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vol. NO. 51 Issue NO. 48 (Pages: 46) 22 to 30 december 2020 ISSN 0970-6054 weekly publication
We wish All our Members & Readers A Very Healthy, Wealthy, Happy and Prosperous New Year
Indian APIs & Formulations for Global Healthcare
India requires Rs. 80,000 crore for vaccine distribution next year: SII (Page No. 23) IndiaIDMA Submissionsuccessfully on Draft shouldered Guidelines itsfor responsibilitydealing cases as (Page No. 4) pharmacyof discontinuation of world of Scheduled amid COVID:Formulations Vikas Swarup (Page No. 25) ‘Why Phytopharmaceutical Drug Discovery?’ by Dr S S Handa Pharma(Page No. 6) revenue, margins likely to remain healthy inAdvisory: next fiscal: COVID-19 ICRA – Amendments/Relaxations/Compliances (Page No. 27) (Page No. 8) Five trends to watch out for in the Pharma Industry Export restrictions on Hydroxychloroquine lifted (Page No. 19) in 2021 (Page No. 37) IDMA Bulletin DoP LI (48) comes 22 to 30 out December with 2020 draft Guidelines for Rs.6,940 crore PLI scheme1 Pharma Industry has a new drug: Artificial Intelligence to promote domestic production of Bulk Drugs (Page No. 32) (Page No. 39)
IDMA Bulletin LI (48) 22 to 30 December 2020 2
Founder Editor: Vol. No. 51 Issue No. 48 22 to 30 December 2020 Dr A Patani IDMA ACTIVITIES: Editor: Dr Gopakumar G Nair Address by Shri Arun Singhal, CEO, FSSAI at the National Executive Committee Meeting of IDMA held on Friday, 18th December, 2020 (via VC on Zoom) on FSSAI Associate Editors: J L Sipahimalani Activities & Initiatives: A Report...... 4 Dr Nagaraj Rao GST MATTERS: Dr George Patani CBIC amends Central Goods and Services Tax Rules, 2017 National President (Fourteenth Amendment of 2020) - reg...... 6 Mahesh H Doshi CBIC matters: Immediate Past National President CBIC notifies Instructions for time bound processing of Duty Drawback claims - reg.... 11 Deepnath Roy Chowdhury th Senior Vice-President CBIC notifies New Exchange Rates w.e.f. 18 December 2020 - reg...... 11 Dr Viranchi Shah DGFT matters: Vice-Presidents: Amendment in Para 2.14 (Modification of IEC) of Chapter 2 of Bharat N. Shah Handbook of Procedures, 2015-2020...... 12 (Western Region) FSSAI matters: Asheesh Roy (Eastern Region) Mandatory online submission of Annual Return by Food Businesses w.e.f. FY 2020-21 - reg...... 13 B K Gupta (Northern Region) companies law amendments: T Ravichandiran Companies (Auditor’s Report) Order, 2020 amended (Southern Region) (Second Amendment of 2020) - reg...... 14 Hon General Secretary PARLIAMENT NEWS: Dr George Patani In Lok Sabha & In Rajya Sabha...... 14 Hon Joint Secretaries J Jayaseelan New Developments: Atul J Shah Brewprint: using yeast to make plant-based drugs...... 21 Hon Treasurer Coronavirus: How the virus interacts with cells...... 21 Vasudev Kataria national news: For information contact IDMA Secretariat: (H.O.) India requires Rs.80,000 crore for vaccine distribution next year: SII...... 23 Daara B Patel Secretary-General FSSAI forms three expert committees to examine non-food & food ingredients...... 23 T R Gopalakrishnan Cipla to experiment with Covid drug Remdesivir Composition Deputy Secretary-General to reduce effect on kidneys...... 24 Melvin Rodrigues Kerala Government Panel to suggest PPP model to set up Sr Manager (Commercial & Administration) COVID-19 vaccine production units...... 25 C K S Chettiar India successfully shouldered its responsibility as Pharmacy Asst. Manager (Publications & Administration) of the World amid COVID: Vikas Swarup...... 25 Delhi Office: Sync between pharma policies and Patient Safety: Need of the hour...... 26 Ashok Kumar Madan Executive Director Pharma revenue, margins likely to remain healthy in next fiscal: ICRA...... 27 S Ranganathan Health Ministry to hold talks with stakeholders to address huge Asst Manager (Administration) demand-supply gap of CP for COVID-19 treatment...... 27 IDMA STATE BOARDs CHAIRMAN Strict Rules to bring in transparency in derma product landscape...... 28 Gujarat State Board : Milan Patel Haryana set to become hub of medical devices as around Haryana State Board : P K Gupta 100 industrial units set up plants in the state...... 29 Himachal Pradesh & ASHC pitches for Madurai as the ideal location to set up Uttarakhand State Board : R C Juneja proposed All India Institute of Siddha...... 30 Karnataka State Board : S M Mudda Madhya Pradesh State Board : Paresh Chawla Government should come out with policies supportive to Tamil Nadu, Puducherry Pharma MSMEs engaged in formulations: Jagdeep Singh...... 30 & Kerala State Board : J Jayaseelan Health Ministry notifies Cosmetics Rules, 2020 for effective Telangana State Board : Shaik Janimiya regulation and compliance...... 31 West Bengal State Board : Utpal Moitra Patents and drug discovery data lucrative targets for cyber A Publication of attackers: Ramesh Mamgain...... 32 Indian Drug Manufacturers' Association 102-B, 'A-Wing', Poonam Chambers, M D Varadarajan of Kniss Laboratories elected President of TN PMA unopposed...... 33 Dr. A.B. Road, Worli, Mumbai - 400 018 A Right Step to Promote Ayush: Pharmabiz-Editorial...... 34 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 e-mail: mail_ [email protected]/ International news: [email protected]/ Website: www.idma-assn.org US FDA takes key action in fight against COVID-19 by issuing Emergency Use Published on 7th, 14th, 21st and 30th of every month Authorization for first COVID-19 vaccine...... 35 Annual Subscription Feature: ` 1000/- (for IDMA members) ` 2000/- (for Government Research/Educational Institutions) Five trends to watch out for in the Pharma Industry in 2021: Sanjeev Goel...... 37 ` 4000/- (for non-members) US$ 400 (Overseas) Slowing sales a concern for Indian Pharma Companies: Clifford Alvares...... 38 Please send your payment in favour of Indian Drug Manufacturers' Association Pharma Industry has a new drug: Artificial Intelligence: Priya Dialani...... 39 IDMAOpinions Bulletin Expressed LIXLIV By (48)The Au(38) 22tho rs08to Of 30to Individu 14December Octoberal Articl e2020 s2013 IDMA Holidays for the Year 2021...... 223 Do Not Necessarily Represent The Official View Of Idma. Invitation to participate in ‘IDMA Margi Memorial Best Patent Awards 2019-20’...... 42 IDMA Bulletin Advt tariff card...... 43 Advertisements...... 2, 40, 44, 45 & 46
IDMA ACTIVITIES Address by Shri Arun Singhal, CEO, FSSAI at the National Executive Committee Meeting of IDMA held on Friday, 18th December, 2020 (via VC on Zoom) on FSSAI Activities & Initiatives: A Report
Mr Daara B Patel Mr Mahesh H Doshi Dr R K Sanghavi Mr George Patani
Mr Arun Singhal
Mr Arun Singhal, CEO of FSSAI, graciously consented in releasing a number of regulations for ensuring safer to address the members on accepting the invite consumption of articles of food, including supplements by IDMA. His talk was with special relevance for and nutraceuticals. He stated that over 700 standardized the Food Business Operators (FBOs) in matters ingredients have been listed under the various schedules pertaining the nutraceutical vertical of healthcare. specified under the regulations for nutraceuticals. The Mr Mahesh H Doshi, National President extended a same being an ongoing process and in 2020 near warm welcome and Mr Daara Patel, Secretary General, 50 standardized ingredients more are being added under IDMA elaborated on Mr Singhal’s achievements the various respective schedules. and experiences. Following the initial pleasantries, Mr Singhal mentioned that India’s Nutraceutical Market In another first, FSSAI has collaborated with AYUSH of Rs.30-35k crores at present is expected to double to to moot a new entity that will be known as AYURAHAR Rs.60-65k crores in the next 10 years. for approval of home-made recipe of traditional healthy Indian food items. Also the FSSAI has jointly with CDSCO Mr Arun Singhal emphasized the role being played resolved the stalemate pertaining to the jurisdiction under by Food Safety Standards Authority of India (FSSAI) which the mere vitamins and minerals supplements
IDMA Bulletin LI (48) 22 to 30 December 2020 4
fall under. Anything product with quantities of vitamins/ Dr Sanghavi requested that FSSAI consider minerals up to specified RDA amounts is to be considered separate listing, in addition to footnote modification, of Health Supplement and under FSSAI; all others having various vitamin derivatives, etc like methylcobalamin, exceeding RDA quantities will be drugs and need to be L-methylfolate, benfotiamine and others under the certified by the DCG(I). Table-B of Nutraceutical Schedule-VI. Since there is already a precedence of mentioning some other Indians averagely spend Rs.15-20 per month on vitamins under this list additionally, Mr Arun Singhal also nutraceuticals whilst in US it is 500 times the amount. requested that the suitable list of vitamins required to be Hence, the FSSAI is on a mission to facilitate the mentioned separate as per above also be forwarded to proliferation of the nutraceutical vertical of healthcare. The the FSSAI. availability of ample of variants of immunity boosters and modulators to counter the COVID-19 crises exemplifies • CONSIDERATION OF REPLACING RDA WITH stimulus for nutraceuticals. TUL UNDER THE FSS ACT (FSSA) FOR ALL PRODUCTS UNDER THE FSS Regulations 2016 Dr Arun Singhal was extremely forthcoming by for Health Supplements, Nutraceuticals, Food for inviting questions to clarify any issue/s from IDMA’s Special Dietary Use, Food for Special Medical Nutraceutical Committee. Dr R K Sanghavi, Chairman of Purpose, Functional Food and Novel Food. the Nutraceutical Committee requested clarifications on Dr R K Sanghavi drew attention of the CEO that the certain pressing concerns of the FBOs: FSSAI in its 2020 amendment has accepted to adopt TUL (Tolerable Upper Limits) as criteria for capping quantities Footnote below Table-B of Schedule-I: of vitamins and minerals that are incorporated in the FSDU The Food Safety and Standards (Health Supplements, (Food for Special Dietary Use) products. He suggested that Nutraceuticals, Food for Special Dietary Use, Food for the same should be generalized and also be applicable Special Medical Purpose, Functional Foods and Novel for Health Supplement, Nutraceuticals and FSMP (Food Foods) Amendment Regulations, 2020 (Draft Guidelines) for Special Medical Purpose) categories as well. on 29th October 2020. Following with deliberations held, FSSAI has agreed to modify the footnote stating as Mr Arun Singhal opined that TUL implying ‘toxic’ (instead of above): quantities the amounts of vitamins and minerals are allowable only as 50% of TUL and that also for FSDU. Also “Suitable esters, derivatives and salts of vitamins and since we consume in usual food items various nutrients, salts and chelates of minerals may be used.” the added load could have potential adverse outcome the Scientific Panel has accordingly taken the decision However, Dr R K Sanghavi suggested that FSSAI to as such. When Dr Sanghavi clarified that TUL implies consider modifying the footnote as: Tolerable and not Toxic upper limits Mr Singhal requested that a suitable representation in detail be made to FSSAI “Suitable esters, derivatives, active moieties, for the consideration of its Scientific Panel. pro-vitamins and salts of vitamins and salts and chelates of minerals may be used.” Dr R K Sanghavi asked the members of IDMA for any other clarifications and in absence of any more queries When Dr Sanghavi stressed upon the need for having thanked Mr Arun Singhal for his suitably addressing the additional words such as ‘active moieties’ or else an various issues that were put forth. important vitamin such as benfotiamine may not be able to have a place in the composition of products, Mr Singhal Mr George Patani, General Secretary, IDMA proposed suggested that a separate suitable representation be a vote of thanks and assured Mr Arun Singhal that IDMA forwarded to FSSAI for its immediate consideration. intends to work in close cooperation with the FSSAI to resolve all clarifications and provide the needed Inclusion of Vitamin Derivatives and other and deserving thrust to the nutraceutical vertical of Pro-Vitamins Additionally under the Table-B of Schedule- healthcare. VI:
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IDMA Bulletin LI (48) 22 to 30 December 2020 5
GST MATTERS CBIC amends Central Goods and Services Tax Rules, 2017 (Fourteenth Amendment of 2020) - reg.
