PRICE LICENSED TO POST WITHOUT PREPAYMENT PER COPY LICENCE NO. MR/Tech/WPP-337/West/2021-23 ` RNI REGN. NO. 18921/1970 25/- Regn No. MCW/95/2021-23

vol. NO. 52 Issue NO. 21 (Pages: 41) 01 to 07 june 2021 ISSN 0970-6054 weekly publication

Indian APIs & Formulations for Global Healthcare

IDMA – ERNST & YOUNG Webinar on PLI Scheme for Pharmaceuticals: “What is in it for the Indian pharmaceutical industry!” Tuesday, 15th June 2021 – 3.00 p.m. to 5.00 p.m. Please forward your registrations… (More details on page No. 4)  IDMA Submission on Draft Guidelines for dealing cases of discontinuation of Scheduled Formulations (Page No. 4)  ‘Why Phytopharmaceutical Drug Discovery?’ by Dr S S Handa (Page No. 6) `  "Advisory:Old is the COVID-19 New normal” – Amendments/Relaxations/Compliances by Dr. Gopakumar G Nair (Page(Page No.No. 8) 5)

Export restrictions on Hydroxychloroquine lifted (Page No. 19)  Pharma next big thing for IT cos (Page No. 27) IDMA Bulletin DoP LII (21)comes 01 to 07 out June with 2021 draft Guidelines for Rs.6,940 crore PLI scheme1  No shortage of Covid drugs: IDMA (Page No. 35) to promote domestic production of Bulk Drugs (Page No. 32)

IDMA Bulletin LII (21) 01 to 07 June 2021 2

Founder Editor: Vol. No. 52 Issue No. 21 01 to 07 June 2021 Dr A Patani IDMA Activities: Editor: Dr Gopakumar G Nair IDMA – ERNST & YOUNG Webinar on PLI Scheme for Pharmaceuticals: Associate Editors: “What is in it for the Indian pharmaceutical industry!”...... 4 J L Sipahimalani “Old is the New normal” by Dr Gopakumar G Nair...... 5 Dr Nagaraj Rao Dr George Patani "Standard Operating Procedures to be followed in all the Industrial National President Commercial Establishments / Work Sites" at Sikkim : IDMA representation Mahesh H Doshi to the Secretary DoP ...... 6 Immediate Past National President IDMA & IPGA donated Covid treatment Medicines to Poor and Needy ...... 8 Deepnath Roy Chowdhury Tribute to Dr K K Aggarwal by Dr. R.K. Sanghavi...... 9 Senior Vice-President Dr Viranchi Shah NPPA Matter: Vice-Presidents: NPPA fixes the Retail Price of Specified 12 Formulation/Brand Name Bharat N. Shah under the Drugs (Price control) order, 2013-reg...... 13 (Western Region) Asheesh Roy DGFT matter: (Eastern Region) Amendment in Export Policy of Amphotericin-B injections...... 15 B K Gupta (Northern Region) GOVERNMENT PRESS RELEASES: T Ravichandiran Government issues Operational guidelines for Production Linked (Southern Region) Incentive Scheme of Pharmaceuticals...... 16 Hon General Secretary Dr George Patani Recommendations of 43rd GST Council meeting...... 17 Hon Joint Secretaries CBDT matter: J Jayaseelan Atul J Shah Extension of time limits of certain compliances to provide relief to Hon Treasurer taxpayers in view of the severe pandemic - reg...... 20 Vasudev Kataria IPR matter: For information contact IDMA Secretariat: (H.O.) Stalling negotiations on waiver will harm WTO’s credibility, warns India...... 22 Daara B Patel Secretary-General National News: Melvin Rodrigues Indemnity, a ‘standard process’ followed in other countries for Sr Manager (Commercial & Administration) vaccines: Wockhardt...... 23 C K S Chettiar Asst. Manager (Publications & Administration) Centre to find partner to operationalise Chengalpattu vaccine complex; Delhi Office: TN CM against any further delay...... 23 Ashok Kumar Madan India may consider indemnity request to vaccine makers...... 24 Executive Director Medium & small hospitals will take a while to offer Covid vaccine shots...... 25 S Ranganathan Asst Manager (Administration) Foreign-approved vaccines no longer need bridging trials in India: DCGI...... 26 Haffkine Biopharma to produce 22.8 cr Covaxin doses a year...... 26 IDMA STATE BOARDs CHAIRMAN Telangana: Biological E starts at risk manufacturing of Corbevax...... 27 „ Gujarat State Board : Milan Patel „ Haryana State Board : P K Gupta Pharma next big thing for IT cos ...... 27 „ Himachal Pradesh & Govt restricts export of Amphotericin-B drug...... 28 Uttarakhand State Board : R C Juneja „ Karnataka State Board : S M Mudda Regulator Looks for Alternative Medicines to treat Black Fungus’...... 28 „ Madhya Pradesh State Board : Paresh Chawla Biological E ties up with Canadian firm Providence for mRNA Covid vaccine...... 29 „ Tamil Nadu, Puducherry & Kerala State Board : J Jayaseelan Eli Lilly’s antibody cocktail drug gets emergency use nod in India...... 30 „ Telangana State Board : Shaik Janimiya Changing GST rates for Covid-supplies no panacea...... 30 „ West Bengal State Board : Shiv Sagar Tewari A Publication of Seeking clarity, guidance from govt for vaccine import: Cipla...... 31 Indian Drug Manufacturers' Association India halts vax exports, may resume in future...... 32 102-B, 'A-Wing', Poonam Chambers, Dr. A.B. Road, Worli, Mumbai - 400 018 Covid drugs rates brought down, NPPA tells Telangana high court...... 32 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 e-mail: [email protected]/ Cabinet secy-led panel wants PLI scheme revamp to boost manufacturing...... 33 [email protected]/ Website: www.idma-assn.org View: How financial incentives for innovation can play a Published on 7th, 14th, 21st and 30th of every month significant role in vaccine development...... 34 Annual Subscription No shortage of Covid drugs: IDMA...... 35 ` 1000/- (for IDMA members) ` 2000/- (for Government Research/Educational Institutions) InterNational News ` 4000/- (for non-members) US$ 400 (Overseas) Please send your payment in favour of India’s Covid Vaccine Rollout “Rescued The World”: Top US Scientist...... 36 Indian Drug Manufacturers' Association IDMAOpinions Bulletin Expressed LIIXLIV By Th(21)e Au(38) t01ho rs08 to Of to07 Individu 14 June Octoberal Ar2021ticle s2013 IDMA Congratulates Prof. Vandana B. Patravale...... 37 Do Not Necessarily Represent The Official View Of Idma. OBITUARY: Mr. T S Jaishankar...... 12

IDMA Bulletin Advt. Tariff card...... 44 Advertisements...... 2, 21, 37, 38, 39, 40 & 41

INDIAN DRUG MANUFACTURERS’ ASSOCIATION H.O.: 102-B, Poonam Chambers, A Wing, Dr. Annie Besant Road, Worli, Mumbai 400 018. Maharashtra. India. Tel: 022 – 24974308 E Mail: [email protected] Indian APIs & Formulations for Global Healthcare ATTENTION MEMBERS IDMA – ERNST & YOUNG Webinar on PLI Scheme for Pharmaceuticals: “What is in it for the Indian pharmaceutical industry!” Tuesday, 15th June 2021 – 3.00 p.m. to 5.00 p.m.

IDMA along with Ernst & Young proudly presents the First Virtual Webinar on PLI Scheme for Pharmaceuticals to be held on Tuesday, 15th June 2021 from 3.00 p.m. to 5.00 p.m.

Please Block Your Calendar. Detailed Agenda, Speakers & Link Follows.

KINDLY NOTE THAT THERE IS NO REGISTRATION FEE But Prior Registration is Necessary

For Registrations kindly contact : Mr. Melvin Rodrigues – [email protected] Ms. Parivaz Irani – [email protected] Request you to kindly rush in your registrations in the below format:

Sr. No. Name of the Participants & Mobile No. Email id Designation

Looking forward to your active participation at this very interesting and informative webinar.

Thanks & regards,

Daara B Patel Secretary – General

IDMA Bulletin LII (21) 01 to 07 June 2021 4

IDMA Activities

A CLARION“Old CALL is the TO N ALLew INDIANSnormal” TO FACILITATE INTENSERESEARCHDr GopakumarRESEARCH AND G PNair,ATENTING ON Editor, NATURAL Indian IN CODrugsVID PRODUCTS TIMES E DITORIAL Dear Reader,Reader, Dear Reader, E DITORIAL GovernmentMore than 100 of years India before is currently India was negotiating recognised Dr. a as limitedGopakumar the “Generic trade G. deal Capital” Nair with is or “Pharmacy of the World, India was acclaimeda forPh.D the in “Materia Organic Medica” Chemistry and “EveryUSA cloud which has is alikely silver to belining”. signed A afterfew “sidethe US elections. Although, the current negotiationsthe extensive do research not cover on thenatural Intellectual products Properties by Sir(1966) Col. (IP) fromDr. or Ram NationalPharmaceuticals, Nath Chemical Chopra, effects” of the Covid era are welcome for diverse athe limited father dealof Indian if concluded Pharmacology. successfully In fact, is Dr. expected M.L.Laboratory, Shroff to be got followed inspired Pune byfrom (P aune fullSir reasons. The “webinars explosion” on the internet TradeR.N. Chopra Deal (FTA), and started which the will first include Pharmacy IP and course PharmaceuticalsUniversity). at Banaras He Hindu too. was University a Post- and the innew 1932. normal Every studentexperience (even ofveterans) “work offrom Pharmacy Doctoral should fellow know atthat IIT Drugs Bombay, Act, In spite of all the negative (or positive?) consequences of COVID-19, home” and1940 online (later renamed operations as Drugs have and produced Cosmetics Act)Powai as well (1967) as formal before courses joining in the Sars2CoV virus has provided humanity with a great learning experience. “travel-saving”,Ayurveda, “time-saving” Siddha and and Unani “overhead were started saving” under his mentorship. DTAB (Drugs Repurposing of known drugs, bio-natural products,the P biologicalsharma Industry. and vaccines He was Technical Advisory Committee) was set up under his stewardship. The first edition economicssuch in ascorporate TB, Leprosy, and academicBCG have environs. all been undertakenDirector in theof Bombaydesperate Drug search for prophylactic, of the Indian Pharmacopoeia (evolved from Indian pharmacopoeial list 1946) 1955 was published with More particularly,therapeutic the as new well “innovation as preventive culture” options. that HoweverHouse it Pis. Ltd.,interesting later Chairman to note and of BDHappreciate Industries that his contributions. “We are reaping the fruits of the plant grown by their sown seeds. We should make has emergedexcept in thefor small-mediumpre-existing patent pharma rights sector (ex:-Remdesivir), as Ltd. as therewell as have CMD hardly of Bombay been any Drugs emphases & Pharma on the same available to our future generations” said the biographer, Roja Rani. Prof.Harkishan Singh the responseprotecting to the the patient Covid needs remedies in the through pandemic patenting. Ltd., which was merged with Strides Arcolab in J.Young Pharm, 2009 (Vol.1/No.3) had profiled Dr.R.N. Chopra (which is reproduced herein). Later tsunami is a welcome development. In the wake of Ltd. in 2001. Dr. Nair served IDMA as office Dr. K.M.Balancing Nadkarni of rights came and out obligationswith “Indian have Materia always Medica” been in an two integral volumes aspect in 1908 of Patent with Foreword Laws ever by bearer for many years from 1972 onwards and this repurposingsinceDr. R.N. the Chopra.spree, Paris Convention many These “grandfather” are wasextremely adopted valuabledrugs in 1883. reference The TRIPs books (Trade for further Related research Aspects in Indianof Intellectual Natural was Chairman of various Committees for nearly have foundPropertyProducts. renewed Rights) interest. has incorporatedThe revival of and HCQ adopted all the provisions of Paris conventions as per has beenArticle relatively 2 of TRIPs.short-lived Further, compared under the to Objectivethe 4 anddecades. Principle He ofwas TRIPs, the Pit residentis explicitly of stated IDMA in There were many more books and publications1999/2000. on Indian Currently, Herbal resources Dr. Nair andis the their Chairman medicinal of “evergreen”Article Paracetamol 7 and 8, which which respectively is being dispensed refer to “transfer and dissemination of technology to the mutual applications. Among them, the following are of highthe interestIPR Committee to herbal inresearchers: IDMA. both to Covidadvantage patients of producers in early andstages users and of technologicalpost knowledge in a manner conducive to social and- economicBritish Herbal welfare, Pharmacopoeia and to a balance – 1996 of rights and obligations” and also “Members may adopt vaccination to one and all. The medical profession Having moved into the Intellectual Property measures- Ayurvedic necessary Pharmacopoeia to protect public of India health – many and volumes nutrition and to promote public interest….”. As as well assuch, clinical member researchers countries have like taken India to do these provide suchfield, balancing he was theprovisions Dean inof theIIP NationalS (Institute Patent of - Ayurvedic Formulary of India – many volumes proven remedieslaws such with as the low Patents but well Act known 1970 of (often India. However,Intellectual in developed Property countries Studies) suchat Hyderabad as USA , the in nil) side effects.patent- provisionsIndianThere Herbal are manyare Pharmacopoeia constantly examples. evolving Recent Vol. I & based II compiled2001/2002. on juridical and published Later,judgments he by Indianset from up Drugthe his US Manufacturers’own Courts. boutique The research USwas Patent shownAssociation law, that 35“Budesonide” jointlyUS code with isRegional inhaler very brief (and Research unlike IP PatentsLaboratory, firm, Act,Gopakumar Jammu. 1970 of NairIndia, Associates, where the as balance well as has moved substantially in favor of the Inventors and the Patent owner. Consequently, USA the BudesonideIDMA and has Formoterol been “naturally” inhalation) active “herbally” is an inGnanlex the early Hermeneuticsdays till the nineties. Pvt. Ltd.,Early havinginterest indone the has been extensively critical of Indian Patent provisions leading to USTR (United Sates Trade effective Indianprophylactic pharmaceutical as well as industry early stage as well Covid- as IDMA inhis herbal L. L. drugsB. from was Mumbai high with University. IDMA members He is suchalso Representative) issuing Super 301 Trade notifications over the last few years. India’s response 19 therapy.as Zandu, Inga, Charak, Amsar, Cipla and manyCEO more. of While Patent global Gurukul giants and such P residentas Lever ofand Bharat P&G has been more defensive, though our Trade negotiatorsEducation have Society, successfully Kurla, explained Mumbai, our managing position oncontinue the balance to be interested of rights in and herbal obligations. and natural However, products, it of is late time both now, Indian especially companies in view such ofas theHimalaya, global Colchicine is another drug reported in use many educational institutions in and around pandemic,Patanjali, Laila, for usDabur to convince and global the cosmetic developed and nutraceutical countries like leaders USA suchto provide as Colgate, needful Unilever, emphasis L’Oreal, on Mumbai from 1500healthcareHerbalife B.C. It andwas protection others approved continue in forpreference medicinalto develop to herbal use,patent cosmetics, protection. nutraceuticals and healthcare products. The though inIndian a narrow pharma safety industry’s efficacy interest range, in herbal since research was eventually almost laid to rest with the hasty 1961. In andrecent Indianuntimely times, patent Biodiversity Colchicine provisions Act, hasas2002 per emerged and Patents the Rules Act,support. 20041970 thereof, has Hydrocortisone been with challenging extremely has harsh for also Indian and been impractical Inventors used in and their Patent Agents/ Attorneys. India’s unique permission under Sec 3“What are not inventions” as the mostenforcement commonly efforts. prescribed The last medicationnail on the coffin in ofmanaging Indian herbal septic research shock initiatives in Covid was patients. the intrusion Indian “Whatof National are notGreen patentable” Tribunal through(Sec 3(d) the for Biodiversity example) Act has to been penalise a real the hurdle herbal unlike researchers USA, andover users and USA, even before the outset of Covid. The modest Pharma Industry has been responding amazingly abovein India. the The tough “benefit-sharing” “Obviousness” objectives criteria of adopted the Nagoya by the Protocol Indian and Examiners. the International “Convention on “gout” drug has now been rediscovered in its new well by repurposing known drugs for affordable Biodiversity (CBD)” was hijacked by vested NGOs and the protagonists of the distorted and anti-benefit Pricing of pharmaceuticals has been tightlytreatment controlled of under the alarming NPPA (National resurgence Pharmaceutical of Covid-19 “Avtar” andgeneration has reborn activists, in treatment so much so of that moderate the Indian research on Natural resources got discouraged. Efforts symptomaticPricing Covid-19 Authority) patients. except Dexamethasonefor patented molecules, extending most fromof which 2020 are to 2021.either wholly imported or exclusivelywere made licensedto reduce with and terms soften and the conditions. impact of the As such,Biodiversity Indian Act Patents by IDMA and healthcareand other likeminded providers and Hydrocortisoneorganisations. have Consequently, also emerged the NBAas useful (National Biodiversity Authority) has repeatedly amended the have been under an advantage vis-à-vis affordableThe “start-up”access and era generic of recent options origin has widely been being quick agents in available“guidelines”Covid therapy. without to make The market “Recoverythe Act monopolies. and Trial” Rules found more friendly for the users, researchers and herbal industry. dexamethasoneHowever, useful the blatantly for patients illegal demandson respiratory from State to Biodiversity reorient and Boards reinvent (SBB) themselves and NGT continues in responding even today.Indian It is Pharmaceuticalimperative and extremely researchers necessary and manufacturers for these agencies in the to field seize of naturaland desist products from further have IDMA Bulletinbeendamaging LII facing (21) the 01 the researchto additional07 June potential 2021 challenge in herbal from and the natural Biodiversity resources. Act, 2002 and the Rules 2004, which5 had been prematurely promulgated ahead of the Nagoya Protocol and which had been very 4 INDIAN DRUGS 57 (01) JANUARY 2020 tardilyINDIAN drafted.DRUGS 57 To (01) add JANUAR insultY to 2020 injury, the procedural provisions have all along been harsh and 5

INDIAN DRUGS 57 (08) AUGUST 2020 5

to pandemic times. Newer medical devices and cooperation between Industry-academia, clinical need-based diagnostic processes and products research, medical profession, medical devices have come up through breakthrough innovations and engineering research industry groups. The in recent times. “silver lining” emerging from the “Covid cloud” is ideal for pharma-bio researchers to ride on by However, academic research institutions, undertaking need-based innovation projects to except through some venture centres and meet current market expectations. start up initiatives, have not been forthcoming adequately to take advantage of these innovation Further to the mad rush for Remdesivir, Gilead has opportunities. Low-hanging fruits in the form issued a press release on availability of Remdesivir, of incremental innovations (based on internet even though Remdesivir is acknowledged as search of prior arts) are available as research only helping to cut the hospital stay by 5 days. Of topics, needed for immediate commercialization in late, considerable interest has emerged among industry. New drug delivery systems are also open Researchers, Clinicians, pharma industry and for remodelling the repurposed drugs for current physicians on MOLNUPIRAVIR, an oral drug for needs. The lack of adequate linkages with clinical treatment of Covid-19 and the variants / mutants. research groups and investigators have kept the There is opportunity for pharma researchers in the academic research institutions away from pursuing academic corridors to undertake work on newer “me too” molecules, which could be extensions of formulations of useful molecules like Molnupiravir. newer large biological drugs like “mabs”, “nibs” etc. This brings us back to our earlier clarion Courtesy: Indian Drugs, Editorial, Vol. 58 (02) call to enhance and enlarge tie-ups and research February 2021

l l l

"Standard Operating Procedures to be followed in all the Industrial Commercial Establishments / Work Sites" at Sikkim : IDMA representation to the Secretary DoP - reg.

The Association have submitted the following We are pleased to inform you that IDMA has about nd representation on 2 June 2021 to Ms. S. Aparna, IAS, 25 member companies who have their factories/plants Secretary to the Government of India, Department at Sikkim. We thank the Sikkim Government for all their of Pharmaceuticals with the copy to the Department support and co-operation extended to our members. of Labour, Government of Sikkim, on the above subject: However, the above mentioned circular issued by the Department of Labour, Government of Sikkim Greetings from Indian Drug Manufacturers’ asking all pharma companies to continue operations Association (IDMA)! by accommodating the work force within the plant premises or in neighbouring schools / housing facilities We refer to the circular no. 53 dated 28/05/2021 on can have damaging consequences to the functioning of “Standard Operating Procedures to be followed in pharma companies in Sikkim and hence not advisable. It would put the workforce in grave danger of Covid-19 all the Industrial Commercial Establishments / Work pandemic spread affecting their colleagues, families and Sites” issued by the Department of Labour, Government neighbours. This will further result in adversely affecting of Sikkim.

IDMA Bulletin LII (21) 01 to 07 June 2021 6

the manufacturing facilities and ultimately resulting in 4) It may also lead to employees resorting to large scale shortages of medicines. absenteeism due to the fear of getting infected.

