times - Vol. 52 - No. 04 - April 2020 10 Pharma Times - Vol. 52 - No. 04 - April 2020 11 evaluating potential vaccine and drug candidates. Until then early countries except Canada to register first 5000 & 10000 positive containment and prevention of further spread are the only viable cases.24 potions to check the ongoing outbreak and to control the novel infectious disease. This will also help in epidemiological data collection and taking further course of action. There are indications from ICMR that it Prevention of infection by Hand hygiene will be possible to locally produce serological test kits in a couple According to the Centers for Disease Control and Prevention of months. These are typically rapid diagnostic tests to detect (CDC), hand hygiene encompasses the cleansing of hands by the presence of antibodies, which can be used for preliminary using hand washing with soap and water, antiseptic hand washes, screening of high-risk individuals and to identify so called safe antiseptic hand rubs such as alcohol-based hand sanitizers (ABHS) individuals who contracted the virus but went undetected. foams or gels. For many reasons, alcohol hand sanitizers are These rapid antibody tests as first line of diagnosis have increasingly being used as disinfectants over hand washing with thrown up false negatives, as many patients in the initial stages soap and water of transmission may not have developed antibodies. This has A study published in 2017 in the Journal of Infectious been reported by some States and ICMR is in the process of Diseases evaluated the virucidal activity of alcohol based hand validating the kits (21 April 2020) Therefore, ICMR has insisted sanitizers against re-emerging viral pathogens, such as Ebola virus, on Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Zika virus (ZIKV), severe acute respiratory syndrome coronavirus tests which take around six hours to give results besides the time (SARS-CoV), and Middle East respiratory syndrome coronavirus taken to collect swab samples from nose or throat. The RT-PCR kit (MERS-CoV) and determined that they and other enveloped developed by Pune based Mylab Discovery approved by CDSCO viruses could be efficiently inactivated by both WHO ethanol and claims it can deliver results in 2.5 hours. The most reliable RT- isopropanol based formulations I and II 22. PCR test has 95 percent accuracy and gives 2-5 percent false Office of CDER USFDA has recently issued Guidance for industry negative or false positive results. Meanwhile, biotech companies regarding Policy for Temporary Compounding of Certain Alcohol- in the US have devised new technologies to reduce testing time Based Hand Sanitizer Products During the Public Health Emergency to a few minutes.25 Chitra Tirunal Institute for Medical Sciences with immediate effect.23 Hand hygiene is an important part of the & Technology, Thiruvananthapuram has developed confirmatory response to COVID-19. Washing hands often with soap and water diagnostic test for N gene of SARS-CoV-2 using RT-L AMP technique for at least 20 seconds is essential, especially after going to the that is simpler, faster & economical than RT PCR test and has bathroom, before eating, and after coughing, sneezing or blowing applied for ICMR approval.26 A team of Indian medical scientists one’s nose. If soap and water are not readily available, the Centre in Kyoto with support from IIT Roorki are developing diagnostic test for Disease Control and Prevention (CDC) recommends an alcohol- based on X rays & AI based software. The Indian Government has based hand sanitizer that contains at least 60 percent alcohol. developed popular mobile App Arogya Setu to find out possibility The hand sanitizer is compounded using only the following of contracting an infection by an individual based on his proximity pharmacopeial grade ingredients in the preparation with percentage to persons who have tested or would test positive for Coronavirus. in final product consistent with World Health Organization (WHO) The public health emergency has led to an unprecedented number recommendations of Emergency use Authorizations (EUAs) for COVID19 diagnostic a. Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous tests in USA. solution duly denatured or Isopropyl Alcohol (75%, v/v) in an aqueous solution; Vaccine for COVID19 infection b. Glycerol (1.45% v/v); serves as humectant and prevents skin Prevention is better than cure and effective vaccine against dryness novel CoV is the long-term solution as achieved for viruses against Smallpox & Polio. The experts say it will take 12-18 months to bring c. Hydrogen peroxide (0.125% v/v); a vaccine to market as one out of ten candidates fail in trials. As d. Sterile distilled water or boiled cold water. per WHO report, two candidate vaccines for COVID-19 have entered the first phase of human clinical trials and another 60 candidate Diagnosis of COVID 19 infection is Key vaccines are in pre-clinical studies. Vaccine jointly developed by In the absence of approved vaccine or therapy isolating the CanSino Biological Inc (who developed Eloba Vaccine in 2017) and infected patients and quarantining the suspect is the only effective Beijing Institute of Biotechnology has entered human trial stage. strategy to contain the virus and arrest the spread. South Korea They are using the non-replicating viral vector as the platform (same and Germany stand out for mass testing which reduced fatalities as that used for non-corona candidates like Ebola) to develop a and prevented health systems from breaking down. Like many other vaccine with a ‘Adenovirus Type 5’ candidate. Adenoviruses are countries, it was important in India to prioritise the available testing common viruses that cause pneumonia and can deliver potential kits for vulnerable sections like symptomatic foreign returnees antigens to stimulate the production of antibodies that work and those coming in close contact with confirmed cases. With against the disease. India is also in the hot race with India’s Serum gradual increase in transmission, regularly testing of medical and Institute, Zydus Cadila and Bharat Biotech working on vaccine 27 healthcare personnel, people living in and around hotspots with development. large outbreak/cluster and those with symptoms resembling the COVID 19 Therapeutic options flu and pneumonia have became the priority. The Government & ICMR have clarified that in view of positivity ratio of 1 in 24 tests, Until now, there is no approved vaccine or drug for management of SARS-CoV-2 infection. However, from earlier experience of India has performed a greater number of tests than most developed management of the Coronavirus, many agents are being used in

Pharma Times - Vol. 52 - No. 04 - April 2020 12 Pharma Times - Vol. 52 - No. 04 - April 2020 13 the treatment of SARS-CoV-2 in experimental settings with some Other Drugs being investigated- Umifenovir, Beloxavir, Favipiravir success. WHO has initiated large scale global randomised trials (Antiviral) and Irvemectin (Antiparasite) called SOLIDARITY based on four existing drugs/combinations as 6. Treatment evidence from China- Antiviral agents used so far under and provided guidelines that local physicians may consider include lopinavir, ritonavir, arbidol, oseltamivir, i.v. ganciclovir. when COVID 19 is suspected on clinical management of severe Immunomodulators- commonly used agents are systematic 28 acute respiratory infection corticosteroids and i.v. immunoglobulin in more serious cases. • Local standard of care alone OR local standard of care plus one of: In one clinical study in China comprising 138 patients reported • Remdesivir (daily infusion for 10 days) in JAMA most patients received Oseltamivir. The most commonly • Chloroquine or Hydroxychloroquine (two oral loading doses, used antibiotics mostly for bacterial infections were Ceftriaxone, then orally twice daily for 10 days) Moxifloxacin and Azithromycin. China also tried administering antibodies from COVID-19 recovered patients to impart passive • Lopinavir with Ritonavir (orally twice daily for 14 days) immunity. • Lopinavir with Ritonavir (ditto) plus interferon (daily injection 7. Convalescent plasma- USFDA has been working across across for 6 days) Government, academia and industry to expedite development Prospective therapeutic options under trial can be broadly of critical medical products to treat novel virus. Convalescent grouped into Antiviral, Immunomodulators and Host directed plasma is an antibody rich product made from blood donated therapies. by people who recovered from disease caused by virus. At home in India, Kerala, Maharashtra, Rajasthan & Delhi have nod 1. Antivirals- of centre for conducting clinical trials of plasma enrichment • Nucleoside analogues- Ribavirin techniques. The initial results are encouraging. • Neuraminidase inhibitors- used in treatment of influenza Limitations of current research- Lack of high‑quality evidence by • Protease inhibitors- Protease have important functions in randomized controlled trials (RCTs) is the most important limitation CoV life cycle. Liponavir & Ritonavir, antiretrovirals used for of the current CoV research. As most of the CoV strains are AIDS are part of WHO mega trials genetically different and the outbreaks occur extremely randomly, 2. Immunomodulators- conducting an RCT is extremely difficult, and reliance has to be done on observational studies.29,30,31,32 • Corticosteroids- Corticosteroids were widely used for the treatment of SARS-CoV and MERS‑CoV and are also used Ethical & Innate Lessons for science & humanity in the management of the current epidemic of 2019‑nCoV Science, ethics and philosophy are complementary to as Methylprednisolone. However, the interim guidelines by our understanding of natural phenomena and corresponding the WHO prohibit the use of routine corticosteroids unless wisdom filled action plan. There are some common and far indicated for other clinical ground reaching lessons for science, humanity and world at large. • Interferons-(IFNs): These are broad‑spectrum antivirals, 1. Change is inherent in nature and nature always fulfills the primarily used in the treatment of hepatitis B. In SARS‑CoV change. patients, compared to Ribavirin or interferon (IFN) alone, the benefit was seen on IFN‑α + high‑dose corticosteroid group 2. Cleanliness of body and psyche of all impurities are only next to and means to Godliness. • Immunoglobulins- In case of critically ill SARS, who show signs 3. We ought to realize uniqueness, interconnectedness and of deterioration, further escalation of immunomodulation equality of every individual & nation state. is indicated and intravenous (IV) immunoglobulin may be considered 4. Isolation is as important as socializing. Besides protecting one’s own self and others from contracting/spreading 3. Host directed therapies- Target improvement of host immune infection, solitude has its own charm and helps discover response or factors associated with viral replication. Apart from one’s unconscious personality. immunomodulators, metformin, atorvastatin, fibrates, as well as nutritional supplements may help in treating acute respiratory 5. Science, profession, law, modern state, religion and distress syndrome (ARDS) by boosting immunity all constituents have to contribute in establishment of righteousness and social order. Transparency, integrity 4. Other therapies- Used rarely like siRNA, tumor necrosis and mutual cooperation are of paramount importance in factor‑alpha inhibitors, neutralizing antibodies, pentoxifylline, this regard. etc. but evidence is quite poor 6. Collective religion aimed at welfare of human family also 5. Recent advances in treatment- Chloroquine & Hydroxychloro- referred to as rashtradharma takes precedence over quine- Latter is the prodrug of chloroquine. It appears to block individual religion. viral infection by increasing endosomal pH of the phagolyso- some needed for virus/cell fusion. It also interferes with ACE 7. Modern system of medicines relies on several physical, 2 glycosylation of CARS- Cov cellular receptors. The drug also biological, medical and other sciences for probing the has immune-modulating activity which is proposed to enhance cause and remedy of any disease. This indeed is helpful its antiviral effect in vivo. to mitigate and at times cure the disease. But science is not able to fully comprehend the complexities of natural Remdesivir- A nucleoside inhibitor has potent activity against phenomenon like antimicrobial resistance or strange several families of RNA viruses. It incorporates into nascent behavior of a very tiny creature like novel coronavirus. viral RNA chains and causes premature termination of the viral More often than not, science brings restoration of some RNA transcription. supreme orderliness and equilibrium prevailing in nature

Pharma Times - Vol. 52 - No. 04 - April 2020 12 Pharma Times - Vol. 52 - No. 04 - April 2020 13 at macro or micro level in different forms like regeneration 23. Office of CDER USFDA ,Guidance for industry regarding Policy for of cells, autophagy or immunity in this case. Social ethics Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, March 2020 & faith in higher reality subtler than our mind and intellect needs to be interwoven in all human endeavors. 24. Coronavirus Only 1in 24 samples positive Govt says, ET Healthworld. com. Sushmi Dey,April17.2020 8. Faith in God, commitment to objective science, compassion 25. Testing is key: Testing more will ease healthcare burden, Editorial- The for the world and hope for oneself, should be the way of Times of India, April 2, 2020 life. 26. Kerala Institute says it has a faster & cheaper test for COVID19,ET Influx of clinical data emerging on day to day basis Healthworld.com, Nidhi Sharma, April17,2020 encourages us to hope that COVID-19 will not be a virus 27. Two Coronavirus vaccine candidates enter human trials,60 in preclinical without a known treatment for long. stage:WHO, P B Jaykar, Business Today,April 5, 2020 28. Public Health emergency SOLIDARITY trial, WHO COVID-19 Core Acknowledgement ProtocolVersion 10.0, march22,2020 29. Sarma P, Prajapat M, Avti P, Kaur H, Kumar S, Medhi B. Therapeutic Author wishes to express sincere appreciation and thanks options for the treatment of 2019-novel coronavirus: An evidence-based to Mr. Shiv P Rathod, good friend & Associate Professor in approach. Indian J Pharmacol 2020;52:1-5. Pharmacology (Retired), Faculty of Pharmacy, M S University 30. Pharmacy Times, USA 11 March 2020 of Baroda for valued inputs and necessary interaction 31. www.fda.gov,COVID 19 update, FDA News Release, March 19, 2020 32. Delhi to start Plasma trials for COVID, www.timesofindia.indiatimes. References com,April 17,2020 1. https://www.who.int/health-topics/coronavirus 2. Michael Ryan, Executive Director World Health Organisation through economictimes.indiatimes.com (March 24,2020. IRF Lifetime Achievement Awardee Asit Ranjan 3. Indian Journal of Pharmacology - Editorial Volume 52, Issue 1, January- Bhattacharya passes away February 2020 IRF Lifetime Achievement Awardee Asit 4. Coronavirus a product of evolution may have been in humans for years: Ranjan Bhattacharya breathed his last on Study. The Indian Express 30 March 2020 24th April 2020. Popularly known as ARB in 5. Global disease call for global response through economictimes. pharmacy circles, Mr. Bhattacharya was a indiatimes.com, March27,2020 pharmaceutical technologist by profession, 6. Ram Nath Kovind, COVID 19: What nature seems to be telling us, Times a philanthropist by heart, a great motivator, of India March 2020 and superb human resource developer, 7. Yang H, Bartlam M, Rao Z. Drug design targeting the main protease, the Achilles’ heel of coronaviruses. Curr Pharm Des 2006;12:4573-90. committed heart and soul to utilize his competencies for betterment of the pharmacy profession. 8. Prajapat M, Sarma P, Shekhar N, Avti P, Sinha S, Kaur H, Kumar S, Bhattacharyya A, Kumar H, Bansal S, Medhi B. Drug targets for corona This visionary, settled in Kolkata, had a chequered career, virus: A systematic review. Indian J Pharmacol 2020;52 :56-65 being a prominent figure in the national pharmaceutical circuit 9. Chang CK, Lo SC, Wang YS, Hou MH. Recent insights into the and state level activities of IPA Bengal and U.P. branches. He development of therapeutics against coronavirus diseases by targeting had worked fervently for close to six decades, empowering N protein. Drug Discov Today 2016;21:562-72. the pharmaceutical industry and academics with his broad 10. Paules CI, Marston HD, Fauci AS. Coronavirus infections-More than just vista, his varied experience weaving a rich tapestry within the the common cold. JAMA 2020; 323:707. profession, down the years. 11. Guo Y, Korteweg C, McNutt MA, Gu J. Pathogenetic mechanisms of severe acute respiratory syndrome. Virus Res 2008;133:4- After completing his B. Sc. from Calcutta University he 12. 12. Gu J, Korteweg C. Pathology and pathogenesis of severe acute moved on to pursue B.Pharm. and M.Pharm. from L. M. College respiratory syndrome. Am J Pathol 2007; 170:1136-47. of Pharmacy, Ahmedabad, during 1954-1960. While at Benger 13. Li W, Moore MJ, Vasilieva N, Sui J, Wong SK, Berne MA, et al. Laboratories (Tata Fison), he was deputed for undergoing Angiotensin-converting enzyme 2 is a functional receptor for the SARS extensive training at Cheshire. U.K., with Benger Laboratories, coronavirus. Nature 2003; 426:450-4. in areas of Fermentation Technology, for technology transfer 14. Mubarak A, Alturaiki W, Hemida MG. Middle East Respiratory Syndrome to its plant at India. Later, he moved on to be Production Coronavirus (MERS-CoV): Infection, Immunological Response, and Manager at Life Pharmaceuticals, where he developed a Vaccine Development. J Immunol Res.2019;2019:1-11. unique haemostatic compound from pig lung extract, which 15. Scientists identify eight strains of Coronavirus, Economic Times is still marketed. Thereafter he worked as works manager of Healthworld April1, 2020 Dey’s Medical Stores (Mfg.) Ltd at Allahabad and retired from 16. Italian Researchers Identify New SARS CoV2 Gene Variants, American Pharmacia Ltd. Hyderabad as VP (Technical). Pharmaceutical Review March 27, 2020 17. FDA releases SARS- COV-2 Reference Grade Sequence Data, American Mr. Bhattacharyya joined IPA during his student life since Pharmaceutical Review, April 2,2020 1955 and continued his association till his last breath. He 18. Gujarat: Genome sequence of coronavirus decoded, ET healthworld. held leadership positions in celebration of first National com,April17,2020 Pharmacy Week (NPW) and several IPCs and was Executive 19. Windtree to Pursue Clinical Study of Lung Injury Treatment in COVID-19 Council Member of IPA Bengal Branch, President of Uttar Patients ThroughAmerican Pharmaceutical Review March 24, 2020 Pradesh State Branch, Central Executive Council Member of 20. Madjid M, Safavi-Naeini P, Solomon S, Vardeny O. Potential Effects of IPA, Executive Council Member of IPCA. Mr. Bhattacharyya has Coronaviruses on the Cardiovascular System. JAMA Cardiology; March received Pharma Achievement (Dr. Bakul Bhaduri Memorial) 27, 2020 Award from IPA, Bengal Branch in 2007, IPA fellowship Award 21. G. Kampf et al. / Journal of Hospital Infection 104 (2020) 246-251 in 1998 and IRF Lifetime Achievement Award in 2016. We at 22. Alcohol sanitizer, Nina A Gold, ncbi.nlm.nih.gov/books/NBK513254, IPA, condole his sad demise. Feb06,2020

Pharma Times - Vol. 52 - No. 04 - April 2020 14 Pharma Times - Vol. 52 - No. 04 - April 2020 15 Article

PHARMACEUTICAL SECTOR OF INDIA,PERSPECTIVES & ITS JOURNEY DURING COVID 19 : RECENT PROBLEMS & STRATEGIC SOLUTIONS –PPP MODE Dr. Dinesh Dua Chief Executive Officer (CEO) & Whole Time Director, M/S Nectar Lifesciences Ltd. India & Chairman, Pharmexcil, Ministry of Com- merce, Govt. of India

India in the field of pharmaceuticals has made its presence FY-19. Because of supply chain disruption in the wake of COVID-19 significantly in the global market by the turn of the century after pandemic and the lockdown in the country, pharma exports were becoming self-sufficient in the previous century. The Indian affected to certain extent and we have recorded 1545 mn USD in Pharmaceutical industry through robust quality management March 2020 with -26.42% negative growth compared to March system and being sensitive to provide medicines at an affordable 2019 exports of 2100 mn USD. Thus, the total exports in FY 2020 price has acquired reputation as the provider of standard, safe and are 20.52 BN USD with7.2% growth. efficacious medicines across the globe and evolved as “Pharmacy Supply chain disruption in the wake of COVID-19 outbreak of the World” with supplies over 206 countries. in China th India is 3rd largest formulations exporter by volume and 10 In view of grim Coronavirus situation, supply chains originating largest by value in the world, besides being the largest exclusive from China have been significantly disrupted globally and generic exporter by value and is having 8 out of top 20 global consequent shutdown of vast segments of Chinese industry in the generic companies. Apart from generics, India is the major supplier Month of January and February 2020, it was expected that Indian of Vaccines & APIs globally. 90% of WHO Prequalified API’s are pharma market especially exports could have negative impact as sourced from India and India Produces 65% of WHO demand for we are relying majorly on China for Key Starting Materials and Active DPT & BCG and 90% of Measles vaccines. India has the distinction Pharmaceutical Ingredients. of saving hundreds of millions of populations from the dreaded diseases like HIV, Malaria & Tuberculosis and known for its quality Fortunately, it didn’t affect Indian industry much in the month & affordable medicines. of January as most of the enterprises stockpiled the inventory required for 03 months in view of the Chinese New Year holidays Over 55% of our Pharma exports of US $21 Billion, are to the and also to meet export obligations. highly regulated global markets in the world & conventionally Indian exporters are focusing more on the USA & Europe and on the Global Restrictions on exports of few pharmaceuticals imposed procurement agencies. In recent years huge market opportunity is by DGFT, Notification NO: 50/ 2015-2020, dt:03rd Mar & emerging for Indian manufacturers in the untapped but potential Industry’s concerns markets of LAC, Africa CIS and Asia. With supply chain disruption in pharmaceuticals as a Indian Pharma, being knowledge-based industry, plays an result of COVID-19 outbreak in China and the increasing no.of important role in the Indian economy and it has been an excellent positive cases in India, a committee constituted by the Dept. of export performer over the years. Pharma is one of the few sectors Pharmaceuticals had recommended restricting the exports of in India that have consistently showed a growth rate, despite certain pharmaceuticals to tackle the possible domestic shortages economic slowdown globally.India exported 19.13 billion USD worth of medicine during the outbreak. Accordingly, Director-General of pharmaceuticals with 10.72% growth in FY-19 and in the first 11 Foreign Trade issued a Notification No:50/2015-20 on March 3, months of this year (April to Feb) recorded 10.70% growth with amending the export policy of 13 APIs and formulations made the export value of US$ 18.97 billion over corresponding period from these APIs from “Free” to “Restricted” with Immediate effect. The list includes paracetamol, Tinidazole, Metronidazole, Dr. Dinesh Dua Acyclovir, Vitamins B1, B6, B12, Progesterone, Chloramphenicol, Erythromycin Salts, Neomycin, Clindamycin salts and Ornidazole. Dr. Dinesh Dua is currently the Chief Execu- tive Officer & Whole Time Director of M/S DGFT Notification-50 had created lot of inconvenience and Nectar Life sciences Ltd. Prior to this, he hardships to the exporters and Industry bodies worried that the was he was Managing Director of Akorn In- notification would affect the nations export performance, since dia Pvt. Ltd.,a 100% subsidiary of US MNC, most of the industries have manufactured the restricted items Akorn Inc. With over 4 decades of profes- before the outbreak of COVID-19 and have planned and committed sional experience across varied industries, Dr. Dua is also to ship the consignments to their customers in agreed timelines. Chairman, CII Regional Committee on Lifesciences - North, Chairman, CII Regional Committee on Startups & Entrepre- Pharmexcil has represented the issued faced by the industry neurship - North, Past Chairman of Confederation of Indian to the Government and requested to revisit the effective date of Industry (CII), Chandigarh Council, Member Executive Council, the notification and to allow the free export of drugs manufactured FOPE, North India Chairman for Startups & Entrepreneurship before the date of issue of the notification i.e 03/03/2020 for Confederation of Indian Industry (CII) & is also Past Chair- as most of these listed drugs (eg: Vitamins & hormones) have man of CII, Chandigarh Council, Member Executive Council, limited shelf life of 18-24 months and if the restrictions prolongs, BDMA. buyers would not accept the material and the same formulations cannot be utilized for domestic consumption because of national

Pharma Times - Vol. 52 - No. 04 - April 2020 14 Pharma Times - Vol. 52 - No. 04 - April 2020 15 regulatory requirements of IP specification for domestic sale. these products cannot be diverted to Indian market and Further, Pharmexcil had requested to examine the feasibility of would be colossal national loss and wastage of good quality exempting the “Drugs Manufactured for Export purpose only” from medicines. Moreover, the growth of exports would decline and the restrictions. the threat of losing market share in prominent destinations is imminent and real. Pharmexcil further guided the industry about the Para 1.05 (b) of Foreign Trade Policy 2015-2020, giving the exporter provision • India has net surplus of formulations to meet global demand. of clearing the shipments with Irrevocable Commercial Letter of Hence restricting a product that is in surplus wouldn’t address Credit (ICLC) and instructed the industry to apply for license “under the issue at hand. the Restricted Export Item (Non SCOMET)” with DGFT for continue • Restricting exports of Finished Dosage Forms will adversely their exports. affect the global brand image created by India over decades, Para 1.05 (b) reads as that too when several countries of Europe, Africa, South East Asia and USA are reporting increasing number of positive “Item wise Import/Export Policy is delineated in the ITC cases day by day, and rely largely on India for supply of generic (HS) Schedule I and Schedule II respectively. The importability/ medicines and APIs. This could force certain countries to shift exportability of a particular item is governed by the policy as on the their requirements in the long run, either to local industries or date of import/export. The date of import/ export is defined in para to other emerging suppliers and may even be detrimental to 2.17 of HBP, 2015-20. Bill of Lading and Shipping Bill are the key India’s image as Pharmacy of the world. documents for deciding the date of import and export respectively. • Due to the notification being issued without any prior intimation, In case of change of policy from free’ to ‘restricted/prohibited/ medicines worth crores of rupees are lying at various locations state trading’ or ‘otherwise regulated’, the import/export already of supply chain and the ports. Many of those medicines will have made before the date of such regulation/restriction will not be to be piled up in warehouses for want of approvals/ clearances affected. However, the import through High Sea sales will not be with no additional benefits and besides, have limited shelf covered under this facility life. Further, the import/export on or after the date of such • Chinese government succeeded in containing the further spread regulation/restriction will be allowed for importer/exporter has a of the COVID-19 and the position of China has substantially commitment through Irrevocable Commercial Letter of Credit (ICLC) improved during the past few weeks with restoration of before the date of imposition of such restriction/ regulation and manufacturing activities in most of the provinces. The Indian shall be limited to the balance quantity, value and period available industries started receiving the few supplies from China and is in the ICLC. For operationalising such ICLC, the applicant shall have expecting more supplies in coming weeks. to register the ICLC with jurisdictional RA against computerized • Industries assured that they have adequate stocks of active receipt within 15 days of imposition of any such restriction/ pharmaceutical ingredients & finished formulations to serve regulation. the domestic requirements and also the exports and reiterated Whenever, Government brings out a policy change of a that industry will maintain sufficient stocks required for 2/4 particular item, the change will be applicable prospectively (from months the date of Notification) unless otherwise provided for” India’s export restrictions of Pharmaceuticals have created The Industry bodies viz IDMA, BDMA, IPA, OPPI, & Pharmexcil panic state in those countries who are depending on Indian had collectively represented the issues to the Hon’ble Minister of generics and it was reported that there was national shortage of Chemicals and Fertilizers during CEOs round table held on 5th certain listed medicines especially Paracetamol in some countries March during India Pharma 2020, in the presence of Secretary-DoP, including Unite Kingdom. Chairperson- NPPPA & DCGI. The issues have also been brought to DGFT Clarifications w.r.t Notification No:50 dated 3rd the notice of the Hon’ble Minister of State, Commerce & Industry March2020 on 12th March 2020 through DVC. Considering the representations of industry bodies, on 20th Industry bodies represented that most of the listed products March, DGFT has given some relaxations to the listed products in Notification No: 50 are not related to COVID 19- treatment as manufactured against the advance licenses as well as to those critical therapy and assured the government that they have enough manufactured in SEZ units. quantities of stock required for domestic market as well as exports. • DGFT had given clarification vide Policy circular No: 33/2015-20 The associations have put forth the following for consideration. that, Restrictions on exports do not apply to SEZs as per SEZ • APIs already manufactured as per importing country standards rules and hence exports of restricted products are allowed from (BP/USP/JP) are not permitted to be sold in the domestic SEZ units and further clarified that all other items under the markets. ITC (HS) in the notification other than ones falling under item description specified are allowed for exports. • Restrictions will lead to many Indian pharma companies getting blacklisted from global tenders/contracts. This could have a • DGFT Policy circular No: 34/2015-20, dt: 20/03/2020, stated negative effect on the economy and our companies will also that all formulations of listed products in the Notification No: 50 are allowed to be exported under Advance licenses issued on lose opportunity to participate in future contracts/ tenders, or before the date of issue of notification (i.e.03/03/2020). besides loss of credibility. • The finished dosage formulations of the affected APIs that are Unresolved issues even after the DGFT clarifications meant for exports are manufactured and packed as per the Despite the relaxations given for products manufactured in specifications, standards and labeling as per the regulations of SEZ units & for those manufactured against Advance licenses, the importing countries. Hence even if their export is restricted, huge shipments of listed products manufactured for export were