Gst-Central Tax Notification No.94/2020, dated 22nd December, 2020 (Central Tax)
In exercise of the powers conferred by section 164 one of the Facilitation Centres notified by the of the Central Goods and Services Tax Act, 2017 (12 of Commissioner for the purpose of this sub-rule 2017), the Central Government, on the recommendations and the application shall be deemed to be of the Council, hereby makes the following rules further complete only after completion of the process to amend the Central Goods and Services Tax Rules, laid down under this sub-rule.". 2017, namely:- 3. In the said rules, in rule 9,- 1. Short title and commencement; (a) in sub-rule (1),- (1) These rules may be called the Central Goods (i) after the words "applicant within a period and Services Tax (Fourteenth Amendment) of", for the word "three", the word "seven" Rules, 2020. shall be substituted; (2) Save as otherwise provided in these rules, (ii) for the proviso, the following proviso shall they shall come into force on the date of their be substituted, namely:- publication in the Official Gazette. "Provided that where- 2. In the Central Goods and Services Tax Rules, 2017 (a) a person, other than a person notified (hereinafter referred to as the said rules), in rule under sub-section (6D) of section 8, for sub-rule (4A), with effect from a date to be notified, the following sub-rule shall be substituted, 25, fails to undergo authentication namely:- of Aadhaar number as specified in sub-rule (4A) of rule 8 or does not opt "(4A) Every application made under rule (4) shall be for authentication of Aadhaar number; followed by— or (a) biometric-based Aadhaar authentication and taking photograph, unless exempted under (b) the proper officer, with the approval sub-section (6D) of section 25, if he has of an officer authorised by the opted for authentication of Aadhaar number; Commissioner not below the rank of or Assistant Commissioner, deems it fit to (b) taking biometric information, photograph and carry out physical verification of places verification of such other KYC documents, of business, as notified, unless the applicant is exempted the registration shall be granted within under sub-section (6D) of section 25, if he thirty days of submission of application, has opted not to get Aadhaar authentication after physical verification of the place of done, business in the presence of the said person, of the applicant where the applicant is an in the manner provided under rule 25 and individual or of such individuals in relation to verification of such documents as the proper the applicant as notified under sub-section officer may deem fit."; (6C) of section 25 where the applicant is not an individual, along with the verification of (b) in sub-rule (2),- the original copy of the documents uploaded (i) for the word "three", the word "seven" shall with the application in FORM GST REG-01 at be substituted;
IDMA Bulletin LI (48) 22 to 30 December 2020 6
(ii) for the proviso, the following proviso shall "(e) avails input tax credit in violation of the be substituted, namely:- provisions of section 16 of the Act or the "Provided that where- rules made thereunder; or (a) a person, other than a person notified (f) furnishes the details of outward supplies in under sub-section (6D) of section FORM GSTR-1 under section 37 for one 25, fails to undergo authentication or more tax periods which is in excess of of Aadhaar number as specified in the outward supplies declared by him in his sub-rule (4A) of rule 8 or does not opt valid return under section 39 for the said tax for authentication of Aadhaar number; periods; or or (g) violates the provision of rule 86B.". (b) the proper officer, with the approval 5. In the said rules, in rule 21A,- of an officer authorised by the (a) in sub-rule (2), the words ", after affording the Commissioner not below the rank of said person a reasonable opportunity of being Assistant Commissioner, deems it fit to heard," shall be omitted; carry out physical verification of places of business, the notice in FORM GST (b) after sub-rule (2), the following sub-rule shall be REG-03 may be issued not later than inserted, namely:- thirty days from the date of submission "(2A) Where, a comparison of the returns of the application."; furnished by a registered person under section (c) for sub-rule (5), the following sub-rule 39 with shall be substituted, namely:- (a) the details of outward supplies furnished in "(5) If the proper officer fails to take FORM GSTR-1; or any action,- (b) the details of inward supplies derived (a) within a period of seven working based on the details of outward supplies days from the date of submission furnished by his suppliers in their FORM of the application in cases where GSTR-1, the person is not covered under or such other analysis, as may be carried out on proviso to sub-rule (1); or the recommendations of the Council, show that (b) within a period of thirty days there are significant differences or anomalies from the date of submission of indicating contravention of the provisions of the the application in cases where a Act or the rules made thereunder, leading to person is covered under proviso cancellation of registration of the said person, to sub-rule (1); or his registration shall be suspended and the said person shall be intimated in FORM GST REG- (c) within a period of seven working 31, electronically, on the common portal, or by days from the date of the receipt sending a communication to his e-mail address of the clarification, information provided at the time of registration or as amended or documents furnished by the from time to time, highlighting the said differences applicant under sub-rule (2), the and anomalies and asking him to explain, within application for grant of registration a period of thirty days, as to why his registration shall be deemed to have been shall not be cancelled."; approved.". (c) in sub-rule (3), after the words, brackets and 4. In the said rules, in rule 21,- figure "or sub-rule (2)", the words, brackets, (a) in clause (b), after the words "goods or services", figure and letter "or sub-rule (2A)" shall be the words "or both" shall be inserted; inserted; (b) after clause (d), the following clauses shall be (d) after sub-rule (3), the following sub-rule shall inserted, namely:- be inserted, namely:-
IDMA Bulletin LI (48) 22 to 30 December 2020 7
"(3A) A registered person, whose registration or services or both under section 37 in FORM has been suspended under sub-rule (2) or GSTR-1, if he has not furnished the return in sub-rule (2A), shall not be granted any FORM GSTR-3B for preceding two months; refund under section 54, during the period (b) a registered person, required to furnish return for of suspension of his registration."; every quarter under the proviso to sub-section (1) (e) in sub-rule (4),- of section 39, shall not be allowed to furnish the (i) after the words, brackets and figure details of outward supplies of goods or services "or sub-rule (2)", the words, brackets, or both under section 37 in FORM GSTR-1 or figure and letter "or sub-rule (2A)" shall using the invoice furnishing facility, if he has be inserted; not furnished the return in FORM GSTR-3B for preceding tax period; (ii) the following proviso shall be inserted, namely:- (c) a registered person, who is restricted from using the amount available in electronic credit ledger "Provided that the suspension of to discharge his liability towards tax in excess of registration under this rule may be ninety-nine percent of such tax liability under rule revoked by the proper officer, anytime 86B, shall not be allowed to furnish the details during the pendency of the proceedings of outward supplies of goods or services or both for cancellation, if he deems fit." under section 37 in FORM GSTR-1 or using the 6. In the said rules, in rule 22,- invoice furnishing facility, if he has not furnished the return in for preceding tax (a) in sub-rule (3), after the words, brackets and FORM GSTR-3B period.". figure "the show cause issued under sub-rule (1)", the words, brackets, figures and letters "or under 9. In the said rules, after rule 86A, with effect from the sub-rule (2A) of rule 21A" shall be inserted; 1st day of January, 2021, the following rule shall be inserted, namely:- (b) in sub-rule (4), after the words, brackets and figure "reply furnished under sub-rule (2)", "86B. Restrictions on use of amount available the words, brackets, figures and letters "or in in electronic credit ledger: response to the notice issued under sub-rule (2A) Notwithstanding anything contained in these rules, of rule 21A" shall be inserted. the registered person shall not use the amount 7. In the said rules, in rule 36, in sub-rule (4), with effect available in electronic credit ledger to discharge his from the 1st day of January, 2021,- liability towards output tax in excess of ninety-nine percent of such tax liability, in cases where the value (a) for the word "uploaded", at both the places of taxable supply other than exempt supply and zero- where it occurs, the word "furnished" shall be rated supply, in a month exceeds fifty lakh rupees: substituted; Provided that the said restriction shall not apply (b) after the words, brackets and figures "by the suppliers under sub-section (1) of section 37", where– at both the places where they occur, the words, (a) the said person or the proprietor or karta or the letters and figure "in FORM GSTR-1 or using the Managing Director or any of its two partners, invoice furnishing facility" shall be inserted; whole-time Directors, Members of Managing (c) for the figures and words "10 per cent.", the figure Committee of Associations or Board of Trustees, and words "5 per cent." shall be substituted. as the case may be, have paid more than one lakh rupees as income tax under the Income-tax 8. In the said rules, in rule 59, after sub-rule (4), the Act, 1961(43 of 1961) in each of the last two following sub-rule shall be inserted, namely:- financial years for which the time limit to file return "(5) Notwithstanding anything contained in this of income under subsection (1) of section 139 of rule,- the said Act has expired; or (a) a registered person shall not be allowed to (b) the registered person has received a refund furnish the details of outward supplies of goods amount of more than one lakh rupees in the
IDMA Bulletin LI (48) 22 to 30 December 2020 8
preceding financial year on account of unutilised restriction after such verifications and such safeguards input tax credit under clause (i) of first proviso of as he may deem fit.". sub-section (3) of section 54; or 10. In the said rules, in rule 138, in sub-rule (10), with (c) the registered person has received a refund effect from the 1st day of January, 2021,- amount of more than one lakh rupees in the (i) in the Table, against serial number 1, in column preceding financial year on account of unutilised 2, for the figures and letters "100 km.", the figures input tax credit under clause (ii) of first proviso of and letters "200 km." shall be substituted; sub-section (3) of section 54; or (ii) in the Table, against serial number 2, in column 2, (d) the registered person has discharged his liability for the figures and letters "100km.", the figures towards output tax through the electronic cash and letters "200 km." shall be substituted. ledger for an amount which is in excess of 1% of the total output tax liability, applied cumulatively, 11. In the said rules, in rule 138E,- upto the said month in the current financial year; (a) in clause (b), for the words "two months", the or words "two tax periods" shall be substituted; (e) the registered person is– (b) after clause (c), the following clause shall be (i) Government Department; or inserted, namely:- (ii) a Public Sector Undertaking; or "(d) being a person, whose registration has been suspended under the provisions of sub-rule (iii) a local authority;or (1) or sub-rule (2) or sub-rule (2A) of rule (iv) a statutory body: 21A.". Provided further that the Commissioner or an officer 12. In the said rules, after FORM GST REG-30, the authorised by him in this behalf may remove the said following FORM shall be inserted, namely-
"FORM GST REG–31 [See rule 21A]
Reference No. Date:
In a comparison of the following, namely,
(i) returns furnished by you under section 39 of the Central Goods and Services Tax Act, 2017; (ii) outwards supplies details furnished by you in FORM GSTR-1; (iii) auto-generated details of your inwards supplies for the period to ; (iv) (specify) and other available information, the following discrepancies/anomalies have been revealed:
□ Observation 1 □ Observation 2 □ Observation 3 (details to be filled based on the criteria relevant for the taxpayer).
IDMA Bulletin LI (48) 22 to 30 December 2020 9
2. These discrepancies/anomalies prima facie indicate contravention of the provisions of the Central Goods and Services Tax Act, 2017 and the rules made thereunder, such that if not explained satisfactorily, shall make your registration liable to be cancelled. 3. Considering that the above discrepancies/anomalies are grave and pose a serious threat to interest of revenue, as an immediate measure, your registration stands suspended, with effect from the date of this communication, in terms of sub-rule (2A) of rule 21 A. 4. You are requested to submit a reply to the jurisdictional tax officer within seven working days from the receipt of this notice, providing explanation to the above stated discrepancy/anomaly. Any possible misuse of your credentials on GST common portal, by any person, in any manner, may also be specifically brought to the notice of jurisdictional officer. 5. The suspension of registration shall be lifted on satisfaction of the jurisdictional officer with the reply along with documents furnished by you, and any further verification as jurisdictional officer considers necessary. 6. You may please note that your registration may be cancelled in case you fail to furnish a reply within the prescribed period or do not furnish a satisfactory reply.
Name: Designation:
NB : This is a system generated notice and does not require signature by the issuing authority.".
F.No.CBEC-20/06/04/2020-GST
Pramod Kumar, Director, Central Board of Indirect Taxes and Customs, Department of Revenue, Ministry of Finance, New Delhi.
Note: The Principal Rules were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide notification No.3/2017-Central Tax, dated the 19th June, 2017, published vide number G.S.R.610(E), dated the 19th June, 2017 and last amended vide notification No.82/2020-Central Tax, dated the 10th November, 2020, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R.698(E), dated the 10th November, 2020.
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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 SPECIFICATION phaRMACEUTICAL PReFORMULATION (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 LI (48) 22 to 30 December 2020 10
CBIC matters CBIC notifies Instructions for time bound processing of Duty Drawback claims - reg.
Instructions No. 21/2020-Customs, dated 16th December, 2020
To, to mention that as per the Circular dated 24.04.2018 All Principal Chief Commissioners/Chief Commissioners issued by the Office of the Principal CCA, CBIC, it of Customs/Customs (Preventive)/ Customs and Central Taxes & has already been instructed to the authorized banks All Principal Directors General/ Directors General under CBIC. that the credit/refund of the drawback amount to the 1. The undersigned is directed to state that to reduce exporters' account may be done either on the same the pendency and improve the rate of disposal of duty day of receiving the Computerized Customs Drawback drawback claims, various timelines relating to duty Advice along with the supporting cheque or on the drawback scheme have been conveyed in the Action next working day. Plan of CBIC for 2020-21 through DGPM's d.o. letter F. No. 503/01/2020-T dated 04.08.2020. 5. In supersession of the timeline referred in para 2 above relating to disposal of drawback claims within 2. Among the action points, it has been mentioned 7 working days, it is instructed that the above-cited therein that all remaining drawback claims should be time-limit given by NCTF for crediting of duty drawback positively disposed of by 31.03.2021 and that while within a period of 3 days should be strictly complied doing so the target of disposing drawback within with. All Zones are requested to take necessary action 7 working days should be achieved. accordingly. A report on action taken in this regard 3. It is to inform that in the 5th meeting of the National may be sent to the Board by 25.12.2020. Committee on Trade Facilitation (NCTF), it has been F. No. 609/41/2018-DBK instructed that at least 90% of Drawback should be credited within a time period of 3 days. Further, Hasan Ahmed, OSD (Drawback), the refund may be deposited into the customer Central Board of Indirect Taxes and Customs, account in T+2 days. Drawback Division, Department of Revenue, 4. As regard the time taken for payment of duty Ministry of Finance, New Delhi. drawback by banks to the exporters accounts, it is
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CBIC notifies New Exchange Rates w.e.f. 18th December 2020 - reg.
Notification No.113/2020-Customs (N.T.), dated 17th December, 2020
In exercise of the powers conferred by section 14 of each of the foreign currencies specified in column (2) of the Customs Act, 1962 (52 of 1962), and in supersession each of Schedule I and Schedule II annexed hereto, of the Notification No.110/2020-Customs(N.T.), dated into Indian currency or vice versa, shall, with effect from 3rd December, 2020 except as respects things done 18th December, 2020, be the rate mentioned against or omitted to be done before such supersession, the it in the corresponding entry in column (3) thereof, for Central Board of Indirect Taxes and Customs hereby the purpose of the said section, relating to imported and determines that the rate of exchange of conversion of export goods.