We therefore request the Government to take into We would like to submit that our member companies consideration the following:- have updated screening methods and SOPs to be followed to ensure total adherence to the covid-19 protocols. 1) There aren’t enough facilities like schools or hotels Screening for signs and symptoms are done from pickup which can accommodate all employees of all point itself and also during entry into the plant. This results Pharmaceutical companies in the vicinity of the in quick identification and isolation of those found to be plant. Further, schools will not have the required infected. The Plant section is then sanitized and shut infrastructure like number of toilets, dining areas down for 48 hours, rest of staff are screened for symptoms and support structure for following the covid-19 before resumption of production. This ensures continuity protocols. of production as well as safety of the staff. 2) During the last pandemic many companies had tried to accommodate employees within the plant premises We request your quick intervention in this matter and which led to large outbreaks and subsequently the to ensure the necessary support to the manufacturing units plants were declared containment zones limiting thereby ensuring continuous production of medicines. movement of people and materials. Thanking you, 3) Also, there was unrest within the units where individuals who are not infected wanted to leave Yours faithfully, the plant, but were not allowed to leave by the For Indian Drug Manufacturers’ Association, Government. Similar consequences can be expected if employees are kept in such facilities. This will have Mahesh Doshi long-term consequences for production. National President

l l l

IDMA Congratulates Prof. Vandana B. Patravale

PROF. VANDANA B. PATRAVALE , Ph.D Professor of Pharmaceutics Department of Pharmaceutical Sciences and Technology, ICT, Mumbai Member of Editorial Advisory Board, Indian Drugs

Congratulations to Prof. Vandana Patravale for being inducted as Independent Director on the Board of Directors of Sahajanand Medical Technologies Limited, a company which has introduced coronary stents in more than 65 countries based on technology suggested by VBP research group.

l l l

IDMA Bulletin LII (21) 01 to 07 June 2021 7

IDMA & IPGA donated Covid treatment Medicines to Poor and Needy

Cyberabad CP Shri. VC Sajjanar, IPS., appreciated IDMA & IPGA association member companies for the Good Cause

Cyberabad: As part of the COVID relief activities to Security Council (SCSC) Cyberabad CP Shri VC Sajjanar, help the poor and needy people in the pandemic situation IPS appreciated Indian Drug Manufacturers’ Association Indian Drug Manufacturers’ Association (IDMA) & Indian (IDMA) and Indian Pharmacy Graduates Association Pharmacy Graduates Association (IPGA) have donated (IPGA) Telangana Branch and its Association members COVID treatment Medicines to Cyberabad Police under like Suraksha Pharma, Crescent Formulations, Pulse CSR activities on 29.05.2021. Medicines were handed Pharmaceuticals, Indu Drugs, Serene Formulations, over to Shri VC Sajjanar, IPS, Commissioner of Police Medmenar Organics, Sain Medicaments, Euro Medicare, Cyberabad by Shri Shaik Janimiya, Chairman, IDMA Vaibhav Drugs, Navya Pharmaceuticals, Vasanth Biotech, Telangana State Board and Shri. G. Koteswara Rao, Dr. Guda Ramana Reddy, Krishcare Formulations for Indian Pharmacy Graduates Association (IPGA) Telangana organizing these donations and motivating their members Branch along with other members of the Association. On for this great contribution. behalf of the Cyberabad Police and Society For Cyberabad

l l l

IDMA Bulletin LII (21) 01 to 07 June 2021 8

TRIBUTE TO DR K K AGGARWAL

The Virus In COVID-19 Needs Always TO BE Cornered & Checkmated Expressly With Mahabharat Strategy 1st June 2021

# RKS:Th TRIBUTEe Dead TOly DRCo Kr onaK AGGARWAL Cannot - Be Dealt to destroy the enemy SARS-CoV-2. NLRP3 is first The Virus In COVID-19 Needs Always TO BE Cornered & CheckmatedWith EXPRESSLY Kid Glo Withve Mahabharats Strategy released followed by IL-6 production. 10% of COVID-

Dear Reader, 19 patients have a raised IL-6 by day 4 or 7 or 11 - an indicator of an upcoming cytokine storm syndrome The 2019-discovered (CSS). Unfortunately, at present, NLRP3 is not being novel coronavirus-2 (2019- estimated and hence there is no earlier and hence nCoV) or SARS-CoV-2 there is no earlier ‘premonition’ of the CSS other than has thus far infected near IL-6 estimation! 3 crore Indians of which 5. The CSS has been initiated to kill the persistent the unfortunate ones have SARS-CoV-2 but the liberated IL-6 and NLRP3 been over 3 lakhs. The total cause collateral damage. Usually the damaged number of doctor fatalities lungs release LDH and there is a rise in D-dimer have been approximately blood concentrations, besides higher serum ferritin

1000 during the pandemic, levels - all of these are markers to indicate CSS. which is 0.5% of the medical 1st June 2021 6. High D-dimer values could predict COVID-19 disease professionals engaged in COVID-19 management. THE DEADLY CORONA CANNOT BE DEALT WITH KID GLOVES severity, lung complications as well as blood clot formation 2 potential even before these consequences occur. Dear Reader, Hence, 1% of infected Indian population die of COVID-

The 2019-discovered19 but, novel in coronavirus the case-2 (2019 of-nCoV) Indian or SARS doctor,-CoV-2 has 1 thus out far of 3 SARS-CoV-2 infected near 3 crore Indians of which the unfortunate ones have been over 3 lakhs. The total numberafflicted of doctor fatalitmedicalies have beenprofessional approximately 1000have during been the pushed to their pandemic, which is 0.5% of the medical professionals engaged in COVID-19 management. grave!! This is alarming and indeed calls for an all-out war against the pandemic-causative virus to save our fellow Dr brethren.

THE UNFOLDING OF COVID-19 SEQUENCE OF EVENTS 1. The SARS-CoV-2 first lodges in the nasal and mouth passages because of entry via floating droplets emanating from the carrier person with whom one interacts, sans maintaining social distancing and / or

masking up. This causes symptoms. 2. When symptoms persist, or there is strong suspicion of contact with a carrier, a RT-PCR testing must be done usually after 4 days following exposure or symptoms occurrence to confirm presence of SARS- CoV-2 infection. 3. The SARS-CoV-2 remains alive seemingly up to 10 days post-entry into the human body. The virus needs to be killed efficiently and promptly by drugs and / or immune defences. 4. If the virus is not promptly killed, dangerous chemical mediators like IL-6 and NLRP3 are liberated by the defence cells of the human body in an effort

Hence, 1% of infected Indian population die of COVID-19 but, in the case of Indian IDMA Bulletin LII (21) 01 to 07 June 2021 doctor, 1 out of 3 SARS-CoV-2 afflicted medical professional have been pushed 9to

7. If there is recovery because of appropriate and 2019-CoV-2 has: effective antiviral drugs, the dead SARS-CoV-2 RNA 1. Structural proteins: M, E & N proteins continues to remain in cells and could be detectable by RT-PCR even 1-2 months after the infection! (This 2. Host cell docking protein: S protein is false positive RT-PCR test.) In addition to the above, there are accessory proteins Thus, the aim has to be to kill the SARS-CoV-2 before and an enzyme called RNA-dependent RNA polymerase the body’s defence cells kick-starts the CSS in an effort (RdRp) which is essential for RNA replication. For the to eliminate the virus. It is important to remember that the virus to be infective the S protein needs to bind with virus is dead in less than 10-14 days but the consequences corresponding S protein ligand (docking point) present of critical condition in hospitalised patient and fatalities are on host cell; similarly RdRp needs to interact with RdRp all the outcome of the already initiated CSS - the virus is ligand of human cell for facilitating viral replication. no-way in the picture at that point of time! Thus, for antivirals to beneficially prevent the SARS- TIME FOR MEDICAL MAHABHARAT CoV-2 from infecting and multiplying, the S protein and the RdRp as well as their respective ligands must Not only our dear patients but we as doctors need to be inhibited. The result of blocking docking (of the S protect our right to life. This SARS-CoV-2 just cannot be protein / RdRp of SARS-CoV-2 as well as the interacting allowed to overwhelm us and render us helpless and push respective ligands of the host cell) are expressed as us in dire striates. The need of the hour is not to be reactive MolDock score. but proactive. After all, as stated, one out of every 3 doctors with COVID-19 disease can have a catastrophic ending. S RdRp SARS- S PROTEIN PROTEIN- RdRp PROTEIN- COV-2 A high blood CRP, which will invariably rise in all LIGAND LIGAND ANTIVIRAL patients in 2-3 days post SARS-CoV-2 infection, can only MolDock Score (Kcal/mol) re-confirm COVID-19 status in a positively RT-PCR tested Ivermectin -140.584 -139.371 -149.9900 -147.608 patient. CRP values can guide regarding the severity of Remdesivir -111.007 -122.699 -160.418 -173.270 infection, and in no way can assist in personalising a Favipiravir -54.595 -68.539 -63.408 -77.835 comprehensive drug regimen. What is more important, once positive RT-PCR and an abnormal high CRP are Higher the negative value better is the inhibitory detected, is: action and more superior is the outcome of antiviral drug. Doxycycline has a MolDock score of -115.46. # Kill the virus with specific antivirals - so that the deadly CSS waves initiating chemical mediators are Since ivermectin has higher MolDock score than NOT generated. doxycycline it should be preferred in combination with # Kill the virus decisively with combination of antivirals favipiravir as far as swallowing antiviral pills are concerned. - depending upon the severity should be the choice Why combine the latter two when favipiravir is weaker? of specific antivirals. This is because ivermectin acts on 4 amino acids # Prevent and, if necessary, tackle the COVID-19 - (threonine, isoleucine, glutamic acid & asparagine) whilst associated disasters with appropriate preventive favipiravir has unique binding action on arginine which regimens - when IL-6 and associated complication compliments that of ivermectin. Injection of remdesivir is markers indicate possible onset of CSS. more suitable for the severe COVID-19 patients and those who are hospitalised. Do not hesitate to start antivirals promptly: it could be a single agent or 2 drugs; or it could be tablets or injection WHY YET FAVIPIRAVIR - A Weak MolDock Scorer? (as per patient condition). The other treatment measures Furin is a widespread enzyme in the body, potentially are secondary and complimentary. granting SARS-CoV-2 countless opportunities to infect WHICH ANTIVIRALS & WHY? cells. One cannot, in fact, live without possessing furin A little information on SARS-CoV-2 mechanism in enzyme! Inhibiting furin is a more beneficial mechanism thriving and causing infection would be enlightening. The than spike protein S blocking.

IDMA Bulletin LII (21) 01 to 07 June 2021 10

In order to invade the body, the spike of SARS-CoV-2 REMEMBERING DR K K AGGARWAL must first be snipped at a specific point by the furin We have paid the price with over 1,000 of our colleagues protease enzyme following which the virus can then latch falling in the battle, including our beloved physician onto a cell’s ACE2 receptor to thereby cause infection. The and cardiologist Dr Krishan Kumar Aggarwal who was spike protein as well as the SARS-CoV-2 docking site on President of Confederation of Medical Association of Asia the cell have an amino acid sequence - arginine-arginine- and Oceania (CMAAO) as well as Heart Care Foundation alanine-arginine. Favipiravir (as tablets) and remdesivir (as of India (HCFI) & Past National President of Indian Medical injection) both inhibit furin because of binding to arginine Association (IMA) - besides being a Padma Shri and B C (unlike ivermectin) but remdesivir is stronger in its action. Roy National award recipient. However, when antiviral tablets are necessitated favipiravir My tryst with Dr K K Aggarwal was first in the is preferable since it has higher affinity than ritonavir month of August 2020 as we planned a special one- and lopinavir for furin enzyme as compared to S protein hour session on CSS for his MedTalks series. This and RdRp and their corresponding ligands. Thus, there was possibly the first time ever, as Editor-in-Chief of is always an implied and urgent necessity to advocate MedTalks Dr K K Aggarwal facilitated an elaborate a combination of ivermectin with favipiravir in positively PowerPoint presentation, at my request, on his 7 pm tested RT-PCR patients. 11th September 2020 show titled - Chemical Mediators Causing Cytokine Storm In Viral Infections: MedTalks CONCLUSION with Dr K K Aggarwal. He was possibly the first medical Favipiravir or remdesivir, when paired with doxycycline professional with whom I had willingly ever given my or ivermectin, can substantially and rapidly clear SARS- presentation knowing fully well that Dr K K Aggarwal CoV-2 from nasal secretions if it was started relatively will be most enthusiastic in wide-spreading my data on early (day 1) or latest by day 7 of confirmed COVID-19 a broader-based platform so as to benefit both Indian infection. If this antiviral is given within the first few hours and overseas doctors. The very next day I was invited of infection, then the SARS-CoV-2 virus is possibly cleared by Dr K K Aggarwal to explain a few of my slides in a in 7 days sans complications! COVID-19 - related meeting of CMAAO and I will always be grateful for this opportunity. For prevention of CSS, corticosteroids can be initiated by day 5, or earlier if pulmonary symptoms are present Dr K K Aggarwal had immense following of his or co-morbidities co-exist, in a COVID-19 sufferer. thrice a day YouTube video talks uploads pertaining Abnormally high D-dimer values naturally signal institution to different aspects of corona pandemic. His crystal of anti-clotting medication. clear views on coronavirus pandemic, and lucid presentation of the same, enabled percolation of Thus, to defeat the SARS-CoV-2 in fighting the COVID-19 knowledge even to the layman. He will COVID-19 the Mahabharat - like forces are: forever be remembered.

1. Yudhistira - The advising Dr The second wave of COVID-19 is scary because 2. Arjuna - The sharp-shooter antiviral of its 80-90% virus transmissibility rate from contacts in comparison to 30-40% in first wave! Most health workers 3. Bhima - The bull-dozer corticosteroid would not seemingly be able to escape getting infected 4. Nakula - The immunity supporters - Vitamins C & D, with SARS-CoV-2 - preventive measures and vaccination zinc (acetate, gluconate) notwithstanding! Be mind-tuned to hit hard the virus if it 5. Sahadeva - The strategist anticoagulant attacks. We cannot afford to lose another luminary from amongst medicos. We doctors need to win COVID-19 war without ultimate sacrifice. Why risk and leave the outcome to destiny and God Bless the warring Doctors. good wishes and faith. We must ensure no loose ends Dr R K Sanghavi, Chairman : Nutraceutical Committee are left and all therapy gaps filled. Under the guidance of (IDMA) Prophesied Enabler, Experience & Expertise: Clinician one of our more trusted but aggressive Dr guru we must & Healthcare Industry Adviser adopt the Mahabharat strategy. l l l

IDMA Bulletin LII (21) 01 to 07 June 2021 11

OBITUARY

IDMA mourns the sudden demise of Mr. T S Jaishankar

IDMA and its members all over India sadly mourn the sudden demise of veteran pharma leader Mr. T S Jaishankar who passed away on May 31, 2021 in Chennai.

Mr. Jaishankar was the founder of the pharmaceutical manufacturing firm Chemech Laboratories Ltd and the clinical research services organization, Quest Lifesciences.

A senior pharma industry captain in the country, Mr. Jaishankar held various positions in several pharmaceutical industry associations including Indian Drug Manufacturers’ Association (IDMA), Confederation of Indian Pharmaceutical Industry (CIPI) and Tamil Nadu Pharmaceutical Manufacturers Association (TN PMA). He was the Past President of CIPI and Past President of TN PMA. He was also one of the Advisory Board Members of Pharmabiz.

Mr. Jaishankar would always be remembered for his hard work and commitment towards the growth of the pharma Small and Medium Enterprises (SMEs) in the country. In Tamil Nadu, he was part of all associations and activities connected with the pharmaceutical sector.

Mr. S V Veeramani, Past President of the Indian Drugs Manufacturers’ Association and MD of Fourrts Laboratories said that Mr. Jaishankar was one of the founder leaders of CIPI and was also President of the confederation for a term. While he was the President of CIPI, he brought all the pharma SME units under one umbrella. With his sudden death the Indian pharma industry has lost a great supporter and a big leader.

Mr. J Jayaseelan, Chairman, IDMA Tamil Nadu, Kerala & Puducherry State Board said that Mr. Jaishankar’s services to the pharma sector were unparalleled and he was a pillar of the Indian pharma industry always. He worked hard for the SME sector and was part and parcel of all activities and conferences on pharma in Tamil Nadu. Personally he was a very nice person.

Mr. M Rajaratinam, Executive Committee Member of IDMA and MD of MMC Pharmaceuticals Ltd. said that Mr. Jaishankar was the pioneer of the biotechnology industry in Tamil Nadu and his efforts in that area had helped the pharma industry grow so much.

In his passing away, the Indian Pharma Industry has lost a Senior Pharma Leader, an active Supporter, a very warm human being and brilliant professional.

May his Soul Rest in Peace and May God grant his family the strength to bear this irreparable loss.

IDMA Bulletin LII (21) 01 to 07 June 2021 12

NPPA Matter NPPA fixes the Retail Price of Specified 12 Formulation/Brand Name under the Drugs (Price control) order, 2013-reg.

NPPA Order S.O.2119(E), dated 01st June 2021

In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O.1394(E) date d the 30th May, 2013 and S.O.701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof;

TABLE Sr. Name of the Strength Unit Manufacturer & Retail No. Formulation/ Brand Marketing Company Price Name (Rs.) (1) (2) (3) (4) (5) (6) 1. Ivabradine Each film coated tablet contains: 1 Tablet M/s Archimedis 15.75 Hydrochloride + Ivabradine Hydrochloride eq. to Healthcare Pvt. Ltd./ M/s Metoprolol Tartrate Ivabradine 5 mg + Metoprolol Tartrate Lupin Limited Tablet IP 25 mg 2. Ivabradine Each film coated tablet contains: 1 Tablet M/s Archimedis 18.14 Hydrochloride + Ivabradine Hydrochloride eq. to Healthcare Pvt. Ltd./ M/s Metoprolol Tartrate Ivabradine 5 mg + Metoprolol Tartrate Lupin Limited Tablet IP 50 mg 3. Telmisartan, Each film coated tablet contains: 1 Tablet M/s Ravenbhel 10.16 Cilnidipine & Telmisartan IP 40mg, Cilnidipine Healthcare Pvt. Ltd./ M/s Metoprolol (ER) IP 10mg Metoprolol Succinate IP Neomac Pharmaceuticals Tablet 23.75mg eq. to Metoprolol Tartrate Pvt. Ltd. (as extended release) 25mg 4. Telmisartan, Each film coated tablet contains: 1 Tablet M/s Ravenbhel 12.41 Cilnidipine & Telmisartan IP 40mg, Cilnidipine Healthcare Pvt. Ltd./ M/s Metoprolol (ER) IP 10mg Metoprolol Succinate IP Neomac Pharmaceuticals Tablet 47.50mg eq. to Metoprolol Tartrate Pvt. Ltd. (as extended release) 50mg 5. Doxycycline & Lactic Each hard gelatine capsule contains: 1 M/s Skymap 6.94 Acid Bacillus Capsule Doxycycline hyclate IP eq. to Capsule Pharmaceuticals Pvt. Ltd. Doxycycline (as pellets) 100mg Lactic Acid Bacillus (As enteric coated pellets) 5 Billion Spores 6. Doxycycline & Lactic Each hard gelatine capsule contains: 1 M/s Skymap 6.94 Acid Bacillus Capsule Doxycycline hyclate IP eq. to Capsule Pharmaceuticals Pvt. Doxycycline (as pellets) 100mg Lactic Ltd./ M/s Glensmith Labs Acid Bacillus (As enteric coated Pvt. Ltd. pellets) 5 Billion Spores

IDMA Bulletin LII (21) 01 to 07 June 2021 13

7. Darunavir + Ritonavir Each film coated tablet contains: 1 Tablet M/s Hetero Labs Ltd./ M/s 145.70 Tablet Darunavir Ethanolate eq. Darunavir IP Cipla Limited 600mg Ritonavir IP 100mg 8. Povidone-Iodine Contains: Povidone Iodine IP 0.5% 1 ML M/s Stedman 0.66 gargle 0.5% w/v w/v (available Iodine 0.05% w/v) Pharmaceuticals Pvt. Ltd. 9. Teneligliptin Each uncoated bilayered tablet 1 Tablet M/s Windlas Biotech 11.00 + Metformin contains: Teneligliptin Hydrobromide Pvt. Limited/ M/s Abbott HydrochlorideIP (SR) Hydrate eq. to Teneligliptin 20mg Healthcare Limited Tablet Metformin HydrochlorideIP (As Sustained Release) IP 500mg 10. Teneligliptin + Each uncoated bilayered tablet 1 Tablet M/s Morepen 10.96 Metormin HCL (ER) contains: Teneligliptin Hydrobromide Laboratories Limited Tablet Hydrate eq. to Teneligliptin 20mg Metformin hydrochloride (As Extended Release) IP 500mg 11. Teneligliptin + Each uncoated bilayered tablet 1 Tablet M/s Morepen 11.48 Metormin HCL (ER) contains: Teneligliptin Hydrobromide Laboratories Limited Tablet Hydrate eq. to Teneligliptin 20mg Metformin hydrochloride (As Extended Release) IP 1000mg 12. Teneligliptin Each uncoated bilayered tablet 1 Tablet M/s Windlas Biotech 11.48 + Metformin contains: Teneligliptin Hydrobromide Pvt. Limited/ M/s Abbott Hydrochloride IP Hydrate eq. to Teneligliptin 20mg Healthcare Limited (SR) Tablet Metformin HydrochlorideIP (As Sustained Release) IP 1000mg Note: (a) The manufacturer of above mentioned formulations i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove. (b) The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (e) The above mentioned retail price is applicable only to the individual manufacturer/marketer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies. (f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (g) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded. PN/219/87/2021/F/F.No.8(87)/2021/D.P./NPPA-Div.-II