Pharma Times - Vol. 52 - No. 04 - April 2020 16 Pharma Times - Vol. 52 - No. 04 - April 2020 17 lying in ports for customs clearances resulted in exporters paying Removal of exemptions given for HCQ exports: huge demurrages. International demand for Hydroxychloroquine has spiked after Exporters were struggled with logistics issues as Air cargo a small-scale test indicated that the drug showed promising results services were deeply impacted & freight charges have shot up against COVID-19. Govt of India & the industries got many requests badly affecting Imports and exports. This can be a major bottleneck for supply of HCQ. going forward unless proper measures taken by Govt on top priority On 4th Apr, the Govt had removed all the exemptions given in with concerned ministries by allocating reserve space for medicine earlier Notification-54 and imposed complete ban on exports of in both inward & outward cargo along with faster clearances. The HCQ & its formulations vide DGFT notification No: 01/2015-20. restrictions on exports coupled with the logistic issues have brought the exporters in a disadvantageous position of losing their valued Government allows exports of 12 APIs & Its formulations importers, loss of credibility, penalties for delayed supplies, huge (DGFT Notification NO: 02/2015-2020, dt:06th Apr demurrages and they were much distressed. 2020) Pharmexcil & other bodies requested the Government to take Almost after a month of imposing export restrictions on up these issues with concerned ministries by allocating reserve 26 pharmaceuticals on 3rd March, the Government of India space for medicines in both inward & outward cargo along with has removed these restrictions for 24 products (12 APIs & its faster clearances. formulations) except for Paracetamol & its formulations on 6th Concerns on Exports from EOUs Apr 2020 considering the no.of representations received from Pharmexcil, IDMA, IPA & other industry bodies and the DGFT issued Though the DGFT has clarified that SEZ units are exempted notification (No:02/ 2015-20, dt:06th Apr 20) in this regard. from the restrictions, DGFT still silent on EOUs. On 23.3.2020 Pharmexcil submitted representation to DGFT to exempt the EOUs Status of Paracetamol & Hydroxychloroquine from Notification No:50 on consideration of the following. Paracetamol: • The products have been manufactured against confirmed order received couple of months ago before the restriction was Paracetamol, being a drug used as front-line treatment for imposed and hence, they may be allowed to export the same. various epidemics because of its dual action as analgesic and as anti-pyretic with minimum side effects after prolonged use has • Products manufactured by EoUs are meant for export markets become the drug of choice in many countries in the COVID-19 only, (approved as per FDA guidelines), and these cannot pandemic. India is the second largest producer of Paracetamol with be used in domestic markets because of the regulatory manufacturing capacity of more than 6350 MT/month and can be technicalities. EOUs import the key starting materials /API's of scaled up further by 20%. Leading manufacturers are Farmson USP/EP/BP specifications and manufactures the finished drugs Pharmaceuticals Gujarat Pvt Ltd, Granules India Ltd, Meghamani as per the specification, labelling & printing requirements of Unichem & Sri Krishna Pharmaceuticals Ltd. the exported country. Since the drugs manufactured by EOUs are not as per Indian Pharmacopeia (IP) specification (the Among the total production, about 2500 MT/month is utilized basic & major regulatory requirement to sell the drugs in India) by domestic industries either for domestic consumption for about these drugs cannot be utilized for domestic sale as per the law 700 MT and balance 1800 MT’s for conversion of the Paracetamol currently prevailing. Thus, the restrictions on exports of listed by companies into Formulations for exports. It was assured by the drugs are causing the loss of shelf life of the manufactured industry that they will maintain enough stock of about 40% of goods by the EOUs with ultimate wastage of the drugs without production at any given time. serving the prime objective of the export restrictions to protect Hydroxychloroquine: the national rug security. India being the world’s largest producer of Hydroxychloroquine Prohibition of the export of Hydroxychloroquine and its (HCQ), exports almost 80-85 % of the production to all parts of Formulations - DGFT Notification No. 54/2015-2020, the world. India’s total exports of HCQ and its formulations during 25th March 2020 financial year 2019 was US$ 51.6 million and in FY 20, it was US$36.41 million during April-February. The Government of India on 25th March prohibited the export of anti-malarial drug Hydroxychloroquine, with immediate effect to Leading manufacturers of HCQ tablets are IPCA Laboratories, ensure enough availability of the medicine in the domestic market Zydus Cadila Healthcare, INTAS Pharmaceuticals and Laurus Labs vide DGFT notification no: 54/2015-2020. It, however, said the Ltd. The global demand for this product has increased manifold exports of Hydroxychloroquine are allowed in following cases. and countries like USA, Brazil had requested India for supply of a) From the SEZ/EOU units and in cases where export is made to this medicine. The domestic production capacity of API is 38MT/ fulfill export obligation under any Advance license issued on or month and it can be scaled up to 58MT. th before 25 March 2020 being the date of the notification Governments decision to supply HCQ & Paracetamol to b) Exports will be allowed also in the case of shipments where affected Nations: Irrevocable letter of credit (ICLC) has been issued before the Upon review of the status of the Indian manufacturers’ date of the notification or in case where in full advance payment capabilities in fulfilling the needs of the nation, the government has been received by the exporter in India against specific has taken a call to release the exports of HCQ & Paracetamol shipment subject to documentary evidence. to countries which needed it the most and made an official c) Exports will be allowed by Govt of India to other countries announcement on 7th April that Government would license on humanitarian grounds on case-to-case basis on the Paracetamol and Hydroxychloroquine (HCQ) in appropriate recommendation of Ministry of External Affairs. quantities to all our neighboring countries who are dependent on

Pharma Times - Vol. 52 - No. 04 - April 2020 16 Pharma Times - Vol. 52 - No. 04 - April 2020 17 our capabilities and the will supply these essential drugs to nations • Lock down period should be declared Zero financial period i.e. who have been badly affected by the pandemic. No interest on borrowing, No GST or Excise liabilities, No time barred cases, for a period of 6 months or so. Previous payment India supplied HCQ tablets to over 50 countries including should be deferred for three months after the lockdown period USA, Spain, Brazil, Germany, Russia, Bahrain, Nepal, Bhutan, is over. Bangladesh, Afghanistan, Maldives, South Africa, Seychelles, Mauritius, Dominican Republic, Kuwait, Antigua & Barbuda & • EMIs on all term loans should be deferred by six months to Palau etc. support the functioning of companies. The extended period should be added in the remaining maturity period of the Pharmexcil’s Advisory to Exporters of HCQ & Paracetamol: loans and the same should be also back ended in six months Basing on the experiences of the companies exported HCQ, installments. Pharmexcil has released advisory on the procedural formalities for • Local police authorities manning the nakas /toll posts/ obtaining license/permission to export these drugs for the benefit check posts in the states of Haryana, Himachal Pradesh and of the industry. Rajasthan are not permitting the employees of Pharmaceutical • In principle the communique between the Government to companies to pass through. This is creating difficulties in Government for supply of HCQ & Paracetamol will be considered carrying out manufacturing of vital medicines and drugs by and export will be allowed after examination on case to case the Pharma Companies. Industry bodies has requested that basis. the concerned State Govts may issue passes/permits subject to compliance to safety procedures stipulated so as to enable • The request received by the Indian External Affairs Ministry the employees of Pharma Companies to report to duties so that from the other country will be examined by the team of officials the production facilities can carry on their work and production nominated to monitor the National Drug Security led by the chains are not disrupted. Dept of Pharmaceuticals. Having assured the obligation of meeting the domestic requirement, export is being allowed by • It is requested that the matter may please be taken up with the Government. concerned authorities of the said state governments in the interest of ensuring that the Pharma companies can carry Removal of export restriction on Paracetamol Formulations- out their production activities so that there is no shortage of DGFT Notification No: 03/2015-20, dt:17th Apr 2020 medicines supply in this hour of crisis. Having assurance from the industry about the availability of Baddi Issues: th Paracetamol stock for domestic need, Government on 17 April For a long time since the lock down Formulations plant which lifted the restrictions on exports of Paracetamol Formulations. manufactures Lifesaving high technology medicines supplied to However, restrictions on exports of Paracetamol API remains India as well as other countries of the world are closed for finished continued. goods lying in the Warehouse losing both potency & expiry of month All the industry associations have requested the Government or thereabouts. to consider the relaxation of export restrictions of Paracetamol • Similarly, raw materials & packaging materials are not being API as well. let in as these industries are not essential & entry is not being allowed for both the industries. Other Issues faced by Pharma Industry during Lockdown • Highly skilled manpower is predominantly located in Panchkula, period & Request made to Government by Industry Pinjore in Haryana & Mohali in Punjab. These employees had associations not been allowed to enter Baddi & therefore industry is forced • Members are struggling with logistics issues as Air cargo to close operations. Subsequently industry was allowed to move services are deeply impacted & freight charges have shot personnel only once & staying arrangements were supposed up badly affecting Imports and exports. This can be a major to be done in the plants which in majority of the units is bottleneck going forward unless proper measures taken by infeasible. Govt on top priority with concerned ministries by allocating reserve space for medicine in both inward & outward cargo In view of the foregoing & so as to ensure there are not drug along with faster clearances. shortages in the country, industry bodies appeal to D.C., Baddi to take proactive & pragmatic view & allow: • The restrictions on exports coupled with the logistic issues are making the exporters in a disadvantageous position of - Interstate & district manpower movement. losing their valued importers, loss of credibility, penalties for - Interstate & district transportation delayed supplies, huge demurrages and thus making them This will help vital & critical pharma industry as well as 700 much distress as they left with only 4-5 working days in this Units in Baddi to continue to supply to the entire country where current financial year. the market share of Baddi alone is 40% in domestic & 20% of the • There is a drastic fall in the business activities vis a vis exports share. lower domestic and international sales at this juncture, the working capital requirement of the businesses should be Governments initiatives to ensure Smooth functioning automatically made double without any collateral and no new of Pharma industry & to see the availability of Essential application. The reason for this request is that the prices medicines of major APIs have doubled and in addition to this, China is • On 21st March 2020, Cabinet approved “Promotion of asking for advance payment or payment against delivery. This Domestic manufacturing of critical Key starting Materials/ additional increase in working capital extended for one year Drug Intermediates and Active pharmaceutical Ingredients with a provision of 3 years repayment period. in the country”, basing on the recommendations of the Dept

Pharma Times - Vol. 52 - No. 04 - April 2020 18 Pharma Times - Vol. 52 - No. 04 - April 2020 19 of Commerce commissioned study report “Strategies to Bulk drugs or Formulations with a view to achieve adequate Reduce Import Dependence of APIs, KSMs and Intermediates” availability of medicines to the public. conducted by Pharmexcil. • On 9th April 2020, Dept of Pharmaceuticals suggested ministry The sanctioned schemes are of Home Affairs to take effective measures to continue pharma and allied industries operations smoothly especially a) Promotion of Bulk Drug Parks- Decision to develop 03 mega w.r.t movement of contact labourers, vehicle drivers & courier bulk drug parks in partnership with states. GoI will give grant services etc. in aid to states with 1000 Cr for each bulk drug park, thus a sum of Rs.3000 Cr approved for this scheme for next 5 yrs. Production of API guaranteed is about 40-50% and hopefully in b) Production Linked Incentive Scheme: Financial incentive the fortnight it will go up to 60-70%. Formulations production is at for eligible manufacturers of 53 critical bulk drugs (26 about 50-60% and it will go upto 70-80%. Huge amount of support Fermentation based & 27 chemical synthesis based bulk drugs) has given by the state Governments especially Telangana, Andhra on their incremental sales over base year 2019-20 for period Pradesh & Gujarat besides the Centre. Despite the challenges faced of 06 yrs. A sum of Rs.6,940 Cr approved for next 8 yrs. by the industry either in terms of export restrictions or operational challenges viz logistic concerns w.r.t ports, air lines, customs • On 26th March 2020, Chairman, National Pharmaceutical clearances and labor movement restriction, Indian pharma industry Pricing Authority has directed all the Chief secretaries of the has performed amazingly well until third week of March. Only states to ensure unobstructed movement of raw material, towards end of March our exports are suffered, and exports are at packing materials, finished products and manpower related to a very slow place even in April. Salutations to the entrepreneurship manufacturing & distribution of drugs & medical devices. of Indian! As soon as COVID-19 gets flattened out and the th • On 26 March 2020, Ministry of Health & Family welfare has transportation is eased out, we will start exporting significantly to allowed the doorstep delivery of medicines. all the countries which are very short of medicines. • On 27th March 2020, HCQ notified under Schedule H1: In view Pharma industry has risen to the occasion in spite of all the of the recommendation of Hydroxychloroquine for prophylactic difficulties of interstate movement, restrictions on transportation use in high risk contacts of COVID-19 by ICMR, the Ministry as well as on man power movement and migration of workers to of Health & Family welfare has notified Hydroxychloroquine their hometowns, due credits to the domestic industries as well under Schedule H1 on 27th Mar, restricting sale only based as to the all the industry associations, Pharmexcil, IDMA, BDMA, on prescription to prevent the self-medication and misuse of IPA & OPPI! Special thanks to the efforts of Ministry of Commerce, medicines by general public. Ministry of Health, Ministry of External Affairs, Ministry of Home th • On 27 March 2020, Ministry of Environment, Forest & Climate Affairs and Department of Pharmaceuticals in particular. Change has appraised all the projects or activities in respect of bulk drugs, intermediates manufactured for addressing The government, the regulatory agencies and the rest of the ailments such as COVID-19 and those with similar symptoms are stakeholders including all the industry associations are paying in categorized as B2 for a period up to 30th Sep 2020 as an interim this very crucial & critical time which is laudable and deserves pat measure to expedite the prior environmental clearance. on back of all stakeholders. • On 28th March 2020, Department of Pharmaceuticals has set Pharmexcil is representing the issues continuously to the Commerce up Control Room to coordinate transportation & other logistic Ministry on the issues being faced by the member companies due to the outbreak of COVID-19 and lock down. In this context, Pharmexcil services for essential supplies in the country. hereby requests you to submit the problems being faced by your • On 31st March 2020, DGFT extends Current Foreign Trade Policy company currently, in the format given below to enable Pharmexcil for one (01) year i.e upto 31.03.2021 vide Notification No:57/ to consolidate the issues and represent to the Commerce Ministry for taking up with concerned Ministry/Department . 2015-2020. Further DGFT stated that the regional authorities th will not insist on valid RCMCs till 30 September, 2020. Problem Type & Required Clearances Please mention your • On 31st March 2020, Director General of Shipping has issued State/Region and describe the problem in brief advisory on non-charging of any demurrage, ground rent beyond the allowed free period or any performance related penalty on Issues related to DGFT non-containerized cargo during the period of effect of COVID-19 Logistics/transport availability pandemic. Availability of Airliners for Cargo movement • On 1st April 2020, Directorate General of Civil Aviation (DGCA), Availability of Shipping Lines for Cargo has relaxed norms and given special permission to conduct movement cargo operations using passenger aircraft during lockdown Permission/Passes for manpower period. movement st Manpower availability at Ports & • On 1 April 2020, Publication of List of Nodal officers of CBIC all Loading and unloading of Materials at over India for facilitating customs clearance amidst COVID-19 ports/ICD crisis. Interstate Raw material Moment • On 4th April 2020, The Government ordered 10 Cr Issues related to CDCSO Hydroxychloroquine tablets from leading manufacturers to Member companies are requested to share their problems in maintain the stockpile required for the domestic needs. the format ASAP by email to [email protected] with a • On 6th April 2020, The Government directed the NPPA to exercise copy to [email protected]. On receipt of the inputs from member companies, Pharmexcil will represent these issues with the functions under Paragraph 3 of DPCO 2013 “Directions the Commerce Ministry for taking up the matter with the concerned to Manufacturers of Active Pharmaceutical Ingredients or Ministry/Department.

Pharma Times - Vol. 52 - No. 04 - April 2020 18 Pharma Times - Vol. 52 - No. 04 - April 2020 19 Article

Pharmacist the ‘Apostrophe’ of the Health profession Dr. B. Suresh President, Pharmacy Council of India, New Delhi Pro Chancellor, JSS Academy of Higher Education and Research, Mysuru

The apostrophe character is a punctuation mark, and reasons. The Pharmaceutical industry clearly established its sometimes a diacritical mark, and serves two basic functions; position as the reliable partner in healthcare needs and even they show possession and indicate letters have been removed to went ahead and stated that the service to humanity is more form a contraction. The apostrophe probably causes more grief important than the pricing of medications. They could easily than all the other punctuation marks put together! The problem connect with the vision of nation and its leader and strategized nearly always seems to stem from not understanding that the and raised to the occasion be it the manufacture of large apostrophe has two very different (and very important) uses in volumes of Hydroxychloroquine and other antivirals or the English: possession and contractions. efforts in the direction of development of vaccines and other immunomodulating therapies. The world strongly believes that The Pharmacist unfortunately has become the apostrophe perhaps India would be first to come out with an affordable of the health profession in the manner that he is the missing vaccine against Coronavirus and towards that many industries letter between the Physician and the Patient and all the time have been driving their research as early as January 2020. playing that missing role without being visible to either provider The Pharmacists and Pharmaceutical scientists in the industry or the user. On the other hand, the Pharmacist also plays the have kept the pride of the Indian pharma sector flying high all role of ‘possession’ where his role is highly important in the the time and have been getting the recognition as scientists healthcare conundrum as the guardian of medicines. Here too and technocrats. the problem stems from not understanding that pharmacist plays two different roles, one that of the invisible healthcare The ‘missing pharmacist’ in community pharmacy identified provider and the visible manufacturer of medicines. While we themselves as ‘chemists and traders’ and sought recognition seek the recognition stemming out of a healthcare provider, the from the government that the ‘chemists’ also be recognised society gives us the recognition that of a provider of medicines as healthcare workers and be eligible for insurance. They also (be it manufacture or sale). If the Pharmacy profession in India expressed concern about the medicines being delivered by really needs to get its recognition in the healthcare team then ‘online Pharmacies’ through a tie up with shared platform of we must play the visible role in being the bridge between the transport services such as Uber and Ola, as the ‘chemists’ are Physician and Patient. already doing home delivery of medicines as per the government orders. When ‘chemists’ are doing this wonderful job and the In the present COVID Pandemic the pharmacists not only in association of chemists is asking respect for ‘Pharma trade’, India but even globally felt that they were not being recognised as I don’t understand that how we expect the health profession an important ‘Frontline Warrior’ in the fight against coronavirus. or the government or the patient to recognise us healthcare The International Pharmaceutical federation (FIP) too, had to provider. If truly we seek recognition as health care provider, bring out a statement supporting the role of Pharmacists as we the ‘Pharmacists of India’ shed the shadow of ‘Chemist’ Corona warriors. The Pharmacy Council of India too had conveyed and ‘trader’ and make our presence visible in the community to the Ministry of Health and Family Welfare, Government of pharmacies as ‘Pharmacists’ rendering professional service in India that the services of the pharmacist in the fight against the the healthcare conundrum. pandemic would be valuable to the nation and the Government of India in their ‘Covid warriors’ database has listed Pharmacists The great comfort to the Pharmacy profession is the stellar available state-wise whose services can be utilised by the role played by the regulatory officers of the country be it the governments and administrators at the time of need. CDSCO or the state drug control departments in working closely with all stakeholders and recommending to the government The Indian Pharmaceutical Industry and the Pharma sector policies that decrease the degree of difficulty and ensure the was the cynosure of the world, for a change, for all good continuous available of medicines for national and international appreciation and they truly deserve our appreciation. Similarly, Dr. B. Suresh the Hospital Pharmacists be it the Government sector or the Prof. Suresh Bhojraj is President, Pharmacy private sector continued to provide their selfless services and Council of India, New Delhi. He is Pro Chan- cellor, JSS Academy of Higher Education and where truly the pharmacists with their ‘white coats’ bringing Research, Mysuru, for the past thirty years respectability amongst the society about the role of Pharmacists has been actively involved in uplifting the in healthcare. The new generation pharmacists, the clinical standards of pharmacy education and pro- pharmacists, were full of passion to raise to the occasion and fession in India. He was elected in 2003 as the President of use their clinical expertise in reaching out to the patients and Pharmacy Council of India, the statutory body regulating the creating awareness on the health advisory of the government pharmacy education and profession in India. He was once and was recognised by the health profession and the community again re-elected as the President of Pharmacy Council of India at large. in August 2008 and August 2013. Dr. Suresh is also the del- egate member of the United States Pharmacopeia Convention The unprecedented challenge was most for the academia in and also the member of the Council of Convention of the USP. the pharmacy field. Unlike the other segments it was not slowdown Prof. Suresh has also been President of IPA from 2008 - 2010. that bothered them, but to suddenly transition from didactic

Pharma Times - Vol. 52 - No. 04 - April 2020 20 Pharma Times - Vol. 52 - No. 04 - April 2020 21 teaching to digital teaching overnight. Though there was lots of Deliver Pharmaceutical care that ensures the efficacy and scepticism associated with this, they responded remarkably well safety of medicines, besides and made the disruption least felt by the students and continued Promote among the pharmacist fraternity through selfless to engage the students with their academics and also prevented service and get due recognition them from their movements by holding them captive through their online classes, seminars, webinars and so on. Perhaps Uphold the dignity of the profession through our action, the productivity from the academia was the highest during this deed and words. pandemic period. This clearly shows that ‘forced experimentation’ The Pharmacists of India declare that as a registered does yield good outcomes. My congratulations to all my academic professional practitioner they will assure the health of people colleagues for their wonderful response. of India by manufacturing quality medicines , dispensing right medicines and the right dose and counselling the patients on the Perhaps it is time for us to resolve that – safety of the medicine and it’s use and through this endeavour We the Pharmacists of India having qualified ourselves as promote the dignity of the pharmacy profession and earn the the “Pharmacist” under the Pharmacy Act, 1948 and practising respect of community.’ the profession of Pharmacy resolve to It is time now for us to shed the identity of ‘apostrophe’ and Serve the citizens of India with our knowledge, skill and come to the fore to be visible and be aware of our roles. expertise on medicines A Proud Pharmacist – even in unprecedented times!

A Tribute to Pharma Legend, Padma Shri Prof. Harkishan Singh Revered Professor Harkishan Singh ji, Emeritus Professor, University Institute of Pharmaceutical Sciences (UIPS), Panjab University, a globally renowned pharmaceutical scientist and science historian, bid adieu to his wonderful life sojourn of 91 years, Friday morning i.e. 20th March 2020. Born in November 1928, Professor Singh completed his graduation in year 1950, ranking first from UIPS, Panjab University, and postgraduation and Ph.D from Banaras Hindu University in 1952 and 1956, respectively. With a total experience of over 40 years in teaching and research in medicinal and pharmaceutical chemistry, over 50 doctoral and master’s theses had been completed under his supervision in the research areas of heterosteroids and natural products for the pharmaceutical developments in India. Professor Singh’s unparalleled achievements and contributions to the profession of Pharmacy have been documented in large number of publications and books and is also evident by his over 330 publications include 21 books, 9 history monographs; 6 book chapters, 16 other review papers; 125 original research papers; 65 research papers on pharmaceutical history; over hundred articles on pharmaceutical education, professional issues and other topics. There are as many as fourteen patents obtained on his name in the area of heterosteroids. Professor Harkishan Singh delivered several invited lectures at institutions and conferences within the country, United States of America, United Kingdom, Canada, and China, including the one at the Harvard Medical School and at the International Symposium on Molecular Structure (1986) sponsored by the International Union of Crystallography, at Beijing. One of the rarest accomplishments to the credit of Professor Singh and of Panjab University, per se, was the discovery of a clinically useful drug Chandonium Iodide (HS-310) which was later named by World Health Organisation (WHO) as Candocuronium Iodide. This is highly pertinent to add that Candocuronium is the only drug discovered from any Indian University till date. In recognition of his illustrious contribution for the development of medicinal and pharmaceutical chemistry, the Panjab University conferred the prestigious Professor Emeritus title upon Professor Singh in the year 2003 and Doctor of Science (Honoris Causa) in the year 2016. Other international recognitions include, D.Sc. (Hons. Causa) by University of the Sciences in Philadelphia, USA in 2014 in recognition of his distinguished academic career and outstanding contributions to scientific research in organic and medicinal chemistry and history of Pharmacy; his standing as a Historian recognized by his election to “the Academie Internationale d’Histoire de la Pharmacie” in 1995. Prof. Harkishan Singh, was conferred the prestigious “Padma Shri” by the Honorable President of India in 2017. We at IPA, condole the sad demise of the stalwart Conferment of the Padma Shri by the then & thespian Prof. Harkishan Singh. President Pranab Mukherjee

Pharma Times - Vol. 52 - No. 04 - April 2020 20 Pharma Times - Vol. 52 - No. 04 - April 2020 21 Article

Commitment to Public Health and Science will go a long way in defeating ‘Pandemics’ Dr. Krishna Ella Chairman & Managing Director, Bharat Biotech

History shows that infectious diseases are a recurrent problem and regulatory support which will help to build the necessary robust resulting in sheer devastation, to human lives, and on the economic infrastructure for better disease preparedness and support vaccine front. The world is mindful that the Spanish flu of 1918 resulted in the development in the long term. death of nearly 50 million people worldwide, and resulted in a severe The goal of the biotech and vaccine industry must be to economic depression. Even during the influenza pandemics of 1957 commit, invest and innovate technologies to address the healthcare and 1968 the development of vaccines, were delayed, failing to provide concerns of a developing world and provide affordable, efficacious effective mitigation during the severe phases of the pandemics. and high-quality vaccines and biotherapeutics. Pandemics have led to large-scale outbreaks of infectious In times of duress, it is invariably the scientists and companies disease that can greatly increase morbidity and mortality over a engaged in research, development, and manufacturing of vaccines wide geographic area and cause significant economic, social and who are urged to find a solution with the shortest timeline dogmatic disruption, and an effective vaccine can halt the spread possible. of the infection. In a pandemic situation, international sharing of data and There is wide acceptance, and data demonstrate vaccines are the surveillance will be vital in drawing a road-map to assess the risks most effective and affordable strategy to fight infectious and pandemic and determine what vaccination policies each nation needs to diseases all over the world. Despite this, preventive health measures adapt to ensure their population is safe and stays protected. especially in the form of vaccines have unfortunately not always been an area of priority and at best only a reactionary response to deadly Comprehensive research should be undertaken to gain outbreaks like H1N1, Ebola, Zika and most recently COVID-19. knowledge about the virus. Clinical research should start at an optimal speed to understand the molecular and immune Challenges Faced: pathogenesis of the disease. This will help to understand and Large parts of the scientific fraternity over the decades have overcome initial vaccine development challenges. advocated the need for better awareness towards medical research Public funding for the development of pandemic vaccines is a pressing need as these are extraordinarily high-risk investments Dr. Krishna Ella and helps to diminish the risk as well as incentivize vaccine Dr. Krishna Ella is the Chairman & Man- manufacturers. Intellectual property issues and regulatory concerns aging Director of Bharat Biotech incor- shouldn’t hinder the quick development of the vaccines. porated in 1996. A gold medallist at university, Dr. Ella worked as a research In the pursuit of vaccine development, companies all over the faculty at the Medical University of world are met with their own distinctive challenges. For example, in South Carolina, Charleston after earning India, we face a few hurdles with regards to the import of ‘knockout his Ph.D. from the University of Wiscon- mice’ which are critical in clinical animal trials. Regulatory approvals sin-Madison. A research scientist in Mo- often take one year to be granted thereby slowing down vaccine lecular Biology, Dr. Ella strongly believes development especially in crucial times such as these. that innovative technology in vaccine We must also take immense pride in knowing that 70% of development is essential to solve public the world’s vaccines are supplied by India. These vaccines are healthcare problems caused by infec- tious diseases. Under Dr. Ella’s lead- manufactured with the highest safety and efficacy and are highly ership, Bharat Biotech has grown to become a global leader affordable being delivered to countries with lower resources. in innovative vaccines. A serial entrepreneur with a passion for innovative ideas, Dr. Ella has also ventured into veterinary The Way Forward: vaccines, food processing, and developing biotechnology in- Work towards developing a vaccine for COVID-19, the deadly frastructure in the country. Dr. Ella is also involved in shaping virus that has crippled even the most prepared and healthcare India’s science education and policy through his association advanced nations, is underway in many countries. An effective with several committees such as: vaccine will help in reducing the rate of infection thereby Scientific Advisory Committee to the Union Cabinet, CSIR Gov- decreasing the number of deaths. It can also decrease the chance erning Council, CCMB Governing Council, Research Council for of resurgence of infections to a pandemic portion at the national CSIR National Laboratories, Board of Visitors – Global Health and global levels. Institute, University of Wisconsin-Madison. The goal of the vaccine industry should be to start working as Several awards have been conferred on Dr. Ella including soon as the first report of an infectious outbreak is reported. There the ET Now Special Recognition for Healthcare Industry Award, should be a selection of vaccine targets and candidates much J R D Tata—Best Entrepreneur of the Year Award, Marico In- before the establishment of an epidemic/pandemic. Individual novation Award and University of Southern California—Asia- governments and regulators must consider devising a 'Pandemic Pacific Leadership Award. Paradigm' vaccine development plan and approve vaccine trials on a fast-track basis during crucial times.