IDMA Bulletin LI (48) 22 to 30 December 2020 11
SCHEDULE-I Saudi Arabian 13. 20.25 19.00 Riyal Rate of exchange of one Sr. Foreign unit of foreign currency 14. Singapore Dollar 56.40 54.50 No. Currency equivalent to Indian Rupees South African 15. 5.15 4.80 (1) (2) (3) Rand (a) (b) 16. Swedish Kroner 9.00 8.65 (For Imported (For Exported 17. Swiss Franc 84.90 81.45 Goods) Goods) 18. Turkish Lira 9.75 9.15 1. Australian Dollar 57.05 54.70 19. UAE Dirham 20.70 19.40 2. Bahraini Dinar 201.70 188.95 20. US Dollar 74.45 72.75 3. Canadian Dollar 58.90 56.80 SCHEDULE-II 4. Chinese Yuan 11.45 11.10 Rate of exchange of 100 5. Danish Kroner 12.30 11.85 Sr. Foreign units of foreign currency No. Currency 6. EURO 91.50 88.25 equivalent to Indian Rupees 7. Hong Kong Dollar 9.65 9.30 1. Japanese Yen 72.55 69.85 8. Kuwaiti Dinar 249.60 233.70 2. Korean Won 6.95 6.55 9. New Zealand Dollar 53.85 51.50 F.No. 468/01/2020-Cus.V 10. Norwegian Kroner 8.65 8.35 Bullo Mamu, Under Secretary, Central Board of Indirect Taxes 11. Pound Sterling 101.25 97.85 and Customs, Department of Revenue, Ministry of Finance, 12. Qatari Riyal 20.85 19.60 New Delhi.
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DGFT matters Amendment in Para 2.14 (Modification of IEC) of Chapter 2 of Handbook of Procedures, 2015-2020.
DGFT Public Notice No.34/2015-2020, dated 24th December, 2020
1. In exercise of powers conferred under paragraph 1.03 to the jurisdictional RA of the new entity along and 2.04 of the Foreign Trade Policy, 2015-2020, with supporting documents. Concerned RA may the Director General of Foreign Trade hereby inserts sanction the given linkage after due scrutiny of the following new sub-paras after sub para (c) of the the evidence provided by the applicant including existing Para 2.14 (Modification of IEC) as laid down in submission of affidavits etc. After RA's approval, Chapter 2 of Handbook of Procedures, 2015-2020: previous IEC(s) shall be treated as surrendered.
(d) In case of change in constitution of a PAN based 2. effect of this Public Notice: IEC by way of merger, acquisition, liquidation, Provisions for modifying PAN based IEC has been inheritance etc such that PAN of the new entity introduced vide para 2.14 (d) and 2.14 (e) under so formed is different from the earlier one, an existing Para 2.14 of Chapter-2 of Handbook of IEC can be availed against the new PAN, if not Procedures, 2015-2020. existing already. Previous IEC(s) can also be operationally linked to the PAN/IEC of the new File No. 01/93/180/20/AM-3/PC-2(B)/E-5200 entity. Amit Yadav, Director General of Foreign Trade & Ex-officio (e) An application for linking the obligations under Secretary, Department of Commerce, Ministry of Commerce & the old/previous IEC may be submitted online Industry, New Delhi. l l l
IDMA Bulletin LI (48) 22 to 30 December 2020 12
FSSAI matters Mandatory online submission of Annual Return by Food Businesses w.e.f. FY 2020-21 - reg.
F.No.15(31)2020/FOSCOS/RCD/FSSAI, dated 18th December 2020
To doing business and help in creation of national level 1. Commissioner of Food Safety of all States/UTs and all Central database. It would further lead to other benefits Licensing Authorities, such as: 2. CITO, FSSAI - for uploading on FSSAI. • The food business need not maintain receipts and 1. Clause 2.1.13 (1) of Food Safety and Standards (Licensing and Registration of Food Businesses) records of physical nature. Regulations, 2011 mandates: • FBOs shall be saved from inadvertent penalties [laid down under clause 2.1.13 of existing FSS "Every manufacturer and importer who has been (Licensing and Registration of Food Businesses) issued a license shall on or before 31st May of each Regulations, 2011. year, submit a return electronically or in physical form as may be prescribed by the concerned Food Safety • Reminders for submission of annual returns would Commissioner, in 'Form D-1' provided in Schedule be sent digitally. 2 of these Regulations to the Licensing Authority in • Country/State-wise analysis of data would be possible. respect of each class of food products handled by • Updated data would be available, as till now all him during the previous financial year. analysis is based on the data provided by the food Provided however that every licensee engaged in businesses at the time of obtaining of license. manufacturing of milk and/or milk products shall • For food businesses involved in manufacturing file half yearly returns for the periods 1st April to of milk and milk products, the half-yearly return 30th September and 1st October to 31st March of (Form D2) shall be discontinued. They shall be every financial year in the form D-2, as provided in required to file the annual return for manufacturers Schedule-2 of these regulations. Such returns will as per the revised format online. be filed within a month from the end of the period." • The new returns are compliance specific and 2. In the absence of any online provision for Food based on the conditions of license and clauses Business Operators to file returns online, presently, as laid down in the existing Food Safety and the returns (whether annual or half-yearly) are being Standards Regulations. This would help in targeted submitted physically to the authorities. In the CoVID enforcement activities with limited staff. pandemic phase, the same has been facilitated by 4. In view of the above, it is decided that online submission allowing the submission by email and the last date has of Annual Returns on Food Safety Compliance st been extended till 31 December 2020 vide FSSAI System (FoSCoS - https://foscos.fssai.gov.in) shall order number 15(6)2020/FLRS/RCD/FSSAI dated be made mandatory for food businesses involved 31st July 2020. However, FBOs are required to maintain in manufacturing and importing of food products, the record of submission of returns. An inadvertent wef FY 2020-21 (window for return filing for FY lapse of non-submission or loss of submission proof 2020-21 will open wef 1st April 2021 onwards). All renders FBOs liable for hefty penalties. licensing authorities are directed to refrain from insisting physical submission of returns and ensure that FBOs 3. The revised format of Annual Return has already been incorporated in Food Safety Compliance are well informed and facilitated to file the returns online System (FOSCOS) and utility for online submission on FOSCOS. of Annual Return is being used by food business 5. This issues with the approval of the Competent voluntarily. The provision of mandatory online Authority. submission of returns would not only facilitate the Dr Shobhit Jain, Executive Director, Compliance Strategy, Food food business operators but also ensure ease of Safety and Standards Authority of India, New Delhi. l l l IDMA Bulletin LI (48) 22 to 30 December 2020 13
companies law amendments Companies (Auditor’s Report) Order, 2020 amended (Second Amendment of 2020) - reg.
Corporate Affairs Notification No.S.O.4588(E), dated 17th December, 2020. (Published in the Gazette of India on 18th December, 2020)
In exercise of the powers conferred by sub-section (11) 2. In the Companies (Auditor’s Report) Order, 2020, of section 143 of the Companies Act, 2013 (18 of 2013), in paragraph 2, for the figures, letters and word the Central Government hereby makes the following Order “1st April, 2020”, the figures, letters and word further to amend the Companies (Auditor’s Report) Order, “1st April, 2021” shall be substituted. 2020, namely:- F.No.17/45/2015-CL-V.Part-I 1. Short title, application and commencement; K V R Murty, Joint Secretary, Ministry of Corporate Affairs, New Delhi. (1) This Order may be called the Companies (Auditor’s Report) Second Amendment Order, Note: The principal order was published in the Gazette of 2020. India, Extraordinary, Part II, section 3, sub-section (ii), vide number S.O.849(E), dated the 25th February, 2020 and was (2) It shall come into force on the date of its subsequently amended vide number S.O.1219(E), dated the publication in the Official Gazette. 24th March, 2020.
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PARLIAMENT NEWS In Lok Sabha & In Rajya Sabha
In Lok Sabha (c): the steps taken by the Government to prevent such kind of unethical practices followed by the pharma Ban on Freebies to Doctors by companies hitherto; and Pharmaceutical Companies (d): whether the Government is having any proposal to Lok Sabha Unstarred Question No: 2134 bring out specific comprehensive law in this regard, if so, the details thereof? Shri P Velusamy: Answered on 23rd September 2020 Q. Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:- A. (a): The Department of Pharmaceuticals has informed that the Government had prepared (a): whether the Government has banned doling out free- and announced in year 2014 a Uniform Code for bies, cruise tickets, paid vacations and sponsorships Pharmaceutical Marketing Practices (UCPMP) for educational conferences and seminars to doctors by for stopping unethical practices employed by pharmaceutical companies from January 1, 2014, if Pharma Companies for promoting sales of their so, the details thereof; medical products, on 12th December, 2014. It was sent to all the pharma associations for voluntary (b): whether the Government is aware that Mumbai implementation with effect from 01.01.2015. branch of the Income Tax Appellate Tribunal has Further, as per clause 6.8.1 of the Indian Medical disallowed an allowance of Rs.76.55 lakhs paid Council (Professional Conduct, Etiquette and Ethics) by a leading pharma company, if so, the details Regulations, 2002, a Registered Medical Practitioner thereof;
IDMA Bulletin LI (48) 22 to 30 December 2020 14
is not allowed to receive gifts, travel facilities, Pharma Companies for promoting sales of their hospitality and cash/monetary grants. medical products, on 12th December, 2014. It was (b): No. sent to all the Pharma associations for voluntary implementation with effect from 01.01.2015. (c): The Department of Pharmaceuticals has Further, as per clause 6.8.1 of the Indian Medical informed that the Uniform Code for Pharmaceutical Council (Professional Conduct, Etiquette and Ethics) Marketing Practices (UCPMP) is voluntary in Regulations, 2002, a Registered Medical Practitioner nature and under UCPMP, there is no provision for is not allowed to receive gifts, travel facilities, Department of Pharmaceuticals to directly deal with hospitality and cash/monetary grants. complaints received regarding unethical practices. As per UCPMP, any complaint received against (b): No. a pharmaceutical company is dealt by an Ethical (c): The Department of Pharmaceuticals has Committee for Pharma Marketing Practices (ECPMP) informed that the Uniform Code for Pharmaceutical constituted in the pharmaceutical associations. Marketing Practices (UCPMP) is voluntary in (d): No. nature and under UCPMP, there is no provision for Department of Pharmaceuticals to directly deal with The Minister of State in the Ministry of Health and complaints received regarding unethical practices. Family Welfare (Shri Ashwini Kumar Choubey) As per UCPMP, any complaint received against a pharmaceutical company is dealt by an Ethical Ban on Freebies to Doctors by Committee for Pharma Marketing Practices (ECPMP) Pharmaceutical Companies constituted in the pharmaceutical associations. (d): No. Lok Sabha Unstarred Question No: 2134 The Minister of State in the Ministry of Health and Shri P Velusamy: Family Welfare (Shri Ashwini Kumar Choubey) Q. Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state; Guidelines to manage Bio-Medical (a): whether the Government has banned doling out waste freebies, cruise tickets, paid vacations and sponsor- Unstarred Question No: 2139 ships for educational conferences and seminars to doctors by pharmaceutical companies from January Shri Sanjay Kumar Bandi: 1, 2014, if so, the details thereof; Q. Will the Minister of HEALTH AND FAMILY WELFARE (b): whether the Government is aware that Mumbai be pleased to state; branch of the Income Tax Appellate Tribunal has disallowed an allowance of Rs.76.55 lakhs paid by a (a): whether the Government has issued any guidelines leading Pharma company, if so, the details thereof; to manage biomedical waste generated in the hospitals due to treatment of patients affected by (c): the steps taken by the Government to prevent such COVID-19, if so, the details thereof; kind of unethical practices followed by the pharma companies hitherto; and (b): whether the Government of Telangana is following (d): whether the Government is having any proposal to the protocol mandated for disposal of biomedical bring out specific comprehensive law in this regard, waste generated in COVID-19 hospitals in the State, if so, the details thereof? if so, the details thereof; and Answered on 23rd September 2020 (c): whether Government/Indian Medical Association have received any complaints from doctors in the (a): The Department of Pharmaceuticals has A. COVID-19 hospitals of Telangana State in this informed that the Government had prepared regard, if so, the details thereof and the action taken and announced in year 2014 a Uniform Code for thereon? Pharmaceutical Marketing Practices (UCPMP) for stopping unethical practices employed by Answered on 23rd September 2020
IDMA Bulletin LI (48) 22 to 30 December 2020 15
A. (a): As informed by Central Pollution Control Board Vaccines being Developed to Combat (CPCB), Corona Virus Disease of 2019 (COVID-19) related bio-medical waste can be disposed safely Coronavirus with existing infrastructure complying with provisions Lok Sabha Unstarred Question No: 2142 under Bio-Medical Waste Management Rules, 2016. However, realizing Pandemic situation, CPCB has Smt Preneet Kaur: prepared the guidelines for ‘Handling, Treatment Shri Manish Tewari : & Disposal of bio-medical waste generated during Treatment/Diagnosis/Quarantine of COVID-19 Q. Will the Minister of HEALTH AND FAMILY WELFARE patients’. These guidelines were initially issued on be pleased to state; 19.03.2019, thereafter revised depending on ground (a): the number of vaccines being developed in the situation and evolving technical guidance. Last country to combat Corona virus, along with the revision of guidelines was issued on 17.07.2020. progress of trials, stage-wise; Further, CPCB has also issued guidelines on (b): the vaccines that have graduated to the stage of 15.09.2020, for monitoring of Common Bio-medical clinical/human trials; Waste Treatment and Disposal Facilities (CBWTFs) to ensure safe handling and disposal of bio-medical (c): the details of the places where such trials are taking waste. place and the success rate of these trials conducted on human beings so far; and (b): CPCB developed waste tracking App named “COVID19BWM”. Both Android Mobile and Web (d): whether a triage or vaccination schedule to versions of software application were designed inoculate the 130 crore people of India has been for waste generators, Common Biomedical Waste conceptualized by the Government, if so, the details Treatment and Disposal Facility (CBWTF) Operators, thereof and action taken thereon? State Pollution Control Boards (SPCBs) / Pollution rd Control Committees (PCCs) and Urban Local Bodies Answered on 23 September 2020 (ULBs). 1st version of the App has been introduced A. (a) to (c): Central Drugs Standard Control Organisation and a demonstration was given to SPCBs/PCCs and (CDSCO) has informed that it has granted test other stakeholders in May, 2020. SPCBs including license permission for manufacture of COVID-19 Telangana State Pollution Control Board were Vaccine for preclinical test, examination and analysis directed to ensure usage of Tracking App: to the following manufacturers in India: • 8 out of 11 CBWTFs located in Telangana State 1. M/s Serum Institute of India Pvt., Ltd., Pune. are using the aforesaid Tracking App. CPCB vide 2. Ms Cadila Healthcare Ltd., Ahmadabad. it’s letter dated 21.07.2020 issued Show Cause Notice to remaining 3 CBWTFs for not using 3. M/s Bharat Biotech International Ltd., Tracking App. Hyderabad. 4. Biological E Ltd., Hyderabad. • Directions under section 5 of Environment (Protection) Act, were also issued to Telangana 5. M/s Reliance Life Sciences Pvt Ltd., Mumbai. SPCB vide letter dated 11.08.2020, to ensure 6. M/s Aurbindo Pharma Limited, Hyderabad. compliance to CPCB guidelines for effective management of bio-medical waste. 7. M/s Gennova Biopharmaceuticals Limited, Pune. • 160 COVID-19 waste generators are registered on Tracking Application. The Indian Council of Medical Research (ICMR), an autonomous organisation under the Department of (c) As informed by CPCB and Indian Medical Health Research, has informed that it is facilitating the Association (IMA), no such complaints from doctors following studies related to COVID-19 vaccines: in the COVID-19 hospitals of Telangana State have been received. (i): An inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 has been developed The Minister of State in the Ministry of Health and by Bharat Biotech International Ltd (BBIL) using Family Welfare (Shri Ashwini Kumar Choubey) the virus isolate (NIV-2020-770) provided by