Prasenjit Das, Deputy. Director, National Pharmaceutical Pricing Authority, Ministry of Chemicals and Fertilizers Department of Pharmaceuticals, New Delhi. l l l

IDMA Bulletin LII (21) 01 to 07 June 2021 14

DGFT matter Amendment in Export Policy of Amphotericin-B injections

DGFT Notification No.07/2015-2020, dated 01st June 2021

1. In exercise of powers conferred by Section 3 of the Foreign Trade (Development & Regulation) Act, 1992 (No.22 of 1992), as amended, read with Para 1.02 and 2.01 of the Foreign Trade Policy, 2015-20, the Central Government hereby makes the following amendment in Schedule 2 of the ITC (HS) Export Policy, 2018 related to export of Amphotericin-B injections: Sr. No. ITC HS Codes Description Present Policy Revised Policy

207AB Ex 30049029 Amphotericin-B Free Restricted Ex 30049099 injections 2. The provision under Para 1.05 of the Foreign Trade Policy (FTP) 2015-20 regarding transitional arrangement is not applicable for this notification. 3. Effect of this Notification: The export of Amphotericin-B injections falling under the ITCHS Codes specified above or falling under any other HS Code is restricted, with immediate effect. File No.01/91/180/24/AM22/EC/E-27724

Amit Yadav, Director General of Foreign Trade, Ex-Officio Additional Secretary, Directorate General of Foreign Trade, Ministry of Commerce & Industry, Department of Commerce, New Delhi.

l l l

NOW AVAILABLE ! IDMA-APA GUIDELINES / TECHNICAL MONOGRAPHs

TECHNICAL MONOGRAPH NO. 1 TECHNICAL MONOGRAPH NO. 2 Stability testing of existing Primary & SecondaryChemical drugs substances and products Reference Substances TECHNICAL MONOGRAPH NO. 3 TECHNICAL MONOGRAPH NO. 4 INVESTIGATION OF OUT OF PHARMACEUTICAL PReFORMULATION SPECIFICATION (OOS) TEST RESULTS analytical STUDIES TECHNICAL MONOGRAPH NO. 5 TECHNICAL MONOGRAPH NO. 6 Environmental Monitoring CORRECTIVE/PREVENTIVE ACTIONS in cleanrooms (CAPA) GUIDELINE TECHNICAL MONOGRAPH NO. 7 TECHNICAL Document NO. 8 DATA INTEGRITY GOVERNANCE QUALITY 4.0 Digital Technology of the Future

Copies are available at IDMA Office, Mumbai. We do not mail any publications against VPP payment. All payments to be made in advance as cheque/DD/RTGS/NEFT in favour of “INDIAN DRUG MANUFACTURERS’ ASSOCIATION” at Mumbai. For more details please contact: PUBLICATIONS Department Tel.: 022 - 2494 4624 / 2497 4308 Fax: 022 - 2495 0723 E-mail: [email protected], Website: www.idma-assn.org/www.indiandrugsonline.org

IDMA Bulletin LII (21) 01 to 07 June 2021 15

GOVERNMENT PRESS RELEASES Government issues Operational guidelines for Production Linked Incentive Scheme of Pharmaceuticals

Applications invited from industry

With an aim to enhance India’s manufacturing application, can apply for more than one product and the capabilities by increasing investment and production in the products applied by an applicant can be in any of the three sector and to contribute to product diversification to high categories. The applicants will be required to achieve value goods in the pharmaceutical sector, Department of minimum cumulative investment per year over a period of Pharmaceuticals notified the 'Production Linked Incentive 5 years as prescribed under the scheme. The investment (PLI) Scheme for Pharmaceuticals' vide Gazette Notification could be under new plant and machinery, equipment and No.31026/60/2020-Policy-DoP dated 3rd March, 2021. associated utilities, research and development, transfer The approved outlay of the scheme is Rs 15000 crore. of technology, product registration and expenditure The scheme envisages to create global champions out incurred on building where plant and machinery are of India who have the potential to grow in size and scale installed. Investment made on or after April 01, 2020 will using cutting edge technology and thereby penetrate the be considered as eligible investment under the scheme. global value chains. Based on a series of consultations with pharmaceutical industry and stakeholders in the Thereafter, the selected manufacturers will be able to Government, the operational guidelines for the scheme receive production linked incentives based on incremental have been prepared and issued on 1st June. The scheme sales of pharmaceutical products for a period of 6 years. is now open to applications from the industry. A selected participant will be able to get a maximum incentive of Rs 1000 crore, Rs 250 crore and Rs 50 crore The applications are invited in three groups based on respectively depending upon its group over the period of the Global Manufacturing Revenue of FY 2019-20 of the the scheme. Additional incentive will be available based on applicants. A special carve out for MSMEs has been kept performance but subject to certain conditions. In no case, under the scheme. All the applications will be submitted the total incentive including additional inventive, would be through an online portal maintained by SIDBI, the Project more than Rs 1200 crore, Rs 300 crore and Rs 60 crore Management Agency for the scheme. Application can per selected participant respectively for the three groups be made on the online portal, URL of which is https:// over the period of the scheme. pli-pharma.udyamimitra.in. The application window is for 60 days staring from 2nd June, 2021 to 31st July, An Empowered Group of Secretaries will undertake 2021 (Both dates inclusive) periodic reviews of the scheme to ensure its smooth implementation along with the other PLI schemes of the The eligible products have been categorized into three Govt. of India. A Technical Committee will assist the categories. The products covered under the scheme are department in all technical issues which arise during formulations, biopharmaceuticals, active pharmaceutical the implementation of the scheme. SIDBI, the Project ingredients, key starting material, drug intermediates, in- management Agency selected for this scheme, will be vitro diagnostic medical devices, etc. The category-1 and responsible for implementation and will be the interface with category-2 products attract 10% incentive and category-3 the industry for all issues with respect to online applications, products attract 5% incentive on the incremental sales. selection of applicants, verification of investments, Incremental sales of a product mean sales of that product verification of sales and disbursal of incentives etc. in a year over and above the sales of that product in FY 2019-2020. The pharmaceutical and the in-vitro diagnostic industry is expected to actively participate in the scheme and Based on clearly laid out selection criteria given contribute to further strengthening the sector. in the guidelines, a maximum of 55 applicants will be Source: PIB, 01.06.2021 selected under the scheme. An applicant, through a single l l l

IDMA Bulletin LII (21) 01 to 07 June 2021 16

Recommendations of 43rd GST Council meeting

Amnesty Scheme to provide relief to taxpayers regarding late fee for pending returns ; Late fee also rationalised for future tax periods COVID-19 related medical goods including Amphotericin B for free distribution given full exemption from IGST upto 31.08.2021 Custom duty exemption also given to Amphotericin B Simplification of Annual Return for Financial Year 2020-21

The 43rd GST Council met under the Chairmanship of items immediately. The GOM shall give its report by Union Finance & Corporate Affairs Minister Smt. Nirmala 08.06.2021. Sitharaman through video conferencing here today. The meeting was also attended by Union Minister of State for OTHER RELIEFS ON GOODS Finance & Corporate Affairs Shri Anurag Thakur besides • To support the LympahticFilarisis (an endemic) Finance Ministers of States & UTs and senior officers of elimination programme being conducted the Ministry of Finance & States/ UTs. in collaboration with WHO, the GST rate on Diethylcarbamazine (DEC) tablets has been The GST Council has made the following recommended for reduction to 5% (from 12%). recommendations relating to changes in GST rates on • Certain clarifications/clarificatory amendments have supply of goods and services and changes related to GST been recommended in relation to GST rates. Major law and procedure: ones are, - COVID-19 RELIEF o Leviability of IGST on repair value of goods re- • As a COVID-19 relief measure, a number of specified imported after repairs COVID-19 related goods such as medical oxygen, o GST rate of 12% to apply on parts of sprinklers/ oxygen concentrators and other oxygen storage drip irrigation systems falling under tariff heading and transportation equipment, certain diagnostic 8424 (nozzle/laterals) to apply even if these markers test kits and COVID-19 vaccines, etc., have goods are sold separately. been recommended for full exemption from IGST, even if imported on payment basis, for donating to the SERVICES government or on recommendation of state authority • To clarify those services supplied to an educational to any relief agency. This exemption shall be valid upto institution including anganwadi(which provide pre- 31.08.2021. Hitherto, IGST exemption was applicable school education also), by way of serving of food only when these goods were imported “free of cost” including mid- day meals under any midday meals for free distribution. The same will also be extended scheme, sponsored by Government is exempt from till 31.8.2021. It may be mentioned that these goods levy of GST irrespective of funding of such supplies are already exempted from Basic Customs duty. from government grants or corporate donations. Further in view of rising Black Fungus cases, the above exemption from IGST has been extended • To clarify these services provided by way of to Amphotericin B. examination including entrance examination, where fee is charged for such examinations, by National Further relief in individual item of COVID-19 after Board of Examination (NBE), or similar Central or Group of Ministers (GoM) submits report on 8th June State Educational Boards, and input services relating 2021 thereto are exempt from GST. • As regards individual items, it was decided to • To make appropriate changes in the relevant constitute a Group of Ministers (GoM) to go into the notification for an explicit provision to make it clear need for further relief to COVID-19 related individual that land owner promoters could utilize credit of GST

IDMA Bulletin LII (21) 01 to 07 June 2021 17

charged to them by developer promoters in respect taxpayers, who did not have any tax liability for of suchapartments that are subsequently sold by the said tax periods; the land promotor and on which GST is paid. The ii. late fee capped to a maximum of Rs 1000/- (Rs. developer promotor shall be allowed to pay GST 500/- each for CGST & SGST) per return for relating to such apartments any time before or at the other taxpayers; time of issuance of completion certificate. • To extend the same dispensation as provided The reduced rate of late fee would apply if GSTR- to MRO units of aviation sector to MRO units of 3B returns for these tax periods are furnished between ships/vessels so as to provide level playing field to 01.06.2021 to 31.08.2021. domestic shipping MROs vis a vis foreign MROs and 2. Rationalization of late fee imposed under section accordingly, - 47 of the CGST Act: o GST on MRO services in respect of ships/vessels To reduce burden of late fee on smaller taxpayers, shall be reduced to 5% (from 18%). the upper cap of late fee is being rationalized to align o PoS of B2B supply of MRO Services in respect late fee with tax liability/ turnover of the taxpayers, of ships/ vessels would be location of recipient as follows: of service A. The late fee for delay in furnishing of FORM • To clarify that supply of service by way of milling of GSTR-3B and FORM GSTR-1 to be capped, per wheat/paddy into flour (fortified with minerals etc. return, as below: by millers or otherwise )/rice to Government/ local (i) For taxpayers having nil tax liability in GSTR- authority etc.for distribution of such flour or rice under 3B or nil outward supplies in GSTR-1, the late fee PDS is exempt from GST if the value of goods in such to be capped at Rs 500 (Rs 250 CGST + Rs 250 composite supply does not exceed 25%. Otherwise, SGST) such services would attract GST at the rate of 5% if (ii) For other taxpayers: supplied to any person registered in GST, including a person registered for payment of TDS. a. For taxpayers having Annual Aggregate Turnover (AATO) in preceding year upto • To clarify that GST is payable on annuity payments Rs 1.5 crore, late fee to be capped to a received as deferred payment for construction of maximum of Rs 2000 (1000 CGST+1000 road. Benefit of the exemption is for such annuities SGST); which are paid for the service by way of access to a road or a bridge. b. For taxpayers having AATO in preceding year between Rs 1.5 crore to Rs 5 crore, • To clarify those services supplied to a Government late fee to be capped to a maximum of Rs Entity by way of construction of a rope-way attract 5000 (2500 CGST+2500 SGST); GST at the rate of 18%. c. For taxpayers having AATO in preceding • To clarify that services supplied by Govt. to its year above Rs 5 crores, late fee to be undertaking/PSU by way of guaranteeing loans taken capped to a maximum of Rs 10000 (5000 by such entity from banks and financial institutions CGST+5000 SGST). is exempt from GST. B. The late fee for delay in furnishing of FORM MEASURES FOR TRADE FACILITATION: GSTR-4 by composition taxpayers to be capped 1. Amnesty Scheme to provide relief to taxpayers to Rs 500 (Rs 250 CGST + Rs 250 SGST) per regarding late fee for pending returns: return, if tax liability is nil in the return, and Rs 2000 (Rs 1000 CGST + Rs 1000 SGST) per To provide relief to the taxpayers, late fee for non- return for others. furnishing FORM GSTR-3B for the tax periods from July, 2017 to April, 2021 has been reduced / waived C. Late fee payable for delayed furnishing of FORM as under: - GSTR-7 to be reduced to Rs.50/- per day (Rs. 25 CGST + Rs 25 SGST) and to be capped to i. late fee capped to a maximum of Rs 500/- (Rs. a maximum of Rs 2000/- (Rs. 1,000 CGST + Rs 250/- each for CGST & SGST) per return for 1,000 SGST) per return. IDMA Bulletin LII (21) 01 to 07 June 2021 18

All the above proposals to be made applicable for C. Certain other COVID-19 related relaxations to prospective tax periods. be provided, such as 3. coVID-19 related relief measures for 1. Extension of due date of filing GSTR-1/ taxpayers: IFF for the month of May 2021 by 15 days. in addition to the relief measures already provided to the taxpayers vide the notifications issued on 2. Extension of due date of filing GSTR-4 for 01.05.2021, the following further relaxations are FY 2020-21 to 31.07.2021. being provided to the taxpayers: 3. Extension of due date of filingITC -04 for QE A. For small taxpayers (aggregate turnover upto March 2021 to 30.06.2021. Rs. 5 crore) 4. Cumulative application of rule 36(4) for i.a. March & April 2021 tax periods: availing ITC for tax periods April, May and June, 2021 in the return for the period ii. NIL rate of interest for first 15 days from the June, 2021. due date of furnishing the return in FORM GSTR-3B or filing of PMT-06 Challan, 5. Allowing filing of returns by companies using reduced rate of 9% thereafter for further 45 Electronic Verification Code (EVC), instead days and 30 days for March,2021 and April, of Digital Signature Certificate (DSC) till 2021 respectively. 31.08.2021. iii. Waiver of late fee for delay in furnishing D. Relaxations under section 168A of the CGST return in FORM GSTR-3B for the tax periods Act: Time limit for completion of various actions, by any March / QE March, 2021 and April 2021 for authority or by any person, under the GST Act, which 60 days and 45 days respectively, from the falls during the period from 15th April, 2021 to 29th June, due date of furnishing FORM GSTR-3B. 2021, to be extended upto 30th June, 2021, subject to iv. NIL rate of interest for first 15 days from the some exceptions. due date of furnishing the statement in CMP- 08 by composition dealers for QE March [Wherever the timelines for actions have been 2021, and reduced rate of 9% thereafter for extended by the Hon’ble Supreme Court, the same would further 45 days. apply] b. For May 2021 tax period: 4. Simplification of Annual Return for Financial Year 2020-21: ii. NIL rate of interest for first 15 days from the due date of furnishing the return in FORM i. Amendments in section 35 and 44 of CGST Act GSTR-3B or filing of PMT-06 Challan, and made through Finance Act, 2021 to be notified. reduced rate of 9% thereafter for further 15 This would ease the compliance requirement days. in furnishing reconciliation statement in FORM GSTR-9C, as taxpayers would be able to self- iii. Waiver of late fee for delay in furnishing certify the reconciliation statement, instead of returns in FORM GSTR-3B for taxpayers getting it certified by chartered accountants. filing monthly returns for 30 days from the This change will apply for Annual Return for FY due date of furnishing FORM GSTR-3B. 2020-21. B. For large taxpayers (aggregate turnover more than Rs. 5 crore) ii. The filing of annual return in FORM GSTR-9 / 9A for FY 2020-21 to be optional for taxpayers i. A lower rate of interest @ 9% for first 15 days having aggregate annual turnover upto Rs 2 after the due date of filing return in FORM Crore; GSTR-3B for the tax period May, 2021. iii. The reconciliation statement in FORM GSTR-9C ii. Waiver of late fee for delay in furnishing for the FY 2020-21 will be required to be filed by returns in FORM GSTR-3B for the tax period taxpayers with annual aggregate turnover above May, 2021 for 15 days from the due date of Rs 5 Crore. furnishing FORM GSTR-3B.

IDMA Bulletin LII (21) 01 to 07 June 2021 19

5. Retrospective amendment in section 50 of the GSTR-1/3B return filing as the default return filing system CGST Act with effect from 01.07.2017, providing for in GST. payment of interest on net cash basis, to be notified Note: The recommendations of the GST Council have at the earliest. been presented in this release in simple language for information of all stakeholders. The same would be OTHER MEASURES given effect through relevant Circulars/Notifications GST Council recommended amendments in certain which alone shall have the force of law. provisions of the Act so as to make the present system of Source: PIB, 28.05.2021

l l l

CBDT matter Extension of time limits of certain compliances to provide relief to taxpayers in view of the severe pandemic - reg.

Circular No. 9 of 2021, dated 20th May 2021

The Central Board of Direct Taxes, in exercise of its to be furnished on or before 15th June 2021 under power under section 119 of the Income-tax Act, 1961 Rule 30 and Rule 37CA of the Rules, may be (hereinafter referred to as "the Act") provides relaxation furnished on or before 30th June 2021; in respect of the following compliances: 6) The Statement of Deduction of Tax from 1) the Statement of Financial Transactions (SFT) contributions paid by the trustees of an approved for the Financial Year 2020- 21 , required to be superannuation fund for the Financial Year 2020-21 furnished on or before 31st May 2021 under Rule , required to be sent on or before 31 st May 2021 114E of the Income-tax Rules, 1962 (hereinafter under Rule 33 of the Rules, may be sent on or before referred to as "the Rules") and various notifications 30th June 2021; issued thereunder, may be furnished on or before 7) the Statement of Income paid or credited by an 30th June 2021; investment fund to its unit holder in Form No 64D for 2) the Statement of Reportable Account for the the Previous Year 2020-21 , required to be furnished calendar year 2020, required to be furnished on on or before 15th June 2021 under Rule 12CB of the or before 31 st May 2021 under Rule 114G of the Rules, may be furnished on or before 30th June Rules, may be furnished on or before 30th June 2021. 2021 ; 8) the Statement of Income paid or credited by an 3) The Statement of Deduction of Tax for the last investment fund to its unit holder in Form No 64C for quarter of the Financial Year 2020-21 , required to the Previous Year 2020-21 , required to be furnished be furnished on or before 31 st May 2021 under Rule on or before 30th June 2021 under Rule 12CB of the 31A of the Rules, may be furnished on or before Rules, may be furnished on or before 15th July 30th June 2021 ; 2021 ; 4) The Certificate of Tax Deducted at Source in Form 9) the due date of furnishing of Return of Income No 16, required to be furnished to the employee by for the Assessment Year 2021-22, which is 31st July 15th June 2021 under Rule 31 of the Rules, may be 2021 under sub-section (1) of section 139 of the Act, furnished on or before 15th July 2021 ; is extended to 30th September 2021 ; 5) The TDSITCS Book Adjustment Statement in 10) The due date of furnishing of Report of Audit under Form No 24G for the month of May 2021, required any provision of the Act for the Previous Year 2020-

IDMA Bulletin LII (21) 01 to 07 June 2021 20

IDMA ACTIVITIES CDSCO MATTERS CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on its Regulatory Members Pathway – reg. DCG(I) Circular Ref.X-11026107/2020-PRO, dated 20th March 2020