Pharma Times - Vol. 52 - No. 04 - April 2020 22 Pharma Times - Vol. 52 - No. 04 - April 2020 23 While developed nations have access to advanced treatment vaccine and testing in laboratory animal models at UW–Madison and medicine, the challenge is to provide the greater populated is expected to take four to six months. The animal trials are crucial developing nations cost-effective vaccines that can be administered and once the safety, efficacy is established, we will move on to with ease by grass-root health care workers. human clinical trials. Our expectations and hope are CoroFlu® to be available in mid-2021. Apart from being safe and highly efficacious, for a vaccine to have a greater impact, they have to be available quickly and in As a vaccine leader, Bharat Biotech has commercialized 16 large quantities. The vaccine developed must have high production vaccines, including a vaccine developed against the H1N1 flu that scalabilities, should facilitate rapid and easy transportation to caused the 2009 pandemic and has developed a vaccine for the remote villages under minimal cold storage facilities. The foremost Zika virus which is currently under clinical trials. factor is to adopt a proven safety platform that allows ease of production. The Future : The vaccine, CoroFlu® which Bharat Biotech is developing in Global pandemics may become the primary public health collaboration with a team of international virologists and leading concern in the times ahead. Modern-day travel has reduced the Influenza expert Dr. Yoshihiro Kawaoka. CoroFlu® will be built on world to become a global village and pandemics which were the backbone of FluGen‘s flu vaccine candidate known as M2SR. considered once in a lifetime events can no longer be ignored and Based on an invention by UW–Madison virologists and FluGen co- may become more frequent. founders and Gabriele Neumann, M2SR is a self-limiting version COVID-19 paralyzed even the most developed and of the influenza virus that induces an immune response against prepared nations’ healthcare systems, leaving many infected the flu. with the virus, and causing loss of several human lives. It The underlying flu vaccine backbone has been tested in has changed our norm of daily lives by confining us to our humans already and has demonstrated a good safety profile in four homes, putting a mask over our face, and made us practice clinical trials on hundreds of human patients. This could probably social distancing. ease the regulatory pathway for future trials. It also will potentially COVID-19 has become the most destructive respiratory address two pressing health issues at the same time, coronavirus disease mankind will face in the modern era and must not be and influenza (common flu). underestimated. Bharat Biotech is committed to manufacture the vaccine, With many promising treatments being studied all over the conduct clinical trials, and prepare to produce almost 300 million world, only a vaccine can be considered as a long-term strategy doses of vaccine for global distribution. Development of the to combat COVID-19 and other pandemics.

Pharma Times - Vol. 52 - No. 04 - April 2020 22 Pharma Times - Vol. 52 - No. 04 - April 2020 23          

             

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Pharma Times - Vol. 51 - No. 09 - September 2019 54 Pharma Times - Vol. 51 - No. 09 - September 2019 55 Pharma Times - Vol. 52 - No. 04 - April 2020 24 Pharma Times - Vol. 52 - No. 04 - April 2020 25 Article

COVID-19: A wake up call for pharma stakeholders Dr. Ajit Dangi President & CEO, Danssen Consulting

There is no industry in the world which has not been impacted by announcing its flagship programme ‘Digital India’ in 2015. COVID by COVID 19 and the pharma industry is no exception. Firstly, we 19 has given it a spurt as more and more people have started doing must acknowledge the excellent work our pharma manufacturers transactions online improving efficiency and speed. It is estimated and healthcare professionals are doing by working 24×7 to ensure that the E-way billing system for truckers who transport goods like that patients not only in India but all over the world get their pharma supplies and other goods on national highways across the medicines on time. While words like carnage, catastrophe etc. are country has reduced transport time by almost 30 per cent and has being used to describe this pandemic, it is also a wake-up call to also improved GST tax compliance. Similar is the case with fast tag the industry and the policymakers to learn from this crisis and draw system for tolls. Efficient logistics and supply chain is the lifeline out an action plan to make the industry future-ready and insulate of pharma industry, particularly for temperature-sensitive products ourselves from such calamities. Following are a few suggestions: and digitalisation will bring speed and efficiency in warehousing, forecasting, planning etc., thereby improving productivity. 1. API imports– It is now well recognised that our overdependence on imports for APIs and drug intermediates is a major geopolitical While the policy on online pharmacies has been incubating for over two risk. While this issue is being discussed for almost a decade, the years, very little progress has been made. One of the reasons being action plan has been missing. We declared the year 2015 as a ‘ resistance from vested interests and fear of counterfeits entering the Year of Bulk Drugs’, however, the government announced a package supply chain. Some of these issues can be addressed effectively by of Rs 14,000 crores to manufacture key APIs indigenously only on putting appropriate legislations in place. Online pharmacy can also March 30, 2020. More than 53 critical bulk drugs covering major reduce price to patients by cutting down intermediaries. therapeutic classes have been identified for domestic manufacture, Another positive development is that Niti Aayog and MCI have just of which 26 are fermentation-based and 27 are based on chemical synthesis, roping in expertise from National Chemical Laboratory, come out with guidelines on telemedicine. They help physicians and Pune. DoP has also formulated a scheme namely ‘Assistance encourage them to consider telemedicine as a part of their normal to Bulk Drug Industry for Common Facility Center (CFC)’ in any practice using videos, internet-based platforms like web chat, apps upcoming bulk drug park promoted by the state governments. etc. without carrying out a physical examination. This fulfils a major We now urgently need to do three things. gap as until now there were no official guidelines or legislations for the practice of telemedicine. Hopefully, product detailing through One, develop more vendors globally for APIs required for medical reps will also undergo a major change. manufacturing essential medicines rather than depending only on one country and second, draw out a plan to incentivise industry 3. Healthcare spends – Our government’s healthcare spend is to do backward integration for their major brands by putting such just over one per cent of GDP. For a country of 1.3 billion people, projects on the fast track. Apart from giving monetary incentives, this is quite miniscule. While we have been talking about doubling accelerating regulatory approvals such as environmental clearance, this for quite some time, with the impending economic slump and land acquisition, FDA licences, and amendment of restrictive a probable recession, this is going to be a major challenge. Policies labour laws and generally improving ease of doing business is also like OTC legislation need to be enacted speedily to reduce the necessary. Needless to mention, states must ensure uninterrupted burden on scarce resources like access to medical consultation electricity and water supply and good infrastructure for the etc., at least for minor ailments. smooth functioning of such plants. Thirdly, we need to activate some of our moribund pharma PSUs like IDPL, HAL, BCPL etc. by 4. Impact on industry growth – The Indian pharma industry bringing in newer manufacturing technologies and more dynamic was expected to grow by 10- 13 per cent in 20 – 21. Fortunately, management. While Bureau of Pharma PSUs was established following representation from Pharmexcil, Government has just in 2008, it has little progress to show. Similarly, fine institutes lifted the ban on exports of certain essential drugs. However, many like Haffkine Institute, Mumbai which is the oldest biomedical manufacturing plants are working at suboptimal capacity due to research institute in the country established way back in 1899, the absence of workforce, hence this growth rate is unlikely to can contribute immensely in times like this with their wealth of be achieved. For instance, plants in Uttarakhand which produce knowledge in vaccine technologies. They need to be activated. about 15 per cent of total formulations in the country, are unable 2. Digitalisation – India rightfully chose the path of digitalisation to work to full capacity as only about 15- 20 per cent workforce is reporting to work either because of fear of COVID-19 infection Dr. Ajit Dangi or because the state government has announced full pay even if Dr. Ajit Dangi is President & CEO of one is absent from work. Looks like we are likely to end up FY 21 Danssen Consulting, a strategy firm with single-digit growth. specialising in life sciences & Health- 5. Change in human behaviour – WHO has recognised the role of care. He has been Director General of positive change in human behaviour in addressing a crisis of this Organization of Pharmaceutical Pro- nature. Good practices like frequent hand washing, social distancing, ducers of India (OPPI) for seven years personal hygiene and good sanitation practices should be continued before this. Dr. Dangi has served as Chairman of the even when this crisis is over. Drugs and vaccines are not substitutes Board of Fulford India Ltd. ( subsidiary of Merck & Co. Inc. USA ) for ten years and also currently serves on the for good hygiene, sanitation and adoption healthy lifestyles. Board of Atul Bioscience Ltd. He is former President Sourced from: Express Pharma, https://www.expresspharma. & Executive Director of Johnson & Johnson India Ltd. in/covid19-updates/covid-19-a-wake-up-call-for-pharma- where he served for 20 years in various capacities. stakeholders/,

Pharma Times - Vol. 52 - No. 04 - April 2020 24 Pharma Times - Vol. 52 - No. 04 - April 2020 25 Article

Safety Of Pharmaceutical Employees In Covid 19 Pandemic S. G. Belapure Senior Technical Advisor, Indian Pharmaceutical Alliance

INTRODUCTION Following are some of the best practices for communication COVID-19 is, first and foremost, a new challenge to mankind. • Requests to adhere to general hygiene & other COVID-19 Thousands of health professionals are heroically battling the safety norms, such as following (local and central) government virus, putting their own lives at risk. Governments and industry notifications, frequent and adequate hand wash procedures, are working together to understand and address the challenge, keeping social distancing support victims and their families and communities, and search • Bulletins from central team to all sites with updated policies, for treatments and vaccines. guidelines and mechanisms to deal with the evolving situation Regular updates from leadership on organization’s response As this global crisis plays out, Pharmaceuticals manufacturing to the crisis has been enlisted as an ‘essential service’ by the Government of India, and hence the need to act swiftly and promptly – both to • Information on current sentiment of employees overall, including ensure continuity of medicine supplies to avoid drug shortages, sharing positive news / developments for boosting moral of the and at the same time, ensure the safety of the workforce in employees. Emergency notification system to keep employees manufacturing facilities during the crisis. up to date with immediate news and actions (e.g. through centralized text messages or messages thru smart screens) The objective is to share the best practices for safety of Hold regular company-wide townhalls (virtual) to share best employees engaged in manufacturing of pharmaceutical products, practices, discuss potential issues / risks, answer key questions and provide a comprehensive set of practices across Indian and around the crisis global pharmaceutical manufacturing companies in response to the COVID-19 crisis. This article is based on Indian Pharmaceutical EMPLOYEE SEGREGATION AND REMOTE WORKING FOR Alliance document on “Employee Safety in Pharmaceutical NON-ESSENTIAL WORKFORCE manufacturing - Covid19 “This is condensed version of the best Segregate entire workforce into two categories: (a) essential practices. workforce needed on-site, and (b) non-essential workforce Close coordination and liaison with the local health authorities • List of essential resources to be made based on production / Government functionaries involved in fight against COVID-19 is plan for the month / week. All personnel directly required necessary. The local authorities would have to be contacted and for in-person activities can be categorized as essential permission sought for continued manufacturing operations during (such as manufacturing shop floor personnel, QC analyst, lockdown as also to seek their approval and support for smooth engineering). operations and movement of goods and people. Employees would • All other personnel to be identified as non-essential for on-site have to be issued passes to ensure travel during lockdown / curfew presence (e.g. planning team, transformation teams, project situations. teams, audit team, supply chain coordination team etc.). • People with conditions such as diabetes, heart and lung disease It is recommended to inform local public health authority the are also more vulnerable to serious illness. It would be ideal to plan developed by the company for protecting the employees and restrict such high-risk profile employees from on-site seek their inputs and recommendation. • If any of the employee has even a mild cough or low-grade COMMUNICATION ACROSS MANUFACTURING NETWORK fever, he should be advised to stay at home. Advise employees To enable effective two-way communication across the in advance that if they have any symptoms or feel unwell, they manufacturing network, companies need to setup two teams should not attend. to drive the communication network– (a) Central Crisis Team at Define working norms, rules and guidelines for all personnel and corporate / head office, closely connected with (b) Local Crisis contractors belonging to each category: Teams at each manufacturing location. • Essential workforce: Ensure safety of essential workforce through implementation of on-site personnel & material movement norms (Additionally, segregate these essential S. G. Belapure resources into “work-teams” to minimize risk of contamination Shirish Belapure is currently with Indian between different sub-teams. Pharmaceutical Alliance as senior technical • Non-essential workforce: discourage (to the extent possible) Advisor & coordinates the activities of Qual- all non-essential personnel (employees, contractors, visitors) ity Forum. With more than 42 years experi- from entering site. Provide for remote working options for such ence in various capacities in pharmaceuti- workforce. cal manufacturing, his last position was Manaaging Director of Zydus Hospira Oncology Pvt. Ltd. & has ON-SITE PERSONNEL-MOVEMENT NORMS worked with Zydus, Sunpharma, Cipla to name a few. Transportation of employees and contractors:

Pharma Times - Vol. 52 - No. 04 - April 2020 26 Pharma Times - Vol. 52 - No. 04 - April 2020 27 Transportation of key personnel to and from manufacturing • Distancing protocols should be established within the canteen, location is very critical to avoid contamination from external such as having only 2 people per table instead of 4+ (to ensure surrounding. It should be ensured that employees wear facemasks minimum distance between employees) and take care of their personal safety & hygiene during traveling. • Disposable cutlery should be used (to the extent possible). Below are recommended key considerations for employee safety: Alternatively, if stainless steel plates, cutlery & utensils are • One person per seat, employees occupying alternate seats, used, they should be washed with soap/detergent & hot water sitting diagonally from each other. It would be ideal to identify using an approved procedure. the seats that should not be occupied. Clear advisory can be • Multiple touchpoints to be avoided to the extent possible, by issued to employees as under: enforcing norms such as food to be served only by canteen  The seats marked as ‘do not sit here’ should not be personnel wearing protective gears, single-touchpoint plate occupied. dispensing  Kindly maintain 1-meter distance while boarding and de • All areas should be sanitized and disinfected between every boarding the bus. staggered meal timing, to the extent possible  Avoid standing while in transit. • Physical transactions such as cash or coupons to be avoided  In case you find the bus fully occupied, please avoid to the extent possible boarding in such circumstances. Wait for the next bus. • Cleaning & sanitization of pick up vehicles & buses before every trip: The vehicles should also be regularly surface-sanitized; e.g. seats, windows, floors, railings etc. after every use. The vehicles should be 'deep-cleaned' at the most frequent interval possible, but at least daily • Distancing protocols and respiratory hygiene should be ensured during travel: Articles like tissues, no-touch dust bins (foot operated) and alcohol-based hand rubs should be abundantly (Exhibit 2: illustrative markings to enforce distancing norms in canteen areas) provided and encouraged at all identified places, which are ear Change rooms / Washrooms marked. • Limit number of employees entering the change rooms and washrooms at a time to maintain distancing protocol Common area norms • Access to change rooms and washrooms should be staggered Entry & exit from plant premises should be monitored. i.e. employees from the same ‘Work-team’ should enter change- • Safe distance of minimum 1 meter should be maintained rooms together, to avoid contamination between different between employees during entry to the site. groups of employees. Frequent sanitation is needed • Body temperature for all employees should be checked and • Garments should be handled carefully to ensure no risk of recorded with infrared thermometer or thermal camera before contamination: entering and exiting the facility at security main gate. o Used garments should be removed on the same day for • Hand wash with soap / sanitization should be carried out by all washing and not stored in locker overnight employees before / during entry to the plant. o Used garments should be soaked in hot water & disinfectant • Biometric attendance system should be avoided. Widespread solution after use usage of other shared items (e.g. pens, registers) should also • Areas that are frequently touched by employees should be be avoided; cleaned regularly, such as phones, lockers, door handles, taps, • Enough PPEs should be provided and encouraged to be used bins, hangers, cross over benches at change room at all points by working staff • Ensure door handles, knobs, elevator keys, handles etc. • It is recommended to take an are covered with cling film to facilitate easy cleaning and explicit health self-declaration sanitization from employees / contractors / Service areas – utilities, water system, HVAC floors, visitors at entry points engineering & maintenance Canteens / cafeterias • Dedicated personnel should be identified for each service area. • Access to canteens / cafeteria Every maintenance personnel should use their own tools (not should be restricted to the to be shared) extent possible; e.g. employees • Tools used for maintenance should be sanitized before and getting their lunch packed from after use home, if possible • Entry of maintenance personnel in the manufacturing / QC area • Zones should be established should be deferred (to the extent possible) for all non-essential within the common areas maintenance activities; e.g. instrument calibration, preventive through physical segregation maintenance or by staggering timings to • Maintenance personnel should enter manufacturing area only avoid mix up of employees from (Fig. 1: illustrative entry and exit during critical breakdowns that cannot be resolved remotely different work places or defined practices on safe distancing in ‘Work-teams’ plant premises) • Visitor entry – such as vendors, technicians – should be avoided

Pharma Times - Vol. 52 - No. 04 - April 2020 26 Pharma Times - Vol. 52 - No. 04 - April 2020 27 to the extent possible. If visitor entry is unavoidable, a guidance a defined location (such as on performance dialogue boards, for entry and exit should be issued to vendors / visitors prior shift huddle areas) to coming to the facility. All procedures defined for employees Adaptation for unions & contractors should be followed (at minimum) for vendors / visitors as well • Essential union workers and contractors should be identified in Use of conference rooms and training rooms advance, and all safety measures should be extended to them • Gathering of employees should be avoided in conference rooms as well (i.e. same safety protocols as permanent employees) / training rooms to the extent possible • Workers and contractors should be dedicated to the same set • Meetings should be conducted through virtual platforms such as of employees (i.e. ‘work-teams’) coming to the plant in a shift. Microsoft Teams, Zoom, Skype, Teleconference (these are just • A record should be maintained for every worker contractor illustrative, and can vary based on organizations’ preference / coming in contact with employee other than the defined matrix policies) / ‘work-team’ • If a meeting or training cannot be avoided, social distancing protocols should be maintained in conference rooms and ON-SITE MATERIAL-MOVEMENT NORMS training rooms Overall material-movement across receipt, testing & release, • Retain the names and contact details of all participants for at dispensing & issuance, finished goods movement, should be carried least one month. This will help public health authorities trace out in line with existing site procedures. In addition, there are a few people who may have been exposed to COVID-19 if one or more select safety practices that may be adopted, mentioned below: participants become ill shortly after the event Receipt of raw material & packing material MANUFACTURING AREA & QC LAB WORKING NORMS • Once the materials are received at the receipt bay, surface sanitization (preferably with 70% isopropyl alcohol) should Essential and non-essential personnel mapping be performed in addition to dedusting (if not already a part of • Minimum manning to be followed on the shop floor and in QC existing procedure). Dedusting should be done without use of lab (to the extent possible), and employees should be dedicated pneumatic blower by unit operations or manufacturing areas / rooms. To be done • Both materials & sampling tools need to be surface-sanitized. by creating segregated ‘Work-teams’ of employees Keep materials sanitized for at least 5 minutes before use • Creation of smaller ‘Work-teams’ of essential employees (sub- teams) to be done to ensure minimum contact between different Testing and release of material groups of employees • External surface sanitization should be done for both material and tools before and after sampling process. • If non-essential personnel are required to be on site, it must be ensured that they do not come in physical contact with essential o Polybags containing the material / tools should ideally be personnel, else be explicitly tagged to ‘work-teams’ single use o Sanitized materials / tools should be left idle for at least 5 Behavior within the plant premises minutes before use • Employees should follow distancing norms even after changing into clean room garments, such as always remaining at least Dispensing & issuance of raw material & packing material 1m apart, not filling documents together, avoiding sharing • The dispensed material should be dropped off at material equipment or tools airlock of manufacturing / packing area • Hands should be disinfected after touching any external object, • Surface sanitization should be done (preferably with 70% such as equipment, doors, documents isopropyl alcohol) before accepting the material into the • Air-lock mechanism should be used while transferring samples manufacturing / packing area from manufacturing area to QC lab. Samples should be Shifting of Finished Goods / Semi Finished Goods to preferably packed into an additional cover / polybag which warehouse & dispatch of finished goods should be removed in the air lock • All equipment (fork lift, hand pallet etc.) should be cleaned and • Documents should not be handled with bare hands; QA personnel sanitized before and after every use, in line with existing plant should also wear gloves while reviewing documents procedures • Use of telephone receivers should be avoided; speaker phone WORKPLACE INFRASTRUCTURE & MECHANISMS TO should be used to the extent possible AVOID CONTAMINATION • Microbiological monitoring of the manufacturing area should be Physical mechanisms to reduce transmission done regularly and any change in microbiological flora should • Physical barriers should be provided where personnel might be reported come in contact with each other; e.g. different areas within the • Ensure personnel cell phones are also sanitized as appropriate, manufacturing floor and QC lab, during material movement, regularly (potentially daily) areas within the cafeteria. If provision of physical barriers is Shift handover not possible, distancing protocols should be enforced • Handovers should happen remotely and not in-person; i.e. • Identify a room or area where someone who is feeling unwell employees working in one shift should exit the facility before or has symptoms can be safely isolated. In terms of the employees from next shift enter the change room contingency plan, transfer to the identified health facility. • Key messages during handover should be written using personal • Where feasible open windows and doors whenever possible to / shift-specific pens on defined sheets of paper and stored at make sure the venue is well ventilated.

Pharma Times - Vol. 52 - No. 04 - April 2020 28 Pharma Times - Vol. 52 - No. 04 - April 2020 29 Cleaning & sanitization procedures • A dedicated quarantine / isolation room should be provided at • For common areas, the frequency of cleaning and sanitization each site to isolate suspect cases until they are transferred to should be increased, especially for areas with highest risk of home quarantine / hospital transmission (i.e. areas with maximum personnel movement), Assess risk and response from official health authority such as corridors, change rooms, cafeteria, wash rooms channels regularly • All materials used in production processes should either be • Employers should routinely monitor updates on risk and sterilized or surface disinfected while transferring in from response on official channels of health authorities (e.g. MOH, outside areas WHO, CDC, local health authorities etc.). • 'Deep-cleaning' procedures should be established for critical areas • Additionally, local site leadership to collaborate with these in case any contamination / infection is suspected or observed. agencies to ensure employee safety at plant and during Tracking employees’ health & contact with other employees travel (e.g. support in creating curfew passes for relevant • All essential and non-essential employees and contractors employees) entering the premises should be explicitly tracked and Update policy and communicate with all personnel recorded • Situation should be monitored on official channels at least on a • Basic monitoring data e.g. body temperature should be regularly daily basis and governance mechanism should be put in place logged and recorded. Any deviations should be reported, and for quick reaction to emerging situation on plant operations appropriate action should be taken • Communicate the change in policy with all employees through • Tracking of personnel gathering at common places should be an emergency notification system to keep employees on top of carried out separately at respective areas, such as in canteens, latest news (e.g. through text Messages or emails) change rooms. COLLABORATE WITH LOCAL HEALTHCARE PROVIDERS • All employees are to log at least daily if close contact has taken place between different employees from different work-teams FOR EMPLOYEE CARE so in case of a potential infection, it is possible to identify who Agreements / arrangements should be put in place with local to quarantine healthcare providers - physicians, hospitals for immediate action to • Details of all external personnel (such as community be put in place if employees need assistance or indicate symptoms stakeholders, government representatives, personnel from for COVID-19. Take updates from verified media & adhere to the media) with whom employees may come in contact with, guidelines/notification from local authorities. Facilities should be must be appropriately recorded and shared with leadership and put in place for incident reporting, quarantine, health plan hotline relevant stakeholders etc. to provide access and support to employees

         

             

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Pharma Times - Vol. 52 - No. 04 - April 2020 28 Pharma Times - Vol. 52 - No. 03 - March 2020 8 Pharma Times - Vol. 52 - No. 04 - April 2020 29 Pharma Times - Vol. 52 - No. 03 - March 2020 9 Article

Pharmacy experiences in India in SARS-CoV-2 Raj Vaidya Community Pharmacist, Hindu Pharmacy, Panaji.

In India, pharmacies and pharmacists have hardly ever even the authorities can track or have a quick overview of the stock been projected/included as part of disaster management positions in the supply chains in the country. Doing this for 8 Lakh plans or teams. The preparation for a COVID-19 pandemic + stores for the huge number of medicines (unknown number of was certainly beyond anyone’s disaster management plans drugs and FDCs), is presently next to impossible. and dreams. And so was the pharmacy profession and trade in India. Formal induction and training of retail pharmacists During lockdown (India) – disruptions and anxieties: and their staff in disaster management has never been heard The lockdown announcement was quite sudden, and brought of in the country. with it multiple challenges for both pharma distributors and Living with the pandemic is no doubt an eye opener for all, pharmacies: and I shall try to pen down some of things which affected the 1. Public transport halted: The biggest impact of this was on the community pharmacy. Media and social media has allowed me to staff working in pharmacies and pharma stockists. Those who get in a lot of insight into the happenings and situations and this were solely dependent on public transport could not report article is based on these readings as well personal experiences to work. Getting transit (curfew) passes was a new thing for in my battle zone – my community pharmacy. And of course, India most people, and there were hurdles in getting it done. Many being a huge country, a lot more a lot more experiences may have of them were refused from proceeding to work (and in some been missed. cases assaulted), even though they were eligible to travel to work. AIOCD had to resort to writing letters to authorities of Pre-lockdown (India) – disruptions and anxieties: various states to ensure that this does not happen again and While we all eagerly watched how China was affected, and how pharma staff are permitted to proceed to work. day by day the cases popped up in different countries, and numbers 2. Fear of COVID-19: Some of the staff did not report to work rose, the hope was that it should not affect our country, our state, for other reasons - worried that they would afflicted, family our city/village. Did the low number of cases in the country make members did not permit to go to work, or they had young us complacent - “we won’t be affected”? A variety of opinions, kids or elderly/sick at their homes. The Govt. also had made theories mixed with rumours of hot climates, good immunity of a clear announcement when going into lockdown that the Indians, BCG vaccination, preventive homeopathy, mystic powers, owners cannot terminate or stop salaries to those who could etc. flooded the social media, and left everyone into a tizzy and a not report to work. state of confusion. A strong sense of reality hit as numbers started 3. This put a heavy burden on those staff reported to duty: to slowly creep up in India too, and then came the announcement Those who stayed nearby and could walk to work, or were of the one day “National Lockdown”, shortly followed by the 21 day, having their own vehicles joined work. Same came along with and then extended to 40 days. their colleague on 2 wheelers, while some were dropped to Information started spurting on social media that the disruption work by their family member and then collected after working in China was likely to affect the availability of medicines in India - hours. It is indeed commendable that these workers in the since we depend heavily on China for imports of APIs. This created pharmacy and pharma wholesalers came to work in spite of anxieties amongst many patients, especially those who were on knowing all the risks, and especially with positive cases being medicines for chronic illnesses – and a common query to the found in their state/city/locality. And especially those in the hot pharmacy staff was whether they should buy adequate stocks spots. Some pharmacies in some pockets remained closed for and keep – just in case there were shortages in the coming days. varying number of days, because of their personal difficulties Pharmacy staff had no concrete answer, but did their best to soothe in doing so – age factor, co-morbidities, reliance on staff to the anxieties of patients. operate, etc. There was information flowing around that pharmacies have Shortage of manpower: This meant various things for the started stocking up, but there is no study or concrete evidence or pharmacy staff: documentation of this. Since there is no system built up by which 1. Less staff had to handle the heavy load of rush, especially for the 1st few days of lockdown as patients rushed to get Raj Vaidya their medical supplies. The timing of the announcement for Raj Vaidya is Practising Community Phar- lockdown was such that it did not give any time to patients macist for past 30 years at Hindu Phar- to get their stock of medicines beforehand. Of course the macy, Panaji. Currently Editor of E-Times, a announcement said that pharmacies will remain open, but bi-monthly publication of IPA – Community nevertheless, there was panic to buy their supplies for at least Pharmacy Division (CPD), he has been Vice a month, and some tried to buy for 2 or 3 months. President & Chairman, IPA-CPD (2006-12) & Fellow of IPA. Raj Vaidya has been proactively involved in up- 2. Most pharmacies usually try and keep inventories in control to gradation of pharmacy practice in India through writing, train- manage their business, and increased demand in medicines ing and advocacy. was not easy to cater immediately for all. Many pharmacies depend on daily ordering and purchases, especially for

Pharma Times - Vol. 52 - No. 04 - April 2020 30 Pharma Times - Vol. 52 - No. 04 - April 2020 31 certain products. There being a large number of brands in the Home deliveries of medicines: Indian market (some estimates say 1.5Lakh+?), and heavy The Ministry of Health, on 26th March, 2020, issued a competition amongst the marketing by companies, it is not notification by which a pharmacy retailer could sell and do home easy to predict stocking quantities many times. delivery of medicines, including those under Sch H, but subject 3. Pharmacies have multiple functions which cannot stop even to conditions: when there are staff shortages – dispensing process (including a. Sale of Sch H shall be against receipt of hard copy or email of billing, packing and taking cash), daily stock ordering, receiving a prescription. and checking goods, feeding of invoice in the software, putting b. Register your Email id with the licensing authority if prescriptions goods in place, basic cleaning, answering queries of patients are to be received by email. in-person and over telephone, etc. c. The drug delivery can only be done within the same district 4. In the mad rush, ordering took a back seat. Besides, many stockists themselves were also working below capacity d. In case of chronic diseases, the prescription shall be dispensed because of staff shortages. Deliveries to pharmacies were only if it is less than 30 days old, and in acute cases, if it is less thus hampered, and pharmacies could not always move out than 7 days old. to bring supplies from stockists. Stockists generally compete e. The bill or cash memo shall be sent by email to licensing with each to provide services to retail pharmacies, which authority and records of all such transactions shall be includes door deliveries, immediate deliveries. In this hour of maintained by the licensee crises, all that was hampered. Some stockists were closed, f. Home delivery of medicines was not permitted for medicines some operated only for few hours every day, some could not in Sch H1, or Sch X, or controlled substances. offer deliveries for a few to many days. The above order, taken out as part of the strategy to keep 5. There was sudden additional demand for other items - people at home, and reach medicines to those who cannot come sanitizers, masks, disinfectants, hand washes, soaps, toilet out. It is known that prescription medicines are often available paper, etc. In addition, there was unexpected demand in without a prescription. In addition, in India, home deliveries of pharmacies for oats, powders for health drinks, milk powder, medicines have been very commonly happening. The above order sanitary pads, biscuits, shaving aids, etc. – because in certain gave some legal sanctity to it. However, many pharmacists raised pockets of the country the groceries or super markets were several questions relating to online pharmacies, who, in spite of either closed or had huge queues for buying. In addition, no regulation in place for the past 3 years were allowed to carry since the immune system was what the new virus attacked, on, and now, while allowing home deliveries for brick and mortar there was lots of advice floating around on social media to pharmacies, rules are being put down… boost one’s immune system. This also included promotion of ayurvedic and homeopathic products. This resulted in Since many doctors are not practising, patients would have additional demands for Vitamin C tablets, Chyavanprash, difficulty getting prescriptions for their chronic conditions, if their Guduchi, Amla, ayurvedic immunity booster proprietary earlier prescriptions are already beyond 30 days? The content, products, etc. This also increased the burden and workload format for a prescription has not been modified for decades. There in the pharmacy, and sales as well. is no legal format for telemedicine in the country, there is no format or guidelines in place for sending a prescription by a doctor to the 6. Demand for pet foods increased, and the stocks in pharmacies patient or the pharmacy directly, or to both. disappeared in no time. 7. Pharmacies soon noticed shortages of various stocks The legal sanctity of the order allowed the drug regulators of with the stockists. Perhaps for various reasons - probably various states to encourage the pharmacies to do home deliveries in this hour of crises, and regulators worked in tandem with the because some retailers had bought extra, which in turn chemists association in various regions in this hour of crises to could be because patients had bought extra (Appeals were give sufficient publicity of this activityto the public so that they do subsequently sent out by chemist associations asking not panic, and are able to receive their medicines without moving pharmacies to limit to one month supplies to patients). And at out of the safety of their homes. the same time, supplies to stockists were hampered because of lockdown, transportation delays and blockades, closure of Challenges faced by patients: some transportation godowns. Yet, it is hats off to the supply a. Many patients, elderly or their family members could not go chain to do its best in challenging times, with so many hurdles, out. They had to depend on someone else or on home delivery to keep the supply chain unbroken. Family members of the of medicines. At times, certain medicines are not available in owners of both stockists and retailers too joined hands in some neighbourhood pharmacies, so they have to be procured covering up for the staff shortages. from pharmacies who are at a distance. Many pharmacies could 8. There were incidences of pharma manufacturers working not do home deliveries, especially in the initial stages, because below capacity, as they too had staff shortages. In some they were short staffed. places, pharma manufacture was permitted, in some places b. In the initial few days of the lockdown, there was a lot of panic it was not. In some places, pharma units were shut down amongst patients as they were worried for their medicines. Many because positive cases were found amongst workers. The rushed or sent their family members/friends/acquaintance medicine shortages issue is likely to trouble us on and who could move out during lockdown to bring their quota of off. medicines.