IDMA Bulletin LI (48) 22 to 30 December 2020 16
ICMR-National Institute of Virology (NIV), Pune. As per details provided by Department Characterization of the vaccine candidate has of Biotechnology (DBT)/Department of been undertaken at ICMR-NIV followed by Science and Technology (DST), more safety and tolerability studies in small animals than 30 vaccine candidates have been like rats, mice and rabbits. Status of Clinical supported which are in different stages Trials is as follows: of development. • Phase I Clinical Trials alongwith CDSCO has informed that it has granted parallel studies in hamsters and rhesus permission to conduct Clinical Trials in macaques have been completed. The various clinical trial sites such as New trial has revealed excellent safety of Delhi, Chennai, Chandigarh, Jaipur, the candidate vaccine. Immunogenicity Kanpur, Surat, Hyderabad, Pune, testing is in progress. Mumbai, Ahmadabad, Bhubaneswar, • Phase II Clinical Trials are ongoing. Patna, Gorakhpur etc and the trials are on going. (ii): A DNA vaccine (ZyCov-D) has been developed by Cadila Healthcare Ltd. Pre- clincial toxicity (d): Presently, under Universal Immunization studies were conducted in small animals: mice, Program (UIP) vaccine distribution rats, rabbits and guinea pigs. The vaccine has is based on Electronic Vaccine been found to be safe and immunogenic. Cadila Intelligence Network (eVIN) system. has partnered with ICMR for conduct of parallel eVIN is an internet based digital system pre-clinical studies in rhesus macaques. Status to track routine immunization, vaccine of Clinical Trials is as follows: stocks, storage temperature in about 25,000 dedicated cold chain storage • Phase I Clinical Trials have been points across the country as well as completed. The trial has revealed movement of vaccine. The vaccine excellent safety of the candidate vaccine. is distributed to health facilities and Immunogenicity testing is in progress. outreach station sites, so as to reach • Phase II Clinical Trials are ongoing. in all areas. eVIN system is regularly monitored by health authorities at state (iii): Serum Institute of India (SII) and ICMR have and district level. eVIN system is being partnered for clinical development of two global enhanced to address the needs for vaccine candidates: distribution and tracking of COVID-19 • ChAdOx1-S, which is a non- replicating vaccine, when it becomes available. viral vector vaccine developed by Further, a National Expert Group on University of Oxford/AstraZeneca. This COVID-19 vaccine has been constituted vaccine is undergoing phase III Clinical to guide the Government on: Trials in Brazil. Phase II/III bridging • Prioritization of population groups for studies have been initiated by ICMR vaccination. at 14 Clinical Trial sites. ICMR-National Institute for Research in Tuberculosis • Selection of COVID-19 vaccine (NIRT), Chennai is the lead institution. candidates. ICMR and SII have also partnered for • Inventory management and delivery clinical development of a glycoprotein mechanism of the vaccine including sub-unit nanoparticle adjuvanted making of vaccination process. vaccine developed by Novavax from • Selection of delivery platforms. USA. The trial will be initiated in • Cold chain and associated infrastructure second half of October after the for roll-out of COVID 19 vaccination etc. vaccine is manufactured by SII. The trial is led by ICMR-National AIDS The Minister of State in the Ministry of Health and Research Institute (NARI), Pune. Family Welfare (Shri Ashwini Kumar Choubey)
IDMA Bulletin LI (48) 22 to 30 December 2020 17
SC 347), which forms the basis of the provisions Draft Environment Impact regarding treatment of cases involving Violation in the Assessment, 2020 Draft Environment Impact Assessment Notification Lok Sabha Unstarred Question No: 2163 2020. Shri Hibi Eden: Minister of State in the Ministry of Environment, Forest and Climate Change (Shri Babul Supriyo) Q. Will the Minister of ENVIRONMENT, FORESTS AND CLIMATE CHANGE be pleased to state; Medical Research (a): whether the Hon’ble Supreme Court has observed Lok Sabha Unstarred Question No: 2175 that Post-facto Environment Clearance is violative of the fundamental principles of environmental Shri Amar Singh: jurisprudence, if so, the details thereof; Q. Will the Minister of HEALTH AND FAMILY WELFARE (b): whether the Government has given any undertaking be pleased to state; before the Madras High Court that no more extension of time will be granted for post facto Environment (a): whether the Government has any plans to identify Clearances, if so, the details thereof; and medical research separately rather than clubbing it with commercial ventures; (c): whether there is any provision for post facto clearance in the EIA 2020 draft notification; and (b): if so, the details thereof; (d): if so, the details thereof? (c): whether digital incentivisation plan is completely missing, if so, the details thereof; rd Answered on 23 September 2020 (d): whether 2019 saw various frameworks initiated such A. (a) to (d): The draft EIA Notification 2020 does not as the National Digital Health Blueprint; and provide for ex post facto clearance to violation cases. (e): if so, the steps taken/to be taken by the Government The Environment Clearance shall be granted only in this regard? prospectively as also held by the Hon’ble Supreme Court in the case of Common Cause Vs. Union of Answered on 23rd September 2020 India. Clause 22 (14) of the draft EIA Notification A. (a) & (b): No Sir. The present strategy of Government 2020 clearly specifies that the project proponent is for promotion and co-ordination of basic, applied liable for action under Section 19 of the Environment and clinical research including Clinical Trials and Protection Act 1986 for the violations committed by operational research in areas related to medical, health, it. In addition, the draft notification also lays down bio-medical and medical profession and education additional liability on the project proponent for causing through development of infrastructure, manpower damage to the environment through assessment of and skills in cutting edge areas and management of environment damage caused, remedial plans and related information thereto continues. community augmentation plan (reference clause 22(5) of the draft notification). The Hon’ble High (c): The Indian Council of Medical Research (ICMR), Court of Madras, in W.M.P.No.3361 and 3362 of an autonomous organization of Department of 2018 in the matter of Appaswamy Real Estates Ltd. Health Research has informed that it has digitized and ors vs. Puducherry Environment Protection many documents and started using online services Association vide order dated 14.03.2018 extended for many activities such as extra-mural research the time window of the notification dated 14.03.2017 project proposal submission and processing, Senior up to 13.04.2018. Since then, the Hon’ble Supreme Research Fellowship, Research Associate ship Court has enunciated the Principles of ‘’Polluter applications, etc. Junior Research Fellowship exam Pays’ and ‘Proportionality’ in various decisions viz. is also now conducted online. All the payments are Indian Council for Enviro-Legal Action Versus Union transferred digitally. of India (the Bichhri village industrial pollution case) (d) & (e): Ministry of Health and Family Welfare (1996 [3] SCC 212); and Alembic Pharmaceuticals has finalized and released the National Digital Ltd. Versus Rohit Prajapati & Ors. (2020 SCC Online Health Blueprint (NDHB) as an architectural
IDMA Bulletin LI (48) 22 to 30 December 2020 18
framework for digital health initiatives in country. concept demonstration to product commercialization. On 15th August, 2020 implementation of National The schemes support entrepreneurs, start-ups, Digital Health Mission (NDHM) has been initiated in Companies and academic institutions, to work on 6 UTs on pilot basis. research ideas that have translational potential. The details of Programs undertaken and their output The Minister of State in the Ministry of Health and during the last three years and the current year Family Welfare (Shri Ashwini Kumar Choubey) including funds allocated may please be seen at Annexure – A. Research in Biotechnology (c):The Department of Biotechnology has a major Lok Sabha Unstarred Question No: 2185 focus on promotion of Biotechnology through Research & Development and also in terms of Shri Raja Amareshwara Naik: Human resource and Infrastructure Development. Smt Sangeeta Kumari Singh Deo: The key areas of support are Research and Development, Demonstration, Product Development Shri Bhola Singh: and Commercialization, Capacity building through Shri Vinod Kumar Sonkar: Human Resource Development and Infrastructure strengthening. Shri Sukanta Majumdar: DBT’s major focus is on building Centre of Excellence Shri Jayanta Kumar Roy in different areas. DBT also has 16 Autonomous Institutions under its administrative control with Q. Will the Minister of SCIENCE AND TECHNOLOGY focus on promoting and strengthening Biotechnology be pleased to state:- through national and international partnerships. The (a): whether the Government has set up Biotechnology key activities supported under Human Resource and Industry Research Assistance Council to promote Infrastructure is enlisted at Annexure B. Research and Development in Biotechnology; (d): Biotechnology sector is recognized as the (b): if so, the details thereof including funds allocated, key driver for contributing to India’s $ 5 Trillion R&D projects undertaken and their output during the economy target by 2024. The biotechnology sector, last three years and the current year; mainly due to its multi-disciplinary approach holds (c): the steps taken/being taken by the Government for the potential to provide an array of solutions for the development of biotechnology as well as physical challenges in Health, Agriculture, Environment, and human infrastructure in this sector; Energy and Industrial Processes. This includes innovative solutions for various societal challenges, (d): whether Biotechnology has varied applications and use of biosimilars for helping millions of people far reaching impact and implications in prominent around the world in battling life-threatening sectors and if so, the details thereof; and medical issues, development and manufacture of (e): whether there is urgent need to formulate regulatory vaccines for nearly 60% of Global immunization. framework for Biotechnology sector at national level, Improved crop varieties for increased production and if so, the details thereof? providing better yields to the farmers while reducing the dependence on heavy consumption of water and rd Answered on 23 September 2020 energy. Industrial biotechnology is being channeled A. (a) & (b): Yes, Biotechnology Industry Research to produce biofuels that can help in ensuring cleaner Assistance Council (BIRAC) has been established environment. Biotechnology impacts each sector and by Government of India as a Public Sector Enterprise the Biotechnology Sector in the country is growing under Department of Biotechnology (DBT) in March, rapidly. 2012 to foster and nurture the Startup Ecosystem (e): The Biotechnology research and development and promoting Academia –Industry Collaboration in activities involving use of r-DNA technology and/ Biotechnology. or hazardous microorganism are being regulated BIRAC, through its various funding schemes, supports in accordance with Rules for the manufacture, all stages of product development right from proof-of- use, import, export & storage of hazardous
IDMA Bulletin LI (48) 22 to 30 December 2020 19
microorganisms, GE organisms or cells,1989 and activities (including small scale field trials, of the Environment Protection Act, 1986. The import, export etc) involving genetically engineered Review Committee on Genetic Manipulation organisms. (RCGM) established under the Department of Minister of Health & Family Welfare; Minister of Biotechnology, Ministry of Science and Technology Science and Technology; and Minister of Earth to monitor the safety of on-going research projects Sciences (Dr Harsh Vardhan) l l l
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IDMA Bulletin LI (48) 22 to 30 December 2020 20
New Developments
Brewprint: using yeast to make particularly vulnerable in times of uncertainty. During the plant-based drugs Covid-19 crisis, we’ve seen that supply chain problems can have a human cost. In the spring, the US Food and Drug Many of our most important medicines are derived Administration reported a shortage of the opioids needed from nature, but the supply chain is vulnerable to upheavals to safely keep patients on ventilators. such as wildfires or pandemics. Natalie Healey speaks to There could be a better way of making the rare synthetic biologist Professor Christina Smolke who has compounds found in nature and avoiding similar supply successfully used yeast to produce plant-based drugs, such chain issues, says Stanford University adjunct Professor as opioids and tropane alkaloids. Christina Smolke. In 2015, she and a small team of researchers proved that opioids could be produced using genetically-modified yeast.
Reimagine fermentation: Smolke’s breakthrough involved a process we’ve known about for centuries: fermentation. Give brewer’s yeast a little sugar and under the right conditions it’ll reward you with alcohol and carbon dioxide. Smolke figured fermentation had the power to speed up drug manufacturing – with yields seen in day or weeks, rather than months or years as with crop farming. It would mean supply could be easily increased if there was an unexpected event.