To, for sale and distribution would be processed on All Stakeholders through CDSCO web site Copy for priority though expedited review/accelerated Information, approval. IDMA ACTIVITIES PS to JS(R), Ministry of Health and Family Welfare, Nirman IDMA ACTIVITIES Bhawan, New Delhi. 4. Any firm having DrugNaccine already approved for IDMA ACTIVITIES CDSCO MATTERS COVID-19 in any otherCSR country Initiatives can directly by approach IDMA with the support of its Members Novel Corona-virus DiseaseCSR I (COVID-19)nitiatives hasby spreadIDMA with the support of its Members IDMA ACTIVITIES CDSCO MATTERSDCG(I) through Public Relations Office regarding over 118 countries with now more than 191,127 cases and expedited review/accelerated approval for marketing CSR Initiatives7807 people CDSCOby haveIDM lostA theirprovides with lives as the on 18.03.2020. guidancesupport World of on its Regulatory Members Pathway – reg. CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on its Regulatory Min embersIndia. Pathway – reg. Health Organization (WHO)DCG(I) has declaredCircular it Ref.X-11026107/2020-PRO,as pandemic. dated 20th March 2020 At present there is no current evidence from randomized 5. Data requirement for animal toxicity study, clinical DCG(I) Circular Ref.X-11026107/2020-PRO, dated 20th March 2020 clinical trials to recommend any specific treatment for study, stability study etc. may be abbreviated, To, for sale and distribution would be processed on suspected or confirmed patients with COVID-19. deferred, or waived on case to case basis depending To, All StakeholdersIDMA through ACTIVIT IES CDSCO web site Copy for for salepriority and distribution though expedited would be review/acceleratedprocessed on NOT FOR PROlTSUPPLY OREQUITY BASEDtiered pricing based vaccines byupon ensuring the robust type safetyof vaccine, and efficacy nature reviews of drug, plant from All StakeholdersInformation,What are the next through steps in the CDSCO trial? web site Copy forSrias will CIILanka people further pharmawho suggested are deemed firms the at adoption highsay risk no fromof shortage wide Covid-19 scale clea“Forrances example, for API cartons parks, protect boosting the product drug formulations from light onIn countries’order21, which to encourageneeds is 30th and Septembercapabilities.” research 2021, & development is extended to of drug andURGENTLY(4)/sub-section removingpriority unwarrantedapproval. (5) though of REQUIRED section political expedited 139 considerationsof the review/accelerated Act, is USED PHARMA Information,PS to JS(R), Ministry of Health and Family Welfare,due E-ICU/tele-consultation Nirman to their agewhich or medical the todrug conditions. tackle is extracted the spread & of its COVID- experiencewhichfrom indigenous in can case otherwise API and degradeIDMA its intermediates ACT theIV IT product;IES and sometimes providing CSR Initiatives byT31sthe resultsI DMOctober soA far 2021 arewith promising, ; the but support their main purpose of itsfrom extendedM theseembersofIDMA drugs, discussions toACT 31stIVITIES notJanuary and to the panic 2022. approval buy process. or vaccine for prevention or treatment of COVID-19, any19,USED especially approval.R in &its phase D EQUIPMENTS 3 and 4. CII has already set up desiccantsincentives arefor usednew toproduct protect development, the product from processes moisture,” and PS toBhawan,Supportis JS(R),to ensure effective New Ministry the Delhi.vaccine and of Healthequitable is safe andenough distribution Family to give Welfare, toof people. these Nirman However, widespread4.of Phyto-pharAny vaccinationfirmmaceuticals. having is likely DrugNaccine to be, at the alreadyMACHINERY approvedIDMA for ACT IVITIES FOR SALE application11) the submitted due date to of CDSCO furnishing will beReport processed from an on highsthe %NHANCESriIDMAcontrol Lanka’s ACT centreIVCOUNTRYITIES pharmaceuticals and READINESS the backend AND firms systemsIN COUNTRY said thererequired DELIVERY is nofor Bhawan,innovations New Delhi. globally: Clarification4. Any 1:firm It is havingclarified DrugNaccine that the extensionCSR already ofInitiatives the approvedshetechnology, said. by for among IDM others.A with the support of its Members The studyAccountant cannot show whetherC SR the vaccineInitiatives can either by earliest, IDM6.A next with Applicationsyear eventheCOVID-19 if supporteverything to manufacture in any goes of other to its plan. countryor M importBorisembers can DrugNaccine directly approach priority. NovelCDSCO Corona-virus willby also persons provide Disease entering guidance into(COVID-19) international on regulatory has shortagedates E-ICUspread SYSTEMS as and of referred drugstheseBYENSURING incan to the in be countryclausesADEQUATE scaled and up (9),EXPERTISE withurged (12)C SRthe theand ANDsupport publicI (13)nitiativesRESOURCES above notof the to by IDMA with the support of its Members prevent people from becoming ill or even lessen their Johnson said:WeCOVID-19 “Obviously areDCG(I) an I’min established any hopeful, through other I’ve country Public got my can Relationsfingers directly Officeapproach“SriCII stated Lanka regarding that is athe small outbreak market could and lead the to significant excellent pathwayNovelh7Etransaction onCorona-virus WILL such STRIVE matter.or specifiedTOWARDS DiseaseCSR EQUITABLE domestic I (COVID-19)nitiatives ALLOCATIONtransaction hasbyOF underOUR spreadIDM engageshallGovernment,A arewith not in placeapplypanic the foras for buying tonecessary. test, supporteffectiveExplanation afteranalysis country two 1 ofdomestically to andplanning, itssection further M embers distribution, 234Atransmitted use of theBA/BE orComplete Clinical tablet section in good oversymptoms 118 countriesof Covid-19.CBIC with MATTE nowRS more than 191,127 casescrossed, and but to say I’m 100% confident we’ll get a vaccine relationships that our Chamber members have with treatment, which boosts “innatePRODUCTS immunity”,section AND SUPPORT92wasE initiallyof the GLOBAL ActIDMAHow for MECHANISMS doestheACTIVITIES Previous Sepsivac LIKE work?Year #/6!8 2020- and follow-upDCG(I) forexpedited new through diagnostics, review/accelerated Public therapeutics, Relations and Office approval shortage regarding for of marketingsupply in the medical technology sector as well, over7807 118 countries people have with nowlostNATIO theirmoreNAL NEWS lives than (SPECIAL) as 191,127 on 18.03.2020. cases andcasesAct,this World pharmaceutical year,Onin of casespharmaceuticals, Coronavirus or indeed whereTrial nextmay thewas year,amount CIIdiscovered.be company said is,processed alas,of that tax just theon anthecurrenthaving within exaggeration. total situation income 7 days. condition (GMP and Standard) approved by the Drug ControllerRECOGNISING MoreGeneral21, which than THEof India MOSTis10,000 31st (DCGI)EFFECTIVE October people APPROACH 2021, will take isTO extended EQUITABLEpart in the toACCESS 30thnext vaccines.expedited review/accelerated approval formultinationalespecially marketing for critical pharmaceutical medicines manufacturers and medical devices worldwide, such IDMA donated medicines to 7807theThe following detailspeople arehave as lost under their - lives2.It as contains onBliss 18.03.2020. heat-killed GVS Pharma mycobacterium Worldas“We’remakes L manufacturingreducedtd. anot compelling w there by (Mw), the yet.” amount incase India. facilityfor as Indian specified Governmentin Navsari, in clauses to declare (i) to for gram negative sepsis whichHealthwillstageCBIC vary is November of a theOrganization diseaseacross trialsnotifies vaccines, caused in2021 the ;UK. by (WHO) Newtherapeutics, However, Exchangehas the declaredtrialand hasdiagnostics. also it been as pandemic. “There7. is currentlyIn case enoughof emergency, stock to meet Import three license months (Form willashaving thermometers, 10)ensure would that Rotary we nebulizers, will 27not runStn. glucometers, out and of stock,” 16 etc. Stn., Chellaraja Institutions: IDMA congratulatesIDMA-TNPKSB Dr Kiranan immunomodulator, CSR Mazumdar-Shaw Activities which is (vi)API a non-pathogenic of as sub-sectionon a strategic beingSource:in India. (1)Expresssector of that asPharma, mostsection 01.10.2020inputs exceeds are (Excerpts)imported.one lakh bacteria. HealthAtWeexpanded presentOrganizationalso will to use otherthere our countries (WHO)collective is noth current becausehas voice3. declared alongside levelsevidenceCachet of itother Coronavirus asP fromharmaceuticals pandemic.global randomized of normal Pdemandvt.5. L td. andDataGujarat. we willrequirement makeIDM sureA donated that for the animalmedicines supply toxicityto thesaid. following study, clinical 2. Bliss GVS Pharma Ltd. 1. Rates12)Any The firm w.e.f.due having date 17of a IfurnishingDMDrug AApril mycobacterium.donated Vaccine of medicines2020 Return under “Normally to-of reg.thedevelopment Income following when you rupees.WhatIndustry developAssociation-Tamil progress a alsovaccine,2.be is suggests Bgrantedbeing liss Nadu, GVS made that Pwithoutharma with firms Lothertd. Registration for vaccines? which capacity Certificate (FormBlisterThe medical 41) 300 devices and 150, market Mass too is Mixer heavily import namedAt presenthealthare low EY stakeholders therein theWorld UK,is no making tocurrent Entrepreneur advocate it hard evidence forto knowthe fromstrengthening if theO randomized fvaccine The Yearchain is 5.2020 not Datadisrupted,” requirement Kasturi  Chellaraja, Institutions: for animal Chairperson toxicity study, clinical 1. Sai Seva But Mandal the scientists – found which thatclinical the organises pathological trialsAssessment symptoms to walking recommendInstitutions: Yyouear grow2021-22, the any organism specific and kill treatment it. It is calledPuducherry for heat killed. & Kerala study, State stability study etc. may be abbreviated, 3. Cachet Pharmaceuticals Pvt. Ltd. for forCOVID-19 the can directly4. approach Fourrts which DCG(I)th (I ndia) is 31st through L aboratoriesutilization The Oxford is 3. 40%P vt. vaccineC achetmay Ltd. be P harmaceuticals ispermitted not the to first produce Pvt. toLtd. reach API which this dependent,The chamber at around was monitoring70-80%, with supply imaging chains equipment and was Notificationofis effective.health No.39/2020-Customs systems and distribution (N.T.), networksdated 16 so April, crucial 2020 of the Sri Lankasubject Chamber to ofapproval the Pharmaceutical1. ofSai Central Seva Industry Mandal Government. – which200 organises kg and walking 100 kg, Fluid bed dryer pilgrimageof this from disease Mumbai and Covid-19clinical to were Shirdi trialsquiteOctober everysimilar. to 2021 recommend And year under given for Sub-section Here any we heat specific (1) killed of section the treatment bacteria. 139 It forisare a Boardstandard ClarificationbeingWe (IDMA-TNPKSB)imported.are vaccinestudy, looking 2: Approvals For stability the forpurpose for used studynew ofinvestments RClarification etc. & mayD should be1, in abbreviated, 4. Fourrts (India) Laboratories Pvt. Ltd. suspectedPublic Relations or confirmedIDMA ACT 1. Office I V ITISaiES patients Seva for seekingMandal with – COVID-19. which guidance organises stage, for walking with groups4. Fourrts indeferred, the (India) US andL aboratoriesor waivedChinapilgrimage also P vt.on publishingL casetd. from Mumbaito caseconfident (CT to basisShirdi & MRI everythere depending scanners), yearwould for cardiac be no interruption. stents, orthopedic implants, the urgency of finding a solutioninnovations toDr the Kiran reach rapidly Mazumdar-Shaw, everyone rising concept,”who5. needs My VishwakarmaI ndbusiness them. Swift focusIn said,L doingaboratories is addingglobal (SLCPI)casehealththatis the of glad careL bacterium ansaidimited toandindividual informin the a is statement.provision that resident on in India referred to in sub- 60 kg, Tray dryer, Strip Packing approximatelyIn exercise 500 pilgrimsof the suspectedpowers conferredThereof theor willby confirmedAct, section be is extendeda 14large ofpatients trialpilgrimage to10. involving30th withNorwegian fromNovember COVID-19. 30,000 Mumbai 2021; topeople Shirdi7.40 everysimilarbe C yearfast-tracked.ON forresults.7.15 SULTANCYdeferred, TheCII has US proposed orCompany waived FO that RModerna on blanketFINANCEapproximately case was environment to casefirst 500 out basispilgrims depending 5. Ind Swift Laboratories Limited Executive Chairperson of India- of universal access to life savingEquipmentsth medicine;For5. however, Ianynd uponSwiftmainly additionalmy L aboratoriesthe fortype informatiTablet Lofimited vaccine, onand kindly nature contact glucometersof drug, Public plant and criticalfrom care equipment cornering a large Covid-19the Customs cases Act, across 1962 the (52 world, ofso,in 1962),regulatory the wethe USscientistsandsupport asin supersession wellpathway. thoughtevidence-based 2,000 of inapproximatelyproduced South prioritisation Africaby fermentation.500 andpilgrims 5,000 so that in section8 June (2) 2020, of section we donated 207 of the Act, the tax paid by him Europe was the largest manufacturer of drugs CSR Initiatives13) basedby I dueDM Biocon dateA with Limited, of furnishing the was support6. ofresponsibility SaiReturnKroner Mirraof ofits asI ncomeI nnopharmM an embers entrepreneurofpermission the “WeP is vt. blocks greaterneed Ltd. upon beto an than beprovidedd sensible itsthe simply vaccine type andto ofmanufacture judiciouscan vaccine,2. produce M. in C.our nature anyneutralising Damanwalla reaction API of ontodrug, CharitablegastrointestinalCombi plant from Dispensary, Pack, medicines UV 6.Spectrophotometer, etc. Sai is slowingMirra Innopharm down, with Pvt. people L td. testingof the the Notification treatment No.37/2020-Customs(N.T.),against the currentInThe order pandemic to encourage caused dated research & development of drugRelations Liquid6. AN Sai DOffice Mirra Departments.SUB Innopharm throughSID IEP tollvt.S L td.free number 1800andshare. 11 Sri 1454Many Lanka raw& imported materials pharmaceuticals and components mostlyare imported from 2. M. C. Damanwalla CharitablehealthcareBrazil. There Dispensary,workers, are also high-risk calls2. M. toindividuals,11. C.perform“The DamanwallaPound treatment “challenge and Sterling other Charitable we priority aretrials” 97.40 testing Dispensary,under According againstRs.18.00 section94.05 Covid-19 to data Lakhs 140A from whichofmarket worth the Act research the within drug firm the AIOCD isU duedvada extracted AWACS, date - This (without Calpol institution & its aimsexperience at helping and in treating case st 2. In Anyordernamed firm to ‘EYencourage A or ssessment World research Entrepreneur research Y ear institute 2021-22,delivering & development having value protocolto shareholders. of drug theantibodies. forsubmission current situation of self-certification and not panic.” to comply The pharma with chamberpollution by1 April,theThis SARS-CoV-2 2020 institution except virus. as aims respectsor at vaccine helping thingsfor the done forand or prevention treatingomitted U dvada or treatment- This institution which of aims isCOVID-19, at30th helping andsawof treating any sales these of `which 317.9 medicines, crore the in December,drug is whenextracted it was the & number its experience 3 India.stayingfrom China. in indoors, caseMulti-mill. eating home-cookedM. CShifter. Damanwalla food etc. andCharitable taking Dispensary, care Udvada: Udvada - groupsin which identified vaccinated by WHO people and areis 12. other designed deliberately healthQatari to Riyal enhanceauthorities infected innate withare21.75 immunity extensionload requirement.Capital whichwrite20.45 under isM. toInvestment, very C .startupinnovPcdsco.nicinthis Damanwalla of Circular) Phyto-phar Interest, C providedharitable maceuticals.GMP,the Dispensary, in poor that GLP, and Act, needy Ushalldvada: patients, villagers and Adivasis to be done before suchor supersession, vaccinerepurposingof The for the Year prevention Central 2020’ of existingBoard at a or ground-the treatment drugs/vaccines poorM. andC. needyDamanwalla of patients,COVID-19, for villagerstreatment C haritableany andsaid Adivasis they were Dispensary, urging drugcalm in because theUdvada: category there were reports from the poor andCSIR needy got the patients, approval tovillagers testNovember “Sepsivac” and 2021 Adivasis against under sub-sectioncritical. PeopleShe (1) who ofadded, sectionare weak“Wealth 139 in innate creationInterested immunityinThey thecan presencearebe will a injecting catalystget parties of ourfor Coronavirus may contact RNAwho live (its inour andgenetic around Udvadaof their and health. also supplies“The industry 1. expectsAlkem L aboratoriesthe value growth Ltd. this applicationprotectedCoronavirus.breaking, for virtual However,thesubmitted duration award there ceremony. toofwho aretheCDSCO13. live ethical pandemic, Saudiin and willconcerns Arabian around beregardless processedUdvada due to 21.10 ofand a alsobe on WHO-GMP,suppliesdeemed high19.80 to1.of be Phyto-phar ERP,A thelkem advance LICT,aboratories Electricalmaceuticals. tax. Ltd. Connection, While the real impact on industry is likely to be visible of Indirect Taxes and Customsof herebyCOVID-19of the determines Act, is will extended thatalso be to given 31stcha December prioritynge, and forall 2021; entrepreneursreview andpharmacies Deputy haveThe a CII Drugresponsibility that recommendations Controller-some customersto towere strengthen freebuying medicines up API two to and them.to yearDespite to slow down China to making 1.5-3 per about cent 60 if the percent crisis ofcontinues. the raw who liveCovid-19 in and in arounda Phase 2applicationUdvada clinicallack trialKiran ofand treatments.aboutsubmitted was also picked10 dayssupplies from to ago. CDSCO among free the 46 medicinesinfection will beRiyal faster,”to processed them. he said. on highcode), which 6.then startsApplications making viral to manufactureproteins in order or Drimport V G Somani, DrugNaccine For Enquiry: 2. Cachet P harmaceuticals Pvt. Ltd. the rate of exchange of conversionpriority.THE COUNTRY of eachCDSCO THEY of the LIVE foreign will IN also 7E WILL provide1. ADVOCATEAlkem guidance FOR LEQUITABLEaboratories on regulatoryforMumbai AprilElectricityLtd. is even2. office Duty, grimmer.Cachet CLCSS, with P harmaceuticals“For relevantthe Finance anti-infectives Pvt. & details: LGujarattd. segment material,only after the April risk 2020, of Sri theLanka local running manufacturer’s out of medicines capacities is The trial is being conducted on approval.50 patients at the All India 14. theSingapore world around them54.60 andthreeF.tointermediates the triggerNDro.225/49/2021- communitiesmonths 6. Manivanan,52.80 an immuneApplicationsof productiondrugs. in IDMA-ITAwhich response.Pharma-II in tothe firms manufactureThe country store companiesWe Drugsdrugs areinclude thankful in ControllerorBioNtech specially creation import to the following GeneralDrugNaccineApart members from (India), whonew donated launches and smaller brands getting hit, free medicinescurrencies to specified them. in priority. columndistribution,14) (2) awardCDSCOThe of each winnersdue recognizing of willdate Schedule from also of41 furnishing thatcountriesprovide sovereignVishwakarma guidance of nationsbelated/revised explained onhave regulatory final that it is a non-specific& Central Subsidies. Mob: 098271528373. Centaur Pharmaceuticals Ltd. pathway on such matter.We are thankfulthey to operate.the following Women members also who(antibioti play TNPKSB-Chairman-donated a hugelycs primarily),3. importantCentaurfor the test, P salesharmaceuticals analysis in the first L td.and15 days further of April use slim,will BA/BE needthe chamber toor beClinical bolstered, said. which would likely become Institute of Medical SciencesWhen (AIIMS),andReturn will territories New I get ofDelhi, a Ivyingncome vaccine? AIIMS for thefor worldthe2. Assessment CDollarachet Year Pharmaceuticals 2021- builtandof large Pfizer warehouses. API P havevt. parksfor L alsotest,td. Incorrectlywith ha analysisdfiscal positiveCentral benefits overstocking results andDrugsmedicines for further usingexistingStandard medicinesfor thistheir use API noble ControlRNA BA/BEand atcause: logisticsOrganization, or Clinical challenges will also affect overall sales,” said CEO I and Schedule II annexedpathway decision-makinghereto, on into such Indian matter.authority,” currencymedicines theyvaccine for stated this role which noble. in couldeconomic cause: be used development, to bothPrajna cure and P and aramita,for protecttoo longDirector, their Central Board of Direct Taxes, reliable sources amidst global4. C oronashortages, Remedies said PCII.vt. Ltd. Bhopal, and Post Graduate3. InstituteApplicationstitle. of Medical Inth the Education award’s for Clinical 20-year15. SouthTrial African permission 4.25 andareintermediatesMr downMeridian Jayaseelan,3.95 by 4.67 plants,perC oronaEnterprises Trialcent Vice- supportiveRemedies compared may be P vt. regulatoryto processedPvt. Lthetd. first Ltd. 15 framework withindays of 7 days. Email: We are thankfulor vice versa, to the shall, following with effect members from22, 17 which April,who is 31st2020,donated December be people. 2021 He explained under sub-section that there are homegenerallyvaccine. canContact: Directoratethree affect types Shashank the Generalefficacy Tatu, of of medicines HealthM:Sai 9879919438, Seva Services, she Mandal: said. Public Relationof a drug Office, major on conditionSource: of Economyanonymit Next,y. 13.03.2020 IDMA donated medicines to the Itfollowing is possible a Coronavirus3. vaccinecontribution2.CRand entaur willBliss behas P GVSharmaceuticalsproven been ignored.P harmaMinistryChairman-Mr It’s ofL important td.Finance, Ltd.Trial Sathish Departmentthatmay we &be processed of Revenue, Newwithin Delhi. 