Pharma Times - Vol. 52 - No. 04 - April 2020 30 Pharma Times - Vol. 52 - No. 04 - April 2020 31 c. The queues were big because the many/most pharmacies were to give it to their frontline workers. Those who did not get short staffed, and also in came the new norm of social (physical) it resorted to picking it up from the private pharmacies. All distancing. this created temporary shortages with the stockists and pharmacies. d. Many patients on chronic diseases s get their free medications from public health centres. Medicines of many patients are Many consumers got hold of information through social available only in specific localities or pharmacies. Many such media that HCQ could be used for prevention, treatment of patients had a, because they could not get the same “brand” of COVID-19. Pharmacies received phone calls and queries across medicines. Many were convinced and many were not convinced the counter asking for HCQ. There were understanding, and the to buy alternate brands. A lot of precious time, and energy, was not-so-understanding clients, when pharmacists explained the spent in the bargain of all those involved. And anxiety of course real position about the use of HCQ. – including of the lockdown restrictions. And there were many patients who were on HCQ for their RA (and lupus, etc.) and using it regularly to keep their symptoms in Protection and safety of Pharmacy staff: control. This sudden shortage of HCQ made them panic. Some News kept flashing on media how the numbers were increasing of the patients complained that while earlier they could buy in other countries. And how the frontline workers were affected, refills for their HCQ without a prescription, some pharmacies how there were casualties. How badly Italy and Spain were hit, were giving them now and insisting on a fresh, hard copy of a and then the USA. Soon news came in that pharmacies in few doctor’s prescription. This is because the CDSCO had come out countries were effected, a few passed away too, due to COVID-19. with a notification on 25th March, 2020, and shifted HCQ from All this created a sense of insecurity, panic amongst pharmacy Schedule H to H1 category. While the intention of the CDSCO staff back home in India, especially in those cities, areas, where order was good, and it gave a stern message (which was further the numbers of patients were steadily rising. Soon we heard news endorsed and circulated to respective pharmacies by state drug of some cities, or locations in India being completely cordoned control departments), the order did not consider the following off, due to rising cases. The pharmacy staff working these areas aspects: were also fearful. 1. It did not give any guidance of what was to be done for patients Pharmacy staff in various countries innovated, and started who have been on HCQ for some time now for their RA, lupus, taking various measures to protect themselves: wearing a mask, etc. Whether any discretion was to be used by pharmacists in and in addition, some used hoods/shields of transparent acrylic dispensing them to patients was not specified to further protect their eyes and face, hair cover, gloves. Some 2. Patients were not aware of this change, and it worked up their innovated by putting plastic sheets in front of their pharmacy anxiety and anger on pharmacies who did not dispense. Many counters to protect themselves. Some directives stated to disinfect patients were not able to produce fresh prescriptions, and also the supplies received from stockists before the supplies were taken stated that their doctors were not accessible in this lockdown in the pharmacy. time. 3. Different pharmacies may have used different yardsticks, Pharmacies in India too took various safety measures, some because there was no sure shot solution to such a problem. indigenous ones: Besides wearing masks, some starting wearing Pharmacies used their own discretion in giving or refusing aprons, and some began using hair covers. Since many pharmacies patients of their regular supply of HCQ. are small, some of them did not allow clients inside, and made them queue outside the pharmacy, maintaining physical distancing Availability of drugs for ICU Management of COVID-19: As (1 metre). Some of them put barricades in front of the counter to the country further planned its emergency preparedness a new keep the clients at a distance, while some used strings to make order was issued by the CDSCO, in mid-April 2020. It asked all such a barrier. Many of them drew squares or circles 1 metre apart, drug regulators to ensure that a list of 55 drugs needed for ICU on the floor/footpath to indicate where clients should stand in a management of COVID-19 were available, in sufficient numbers queue. Medicines were dispensed through a dispensing window across the country. This list included vasopressors, emergency or by keeping a distance from the client. Facilities to use hand cardiac drugs, injectable sedatives/muscle relaxants, injectable sanitizers was provided to clients visiting the pharmacy – to use antimicrobials, injectable anti-epileptics, IV fluids, and some them before entering and after leaving. Pharmacies put up their other drugs. Some of the drug regulators forwarded the list to own handmade or computer printout posters to educate, guide their all the pharmacies in their region and requested for a weekly clients to follow the new set of norms which cropped up under the information by Email of how much of these medicines they new circumstances. Besides, basic in-house training was provided were holding. to their staff. The media reported the next day about this, and it read Battling unexpected situations: that the Govt has asked all the pharmacies in the country to Hydroxychloroquine (HCQ): As the numbers of suspect and stock all of these 55 drugs in sufficient quantities. The reality confirmed slowly started inching up, the first to be alerted to is that many pharmacies even in the cities and metros do not use HCQ as a preventive were the medical professionals. By stock most of these medicines. That is because most of such then the ICMR had issued guidelines for its preventive use medicines are either stocked by hospitals or their pharmacies, for frontline workers. There was quite a rush by doctors in or at the most by pharmacies close to hospitals. Making all public hospitals to acquire the 400mg tablets of the drug. these medicines available in all the pharmacies in the country The respective departments managing the public hospitals is next to impossible. This is just an example of the chaos that procured their stock of HCQ directly from the wholesalers the pandemic has created.

Pharma Times - Vol. 52 - No. 04 - April 2020 32 Pharma Times - Vol. 52 - No. 04 - April 2020 33 Restrictions to sell medicines for fever, cough and cold: In addition, various Guidelines/directives were issued in In certain hotspots (in different parts of the country), with high various locations/hotspots, in specific areas where there strict positive cases of SARS-CoV2, the District Collectors, the police curfews, to restrict the moving out of people from their homes. or the drug administration issued guidelines (and then orders in The administration restricted/reduced the timings of opening of certain locations) to pharmacies in their jurisdiction to dispense pharmacies, so that with shortened duration, there would lesser medicines for cough, cold and fever strictly, only against the movement of people, and reduce the risk of spread. prescription of a doctor (The names of the medicines were not Recognition of COVID warriors: Of course, in India too, there listed by the authorities). Pharmacies are also been asked to send was a lot of praise for the frontline workers in the battle against a daily report to the local drug regulator and the police on Email/ COVID-19 – the doctors and nurses. And those working in the WhatsApp of the details of the medicines sold, the details of the hospitals, and the policemen, and sanitary workers, and so on. patient and details of the doctor who prescribed. And further, to However, pharmacists, and those in the medicine supply chain take down and send the details of any patient who comes to the staff are no less of COVID warriors. They too have played a very pharmacy asking for medicines for cough, cold or fever, or who big role in ensuring that patients gets their medicines, guidance shows any signs or symptoms of these – to the police, and FDA, with the touch of care and concern. and also direct the patient to visit the nearest flu clinics/govt clinic/hospitals in the locality. In the pharmacy world also have to come to terms with the huge new changes the pandemic will bring about, and should do The reason behind the move was that patients were hesitant a massive rethink on various aspects. The pharmacy profession to self-report of COVID-19 symptoms, and were not going to in India has to change gears and surge ahead – to improve the hospital clinics – and could try to self-medicate. These were knowledge and skill levels of pharmacists on the front line, use stringent measures put in place by the various administrative of technology, and also equip them with disaster management heads to try and trace as many suspects of COVID-19 to stop the skills. spread of the virus.

Letter to Editor Awareness of Pharmacy services and Pharmacists 1. Promotion of Pharmacists Qualifications Availability of Now a days we all are fighting against the COVID-19 pandemic. different categories of qualified Pharmacists i. e. D.Pharm., Pharmacists are engaged in different sectors of pharmacy B.Pharm., M.Pharm., Pharm.D. and Ph.D. in pharmacy . profession and are playing their crucial role in different capacities. 2. Amendment in Drugs and Cosmetics Rules for retaining only Particularly hospital pharmacists are working in hospitals with one category of retail Drugs Store 'Pharmacy' having presence doctors and nurses & other health care members and also of qualified pharmacist only. All other categories need to be community pharmacists are supplying medicines to masses deleted. For villages, restricted licence may be permitted on through their pharmacies in this crisis. Also manufacturing, QA seeing village conditions & QC pharmacists are producing medicines in drug industry 3. In community pharmacy actually we are not playing even in this crisis to ensure availability of medicines in market. professional role. It is a fact that Community pharmacy is Regulatory (Drugs Control) pharmacists are ensuring legal a profession and not a trade but it is totally in the hands compliance and availability of quality and standard medicines of traders. We community pharmacists, have to work as and medical devices in market. Further, few of our research pharmacy professionals and to provide pharmacy services at pharmacists are engaged in searching medicines to fight COVID. pharmacies. All should start pharmacy practice as provided It is also remarkable that two hospital pharmacists were in to us legally by PPR 2015. the team with Doctors who were subjected to stone pelting in 4. All Community and Hospital pharmacists should wear apron Moradabad in UP in 3rd week of April. with nameplate designated as Pharmacist with name and Hope we would get success in fighting against the COVID-19 emblem. pandemic. But it is surprising to note that our pharmacy services 5. Patient Counselling is to be started in each hospital and and pharmacists are not popularized /recognized among masses pharmacy. as it should be. In television discussions or even our Hon'ble PM and many CMs and many leaders are not aware of our 6. Celebration of NPW is to be reformulated. It should be services. Our community pharmacists’ services are referred to celebrated in each hospital inviting all doctors, dignitaries as ‘dawa dukandar’. The name of hospital pharmacists is not of that area, media and display of posters in hospital. Also uttered where as they are engaged in hospital with physicians posters are to displayed in each pharmacy and some special too and they are working day and night without recognition of services may be provided during NPW to patients/customers their work. to popularise us. On introspection, it is noted that we could not establish our image At State level we should invite Minister, Health official, media, among masses and leaders and government officials though we HOD of all Medical Colleges /hospitals Principal of all schools the Pharmacists are engaged in such vital services of health and colleges etc to actually popularise the profession. care. We have celebrated NPW more than 50 years, our pharmacy Dr. R. N. Gupta, education is more than 85 years old. Hence once again we have Fellow IPA, Eminent Pharmacist to take following measures after winning the COVID fight: Chairman- IPA HPD & Vice President, IPA

Pharma Times - Vol. 52 - No. 04 - April 2020 32 Pharma Times - Vol. 52 - No. 04 - April 2020 33 PharmaPharma TimesTimes -- Vol.Vol. 5252 -- No.No. 0403 -- AprilMarch 2020 2020 34 24 Pharma Pharma Times Times - -Vol. Vol. 52 52 - -No. No. 03 04 - -March April 20202020 3525 Pharma Times -- Vol.Vol. 5252 -- No.No. 0304 -- MarchApril 2020 2020 34 24 Pharma Pharma Times Times - Vol.- Vol. 52 52 - No.- No. 03 04 - March- April 20202020 2535 Article

EMBRACING 4.0 IN PHARMA ACADEMICS: WAY FORWARD Dr. Richa Dayaramani Principal, Khyati College of Pharmacy

The recent global scenario in the wake of COVID – 19 outbreak and decentralised decision ability of cyber physical systems to has brought a sea of opportunities clad in the form of challenges for perform their tasks almost autonomously. To summarize, the pharmaceutical industry requiring healthcare concerns in terms of I4 comprises of technologies like IoT, mobile devices, location both service as well as manufacturing sector. It drew our attention detection technologies, advanced human machine interfaces, 3D towards the fact that this is high time we come out of our comfort printers, smart sensors, augmented reality, big data analytics and zones and prepare ourselves to address and foster futuristic needs advanced algorithms, multilevel customer interaction and customer of healthcare both for goods as well as for service industry. The profiling, cloud computing, cognitive computing etc. The fourth industrial revolution is changing the world around us. Artificial technical and professional pharma education sector stands on the intelligence (AI), robotics, big data and the internet of things (IoT) fact that we have to cater the needs of the industry by providing them will combine to impact on jobs and industry. From diagnostics to trained and qualified manpower to suit their dynamic requirements. patient care optimization and security automation AI is changing the The focus of pharmaceutical education outcome is more placements world and the way we live. In order to make healthcare more cost- oriented unlike humanities and other academic sectors. As the effective, accurate and rapid latest machine learning technologies demands of industry are not static hence it implies that the academic are being used by the industry. Albert Einstein said that “Education deliberations are bound to be dynamic in nature. Of late, we are needs to be aligned with the fundamental changes in the nature experiencing an interdisciplinary and multidisciplinary approach of work and address the issue of employability.” involving basic sciences and application sciences to come up with With ever changing times the concept of how a university should innovations and breakthrough in research and technology together. be and how it should function has also changed especially in the On a global level there is a change being witnessed which is forcing last 30 years after the introduction of privatisation in education. our academic fraternity to update, review and revise itself to keep pace with the current industrial needs. This communication is aimed 'Knowledge Economy' a term coined by Peter Drucker (1969) at reviewing the present status of pharma education with respect to in his book 'The Age of Discontinuity', discerns four major areas industry 4.0 scenario and way forward to overcome the challenges of discontinuity – of outcome based learning via academics 4.0. (1) The impact of the new technology on the industrial structure Concept of 4.0 for both industry and education (2) The shift from an 'international economy,' to a 'world economy' which as yet lacks policy, theory, or institutions Industry 1.0 refers to first industrial revolution comprising of use of steam and hydropower based machines to produce goods and (3) A new socio-political reality, embracing business, government commodities that were prepared by hand or manual operations. The and other pluralistic institutions, which poses drastic political, machines were simple and there was a requirement of manpower philosophical and spiritual challenges or labour to operate them and carry out other operations. Industry (4) The rising importance of knowledge and of formal education, with 2.0 was marked by usage of modern production lines comprising of resulting implications for work, life, leisure and leadership. electrically operated machines. The requirement of labour was less but there was a need of trained manpower to operate them and handle the operations. The production scales were massive and it was a period of great economic growth. Industry 3.0 dawned in the late 20th century and is often known as 'Digital Revolution'. With extensive use of computers and immense industrialization along with technological advancements, there was a significant growth in communication technologies with the supercomputer. Machines started to abrogate the need for human power in life although productivity, consumerism and technological advancements were in the peak levels.

The term Industry 4.0 or simply I4, originated in 2011 from The education system in India has evolved from Education 1.0. a project in the high-tech strategy of the German government, (home schooling and primary methods of teaching), Education which promotes the computerization of manufacturing. The 2.0 (providing education on mass scale with the teacher as the basic four components of the fourth industrial revolution are interconnection, information transparency, technical assistance knowledge provider and the student as the passive recipient), Education 3.0 (use of computers and internet in teaching and learning, which helped in increasing access and equity) and Dr. Richa Dayaramani Education 4.0 (high-speed internet, mobile technology, social Dr. Richa Dayaramani (M.Pharm., PhD) media platforms etc. facilitating personalized learning anytime is currently Principal at Khyati College of anywhere and redefining the role of teachers as facilitators and Pharmacy, Ahmedabad. She has 15 years mentors). Currently we are in a state of massive transformation of teaching along with 5 years of industry from Education 3.0 to Education 4.0, where the focus is on experience and was awarded the 2019 PC student’s learning outcomes. The primary focus areas of delivery Kharia APTI Best Principal Award. are employability, student engagement and experience, research excellence and society including industry responsibility.

Pharma Times - Vol. 52 - No. 04 - April 2020 36 Pharma Times - Vol. 52 - No. 04 - April 2020 37 PRESENT SITUATION one-time course/degree that can ensure life-long employment, but According to a survey report by the British Chambers of a continuous endeavour towards up-skilling that can achieve it. The Commerce in April 2018, it was realised that 75% of the businesses responsibility of universities today is to ensure two things: were facing a shortage of digital skills in their workforce. Now this 1. Students should possess hard and soft-skills to be ready for is the realisation of business firms in one of the most advanced their jobs. countries so India can also anticipate the same by now. As defined 2. The students must have necessary attitude to become a lifelong by Cornell University, digital skills is the ability to find, evaluate, learner. utilize, share and create content using information technologies This can be achieved by universities offering a continuous, and internet. The industrial requirements are changing at a faster comprehensive learning system, which, besides offering pace than what we educators perceive. The recruitment models programmes to provide the right skills for the start of a career, also have changed from 'Hire, Train, Deploy' to 'Train, Hire and Deploy' provides for re-skilling students while they are on the job. and work outsourcing or contract employment which drastically reduced the deployment time from 6-8 months to 15-30 days. Research is an important vertical in pharmaceutical academia and industry and inducing the right skills for creating a competent According to a study by Mc Kinsey Global Institute, out of 750 research workforce is the need of the hour. Such content will enable occupations, nearly 75% are highly susceptible to automation. This switching between online, blended, or on-campus courses that can means that in near future several skills will become futile and dead suit various learning styles and learner preferences. These can along with mass unemployment if newer skills are not embraced then be offered as learning credits be it for award of a degree, or for by the job seekers and the educators. shorter certifications. Focus shift from 'learn and do' to 'learn by doing' In present times universities need to think about more evolved in a manner that makes the students to work on industry projects forms of brick and mortar universities. They should offer courses supported by learning resources content, courses and faculty as with technological disruptions, learning freedom with respect to mentors. Such self-paced, credit-based, and on-demand education will subject, content, time and place. The courses should enhance promote a pool of professionals, eager to invest in learning. This model the learning experience of the students. This need of near future can create a viable ground for academia-industries partnership. is raising a big question upon all of us as educators: Whether WAY FORWARD we are ready and what is our readiness to prepare the future generations to thrive in this changing landscape? The future The good news is that Industry 4.0 cannot exist without work generation requires skills such as problem solving abilities, academics 4.0. Modern learning cannot take place without creative thinking, digital skills, team work and leadership by modernizing the delivery. Faculty 4.0 needs to be updated with example and not by authority. The present education system of curriculum 4.0. Teachers should focus their efforts on using teaching – learning hardly has any emphasis on imparting these. technological applications that support and enhance cognitive Students are exposed to such abilities only during their professional learning abilities. Learning outcomes should be based on journey or professional studies but by that time their attitude belief personalized adaptive learning techniques. Intelligent digital assets system becomes cemented and there is not much room for new and teacher – student interaction should guide teaching concepts. adaptations. Teacher – student interaction should be based on a smart approach to make the whole experience engaging and interesting. There has It is high time we focus and revamp the pharma education system to be a greater flexibility in choosing their mode of engagement. right from delivery techniques, mentoring techniques, futuristic This would be supported and enabled with the help of technology. subjects and content to make it future ready so that our students Such newer forms of learning models would become important to are suitable to the demands of industry 4.0 and beyond. develop a holistic view of learners’ engagement and progress. TWINING PHARMA ACADEMIA WITH PHARMA INDUSTRY 4.0 Indian education system is no exception to equip itself with India’s re-skilling challenge can be met through an evolved futuristic education delivery and assessment techniques to build understanding between the three links of this chain: the industry, the a workforce for enterprise 4.0 by preparing a robust professional jobseekers and the universities. With the right learning environment, framework. Career planning in a rapidly changing world will be professionals in this country will always find themselves equipped based on inter disciplines that are more advanced and futuristic. enough to handle the jobs of the future. To take full advantage of Some examples of inculcating technology based delivery are: the opportunity created by advanced technology we need a similar revolution in education – not just to meet the needs of industry, but 1. Modern techniques such as Machine Learning (ML) can be also to ensure the best possible student experience, use of staff time used for granular assessment of student progress and provide and investment in infrastructure and facilities. Students look after a valuable insights into a student’s strengths and weaknesses. combination of instructor-led educational model and learning from Fair and transparent student evaluation using different machine own resources at own pace. They want enhancement of employability learning algorithms can be utilised by mentors. The final grades skills along with academic excellence. There is an urgent need of the student can be predicted and the prediction results can for collaborations of industry and universities / institutions. The be utilised to mentor the students to achieve better grades. curricula have to be dynamic in nature (that changes with the 2. Transformed teaching – extensive use of Artificial intelligence changing requirements of industry or employer). We have to work (AI) models and augmented reality based demonstrations (AR) with universities to design and deliver the technological solutions for in Program Educational Objectives and Program outcomes a future-proof student experience that can also help tackle the big challenges in higher education. Choice based credit system (CBCS) 3. Mixing campus-based and distance learning on a module-by- enables students to choose courses even outside their program but module basis it is yet to enter into Indian education system in true sense as there 4. Using learning analytics as a tool for tutors to develop a holistic are too many regulatory and governing limitations. It is no longer a view of learners’ engagement and progress

Pharma Times - Vol. 52 - No. 04 - April 2020 36 Pharma Times - Vol. 52 - No. 04 - April 2020 37 5. Faculty of the future needs to have a blend of academics and • Personalised adaptive learning – An individualised approach that practice. So, merely an academic qualification like PhD or being takes learner diversity, performance and behaviour into account an all throughout practitioner will not help. The future faculty has • Assessment re-imagined – Can AI, digital experiential learning to have a blend of both in order to develop their own learning and micro-credentials replace high stakes summative tests? and teaching pedagogy • Intelligent digital and physical estates – This concept is 6. Inculcating technology and innovation in research - Novel ideas responsive to student journeys and interactions, helping in the development of drug delivery till the level of proof of universities deliver efficiencies and a smart approach to campus concept can be initiated that are developed in the academia design and later can be taken up by the interested industry partners • An award-winning Chatbot in Leeds where by using AI and 7. More Train the Teachers programs for preparing the task force Chatbot technology, a Chatboat named Becky provides an to deliver the curricula 4.0 instantaneous response and information to prospective 8. Like evidence based medicine, concept of evidence based students going through clearing learning can be initiated • Northampton’s blended learning where Active Blended 9. The industry lacks the cognitive workforce but has a huge Learning provides a learning environment where students play investment and ready research infrastructure where as the an active role and are given the opportunity to engage in a academic institutions lack the latest research infrastructure. variety of ways in and outside the classroom, in the field, in the Thus more research collaborations and twining projects can be lab, in the studio and in the workplace. Those study modes are taken up to have an efficient delivery and a win-win situation fully integrated into a proper blend, not different strands of for both stakeholders. This will also ensure that the students a course running in parallel are exposed to real research environment. • A reason to be proud of is provided by Indus International School of Bangalore where Eagle 2.0, a humanoid teacher assistant As put forth by Bill Gates “The first rule of any technology used in is working along with teacher (human mentors) to deliver the a business is that automation applied to an efficient operation will lessons magnify the efficiency. The second is that automation applied to an inefficient operation will magnify the inefficiency.” We should also • With the COVID – 19 outbreak online teaching is introduced not forget the risks associated as technology can sometimes create and utilised as a tool of crisis management in school and perverse incentives, such as the reduced student engagement higher education with the help of various platforms like seen when lecture capture is made available online and it is no Google classroom, Zoom cloud meeting, A-VIEW, GoToWebinar, longer necessary to attend lectures in person. Having a 100% Facebook live etc. Teachers and students have started exposing digital education is not an all-inclusive solution, nor should it be themselves to online videos, online submission of assignments the only method of teaching in use. However, benefitting from and assessment systems ‘hybrid education’ can only happen if teachers’ digital skills are CONCLUDING REMARKS encouraged and implemented through experimental collaborations and partnerships with tech industries. Pharma education 4.0 is in response to the Industry 4.0 and shall define the University of the Future. Industry model is Government’s initiatives based on sound authentic delivery and not mere lip service. In Fortunately, recognising the need for an overhaul in the pharmaceutical education, building a robust industry interface is education system and build a talent pool, the government too the most critical differentiator criterion. is introducing measures to meet this goal. For instance, the Life The critical indicators of the level of industry institute interface Sciences Sector Skill Development Council (LSSSDC) has been are the number of joint research projects taken up in association established by and for the life sciences sector in India, to address with industry, the number of field cases authored by faculty, the the skill gaps across functional areas and levels in the sector, number of live cases that students take up with industry, the by helping to generate a sustained stream of high quality skilled number of open management development programmes (MDPs) individuals. Pharmacy Council of India (PCI) has collaborated with conducted, the number of consulting projects taken up by faculty LSSSDC and constituted a working committee to develop electives and the revenue generated from them, and the frequency of oriented to nurture the learners according to current industrial revamping the curriculum and periodic assessment of its relevance requirements. Many Universities are now adopting the MOOCs apart from the existing practices of mere public relations work (Massive Open Online Courses) – for example 'SWAYAM' initiated done by organising guest lectures and seminars. The scope of by the Government of India to provide online teaching and learning involving and integrating tools of artificial intelligence, augmented resource to all. Academic research, Management Development reality, robotics and mechatronics with the practical deliverables Programs and Consulting are of paramount importance for the need to be assessed and opportunities to be created for the same. future Universities. USFDA in 2018 permitted the marketing of Universities and institutions should explore the opportunities for first AI based medical screening device which does not require a collaboration with other institutions and industry to satisfy this clinician to analyse the findings. requirement. The wealth of knowledge too has to be not weak Examples of Education 4.0 in action or superficial and the world needs distils of reliable knowledge, not mountains of unemployable research and casuistry-laden Some of the following trends are being used around the world publications. Governance and politician’s control have to become in futuristic and progressive universities: honest enough, only then looming societal challenges shall face • Teaching transformed – How should human teachers focus redemption. Although the present situation has exposed the their efforts if AI and other technologies become used to their teachers and learners towards use of technology but these are just full potential in the university experience? baby steps towards a bright and futuristic pharma education.