Could yeast be an alternative way to develop drugs without But plant-derived medicines are made from more undermining the supply chain? Credit: Shutterstock complex stuff than ethanol or carbon dioxide. “If you look It takes a lot of poppies to make serious painkillers: at the types of molecules plants make, they’re incredibly complicated from a structural perspective,” says Smolke. Morphine is classed as an essential medicine by “The way they are able to survive and interact with their the World Health Organization, but it wouldn’t exist environment is through chemistry.” without Papaver somniferum (better known as the opium poppy). Around 100,000 hectares of the flowers are Source: Natalie Healey, Pharmaceutical Technology, 10.12.2020 (Excerpts) cultivated every year – primarily in Australia, Spain, France, India, Turkey and Hungary – to meet demand for opioid l l l medication worldwide. Approximately 800 tons of the natural opiates morphine and thebaine are extracted from Coronavirus: How the virus interacts the harvested straw, some of which are then chemically with cells converted into higher value drugs, such as codeine, SARS-CoV-2 infections pose a global threat to human oxycodone and hydrocodone. Although fields of beautiful health and a formidable research challenge. One of the blooms sound idyllic, industrial poppy farming isn’t easy. most urgent tasks is to gain a detailed understanding of the Pests, disease and poor weather conditions can molecular interactions between the virus and the cells it dramatically impact the yield. Plus, growing drugs from infects. It must also be clarified, whether these interactions plants takes a long time and the poppies themselves favour the multiplication of the virus or - on the contrary contain very low levels of the active ingredient. If there is - activate defence mechanisms. a spike in demand for opioid medicines, the supply chain In order to multiply, SARS-CoV-2 uses proteins of the can struggle to respond fast enough. These issues mean host cell. However, thus far no detailed information on the problems for the pharmaceutical industry, which in-turn part of the human proteome - i.e. the total of all proteins means drug shortages for doctors and patients. Medicines occurring in human cells - that is in direct contact with derived from nature (as around 40% of our drugs are) are the viral RNA existed.
IDMA Bulletin LI (48) 22 to 30 December 2020 21
Publication in Nature Microbiology: and defence strategies, a crucial prerequisite for the development of new therapeutic strategies,” says Jochen This void has now been filled. Scientists from the Bodem. In total, the scientists identified 18 host Helmholtz Institute for RNA-based Infection Research proteins that play an important role during SARS-CoV-2 (HIRI) Würzburg, the Julius-Maximilians-Universität infection. Würzburg (JMU) and the Broad Institute (Cambridge, USA) have succeeded in creating the first global atlas According to them, the two factors CNBP and LARP1 of direct interactions between the SARS-CoV-2 RNA are particularly interesting. Using genetic tools, the authors and the proteome of the human host. In addition, the identified the exact binding sites of these two host proteins authors identified important regulators of viral replication. in the viral genome and showed that they can specifically Dr Mathias Munschauer from HIRI and Professor Jochen inhibit the replication of the virus. According to Mathias Bodem from the Institute of Virology and Immunobiology Munschauer, the characterisation of LARP1 as an antiviral at JMU were responsible for the study. They present the factor is a major finding: “The way LARP1 binds to viral results of their work in the latest issue of the journal Nature RNA is very interesting, because it is similar to the way Microbiology. LARP1 regulates certain cellular messenger RNAs that we already know. This in turn provides insights into possible In the biosafety level 3 suite at HIRI, the scientists mechanisms of action.” infected human cells with the new Coronavirus, which uses RNA as genetic material. In a second step, they purified The multidisciplinary nature of the study also enabled the viral RNA and identified the proteins bound to it. “Mass the identification of 20 small molecule inhibitors of host spectrometry allows us to accurately determine the host proteins that bind SARS-CoV-2 RNA. The authors show proteins that directly associate with the viral genome. In that three out of four inhibitors tested actually inhibit viral this particular case, we were able to perform quantitative replication in different human cell types. This result could measurements to identify the strongest specific binding open up new ways to treat infections with SARS-CoV-2 and partners,” says Mathias Munschauer. other RNA viruses. (Story: Materials provided by University of Würzburg. Original 18 proteins, 2 key factors and 20 potential inhibitors: written by Tim Schnyder/Gunnar Bartsch. Note: Content may be “The atlas of RNA-protein interactions created in this edited for style and length). way offers unique insights into SARS-CoV-2 infections Source/Courtesy: University of Würzburg, Science Daily, and enables the systematic breakdown of central factors 21.12.2020 (Excerpts) l l l
IDMA HOLIDAYS FOR THE YEAR 2021
1. 1st January Friday New Year 2. 26th January Tuesday Republic Day 3. 11th March Thursday Maha Shivratri 4. 29th March Monday Holi (Second Day) 5. 2nd April Friday Good Friday 6. 13th April Tuesday Gudi Padwa 7. 16th August Monday Parsi New Year 8. 31st August Tuesday Gokulastami (Dahi Handi) 9. 10th September Friday Ganesh Chathurthi 10. 15th October Friday Dussehra (Vijaya Dashami) 11. 4th November Thursday Laxmi Puja 12. 5th November Friday Diwali Balipratida
IDMA Bulletin LI (48) 22 to 30 December 2020 22
national news
India requires Rs.80,000 crore for food processing companies were using new ingredients vaccine distribution next year: SII or a new food not known in India or an extract or herb coming from abroad which might not have safety data Pune-based vaccine-maker Serum Institute of India, and come under the category of non-specified foods for which has partnered with AstraZeneca to manufacture the which standards have not been given in the Food Safety Oxford-AstraZeneca vaccine, on Saturday,19.12.2020 and Standards Act, 2006. The food ingredients could be said that the country would require a massive funding of flavour, colour, additives, stabilisers, preservatives, stated Rs.80,000 crore for distribution of the Covid vaccine for industry experts. the next one year. “In the wake of so many regulations prescribing The Central Government plans to vaccinate nearly 30 standards and the way things have to be done under the crore people in the first phase of drive. It will be offered to Food Safety and Standards Act had been put in place one crore healthcare workers, along with two crore frontline during various periods of time. Regulations for primary and essential workers and 27 crore elderly, mostly above ingredient, additives, residues, milk and milk products, oil the age of 50 years with comorbidities. products including Nutraceuticals and Functional Foods Three vaccine candidates - Serum Institute-Oxford’s are standards and not just specification which means the Covishield, Bharat Biotech’s Covaxin and Pfizer vaccine are way a type of food product would be regulated. Therefore in the fray for emergency use authorization. The Central an expert committee comprising three groups will enable Drugs Standard Control Organisation (CDSCO) has sought assessment of applications in an efficient and time-bound additional data from the Serum Institute as well as Bharat manner,” they added. Biotech to get approval. Speaking about the logistics of the Now these expert members depending on the food vaccine after it is granted approval, Dr Satish D Ravetkar, category in which the application is received could invite Executive Director of Serum the Chairman of the concerned Scientific Panel as and Institute of India said, “The funding for such large scale when required. distribution would be huge, and India should be ready with The first Expert Committee comprises Prof H P Sachdev, a funding of around Rs.80,000 crore for next one year for Senior Consultant, Paediatrics and Clinical Epidemiology; distribution of the Covid-19 vaccine.” Sita Ram Bharatia, Science and Research, New Delhi; Source: IANS, The Times of India, 20.12.2020 Dr Suman Kapur, Dean, International Programmes l l l and Collaborations, BITS Pilani, Hyderabad campus; Prof R K Khar, Principal (Retd), Pharmaceutical Scientist, FSSAI forms three expert committees to BS Anangpuria Institute of Pharmacy, Faridabad; Dr Lalitha examine non-food & food ingredients Gowda, former Chief Scientist, CFTRI; and Dr Supriya Bhalerao, Ayurveda, Interactive School of Research for The Food Safety and Standards Authority of India Health Affairs (IRSHA), Bharati Vidyapeeth, deemed to (FSSAI) has now constituted three expert committees be University, Pune. to examine the approval of non-specified foods and food Another Expert Committee has Dr Bikas Medhi, Professor, ingredients regulations 2017 among other things. Pharmacology, PGI, Chandigarh; Dr V Kalaiselvan, Principal In order to fast track the scrutiny of applications in a Scientific Officer, Indian Pharmacopeia Commission; time-bound manner, the competent authority has approved Dr K Madhavan Nair, former Scientist, Micronutrient the formation of the three expert committees to examine Research Group, Department of Biophysics, National all the applications. These committees, according to the Institute of Nutrition, (ICMR), Hyderabad; Dr R K Marwaha, FSSAI note, are expected to meet at frequent intervals to Scientific Advisor, endocrinology, International Life facilitate speedy clearances of applications. Sciences Institute, India, and Advisor, Project, Department On the key objective of the three expert groups, industry of Endocrinology, AIIMS, New Delhi; and Dr Balkumar experts noted that it was much wanted especially when Marthi, former Scientist in Biological Research, including
IDMA Bulletin LI (48) 22 to 30 December 2020 23
food and nutrition, besides expertise in human studies, “SEC in the meeting noted that in the proposed claims substantiation, analysis, GMP and HACCP. formulation SBECD (sulfobutylether-b-cyclodextrin) is Expert Committee 3 is represented by Dr D B A Anantha replaced with Polysorbate 80 and PEG 300 with the Narayana, Expert Member (Retd), Indian Pharmacopeia intention to reduce the renal toxicity,” read the minutes Commission; Dr Renuka Munshi, Professor, BYL Nair of the meeting, uploaded on the Central Drugs Standard Hospital; Dr Prema Ramachandra, Director, Nutrition Control Organisation’s (CDSCO) website Tuesday, Foundation of India; Dr Dheeraj Shah, Professor of 22.12.2020. Paediatrics, University College of Medical Sciences, New The CDSCO is the Health Ministry arm that regulates Delhi; and Dr B Dinesh Kumar, Scientist-F and HoD, quality of drugs and vaccines in the country while the Department of Toxicology, National Institute of Nutrition, SEC advises the Drugs Controller General of India on Hyderabad. applications seeking approvals for new drugs and vaccines. The FSSAI has also provided Terms of Reference SBECD is used to make drugs more soluble for intravenous where the Expert Committee will need to undertake administration, whereas polysorbate is a thickening agent preliminary risk assessment of the applications under that is used in personal care products and also as a food non-specified foods and food ingredients. The experts can additive. PEG is used as an inactive substance in drug seek clarification from FSSAI before granting approval and manufacturing, as a vehicle for drug transportation in the also could reject applications. human body. If need be, the Expert Committee could also refer the Along with the bioequivalence study, the SEC has also application to the concerned Scientific Panel for further asked Cipla to conduct Clinical Trials to assess renal toxicity safety evaluation or any other expert or institution for of the new formulation. “Accordingly, the firm should scientific opinion, according to Dr N Bhaskar, Advisor, submit bioequivalence study protocol and Clinical Trial Safety & Standards, FSSAI. protocol to CDSCO for further review by the committee,” Source: Nandita Vijay, Pharmabiz, 23.12.2020 the minutes of the meeting noted.
l l l Remdesivir’s effects on kidneys: The possible impact of Remdesivir on the kidneys Cipla to experiment with Covid drug is not yet known but an assessment of renal function in remdesivir composition to reduce Covid-19 patients is recommended before and during effect on kidneys treatment with Remdesivir.The European Medicines Mumbai-based drug maker Cipla has submitted Agency, which is responsible for regulating drugs in a proposal before the Government’s Subject Expert the continent, had in October announced that it will Committee (SEC) to change Remdesivir’s composition determine whether there was a causal relationship in order to reduce the Drug’s Adverse Effects on the between acute kidney injury and Remdesivir. kidneys. According to a study published in Journal of American Antiviral medicine Society of Nephrology, animal studies have associated Remdesivir is one of the SBECD accumulation with liver and renal diseases. most closely watched However, these had occurred in animals at doses 50 drugs in the Global to 100 times higher than expected in a five-to-10-day Clinical Trials against Remdesivir course. The study, however, also said that the Covid-19 disease. In “available data from a single randomized, controlled trial © Provided by The Print a meeting held on 17-18 in Covid-19 did not demonstrate an increased risk of December, the SEC had Renal Adverse Events in patients randomized to receive asked the company to conduct a bioequivalence study i.e., Remdesivir”. compare different proprietary preparations of the same drug — one which is presently available in the market and Source: Himani Chandna, ThePrint, 23.12.2020 another with the proposed changes. l l l
IDMA Bulletin LI (48) 22 to 30 December 2020 24
Kerala Government Panel to suggest Earlier, while forming the committee, Health PPP model to set up COVID-19 Department officials said that it would hold talks with Pharmaceutical companies, which have claimed to have vaccine production units 12/22/2020 Kerala government panel to suggest PPP model to set up COVID-19 vaccine production units- The New Indian Express developed vaccines for making use of their manufacturing licence to set up production units. The companies under consideration are Serum Institute of India, Bharat Biotech and Zydus Cadila. Following some talks with Bharat Biotech and their letter on September 15, the Chief Minister chaired a meeting on vaccine trials and a five-member committee was constituted with T Jacob John, former Head of the Departments of Clinical Virology and Microbiology at Christian Medical College, Vellore, as its Chairman. For representForational prepresentationalurposes. (Photo | AP) purposes. (Photo | AP) By Dileep V Kumar Source: Dileep V Kumar, Express News Service, The New ExpressThe News S five-memberervice committee formed by the Government Indian Express, 22.12.2020 (Excerpts) toTH IexploreRUVANAN TtheHAP UpossibilityRAM: The offiv edeveloping-member comm ait tevaccinee formed againstby the government to explore the possibility of developing a vaccine against COVID-19 l l l COVID-19has concluded thhasat it isconcluded impractical at ththatis stag eit. is impractical at this stage. However, it will recommend to set up vaccine However, it will recommend to set up vaccine manufacturing units on public- India successfully shouldered its manufacturingprivate partnership ( PunitsPP) mo donel w iPublic-Privateth the manufactures Partnershipof the vaccine ca n(PPP)didates modelthat are within tri athel ph amanufacturesse. On November 1of6, thethe s vaccinetate consti tcandidatesuted a five-me mthatber responsibility as Pharmacy of the committee to explore possibilities of collaborations for vaccine production and arehavi ning atrial vacc iphase.ne devel oOnpme nNovembert unit, includ i16,ng p rtheotein state-based bconstitutediologicals like World amid COVID: Vikas Swarup ae nzfive-memberymes and cancer d rucommitteegs. to explore possibilities of India emerged as a net provider of health security and collaborations"There are some pr aforctic avaccinel difficulti eproductions. The vaccine iands the havingneed of t hae vaccinehour. For successfully shouldered its responsibility as the Pharmacy developmentdeveloping it, pai nunit,stakin gincluding research eff oprotein-basedrts, resources and fbiologicalsunds are requ ilikered. of the World, said Vikas Swarup, Ministry of External Affairs enzymesMost import aandntly, itcancer will take tdrugs.ime," said a member of the committee. On collaborative efforts, the member said big pharmaceutical companies Secretary (West), at the UNGA Special Session on Covid-19 devel“Thereoped the arelead insomeg vacc ipracticalne candidat edifficulties.s and persuadin g Thethem vaccine to set u pis on Tuesday, 22.12.2020. theprod needuction uofni tthes in t hhour.e state Foris a h developingerculean task. it, painstaking research Speaking virtually at the 31st Special Session of the UN efforts,"Convinci nresourcesg them requ andires efundsfforts fr areom trequired.he chief mi nMostister. Iimportantly,t also remains doubtful whether such companies will make efforts to set up production units at General Assembly in response to the Covid-19 Pandemic it will take time,” said a member of the committee. their own cost. If they are unenthusiastic, setting up facilities on PPP model will on Tuesday, 22.12.2020 Swarup said, "Within two months have Onto be ecollaborativexplored," added the m efforts,ember. the member said big https://www.newindianexpress.com/states/kerala/2020/dec/21/kerala-government-panel-to-suggest-ppp-model-to-set-up-covid-19-vaccine-produ… 2/13 of the India testing to more than 2,000 today. From having pharmaceutical companies developed the leading vaccine almost no domestic manufacturing of PPE kits, we have candidates and persuading them to set up production units become the second-largest manufacturer. in the state is a herculean task. More than 17,000 dedicated Covid facilities were set “Convincing them requires efforts from the Chief up with 1.6 million isolation beds. Digital tools such as the Minister. It also remains doubtful whether such companies Aarogya Setu App were developed and are being effectively will make efforts to set up production units at their own used for extensive contact tracing." On India's role to cost. If they are unenthusiastic, setting up facilities on PPP model will have to be explored,” added the member. combat the Covid-19 pandemic, the top official said that India has emerged as a net provider of health security and As per sources, a few days ago, the committee decided successfully shouldered its responsibility as the Pharmacy to prepare an agenda for making a firm proposal based of the World, sending consignments of medicines and on the need for setting up an effective manufacturing medical supplies to almost 150 partner countries. facility for biologicals. Meanwhile, the committee, which will submit its report to the Government, will highlight the He further said that India's "timely, graded and possibility of having a PPP and bringing in institutions proactive" response to the Covid-19 pandemic and like the Kerala State Drugs and Pharmaceuticals Limited, calculated measures were designed to protect the country's Institute of Advanced Virology and State Public Health Lab huge population and ensure that minimal damage is caused for vaccine production. to the economy.