7 days. IDMA is thankful to the above members for their help andthe rateResearch history,mentioned (PGIMER), Kiran against becomes Chandigarh. Theit inapplications thethe details thirdcorresponding EY are World to as import entryEntrepreneur underSai Seva or - manufactureMandal: Drug VaccineMarch,”and Email: common said [email protected] the infrastructure senior official facilitating of a Mumbai-based single window drug [email protected] Delhi. Source: Pharmabiz, 21.03.2020 IDMmedicinesA donated for this medicines noble cause: to the followingMaintaineffective publicbefore confidencethe end of theinof ourvaccines.2.year, innovations: usehoweveB lissthe platformr, GVS it will Pofnotharma EY be World LEntrepreneurSource:td. Email: James of [email protected],IDMA Year is thankful to Health to and the1. aboveScience Alkem members Correspondent, Laboratories for their help Ltd. and support. Institutions: of The Year AwardThe winner details from are India. as She under follows - former16. Swedish Kroner 7.75 major.Members He7.50 reasoned 7. Mr Pandian thatIn case demand of emergency, for antibiotics, Import and even license (FormSource: 10) wouldSohini Das, Business Standard, 25.04.2020 in column“We expect (3) thereof, the results for the from purpose this Phase of the 2said trial section, within1. Alkem4. L aboratoriesCorona Ltd. Remedies Pvt. 7.LContacttd. andIn case support. No.: of emergency, BBC022-66084217 News, 20.07.2020 Import license (Excerpts) (Form 10) would Institutions: Indian world title winnerswidely “We Uday available. will Kotak continue ofHealth Kotak makingandMahindra care17. “Therethe workers Swissencouragesafety3. are will therapeuticFranc Cof be achetmoreindividuals prioritised women vaccines, P80.85harmaceuticals to participate where& you Mr77.80 ingive Rajesh.entrepreneurial them Pvt. L Wetd. IDMA donated medicines   to   the following 2. Bliss GVS Pharma Ltd. 30-45relating days to imported from now. and And export if1. the goods. resultsAny are firm encouraging, having a IDMDrug3.A donated VaccineCachet medicines under Pharmaceuticals to l thedevelopment following  l l P vt. Ltd.2.be Bgrantedliss GVS PwithoutIDMharmaA donated Ltd. Registration medicines to Certificatethe following (Form 41) 2. Bliss GVS Pharma Ltd. 1. Any firm having a IDMDrugA donatedas Vaccine18. a drug medicinespursuits.Turkish for under curing. Lira I’mto thedevelopment truly There following honoured 11.45 are prophylactic to were receive 10.75 fortunate vaccines, this2.be prestigious Bgrantedliss to GVS have P without harma  L td.RegistrationInstitutions: Certificate  (Form  41) 3. Cachet Pharmaceuticals Pvt. Ltd. Sai1. Seva Sai Mandal: Seva Bank Mandal (2014) and– Narayana whichwho receive Murthy organises ofproducts Infosys Technologies walkingwe areInstitutions: developing or supporting   Institutions:    1. SaiI DM SevaA wedonated will Mandal seek medicines approval – whichSCfrom Hto EDUthe the Drug organisesL followingE-for IController COVID-19 because walkingInstitutions: ofcan directly2. Baward.”IDMA4.liss approach GVS Fourrtsis thankful Pharma DCG(I) (India) Ltotd. the through L aboveaboratories members3. subjectP vt. Cforachet L theirtd. to Pharmaceuticals approval help of P Centralvt. Ltd.  Government.  3. Cachet Pharmaceuticals Pvt. Ltd. LimitedThe (2005). Adyar Cancer Shethe foralso Institute highest COVID-19 becomes (WIA), priority. the as second can you Adherence are directly woman aware,which19. 4. to istoapproach youtheUAEFourrts givestrictest Dirham to DCG(I)people (scientificIndia) to protectthrough21.60 L aboratories them. And20.25 there3. subjectP vt.areCachet Ltd. to Pharmaceuticals approval of P Centralvt.1. L td. Sai Government. Seva Mandal – H whichave you organises renewed your walking Membership 4. forFourrts the (India) Laboratories Pvt. Ltd. pilgrimageemergency from and keep Mumbai on continuing to the Shirdi Phase 3 every trial. That’s year 1. for Sai Seva Mandal – which organises walking 1. Sai Seva Mandal – which organises walking 4. Fourrts (India) Laboratories Pvt. Ltd. 1. pilgrimageAlkemInstitutions: Laboratories fromholda public Mumbai the title,charitable Ltd. following to voluntary Shirdi OliviaPublic institute Lum every of dedicated RelationsHyflux year Limited for to the somefrom Office 20.careand which support.US for Manny haveDollar seeking – both Stul, which the Chairman organises properties,guidance77.65Have you and renewed walking which Co-CEO for 75.95 your are of calledM embershipMoose 4. Toys Fourrtsfor the (India) Laboratoriespilgrimage Pvt. Ltd. from Mumbai to Shirdi every year for howSr. it happens,”Foreign Ram Vishwakarma,RateandPublic ofethical exchange Director, Relations standards Integrativeof one 1. Office in Saiproduct 3. Seva for pilgrimage Cdevelopment seekingMandal5.achet fromI ndPharmaceuticals guidance MumbaiSwift and in toL aboratories Shirdi for P everyvt. L td. year4. L forimitedFourrts (India) Laboratoriespilgrimage Pvt. Ltd. from Mumbai to Shirdi every year for 5. Ind Swift Laboratories Limited approximatelySingaporeof cancer 500 forin pilgrims 2011.the last 60 years. During these Covidpilgrimage Times,immunomodulators.5. fromInd MumbaiSwift toL aboratories Shirdi every year L forimited For any additional informatiapproximatelyon kindly 500 pilgrims contactYear 2019-2020 Public 5. & I2020-2021nd Swift Laboratories Limited approximatelyNo. 500Currency pilgrims– whichunitmanufacturing of foreignregulatory organises currency processes walking pathway. will remainapproximatelyand the Chair top of priority500 the pilgrims EY Worldover Entrepreneur of The Year 5.judging Ind Swift Laboratoriesapproximately Limited 500 pilgrims 1. SaiMedicine Seva (Council Mandal of Scientificregulatory & Industrial pathway. Research), approximately4. Fourrts 500 pilgrims (India)SC HLEDUaboratoriesYearLE- II2019-2020 Pvt. ForL5.td. & Iany2020-2021nd Swift additional Laboratories informati Limited on kindly contact Public 6. Sai Mirra Innopharm Pvt. Ltd. the Drinstitute Mazumdar-Shaw, is badlyequivalentspeed in need 67, or to ofpolitics,” founded funds/materialsIndian rupees Bangalore-based guaranteed (as Covid the drug panel,6. makers. says:Sai “Kiran Mirra is Iannnopharm inspirational entrepreneurPvt.Relations Ltd.6. whoSai Office Mirra Innopharm through2. P tollvt.M. L td.free C. Damanwalla numberIf not,1800 Charitable please 11 do 1454so; kindly Dispensary, & contact 6. Sai IDMA Mirra Secretariat Innopharm at: Pvt. Ltd. 2. M. C.pilgrimageJammu, Damanwalla told. from Mumbai Charitable to Shirdi every Dispensary, year for 2. 6.“SepsivacM. C.Sai Damanwalla will Mirra be an immunomodulator,InnopharmI f Charitablenot, please do so;P Dispensary, whichvt.kindly L willcontacttd. have IDMA Secretariat at: 2. M. C. DamanwallaThis Charitable institutionEmail: [email protected] aims Dispensary, at helping and treating / [email protected] 2. M. C. Damanwalla(1) materials(2) to Charitable each health2. warriorAny Dispensary,(3) in firm the hospital or research2. is anM. extra C. Damanwalla institutedemonstrates having Charitable that determination, protocol Dispensary, forRelations perseverance 6. Sai Office Mirra and aInnopharm through P tollvt. L td.free numberUdvada - 1800 11 1454 & Biocon Limited2. in 1978Any with firm just or two research employees protective instituteSr.and5. U dvadaInd Foreigneffect having Swift- This and institution L therapeuticaboratories protocolEmail:Rate aims [email protected] ofeffect at exchangefor helpingLimited both,” and heof treating 100said. / [email protected] Udvada - This institution aims Tel.:at helping 022 - 2494 and 4624 treating / 2497 4308 / Fax: 022M. -C 2495. Damanwalla 0723 Charitable Dispensary, Udvada: Udvadaapproximately - This institution 500 pilgrims aims at helping and treating - This institution aims at helping and treating writeFor Advertising to startupinnovPcdsco.nicin in the Classified Columnsthe poor and and needy also patients,for series villagers and AdivasisM. C. Damanwalla Charitable Dispensary, Udvada: Udvada - ThisVishwakarma currentlyinstitutionburden to saidleads such aimsthat thecharitable onceT companyathe(a) helping itC ollaborationhospital,applies, that andis butthe now (b) stilltreatingapproval hasworth many also close patientsU dvada No. called tothe poorwillingness Currency upon and Governments, needy to innovate patients,Tel.:units 022 can ofvillagers- 2494 foreign create 4624 and /writecurrencylong-term 2497 Adivasis 4308 to /startupinnovPcdsco.nicinvalue. Fax:M. 022 CThe. - Damanwalla2495 0723 Charitablethe poor and Dispensary, needy patients, Udvada: villagersHave andyou Adivasis renewed your membership for the repurposingrepurposingFor Advertising of existingin theof Classifiedexistingthe drugs/vaccines poor6. Columns and drugs/vaccinesSaiM. needy Mirra andC. patients,alsoDamanwalla Innopharm for series villagerstreatment for treatment Pandvt. C Adivasis Lharitabletd. M. C .Dispensary, Damanwallaadvertisements Charitable Udvada: Dispensary, pleasewho contact: 525/- liveUdvada: in and around Udvada and also supplies 1. Alkem Laboratories Ltd. the2. poorM.from C. theand Damanwalla areDrug needy dependent Controller patients, on(For is Charitable expectedthem), Imported H villagersasave toall come patients you(For Dispensary, fast Exportedrenewedand are as treateditAdivasis is your thereM. VishwakarmaMwho Cembership .live Damanwalla in and is hopeful aroundfor equivalentthe that Udvada C theharitable Phase andto Indian also2 clinical suppliesDispensary, rupees trials Udvada: who live in and around Udvada and also supplies 1. Alkem Laboratories Ltd. the poor andIDM needyRsA donated 50,000 patients, medicines crore by multilateralto villagersmarket-cap the following and andinstitutions, employsadvertisementsAdivasis morecompanies,2. who B thanpleaseliss live GVS in contact: judging Nand PGharmaO s,around andpanel Ltd. othersUdvada were impressed to:and also suppliesby her ability to build1. andAlkem Laboratories Ltd.free medicines to them. of COVID-19 will also be given priority for review and 1. MrAlkem Chettiar Laboratories (+9820629907) LIDMAtd.free Bulletin medicines Publications LI (11)250/- to 15them. Departmentto 21 March 2020 2. Cachet Pharmaceuticals Pvt. Ltd. 5 who Uanlivedvada emergency Institutions:in11,000 either -and This situation. free aroundinstitutionpeople. or at Soa very ifUdvadaaimsGoods) ofthe minimal COVID-19 Phaseat helpingMr cost.and2Chettiar trial Goods) Onand alsoshows will(+9820629907) the treating mass alsothatsupplies request beof(1) Publicationsthegivenfree treatmentsustain medicines1. priority (2) Department growthwillAlkem to providefor them. over review L positivetheaboratories past and results.30(3) years And and L becausetd. by her integrity Dr V G Somani,DrC Vurrent G Somani, Year 2. C2016-2017?achet Pharmaceuticals Pvt. Ltd. who live in and around Udvada and also suppliesIDMA3. free BulletinC achetM.medicines1. C P.LI harmaceuticalsDamanwallaA (11)lkem to 15them. to L21 aboratories MarchPvt. C Lharitabletd. 2020 LDispensary,td. Udvada:2. Cachet Pharmaceuticals Pvt. Ltd. 5 the1. poorAustralian and needy Dollar patients,s49.30 0ROVIDEvillagersapproval.SUFlCIENT and47.10 AdivasisDEDICATED the drugSUSTAINABLE is already AND in useTIMELY for sepsis or septic2. shock Cachet Pharmaceuticals Pvt. Ltd.WeDrugs are 45/-thankful Controller to the following General members (India), who donated 3. Centaur Pharmaceuticals Ltd. free medicines“Sepsivac”1. bySai theis Sevaeffectiveto Hospital them. Mandal againstfor donors– approval. which Covid-19,Y & organisesearon a specific the 2019-2020 walkingworld request may for drugs & and 2020-2021 passion for philanthropy(a) that has delivered(b) huge global WeDrugs are thankful Controller to the following General members (India), who donated 3. Centaur Pharmaceuticals Ltd. free medicines to Onthem. being anointed as the EY World Entrepreneur4.We areFourrtsWe thankful are (India) thankful to theLaboratories following to the following members Pvt. Ltd. members who donated who donated 3. Centaur Pharmaceuticalsmedicines Ltd. for this nobleIf not, cause: Forplease Advertising do so Kindly Contact in the I DMAClassified Secretariat at: whohave2. livea vaccineBahrainifrom pilgrimagein and the against Dinar mostaround from respectedthe Mumbai diseaseUdvada206.20 tofunding Chairman Shirdias andearly every for also asof 200.90 thetheone year supplies Hospital procurementmonth for treatment,1. andA 2.deliverylkem “human CLaboratories achetof safety the tools isP alreadyharmaceuticals Ltd. assured,” he3. said, PCentaurvt. L td.PharmaceuticalsIDMACentralmedicines LBULLETIN td.Drugs for this Standardnoble10/- cause: Control Organization, of the Year, Dr Mazumdar-Shaw said,IDMA “At itsPadma BULLETINmedicines core,2. impact. Cforachet this Shenoble Phas harmaceuticalscause:(For built Imported India’s largest (For Pbiopharmaceutical Exportvt. Ltd. Central Drugs Standard Control Organization,Email: [email protected]. Corona / Remedies Pvt. Ltd. free3. medicinesCanadianapproximately Dollarto them. 500 pilgrims I3.f55.30 not, necessary Applicationsplease doto53.45 end so; kindlythemedicines for5.COVID-19 addingIcontactnd Clinical for Swift this that pandemic.L aboratoriesInobleDMA it willTrial cause: beSecretariat Lapplicableimited permission at:for all age and groups. 4. Corona Remedies Pvt. Ltd. Columns and4. alsoCorona for Remedies series Pvt. Ltd. from now,Vibhushan at least for Dr emergency3. V Shanta,Applications use. weTel.: volunteered 022 - 2494 for to 4624 contribute Clinical / 2497 the4308 Trial/company Fax: 022 permission on- 2495 a foundation 0723/Goods) of and compassionate DirectorateGoods)4. capitalism DirectorateCorona General and Remedies General of Health Pvt. ofLtd. HealthServices, Services, 325/-Public Relation Public Relation Office, Office, WeWe are arethankful thankful4. Chinesetoentrepreneurship the to following theYuan following is membersabout11.00 members solving who problems.10.70 whodonated The donated6. greatest Sai2. Mirra C DrI3.nnopharmachet Shanta C Pentaur inharmaceuticalsPvt. Person Ltd. atP theharmaceuticals time P ofvt. donating Ltd. Tel.: the medicines.022Ltd. - 2494 4624 /Sai 2497 Seva 4308Sai Mandal: Seva/ Fax: Mandal: 022 - 2495 0723/ E-mail: [email protected] IDMA is thankful to the above members for their help 2. listM. of C. 3 DamanwallamedicinesEmail: requested Charitable [email protected] by Dispensary,them.E-mail: Namely [email protected], to importSai1.3. Seva/ , [email protected] manufactureCMandal:entaur patient Yen P needsharmaceuticals Drug72.40 before Vaccine profits.” 69.80 Ltd. advertisementIDMA discount is thankful to the above members for their help Meanwhile,opportunities Vishwakarma often arisesapplications informed $IVERSIFYat the toughest thatREPRESENTATION to CSIR times, import Sai has andNeukine Seva IN orthat’sCRITICAL manufactureMandal:“We areSheDECISION MAKING keeping was very ourDrug thankful fingers ANDVaccine crossedto IDMA and & all hoping its members. for the MayIDMA our [email protected], thankful to the above members85/- for theirTel.:New help 022 Delhi.- 2494New 4624 Delhi. / 2497 4308 / Fax: 022 - 2495 0723 medicinesmedicines forWe thisfor 5.are this thankfulnobleDanishU dvadanoble cause:Kroner to - theThis cause: institutionfollowingTel.:11.40 aims members 022Website: at helping - 2494 www.idma-assn.org,and who11.00 4624treating donated / 2497 4308 www.indiandrugsonline.org / Fax: 022 - 2495 0723 IDMA is thankful to the1. above Alkem members1. LaboratoriesAlkem for their Laboratories help Ltd. Ltd. and support.and support. beenPegastathe poor my experienceand & needyPeg-Grafeel patients, throughoutcoordination villagers. Indian my entrepreneurialand Drug Adivasis bodies Manufacturers’ withM. journey. C1.. Damanwallaspecial 2.3. A lkemKoreanC emphasisentaur L aboratoriesCharitable Won Pharmaceuticals on Dispensary, voices Ltd.6.45 Udvada: Ltd. 6.05 Website:and www.idma-assn.org,support. www.indiandrugsonline.orgplease contact: Mr Chettiar medicinesalso6. got for approval thisEURO noble for conductingcause:85.00 Phase 3 clinical81.95 trial1. of Alkembest,”4. L aboratoriesVishwakarmaservice4.Corona Cto L oronaHumanity td.said. Source:Remedies As Moneycontrol,developingRemedies Continue P vt. asa PRNewswire,vaccine ever...L Ptd.vt. againstand Ltd. 04.06.2020support. who live in and around Udvada and also supplies 1. Alkem Laboratories Ltd.    “Sepsivac”7. Hong against Kong Covid-19. 10.10representing9.75 low-income a new4. and disease lower-middle-incomeC orona takes Remedies time, researchers P vt. L td.the world over are 425/- (+9820629907) Publications    Department free medicines to them. F.No . 468 / 01 /2020-Cus.V       SaiSai Seva Seva Mandal: Mandal:Dollar countries. 2. rushingCachet Ptoharmaceuticals repurposeIDMA existing Pisvt. thankful Ltd. drugs, vaccines to the against above the members for their help Sai Seva“The Mandal: Phase 3 trials will be done on 1,100 people IDMA is thankful to the above members for their help IDMA Bulletin 8.LI (11)KuwaitiWe are15 thankful Dinarto 21 to IDMAtheMarch following254.65 Bulletin 2020 members whoLI238.80 donated(12) 22 3. to disease.PramodC30entaur MarchIDMA P Kumar,harmaceuticals is2020 Director,thankful L td. Centralto the Boardabove of members Indirect Taxes for their help 5 Have you16 renewedHave you your renewed Membership your M forembership the for the 1. 1. AlkemAlkem L600aboratories L medicinesaboratories will be for those this Ltd. noble whoL td.cause: s have #ONTINUE tested positiveQUICKLYDEVELOPING but andAND support.COMMUNICATINGand support.CLEARHave youH renewedave you renewedyour Membership your Membership for the for the 1. Alkem9. NewLaboratories Zealand Ltd.46.95 44.75 4. andCoronaand Customs, support.Remedies Ministry Pvt. L oftd. Finance, Department of Revenue, Guidance on product needs in lower resource Source: settings IANS, IndiaTVNews, 02.05.2020 non-symptomatic,Dollar and 500 will be those who are out of New Delhi. Year 2019-2020Year 2019-2020 & 2020-2021 & 2020-2021 Sai Seva Mandal: IDMA is thankful to the above membersYear for 2019-2020Ytheirear help 2019-2020 & 2020-2021 & 2020-2021 KIIDMAND ATTENTIO NB OFU ALLLLETIN SUBSCRIBERS OF hospital,” Vishwakarma said. as early as possible as our understanding of COVID-19   If not, pleaseIf donot, so; please kindly do contact so; kindly IDMA contact Secretariat IDMA at: Secretariat at: 1. Alkem Laboratories Ltd.  and support.    and the tools to combat it evolve. If not, pleaseIf not, do please so; kindly do so; contact kindly IDMA contact Secretariat IDMA Secretariat at: at: Email: [email protected]: [email protected] / [email protected] / [email protected] Email: [email protected]: [email protected] / [email protected] / [email protected] Tel.: 022 - 2494 4624 / 2497 4308 /    For AdvertisingFor Advertising in the Classified in the Classified Columns Columns and alsoTel.: andfor 022 series also - 2494Tel.: for 4624I 022 NDIANseries /- 24942497 46244308 / D/ 2497 Fax:RUGS 4308022 - 2495/ Fax: 0723 022 - 2495 0723 s !DVANCEHave youFIT FOR PURPOSE renewed your MREGULATORYembership ANDfor the LIABILITYTel.: 022 Tel.:- 2494 022 4624 - 2494 / 2497 4624 4308 / 2497 / Fax: 4308 022 / - Fax:2495advertisements 022 0723 - 2495 0723 please contact: Fax: 022 - 2495 0723/ For AdvertisingHaveH youave in renewed youthe Classified renewed your Columns Myourembership M embershipand also for for the series for the advertisements advertisements please contact:We are pleased to state that INDIAN DRUGS – our monthly magazine - is processesHave you for renewed all stakeholders your Membership involved, for the which prioritize Mr Chettiar (+9820629907) Publications Department please contact:Mr Chettiar (+9820629907) Publications Department Mr Chettiar IDMA(+9820629907) BulletinIDMA LI Bulletin (11) Publications 15 LIto (11)21 March 15 DepartmenttoE-mail: 202021 availableMarch [email protected],ONLINE.2020 In order to enable you to have access of 5 5 safetyYear while 2019-2020 not slowingIDMA Bulletin IDMAdown & Bulletin LIaccess2020-2021 (11) 15LI to (11)to critical21 15 March to 21 new 2020 March 2020 5 Indian5 Drugs online, kindly arrange to E-mail us your updated email ID on Year 2019-2020 & 2020-2021 [email protected]: www.idma-assn.org, / [email protected] IYftools. not,ear Ypleaseear 2019-2020 do 2019-2020so; kindly contact & IDMA2020-2021 & Secretariat2020-2021 at: If not, please do so; kindlyIDMA contact IDMA BULLETIN Secretariat at: IDMAIDMA BULLETIN BULLETIN For morewww.indiandrugsonline.org details, please contact: Publications Department : Ifs not,Email:Email:I "UILDf pleasenot, [email protected] [email protected]AND please doMAINTAIN so; do kindly so;PUBLIC / [email protected] contact CONlDENCE/ [email protected] contact IDMA INI DMA Secretariat THEAPPROVAL Secretariat at: at: Tel:022-24944624/ 24974308 / Fax: 022-24950723 / E-mail: mail_idma@ Tel.: 022 - 2494Tel.: 0224624 - 2494 / 2497 4624 / 43082497 4308 / Fax: / Fax: 022 022 - 2495 0723 0723/ E-mail: [email protected],Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723/ E-mail: Email:Email: Tel.:[email protected] 022 [email protected] - 2494 4624for /diagnostics, 2497 4308 / [email protected] / Fax: /therapeutics, [email protected] 022 - 2495 0723 and Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 -idmaindia.com 2495 0723/ / web: E-mail:www.idma-assn.or g / www.indiandrugsonline.org Website: www.idma-assn.org, www.indiandrugsonline.org [email protected],[email protected], Tel.: Tel.:022 - 0222494 - 24944624 /4624 2497 / 43082497 4308/ Fax: / 022 Fax: - 2495022 -0723 2495 0723 IDMA Bulletin LI (11) 15 to 21 March 2020 5 Website:Website: www.idma-assn.org, www.idma-assn.org, www.indiandrugsonline.org www.indiandrugsonline.org    IDMA IDMABulletin Bulletin LI (11) LI (15) 15 15to 21to 21 IDMAIDMAMarch April Bulletin Bulletin 20202020 LILII (37) (21) 01 01 to to 07 07 October June 2021 2020  IDMAIDMA IDMA  BulletinBulletin Bulletin XLVIII11 LIXLVII (12) (04)(44) 22 5 to22 30 to March30 NovemberJanuary 2020 2017 2016 3921 403829 IDMA BulletinIDMAIDMA LIBulletin Bulletin (18) 08 LI LI to(21) (22) 14IDMA 01 May08 to to 202007 Bulletin14 June June 2020 LI2020 (28) 22 to 30 July 2020 IDMAIDMA BulletinBulletin LI24LI (11)(16) 152285 toto 2130 MarchApril 2020 2020 36 3431 IDMAIDMA Bulletin Bulletin LI (11) LI (11) 15 to 15 21 to IDMAMarch 21 IDMAMarch Bulletin 2020 Bulletin 2020 LI (12) LI (12)22 to 22 30 to March 30 March 2020 2020 5 5 16 16 INDIAN DRUGS ONLINE For AdvertisingPU inBLISHED the ON 28th OF EVERY MONTH ClassifiedADVERTISEMENT Columns and BANNER also RATES FOR INDIAN DRUGS WEBSITE for Series Advertisement(Rates in Rupees per insertion) 331,Kalyandas Udyog Bhavan,Century Bazar Lane, Position Size RATES VALIDITY Worli, Mumbai-25 DRightiscount Side Banner 180 X 150 Pixel 25,000 3 MONTHS PleaseLeft Side contact Banner : 180 X 150 Pixel 25,000 3 MONTHS NEED MANPOWER FOR Terms and Conditions  All paymentsAdvertising by DD in advance Dept. only to be made in favour of Indian Drug Manufacturers’ Association, payable at YOUR COMPANY? Mumbai “We are a leading job placement  25% discount applicable only for IDMA members consultant working for the Pharma Industry IDMA 15% discount is applicableBULLETIN on Annual Contract for Non IDMA Members with excellent candidate profiles  Please provide Banner Artwork as per the size for advertisements before the deadline to suit all your requirements.”  Tel.:Advertisement 022 - material 2494 must 4624 reach / us 249710 days before the date of release Contact: 4308 / Ext.:For more103 details please contact Publications Department Gargi Mukherjee: 9987799131/02232261414 Indian Drug Manufacturers’ Association email: [email protected] Fax: 022102-B, - 2495 Poonam Chambers,0723 Dr/ A E-mail:B Road Worli, Mumbai 400 018. Tel: 24944624/24974308 Fax: 24950723 Candidates can also register their resume at Email: [email protected]/ [email protected]. / Website: www.idma-assn.org / www.indiandrugsonline.org email: [email protected] [email protected]