Pharma Times - Vol. 52 - No. 04 - April 2020 38 Pharma Times - Vol. 52 - No. 04 - April 2020 39 Article

An International Crisis: Long Term Impact of Covid-19 Pandemic on Health Care Scenario, Worldwide Phar- maceutical Growth and Global Economy Anil Kharia*, Sapna Malviya1, Ankur Joshi1 *President, IPA MP State Branch, Indore 1Indian Pharmaceutical Association, MP State Branch, Indore ABSTRACT COVID-19 is a disease caused by the new coronavirus, initially called 2019-nCoV, which is then experts from the International Virus Taxonomy Committee called it SARS-CoV-2. The World Health Organization had previously declared COVID-19 an international emergency as the disease is spreading at an alarming level affecting 199 countries and territories around the world. The impact of Covid-19 has blocked down the United States, India and other countries, as well as increased the chances of rising costs of raw materials and drugs. 13% of branded and generic manufacturers are based in China. According to the FDA, as of 2018, 24% of the drugs and 31% of the medical ingredients have been imported from India. If the current situation continues, the cost of essential medicines could rise in the United States and other countries as well. This review document will emphasize the impact of COVID 19 on the pharmaceutical industry, education and the community. KEYWORDS: COVID-19, Pharmaceutical Industry, Education, Community

INTRODUCTION Coronaviruses are important human and animal pathogens. Identified in late 2019 as the cause of a group of pneumonia cases in Wuhan, a city in the Chinese province of Hubei. It spread rapidly, causing an epidemic in China, followed by an increasing number of cases in other countries of the world. WHO has officially designated COVID-19 as a pandemic belonging to β coronavirus, a large class of viruses prevalent in nature. Like other viruses, COVID-19 has many potential natural hosts, intermediate hosts and end hosts. In recent decades, India has become the world's pharmaceutical center, being the largest supplier of generic drugs worldwide with a 20% share in the volume of the global supply and 50% of the world demand for vaccines. The COVID-19 crisis has highlighted the contribution of the Indian pharmaceutical industry as a major exporter of hydroxychloroquine in several countries that can help save thousands of lives. COVID-19 is a health threat and is rapidly proving an economic threat. It could cripple several economies starting with employees and industries affected by Fig No. 1: Impact of COVID 19 on Indian Economy stock market crashes and the closure of workplaces due to the IMPACT ON THE PHARMACY INDUSTRY [1,2,3] inability of the workforce function. In India, the impact has not been fully anticipated, but as the Chinese economy stagnates, we Escalation in cost of Pharmaceutical Raw material: The impact can expect some sectors to be hit almost immediately. The COVID- that COVID-19 has created in China and cause lock down in India, 19 has impact on the economy affecting all sectors-Education, the United States and other countries further raise the chances of Manufacturing, Health Sectors, Trade and Transport and entire increasing the cost of raw materials and drugs. 13% of brand and generic manufacturers are based in China. According to the FDA, as services (Fig No.1). of 2018, 24% of the drugs and 31% of the medical ingredients have been imported from India. For example, the cost of acetaminophen Mr. Anil Kharia in India has increased to Rs 400-450 per kilogram from Rs 250- 300 per kilogram and the price of vitamins and penicillin has Mr. Anil Kharia is President, IPA MP State increased by 40-50% in India. If the current situation continues, Branch, Chairman of Modern Group of Insti- the cost of essential drugs could also rise in the India as well as tutes & MD, Modern Laboratories and Nan- in other countries. dani Medical Laboratories Pvt. Ltd., Indore. With B. Pharm and M. Pharm from Dr. Hari FDA policies: The impact of COVID, drug demand and lock down Singh Gour University, Sagar & M.B.A. from in several countries may force the FDA to allow relaxation in some Devi Ahilya Vishvidhalaya Indore (M.P), Mr. Kharia has been areas, as the generic drug review process is long, the demand and leading various other organizations. shortcomings created can also force change minors. The Federal law requires the manufacturers to notify the FDA about shortages

Pharma Times - Vol. 52 - No. 04 - April 2020 38 Pharma Times - Vol. 52 - No. 04 - April 2020 39 when the circumstance arises. The rules do not apply to medical This obvious discrepancy indicates the relatively lower price of devices since they are manufactured in multiple plants. The Indian pharmaceutical products and the strong demand enjoyed shortage of devices during the pandemic could force the FDA to in the global market. As a leading supplier of affordable low-cost rethink on device regulations. For example, to maximize the number medicines worldwide, India's role as a "global pharmacy" is well of respirators available, the FDA and CDC recently announced that recognized by experts. So that the government can plan the import some respirators regulated by the CDC, but not by the FDA, may substitution industrialization to increase API production. The import also be used. substitution industrialization (ISI) industrial policy is premised on the realisation that economic development and more specifically, Pharmaceutical Data and Analytics: Pharma industry has an industrialisation can only be achieved by developing local capacity enormous amount of data, which also brings in various challenges that is capable of substituting imports in order to reduce or possibly like Integrating Big Data, leveraging unstructured data, advance eliminate economic leakages. insights from clinical trials, data privacy, social listening. The cost of developing a drug is skyrocketing and the time required to launch Moreover, the import substitution industrialization is seen a drug is also high. The industry has been using data for years, as a promoter to achieve economic diversification. In that, the but the challenge lies in leveraging its full potential. Numerous mechanisms deployed in the implementation of this policy clinical and molecular data available over the years can aid in (reduction of tariffs on input resources, high import duties or locally predictive analysis, which can be used to accelerate the clinical trial manufactured goods, exchange rates differential, and eventual process and drug development. Companies are leveraging data and abolition of export duties) help the developing economies to analysis, but the current situation may want them to use the data garner the requisite industrial know-how to embark on competitive even more efficiently for clinical trials, forecasts and marketing. Big exportation of manufactured goods. data infrastructure and social listening will also play a key role. In Indian Pharma to focus on import substitution: Indian addition to costs, the time required for development and clinical pharmaceuticals industry is on path to improve its infrastructure trials could draw more attention to real-world data (RWD). Almost and technical capabilities. The industry is now actively making 95% of companies are using RWD or will be using it by 2021. Data efforts to work towards import substitution through a task force accessibility and security concerns are some of the challenges of constituting various stakeholders that include government officials, using RWD, but they can be solved and will gain greater popularity Pharmexcil, manufacturers, CSIR (Council of Scientific and as companies and regulatory agencies they can, from now on, try Industrial Research) labs and others. The task force is identifying to introduce innovative measures in clinical trials. Clinical trials are top 100 imported raw materials and products. These products gold dust for the pharmaceutical industry, but in the past, there could be individually or jointly developed. have been cases where the drugs have been recalled even after FDA approval. The main problem with the clinical trial is that it The Government should focus more on the idea of import observes a homogeneous population. To address this, FDA might substitution and lay the guideline for manufacturers regarding relax the regulations on RWD. infrastructure, plant layout, economic viability, project reports and other associated know-how of the pharmaceutical industries. Digital health is a cultural transformation of traditional healthcare: Digital health may be the next big news, as telemedicine/ The industry is expecting a healthy growth of 12-15 per video consultations, videos and health-related apps are gaining cent CAGR in value terms and 10 per cent year-on-year growth popularity. Investments in online portals that help doctor-patient in pharmaceutical exports this year, said, Pharmexcil chairman interaction will increase. For example, Wellmind Health (which Madan Mohan Reddy, in Pharma Lytica Summit in Hyderabad on offers online courses for awareness-based cognitive therapy) has 20th April 2020. seen a recent trend of increasing purchases and demands. Due to the current pandemic situation, NHS England has instructed As patents are expiring, India has a great opportunity. Indian UK hospitals to increase consultations on telemedicine / video. industry can meet the global regulations and this offers substantial Meditation apps for calm and headspace have launched free digital growth to almost about 15-20% growth annually in the coming offers to help people cope with panic and anxiety. years. Government is pushing for manufacturing that will help sustainability and address the import burden. Import substitution centre and government measures to increase API production: The global COVID-19 pandemic Government help for firms making import substitute products has revealed the intricate interdependencies that exist in the and Bulk Drugs [5]: India is far ahead of the world in drug international pharmaceutical market. China, the epicenter of production. However, the country still imports key raw materials, the global epidemic, is also the world's largest supplier of active largely 53 active pharmaceutical ingredients (APIs) and basic pharmaceutical ingredients (APIs), also known as bulk drugs. India, materials (KSM) or intermediaries. To meet the Prime Minister's which is a major exporter of generic drugs worldwide, depends on vision of ensuring national drug safety, the Ministry attributed Rs. China for over two thirds of its drug needs. 13.76 billion program to increase the production of medical and bulk devices. Estimates indicate that India provides up to 50% of the generic • The first scheme is helping states create three bulk drug parks drug needs and vulnerabilities in the United States caused by spread over at least 1,000 acres. The Center will provide aid COVID-19 causing disruptions in global pharmaceutical supply through grants of up to 1 Crores. This amount will be allocated chains. Perhaps this is also a good opportunity for India to revaluate to various common structures such as solvent recovery plants, dependencies and plan for the future. power and steam plants, distillation plants and effluent According to Indian government estimates, India ranks third in treatment plants. These structures are individually expensive, pharmaceutical production by volume and 13 in value. It represents making internal production impossible. Common structures will around 10% of world production in volume and 1.5% in value. help Indian companies keep production costs on par.

Pharma Times - Vol. 52 - No. 04 - April 2020 40 Pharma Times - Vol. 52 - No. 04 - April 2020 41 • The second scheme aims to provide incentives for incremental production during the base year of critical drugs. The government has identified 26 fermentation and 27 chemical based raw materials, on which India relies heavily for imports and has formulated a scheme to incentivize 20% for the first four years, 15% for the fifth year and 5% for the sixth year in incremental production. They have also identified 27 key chemical based raw materials for which an incentive rate of 10% will be provided during the six-year period of the scheme. These APIs largely contain anticancer drugs, antibiotics, anti- inflammatories and antidiabetic agents. • The third scheme focuses on promoting the national manufacture of medical devices. It offers grants in aid to state governments to set up four medical device parks, at the cost of Rs. 100 million rupees each. The parks will have common facilities such as a test center, an electromagnetic interference Fig No. 2: Opportunities for India in COVID 19 laboratory, a medical-grade low vacuum modulation, a Mouth masks, disinfectants and hygiene products have become sterilization centre and electricity testing. expensive: This is a direct effect of coronavirus outbreak in India. • The fourth scheme is to help medical device manufacturers. A While the WHO discourages the accumulation of masks and manufacturing-related incentive scheme has been formulated disinfectants against pollution, the market may face strong demand to provide 5% incentives for six years to medical device that has already started as India reports cases in Rajasthan, Delhi, manufacturers. An incentive scheme linked to production Telangana and Maharashtra. Currently, the principles in the N95 has been formulated to provide a 5% incentive in six years to masks have been shot online. Sellers like Amazon and Flipkart manufacturers of medical devices in four categories: cancer are listing skins ranging from INR 499 to over INR 1,000. Some treatment / radiotherapy, aesthetic and cardiorespiratory products are no longer available and some have 9,999 original medicine, radiology and nuclear and all implants such as prices with a significant discount. As companies rush to raise prices cochlear and pacemaker. During these years, Rs. 3.42 billion due to demand and healthcare sectors suffer from unavailability, it will be distributed as incentives to producers under the scheme. is not difficult to predict the scarcity of masks as people make their The government is also looking for additional production of way to local pharmacies and shopping online to get their supplies. medical devices worth Rs. 68,437 crores in the first five years Likewise, hand sanitizers are installed in most stores, and nearly Rs 19 billion of import substitutions per year, which The costs of medicines and medical treatment are expected to will also help us export medical devices. Similarly, it is targeting increase: The Indian pharmaceutical sector depends on Chinese an incremental API production of Rs 46.8 billion over the next raw materials. With the blockades in China, the supply route has five years and replacing imports of Rs 19 billion per year. These been largely interrupted. The stock of raw materials for medicines efforts will promote Make in India, the replacement of imports, will have difficulty reaching the Indian pharmaceutical industry. This exports and guarantee the safety of medicines. is already affecting drug prices. According to CRISIL reports (via IMPACT OF COVID-19 ON THE COMMUNITY [6,7] Business Today), the cost of common medicines like paracetamol, which is a common pain reliever, has increased by a whopping 40%, The coronavirus epidemic in China and other parts of the world while 69% of Indian medicines come from China in bulk purchases. can have a direct and indirect impact on the Indian economy. In addition to relying on the offer of the sector, we have not yet Coronavirus spread across India in March and since then, India received concrete updates on the costs of treatment, testing and has over 2000 cases of COVID-19. After the outbreak of the most prevention of the spread of the virus. affected countries such as China, Iran and Italy in Spain, Germany, South Korea, the United States and the United Kingdom, the Industries that depend on cheap labour could suffer a blow: World Health Organization has declared that COVID-19 is a global As the Ministry of Family Health and Welfare prepares for a health pandemic. The rapidly spreading virus has a huge human cost with emergency, Union Minister Harsh Vardhan announced a multi- over 20 lakh patients who tested positive and a number of deaths step strategy to combat COVID-19. The plan calls for India to be that has crossed 1,36,000 since April 15, 2020. Maintaining the quarantined by the rest of the world in terms of air travel. Returning resources is necessary to fight the epidemic and flatten the growth foreign or Indian citizens will have to specify a compelling reason curve, of the world. The economy is about to face a setback. China to enter the country if they are not on the diplomatic mission of is an important player in the world market and, due to the way the United Nations and WHO. At the state level, the government India integrates with the Chinese economy, will have a significant has been trying to curb community broadcasts since Section 2 of impact on the Indian economy. According to UNCTAD, the cost the Emergency Illness Act was issued by the Ministry of Health of the pandemic is $ 2 trillion. COVID-19 is a health threat and and Family. While immigration will be controlled, there are several is rapidly proving an economic threat. It could cripple several parts of India that the government cannot even begin to evaluate. economies starting with employees and industries affected by stock Cheap labor is a large part of the Indian economy. As the virus market crashes and the closure of workplaces due to the inability travels through the populated country, local broadcasts could of the workforce function. In India, the impact has not been fully increase the number of cases. Workers do not receive health care anticipated, but as the Chinese economy stagnates, we can expect and employment benefits to treat the viral epidemic. Poor health some sectors to be hit almost immediately. On the contrast the is very likely to be affected by the workforce, which could result opportunities for India in COVID-19 are stated below (Fig No. 2). in a lack of assistance, which would further paralyze sectors that

Pharma Times - Vol. 52 - No. 04 - April 2020 40 Pharma Times - Vol. 52 - No. 04 - April 2020 41 are dependent on cheap labor. Containment becomes a difficult 5. https://economictimes.indiatimes.com/news/economy/policy/ task. covid-19-centre-chalks-out-four-schemes-to-boost-production-of-bulk- drugs-and-medicaldevices/articleshow/74867468. CMS? utm_source CONCLUSION = contentofinterest & utm_medium = text & utm_campaign = cppst (consulted April 18, 2020) Coronavirus spread across India in March and since then, India 6. https://www.business-standard.com/article/economy-policy/govt- has more than 12,799 cases of COVID-19. After the outbreak in the approves-rs-13k-crore-package-to-boost-bulk-drugs-manufacture- most affected countries such as China, Iran, Italy, Spain, Germany, 120032101140_1.html (access April 18, 2020) South Korea, the United States and the United Kingdom, the World 7. https://economictimes.indiatimes.com/https://economictimes. Health Organization declared that COVID-19 is a global pandemic. indiatimes.com/industry/healthcare/biotech/pharmaceuticals/ The rapidly spreading virus has a huge human cost with over 23 remove-policy-hurdles-grant-infrastructure-status-to-bulk-drug- lakh patients who tested positive and a death toll that crossed industry-cii- kpmg-report / articleshow / 75208267.cms? utm_source 161,191 through April 19, 2020. Maintaining the resources needed = contentofinterest & utm_medium = text & utm_campaign = cppst to fight the epidemic and flatten the growth curve. The global (Consulted April 18, 2020) economy will face a setback in the midst of a global emergency. Advertisement Index Despite being the main player in the pharmaceutical Sr. No. Company Name Pg. No. industry, a large gap that has developed 1. Aczet Pvt. Ltd...... 60 over the years in 2. Ami Polymer Pvt. Ltd...... 23 the Indian industry is the excessive 3. Brothers Pharmamach (I) Pvt. Ltd...... 6 d e p e n d e n c e o n 4. CONDOT...... 62 Chinese APIs (bulk drugs), in particular 5. Elmach Packages (India) Pvt. Ltd...... 34,35,63 fermentation-based 6. Fourrts (India) Laboratories Pvt. Ltd...... 61 products such as 7. Gattefosse (India) Pvt. Ltd...... 2 Penicillin G and many intermediate 8. J.S.S. College of Pharmacy...... 3 materials (KSM or 9. SRICO...... 29 key start for API). Therefore, the great opportunity fo r I n d i a i s t o Advertisement Tariff for Pharma Times Fig No.4: General Information On the Public internalize the entire Health of the World Health Organization supply chain for our Positions For Color For B/W sake, in addition to page (Rs.) page (Rs.) presenting ourselves Per insertion Per Insertion as an end-to-end giant in the pharmaceutical supply chain. A strong Front Cover Gate Fold 50,000.00 - pharmaceutical industry has always been a pillar of affordable health care in India and this trend can be expected to be further Back Cover 44,000.00 - strengthened now. Inside Front 30,000.00 - Current crisis of fans, PPE, masks, diagnostic kits: Almost all Inside Back 28,000.00 - navigation equipment arrives in China. In India, several non-medical First Page (Page 3) 30,000.00 - equipment companies took the opportunity and transformed their Last Page (Opp. Inside Back) 20,000.00 - production to produce fans and other equipment that is currently Page Facing Content & 20,000.00 - needed. The pandemic will eventually disappear, but the team Editorial Note will remain. A push through Make-in-India for medical equipment can further strengthen this trend. The General Information and Double Spread (Or Centre 35,000.00 - Precautionary Measures On the Public Health by World Health Spread) Organization is stated in figure number 4. Full Page 16,000.00 10,000.00 REFERENCE Half Page 9,000.00 6,000.00 1. https://www.expresshealthcare.in/blogs/covid-19-pandemic-long- Discount for 1 to 3 insertions - 10% term-impact-on-indian-healthcare/418670/(Consulted April 15, 2020) Discount for 4 to 6 insertions - 15% 2. https://www.abpi.org.uk/medicine-discovery/covid-19/what-are- Discount for 7 to 12 insertions - 20% pharmaceutical-companies-doing-to-tackle-the-disease/(Consulted April 15, 2020) Note: From 1st July, 2017 GST 5% will be applicable for advertisements. 3. https://www.ameexusa.com/blogs/covid-19-impact-on- For Advertisements: Contact us at Tel. 022-26671072 / 26670744 pharmaceutical-industry (Consulted April 15, 2020) [email protected]/[email protected] 4. https://qz.com/india/1830849/coronavirus-could-be-indian-pharmas- big-opportunity-in-africa/(Consulted April 16, 2020) Website: www.ipapharma.org

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CLUES ACROSS 41. Covid19 protective gear for your eyes (7) 1 . New norm for keeping away from others [6, 1st 9 of 10 letters] (6, 42. Disease spread across the world (1st 7 of 8 letters) (7) 9) 9. The highest number of Covid19 cases are __ ___ [in reverse order] DOWN (2,1,1,1) 1 . In lockdown, don’t go out [4, 2, 1st 3 of 4 letters] (4,2,3) 10. From here a swab could be taken to check for CoV-2 [1st 3 of 4 letters, 2 . One of the ‘symptoms’ you hear to be alert of a Covid19 suspect (5) read backwards] (3) 3 Zydus, ICPA make the ___ of this tablet currently in hot demand 11. The tiniest being that shook the high and mighty the world over [read (1,1,1) backwards] (5) 4. Kill the microbes on the non-living substance (9) 12. Machine learning - will this application help in the fight against 5. The “handy” thing that went off the shelves in a mad rush for cleaning Covid-19? (1,1) (9) 13. This type of cat could be an intermediate host for the new corona ? 6. Homeopathic preventive remedy for Corona, suggested by AYUSH. Not [middle 3 of 5 letters] (3) a poison in the album (1st 5 of 8 letters) (5) 14. From RA to Covid19 prophylaxis limelight (1,1,1) 7. The new worldwide buzzword with a genetic strand and crowns (6) 16. You must compulsorily report a Covid-19 diseases case to the 8. A strain not known before, so the new name (5) authorities. Because it is now ______[1st 3 of 10 letters] (3) 18. Fruit bats hosted this virus in West Africa[1st 3 of 5 letters, in reverse 17. Homemade masks qualify as ___ - medical ones (3) order] (3) 19. The prime flying suspect for transmission of nCoV (3) 15. Isolate for 14 or 28 days (1st 4 of 10 letters) (4) 20. Could this climatic temperature kill the nCoV ? (3) 22. It ‘flu’ in a century ago (7) 21. If you took the current pandemic’s most discussed drug, you could 23. The world eagerly watched every day for any ‘sudden’ rise of nCoV get ______as a rare side effect (1,7) cases [last 3 of 5 letter word] (3) 23. This gun at your forehead – measures how hot you are [in reverse 26. The single strand in nCoV [in reverse order] (1,1,1) order] (1,1) 27. Something similar to nCoV struck in the middle-east in 2000 [2nd, 24. Crucial shielding kit, for COVID-19 frontline warriors. But in short 3rd, 4th initialism of 4 letters, in reverse order) (1,1,1) supply across the world [in reverse order](1,1,1) 28. When you detect a CoV-2 positive patient, you ______him/her? 25. Another frontline cover-up warrior on the face (4) [1st 3 of 7 letters, in reverse direction) (3) 27. In the lockdown period, non-essential ______are not permitted to 29. Manoeuvre it in the throat, take a sample and test for CoV-2 (1st 3 open for business (6) of 4 letters) (3) 30. Settling of RBCs – a strong factor to predict disease progression in 32. LPV/R are _____, being tried out in COVID-19 (1,1,1) COVID-19 ? (1,1,1) 33. These changes made the coronavirus deadly (1st 5 of 7 letters in 31. Birthplace of current pandemic (5) reverse direction) (5) 32. This HIV treatment could help in getting the better of SARS-CoV2 ? 35. Version 1 (2003) of COVID-19 (1,1,1,1) (1,1,1) 36. Simple and cheap CoV-2 killer. Use with water for 20+ seconds (4) 34. Intermediary host for MERS-CoV. Water storer? [1st 2 of 5 letters] (2) 37. The UK wanted its population to get CoV-2 infected to get this immunity (4) 37. In the Covid and post era the warm _____ with friends and colleagues could be a strict No No (4) 39. If you are ___, strictly do not report to work (3) 38. Mechanical breather. Costly, heavy shortages in the pandemic (10) 40. New evidence in this animal showing that Remdesivir could help in Covid? Shares 93% DNA sequence with humans. (1,1) Read the Next issue for the quiz results & the names of the winners !!

Pharma Times - Vol. 52 - No. 04 - April 2020 42 Pharma Times - Vol. 52 - No. 04 - April 2020 43 customers and for the pharmacists. Posters for pharmacists were especially made to salute the dedicated services of the pharmacists and pharmacy team during this pandemic and to give recommendations for personal safety and care. Both of these posters were made in English as well as in Hindi and were widely circulated to all the pharmacists across the country through social IPA Community Pharmacy Division media and IPA website. IPA CPD prepared special informative posters for the pharmacy

IPA Industrial Pharmacy Division facemasks to 4 medical colleges of Tamilnadu. This support was IPA Industrial Pharmacy Division (IPD) under the leadership of also gratefully acknowledged by the Minister of Health & Family IPD Chairperson, Dr. J. Jayaseelan has been involved in public Welfare, Tamilnadu, Dr. C. Vijayabaskar. service programs during the COVID-19 pandemic and distributed IPA Hospital Pharmacy Division total 1000 litres of alcohol- based sanitizer and 500 units of N95 IPA Hospital Pharmacy Division (HPD) Executive Committee member, Dr. Suresh Saravdekar engaged a webinar on 'Patient Centric Hospital Pharmacy Services', on 17th April, 2020. The webinar was supported by Cipla. The 10 salient learnings for hospital pharmacists from the webinar are as follows : 1. Hospital Health Care Services is most important and essential services of patient care and Hospital Pharmacy Services plays a key role in Safe and Effective Medication Management in the hospitals 2. World over, use of medicines is essential and basic aspect of in all health care services. IPA National Vice Chairman, Industry Division Mr. J. Jayaseelan has 3. World over, medicines are used by the people as a consumer handed over 1000 Ltrs of Hand Sanitizers and 500 N 95 Masks to good for Self Care as well medicines are used by health care Tamilnadu Health Minister Dr. C. Vijayabaskar along with Mr. S V P S providers for Sick Care. Sivanandhan

Pharma Times - Vol. 52 - No. 04 - April 2020 44 Pharma Times - Vol. 52 - No. 04 - April 2020 45 4. Irrespective of who uses medicines, all medicines have two IPA Delhi State Branch fundamental and basic characteristics. Firstly, all medicines 1. Dr. Gaurav Kumar Jain, Secretary, IPA Delhi branch, along with including natural ones are foreign to the body and secondly, Shri Balaji Sewarth has run campaign for providing food and currently used medicines cannot be selective and targeted only groceries to poor and needy people during COVID-19 lockdown. to effected organ or system. The campaign was run throughout country and Dr. Jain was 5. Consequently, being foreign to body when medicines are incharge for Haryana State. consumed or administered in the body, the body tries to throw 2. Team of IPA Delhi Branch Students’ Forum under leadership of these foreign substances outside body. Dr. Gaurav Jain distributed free of cost hand sanitizers to Delhi Police and common people for best hygiene practice. The hand 6. Body does this mainly through two organs; first liver converts sanitizers were prepared in Nanomedicine Laboratory, Jamia the medicines in urine soluble form and then kidneys throws Hamdard, New Delhi under guidance of Dr. Farhan Jalees it outside body through urine. Subsequently, these two organs Ahmad. liver and kidneys are overburdened after habitual and chronic use of medicines. 7. Further, because medicine is non-specific and cannot be targeted for its action, when consumed or administered into body, medicine gets absorbed into the blood and travels all over body including desired site of its action in the body as well undesired sites. This undesired effects on the untargeted organs produce undesired effects. These unavoidable effects are called as Untoward / Side Effects and Adverse Drugs Dr. Gaurav providing free hand sanitizer to police person and health worker Reactions. 3. IPA Delhi branch team sensitized people 'to stay home and 8. Therefore, it should clear that the consumption of Medicine is follow lock-down' through a collage circulated via Facebook, not as simple and similar to the consumption food, which is a Instagram and various other social media. natural to the body. Use of medicines involves various complex and different systems of the body. 9. Hospital Pharmacist who is well equipped with the knowledge and experience about the intricacies and details about medicine use which occur during use of medicines either for Self Care and for Sick Care, can play a crucial role in safe and effective Medication Management in the hospital health care services. 10. The Hospital Pharmacist should use the knowledge of safe use of medicines to educate the patients and also to empower him/ herself. This would help in evolving and designing a health care system which would be 'Patient Centric rather than Product Centric.'

IPA Assam State Branch The members of IPA Assam State branch and the Department of Pharmaceutical Sciences, Dibrugarh University prepared 30 liters of liquid sanitizer and 40 liters of liquid hand wash and had distributed to Assam Medical IPA Delhi Branch Team awareness campaign for Support of Lockdown C o l l e g e a n d 4. Dr. Gaurav Kumar Jain was invited as a Speaker for a COVID-19 Hospital (AMCH). related webinar titled 'The Upside Down World- The Changed Another lot of Paragon of Education and Research' jointly organized by ICT liquid hand wash Mumbai and NIPER, Mohali on 15th April, 2020. Dr. Gaurav Jain was also provided emphasized on the topic 'New Considerations and Challenges to the Indian Bank, for Student Under COVID-19- How to be prepared for the after Dibrugarh Branch. effects'. The lecture was well appreciated and was found to be Research Scholars handing over the consignment Moreover the very relevant by most of the attendees. to AMCH Officials faculty members 5. Dr. Sushma Talegaonkar, EC Member of IPA Delhi branch and of the Dept. of Pharmaceutical Sciences along with all the teaching Isha Aggarwal, IPA-SF Member organized E-article competition and non-teaching staff of Dibrugarh University have donated one and E-poster competition on Theme 'COVID-19 impact on day salary of Rs. 15 lakhs to the Chief Minister Relief Fund, Assam Global Pharmaceutical Industry.' The competition had over Arogya Nidhi. 500 participants.