IDMA Bulletin LI (48) 22 to 30 December 2020 25
"The Government has also been doing its best to dependence on the global world for various drugs; the road ensure that the economy and the livelihoods of people are to make India self-sufficient is not easy. not adversely hampered. We announced a massive USD The Pharmaceutical Export Promotion Council wrote 266 billion stimulus package, amounting to almost 10 to the Government of India, raising their concerns percent of our gross domestic product, directed at helping about delay in consignment clearances of basic low-income groups, marginal farmers, small businesses, chemicals required to make drugs for COVID-19 migrants and those in the informal sector. treatment. The self-reliance rhetoric falls flatin To ensure food security, the world's largest food transfer the absence of quality drugs which are led by programme was initiated to give extra rations to 800 million innovations, not just in India but around the world. people," Swarup said. Emphasising that the ongoing crisis What we need to understand at this point is that has laid bare the gap that exists in global cooperation and evidence-based solutions, and not policies that deter governance structures of multilateral organisations, he said: innovations from coming to India and making these "It is important that we make reformed multilateralism our innovative products unavailable to Indian patients. guiding principle." In the middle of a pandemic, we also find ourselves The MEA Secretary reiterated that India's vaccine struggling with policies that are critical to Indian production and delivery capacity will be used to help pharmaceutical sector. For instance, until last year, humanity in fighting this crisis. "India will also help all Para 32 of the Drug Price Control Order (DPCO) says the countries in enhancing their cold chain and storage that the price cap won’t apply if a newdrug is developed capabilities for delivery of the vaccine," he added. through a unique and indigenous process. So, for instance, if acompany, whether global or Indian, sets up its R&D Source: IANS, The New Indian Express, 22.12.2020 (Excerpts) centre here, and patented inIndia, would still be allowed to launch that product outside the purview of price control l l l over a period of five years. Now, after many deliberations, the government is looking at revoking the provision for Sync between pharma policies and global player, following which, if a product is researched Patient Safety: Need of the hour abroad, and even they register for a patent in India, they The pandemic has cannot get exemption from price control. (Following an brought along many Amendment in January 2019, exemption isprovided if drug revelations and lessons is patented in India irrespective of where is it is developed. forthe pharmaceutical Hence this para may be deleted) i n d u s t r y a s w e l l , Such restrictive policies deter global innovations from deliberating the need investing in the Indian pharmaceutical market. Global to rethink the policies researchers deserve the value for the irinnovations, and we have been making such restrictions stand in the way. Moreover, until we so far. Along with India, strength enour own domestic market, it is important to the world witnessed the value of inter-dependence to support policies that foster innovation. ensure the demand to produce most essential drugs We need regulatory policies that welcome innovations. are met domestically. When we speak of atmanirbhar With self-reliance leading the healthcare space, we might future, we should not ignore the fact that the contours of lose out on what the world has to offer. Restrictive policies self-reliant India will take its own time to unveil. And in imports can pose a threat to accessibility of quality most importantly, whether it is in the best interest of the healthcare in thecountry. The government, for nearly a patients or not at all? decade now has been pushing the use ofgeneric medicines We need to strengthen the domestic manufacturing with an intent of making healthcare affordable. However, before “promising big” and robust policy decisions are a wemust look at providing innovative healthcare solutions crucial part of this story. The pandemic has highlighted without compromising onthe patient safety and standard certain areas of improvement for the Indian pharmaceutical treatment guidelines. Looking at price of drugsalone to industry inthe global pharmaceutical supply chain and our make treatment affordable and not the entire healthcare
IDMA Bulletin LI (48) 22 to 30 December 2020 26
system, will be aclassic case of missing the wood for the The trend is expected to reverse once the pandemic trees. situation resolves and FY2022 margins will remain in line with the pre-Covid levels, the report said. The credit The pandemic also highlighted how NCDs continue metrics of leading Pharma companies are expected to put many vulnerable group sat an added risk. From the to remain stable in view of future growth prospects in rising CVD burden to be the diabetes capital of theworld, regulated markets and relatively strong balance sheets, India has many battles to fight. These challenges can only ICRA said adding that the capital structure and coverage be countered by using new innovations. The choice of these indicators are expected to remain strong despite pressure drugs should not be decided by geography but efficacy of on profitability and a marginal rise in debt levels given the the drugs. The argument should be around patient safety inorganic investments. and not where the drug is manufactured. Considering (Only the Headline and Picture of this Report may have been the current situation, for drug companies and scientists reworked by the Business Standard staff; the rest of the content worldwide, there is only one priority now— fight. is auto-generated from a syndicated feed.)
Source: Health News, ET Health World, 22.12.2020 Source: IANS, Business Standard, 23.12.2020 nn
l l l l l l Pharma revenue, margins likely to remainPharma healthy revenue, in next fiscal: margins ICRA likely to Health Ministry to hold talks with Revenue growth for IPM (Indian Pharmaceutical Market) is expected to be 7-9 percent in FY2021 despite muted Growth in Q1 FY2021 remain healthy in next fiscal: ICRA stakeholders to address huge
With inelastic demand demand-supply gap of CP for drugs and resumption for COVID-19 treatment of production to the In order to encourage use of Convalescent Plasma (CP) near pre-Covid levels by therapy in COVID-19 patients, the Union Health Ministry Q3 FY2021, revenue will soon hold talks with stakeholders like blood banks and growth for IPM (Indian hospitals to address the huge demand-supply gap of CP in Pharmaceutical Market) is the country currently widely used for treatment of moderate expected to be 7-9 percent Representational image.Representational image. to severely ill COVID-19 patients. in FY2021 despite muted With inelastic demand for drugs and resumptionGrowth of production in Q1 FY2021, Repeated correspondences on the issue have been to the near pre-Covid levels by Q3 FY2021, revenue growth for ratingsIPM (Indian agency Pharmaceutical ICRA Masaidrket) in is a expected report. to The be 7 -9revenue growth in made to the Drugs Controller General of India (DCGI) and percent in FY2021 despite muted Growth in Q1 FY2021, FY2022ratings agency is ICRAexpected said in a to report. be Theslightly revenue better growth in at 8-11 percent, Indian Council of Medical Research (ICMR) to encourage FY2022 is expected to be slightly better at 8-11 percent, though thoughlower incidences lower of incidences acute diseases, oflesser acute OPDs diseases, and elective lesser OPDs and use of CP therapy in COVID-19 patients. An evidence based surgeries may continue to have some bearing on Growth and advisory of ICMR had also been issued to the stakeholders electivewill depend uponsurgeries the course may of the pandemic,continue the reportto have added. some bearing on
GrowthThe API/KSM and (Key will Starting depend Materials) upon supplies the fromcourse China, of the pandemic, recently to address inappropriate use of CP in COVID-19 thewhich report were initially added. hit due to the Covid-19, have resumed patients. The API/KSM (Key Starting Materials) supplies from Barring a few states like Gujarat, Rajasthan and Delhi China, which were initially hit due to the Covid-19, have where CP therapy is going on successfully, Maharashtra has resumed gradually since March 2020 and are nearing the been struggling to keep its plasma banks functional due to normalcy levels. Approximately 60 percent of the APIs/ price control issues which have not yet received its logical KSM consumed, is imported from China. Production end despite several talks between the state Government disruptions owing to restrictions in mobility of manpower and plasma banks. and materials eased significantly after the first few weeks Meanwhile, the Central Government has also been of the lockdown. considering removing CP therapy from the National Clinical At present, the production has reached 90-95 percent Management protocol for COVID-19. However, Clinicians of the pre-Covid levels. The profitability has improved have contested that Clinical Trial studies to prove the in H1 FY2021 owing to lesser overheads during the efficacy of CP therapy are still ongoing and need some lockdown period - primarily travel, marketing and selling more time to arrive at the right conclusion in the interest expenditure. of patient safety.