IDMA Bulletin XLVII (48) 22 to 30 December 2016 48 IDMA Bulletin XLIV (14) 08 to 14 April 2013 43

IPR matter Stalling negotiations on waiver will harm WTO’s credibility, warns India

India on Monday said the co-sponsors of the proposal February they asked co-sponsors such as India and recognise that intellectual properties (IPs) are not the South Africa if spare manufacturing capacity is available only barrier to augmenting manufacturing and addressing to produce vaccines even if a waiver is granted. supply side constraints. EU said while it agrees that the ramping up of The warning came after the EU, UK, Australia and manufacturing capacity is a clear priority now and any Singapore opposed negotiations at the WTO for such a available manufacturing capacity anywhere in the world waiver should be used to the full extent, “any indication of where underused capacity exists as indicated by some members With countries of European Union, United Kingdom, would be very welcome”. Australia and Singapore opposing text-based negotiations for intellectual property waiver for covid-19 vaccines India on Monday said the co-sponsors of the proposal and drugs, India on Monday cautioned this will do more recognise that intellectual properties (IPs) are not the harm to the credibility of the World Trade Organisation only barrier to augmenting manufacturing and addressing (WTO) and the collective failure will be remembered by supply side constraints. posterity. “However, we do believe that IPs are the biggest “We often hear that the WTO is losing its relevance barrier in addressing supply side constraints, and thus and credibility, well, if WTO does not deliver during the need to be addressed on priority. The waiver is not pandemic on the issues and agreements for which it bears sufficient but rather necessary element of a multipronged responsibility, and to think that by concluding the fisheries strategy. The TRIPS waiver is a necessary, proportionate negotiation alone amidst these difficult times will the WTO and temporary legal measure for removing IP barriers and reinstate its credibility and relevance, would be a grave paving the way for more companies to produce COVID-19 mistake. Not allowing text-based negotiations will do more vaccines, therapeutics or diagnostics by providing them harm to WTO’s credibility and this collective failure will be freedom to operate without the fear of infringement of IP remembered by posterity,” India said during the informal rights or the threat of litigation,” it added. TRIPS (Trade-Related Aspects of Intellectual Property Rights) Council meeting on Monday. The IMF in a recent paper has calculated that an immediate investment of $50 billion by developed The co-sponsors of a patent waiver to boost supplies countries for global vaccination efforts would yield a of life-saving drugs and vaccines for covid-19, pioneered whopping $9 trillion in economic growth by 2025, holding by India and South Africa presented a revised proposal on that this could be the highest return on public investment 21 May seeking that the temporary waiver be in place for at in modern history. least three years, given the uncertainty regarding vaccine “We have been presenting similar arguments in our effectiveness for children and against new variants. previous statements emphasising upon the need for However, the proposal has hit a roadblock even though the urgent steps for containing the pandemic by augmenting US last month, came out in the open supporting the idea vaccine production to salvage the loss of $9.2 trillion in and expressing its readiness for text-based negotiation economic output and additional burden of $26 trillion in at the WTO. crisis support to the global economy. With IMF echoing similar sentiment we hope that the members will pay more Dissenting economies have questioned the heed,” India said. effectiveness of TRIPS waiver for fast-tracking access to covid vaccines across the world. In a meeting on 23 Source: HT Mint, 02.06.2021 l l l

IDMA Bulletin LII (21) 01 to 07 June 2021 22

National News

Indemnity, a ‘standard process’ Wockhardt has an alliance with the British government followed in other countries for up to August 2022 to make 100 million doses of the AstraZeneca vaccine, at its UK facility. vaccines: Wockhardt Source: PT Jyothi Datta , The Hindu Business Line, In discussion to bring to India next-gen ‘multi-variant’ 03.06.2021 vaccines l l l Even as drugmaker Wockhardt explores multiple options for next-generation Covid-19 vaccines, its founder- Centre to find partner to operationalise Chairman Habil Khorakiwala says the “indemnity” being Chengalpattu vaccine complex; TN CM sought by foreign vaccine makers is a “standard approach” against any further delay in other countries, and not a request being made just in M.K. Stalin wrote to Union Health Minister Harsh India. Vardhan on Wednesday, assuring him of “unflinching and wholehearted support” from his government in This exemption is specific to vaccines, and would not putting this national asset to its full use set a precedent for pharmaceutical or biological products, Khorakiwala told Business Line. His statement came The Tamil Nadu government has been informed that against the backdrop of foreign companies, including the Union government will find a partner to operationalise Pfizer and Moderna, seeking indemnity against litigation the Integrated Vaccine Complex (IVC) at Chengalpattu, for their Covid-19 vaccines. For decades now, such established by HLL Bio-Tech Ltd. However, Tamil Nadu protection has been extended by the US, he said, adding Chief Minister M.K. Stalin on Wednesday urged the Union that there was a sense of urgency now because of the government to ensure against any further delay in the pandemic. process. The pharma veteran is busy with discussions on second In response to the Tamil Nadu government’s repeated generation “multi-variant” vaccines being developed by requests and its representatives personally calling on research companies, besides nasal vaccines that are also multiple Union Ministers in Delhi last week over the easier to administer. The companies involved with both proposal to hand over the facility to the State government, products were still in the early phase of clinical trials, the Stalin-led government has been informed that the he said, but added the pandemic would quicken the Union government intends to bring in a partner on its own development timelines. to operate the plant. First off the blocks, though, is another tech-transfer “While I would like to reiterate our earlier request, I deal that he expects to announce in a month. Without wish to highlight to you the urgency of the moment, given divulging names, he said, about 500 million doses will the need for immediate commencement of production. be supplied by October, and its distribution to different Irrespective of whether it is the Union government or markets would depend on the original company. the State government, which is to find the partner to operationalise the plant, the need of the hour is to ensure The product would be made at Wockhardt’s facility at that there is absolutely no further delay in the process,” Aurangabad, and if other alliances come through, he said, Mr. Stalin wrote to Union Health Minister Harsh Vardhan they would scale up capacity to meet the requirement. The on Wednesday. company can make all three types of vaccines in circulation — vector-based, protein-based and mRNA vccines, he In his letter (a copy of the communication was said. But Covaxin is not a vaccine they would be able to circulated to the media), Mr. Stalin assured the Union make, as it requires required a Bio Safety- Level 3 facility, Minister of “unflinching and wholehearted support” from he said. The company has also offered its services to the his government in putting this national asset to its full Government, to make affordable vaccines for the country, use. He also recalled his earlier letter to Prime Minister he said. Narendra Modi in this regard.

IDMA Bulletin LII (21) 01 to 07 June 2021 23

Stalin urges for more vaccines, swift supply India has not provided indemnity to any vaccine makers so far, including Indian vaccine makers Serum Institute of The TN CM also pointed out that the COVID-19 India, which makes a version of the AstraZeneca/Oxford vaccine supply to Tamil Nadu was almost exhausted and shot locally, and Bharat Biotech , which makes Covaxin. went on to request the Centre to prioritise Tamil Nadu and frontload the June month’s supplies from the first week During the Carnegie India’s Global Tech Summit 2020 itself. “This would help us to recommence our vaccination in December, SII CEO, Adar Poonawalla, also talked about drive and sustain the momentum generated by us in the the need for the government to provide indemnity to vaccine last fortnight.” manufacturers against frivolous complaints. Mr. Stalin also recalled his communications earlier “No formal decision has been taken on the matter yet over COVID-19 vaccines, which were not in proportionate but the request is being seriously considered by experts, to the State’s population and caseload and contended it especially the conditions under which it should be allowed could be corrected only by a special allocation of 50 lakh -- probably only during a pandemic. It is a big decision, doses each under the Government of India channel and and needs to be thought through. They might agree Other than Government of India channel. eventually with certain riders but at this stage nothing can be said for sure,” said one of the people cited in the The CM thanked the Centre for the allocation of 25.84 first instance. lakh doses under the former and 16.74 lakh doses under the latter. “Meanwhile, I would also like to point out that Dr VK Paul, member (health), Niti Aayog, who heads this allotment is just commensurate with the broader the empowered group responsible for procurement, increase at the national level and our request for a special manufacturing, import, logistics, daily supply, and allotment to correct the earlier lower allocation is still to utilization of vaccines id not respond to queries. be addressed.” In a media briefing last wee Paul said Pfizer’s request Mr. Stalin reiterated the request to the Centre to look for an indemnity is being examined. into this issue and ensure that Tamil Nadu was allocated India has already waived for vaccines approved by vaccines at levels comparable to comparable States. regulators of some countries (such as the US and UK) or Source : The Hindu, 02.06.2021 WHO, local bridging trials and the need for testing every vaccine batch at the central drugs laboratory. The national l l l drugs regulator, VG Somani, formally issued an order in India may consider indemnity request this regard on Tuesday. to vaccine makers According to media reports, Pfizer indicated the availability of 50 million doses of its Pfizer-BioNtech India has not provided indemnity to any vaccine makers vaccine between July and October. A Pfizer spokesperson so far, including Indian vaccine makers Serum Institute of said in a statement on May 25 that the company was in India, which makes a version of the AstraZeneca/Oxford talks with the Indian government. shot locally, and Bharat Biotech, which makes Covaxin. “Pfizer remains committed to continuing our engagement India may look at providing indemnity, under certain with the Government of India towards making the Pfizer conditions, to foreign Coronavirus disease (Covid-19) BioNTech Covid-19 vaccine available for use in the country. vaccine makers, even though no final decision has been Since the ongoing discussions are confidential, we cannot taken on this, people familiar with the matter said on provide any further comments.” condition of anonymity. In another statement on May 25, it said, “…during Pfizer and Moderna have both reportedly sought this pandemic phase, across the world, Pfizer is supplying protection from lawsuits related to unforeseen its Covid-19 vaccine only to central Governments and complications from their vaccines, much like the supra-national organizations for deployment in national indemnity they have been provided in the US and the immunization programs. Neither Pfizer Inc nor any of UK, and it is believed that this issue is holding up their its affiliates globally, including in India, have authorized entry into India, which is short of vaccines to protect its anyone to import/market/distribute the Pfizer-BioNTech huge population. Covid 19 vaccine. We continue to have ongoing discussions

IDMA Bulletin LII (21) 01 to 07 June 2021 24

with the Government of India towards making our vaccine scenario. It takes four weeks for every batch of vaccines available for use nationally.” to get cleared,” said Jogesh Gambhir, president, AHPI, Jharkhand chapter. SII did not respond to email queries Indian generics giant Cipla Ltd, is also working on sent by ET. importing the Moderna vaccine to India. HT learns that Cipla is seeking fast-track approvals to bring Moderna’s single-dose Covid-19 booster vaccine into India expeditiously. The company has refused to disclose any details of the ongoing discussion except for the fact that it is seeking seeking clarity and guidance from the government. “Cipla has been at the forefront of Covid care. We are in the process of seeking clarity & guidance from the Government of India for exploring the possible roadmap for vaccine importation to India. At this stage, no definitive AHPI had placed a bulk order for 7 million terms have been finalized and hence, the Company cannot doses for 750 hospitals to SII. It has also engaged comment further,” the company said in an email on with Bharat Biotech (BB) for Covain and Dr Reddy’s Tuesday. Laboratories for Sputnik V. While it expects to get Source : Hindustan Times, 03.06.2021 some doses of Sputnik V, the Indian manufacturers are yet to commit. l l l A few big hospital chains like Max Healthcare, Fortis Medium & small hospitals will take a and Indraprastha Apollo have managed to get supplies while to offer Covid vaccine shots directly from the vaccine makers, while medium and small-sized hospitals such as Narayana Hrudayalaya and These hospitals under the umbrella of Association of the Indian Spinal Injuries Centre, among others, are yet Healthcare Providers India (AHPI) had approached SII to get their quota of vaccine supplies. to place orders in bulk. “SII has said it will send the list to the government for approval and it will revert after it Gambhir said that the delay in the supplies will have gets approval,” said Girdhar Gyani, director general of the an adverse effect on the vaccination drive. AHPI. “It will have an adverse impact. The bigger hospital Medium and small hospitals have been told by Serum chains will keep on making profits. Association of Institute of India (SII) that they will have to take approval Healthcare Providers India has committed to give it from the government before it starts supplying Covishield to people under Rs 800. Our apprehension is that the vaccines to them, said industry executives. consequences would be counter-productive as there will These hospitals under the umbrella of Association of be not enough competition,” he added. Healthcare Providers India (AHPI) had approached SII Gyani said that AHPI is trying to help small hospitals to place orders in bulk. “SII has said it will send the list as they can run the vaccination drive in smaller towns. “For to the government for approval and it will revert after it Serum, it is easy to ship bigger quantity to a few sources gets approval,” said Girdhar Gyani, director general of the but then the whole objective is lost,” he said. AHPI. The AHPI has been in discussion with SII for the SII has said after the government approves the list last three weeks. “Now they are saying they have to take of hospitals, it will take another six weeks before supplies permission from the government before supplying. A lot of begin. time has already been wasted,” said Gambhir.

“During our discussions with SII on June 1, the Source : Economic Times, 03.06.2021 company said delivery in six weeks after government’s l l l approval and confirmation of payment was the best-case

IDMA Bulletin LII (21) 01 to 07 June 2021 25

Foreign-approved vaccines no longer Haffkine Bio-Pharmaceutical Corporation, a need bridging trials in India: DCGI Maharashtra government undertaking, will manufacture 22.8 crore doses of Covaxin per annum under a technology New Delhi: India’s apex drug regulator has waived the transfer arrangement with Bharat Biotech. The company requirement of testing every batch of foreign-made COVID- has received funding of `159.80 crore for producing 19 vaccines by the Central Drugs Laboratory, Kasauli and Covaxin. post-launch bridging trials for such firms, a move that will Haffkine BioPharma MD Dr Sandeep Rathod said the bolster the availability of vaccines. company has been provided with a grant of `65 crore by the The decision by the Drugs Controller General of India Centre and `94 crore from the Maharashtra government. (DCGI) comes in the backdrop of Pfizer and Cipla putting “We have been given a timeline of eight months and the forth similar demands during negotiations to supply work is being executed on a war footing,” Rathod said. imported vaccines to India. The company had earlier estimated around a year to make These exemptions have been made in light of the the vaccine. huge vaccination requirements in India in the wake of Vaccine production will be done at the firm’s Parel the recent surge of COVID-19 cases and the need for complex in Mumbai. The process would involve two stages increased availability of imported vaccines to meet national – drug substance and final drug product. For the production requirements, according to DCGI. of drug substance, Haffkine would need to build a Bio “It has been decided that for approval of COVID- Safety Level 3 (BSL 3) facility. BSL 3 is a safety standard 19 vaccines in India for restricted use in an emergency applicable to facilities where work involves microbes that situation which is already approved for restricted use by can cause serious disease via the inhalation route. It already US FDA, EMA, UK MHRA, PMDA Japan or which are has a fill-finish facility. listed in WHO Emergency Use Listing and which are well- Making Covaxin at Haffkine is part of the government’s established vaccines from the standpoint that millions of plans to accelerate domestic vaccine production by using individuals have already been vaccinated with the said the capacities of the public sector units. Apart from vaccines, the requirement of conducting post-approval Haffkine, these vaccines will also be made at Indian bridging clinical trials and of testing every batch of vaccine Immunologicals, Hyderabad and Bharat Immunologicals by CDL, Kasauli can be exempted, if the vaccine batch/ & Biologicals, Bulandshahar, Uttar Pradesh. lot has been certified and released by National Control ‘Enhancing vaccine production capacity using public Laboratory of the country of origin,” it said. sectors assets will go a long way in building production However, scrutiny of their summary lot protocol and capacity of vaccines in our country to support the massive certificate of analysis of batch or lot shall be undertaken vaccination drive,” said Renu Swarup, secretary, department by CDL, Kasauli for release as per standard procedures and of biotechnology and chairperson, Biotechnology Industry requirement of assessment on the first 100 beneficiaries Research Assistance Council. for seven days for safety outcomes before the vaccine is The department of science and technology had rolled out for further immunisation programme, the DCGI approved Haffkine in April 2021 to produce Covaxin. said in a notice issued on June 1. Haffkine Biopharmaceuticals had asked for around 12 Source : Millennium Post, 03.06.2021 months to complete this task. The central government l l l wanted them to expedite and complete the task urgently within six months. Now the timeline has been set at eight Haffkine Biopharma to produce 22.8 cr months. Covaxin doses a year The pharma company is an offshoot of the 122-year-old Haffkine Institute, one of the oldest biomedical research Making Covaxin at Haffkine is part of the government’s institutes in the country and focuses on research and plans to accelerate domestic vaccine production by using manufacturing of polio vaccines. Haffkine has installed the capacities of the public sector units. capacity to make 22.8 crore vials a year. A committee The department of science and technology had formed by the Maharashtra state government under approved Haffkine in April 2021 to produce Covaxin. the chairmanship of scientist, Raghunath Mashelkar,