Pharma Times - Vol. 52 - No. 04 - April 2020 44 Pharma Times - Vol. 52 - No. 04 - April 2020 45 IPA Gujarat State Branch List containing 3000 plus members willing to render any necessary Gujarat State Pharmacy Council, in co-operation with IPA Gujarat service. The pharmacists rendered services in home quarantine State Branch and other organizations, has taken several initiatives and screening of labourers. The Council has prepared e-link that to display professional role of pharmacists in testing times like enables any one to locate nearby Chemist & Druggist store/ Pharmacy and inquire about availability of any particular medicine during lockdown. The Council jointly with other institutes have set up a platform United for humanity to serve as a bridge between volunteers who are willing to serve and all in need of service like residence/food/health/security etc. Mr. Montu Patel, President of GSPC has been appointed as State nodal officer for Gujarat. NIC has appointed 58 nodal officers in all in different states as part of empowered group 4 on COVID 19 for augmenting human resources & capacity building. Graduate School of Pharmacy, Gujarat Technological University in association with IPA Gujarat State Branch prepared alcohol-based COVID crisis. To begin with, President and members of State hand sanitizer as per WHO recommended formula and distributed Pharmacy Council met Mr. Nitin Patel, Deputy Chief Minister of to cops and all staff on official duty. IPA Jharkhand State Branch IPA Jharkhand state branch has taken some steps to fight COVID-19 under the guidance of IPA President, Dr. R. N. Gupta. The branch arranged awareness programme among nearby villagers and local people to fight coronavirus pandemic by distribution of pamphlet and orally through nukkad sabhas. They were informed about use of mask, hand washing, safety precautions and also the importance of maintaining social distancing while going out for emergency work only. Dr. M. P. Chopra, Secretary of branch and Secretary of Lions Club International, Ranchi joined hands with Ramakrishna Ashram, Ranchi, and distributed raw foods to around 300 needy family in different parts of Ranchi. Dr. Abhimanyu Dev, Dr. Venketash and Dr. K. K. Pradhan, IPA member and faculty member of Department of Pharmacy, Birla Institute of Technology, Mesra, Ranchi, have started research work to select drug from existing molecules to fight COVID-19 using different techniques. IPA Madhya Pradesh State Branch 1. Sanitizer distribution campaign to Nagar Nigam Indore: Gujarat and offered donation of Rs. two lakhs towards CM Relief Mr. Anil Kharia, President, IPA MP State branch prepared Fund. Equally important, the Council offered Pharmacist warriors sanitizer and distributed approximately 1700+ sanitizer bottles to the government authorities of the Madhya Pradesh to prevent viral infection amongst the community. Awareness about measures to prevent getting infected were also given.

2. Pharma student awareness in society regarding corona virus: Students of the Modern Institute of Pharmaceutical Sciences under the aegis of the IPA MP State Branch prepared various slogans and video for the awareness of the corona virus in society.

Pharma Times - Vol. 52 - No. 04 - April 2020 46 Pharma Times - Vol. 52 - No. 04 - April 2020 47 provided. IPA-MSB also demonstrated efforts to support the Corona health warriors. 50,000 Hydroxychloroquine Tablets were received from Sun Pharma Ltd. and The Pharmaceutical Wholesalers A s s o c i a t i o n , w i t h coordinated efforts, for distribution to Municipal Corporation’s health worker s at Mumbai and Navi Mumbai. The branch has also aided in arranging four blood donation camps with Mobile Blood Donation

Facility. Timely availability of 3. Online interactive session for awareness of COVID-19 140 units of blood benefited Dr. Sapna Malviya, Professor and Head, Modern Institute of 130 Thalassaemic Major Pharmaceutical Sciences under the aegis of IPA MP state children for maintaining Branch addressed students and faculties on COVID-19 their haemoglobin level and precautionary measures and Ayurveda – based diet, yoga and boosting their immunity during this critical period. meditation that can boost immunity. M s . M a n j i r i G h a r a t , 4. Preparation of the hand rub sanitizer as per WHO Chairperson, Community Mr. Ankur Joshi, Assistant Professor of the Modern Institute Pharmacy Division- of Pharmaceutical Sciences under the aegis of IPA MP state IPA, delivered a talk in Branch prepared hand rub sanitizer as per WHO (World health a webinar organised by Organization). The hand rub formulation contained Ethanol Cipla Ltd. for Practising 96%, Hydrogen peroxide 3 %, Glycerol 98% and Sterile distilled Pharmacists on ‘Safety of water. The prepared hand rub sanitizer was distributed in Pharmacist & Responsible various department of the institute for the purpose of safety use of medicines’, on 20th April, 2020 which from COVID-19. was attended by more IPA Maharashtra State Branch than 3,200 Practising Pharmacists across To support the ongoing battle against COVID-19, several measures India. have been undertaken by IPA-Maharashtra State Branch (IPA- MSB). IPA-MSB has On announcement of supported opening lockdown, the BCP of a Community m a n a g e m e n t h a s Clinic, which is ensured enforcement of proper first of its kind, measures on campus to prevent any jointly with Prabhat infection. The management has also Charitable Trust successfully accommodated all 45 and Om Gagangiri labourers involved in construction of O c c u p a t i o n a l the IPA building. The migrant workers Health Services, from Bihar, UP, West Bengal, Jharkhand, along with mobile etc. have been provided with proper van facility for digital X-ray and blood sample collection at Ghansoli, facilities related to stay at IPA building with social distancing and Navi Mumbai. Mr. Satish Shah Vice President, IPA-MSB and the food. Counselling is being provided to them in a simple language Council Members, Mr. Vijaykumar Ghadge and Mr. Sureshkumar C h a u d h a r y h a v e been instrumental in providing medicines and other related materials like face masks and sanitizers worth Rs. 25,000. Four Community Clinics have been opened till and periodic interactive sessions are conducted about dos and the third week of April jointly with Indian Medical Association and don’ts to prevent Covid 19 infection and to raise awareness. Proper Ghatkopar Medical Association at four localities in Ghatkopar, quarantine measures and facilities including bedding, pedestal fans Mumbai. Medicines and other related materials like face masks, were provided to the laborers. One of the laborers showing malaria sanitizers, infrared thermometers worth one lakh rupees were symptoms was provided proper treatment. To prevent further

Pharma Times - Vol. 52 - No. 04 - April 2020 46 Pharma Times - Vol. 52 - No. 04 - April 2020 47 such cases, mosquito repellent cream was provided to everyone from government and other agencies. IPA-MSB’s BCP has also in campus. Furthermore, to boost their immunity levels, they are undertaken various academic initiatives to support its staff, given lemon water and hot turmeric water twice a day. The security faculty and students during the lockdown period. The faculties and students are using the various digital tools from the licensed version of Microsoft 365 to aid visualization-based learning. Few of the students have contributed by preparing hand sanitizer using WHO formula and cloth face masks which were distributed by them to needy persons. IPA Students’ Forum Indian Pharmaceutical Association Students’ Forum (IPA-SF) organized various awareness campaigns, camps, community drives, competitions all across the country for the prevention and management of COVID-19 with banners, posters and quotes. and housekeeping personnel have been provided accommodation 1. Indian Pharmaceutical Association and IPA-SF-BIHAR organized in campus. The campus has been frequently sanitized using a community-based awareness program on prevention and fogging technique management of COVID-19 in the month of February in different and all personnel hospitals and rural areas of Bihar. Members of IPA-SF explained have been provided about the importance of social distancing, hand washing with face masks techniques, maintaining hygienic conditions and building a n d i n d i v i d u a l immunity by food with the help of banners, posters and leaflets hand sanitizer on Corona printed both in English and Hindi. bottles. Everyone staying on campus

is being monitored p e r i o d i c a l l y fo r body temperature using a thermal thermometer. The p e r s o n n e l a r e supported financially to buy personal hygiene materials. The resident team of senior Ph.D. student and The first camp was organized at 8th February, 2020 at Nalanda maintenance staff also helped people in surrounding localities to Medical College and hospital (NMCH), Agamkuan, Patna. Second maintain social distancing camp was at Patna Medical College and hospital (PMCH), Patna while buying vegetables and third on 21th February, 2020 at SKMCH, Muzaffarpur. and grocery from local vendors. The awareness camp was successful under the guidance of Secretary of IPA Bihar State Branch Shri R. Bandopadhyay and To ensure good health Mr. Sanjeev Rai. of all students of IPA MSB’s BCP, IPA-MSB staff 2. The members of the IPA-SF SJCOPS Chapter, Chalakudy, enquired numerous times Kerala in coordination with the Students Council of St. James with students and their College of Pharmaceutical Sciences, Chalakudy conducted an parents about their health awareness program on the 'Current scenario of Novel Corona th and assured them of providing any aid, if needed. The BCP virus and its preventive measures' on 7 February, 2020. A total management has also created a class wise group of students along of about 600 students and staffs participated in the session. with their parents on WhatsApp for sharing information quickly

The students and members of IPA-SF SJCOPS chapter also reached the public by counselling the individuals by visiting their homes in the municipal ward and educating them about the preventive measures, hand washing techniques to prevent and effectively. Ms. Swati has been coordinating with parents the pandemic disease. They distributed the pamphlets which and students to ensure effective communication of directives include the preventive and safety measures against COVID-19.

Pharma Times - Vol. 52 - No. 04 - April 2020 48 Pharma Times - Vol. 52 - No. 04 - April 2020 49 Awareness campaign was successful under the guidance of Dr. IPA Enikepadu Local Branch KrishnaKumar, Principal St. James College of Pharmaceutical Sciences and Dr. David Paul, Dean, Pharmaceutical Sciences. The students and the public given a good response and actively listened to the instructions.  RESPIRATORY DROPLETS 3. Chebrolu Hanumaiah Institute of Pharmaceutical Sciences along - When droplet particles are > 5-10 then they are called respiratory droplets and can with its IPA-SF Chapter organised awareness campaign about travel up to 6 feet (nearly 2 meters).μm in diameter, Coronavirus and COVID - 19 in the villages of Obulunaidupalem, - When droplet particles are < in diameter, then they are called respiratory nuclei and can Potturu, Yanamadala, Chowdavaram and Dasaripalem in Guntur travel longer distances in air. 5μm - Coronavirus is primarily transmitted through district well before the spread of Corona virus in the country. respiratory droplets.

CLOSE CONTACT - Respiratory droplet transmission occurs when a person is in close contact (within 1m) with someone who has respiratory symptoms (cough or sneeze). - Hence the person is at risk of having his/her mucosa (mouth, nose) or conjunctiva (eyes) exposed to potentially infective droplets.

CONTACT WITH INFECTED SURFACES OR OBJECTS - Coronavirus can transmit through indirect contact with surfaces in the immediate environment or with the objects used on the infected person (e.g., stethoscope or thermometer). - Some of the objects or surfaces that may transmit the virus from the infected person are digital The Principal of CHIPS, Dr. S. Vidyadhara flagged off the event. devices (mobile, laptops, mouse), lift buttons, pens, The students organised a rally and also went on a door to door door knobs, stair bannister. campaign educating the people about the virus, it's spread,  maintenance of self hygiene, hand washing and importance of Prepared by social distancing. So far, no cases of coronavirus were reported Y.S.N.S. Surya Akhila Pharm.D – V/VI Year in all the five villages and people are healthy, practicing the IPASF-VIPW isolation measures. Nagarjuna Education Society, contributed VIJAYA INSTITUTE OF PHARMACEUTICAL SCIENCES FOR WOMEN (Approved by AICTE & PCI, New Delhi; Recog. by Govt. of AP & Affiliated to JNTU, Kakinada) an amount of Rs. 5,00,000/- each to PM Cares and to Andhra Voluntary serviceENIKEPADU, activities VI forJAYAWADA containment - 521108, of Naval ANDHRA Corona PRADESH, Virus INDIA (Covid -19) and Pradesh CM's Relief Fund. Difference between surgical masks and How to Put on, Use, Take off and financial contributionrespirators: to CM Relief Fund of AP andDispose Telangana the mask? Voluntary service activities for containment of Naval Corona Virus (Covid-19) and 4. Department of pharmacy practice, ASN Pharmacy College, Surgical masks help to prevent droplets being  Loosely cover the mouth and nose. expelled out to the environment by the wearer and  Should be light in weight. financial contribution to CM Reliefto protect Fund patients andof operative AP and site. Telangana  Avoid touching the mask while using it. Tenali, Andhra Pradesh organized a community based As a generous move towards the pandemic outbreak of COVID-19, the IPAIf in Khammamneed to touch clean local the hands branch with th a lco ho l-based hand rub or soap and awareness program on COVID pandemic on 20 March, 2020in associationAs a generous with move KLR towards Pharmacy the pandemic College outbreak conducted of COVID covid-19, the-19 IPA awareness Khammam local program branchwater. and distributed free at some rural areas surrounding Tenali. IPA-SF membersin associationfood packets with KLR to thePharmacy commuters College conducted on highways, covid-19 orphanages awareness program and poorand distributed people freeat Paloncha, Bhadradri

Respirators are used to potential contact of the distributed the pamphlets to them regarding steps to befoodKothagudem packets to the district commuters of Telangana on highways, state orphanageswearers; Rajanagaram to andairbone poor haz of ardous people East contaminant Godavariat Paloncha,s. district Bhadradri and Ongole district in

followed to prevent COVID-19, as per safety measures to beKothagudemAndhra Pradesh district of. Telangana state; Rajanagaram of East Godavari district and Ongole district in  To remove mask: Remove it from the followed given by WHO. The villagers listened to all suggestions Mrs.K.Nagamani Chairman and Mr.Y.Madhusudan Reddy Secretary of KLRbehind Institutionsand do not touch the along front of thewith Andhra Pradesh. mask.  Discard immediately in a closed bin and actively in large number and presented good response. Prof.G.Nagarjuna Reddy, Director of KLR Pharmacy college and KLR Lenora Dentalimmediately College clean the and hands .all its KLR Mrs.K.Nagamani Should be breathable. Chairma n and Mr.Y.Madhusudan Reddy Secretary of KLR Institutions along with  Should have elastic strap band instead of tie- When to Use Mask? on strap and is made of soft materials. Prof.G.NagarjunaInstitutions studentsReddy, Director and staffof KLR members Pharmacy collegehave Wear contributedand a KLR mask Lenora if you Rs. Dental are10 coughing,00,000/ College or -and to allCM its Relief KLR fund of Telangana  Shri. A. Sivakumar, MLA Tenali sponsored sanitizer bottles Should have 2 headbands, nose foam & clip. sneezing. and Andhra Pradesh states. Mrs.K.Nagamani Masks Chairman are effective also only came when used forward in and provided the ration and that were distributed to rural people. The awareness campInstitutions students and staff members have contributedcombination Rs.10,00,000/ with frequent- to CM hand Relief cleaning fund of Telangana with alcohol-based hand rub or soap & water. andshelter Andhra forPradesh about states 15.0 Mrs.K.Nagamani commuters at Chairman Rajahmundry also came and forward Rajanagaram and provid edof theEast ration Godavari and district in Andhra was successful under the guidance of Dr. K. Venkata Ramana,  shelterPradesh. for about We 1 are50 commuters also providing at Rajahmundry allPrepared personal by: and M. RajanagaramcareSivakshari products, Pharm. of DEast ( -Bedding, V/VI Godavari Year, IPASFsoap, district-VIPW brush, in Andhra paste, hair oils, first aid Professor & Principal, ASN Pharmacy college, Tenali. VIJAYA INSTITUTE OF PHARMACEUTICAL SCIENCES FOR WOMEN Pradesh.kit etc.) We for are above also providing 150 people(Approved all personal in by shelter.AICTE care & products PCI, New (Delhi,Bedding, Recog. soap, By Govt brush, of AP paste, & Affiliated hair oils, to JNTU first Kakinada)aid 5. IPA-SF St. Pauls chapter from St. Pauls College of Pharmacy ENIKEPADU, VIJAYAWADA – 521108, ANDHRA PRADESH, INDIA kit etc.) for aboveThe 150 Staff people of KLR in shelter. Lenora Dental College have trained the staff and students of KLR Pharmacy conducted awareness programs about COVID-19 in Shanti CollegeThe Staffwho ofwere KLR Lenorainvolved Dental in volunteering College have trainedand educating the staff and the students public ofsafety KLR Pmeasuresharmacy of COVID-19. The kiranalu orphanage, Hyderabad on 18th March, 2020 and IPA Khammam Local Branch Collegefinal whoyear were Pharm.D involved students in volunteering and staff and ofeducating KLR Pharmacy the public College safety measures along with of COVID Govt.-19. officials The and Students and finalstaff year ofAs Pharm.D KLR a Lenoragenerous students Dental and staff College move of KLR, Pharmacy educat towardsed College the public thealong with pandemicover Govt. importance officials andoutbreak of Students social distance,and of COVID-19, usage of mask, staffsanitizer of KLRthe Lenora and IPA methodDental Khammam College of washing, educated the local the hands public branch etc.,over importancefor the in containment associationof social distance, of COVID usage with -of19. mask, KLR Pharmacy sanitizer andCollege method of conductedwashing the hands etc., Covid-19 for the containment awareness of COVID-19. program and distributed free food packets to the commuters on highways, orphanages and poor people at Paloncha, Bhadradri Koth- agudem district of Telangana state; Rajana- garam of East Godavari dis- explained handwashing and other social distancing techniques trict and Ongole to 70+ orphan kids. IPA-SF team prepared posts in English and district in And- Dr.G.Nagarjuna Dr.G.Nagarjuna Reddy (Left side Reddy Photo) and (Left Dr.J.V.Suresh side (RightPhoto) side Photo)and Dr.J.V.SureshDistributing Food & water for high way commuters, vernacular languages and uploaded in social media to make (Right side Photo) Distributingpoor andFood daily &wage water workers. for high way hra Pradesh. sure it reaches each and every person in the society. Dr.G.Nagarjuna Reddy (Leftcommuters, side Photo) and Dr.J.V.Suresh poor (Right and side Photo)daily Distributing wage Food workers. & water for high way commuters, poor and daily wage workers. Mrs. K. Naga-

Pharma Times - Vol. 52 - No. 04 - April 2020 48 Pharma Times - Vol. 52 - No. 04 - April 2020 49

(Right to left) Shri V.Vijaya Sai Reddy Member of Rajya Sabha; Dr.Satheesh Kumar Reddy President A.P. State Dental Council and Dean of KLR Lenora Dental College; Dr. T. Murali Mohan Registrar, AP State Dental Council and Mr.Y.Madhusudan Reddy Secretary of KLR Institutions (Right to left) Shri V.Vijaya Sai Reddy Member of Rajyahanding Sabha; Dr.Satheesh over the ChequeKumar Reddy to A.P. President Chief A.P. Minister State Dental Relief Council fund. and Dean of KLR Lenora Dental College; Dr. T. Murali Mohan Registrar, AP State Dental Council and Mr.Y.Madhusudan Reddy Secretary of KLR Institutions handing over the Cheque to A.P. Chief Minister Relief fund. Voluntary service activities for containment of Naval Corona Virus (Covid-19) and financial contribution to CM Relief Fund of AP and Telangana

As a generous move towards the pandemic outbreak of COVID-19, the IPA Khammam local branch in association with KLR Pharmacy College conducted covid-19 awareness program and distributed free food packets to the commuters on highways, orphanages and poor people at Paloncha, Bhadradri Kothagudem district of Telangana state; Rajanagaram of East Godavari district and Ongole district in Andhra Pradesh. Mrs.K.Nagamani Chairman and Mr.Y.Madhusudan Reddy Secretary of KLR Institutions along with Prof.G.Nagarjuna Reddy, Director of KLR Pharmacy college and KLR Lenora Dental College and all its KLR Institutions students and staff members have contributed Rs.10,00,000/- to CM Relief fund of Telangana and Andhra Pradesh states. Mrs.K.Nagamani Chairman also came forward and provided the ration and shelter for about 150 commuters at Rajahmundry and Rajanagaram of East Godavari district in Andhra Pradesh. We are also providing all personal care products (Bedding, soap, brush, paste, hair oils, first aid kit etc.) for above 150 people in shelter. The Staff of KLR Lenora Dental College have trained the staff and students of KLR Pharmacy College who were involved in volunteering and educating the public safety measures of COVID-19. The final year Pharm.D students and staff of KLR Pharmacy College along with Govt. officials and Students and staff of KLR Lenora Dental College, educated the public over importance of social distance, usage of mask, sanitizer and method of washing the hands etc., for the containment of COVID-19.

mani, Chairperson and Mr. Y. Madhusudan Reddy, Secretary of VIPER IPASF has prepared pamphlets in local language which Dr Raghavan Varadarajan of the Molecular Biophysics Unit of IISc KLR Institutions along with Prof. G. Nagarjuna Reddy, Director explain how to boost the immunity and the preventive measures is looking at a bunch of vaccine candidates to determine which is Dr.G.Nagarjuna Reddyof (Left KLR side PharmacyPhoto) and Dr.J.V.Suresh college and (Right KLR side Photo)Lenora Distributing Dental FoodCollege & water and for highto way be commuterstaken by , the individual. the most efficacious. Drawing upon previous studies on the 2003 all its KLR Institutions,poor students and daily wageand workers.staff members contributed SARS-CoV virus, these studies have shown that the antibodies Rs.10,00,000/- to CM Relief fund of Telangana and Andhra Pradesh against the spike glycoprotein found on the surface of the SARS- CoV virus inhibit viral infection. IISc (like some other researchers) is Vaccines against Novel coronavirus trying to design and test variants of the spike glycoprotein as vaccine India sets up high-level task force to develop vaccine for candidates. Currently, these vaccine candidates are being tested coronavirus; to co-ordinate with global researchers in animal models through Mynvax, a start-up jointly founded by Dr Varadarajan and one Dr Gautham Nadig. The team estimates that at www.businesstoday.in; 20 April, 2020 least 10 crore doses would be required to meet India’s requirement India has formed a high level task force to research on coronavirus if the SARS-CoV-2 infection persists for the medium to long term. It and develop a vaccine. The task force will also coordinate with has given itself four months to identify a first generation vaccine international community on vaccine development process for candidate, develop production technology in eight months and begin coronavirus. The task force will be co-chaired by Member, Niti human clinical trials in a year. Aayog, and Principal Scientific Adviser to the Government of India, China approves third COVID-19 vaccine for clinical trials (Right to left) Shri V.Vijaya Sai Reddy Member of Rajya Sabha; Professor K Vijay Raghavan. AYUSH, ICMR, Department of Science Dr.Satheesh Kumar Reddy President A.P. State Dental Council and and Technology (DST), Department of Biotechnology (DBT), CSIR, www.expresspharma.in; 25 April, 2020 (Right to left) Shri V.Vijaya Sai Reddy Member of Rajya Sabha; Dr.Satheesh Kumar Reddy President A.P. State Dental Council and Dean of KLR Dean of KLR Lenora Dental College; Dr. T. Murali Mohan Registrar, AP China has approved its third coronavirus vaccine for the second Lenora Dental College; Dr.State T. Murali Dental Mohan Council Registrar, and AP StateMr.Y.Madhusudan Dental Council and Reddy Mr.Y.Madhusudan Secretary Reddy of KLR Secretary of KLR Institutions DRDO, DG-Health Services, and Drug Controller General of India handing over the Cheque to A.P. Chief Minister Relief fund. Institutions handing over the Cheque to A.P. Chief Minister Relief fund. are also members of the task force. The task force has Department phase of clinical trials. An “inactivated” vaccine developed by of Biotechnology (DBT) as central coordinating authority. Its main Wuhan Institute of Biological Products under the China National states. Mrs. K. Nagamani also provided the ration, shelter and focus will be to set up a process for vaccine development. The task Pharmaceutical Group (Sinopharm) and the Wuhan Institute of personal care products (Bedding, soap, brush, paste, hair oils, force will make a list of national and international organisations Virology (WIV) started its clinical trials, state-run Xinhua news first aid kit etc.) for about 150 commuters at Rajahmundry and working on vaccine development. DBT will monitor the progress of agency reported. An “inactivated” vaccine consists of virus particles, Rajanagaram of East Godavari district in Andhra Pradesh. The VIPER IPASF prepared placards to promote community education research works and also facilitate the process. The task force will bacteria, or other pathogens that have been grown in culture and Staff of KLR Lenora Dental College trained the staff and students r e g a r d i n g create clinical cohorts focussing on long term follow-up of people then lose disease-producing capacity. In contrast, live vaccines use of KLR Pharmacy College who were involved in volunteering and significance of for better understanding of the disease. pathogens that are still alive. A total of 96 persons in three age educating the public safety measures of COVID-19. The final year lockdown and DBT approves funding for three companies for developing COVID- groups have received the vaccine in the first phase of clinical trial Pharm. D. students and staff of KLR Pharmacy College along with importance of 19 vaccine as of April 23. The vaccine has shown good safety results so far government officials and students and staff of KLR Lenora Dental staying home. and vaccine receivers are still under observation. The randomised, www.outlookindia.com; 20 April, 2020 College, educated the public over importance of social distance, D e v e l o p e d double-blind and placebo-controlled clinical trials of the inactivated usage of mask, sanitizer and method of washing the hands etc., sensor based The Department of Biotechnology has so far short-listed three vaccine are conducted in Jiaozuo, central China’s Henan Province, for the containment of COVID-19. hand sanitizer companies for funding the development of a vaccine for COVID-19, and the second phase of clinical trial will focus on the vaccination besides 13 other proposals it received for diagnostics, therapeutics procedure. The vaccine will also go through the third phase of the IPA Narsapur Local Branch c h a m b e r for students and other interventions to fight coronavirus. The three companies are clinical trial, and it may take about one year to complete the clinical As the whole world grapples with global pandemic of COVID-19, p o s t C OV I D Cadila Healthcare Ltd, Bharat Biotech International Ltd and Serum trial before finally reaching the conclusion on the vaccine’s safety Vishnu Institute of Pharmaceutical Education & Research (VIPER), Preparations Institute of India Private Limited. The Department of Biotechnology and efficacy. An adenovirus vector vaccine, developed by Institute of Sri Vishnu Educational Society (SVES), in association with IPA & and the Biotechnology Industry Research Assistance Council had Military Medicine under the Academy of Military Sciences, was the C l i c k t h e IPASF Narsapur Branch, Telangana has been taking a number of invited applications on the COVID-19 Research Consortium. The first first vaccine approved in the country to enter a clinical trial. below link to steps to prevent the spread of virus, educating phase of the call ended on March 30 and around 500 applications w a t c h h o w Coronavirus vaccine: Hyderabad’s IIL fourth Indian firm to join quest society and service at different level during were received from academia and industry. Funding support has sensor-based www.businesstoday.in; 07 April, 2020 the pandemic conditions. been recommended to Cadila Healthcare Ltd for advancing the hand sanitizer The Hyderabad-based Indian Immunologicals Limited (IIL) has joined One of the main strategies is to make development of a DNA Vaccine candidate against novel coronavirus hands with Griffith University of Australia to conduct exploratory sure there is no 'food insecurity'. With this chamber works SARS-CoV-2 and to Bharat Biotech International Ltd for COVID-19 research to develop a lead vaccine candidate for coronavirus. The objective, the branch has distributed rice, https://drive.google.com/file/ vaccine candidate utilising the inactivated rabies vector platform. IIL-Griffith combine is the fourth Indian biotech company, after Serum oil, vegetables and essential commodities to d/1fqTGo1W03izzxmQWiC7u_ For the Phase III human clinical trials study of recombinant BCG vaccine planned in high-risk population, Serum Institute of India Institute, Zydus Cadila and Bharat Biotech, to join 60-plus research the homeless and migrants, hcUQjW0GtxG/ Private Limited (SIIPL) will be supported. Development of a novel initiatives worldwide to develop a vaccine against the virus, which most importantly to the view?usp=sharing vaccine evaluation platform at National Institute of Immunology, an has so far killed over 155,000 globally. Scientists of the company people from other states VIPER staff is also supporting institute under the Department of Biotechnology, to support SARS- and Griffith University will develop a ‘Live Attenuated SARS - CoV-2 residing in Narsapur. engineering faculty in CoV-2 vaccine development has also been approved for financial vaccine’ using the latest codon de-optimisation technology. Upon VIPER has prepared sanitizers developing ventilators. support. The DBT has been designated the central coordination completion of the research, the vaccine strain will be transferred to as per the WHO guidelines Indian Immunologicals and the vaccine maker will work accordingly All the above agency for the development of a vaccine for COVID-19. To boost and handed the sanitizers with the country’s regulator - Central Drugs Standard Control a c t i v i t i e s indigenous production and to scale-up the production of molecular to the SI of Narsapur police Organisation - to further conduct clinical trials which will be taken were done and rapid diagnostic tests, Mylab Discovery Solutions Pvt Ltd, station. up in a phased manner. IIL intends to use its existing Vero cell under the Huwel Lifesciences, Ubio Biotechnology Systems Pvt Ltd, Dhiti Life platform technology for mass production of the virus. IIL, India’s VIPER IPASF has done various activities such as community guidance of Sciences Pvt Ltd, MagGenome Technologies Pvt Ltd, Bigtec Pvt Ltd largest veterinary biologicals and the third largest animal health education through video of about 5 minutes which explains Dr. Ramesh and Yaathum Biotech Pvt Ltd will also receive funding. drug maker, is already working with Griffith University, Australia for information about COVID-19, DOs and DONT's, preventive measures A l l u r i , IISc, start-up developing vaccine for Covid-19 conducting research and development of a Zika virus vaccine, which and circulated to community through all the social networks. President, www.thehindubusinessline.com; 17 April, 2020 is currently at pre-clinical toxicology testing stage. The technology https://drive.google.com/file/d/1X355RkUczynzfVuWmBQvp7Cs IPA Narsapur Branch and Coordinated by Mr. Rajashekar The Indian Institute of Science (IISc) has jumped into the fray to looks promising for developing a vaccine for prophylactic, active, rvYAQaR4/view?usp=sharing Perusomula, Secretary, IPA Narsapur Branch, Telangana. develop a vaccine for coronavirus (Covid-19). A team headed by single dose immunisation against coronavirus in humans, with an