IDMA Bulletin LI (48) 22 to 30 December 2020 27
As per the ICMR advisory, convalescent plasma therapy COVID-19 Titre of 1:640 (ELISA) or 13 AU (Absorbance or passive immunotherapy has been tried in the past Unit)/mL9 (CLIA) or Neutralising Antibody Titres of 1:80 for treatment of viral infections like H1N11, Ebola and (PRNT/MNT), as per the advisory. SARS-CoV-13 etc. Benefits of CP therapy in improving the Source: Shardul Nautiyal, Pharmabiz, 24.12.2020 clinical outcomes, reducing severity of disease, duration of hospitalization and mortality in COVID-19 patients are l l l dependent on the concentration of specific antibodies in convalescent plasma that could neutralize the effects of Strict Rules to bring in transparency SARS-CoV-2. in derma product landscape ICMR conducted an open label phase II multicentre Strict rules and the setting up of a Central Cosmetics randomised controlled trial in India across 39 Public and Laboratory are expected to strengthen and bring in Private Hospitals on use of convalescent plasma in the transparency to manufacture, quality control and market Management of cases with moderate COVID-19 disease tracing on the derma product landscape. This according (PLACID Trial). It was concluded that CP therapy did to experts not only provides better clarity on manufacture not lead to reduction in progression to severe COVID-19 and imports to the fast growing derma care industry OR all-cause mortality in the group that received CP but prevents counterfeit versions to safeguard access to therapy as compared to the group that did not receive misbranded and adulterated products which are unsafe CP therapy. for use. Derma care covers face, hair and hand. Only the PLACID is the world’s largest pragmatic trial on color cosmetics including hair dyes and lipsticks come CP therapy conducted in 464 moderately ill laboratory specifically under the beauty classification. confirmed COVID-19 affected adults in a real world Noting that the cosmetics regulations are now in a setting wherein no benefit of use of CP therapy could separate category with assigned rules under the purview be established. Similar studies conducted in China and of the Drugs and Cosmetics Act, Dr B R Jagashetty, former Netherlands have also documented no significant benefit National Advisor to CDSCO, said that the industry will now of CP therapy in improving the clinical outcomes of have a proper direction. The creation of Central Cosmetics hospitalised COVID-19 patients. Lab and making it appellant lab will help a lot in the As per the ICMR advisory, indiscriminate use of CP coming years. Even though the cosmetics rules have been therapy is not advisable. It is speculated that convalescent carved out from the Drugs & Cosmetics Act into the new plasma having low concentration of specific antibodies regulation, the Chapters and Rules have been expanded to against SARS-CoV-2 may be less beneficial for treating include import, import registration and new cosmetics, said COVID-19 patients as compared to plasma with high Dr D B A Narayana, expert on regulatory affairs. concentration of such antibodies. However these rules would have introduced a norm This advisory therefore embraces the principle that for the regulation of sales either by way of licensing or a potential donor for convalescent plasma should have registration which will help drug inspector to trace back the sufficient concentration of antibody working against COVID- actual manufacturer in case of substandard or adulterated 19 as narrated in the matrix below. It also highlights that or spurious cosmetics are found in market, he added. presence of antibody against COVID-19 in a potential Terming it as a long awaited regulation, Dr Narayan said recipient makes transfusing convalescent plasma a futile all along cosmetics received ‘band aid’ treatment where intervention. rules were mostly patched up. Even though cosmetics do not need to be regulated as strictly as drugs, except for their CP therapy therefore should only be used, as advised safety on application and use, yet for hair dyes, lipsticks by ICMR for management of COVID-19 when specific and eye liners the safety concern was much needed. criteria as mentioned are met. The appropriate age for CP donation is between 18 and 65 year three to seven days The new rules for import of cosmetics are now in place from onset of symptoms but not later than 10 days. There with provisions for registration with the CDSCO. This is should be screening to rule out ABO incompatibility and because globally there could be several new ingredients blood borne pathogens such as HIV, HBV, HCV etc. There and substances being added to cosmetics to improve the should be required concentration of IgG antibody against skin texture. But if these ingredients have not been used in
IDMA Bulletin LI (48) 22 to 30 December 2020 28
India, one would not know its impact on people of different growth as the day-to-day expenses are increasing without natives, now with the central cosmetics lab all imported limit. In addition to this, the regulatory department is also products will get tested. More over a dedicated facility is acting not supportive to the industries.” needed because testing for cosmetics is different from However, Gupta said, the state Government brings out the drug analysis. While drug tests include analysis of certain attractive projects to retain the existing units and impuritiesties, related substances and its dosage forms, in tries to bring more companies to Haryana for a sustainable the case of testing is more on sensorial stability and safety Pharma market. But the implementing agencies do not act of applications, said Dr Narayana. properly for the development of the industry. Further, the new rules rightly insist that all imported HPMA finds that the Government’s industry as well as cosmetics need to comply with the Bureau of Indian regulatory policies helps only the multinational giants and Standards where they exist. If there are no stipulations the medium level players. Such companies will remain, in BIS, then the manufacturer has to provide their own and the SSI units will vanish from the scene very shortly specifications against which the Central Cosmetics Lab will unless the Government takes a favorable stance towards conduct comprehensive testing for contaminants which are the small scale players. heavy metals and microbiology related, he said. “In an interaction with Pharmabiz, the President of the Source: Nandita Vijay, Pharmabiz, 24.12.2020 HPMA said Haryana was once a prosperous industry base l l l for Pharmaceutical formulations and it was on the top. On every one out of three strips of medicines, one Haryana Haryana set to become hub of medical based manufacturer’s name was there. About 25 years ago devices as around 100 industrial there were 300 actively operating manufacturing units units set up plants in the state which supplied medications to the entire nation. When the rigorous Schedule M norms came, Haryana Pharmaceutical Haryana, the erstwhile popular hub of pharmaceutical Manufacturers Association worked very hard along with the formulations in the northern part of the country, is now Government to upgrade the technologies in the facilities turning out to be the centre of the medical devices of the companies to become at par with global regulations industry to manufacture and sell elite medical diagnostic and enhance the capacities. instruments. Around 100 medical devices industrial However, in later years due to tax free benefits in units have already established their plants in the state at Uttarakhand and Himachal Pradesh states, several units Karnal. closed down their facilities here and moved to those states This exponential rise in the number of manufacturing taking incentives. Gradually the Haryana Pharmaceutical units for medical instruments and equipment is happening sector lost its wonderful industry atmosphere”, said at a time when many formulation units are closing down Gupta. their production facilities and moving out of the business On the side of challenges faced by the Pharma sector, sector due to lack of supportive industrial policies, says the industry visionary said unlike south Indian states the P K Gupta, President of the Haryana Pharmaceutical pharmaceutical manufacturers in Haryana faces one crucial Manufacturers’ Association (HPMA). He said, among other problem and that is with regard to technical personnel and issues, bureaucracy is the main hurdle for the development skilled labourers. As regards raw materials and distributors, of the small scale industry sector in Haryana. they have no issues. But availability of technical-hands for “The industry policies of the Government most often the industry still continues to be a burning issue. become detrimental to the growth of small scale units, or otherwise I would say that bureaucracy is the main hurdle Talking about the developmental activities in the for the growth of the SSI sector. This is not only for the manufacturing sector, P K Gupta said HPMA is taking Pharma manufacturing industry, but for all the industries. initiative with the Government to set up one Pharma In Haryana, I understand that about 10% of the total units Park in Karnal. There is a proposal from the central were closed down due to cumbersome regulatory policies Government to set up one API Park and a medical devices and several more units are shrinking now without any park somewhere in Haryana. State Government has good growth. The industry cannot survive if there is no business vision about the future prospects of the pharmaceutical
IDMA Bulletin LI (48) 22 to 30 December 2020 29
sector although they do not provide any help for the SSIs. the All Institute of Siddha,” says Dr Jayavenkatesh who has “We are hopeful that one Pharma park will be set up in taken the initiative with the central and state Governments the state somehow”. to shift the proposed institute from Chennai to Madurai. Source: Peethaambaran Kunnathoor, Pharmabiz, 23.12.2020 He said apart from teaching and treating facilities, the proposed AIIS will generate employment for several l l l people and help farmers to cultivate medicinal plants in the southern districts. ASHC pitches for Madurai as the ideal location to set up proposed All India The Siddha practitioners in Madurai and nearby Institute of Siddha districts feel that since Madurai is a tourist centre, the domestic arrivals and the inflow of overseas tourists to Hailing the initiative being taken by the Tamil Nadu the temple city will increase when these two national Chief Minister with the Central Government to approve medical institutes, AIIMS and AIIS, are established once in one All India Institute of Siddha (AIIS) in the state, the Madurai. It is also accessible for people from Kerala, who Madurai-based Association of Siddha Hospitals and Clinics visit the temples in Madurai and nearby districts during (ASHC) has wanted the Prime Minister and the Chief festival seasons. The Madurai District Tiny and Small Minister to select Madurai as the ideal location for the Scale Industries Association (MADITSSIA) has also wanted proposed All India Institute. ASHC’s demand comes in the the state Chief Minister to recommend for the proposed wake of the Chief Minister’s request to the Prime Minister institution in Madurai. The President of the Association in to set up one All India Institute of Siddha in Chennai. his letter to the Chief Minister said Madurai is one of the important areas where practice of Siddha medicine was In Madurai district and nearby localities, there are first started decades ago. around one hundred medicine manufacturing companies operating and out of them prominent 25 units are of Meanwhile, Dr T Thirunarayanan, Secretary of the Siddha and Ayurveda systems. ASHC argues that work for Chennai based Centre for Traditional Medicines and the central Government approved establishment of the All Research (CTMR), an exclusive research institute for India Institute of Medical Sciences (AIIMS) in Madurai Siddha medicines, has opined that if Siddha has to has already begun, so it will benefit the development be popular across the country the Central Government of the all India Siddha institute. Further, the location is sponsored institute should be established outside of Tamil easily accessible through road, railway and air (Madurai Nadu. He suggested Bengaluru as the ideal place for the Airport). AIIS. However, he said, since the state Chief Minister has recommended it for the state, it can be set up either in According to Dr Jayavenkatesh, President of ASHC, Trichy or in Coimbatore. if the National Institute of Siddha is opened in Madurai, the city will become an iconic medical education hub for Source: Peethaambaran Kunnathoor, Pharmabiz, 22.12.2020 teaching and treating. Further, it will cater to the healthcare l l l and medical education needs of thousands of people and students of southern Tamil Nadu. Madurai is surrounded by Government should come out with the districts Dindigul and Trichy (North), Sivagangai (East), Theni (West) and Virudhunagar (South) which depend on policies supportive to Pharma MSMEs Madurai for medical and education facilities. Besides, the engaged in formulations: soil in these resourceful districts is fertile for herbs and Jagdeep Singh medicinal plant cultivation. Unless the Government comes out with effective “Chennai has already got one central institute, the Pharma policies supportive to the thousands of struggling National Institute of Siddha (NIS) at Thambaram. The Small and Medium Enterprises (SMEs) engaged in Pharma Central Council of Research in Siddha (CCRS) under the formulations, big Pharma companies and multinationals Ministry of Ayush is also working in Chennai. In addition will take over the sector. The SMEs cannot get along with to this, one Siddha medical college and hospital is run the present policies which are tilted towards big players, there by the state Government. So, the Government should observes Jagdeep Singh, President of the Punjab Drug consider Madurai as the ideal place for the establishment of Manufacturers Association (PDMA) and Managing Director
IDMA Bulletin LI (48) 22 to 30 December 2020 30
of Parex Pharmaceuticals Pvt Ltd, Mohali. The PDMA units are operating in the state. Singh said Punjab will President alleges that the Government policies are framed be a promising destination for pharmaceutical industry as per the interest of the big players and of the multinational like Gujarat or Maharashtra if an industry friendly companies. When a lot of MSMEs are struggling and closing atmosphere is established. As long as the present down units for want of help, Government of India is not situation continues, there will not be a progress in the interested to listen to their issues. pharma sector in the state. Even today, a good number of companies in Punjab export their products to eastern He said the golden age of the Punjab Pharma industry and western countries. vanished from the scene 20 years ago. It was doing more or less well until 2005 when suddenly the rate of excise rose Source: Peethaambaran Kunnathoor, Pharmabiz, 21.12.2020 to 25%. Following it, there was a big exodus of units from l l l Punjab to the Excise Free Zones (EFZ) areas in Uttarakhand and Himachal Pradesh by diminishing the number of factories in Punjab. Even now the Pharma policies of the Health Ministry notifies Cosmetics central and state Governments everywhere are not industry- Rules, 2020 for effective regulation friendly to the sector. This has to be changed to evade and compliance further setbacks. In order to separately codify rules relating to cosmetics “Even in the midst of struggle, the Pharma sector in for effective compliance, the Union Health Ministry, Punjab is moving ahead with 200 Small and Medium scale through a Gazette Notification, has notified the Cosmetics Pharma units (MSMEs) and four big players. No MNC has Rules, 2020. presence in the state. If an industry-friendly atmosphere The Ministry issued the Notification in exercise of the is created by the Government, it will help the small scale powers conferred by section 12 and section 33 of the Drugs players’ opportunities for indulging in exports. It is the and Cosmetics (D&C) Act, 1940 (23 of 1940). These rules central Government that should let the MSME sector grow shall be applicable to the cosmetic as defined in clause without making frequent policy changes,” says the leader (aaa) of Section 3 of the D&C Act, 1940 (23 of 1940). while briefing Pharmabiz about the present situation of Pharmaceutical industry in Punjab. In these rules, unless the context otherwise requires, Act means the Drugs and Cosmetics Act, 1940 He further said unlike the problems faced by other (23 of 1940); (b)? Actual manufacturer in relation to states, Punjab has no infrastructure or raw material issues. import of cosmetics, means a person who manufactures There is minor issue of skilled workers, but marketing often cosmetics at his own manufacturing site in a country other becomes a problem for the entire MSMEs. The domestic than India approved by National Regulatory Authority or Pharma sector can address all these challenges provided any authorised competent authority in that country for Government introduces policies for the growth of small that purpose, by whatever name called for the purpose of players rather than helping big players and MNCs. this clause, person includes a company or a unit or a body Singh agrees on one point that the Government is corporate or any other establishment. introducing so many measures to bring up the bulk drug production (APIs) to promote indigenous manufacture of As per the notified rules, authorised agent means medicines. But, he says, the Pharma MSMEs engaged in a person in India authorised by the manufacturer. The formulations are facing myriad issues due to the Government authorised agent shall be responsible for the business policies. Punjab drugs manufacturers association is fighting activities of the manufacturer in India including compliance for the development of the sector through representations to the provisions of the Act and rules made thereunder for and discussions with the Government authorities. the purpose of this clause, person includes a company or a unit or a body corporate or any other establishment. As regards the total development of the industry sector, Bureau of Indian Standards (BIS) means the Bureau of he said PDMA is taking all efforts with the Government to Indian Standards established under Section 3 of the set up one Pharma cluster. For the purpose, one Society was Bureau of Indian Standards Act, 2016 (11 of 2016). registered for promoting it. There also the industry faces the cumbersome policies of the Government. The association No cosmetic shall be imported into India unless the has only the memberships of 70 companies despite 200 product has been registered in accordance with these
IDMA Bulletin LI (48) 22 to 30 December 2020 31