IDMA Bulletin LII (21) 01 to 07 June 2021 26

had recommended allocations of around `1,100 crore be manufacturing up to 1 billion doses per annum of the to implement projects over five years for the revival of mRNA vaccine in 2022. Haffkine. Source : Swati Bharadwaj , TNN , 03.06.2021 Source: Financial Express, 03.06.2021 l l l l l l

Telangana: Biological E starts at risk Pharma next big thing for IT cos manufacturing of Corbevax Healthcare sector will also offer big growth opportunity for software firms HYDERABAD: Vaccine maker Biological E has LIFE sciences and pharmaceutical vertical is slowly begun at risk manufacturing of its recombinant protein emerging as the next growth spot for the IT services Covid-19 vaccine – Corbevax that it is developing in tie- industry with growth opportunities spanning over the next up with Texas-based Baylor College of Medicine (BCM), decade. TOI has learnt. Experts and company officials are of the opinion that The company has already begun churning out doses of ongoing pandemic has brought healthcare as one of the the vaccine as part of plans to create a stockpile ahead of top priorities of countries, leading to higher public and an emergency use approval (EUA), sources said. However, private investment in life sciences and pharmaceutical the actual quantum of doses that has been manufactured sector. so far could not be ascertained. As the pandemic is going to remain here for some years, Corbevax, which is slated to be the most affordable the application of software services in life sciences sector vaccine to hit the market with an estimated production will grow over the years. cost of around $1.5 per dose, is expected to be available for use in the country by August. Biological “The technology spend of life sciences and E is looking at hitting a capacity of 75-80 million pharmaceutical vertical has increased manifold during doses per month for this vaccine candidate from this Covid period. Therefore, tier-I IT services players, August this year. engineering services companies that are into medical “It’s a significant capacity and we have already scaled devices design and development and BPM players have up. We have confidence in our manufacturing capabilities benefitted from this rising spend. As nations increase to be able to deliver that number from August onwards,” their healthcare spend, this is a growth story for the next Biological E managing director Mahima Datla had told decade,” said Pareekh Jain, an IT outsourcing advisor and TOI earlier. founder of Pareekh Consulting. At present, only three vaccines have got EUA in The growth in spend has already been visible in the the country – Bharat Biotech and ICMR-NIV’s Covaxin, fourth quarter earnings of IT services firms. For instance, AstraZeneca-Oxford vaccine being made by Serum Institute Infosys witnessed a year-on-year growth of 18.3 per cent of India (SII) under the Covishield brand and Russian (constant currency term) in the Q4 of FY21 in its life vaccine Sputnik V. The vaccine candidate is currently sciences vertical. Out of 23 large deals the company won undergoing phase-III trials on 1,268 healthy volunteers in in January-March period, three came from life sciences the 18-80 years age group at 15 centres across the country vertical. Similarly, Tata Consultancy Services saw its life as part of a larger global Phase III study to evaluate the sciences vertical growing 19.3 per cent in the fourth quarter immunogenicity and safety of the vaccine against Covid- of this fiscal year. 19. Cognizant Technology Solutions, which is considered Apart from the two-dose Corbevax, Biological E has just one of the big players in healthcare technology space, joined hands with Providence Therapeutics Holdings Inc of witnessed 7 per cent rise in CC term. This growth came Canada for licencing the latter’s mRNA vaccine candidate from increased demand for its integrated payer software PTX-COVID-19-B for the Indian market as well as some solutions and continued strong demand among its life other markets. The Hyderabad-based vaccine maker will sciences clients.

IDMA Bulletin LII (21) 01 to 07 June 2021 27

Apart from IT services players, even engineering it in the GST exemption list of imported items. services companies such as L&T Technology Services, “The export of Amphotericin-B injections... ..is Cyient, Tata Elxsi and others operating in designing of restricted, with immediate effect,” said the DGFT smart healthcare devices are also witnessing higher demand notification. from this sector. For instance, L&T Technology Services’ medical devices vertical grew 21 per cent YoY in Q4 of Meanwhile, DV Sadananda Gowda, Chemicals & FY21, making it the best performer among all verticals. Fertilizers Minister, said on Tuesday that 2,70,060 vials of Amphotericin-B have been allocated to States/UTs and Amid the Covid pandemic, pharmaceutical companies Central institutions from May 11 to May 30. This is in are spending more on technology to reduce time for vaccine addition to the 81,651 vials that were allocated to the trial and its subsequent release. Many IT firms have States in the first week of May. collaborated with vaccine producers to create technology platforms for interpretation of data coming out of vaccine In addition, a total of 98.87 lakh vials of Remdesivir trial. were allocated to States, UTs and Central institutions from April 21 to May 30, the government informed on Tuesday, Not only IT firms and engineering services companies, while further adding that its production has been ramped even BPM (business process management) service providers up 10 times, leading to enough supply than the demand. operating in the healthcare segment like telemedicine and The government is also planning to supply up to 91 lakh insurance have also seen surge in demand. “Bioinformatics vials till June-end. is the other area which will see rising spend in the coming years. Though it is there for quite some time, there will Gowda further informed that Cipla has imported be greater momentum this time around. So, while the 11,000 vials of 400 mg and 50,000 vials of 80 mg of pandemic creates demand for IT companies with domain Tocilizumab from April 25-May 30. In addition, the Health knowledge, it also enables technology firms to provide Ministry received 1,002 vials of 400 mg and 50,024 vials various digital technology-powered solutions to healthcare of 80 mg via donation in May. Further, 20,000 vials of 80 players,” said Jain of Pareekh Consulting. mg and 1000 vials of 200 mg are likely to arrive in June, he said. Though the growth of life sciences vertical will support the overall revenues, the supplementary impact will not be Supply of Covid drugs that big as this vertical typically contributes around 10 per The production, supply and stock position of other drugs cent of the total revenues of most IT firms, experts said used in the treatment of Covid, such as Dexamethasone, Source : Debasis Mohapatra, Hans India Bizz Buzz, Methylprednisolone, Enoxaparin, Favipiravir, Ivermectin 02.06.2021 and Dexamethasone tablets, are also being reviewed l l l weekly. The production has been augmented and stocks are Govt restricts export of available to meet demand, Gowda further stated. Amphotericin-B drug Source : The Hindu Business Line, 01.06.2021

Mucormycosis cases are on the rise in the country l l l The government has imposed curbs on the export of Amphotericin-B drug used in the treatment of black Regulator Looks for Alternative fungus disease, according to the notification of the Medicines to treat Black Fungus’ Directorate General of Foreign Trade. Now, under the India’s drug regulator is examining the use of revised policy, export of Amphotericin-B is under the alternative drugs for the treatment of mucormycosis, the restricted category. fungal infection which has become the latest health worry, Rise in cases said people with knowledge of the matter. India’s drug regulator is examining the use of alternative drugs for the The decision comes in the backdrop of rising cases of treatment of mucormycosis, the fungal infection which has Mucormycosis in the country. It may be recalled that the become the latest health worry, said people with knowledge GST Council, at its 43rd meeting, had recently included of the matter. A large number of cases has led to a shortage

IDMA Bulletin LII (21) 01 to 07 June 2021 28

of Amphotericin B, the medicine commonly used to treat Biological E ties up with Canadian firm the affliction. Providence for mRNA Covid vaccine With the unprecedented surge in mucormycosis The vaccine, named PTX-COVID19-B, is under infections causing a clamour for the anti-fungal drug, the development in Canada; the deal assumes significance drug regulator is reviewing the use of alternative drugs, as this gives India access to the mRNA tech notably those used at present to treat ‘Kala Azar’. “In a Hyderabad-based Biological E tied up with Calgary- bid to bridge the gap between demand and supply, while based Providence Therapeutics to manufacture its mRNA this is the preferred drug, the drug regulator is looking at technology-based Covid-19 vaccine and do clinical trials alternatives especially those drugs which are used to treat in India. The deal assumes significance as this gives India Kala Azar. The decision is likely to come soon,” added the access to the mRNA technology. same people. The vaccine, named PTX-COVID19-B, is under The government is also considering releasing a clinical development in Canada at the moment. Providence management protocol with guidelines regarding the use of announced data from the phase 1 trials in May and will Amphotericin B. “The experts are looking to recommend use of Amphotericin B only in severe cases and less severe begin the phase 2 trials soon. cases be treated with alternative medicines. Guidelines “The mRNA platform has emerged as the front runner regarding the use of Amphotericin B will soon be out, too,” in delivering the first vaccines for emergency use to combat added the people. the COVID-19 pandemic. Amphotericin B, an antifungal drug, is used to Biological E. is very pleased to be able to work with treat mucormycosis which can cause blindness, organ Providence on its promising mRNA vaccine candidate. We dysfunction, and can be fatal if not treated in time. Certain hope to provide India and other countries yet another option parts of India are seeing a large number of cases of black to ramp up their efforts towards achieving herd immunity fungus. Some experts blame it on the overuse of steroids against COVID-19,” said Mahima Datla, Managing Director during Covid. Those with diabetes are believed to be of Biological E Limited. particularly susceptible to the disease. While the financial terms of the deal were not disclosed, Doctors have said that while they would previously see 10-15 cases a year, they now have close to a 100 in Providence will sell up to 30 mn doses of its mRNA a matter of weeks. vaccine to Biological E. It would also provide the necessary technology transfer to make the vaccine in India, with a The number of cases of rhino-cerebral mucormycosis minimum production capacity of 600 mn doses in 2022 is showing no respite. Many patients are presenting themselves in advanced stages. They are being treated by and targets capacity of 1 bn doses. endoscopic debridement followed by antifungals, “ said “Biological E will be responsible for all clinical K K Handa, chairman, department of ENT and head neck development and regulatory activities for the mRNA vaccine surgery, Medanta Medicity. in India and other jurisdictions licensed by Biological E,” Union minister for chemicals and fertilizers Sadananda the company said. Gowda said that domestic production has been ramped up. “Over 1.63 lakh vials are available from existing domestic “This initiative is an important commitment by a manufacturers in May which is about 260% higher than Canada-based company to help India and other nations the production in April, “he tweeted. vaccinate their citizens against COVID19. Providence On Tuesday the centre allocated more than 2.5 lakh was founded to serve patients, and this commitment by vials of Amphotericin B to the states and UTs. “This is in Biological E allows us to achieve that essential goal,” addition to the supplies of 81,651 vials that had been indicated Brad Sorenson, CEO of Providence. made available by manufacturers to states in the first week Biological E already has a deal in place to make over of May,” Gowda further tweeted. 500 mn doses of the single dose Johnson and Johnson Source : Economic Times, 02.06.2021 (J&J) vaccine. J&J’s is a viral vector based vaccine which uses human adenovirus Ad26. l l l

IDMA Bulletin LII (21) 01 to 07 June 2021 29

India already has one mRNA vaccine in development continue to be at the forefront of the battle against Covid- by Pune-based Gennova Biopharmaceuticals which is in 19. Lilly is committed to contributing to the alleviation phase 1 clinical trials. of the Covid-19 pandemic in India and around the world. We will continue to assess and evaluate how our existing In a May 12 press statement, Providence has said portfolio and ongoing research can benefit patients with that its phase 1 studies on 60 subjects have shown Covid-19,” said Luca Vasini, Managing director, India PTX-COVID19-B to be generally safe and well tolerated. subcontinent, Lilly India. It exhibited “strong virus neutralisation”. It already has an agreement in place to supply 2 mn doses of PTX- Bamlanivimab and Etesevimab together can be COVID19-B to the government of Manitoba in Canada. administered via injection in a restricted manner to adults and paediatrics patients (12 years and older, weighing at According to media reports, Providence was planning least 40 kg) in emergency situations at hospitals to treat to move the clinical trials out of Canada. mild to moderate Covid-19. Apart from the J&J and Providence Covid-19 vaccine According to the company statement, Lilly is engaging deals, Biological E also has under development a third in active dialogue with the India government and regulatory candidate with Baylor College of Medicine. The Baylor authorities to donate Bamlanivimab and Etesevimab in College of Medicine – Biological E vaccine is set to begin order to speed up access and provide more treatment phase 3 clinical trials in June. This is a protein sub-unit options for patients with Covid-19. (ANI) technology based vaccine, a technology that Biological E already had. This technology is used to make Hepatitis B Source: Shalini Bhardwaj, ANI, 01.06.2021 vaccines. l l l The Indian government has indicated that in the second half of the year, it expects to receive 300 mn doses of the Changing GST rates for Covid-supplies Biological E vaccine. no panacea India is already in talks with US players Pfizer and The solution lies in ensuring adequate supply and not Moderna for bringing their USFDA-approved mRNA Covid- making ad hoc changes to GST rates 19 vaccines to India. Canada is using both Pfizer and Moderna vaccines to inoculate its citizens. As there is market failure due to high externality, the responsibility to vaccinate and financing the expenditures Source: Sohini Das, Business Standard, 02.06.2021 from the Consolidated Fund falls squarely on the l l l government. The 43rd meeting of the GST Council convened on Eli Lilly’s antibody cocktail drug gets May 28 to decide on matters including tax treatment of emergency use nod in India Covid-19 supplies, dealing with inverted duty structure for certain items and extension of relief to small taxpayers, Eli Lilly and Company India on Tuesday announced that and extension of compensation period beyond June 2022, it has received emergency use approval in the country for when the current scheme comes to an end. With as many its monoclonal antibody drug combination used for treating as eight finance ministers from Opposition-ruled states, Covid-19 patients with mild to moderate symptoms. the deliberations of the Council were not expected to be smooth, and it is not surprising that key decisions have The drug, a combination of Bamlanivimab 700 mg and been deferred. Etesevimab 1400 mg has been approved for use in the country by the Drugs Controller General of India (DCGI). The most urgent issue was lowering tax rates on Covid- 19 related supplies such as vaccines, drugs and medicines, This will be the second cocktail drug approved by oxygen cylinders and concentrators, and other material DCGI for emergency use, after the drug regulator gave its and equipment required for Covid-care. Some states have nod to the antibody cocktail Casirivimab and Imdevimab asked for exempting vaccines (currently taxed at 5%), but developed by Roche. given the higher rates on inputs, this would make them “We are pleased that we have another innovative ineligible for availing input tax credit, and that may actually treatment option to offer India’s healthcare providers who increase prices.

IDMA Bulletin LII (21) 01 to 07 June 2021 30

Some have suggested zero-rating of the tax and some are concerned. For FY22, too, 7% ‘as-normal’ growth has others have suggested levying a small rate of 0.1% to been assumed, pegging the shortfall at Rs 2.7 trillion enable input tax credit. However, zero rating is done and, after adjusting the revenue of Rs 1.1 trillion from only for exports and levying a low rate would cause heavy the compensation cess, the compensation payment is refunds to be made. Considering the differences, the estimated at Rs 1.58 trillion; the Centre is supposed to Council constituted an 8-member panel headed by the borrow this amount and on-lend it to the states. Given Meghalaya CM to deliberate and submit a report by June the dire need for resources, the states will be left with no 8 on the matter. choice but to accept. However, the entire episode of GST compensation has left the states helpless and eroded their The important point that is missed in the discussion is trust, and this could make them wary of future reforms. that tax component is not a major determinant of the price of the vaccine today; it is the convoluted vaccine policy, The issue of compensation in the future after the combined with the supply-demand mismatch. As there is present agreement ends in June 2022 is another major market failure due to high externality, the responsibility concern for the states. The problem would not have arisen to vaccinate and financing the expenditures from the if GST had been a money machine as was promised. Consolidated Fund falls squarely on the government. Thankfully, as the technology platform has stabilised, the monthly collections have consistently exceeded Rs The Constitution places prevention and containment 1 trillion since October 2020. Unfortunately, due to the of contagious diseases in the Concurrent List (Entry 29), second wave, the estimated 17% increase over FY21 RE and the Union Government should take the responsibility may not accrue. The future collections will depend upon of financing the programme, and the states as well as economic recovery. the private sector should be involved in administering the vaccine. The government should have assessed In 2017, when GST was introduced, the Centre agreed the requirements when the pandemic was raging, and to a generous compensation scheme to clinch states’ considering the capacity constraint of the two domestic assent. Now that states have nowhere to go, it remains to producers, it should have opened the market for imports. be seen how the Centre will address the matter. The entire process is likely to place severe challenges in Union-state Instead, the decision to import was delayed, and the financial relations, and it remains to be seen how these Centre simply asked the states to vaccinate 590 million will be navigated. people in the 18-45 age group that would require 1.22 billion doses. Monopsonistic procurement of vaccine by the (M Govinda Rao- Chief Economic Adviser, Brickwork Centre and its distribution among the states would have Ratings, and former director NIPFP) helped bring down the prices instead of States going for Source: M Govinda Rao, Financial Express, 02.06.2021 global tenders. Even for the domestic manufacturers, the initial price was relaxed, and Covishield is now priced at l l l Rs 300/dose to the states and Rs 600/dose to the private sector. Covaxin is priced at Rs 400/dose to the states and Seeking clarity, guidance from govt for Rs 1200/dose to the private sector. Even now, it is not vaccine import: Cipla too late to reverse the decision. In the case of Covid-19 The statement came after a report by PTI on Monday drugs and other supplies, the common man is made to pay said the company is seeking fast-track approvals to black-market prices due to scarcity. The solution lies in expeditiously bring Moderna’s single-dose COVID-19 ensuring adequate supply and not making ad hoc changes booster vaccine into India. to GST rates. Pharma major Cipla on Tuesday said it is seeking clarity Compensation to the states for the shortfall in revenue and guidance from the government on the possible roadmap collections has been a vexed issue. In FY21, the shortfall to import vaccine, while stressing that it has been at the was estimated by assuming that the states’ GST collections forefront of COVID-19 care. will increase by 7%, and the states were given a loan of The statement came after a report by PTI on Monday Rs 1.1 trillion after adjusting the shortfall with estimated said the company is seeking fast-track approvals to collections from compensation cess. The actual collection expeditiously bring Moderna’s single-dose COVID-19 was lower than the previous years by 3.3%, and the states booster vaccine into India.