Pharma Times - Vol. 52 - No. 04 - April 2020 50 Pharma Times - Vol. 52 - No. 04 - April 2020 51 Dr Raghavan Varadarajan of the Molecular Biophysics Unit of IISc is looking at a bunch of vaccine candidates to determine which is the most efficacious. Drawing upon previous studies on the 2003 SARS-CoV virus, these studies have shown that the antibodies against the spike glycoprotein found on the surface of the SARS- CoV virus inhibit viral infection. IISc (like some other researchers) is Vaccines against Novel coronavirus trying to design and test variants of the spike glycoprotein as vaccine India sets up high-level task force to develop vaccine for candidates. Currently, these vaccine candidates are being tested coronavirus; to co-ordinate with global researchers in animal models through Mynvax, a start-up jointly founded by Dr Varadarajan and one Dr Gautham Nadig. The team estimates that at www.businesstoday.in; 20 April, 2020 least 10 crore doses would be required to meet India’s requirement India has formed a high level task force to research on coronavirus if the SARS-CoV-2 infection persists for the medium to long term. It and develop a vaccine. The task force will also coordinate with has given itself four months to identify a first generation vaccine international community on vaccine development process for candidate, develop production technology in eight months and begin coronavirus. The task force will be co-chaired by Member, Niti human clinical trials in a year. Aayog, and Principal Scientific Adviser to the Government of India, China approves third COVID-19 vaccine for clinical trials Professor K Vijay Raghavan. AYUSH, ICMR, Department of Science and Technology (DST), Department of Biotechnology (DBT), CSIR, www.expresspharma.in; 25 April, 2020 DRDO, DG-Health Services, and Drug Controller General of India China has approved its third coronavirus vaccine for the second are also members of the task force. The task force has Department phase of clinical trials. An “inactivated” vaccine developed by of Biotechnology (DBT) as central coordinating authority. Its main Wuhan Institute of Biological Products under the China National focus will be to set up a process for vaccine development. The task Pharmaceutical Group (Sinopharm) and the Wuhan Institute of force will make a list of national and international organisations Virology (WIV) started its clinical trials, state-run Xinhua news working on vaccine development. DBT will monitor the progress of agency reported. An “inactivated” vaccine consists of virus particles, research works and also facilitate the process. The task force will bacteria, or other pathogens that have been grown in culture and create clinical cohorts focussing on long term follow-up of people then lose disease-producing capacity. In contrast, live vaccines use for better understanding of the disease. pathogens that are still alive. A total of 96 persons in three age DBT approves funding for three companies for developing COVID- groups have received the vaccine in the first phase of clinical trial 19 vaccine as of April 23. The vaccine has shown good safety results so far and vaccine receivers are still under observation. The randomised, www.outlookindia.com; 20 April, 2020 double-blind and placebo-controlled clinical trials of the inactivated The Department of Biotechnology has so far short-listed three vaccine are conducted in Jiaozuo, central China’s Henan Province, companies for funding the development of a vaccine for COVID-19, and the second phase of clinical trial will focus on the vaccination besides 13 other proposals it received for diagnostics, therapeutics procedure. The vaccine will also go through the third phase of the and other interventions to fight coronavirus. The three companies are clinical trial, and it may take about one year to complete the clinical Cadila Healthcare Ltd, Bharat Biotech International Ltd and Serum trial before finally reaching the conclusion on the vaccine’s safety Institute of India Private Limited. The Department of Biotechnology and efficacy. An adenovirus vector vaccine, developed by Institute of and the Biotechnology Industry Research Assistance Council had Military Medicine under the Academy of Military Sciences, was the invited applications on the COVID-19 Research Consortium. The first first vaccine approved in the country to enter a clinical trial. phase of the call ended on March 30 and around 500 applications Coronavirus vaccine: Hyderabad’s IIL fourth Indian firm to join quest were received from academia and industry. Funding support has been recommended to Cadila Healthcare Ltd for advancing the www.businesstoday.in; 07 April, 2020 development of a DNA Vaccine candidate against novel coronavirus The Hyderabad-based Indian Immunologicals Limited (IIL) has joined SARS-CoV-2 and to Bharat Biotech International Ltd for COVID-19 hands with Griffith University of Australia to conduct exploratory vaccine candidate utilising the inactivated rabies vector platform. research to develop a lead vaccine candidate for coronavirus. The For the Phase III human clinical trials study of recombinant BCG IIL-Griffith combine is the fourth Indian biotech company, after Serum vaccine planned in high-risk population, Serum Institute of India Institute, Zydus Cadila and Bharat Biotech, to join 60-plus research Private Limited (SIIPL) will be supported. Development of a novel initiatives worldwide to develop a vaccine against the virus, which vaccine evaluation platform at National Institute of Immunology, an has so far killed over 155,000 globally. Scientists of the company institute under the Department of Biotechnology, to support SARS- and Griffith University will develop a ‘Live Attenuated SARS - CoV-2 CoV-2 vaccine development has also been approved for financial vaccine’ using the latest codon de-optimisation technology. Upon support. The DBT has been designated the central coordination completion of the research, the vaccine strain will be transferred to agency for the development of a vaccine for COVID-19. To boost Indian Immunologicals and the vaccine maker will work accordingly indigenous production and to scale-up the production of molecular with the country’s regulator - Central Drugs Standard Control and rapid diagnostic tests, Mylab Discovery Solutions Pvt Ltd, Organisation - to further conduct clinical trials which will be taken Huwel Lifesciences, Ubio Biotechnology Systems Pvt Ltd, Dhiti Life up in a phased manner. IIL intends to use its existing Vero cell Sciences Pvt Ltd, MagGenome Technologies Pvt Ltd, Bigtec Pvt Ltd platform technology for mass production of the virus. IIL, India’s and Yaathum Biotech Pvt Ltd will also receive funding. largest veterinary biologicals and the third largest animal health IISc, start-up developing vaccine for Covid-19 drug maker, is already working with Griffith University, Australia for conducting research and development of a Zika virus vaccine, which www.thehindubusinessline.com; 17 April, 2020 is currently at pre-clinical toxicology testing stage. The technology The Indian Institute of Science (IISc) has jumped into the fray to looks promising for developing a vaccine for prophylactic, active, develop a vaccine for coronavirus (Covid-19). A team headed by single dose immunisation against coronavirus in humans, with an

Pharma Times - Vol. 52 - No. 04 - April 2020 50 Pharma Times - Vol. 52 - No. 04 - April 2020 51 enhanced safety profile. Indian Immunologicals Limited is expected to HYDROXYCHLOROQUINE: SAVING THE WORLD submit the application for conducting clinical trials in due course. Novartis to sponsor large clinical trial of hydroxychloroquine in Bharat Biotech in tie-up to develop a Covid vaccine hospitalized COVID-19 patients www.economictimes.indiatimes.com; 04 April, 2020 www.sandoz.com; 20 April, 2020 Bharat Biotech has partnered with the University of Wisconsin Madison Novartis has reached an agreement with the US Food and Drug and US-based Company FluGen to develop a vaccine, Coro-Flu, against Administration (FDA) to proceed with a Phase III clinical trial with Covid-19. The Hyderabad-based company will manufacture the vaccine, approximately 440 patients to evaluate the use of hydroxychloroquine conduct clinical trials and prepare to produce almost 300 million doses for the treatment of hospitalized patients with COVID-19 disease. of vaccine for global distribution. Under the collaboration agreement, The clinical trial drug supply will be provided by Sandoz, the generics FluGen will transfer its existing manufacturing processes to Bharat and biosimilars division of Novartis. The large trial sponsored by Biotech to enable the company to scale up production and produce the Novartis will be conducted at more than a dozen sites in the United vaccine for clinical trials. CoroFlu will build on the backbone of FluGen’s States. Novartis plans to begin enrollment for this study within the flu vaccine candidate known as M2SR, which is a self-limiting version next few weeks and is committed to reporting results as soon as of the influenza virus that induces an immune response against the flu. possible. To help achieve broad access to hydroxychloroquine as Kawaoka’s lab will insert gene sequences from SARS-CoV-2, the novel quickly as possible in these extraordinary circumstances, Novartis coronavirus that causes the disease Covid-19, into M2SR so that the new will make any intellectual property within our control that relates to vaccine will also induce immunity against the coronavirus. Refinement the use of hydroxychloroquine to treat or prevent COVID-19 available of the CoroFlu vaccine concept and testing in laboratory animal models through non-exclusive voluntary licenses, appropriate waivers, or at UW-Madison is expected to take three to six months. Bharat Biotech similar mechanisms. Patients in the trial will be randomized into will then begin to scale up production for safety and efficacy testing in three groups. The first group or arm will receive hydroxychloroquine. humans. Four Phase I and Phase II clinical trials have shown the M2SR The second group will receive hydroxychloroquine in combination flu vaccine to be safe and well tolerated. with azithromycin, which is an antibiotic therapy. The third group Johnson & Johnson announces a lead vaccine candidate for will receive placebo. Patients in all treatment groups are receiving COVID-19 standard of care for COVID-19. Researchers at the company www.worldpharmanews.com; 30 March, 2020 compressed months of work into a few weeks to design the large clinical trial in order to rapidly respond to the need for COVID-19 Johnson & Johnson announced the selection of a lead COVID-19 disease treatments. In addition to hydroxychloroquine, Novartis vaccine candidate from constructs it has been working on since January plans to sponsor or co-sponsor clinical trials to study ruxolitinib and 2020; the significant expansion of the existing partnership between the canakinumab for hospitalized patients with COVID-19 infections. Janssen Pharmaceutical Companies of Johnson & Johnson and the Requests for investigator-initiated trials have been granted for COVID- Biomedical Advanced Research and Development Authority (BARDA) 19-related clinical studies of ruxolitinib, canakinumab, imatinib with the goal of providing global supply of more than one billion doses mesylate, secukinumab, hydroxychloroquine and valsartan. of a vaccine. The Company expects to initiate human clinical studies Coronavirus pandemic: India to export anti-malaria drug of its lead vaccine candidate at the latest by September 2020 and Hydroxychloroquine to 55 countries anticipates that the first batch of COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated www.financialexpress.com; 17 April, 2020 timeframe in comparison to the typical vaccine development process. India has cleared the export of the anti-malaria drug – Through a landmark new partnership, BARDA, which is part of the Office Hydroxychloroquine (HCQ) tablets to 54 more countries across the of the Assistant Secretary for Preparedness and Response (ASPR) at globe along with the US. Leaders from across the globe have been the U.S. Department of Health and Human Services, and Johnson & reaching out to India seeking help in the form of HCQ. The Ministry Johnson together have committed more than $1 billion of investment of External Affairs which is handling the requests has prepared two to co-fund vaccine research, development, and clinical testing. Johnson lists so far and a third one is in the process of being finalized. A list of & Johnson will use its validated vaccine platform and is allocating 55 countries has been readied and this was prepared on the basis resources, including personnel and infrastructure globally, as needed, of specific requests received from the leaders of these countries. Exporting of HCQ tablets to these countries whether in the form of to focus on these efforts. aid or through commercial basis has been decided after ensuring Serum Institute eyes COVID-19 vaccine by October that there is adequate supply for the domestic market. The export of www.thehindu.com; 24 April, 2020 HCQ is being done in small quantities. Out of the 55 countries, 34 City-based Serum Institute of India has said that it expects the will receive the HCQ as a grant and the balance of 21 nations have vaccine for coronavirus (COVID-19) developed by the University purchased these tablets from India. Countries getting HCQ from of Oxford (ChAdOX1) in the market by October or November India include - Afghanistan, Bhutan, Bangladesh, Nepal, Maldives, provided the safety and efficacy of the product is established Mauritius, Seychelles, Sri Lanka, Philippines, Myanmar, Slovenia, during trials. The institute has partnered with the Oxford France, the Netherlands, the UK, the US, Marshall Islands, Ukraine, vaccine project as one of the seven global institutions that will Russia, Bolivia, Peru, Ecuador, Uruguay, Colombia, Guyana, Dominican manufacture the vaccine. If the vaccine works in UK, another Republic, Jamaica, Bahamas, Senegal, Jordan, Zimbabwe, Nigeria, trial will start shortly in India. The Institute will use one of its Egypt, Republic of Congo, Sierra Leone, Chad, Burkina Faso, Niger, existing facilities to manufacture the vaccine. A new facility will Mali, Syria, Kenya, Eswatini, Tanzania, Algeria, Madagascar, South be setup in a year or two. SII would be partnering with ICMR for Africa, Zambia, Uganda, Oman, UAE, Uzbekistan, Kazakhstan. the clinical trials and that he was in touch with the Department Bajaj Healthcare gets Gujarat FDA nod to manufacture of Biotechnology. The manufacturing plant in Pune would have hydroxychloroquine sulphate an investment of INR 500-600 crore www.moneycontrol.com; 17 April, 2020

Pharma Times - Vol. 52 - No. 04 - April 2020 52 Pharma Times - Vol. 52 - No. 04 - April 2020 53 Drug firm Bajaj Healthcare has received approval from the Gujarat Sanofi has committed to donating 100 million doses of Food and Drug Administration for manufacturing hydroxychloroquine hydroxychloroquine to 50 countries around the world, and has sulphate active pharmaceutical ingredient (API) and formulations. begun to progressively deliver the medicine to authorities that have The company will commence production of hydroxychloroquine requested it. In this global health emergency, Sanofi stands ready to sulphate API at its Vadodara facility and is estimated to produce 15 assist as many countries as possible, starting with countries where metric tonnes of API per month. It has already started the production its medicine is registered for current approved indications as well of hydroxychloroquine FDF (tablets) at Vadodara unit and is expected as countries where there are no hydroxychloroquine suppliers or to produce around 1.5 crore hydroxychloroquine sulphate tablets. countries with underserved populations. Since the beginning of the Hydroxychloroquine makers Zydus, Ipca, others plan 6 times COVID-19 crisis, Sanofi has received a growing number of requests capacity to meet demand from local governments around the world. The company is regularly evaluating its increasing supply capacity and re-assessing how best www.businesstoday.in; 13 April, 2020 to help those countries in the most ethical way. Sanofi’s priority is Indian pharmaceutical companies are raising monthly production of to ensure supply continuity for patients treated under the current anti-malarial drug Hydroxychloroquine (HCQ) four times to 40 metric approved indications of the medicine, notably including lupus and tonnes (MT) by the end of this month and five to six times to over 70 rheumatoid arthritis, while working hard to supply governments metric tonnes (MT) by next month. The plan to step up production wishing to increase stocks in the hope that it may be an effective came after the Government of India indicated it will help countries treatment of COVID-19. Sanofi will continue to donate the medicine in dire need of the drug to fight novel coronavirus. Peak capacity to governments and hospital institutions if ongoing clinical studies would produce 35 crore (350 million) tablets of 200 mg dosage demonstrate its efficacy and safety in COVID-19 patients. every month. India’s own requirement is unlikely to exceed 10 crore Zydus Cadila boosts HCQ production 10X tablets for which the government has already placed an order with leading domestic manufacturers Zydus Cadila and Ipca Laboratories. www.economictimes.indiatimes.com; 08 April, 2020 Industry experts say 10 crore tablets are good enough to treat seven Zydus Cadila, one of the two largest manufacturers of key Covid crore people, if required. In India, HCQ costs less than Rs 3 per tablet. drug hydroxychloroquine (HCQ), has ramped up its production by The remaining production will be exported to neighbouring countries nearly 10X to 30 metric tonnes (15 crore tablets of 200mg) per as well as countries such as the US which need them. According month in view of the huge spike in demand expected due to rising to some studies, HCQ has shown strong antiviral effects on the cases of Covid-19.The company will be supplying the drug to ICMR coronavirus infection, which prompted US President Donald Trump to (Indian Council of Medical Research) at a price even lower than the seek India’s help in procuring the drug. Other leading manufacturers government-regulated price, at a little over Rs 3 per tablet. of HCQ include Intas Pharmaceuticals, McW Healthcare of Indore, Prepared to supply 10 crore tablets of Hydroxychloroquine to Macleods Pharmaceuticals, Cipla and Lupin. API suppliers for Indian government: IPCA Labs the drug include Abbott India, Rusan Pharma, Mangalam Drugs, www.economictimes.indiatimes.com; 07 April, 2020 Unichem Remedies, Laurus Labs, Vijayasri Organics, etc. Two major Indian manufacturers - Zydus Cadila and Ipca Laboratories have Hydroxychloroquine, the anti-malarial drug that is used for treating patients backward integrated production capacity - from key raw materials of Rheumatoid Arthritis has become a test case for India-US diplomatic that can be converted to intermediates and then to APIs and to final relations. The drug has come to focus as several countries are using this formulations, in the 12-15 step process to make the medicine. Most drug as a preventive measure for Covid-19, despite inconclusive studies of the other Hydroxychloroquine API manufacturers import some key on its effectiveness. US President Donald Trump who has also been raw materials and intermediates from China or source them from promoting this drug for Covid-19 treatment has prompted India to lift the countries like South Korea, Italy or Finland. ban on exports of Hydroxychloroquine. Indian government has ordered around six crore tablets from IPCA Labs which it will supply by the end of Bengal Chemicals to produce hydroxychloroquine this month. IPCA will also stock around 20 tonnes of HCQ API to ensure www.expresspharma.in; 11 April, 2020 smooth and uninterrupted supply of HCQ tablets. Bengal Chemical has got the necessary license from West Bengal ICMR recommends HCQ for prophylaxis against COVID-19 for Directorate of Drugs Control to manufacture hydroxychloroquine. The healthcare professionals and contacts of confirmed cases West Bengal government has granted approval to Bengal Chemical www.icmr.nic.in; 23 March, 2020 and Pharmaceuticals Limited to manufacture hydroxychloroquine (HCQ) to fight against COVID-19 infection. The West Bengal Hydroxychloroquine is found to be effective against coronavirus in Directorate of Drugs Control gave necessary license to the country’s laboratory studies and in-vivo studies. Its use in prophylaxis is derived first and oldest pharmaceutical company after the Kolkata-based from available evidence of benefit as treatment and supported by pre- firm, the only public sector unit that manufactures anti-malarial clinical data. The National Taskforce for COVID-19 recommends the drug in India, recently applied for a licence to produce HCQ. During use of hydroxychloroquine for prophylaxis of SARS-CoV-2 infection for a meeting with Chief Minister Mamata Banerjee, a senior official of asymptomatic healthcare workers involved in the care of suspected or the company requested the state government to grant them licence confirmed cases of COVID-19 and asymptomatic household contacts to that it could produce the drug. After getting the sanction, the PSU of laboratory confirmed cases. Dose for healthcare workers should be will now be able to manufacture hydroxychloroquine tablet IP 200 400 mg twice a day on Day 1, followed by 400 mg once weekly for next and 400 mg. The company has a capacity of producing 10 lakh 7 weeks and for asymptomatic household contacts - 400 mg twice a tablets every day. Use of hydroxychloroquine as prophylaxis has been day on Day 1, followed by 400 mg once weekly for next 3 weeks. The suggested by a section of experts to combat COVID-19 infection. drug is not recommended for prophylaxis in children under 15 years of age and contraindicated in persons with known case of retinopathy, Sanofi to donate 100 million doses of hydroxychloroquine across known hypersensitivity to hydroxychloroquine, 4-aminoquinoline 50 countries compounds. ICMR reiterates that intake of HCQ in no way should instill www.thepharmaletter.com; 10 April, 2020 a feeling of false security against corona virus.

Pharma Times - Vol. 52 - No. 04 - April 2020 52 Pharma Times - Vol. 52 - No. 04 - April 2020 53 Testing kits for Covid-19 Biolidics to launch ten-minute rapid test kits for COVID-19 ICMR approves the Probe-free COVID-19 detection assay www.mobihealthnews.com; 31 March, 2020 developed at IIT Delhi Singapore-listed medtech company Biolidics recently launched its www.iitd.ac.in; 23 April, 2020 rapid test kit for COVID-19 and has entered into a manufacturer agreement with a diagnostic kit manufacturer to customize and Researchers at IIT Delhi Kusuma School of Biological Sciences manufacture the rapid test kits. The first batch of Biolidics’ rapid test (KSBS) have developed a detection assay for COVID-19 which has kits is expected to be available in April 2020. Biolidics has obtained now been approved by ICMR. The assay has been validated at ICMR provisional authorization from Singapore’s Health Science Authority with a sensitivity and specificity of 100%. This makes IITD the first (HSA) for its rapid test kit to be used in Singapore. The medtech academic institute to have obtained ICMR approval for a real-time company, which focuses on diagnostic cancer solutions, is working PCR-based diagnostic assay. Using comparative sequence analyses, closely with Clearbridge Health to obtain the relevant approval and/ the IIT Delhi team identified unique regions (short stretches of RNA or authorization from the various health authorities in the region for sequences) in the COVID-19 /SARS COV-2 genome. These regions are the use of the rapid test kit. not present in other human corona viruses providing an opportunity to specifically detect COVID-19. This method uses primers targeting Firms shortlisted for rapid antibody testing kits unique regions of COVID-19 that were designed and tested using real www.economictimes.indiatimes.com; 29 March, 2020 time PCR. These primers specifically bind to regions conserved in Singapore based Sensing Self Ltd and China’s Wondfo are the two over 400 fully sequenced COVID-19 genomes. This highly sensitive companies who have cleared the National Institute of Virology (NIV) assay was developed by extensive optimization using synthetic DNA validation for the rapid antibody test kit for Covid-19. The decision constructs followed by in vitro generated RNA fragments. This is the comes days after the Indian Council of Medical Research (ICMR) first probe-free assay for COVID-19 approved by ICMR and it will be decided to start antibody tests to check whether an individual was useful for specific and affordable high throughput testing. This assay previously infected with the SARS-Cov2 virus before. This is done to can be easily scaled up as it does not require fluorescent probes. understand the epidemiology of the disease. The company will offer The team is targeting large scale deployment of the kit at affordable the kits at an affordable price to the Indian government and prioritise prices with suitable industrial partners as soon as possible. The team the shipment to the country. includes Prashant Pradhan (PhD Scholar), Ashutosh Pandey (PhD Pune based Mylab becomes firstI ndian company to get Covid-19 Scholar), Praveen Tripathi (PhD Scholar), Dr. Akhilesh Mishra, Dr. test kits validated Parul Gupta, Dr. Sonam Dhamija, Prof. Vivekanandan Perumal, Prof. Manoj B. Menon, Prof. Bishwajit Kundu, Prof. James Gomes. www.economictimes.indiatimes.com; 24 March, 2020 Andhra Pradesh starts making rapid Covid-19 testing kits Pune based molecular diagnostic company Mylab has become the first Indian company to receive the validation for its Covid-19 diagnostic test www.economictimes.indiatimes.com; 08 April, 2020 kits also known as the Reverse transcription polymerase chain reaction Andhra Pradesh has started manufacturing Covid-19 rapid (RT-PCR) tests by the Drug Controller of India, after the National Institute testing kits that can offer results in less than an hour. The of Virology validated its test. The other company to have received the facility is also expected to start making ventilators from April approval is Germany’s Altona Diagnostics. In the current lab based 15, increasing the capacity in phases to 6,000 units per month. testing it takes four hours for test results to come out whereas Mylab’s The unit at AP MedTech Zone in Visakhapatnam can produce turnaround time is 2 1/2 hours. The company’s kits can study 1000 2,000 testing kits a day, according to the state government. This samples from large labs and 200 from smaller labs. Mylab is looking capacity may be ramped up to 25,000 kits a day soon. The Indian to price its kits around INR 1200. Council of Medical Research had approved the manufacture of IIT Delhi researchers develop affordable test for COVID-19 the testing kits at the AMTZ while the Drug Controller General of India granted exemption from manufacturing approvals for www.economictimes.indiatimes.com; 22 March, 2020 ventilators in view of the current crisis, the state government Researchers at the Indian Institute of Technology here have developed said in a statement. a method to detect COVID-19 which can significantly reduce the test Siemens Healthineers Releases Test Kit for Coronavirus COVID-19 cost making it affordable for large sections. The National Institute of Virology (NIV), Pune is in the process of validating this test on www.siemens-healthineers.com; 02 April, 2020 clinical samples. The “probe-free detection assay” developed by Siemens Healthineers announced the availability of its molecular Fast the researchers at the prestigious institute’s Kusuma School of Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the Biological Sciences has been optimised and tested for sensitivity diagnosis of infection by the SARS-CoV-2 virus that causes the COVID- at the research laboratories of the Institute. According to the team, 19 disease. Test kits are already being shipped within the European considering the scale of the ongoing pandemic, development of Union for research use only (RUO) to expedite availability while the indigenous kits is the need of the hour. The central government on company continues to pursue Emergency Use Assessment and Saturday recommended that the maximum charge for each COVID-19 Listing (EUAL) from the World Health Organization (WHO) for clinical test by private laboratories should not exceed Rs 4,500. However, use. In addition, Siemens Healthineers has begun discussions with the team at IIT claims that their test can be performed at a much the U.S. Food and Drug Administration (FDA) for release of the test cheaper cost and hence will be affordable for general public. under Emergency Use Authorization (EUA). Both applications are in 14 firms get license to evaluate COVID-19 tests kits progress. While the controlled roll-out of the assay for research use is continuing, Siemens Healthineers is simultaneously expanding www.economictimes.indiatimes.com; 20 March, 2020 its production capacity. The FTD SARS-CoV-2 Assay was developed Fourteen private companies including Swiss firm Roche Diagnostics by Fast Track Diagnostics, a Siemens Healthineers Company, in India have been given test license by the drug regulator DCGI for Esch-sur-Alzette, Luxembourg. Fast Track Diagnostics was acquired evaluation of the quality of COVID-19 testing kits. Apart from Roche by Siemens Healthineers at the end of 2017. Diagnostics India, rest of the 13 are Indian firms include CoSara

Pharma Times - Vol. 52 - No. 04 - April 2020 54 Pharma Times - Vol. 52 - No. 04 - April 2020 55 Diagnostics from Ahmedabad and CPC Diagnostics from Chennai. All two non-peer reviewed research articles. The first one by the University these companies will evaluate the quality of testing kits and submit of Texas Medical Branch, Galveston, showed an evidence of a direct their data to the Drug Controller General of India. Roche Diagnostics anti-viral effect of Interferon alpha against novel Coronavirus in vitro. India received the license from the country’s drug regulator DCGI for The study demonstrated around 10,000 fold reduction in virus titre its ‘cobas SARS CoV-2’ diagnostic test kit on March 17. in cells that were pre-treated with Interferon alpha 48 hours earlier. The second by a group of universities in China, Australia and Canada Industries and Research Institutes at forefront retrospectively analysed 77 moderate COVID-19 subjects in Wuhan against CORONA and observed that those who received Interferon alpha-2b showed a significant reduction in the duration of virus shedding period and Strides Pharma develops Favipiravir antiviral tablets; drug shows even in levels of the inflammatory cytokine, IL-6. This suggests that positive outcome in COVID-19 treatment if a long-acting molecule like Pegylated Interferon alpha is given www.economictimes.indiatimes.com; 29 April, 2020 early on in the infection, the patient suffering from COVID 19 will Strides Pharma Science Ltd has developed and commercialised have a significant benefit as the viral load is reduced, lesser IL-6 Favipiravir antiviral tablets and stressed that the drug has is produced and virus eliminating specific immune response is demonstrated positive outcomes in COVID-19 treatment globally. generated. When the human body contracts an infection due to a viral Favipiravir is an antiviral medication that was initially developed attack, it produces a group of molecules called Type 1 interferons as to treat influenza in Japan. In February 2020, post the outbreak of a first line of defence. Interferon alpha is one such Type 1 Interferon Novel Coronavirus (COVID-19), Favipiravir was studied in China and molecule, that not only slows down the viral replication but also helps several other countries as an experimental treatment of COVID-19. activate the two arms of our immune system – Innate, for immediate The drug has demonstrated positive outcomes, including a reduction killing of the virus and Adaptive, for long lasting immunity. To make in the duration of COVID-19 and improved lung conditions for the it more effective, the molecule is coupled with polyethylene glycol patients. The product is a generic version of Avigan of Toyama to produce a new molecule called, Pegylated Interferon alpha, that Chemical, Japan. The filing said Strides is the first Indian company has the same functionality as Interferon alpha but remains in the to have commenced export of Favipiravir tablets. The company body longer and therefore requires only once-a-week injection, thus will immediately apply to Indian Drug Authorities to commence providing a much better efficacy profile. Interferon alpha-2b has been necessary studies and make the drug available to Indian patients used in the treatment of COVID-19 in China and Cuba and is a part expeditiously. Strides has developed Favipiravir tablets in 400mg of treatment guidelines of the Chinese Government. Zydus has been and 200mg strengths for convenient dosage administration. The commercially manufacturing Pegylated Interferon alpha-2b under product is currently being exported to Gulf Cooperation Council the brand name, PegiHep, since 2011 for the treatment of Hepatitis (GCC) countries to treat patients under their treatment programme B and C with 1.5 lac doses being administered. PegiHep is not yet for COVID-19. Favipiravir tablets are being manufactured at Strides' licensed or approved for the treatment of COVID-19. flagship facility in Bangalore, India. The facility can produce up to 6 Coronavirus vaccine soon? Oxford scientists aim for 1 million billion units of solid orals annually and is approved by the USFDA, doses of drug candidate by September MHRA, WHO, TGA, among others. www.businesstoday.in; 18 April, 2020 First trial for potential Covid-19 drug shows it has no effect Scientists at Oxford University have said that they will be able to www.theguardian.com; 23 April, 2020 come up with a vaccine for the coronavirus by September this year. Remdesivir, a drug thought to be one of the best prospects for treating Earlier, WHO health experts had said that a possible coronavirus Covid-19, failed to have any effect in the first full trial. The drug is in vaccine was 1.5 years away at the minimum. Lead researcher of short supply globally because of the excitement it has generated. the vaccine development programme, Prof Sarah Gilbert and her It is one of the drugs Donald Trump claimed was “promising”. In team were confident that ChAdOX1 vaccine can work against the a “gold standard” trial of 237 patients, some of whom received coronavirus. The group has promised that they will make one million remdesivir while others did not, the drug did not work. The trial was vaccine doses available by September. The ChAdOx1 is the fourth also stopped early because of side-effects. The drug, made by the US COVID-19 vaccine candidate in the world which has entered the company Gilead Sciences, is an antiviral that was trialled in Ebola, clinical trial phase of vaccine development. What’s different about but which failed to show benefits in Africa. In the trial, 158 patients the ChAdOx1 is that it will take significantly less time than other were randomly assigned to be given remdesivir, while 79 others vaccine candidates to be delivered in mass quantities. The other had standard care with a placebo instead. There was no difference three vaccine candidates have been proposed by two US groups and between the groups with respect to recovery time. Just under 14% one Chinese group, it is expected to take at least 12 to 18 months of those on remdesivir died, compared with nearly 13% of those not to mass produce these vaccines. taking the treatment. Remdesivir was stopped early in 18 (11.6%) Covid medicine: Dr Reddy’s Laboratories begins work on Gilead patients because of adverse effects, compared with 4 (5.1%) in the drug clone control group. The trial of the drug in China, on patients with severe www.economictimes.indiatimes.com; 17 April, 2020 Covid-19 symptoms, may give some doctors pause. Gilead, however, Dr Reddy’s Laboratories is in the early stages of creating a generic claimed there were still signs that it could be useful, possibly in copy of remdesivir, the experimental drug developed by Gilead patients with milder versions of disease. that’s said to have improved the condition of critically ill coronavirus Zydus explores the biologicals route to treat novel Coronavirus patients in a multi-country trial. While scientists across the world with long-acting Interferon alpha-2b are racing to develop drugs and vaccines against the coronavirus, www.zyduscadila.com; 20 April, 2020 remdesivir is among the few that have shown promise. The antiviral Zydus Cadila has announced that its biological therapy Pegylated was originally meant to treat ebola but wasn’t successful. Gilead Interferon alpha-2b, ‘PegiHepTM’ can emerge as one of the pathways said earlier that a compassionate drug use programme sponsored to treat COVID 19. The treatment has emerged after the publication of by the company found that out of 53 patients with severe Covid-

Pharma Times - Vol. 52 - No. 04 - April 2020 54 Pharma Times - Vol. 52 - No. 04 - April 2020 55 19 (coronavirus) infections, clinical improvement was observed AstraZeneca initiates CALAVI clinical trial with Calquence against in 36. COVID-19 Rome varsity conducting pilot run of tool to test COVID-19 through www.fiercepharma.com; 14 April, 2020 voice-based diagnosis developed by Indian students AstraZeneca will initiate a randomised, global clinical trial to assess www.businessinsider.in; 16 April, 2020 the potential of Calquence (acalabrutinib) in the treatment of the A university in Rome is conducting a pilot run for a patented artificial- exaggerated immune response (cytokine storm) associated with intelligence based tool developed by three biotechnology students COVID-19 infection in severely ill patients. The trial design is based and a professor from Mumbai which they claim can test COVID-19 upon strong scientific evidence supporting the role of the Bruton’s through voice-based diagnosis using a smartphone. The tool is being tyrosine kinase (BTK) pathway in the production of inflammatory tested by University of Tor Vergata in Rome and has already been cytokines and on encouraging early clinical data. Calquence is a tested on 300 individuals and has yielded 98% accurate results. next-generation, highly selective BTK inhibitor currently used to treat According to the team from DY Patil Institute of Bio Technology and certain types of blood cancers. The trial, called CALAVI, is based on Bio Informatics, Mumbai, the tool is based on a voice-based diagnosis early clinical data with Calquence demonstrating that a decrease through an app. The team includes bioinformatics students - Rashmi in inflammation caused by BTK inhibition appears to reduce the Chakraborty, Priyanka Chauhan and Priya Garg. While several foreign severity of COVID-19-induced respiratory distress. The goal of the universities are trying to launch a voice-based AI tool for COVID-19 trial is to evaluate the efficacy and safety of adding Calquence to best detection, this Indian tool is fully functional and currently in use in supportive care (BSC) to reduce mortality and the need for assisted Italy to successfully identify COVID-19 patients. The students have ventilation in patients with life-threatening COVID-19 symptoms. This a full-fledged working software with a rich database of patients large, multicentre, global, randomised trial uses a two-part patient- and healthy samples. The project is being supervised by professor centric design developed in record time to accelerate data capture Santosh Bothe. and analysis. Part one evaluates the addition of Calquence to BSC versus BSC alone in patients hospitalised with COVID-19 who are IISc researchers working on tool for COVID-19 diagnosis based not in the intensive care unit (ICU). Part two evaluates the addition on cough, speech sounds of Calquence to BSC in a cohort of patients in the ICU. www.financialexpress.com; 15 April, 2020 Airtel and Apollo Hospital join forces to help India break the A team of researchers at the Indian Institute of Science (IISc), COVID-19 chain Bangalore, is working on a tool for diagnosis of COVID-19 based on www.pharmabiz.com; 13 April, 2020 respiratory, cough and speech sounds. The tool, once validated, will offer a test which poses minimum risk of exposure to the healthcare Bharti Airtel has collaborated with Apollo 24|7, the digital business professional and can give the results faster than the current testing unit of The Apollo Hospitals Group to support India’s battle against method. The eight-member team, has named the project for speech the COVID-19 pandemic. The partnership aims to bring together and sound based diagnostics “Coswara”, with an aim to detect and Airtel’s pan-India network reach and Apollo Hospital’s industry quantify biomarkers of the disease in the acoustics of these sounds. leading digital healthcare platform – Apollo 24/7 to raise awareness The project requires participants to perform a recording of breathing and break the chain of spread of COVID-19. It has launched a free sounds, cough sounds, sustained phonation of vowel sounds and a digital self-assessment test on Airtel Thanks app to enable its counting exercise. The entire response requires about five minutes customers to check their COVID-19 risk profile. The test uses AI of recording time. based technologies to allow users to assess their COVID-19 risk profile by answering a few simple questions. Based on the user ICMR announces protocol for Therapeutic Plasma Exchange responses, the digital tool generates a risk score and suggests next therapy in COVID-19 patients best action including online consults on Apollo 24|7 free, dialing www.pharmabiz.com; 15 April, 2020 COVID non-prescriptive helpline from the app itself, self-care tips, The Indian Council of Medical Research (ICMR) has announced social distancing guidelines and other important prevention steps protocol for a multi-center, phase II, open label, randomized as suggested by WHO and MOHFW. controlled study named Therapeutic Plasma Exchange (TPE) in ICMR validates TB-testing machine for COVID-19 screening. COVID-19 for its therapy. The therapy is also called convalescent www.businesstoday.in; 10 April, 2020 plasma therapy which according to health experts has the potential to treat critically ill COVID-19 patients. The primary objective of the The Indian Council of Medical Research (ICMR) has approved the use study is to assess the efficacy of TPE in improving the clinical status of diagnostic machines used for testing drug-resistant tuberculosis of COVID-19 patients. It will also evaluate the safety of treatment with for conducting coronavirus tests. The ICMR has validated ‘TruenatTM anti SARS-CoV-2 plasma in patients with COVID-19. The subjects for beta CoV test on TruelabTM workstation’ and has recommended it inclusion in the trial study are hospitalised COVID-19 patients who as a screening test. Issuing a guidance on the use of Truenat beta are critically ill, fulfill the inclusion and exclusion criteria and are CoV, the ICMR said throat/nasal swabs will be collected in the viral admitted for care at COVID-19 management facilities in India. In transport medium (VTM) with virus lysis buffer provided along with this experimental treatment, plasma of a treated COVID-19 patient the kit. Earlier studies have shown that virus lysis buffer neutralizes is indicated to an existing patient. Theoretically, plasma from a cured Nipah and H1N1 viruses. The results of stability of viral RNA after patient is assumed to have antibodies against the virus and this neutralization of SARS-CoV-2 by virus lysis buffer are awaited from can then be used to cure another patient. At this moment, ICMR ICMR-NIV, Pune. does not recommend this as a treatment option outside of clinical COVID-19 drug leads identified trials. ICMR has invited LOI from institutions with the equipment www.uq.edu.au; 09 April, 2020 and infrastructure available to participate in a clinical trial to study An international team of researchers has tested more than 10,000 the safety and efficacy of therapeutic plasma exchange in COVID-19 compounds to identify six drug candidates that may help treat patients, subsequent to necessary approvals and clearances. COVID-19. The research, involving University of Queensland scientist

Pharma Times - Vol. 52 - No. 04 - April 2020 56 Pharma Times - Vol. 52 - No. 04 - April 2020 57 Professor Luke Guddat, tested the efficacy of approved drugs, drug engaged in planning research studies to give insights into the virus, candidates in clinical trials and other compounds. Currently there the disease, and its prevention and management. A review committee are no targeted therapeutics or effective treatment options for to formulate National Task Force studies has been constituted for COVID-19. In order to rapidly discover lead compounds for clinical the same. At the national level, ICMR is also collaborating with other use, high-throughput drug screening, both in laboratories and also science and research agencies (DST, DBT, CSIR, DRDO, DAE, ICAR) using the latest computer software was used to predict how different for developing research solutions to the COVID-19 situation. ICMR will drugs bind to the virus. The project targeted the main COVID-19 virus also collaborate with the World Health Organization for public health enzyme, known as the main protease or Mpro, which plays a pivotal emergency SOLIDARITY TRIAL – an international randomised trial of role in mediating viral replication. This makes it an attractive drug additional treatments for COVID-19 in hospitalised patients. target for this virus, and as people don’t naturally have this enzyme, Trial drug can significantly block early stages of COVID-19 in compounds that target it are likely to have low toxicity. The drugs are engineered human tissues added directly to the enzyme or to cell cultures growing the virus and www.worldpharmanews.com; 06 April, 2020 assess how much of each compound is required to stop the enzyme from working or to kill the virus. After assaying thousands of drugs, An international team led by University of British Columbia researcher researchers found of the six that appear to be effective in inhibiting Dr. Josef Penninger has found a trial drug that effectively blocks the enzyme, one is of particular interest. the cellular door SARS-CoV-2 uses to infect its hosts. The findings, published in Cell, hold promise as a treatment capable of stopping Boehringer Ingelheim steps up effort with Global Support early infection of the novel coronavirus. The study provides new Program insights into key aspects of SARS-CoV-2, the virus that causes COVID- www.worldpharmanews.com; 08 April, 2020 19, and its interactions on a cellular level, as well as how the virus Boehringer Ingelheim has significantly stepped up its support to the can infect blood vessels and kidneys.ACE2 - a protein on the surface fight against COVID-19. A Global Support Program has been set up to of the cell membrane - is now at centre-stage in this outbreak as the bring more financial relief, protective materials and medicine donations key receptor for the spike glycoprotein of SARS-CoV-2. ACE2 is the to healthcare institutions and communities in need around the world. key receptor for SARS, the viral respiratory illness recognized as a Boehringer Ingelheim initially started a EUR 1 million donations program global threat in 2003. His laboratory also went on to link the protein in January for affected regions in China. With the Corona virus spreading to both cardiovascular disease and lung failure. In cell cultures to become a global pandemic, efforts to provide relief and scientific analyzed in the current study, hrsACE2 inhibited the coronavirus support grew strongly these past few weeks. This ultimately resulted in load by a factor of 1,000-5,000. In engineered replicas of human a Global Support Program with four focus areas like donations, research blood vessel and kidneys - organoids grown from human stem cells for Covid-19, volunteering, and making more health relief fund. - the researchers demonstrated that the virus can directly infect and ICMR sets up national task force to carry out COVID-19 duplicate itself in these tissues. This provides important information research on the development of the disease and the fact that severe cases of COVID-19 present with multi-organ failure and evidence of www.businesstoday.in; 08 April, 2020 cardiovascular damage. Clinical grade hrsACE2 also reduced the The Indian Council of Medical Research (ICMR) has set up a SARS-CoV-2 infection in these engineered human tissues. national task force to aid in fight against COVID-19. The national Possible coronavirus drug identified by Australian scientists task force has been divided into five research groups to identify research priorities and initiate research studies. The research www.sciencedaily.com; 03 April, 2020 groups include clinical research, research on diagnostics and A collaborative study led by Monash University’s Biomedicine biomarkers, epidemiology and surveillance, operation research, Discovery Institute (BDI) in Melbourne, Australia, with the Peter and vaccines/drug research and development. Members had Doherty Institute of Infection and Immunity (Doherty Institute), has already been nominated for each research group which was a part shown that an anti-parasitic drug already available around the world of the task force. It also said the Terms of Reference (ToR) for all kills the virus within 48 hours. The Monash Biomedicine Discovery groups had been decided. The clinical research group will be led by Institute’s scientists showed that the drug, Ivermectin, stopped the AIIMS Director Dr Randeep Guleria and its immediate priority is to SARS-CoV-2 virus growing in cell culture within 48 hours. Ivermectin establish an India COVID-19 clinical research collaborative network. is an FDA-approved anti-parasitic drug that has also been shown to The diagnostics and biomarkers group is headed by Dr DA Gadkari, be effective in vitro against a broad range of viruses including HIV, who is a former director of the National Institute of Virology in Pune. Dengue, Influenza and Zika virus. Scientists also cautioned that the The priority for this group is to periodically advise on testing strategy. tests conducted in the study were in vitro and that trials needed to Epidemiology and surveillance group will be looked over by Dr be carried out in people. These scientists have been researching DCS Reddy, community medicine expert. Its priority is to decide Ivermectin for more than 10 years with different viruses. Scientists on lockdown or partial lockdown. NK Arora, who heads a health started investigating whether it worked on the SARS-CoV-2 virus research organization, will head the operations research group and as soon as the pandemic was known to have started. The use of Dr Gagandeep Kang, Executive Director, Translational Health Science Ivermectin to combat COVID-19 would depend on the results of and Technology Institute, will head the group on vaccines. further pre-clinical testing and ultimately clinical trials, with funding ICMR scales up its capacity to fight COVID-19 urgently required to keep progressing the work. www.icmr.nic.in; 06 April, 2020 Clues to COVID-19 coronavirus’s vulnerability emerge from an antibody against SARS The Indian Council of Medical Research (ICMR) is working relentlessly to implement scientific interventions to combat the SARS-CoV-2 (COVID- www.worldpharmanews.com; 03 April, 2020 19) pandemic. The Council has expanded its capacity to diagnose and An antibody recovered from a survivor of the SARS epidemic in manage COVID-19. In addition to the diagnosis, ICMR has isolated the early 2000s has revealed a potential vulnerability of the new and sequenced the SARS-Cov2 virus and the scientists at ICMR are coronavirus at the root of COVID-19, according to a study from

Pharma Times - Vol. 52 - No. 04 - April 2020 56 Pharma Times - Vol. 52 - No. 04 - April 2020 57 scientists at Scripps Research. The study is the first to map a human an immediate basis. Cipla would upscale the process on the basis antibody’s interaction with the new coronavirus at near-atomic- of know-how given by CSIR-IICT. scale resolution. Although the antibody was produced in response to an infection of SARS (severe acute respiratory syndrome), which REGULATORY AFFAIRS is caused by the SARS-CoV virus, it cross-reacts with the new coronavirus, SARS-CoV-2.The structural mapping revealed a nearly Glenmark receives approval from the regulator (DCGI) to conduct identical site on both coronaviruses to which the antibody binds, Clinical Trials in India on Favipiravir Antiviral tablets for COVID-19 suggesting a functionally important and vulnerable site for this family patients of coronaviruses. Along with hundreds of other labs around the world, www.glenmarkpharma.com; 30 April, 2020 Wilson’s team is now focused on SARS-CoV-2.The new study centers Glenmark Pharmaceuticals, a research-led, integrated global on an anti-SARS-CoV antibody called CR3022 that was originally pharmaceutical company has announced that it has received isolated in 2006 by the pharmaceutical company Crucell Holland B.V. approval from the DCGI (Drug Controller General of India), the in the Netherlands. A report from Chinese scientists earlier this year regulator in India to conduct clinical trials on Favipiravir Antiviral indicated that CR3022 cross-reacts against SARS-CoV-2. Wilson’s tablets on COVID-19 patients. The product is a generic version of team used their structural mapping expertise to determine how the Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary antibody binds to SARS-CoV-2. A key finding is that the antibody’s of Fujifilm Corporation. Favipiravir has demonstrated activity against binding site is highly similar between the two coronaviruses--differing influenza viruses and has been approved in Japan for the treatment by just four protein building blocks called amino-acids. The high of novel influenza virus infections. Recently in the past few months, degree of similarity implies that the site has an important function post the outbreak of COVID-19, multiple clinical trials have been that would be lost if it mutated significantly. initiated on COVID-19 patients in China, Japan and in the US. Having Novartis announces plan to initiate clinical study of Jakavi® internally developed the API and the formulations for the product, in severe COVID-19 patients and establish international Glenmark filed the product for clinical trials with the DCGI and has compassionate use program. received approval for conducting the trial on mild to moderate www.worldpharmanews.com; 02 April, 2020 patients. As on date, Glenmark is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on Novartis announced plans to initiate a Phase III clinical trial in COVID-19 patients in India. As per the clinical trial protocol approved, collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) 150 subjects with mild to moderate COVID-19 will be randomized in for treatment of a type of severe immune overreaction called cytokine the study in a 1:1 ratio to Favipiravir with standard supportive care storm that can lead to life-threatening respiratory complications in or standalone standard supportive care. Treatment duration is a patients with COVID-19. The decision is based on pre-clinical evidence maximum of 14 days and the total study duration will be maximum and preliminary reports from independent studies, and is supported for 28 days from randomization. by extensive data on the safety and efficacy of Jakavi in conditions like acute graft versus host disease and myeloproliferative neoplasms. The Algernon receives positive feedback from USFDA for Ifenprodil proposed trial will assess Jakavi in combination with standard of care for COVID-19 human trial (SoC) therapy, compared to SoC therapy alone, in patients with severe www.pharmabiz.com; 15 April, 2020 COVID-19 pneumonia as a result of SARS-CoV-2 infection. Algernon Pharmaceuticals, a clinical stage pharmaceutical CSIR lab working on the genome sequencing of Covid-19 development company, announced that it has received positive www.thehindubusinessline.com; 26 March, 2020 feedback from the US Food and Drug Administration (FDA) regarding the company’s plans to conduct a phase 2 COVID- The Hyderabad-based Centre for Cellular Molecular Biology (CCMB), 19 clinical trial using its repurposed drug NP-120 (Ifenprodil). which is one of the 38 research institutes under the Government Based on the feedback, the company plans to submit, as soon as of India’s Council for Scientific and Industrial Research (CSIR), is possible, an Investigational New Drug (IND) application to the FDA, working on sequencing the whole genome of the Covid-19 virus to conduct a phase 2 clinical trial with Ifenprodil, as a therapy for taken from “isolates” from people who have tested positive. The patients who experience respiratory complications as a result of Centre’s Director said that large-scale genome sequencing will help contracting COVID-19. NP-120 (Ifenprodil) is an N-methyl-D-aspartate understand how similar or different Indian isolates are compared (NMDA) receptor antagonist specifically targeting the NMDA-type with others. For this purpose, the Centre had sought samples from subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. AIIMS, Delhi. Another CSIR institute, the Kolkata-based Indian Institute of Chemical Biology, has also got into the act. Two scientists Government removes custom duty, health cess on test kits, in the division have designed a research proposal to find “inhibitors” ventilators till Sept 30 against the coronavirus’ proteins. www.businesstoday.in; 10 April, 2020 CSIR-IICT ties up with Cipla to develop anti-COVID-19 drug The central government has removed customs duty and health www.expresspharma.in; 19 March, 2020 cess till September on ventilators, coronavirus testing kits and other medical supplies to increase domestic availability of these Hyderabad-based CSIR – Indian Institute of Chemical Technology products to fight the COVID-19 pandemic .With the removal of (IICT) has tied up with pharmaceutical giant Cipla to work on the duty and cess, prices of these products that include personal development of anti-viral drugs to contain COVID-19. Research on protection equipment and face and surgical masks would also anti-viral drugs has been on throughout the world for long and many come down. These exemptions will also be applicable on inputs companies have developed molecule shaving anti-viral properties. used to manufacture these items. Currently, there is a 10 % duty on But due to lack of demand, these molecules were not widely ventilators, and test kits; and 7.5 % on face and surgical masks. It marketed. However, the CSIR-IICT decided to work on three such ranges from 7.5 % to 10 % on PPE. Health cess is flat 5 % on all these molecules — remdesivir, favipiravir and baloxavir. Cipla urged the goods. With the number of COVID-19 patients increasing, there is a IICT director S Chandrasekhar to start work on these molecules on significant rise in demand for these items in the domestic market.

Pharma Times - Vol. 52 - No. 04 - April 2020 58 Pharma Times - Vol. 52 - No. 04 - April 2020 59 India has already restricted exports of diagnostic kits to discourage clinical trials for the COVID-19 vaccine candidates initially in the outbound shipments. The government has also banned exports United States and Europe across multiple0 sites. BioNTech and of all kinds of ventilators, sanitizers, and textile raw materials for Pfizer intend to initiate the first clinical trials as early as the end masks and coveralls. of April 2020, assuming regulatory clearance. During the clinical development stage, BioNTech and its partners will provide clinical Collaborations supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale- IIT Guwahati collaborates with Hester Biosciences for Covid-19 up manufacturing capacity at risk to provide worldwide supply in vaccine response to the pandemic. BioNTech and Pfizer will also work jointly www.business-standard.com; 29 April, 2020 to commercialize the vaccine worldwide (excluding China, which is The Indian Institute of Technology (IIT), Guwahati, is collaborating with already covered by BioNTech’s collaboration with Fosun Pharma) Ahmedabad-based animal healthcare company Hester Biosciences upon regulatory approval. to develop a vaccine against Covid-19. It expects the vaccine to GSK and Vir Biotechnology enter collaboration to find coronavirus be ready for animal studies by the end of this year. The vaccine is solution planned to be based on the recombinant avian paramyxovirus-based www.worldpharmanews.com; 08 April, 2020 vector platform. The recombinant avian paramyxovirus-1 will be used GlaxoSmithKline and Vir Biotechnology, Inc have announced a to express the immunogenic protein of SARS-CoV-2, and that will be binding agreement to enter into a collaboration to research and a vaccine candidate for further study. The avian paramyxovirus-1 has develop solutions for coronaviruses, including SARS-CoV-2, the virus been explored as a vaccine vector for various animals and human that causes COVID-19.The collaboration will use Vir’s proprietary pathogens and used to express the immunogenic protein of human monoclonal antibody platform technology to accelerate existing and pathogens like human immunodeficiency virus (HIV), avian influenza identify new anti-viral antibodies that could be used as therapeutic or virus, human parainfluenza virus, and SARS-CoV. Similarly, it has preventative options to help address the current COVID-19 pandemic also been explored as a vaccine vector for animal pathogens like and future outbreaks. The companies will leverage GSK’s expertise infectious bursal disease virus, infectious laryngotracheitis virus, in functional genomics and combine their capabilities in CRISPR bovine herpes virus, and Nipah virus, among others. The work is screening and artificial intelligence to identify anti-coronavirus currently in its early stage of development. The institute’s role will compounds that target cellular host genes. They will also apply their be to produce the recombinant vaccine candidate. combined expertise to research SARS-CoV-2 and other coronavirus GSK, Sanofi team up to bring out Covid-19 vaccine vaccines. Due to the urgent patient need for COVID-19 solutions, the www.economictimes.indiatimes.com; 15 April, 2020 initial focus of the collaboration will be to accelerate the development Two of the world’s largest vaccine manufacturers, GSK and Sanofi of specific antibody candidates identified by the Vir platform, VIR- are coming together to work on a Covid-19 vaccine, which if it passes 7831 and VIR-7832 that have demonstrated high affinity for the the clinical trials would become available by 2021. Sanofi and GSK’s SARS-CoV-2 spike protein and are highly potent in neutralising SARS- announcement comes a few days after Pfizer announced that it CoV-2 in live virus-cellular assays. Subject to regulatory review, the had invested in a New York-based company that was developing companies plan to proceed directly into a phase 2 clinical trial within a vaccine for Covid-19. French company Sanofi and UK’s GSK the next three to five months. The collaboration will also utilise Vir’s would be collaborating to develop an adjuvanted vaccine using CRISPR screening and machine learning approach to identify cellular technology from both companies. Sanofi and GSK have vaccines for targets whose inhibition can prevent viral infection. pneumonia and flu, which are among the commonly administered Amgen and Adaptive Biotechnologies announce strategic partnership vaccines in the West. In this new JV, Sanofi would contribute its to develop a therapeutic to prevent or treat COVID-19. S-protein Covid-19 antigen, which is based on the recombinant DNA www.worldpharmanews.com; 02 April, 2020 technology. The technology has produced an exact genetic match to Amgen and Adaptive Biotechnologies announced a collaboration the proteins found on the surface of the SARS-Cov2 virus, and the aimed at helping address the COVID-19 pandemic. The companies DNA sequence encoding this antigen has been combined into the will combine expertise to discover and develop fully human DNA of the baculorvirus expression platform which is the basis of neutralizing antibodies targeting SARS-CoV-2 to potentially prevent Sanofi’s influenza vaccine. GSK will provide its adjuvant technology or treat COVID-19. The mutually exclusive collaboration brings platform which helps in mass production of dosages with less dose together Adaptive’s proprietary immune medicine platform for the of vaccine proteins. The companies are aiming to get on with the identification of virus-neutralizing antibodies with Amgen’s expertise Phase 1 of the clinical trial by the second half of 2020 and expect in immunology and novel antibody therapy development. Given the to make the vaccine available by 2021. rapidly rising incidence of COVID-19 around the world, the companies Pfizer andB ioNTech announce further details on collaboration to will begin work immediately and finalize financial details and terms accelerate global COVID-19 vaccine development. in the coming weeks. Amgen will leverage its world-class antibody www.worldpharmanews.com; 10 April, 2020 engineering and drug development capabilities to select, develop and BioNTech SE and Pfizer Inc. disclosed additional details of their manufacture antibodies designed to bind and neutralize SARS-CoV-2. collaboration to advance candidates from BioNTech’s mRNA deCODE Genetics, a subsidiary of Amgen located in Iceland, will vaccine program. The collaboration aims to rapidly advance multiple provide genetic insights from patients who were previously infected COVID-19 vaccine candidates into human clinical testing based on with COVID-19. The two companies have signed a Memorandum of BioNTech’s proprietary mRNA vaccine platforms, with the objective Understanding to enable the parties to start work immediately and of ensuring rapid worldwide access to the vaccine, if approved. The are planning to execute a Collaboration and License Agreement. collaboration will leverage Pfizer’s broad expertise in vaccine research Terms of the agreement are not being disclosed. Both companies and development, regulatory capabilities, and global manufacturing aim to accelerate the development of a potential antibody against and distribution network. The two companies plan to jointly conduct COVID-19 as fast as possible for patients in need.

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Pharma Times - Vol. 52 - No. 03 - March 2020 46 Pharma Times - Vol. 52 - No. 04 - April 2020 62 Pharma Times - Vol. 52 - No. 03 - March 2020 47 Pharma Times - Vol. 52 - No. 04 - April 2020 63 RNI No. 18943/69 Date of Publication on 17th April, 2020 Regd. No. MCN/206/2018-2020 at Mumbai Patrika Channel Sorting Office Mumbai - 400 001 on 21st of every month. Licence to post without prepayment No. MR/Tech/WPP-151/North/2018-20 Dadar (W), Mumbai on behalf of the Indian Pharmaceutical Association Printed at Ebenezer Printing House,

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