IDMA Bulletin LII (21) 01 to 07 June 2021 31

The report quoting sources said Cipla has requested For instance, the Centre has said it has no record or the government for indemnification and exemptions from documents if any committee was formed by the government price capping, bridging trials and basic customs duty, while to decide on the vaccines export, its members, the details stating that the firm is close to committing over USD 1 and minutes of the meetings if any of such a committee. billion as advance to the US major. “This is quite mysterious. Which ministry has actually In a regulatory filing, the pharma firm said, “Cipla has taken the decision for the massive donations or exports been at the forefront of COVID care. We are in the process especially since at least two key ministries – Health and of seeking clarity and guidance from the Government MEA – could be directly involved in the process,” Sarda of India for exploring the possible roadmap for vaccine pointed out. The RTI reply has mentioned in passing that importation to India”. At this stage, no definitive terms have the vaccines were procured for the export purposes – as been finalised and hence, the company cannot comment Grant, contractual supplies and under the Covax facility further, it added. – as per the authorization from the Ministry of Health & Source : PTI, 01.06.2021 Family Welfare. l l l However, it throws no light on who took such a critical decision when the country is reeling under the massive India halts vax exports, second wave of the Covid-19 pandemic, said Sarda. may resume in future As per the official data, the Centre has given away The MEA has also made it clear that in future; supplies a whopping 107.15 lakh vaccines free as ‘Grant’ to 47 (export) would be undertaken, keeping in view of the countries, sold 357.92 lakh doses at commercial rates to domestic production and the requirements of the national 26 nations, and under the Covax programme sold 198.63 vaccination programme Pune lakh vaccines to another 47 countries – totaling to a staggering 663.70 lakh doses. In a relief of sorts, from May 5, India has apparently halted the contentious doles and exports of vaccines which Till May 31 (today), India has vaccinated a total of has erupted into a massive political furore across the 21,31,54,129 people under various approved categories, country, as per an RTI reply released here on Monday. In including those who got their second dose. “This proves a response to the RTI query filed by Pune-based activist that the government has virtually sent away more than 6.60 Prafful Sarda, the Ministry of External Affairs (MEA) has crore doses abroad that could have, for instance, vaccinated provided details of the vaccines exported in different by now the entire adult population of Maharashtra - which is the country’s worst-hit in terms of infections and fatalities,” categories to 95 countries till May 5. Sarda said. To a question, the MEA has also made it clear that in For the ‘Grant’, the government had purchased the future; supplies (export) would be undertaken, “keeping vaccines from Pune-based Serum Institute of India Ltd in view of the domestic production and the requirements (SII) at Rs 200+GST per dose, and from Hyderabad-based of the national vaccination programme”. Bharat Biotech International Ltd at Rs 295+GST per The IANS had first reported the vaccines exports vaccine, said the RTI reply. details on April 27, (Centre’s Covid jab for world spells Source : Quaid Najmi, Hans India Bizz Buzz, 01.06.2021 ‘ouch’ in India!), triggering a massive political furore. All major parties in the country including Congress, Nationalist l l l Congress Party, Shiv Sena, Aam Aadmi Party, the Left and other opposition parties had repeatedly slammed Prime Covid drugs rates brought down, NPPA Minister Narendra Modi and the Bharatiya Janata Party- tells Telangana high court led central government on the issue. “However, barring HYDERABAD: Amid charges of exploitation of the basic export data, the government has kept mum on Covid-19 patients by private hospitals by collecting many other related info but critical aspects pertaining to exorbitant bills, the National Pharmaceutical Pricing the exports of such a huge quantity of doses which deprived Authority (NPPA) said the prices of Covid-19 management Indians in a big way,” Sarda told IANS. drugs like remdesivir have been brought down following

IDMA Bulletin LII (21) 01 to 07 June 2021 32

the intervention of the Centre. The price of remdesivir production-linked incentive (PLI) scheme to boost was brought down to Rs 3,500 from Rs 5,400 per vial, domestic manufacturing and make the initiative more it said. investor-friendly by “regular hand-holding” and removing hurdles at the earliest. The drug manufacturing companies have volunteered to bring the rates down following the intervention of the The development comes against Centre, the NPPA said in its affidavit before the Telangana the backdrop of several high court which made NPPA a respondent in the ongoing companies, especially electronic manufacturers, requesting the case on Covid-19. The court, while hearing a batch of PILs government to relax the targets on Covid-19 questioning the high charges on one hand laid out under the scheme owing and failure of the authorities on the other, had asked the to disruptions caused by the NPPA to file an affidavit specifying its efforts to contain Covid-19 pandemic. They have the exploitative practices of the hospitals. also sought a change in the base year from 2019-20. NPPA deputy director T Rajesh Kumar said in his affidavit that manufacturers of non-scheduled drugs cannot While there has been no formal increase the maximum retail prices of their drugs by more announcement regarding the than10 per cent in a year. “Remdesivir is a non-scheduled easing of norms, a process- driven method to address the drug. NPPA is monitoring the situation in respect of industries’ woes can boost nonscheduled drugs used in the management of Covid-19 investor confidence and promote to ensure that the manufacturers do not increase the prices ease of doing business. Apart beyond10% per annum,” he said. from this, constant support from state governments will be For Covid-19 drugs, the NPPA is monitoring the required to resolve issues, situation regardless of the classification of the drug, including speedy clearances for scheduled or non-scheduled. “The NPPA is also setting up new units, the official coordinating with the All India Organisation of Chemists said. and Druggists (AIOCD) for removing bottlenecks in the According to the government’s supply chain,” Rajesh Kumar said. NPPA issued an office estimates, the PLI scheme will memorandum on April 17 notifying the reduced prices result in minimum production of of the drugs used in Covid-19 with a direction to drug more than $500 billion in five controllers in the states to ensure that these drugs were years in India. Besides, India is available at reduced rates, he said. trying to diversify supply chains, amid tensions with China. The central agency’s affidavit said NPPA fixes the ceiling price of scheduled medicines specified in the first The panel has asked schedule of the Drugs (Prices Control) Order, 2013, known government departments to as DPCO. Manufacturers of scheduled drugs will have to devise ways to reduce the sell their products within the ceiling price and GST can timeframe for the implementation be added to this. However, the price fixation methods are of the scheme. Besides, all schemes need to take off fully not the same for all drugs. over the next three months. Source : Sagar Kumar Mutha, TNN , 01.06.2021

l l l

Cabinet secy-led panel wants PLI scheme revamp to boost manufacturing Out of the 13 schemes, three schemes have been notified; seven have been approved The panel, in a recent meeting with different ministries, by the Cabinet; and three – automobile, steel, and textile – are yet to get the Cabinet’s Suggests institutional mechanism, callednod. for setting up an effective “institutional mechanism” regular hand-holding for firms to constantly engage with companies that have decided to A high-level committee headed by Union Cabinet participate in the Rs 1.97 trillion scheme, an official aware of the matter said. Secretary Rajiv Gauba has suggested a revamp of the

IDMA Bulletin LII (21) 01 to 07 June 2021 33

The mechanism will focus on addressing challenges the Cabinet; and three – automobile, steel, and textile – are faced by investors, including global giants, which have yet to get the Cabinet’s nod. shown interest in participating in the National Democratic Source: Shreya Nandi, Business Standard, 03.06.2021 Alliance government’s flagship scheme, the official said. l l l Last year, the Centre announced the PLI scheme now extended to 13 key sectors such as telecom, textile, View: How financial incentives for automobile, white goods, and pharmaceutical drugs -- to innovation can play a significant role in improve cost competitiveness of locally produced goods, vaccine development create employment opportunities, curb cheap imports, and boost exports. The scheme offers incentives to companies ​​Angela Merkel opposed this move, warning that it would on incremental sales of goods manufactured in India for discourage production of important vaccines. Merkel is right. a period of five years. Monetary incentives for innovation are critical to stimulating and growing innovation. “The idea is to engage with industry regularly, monitor various milestones achieved (as part of the scheme). There Virtues of the reward system include providing should also be regular hand-holding for companies,” the incentives to innovate without granting monopoly power official cited above said. over price, or nonoptimally restricting the use of essential innovations. A system will have to be introduced to enable prompt decision making and look into the “legitimate requirements” The world has witnessed an unprecedented race by the of the companies availing of incentives under the scheme, private sector to develop and produce Covid-19 vaccines. suggested the panel, which also includes senior officials Since the outbreak of the pandemic, at least five different of the NITI Aayog, finance ministry, and commerce and vaccines have proven effective against the virus. Vaccine industry ministry. development is a risk-intensive process. The development comes against the backdrop of It requires substantial investments in pre-clinical several companies, especially electronic manufacturers, research, human clinical trials, regulatory submissions requesting the government to relax the targets laid out and market creation, with relatively low likelihood of under the scheme owing to disruptions caused by the product success and market entry. So, what incentivised Covid-19 pandemic. They have also sought a change in private pharmaceutical companies such as Pfizer, the base year from 2019-20. Moderna, AstraZeneca Johnson & Johnson and Bharat Biotech to spend hundreds of millions of dollars in While there has been no formal announcement mobilising resources and capabilities for vaccine R&D? regarding the easing of norms, a process-driven method to No doubt the desire to do good. But these companies also address the industries’ woes can boost investor confidence have afiduciary duty towards their investors and an equally and promote ease of doing business. Apart from this, important, if not more important, incentive for innovation is constant support from state governments will be required provided by potential profits from the sale of these vaccines to resolve issues, including speedy clearances for setting to billions around the world. up new units, the official said. Profits are only possible if pharma companies are According to the government’s estimates, the PLI allowed to sell their vaccines at a price that covers not just scheme will result in minimum production of more than the marginal cost of production, but also the significant $500 billion in five years in India. Besides, India is initial costs incurred during R&D. This can only happen trying to diversify supply chains, amid tensions with if companies are granted some monopoly power either China. through patent protection, where innovators have exclusive The panel has asked government departments to devise rights to market the vaccines they develop, or by regulation ways to reduce the timeframe for the implementation of that limits generic drug manufacturers from reengineering the scheme. Besides, all schemes need to take off fully the manufacturing process at lower costs of ownership and over the next three months. Out of the 13 schemes, three selling those generic equivalents at slightly above marginal schemes have been notified; seven have been approved by costs of production.

IDMA Bulletin LII (21) 01 to 07 June 2021 34 Yet, granting monopoly power to pharma firms, while their populations during the period of patent protection. providing incentives to innovate, allows a large number Thereafter, they should distribute or sell these at near-marginal of people who could have obtained life-saving vaccines, costs of production, or subsidise for poorer and more needy especially in poorer countries, to suffer and perhaps die. populations. At the same time, the underlying technologies could be open-sourced for anyone else to use, copy or modify, Such monopoly power also hinders improvements and including the innovating company, so that the most efficient subsequent innovations if patent holders disallow that. This producers can produce it in large quantities. is the dilemma we currently face. In response to mounting pressure from Democrats and nearly 100 countries, Joe If there is more than one innovator, as is currently the Biden waived patent protection for Covid vaccines being case with Covid vaccines, an auction mechanism could produced in the US. be instituted that will facilitate price discovery through information aggregation about potential demand and costs Angela Merkel opposed this move, warning that it of production. would discourage production of important vaccines. Merkel is right. Monetary incentives for innovation are critical to To encourage organisations to invest in cures for future stimulating and growing innovation. public health crises, intrinsic motivation alone will not suffice. We must provide financial incentives for innovation, Economists have implicated the significant gap and keep financial incentives intact, even as we unshackle between private and social returns to research in limited ourselves from its limitations by judicious use of public development of vaccines for diseases like malaria and and philanthropic funding. tuberculosis that plague developing countries. While waiving patent protection for the Covid vaccine, it is Source: Bhagwan Chowdhry & Deepa Mani, Economic important to design an alternative system that rewards Times, 01.06.2021 innovators for this critically important quest. Economists l l l and intellectual property advocates, including Joseph Stiglitz, have long emphasised rewards paid by the government to innovators — such as prizes and purchase No shortage of Covid drugs: IDMA commitments — as an alternative to patents in spurring Seeks cut in taxes on medicine; hails PLI scheme for innovative activity. pharma sector Virtues of the reward system include providing The pharmaceutical experts have said that industry incentives to innovate without granting monopoly power has managed to manufacture required quantity of essential over price, or nonoptimally restricting the use of essential drugs in the country during Covid-19 second wave. The innovations. A prize could compensate the innovator and Indian Drug Manufacturers Association (IDMA) said that then render the innovation open source so that it can the sector was able to produce both Covid and non-Covid be produced and distributed widely. What should be the related drugs despite various challenges including shortage size of the prize? Who should fund it? How should it be of on-site workforce and restrictions in supply chain. administered? In the 2006 paper, ‘Regulation of Natural Monopolies’, MIT economist Paul Joscow’s suggests that a Viranchi Shah, Senior Vice-President, IDMA, told Bizz lump sum prize to compensate for initial R&D costs, along Buzz, that upon realising the surge in Covid cases, pharma with licensing fees for production paid by government companies scaled up their manufacturing capacities. He and philanthropic organisations, would provide the right said that critical Covid related drug such as remdesivir saw incentives. Further, vaccine R&D is a global public good. increase in production from 38 lakhs injections/month to So, each country has the incentive to free-ride research 1.2 crore injections/month since April and May. Similarly, financed the governments of other countries. Shah claims that given the surge in cases of black fungus in Covid patients, Amphotericin b drug production has also Governments (read: taxpayers) and philanthropic been increased by Ambalal Sarabhai Enterprises (ASE) by organisations must pay for the right outcome, with richer four times this year. The industry expert had said that they countries with greater willingness to pay contributing more do not assume any significant long-term term losses for towards R&D costs. In effect, richer countries can purchase the pharma manufacturers, with some setback in the first vaccines at near-monopoly price they would have paid for quarter of Financial Year 2021-22.

IDMA Bulletin LII (21) 01 to 07 June 2021 35

The IDMA vice-president explained that although the industry was impacted for the month of April-May, since workers could not come to the plants and manufacturing could not go on, the situation wasn't as severe as previous year's lockdown where supply chain was completely disrupted. Given the ongoing high demand of essential medicines, the Ministry of Chemicals and Fertilisers gave its nod to 46 companies for domestic manufacturing of critical Key Starting Materials (KSM) or drug intermediates and active pharmaceutical ingredients (APIs) under the Production Linked Incentive "We had two major impacts. Number one was in Covid- (PLI) Scheme. related drugs, because of the sudden demand, the Active Pharmaceutical Ingredients (APIs) went up, and that's Shah said that the decision will give a boost to the where our margins were hit. Companies continued with industry in the next two to three years and reduce the the standard price. We can't go to the government and dependency on imports of essential drugs from countries use the arm-twisting technique. We had meetings with the such as China and Europe. According to him, out of about government. And the government also said that increasing $ 9-10 billion industry of APIs, India is importing close the prices would not give the right message to the society. to $ 3.5 to 4 billion of APIs directly. Out of total the So, you (manufactures) have to find the way to sustain for import of KSM (out of which the APIs are manufactured), some months, it said. And we acceded to the government's 67 per cent of those KSM and APIs come from China and request," said Shah rest from Europe and South-East Asian countries.

"It is not the right time to escalate the prices. Although The IDMA however sought relief on customs duty on all of us have suffered losses and profits were gone. So, essential drugs. At present, the custom duty on medicine that was one of the impacts where our bottoms lines will in India stands at 23.2 per cent after GST. definitely be impacted. Everybody's profits get eroded as input prices are the same but the output is doubled," he Source: Archana Rao, Bizz Buzz, 07.06.2021 added.

l l l

InterNational News

India’s Covid Vaccine Rollout “Rescued India is called the pharmacy of the world during the COVID- The World”: Top US Scientist 19 pandemic with its vast experience and deep knowledge in medicine. The country is one of the world’s biggest drug- Dr Hotez, an internationally-recognised physician- makers and an increasing number of countries have already scientist in neglected tropical diseases and vaccine approached it for procuring coronavirus vaccines. development, said that the COVID-19 vaccine rollout is “India’s gift’’ to the world in combating the virus. Dr Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine (BCM) in Houston Houston: during a recent webinar said that the two mRNA vaccines may not impact the world’s low and middle income The rollout of the COVID-19 vaccines by India countries, but India’s vaccines, made in collaboration with in collaboration with leading global institutions has universities across the world such as BCM and the Oxford “rescued the world” from the deadly coronavirus and the University, have “rescued the world” and its contributions contributions by the country must not be underestimated, must not be underestimated. During the webinar, “COVID- a top American scientist has said.

IDMA Bulletin LII (21) 01 to 07 June 2021 36

19: Vaccination and Potential Return to Normalcy - If There has also been a boost in the collaborative and When”, Dr Hotez, an internationally-recognised medical partnerships emerging between the US and India physician-scientist in neglected tropical diseases and during this pandemic. In addition, India is one of the vaccine development, said that the COVID-19 vaccine fourth largest destinations in Asia for medical devices rollout is “India’s gift’’ to the world in combating the virus. manufacturing and many US companies have expressed India’s drugs regulator gave emergency use authorisation interest in collaborating on this front,” Mr Mahajan said. to Covishield, produced by Pune-based Serum Institute of IACCGH Founding Secretary/Executive Director Jagdip India after securing licence from British pharma company Ahluwalia said that “India’s response to the COVID crisis, AstraZeneca, and Covaxin, indigenously developed jointly as acknowledged by Dr Hotez, falls in line with Chamber’s by Hyderabad-based Bharat Biotech and Indian Council of vision. Since its inception, 21 years ago, India would be a Medical Research scientists. The webinar was organised by future global player in key areas like technology, medicine, Indo American Chamber of Commerce of Greater Houston manufacturing and international trade. This belief has been (IACCGH). proved time and again particularly in the last decade.” Chamber President Tarush Anand expressed pride that “This is something very special and I see it myself India has risen to this global challenge by leveraging because I’m on weekly teleconferences with our colleagues the brilliance of its scientific community and extensive in India, you make a recommendation, and within days manufacturing capabilities in the most efficient manner to it’s done and not only done, but it’s done well and with help the world recover from a deadly pandemic. incredible rigor and thought and creativity,” Dr Hotez said, stressing that he felt compelled to make this statement Source : PTI, 08.03.2021 because “India’s huge efforts in combating global pandemic l l l is a story that’s not really getting out in the world.” Dr Hotez, considered as the authority on vaccinations, is working on an affordable coronavirus vaccine in collaboration with Indian pharmaceutical companies. There is increasing evidence that vaccines not only “interrupt symptomatic illness and keep you out of the Contact hospital” but halts asymptomatic transmission as well. However, the troubling news is that the vaccines work well against the UK B.1.1.7 variant, which is now accelerating For Purchase across the US, but doesn’t work quite as well against the variant coming out of South Africa. It is likely that all the vaccines will require a booster for two reasons: the and Sale of durability of protection for the vaccines is unknown and to create an added immune response that’s better tailored towards the South African variant. Pharma Units Consul General of India in Houston, Aseem Mahajan, along with a distinguished panel of doctors participated Korporate in this webinar, that tracked the possibilities of a return to some semblance of normality due to the accelerated roll out of vaccines across the country. Appreciating Dr. Consulting Hotez for commending India’s efforts in getting vaccines to the world, Consul General Mahajan, said, “in keeping with “our tradition of sharing with the world,” India has Enterprise exported vaccines to many countries across the world. India has provided 56 lakh doses of coronavirus vaccines under grants assistance to a number of countries. The vaccines M: 9712829295 were sent to Sri Lanka, Bhutan, Maldives, Bangladesh, Nepal, Myanmar and Seychelles.

IDMA Bulletin LII (21) 01 to 07 June 2021 37

PUBLISHED ON 7th, 14th, 21st and 30th of Every Month ADVERTISEMENT TARIFF (Effective from 01.11.2017) Magazine Size: 21.5 cm x 27.5 cm / Print Area: 18.5 cm x 23.5 cm Position Rate per Insertion ` B/W Colour Full Page (18 cm wd x 23.5 cm ht) : 9,000 12,500 Half Page (18 cm wd x 11.5 cm ht) (Horizontal) 5,000 8,500 Half Page (8.5 cm x 23.5 cm) (Vertical) : 5,000 8,500 Quarter Page (8.5 cm wd x 11.5 cm ht) : 2,500 6,000 Strips Advts (4 cm ht x 18 cm wd) : 2,500 - Inside Cover Pages : - 18,000 Back Cover : 25,000 Centre Spread (double spread) Print area (40cm wd x 27cm ht) : 25,000 30,000

Terms and Conditions: • All payments by Cheque/ Demand Draft/RTGS in advance only to be made in favour of “Indian Drug Manufacturers’ Association”, Payable at Mumbai The RTGS details are as follows:- BANK: BANK OF BARODA Account Name : Indian Drug Manufacturers’ Association, Bank A/c No. : Current A/c 76080200000242 Bank : BANK OF BARODA, Branch Address : Worli Branch, Mumbai-18, IFSC : BARB0VJWORL MICR CODE : 400012339 • GST will be charged extra, as applicable. (Current Rate is @5%) • SPECIAL DISCOUNTS for Series Advertisements • For colour advertisements, positives to be supplied otherwise processing charges to be paid. • Advertisement material must reach us 7 days before the date of publication. • Positioning of the Advt other than Cover Positions will be at our discretion. • Only Colour Advts will be entertained on Cover Positions.

Classified Advertisements  Upto 80 words — `2,000/-  50% extra for Advt Box Number  50% extra for indent/layout spacing, bold captions, etc.  `50/- extra for voucher copy  Series discount not applicable for classifieds

For further details such as series discounts etc, please contact: Melvin Rodrigues — Cell: +9821868758 (Email: [email protected])/ Geeta Suvarna — (Email: [email protected]) PUBLICATIONS DIVISION INDIAN DRUG MANUFACTURERS’ ASSOCIATION 102-B, Poonam Chambers, Dr. A. B. Road, Worli, Mumbai 400 018. Tel: 022-2494 4624/2497 4308 Fax: 022-2495 0723 Website: www.idma-assn.org www.indiandrugsonline.org

IDMA Bulletin LII (21) 01 to 07 June 2021 38

IDMA Bulletin LII (21) 01 to 07 June 2021 39

IDMA Bulletin LII (21) 01 to 07 June 2021 40

LICENSED TO POST WITHOUT PREPAYMENT LICENCE NO. MR/Tech/WPP-337/West/2021-23 RNI REGN. NO. 18921/1970, REGN.NO.MCW/95/2021-23 Published and Posted on 7th, 14th, 21st and 30th of every month This issue posted at Mumbai Patrika Channel Sorting Office on 07.06.2021

Turning helpless into help

Unit Dose System, the single shot nasal drug delivery device from Aptar Pharma

You may recognize our UDS as the delivery device for NARCAN®, the first and only FDA-approved nasal form of Naloxone, used for the treatment of an opioid emergency. What you may not recognize is that there is so much more to this device than just for emergency situations.

UDS was designed to enable the systemic delivery of drugs without the need for injection or administration by a healthcare professional. Primeless, with one-handed actuation and 360˚ functionality, this device is approved with multiple drug products by the FDA and is used by thousands of people every day in a range of scenarios from migraine medication through to breakthrough pain relief in end-of-life situations.

All delivered with the certainty of science and safety you’d expect from Aptar Pharma, one of the world’s leading providers of drug delivery systems.

To find out more about how Aptar Pharma can help you make a positive impact on patients’ lives, call Herve Pacaud, Business Development Director at Aptar Pharma on +33 1 3917 2020 or email [email protected]

Delivering solutions, shaping the future.

IDMA Bulletin LII (21) 01 to 07 June 2021 41