rules by the Central Licensing Authority or by any officer specifications, the Central Licensing Authority shall be to whom such powers may be delegated under sub-rule informed by manufacturer or by the authorised agent or (1) of rule 5. the importer or the subsidiary in India authorised by the manufacturer within fifteen days along with an undertaking An application for registration of a cosmetic product that products comply with standards laid down by the intended to be imported into India shall be made through Bureau of Indian Standards as referred in the Ninth the online portal of the Central Government in Form COS-1 Schedule. either by the manufacturer himself or by his authorised agent or the importer in India or by the subsidiary in Source: Shardul Nautiyal, Pharmabiz, 19.12.2020 India authorised by the manufacturer. An authorisation l l l by the manufacturer to his agent in India shall be duly authenticated either in India before a first class Magistrate or in the country of origin before the authority competent Patents and drug discovery data under the laws of that country or by an authority specified lucrative targets for cyber attackers: in the First Schedule. Ramesh Mamgain The applicant referred to sub-rule (2) above shall Patents and drug discovery data which are critical furnish along with the application such other information for pharmaceutical companies are now lucrative to and documents as specified in Part I of the Second cyber attackers. Pharma industry has never been in the Schedule provided also that in the event of application limelight for cyber-attacks than now and the threat of for import of bulk finished formulation ready to fill, the losing the valuable data has also never been greater, said following additional documents shall also required to be Ramesh Mamgain, Country Manager, India and SAARC, furnished. A registration certificate granted under rule Commvault. 13 shall remain valid in perpetuity, subject to payment The spike in cyber-attacks is attributed to the virtual of registration certificate retention fee as specified in the nature of conducting business. Pharma companies’ Third Schedule before completion of the period of five and customers’ critical data are no longer confined and years from the date of its issue, unless, it is suspended or cocooned in a fortified single location because of online cancelled by the licensing authority. business practices. Many Pharma manufacturing plants If the licensee fails to pay the required registration have outdated operating and processing systems, which certificate retention fee on or before the due date as make it difficult to patch advanced technology, eventually referred to in sub-rule (1), the registration certificate holder making them vulnerable to attacks, he noted. shall, in addition to the registration certificate retention With SaaS (Software as a Service) booming in India fee, be liable to pay a late fee calculated at the rate of also increased threat to concepts like Hack-for-Hire or two percent of the registration certificate retention fee for Ransomware-as-service. Anyone with cash to spare can every month or part thereof within one hundred and eighty hire experienced hackers to sabotage someone’s critical days and in the event of non-payment of such fee during data easily, Mamgain told. that period, the registration certificate shall be deemed to have been cancelled. The most disastrous impact is data breach especially when enterprises are rushing to find lifesaving antidotes. In case of change in constitution of a registration holder During the drug discovery process, patients’ information or overseas manufacturer, after grant of registration under becomes crucial to ensure the authenticity of the vaccines sub-rule (1) of rule 13, an application shall be made under being created. While firms are running to secure the sub-rule (2) of rule 12 for grant of fresh registration within formulas for vaccines, notorious players might indulge in a period of one hundred and eighty days from the date corporate espionage to sabotage the progress made by their of such change in constitution provided that the existing competitors. There are two critical aspects that come into registration shall be deemed to be valid till such time, play here, one is sensitive data Governance and the other fresh registration is issued or application is rejected by is e-discovery tools for compliance that needs stringent the Central Licensing Authority. attention, he noted. In case of any change in respect of labelling or Data breaches can cost a tremendous damage to composition or testing of registered product or its industries which is both reputational and monetary. Quoting
IDMA Bulletin LI (48) 22 to 30 December 2020 32
a recent survey, Mamgain said, “Average cost of a data Executive Committee. In the new team of office-bearers, breach in India $2 million. Ransomware attacks will only D Harirajan, Managing Director of Axon Drugs, Chennai, continue to be more sophisticated and nefarious with time. has been elected Honorary Secretary of the association. The only solution to keep critical data safe is intelligent The veteran Pharma industry Expert and Director of management from protection to disaster recovery, which Medopharm, R Sabapathy is the new Treasurer. Leading are knights in shining armour.” drug manufacturers S Madhavan and M Elangovan will act as Vice-Presidents and M R Chandramohan as the new Although the Pharma is traditionally known for Joint Secretary. a slower adoption of Information Technology, this COVID-19 pandemic has accelerated its digital The election for new office-bearers for the association transformation, especially when it comes to shorten the became imperative following the death of sitting President time duration and enhancing the quality of drug discovery B Sethuraman who was an active industry captain in process. Cloud migration is the new norm to secure and dealing with the regulatory and legal issues faced by Small, access the critical IP data in a better way, while intelligent Medium and Micro level Pharma industrial units all over the data management and protection solutions empowered country by representing them to the concerned departments them to work remotely in a compliant and cost-effective of central and state Governments. He had taken several manner, he said. legal issues of the industry with various courts and obtained favorable verdicts for the Pharma sector. In the post-pandemic world, use of data-centric technologies like Machine Learning & Artificial Intelligences Varadarajan said he will work for the improvement of not only shorten the drug discovery process, but also help the pharmaceutical manufacturing sector by mobilizing researchers predict modelling in a much better way than support of all units and representing them to the central a human brain can possibly achieve. and state Governments as and when problems arise. The association will also fight for the advantages of the member This is where Pharma industry’s Chief Information companies and support them to develop their infrastructure Officer (CIO) will need to primarily focus on the sustained facilities. Varadarajan, with more than 30 years experience digital transformation adopt constructive IT strategies. in the Pharma industry, was the Secretary of TN PMA from They will need to maximize data protection and propose 1988 to 2000 and continued as Vice-President of the cloud-based apps to proactively monitor and measure the association till he was elevated to the President post. company’s data environment. There is need to ensure compliance to safeguard the interest companies. To reduce Mr S V Veerramani, former National President of cost-based redundancies in disparate systems, CIOs are the Indian Drug Manufacturers’ Association (IDMA) and looking at managing data through a single pane of glass, Managing Director of Fourrts Laboratories, Chennai, said to keep expenditures at bay to enable IT solutions, said Varadarajan is a successful entrepreneur and an able leader the Chief of Commvault which is a data management and whose leadership will largely help increase the status of protection software company. the association and resolve all issues of the manufacturing Source: Nandita Vijay, Pharmabiz, 19.12.2020 companies, including the teething problems of the start-up units. Mr J Jayaseelan, Chairman of TN IPA and Managing l l l Director of Delvin Formulations, Chennai, expressed the
Thehope Tamil that NaduVaradarajan Pharmaceu andtical his Manufacturers team M D Varadarajan of Kniss Laboratories Associationof office-bearers (TN PMA) has will unanimously do wonderful elected M D elected President of TN PMA Varadarajan,activities forM anagingthe growth Director and welfare of Kniss Laboratories, Chennai, as the new President of the unopposed associationof the pharmaceutical for the manufacturing term 2020 -22. companies operating in the entire The Tamil Nadu Pharmaceutical Manufacturers The Annual General Body meeting, held last week, Tamil Nadu. He further said, being a Association (TN PMA) has unanimously elected M D also elected six other office-bearers and eight membersPharmacist, to the Varadarajan’sExecutive Committee. services In the as new Varadarajan, Managing Director of Kniss Laboratories, teamPresident of office of the-bearers, PMA will D Harirajan, be helpful M anagingfor Chennai, as the new President of the association for the Director of Axon Drugs, Chennai, has been elected Honorary Secretary theof the Pharmacist association. communityThe veteran Palso.harma industry Expert and Director of term 2020-22. Medopharm, R Sabapathy is the new Treasurer. Leading drug manufacturersTN PMA Swas Madhavan established and in M the Elangovan year 1979 will actfor asthe V ice- The Annual General Body meeting, held last week, also purposePresidents of andaddressing M R Chandramohan the problems asof the pharmaceutical new Joint Secretary. elected six other office-bearers and eight members to the The election for new office-bearers for the association became imperative following the death of sitting President B Sethuraman who IDMA Bulletin LI (48) 22 to 30 December 2020 was an active industry captain in dealing with the regulatory and33 legal issues faced by Small, Medium and Micro level Pharma industrial units all over the country by representing them to the concerned departments of central and state Governments. He had taken several legal issues of the industry with various courts and obtained favorable verdicts for the Pharma sector.
Varadarajan said he will work for the improvement of the pharmaceutical manufacturing sector by mobilizing support of all units and representing them to the central and state Governments as and when problems arise. The association will also fight for the advantages of the member companies and support them to develop their infrastructure facilities. Varadarajan, with more than 30 years experience in the Pharma industry, was the Secretary of TN PMA from 1988 to 2000 and continued as Vice-President of the association till he was elevated to the President post.
Mr S V Veerramani, former National President of the Indian Drug Manufacturers’ Association (IDMA) and Managing Director of Fourrts Laboratories, Chennai, said Varadarajan is a successful entrepreneur and an able leader whose leadership will largely help increase the status of the association and resolve all issues of the manufacturing companies, including the teething problems of the start-up units. Mr J Jayaseelan, Chairman of TN IPA and Managing Director of Delvin Formulations, Chennai, expressed the hope that Varadarajan and his
manufacturers in the state. The association takes up a lot The Government’s decision cannot have come at a of issues faced by the member units and finds solutions. more opportune time as there is a growing global interest in Ayush-based solutions for disease resistance and Source: Peethaambaran Kunnathoor, Pharmabiz, 19.12.2020 (Excerpts) treatment for the COVID-19. It is an undisputed fact that Ayush products played a key role in providing the much- l l l needed immunity to the general public to fight the deadly Coronavirus Disease, which has taken a huge toll across A Right Step to Promote Ayush the world, especially in the developed world including the In a welcome decision, the Union Ministry of Commerce US. The emerging evidence of a correlation between the and Industry and the Ministry of Ayush have decided low COVID-19 mortality rates and large-scale adoption of to jointly set up an Ayush Export Promotion Council to Ayush prophylactic solutions by the population in India is boost Ayush exports. The decision to set up an exclusive significant for the public health practice in the country. As Council on the lines of Pharmexcil was taken jointly by the entire world was running amok for a timely solution to both the Central Ministries at a high level joint review fight the deadly virus, the frontline role played by the Ayush meeting held to review Ayush trade and industry where sector in the fight against COVID-19 received kudos from both the Commerce & Industry Minister Piyush Goyal and one and all. The Ayush immunity protocols and the National Ayush Minister Shripad Naik were present. Both the Clinical Management Protocol for COVID-19 for Ayurveda Ministers have expressed strong resolve to work together and Yoga were timely interventions which provided relief to facilitate more exports of Ayush products from the to large section of the population. The protection offered country. The ministers have also resolved to expedite the by the Ayush systems to the common people during the standardisation of Harmonization System Code (HSC) for pandemic neutralised the scepticism that many people had Ayush products which is used for global trade. As per about the efficacy of the medicines and products offered the decision, the Ministry of Ayush, where the proposed by these systems. The spurt in exports of Ayush products Ayush Export Promotion Council will be housed, will in the recent months is a direct reflection of their growing work in collaboration with Bureau of Indian Standards popularity in many countries. Now, the sector should cash to develop international standards for Ayush products in on the prevailing situation and needed to upscale trade as well as services. The Ministry of Ayush and the Ayush quickly in order to meet the growing demands from India industry will identify best practices and success stories and abroad, and to serve the larger number of people and promote them amongst the public. To promote the who are now looking up to Ayush systems for maintaining Ayush products, it was also decided that the Ayush their health by boosting immunity. All said and done, the industry will work on ensuring quality and standards of strong resolve shown by the Government should not be Ayush products as well as to become price-competitive. just in paper as was the case with several existing export Besides, the Government has taken the decision that promotion councils. Ayush will figure in the Brand India activities which are Source: Ramesh Shankar, Pharmabiz-Editorial, 23.12.2020 aimed to boost exports.
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IDMA Bulletin LI (48) 22 to 30 December 2020 34
International news
US FDA takes key action in fight against that instructs cells in the body to make the virus’s COVID-19 by issuing Emergency Use distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, Authorization for first COVID-19 vaccine which does not cause disease, but triggers the immune The US Food and Drug Administration issued system to learn to react defensively, producing an immune the first Emergency Use Authorization (EUA) for a response against SARS-CoV-2. vaccine for the prevention of Coronavirus Disease 2019 “While not an FDA approval, today’s emergency use (COVID-19) caused by Severe Acute Respiratory Syndrome authorization of the Pfizer-BioNTech COVID-19 Vaccine Coronavirus 2 (SARS-CoV-2) in individuals 16 years of age holds the promise to alter the course of this pandemic in and older. The Emergency Use Authorization allows the the United States,” said Peter Marks, MD., Ph.D., Director Pfizer-BioNTech COVID-19 Vaccine to be distributed in of the FDA’s Center for Biologics Evaluation and Research. the US. “With science guiding our decision-making, the available “The FDA’s authorization for emergency use of the first safety and effectiveness data support the authorization COVID-19 vaccine is a significant milestone in battling of the Pfizer-BioNTech COVID-19 Vaccine because the this devastating pandemic that has affected so many vaccine’s known and potential benefits clearly outweigh families in the United States and around the world,” its known and potential risks. said FDA Commissioner Stephen M Hahn, MD. “Today’s The data provided by the sponsor have met the FDA’s action follows an open and transparent review process expectations as conveyed in our June and October guidance that included input from independent scientific and documents. Efforts to speed vaccine development have public health experts and a thorough evaluation by the not sacrificed scientific standards or the integrity of our agency’s career scientists to ensure this vaccine met FDA’s vaccine evaluation process. The FDA’s review process also rigorous, scientific standards for safety, effectiveness, and included public and independent review from members manufacturing quality needed to support Emergency Use of the agency’s Vaccines and Related Biological Products Authorization. Advisory Committee. Today’s achievement is ultimately a The tireless work to develop a new vaccine to prevent testament to the commitment of our career scientists and this novel, serious, and life-threatening disease in an physicians, who worked tirelessly to thoroughly evaluate expedited timeframe after its emergence is a true testament the data and information for this vaccine.” to scientific innovation and Public-Private Collaboration FDA Evaluation of Available Safety Data: Worldwide.” Pfizer BioNTech COVID-19 Vaccine is administered The FDA has determined that Pfizer-BioNTech as a series of two doses, three weeks apart. The available COVID-19 Vaccine has met the statutory criteria for safety data to support the EUA include 37,586 of the issuance of an EUA. The totality of the available data participants enrolled in an ongoing randomized, placebo- provides clear evidence that Pfizer-BioNTech COVID-19 controlled international study, the majority of whom are US Vaccine may be effective in preventing COVID-19. The participants. These participants, 18,801 of whom received data also support that the known and potential benefits the vaccine and 18,785 of whom received saline placebo, outweigh the known and potential risks, supporting the were followed for a median of two months after receiving vaccine’s use in millions of people 16 years of age and the second dose. older, including healthy individuals. The most commonly reported side effects, which In making this determination, the FDA can typically lasted several days, were pain at the injection assure the public and medical community that it has site, tiredness, headache, muscle pain, chills, joint pain, conducted a thorough evaluation of the available safety, and fever. Of note, more people experienced these side effectiveness and manufacturing quality information. The effects after the second dose than after the first dose, so Pfizer-BioNTech COVID-19 Vaccine contains messenger it is important for vaccination providers and recipients to RNA (mRNA), which is genetic material. The vaccine expect that there may be some side effects after either contains a small piece of the SARS-CoV-2 virus’s mRNA dose, but even more so after the second dose.
IDMA Bulletin LI (48) 22 to 30 December 2020 35
It is mandatory for Pfizer Inc and vaccination providers Once a manufacturer submits an EUA request for a to report the following to the Vaccine Adverse Event COVID-19 vaccine to the FDA, the agency then evaluates Reporting System (VAERS) for Pfizer-BioNTech COVID-19 the request and determines whether the relevant statutory Vaccine: all vaccine administration errors, Serious Adverse criteria are met, taking into account the totality of the Events, cases of Multisystem Inflammatory Syndrome scientific evidence about the vaccine that is available to (MIS), and cases of COVID-19 that result in hospitalization the FDA. or death. The EUA also requires that fact sheets that provide FDA Evaluation of Available Effectiveness Data: important information, including dosing instructions, and information about the benefits and risks of the The effectiveness data to support the EUA include an analysis of 36,523 participants in the ongoing randomized, Pfizer-BioNTech COVID-19 Vaccine, be made available to placebo-controlled international study, the majority of vaccination providers and vaccine recipients. whom are US participants, who did not have evidence of The company has submitted a Pharmacovigilance SARS-CoV-2 infection through seven days after the second plan to FDA to monitor the safety of Pfizer-BioNTech dose. Among these participants, 18,198 received the COVID-19 Vaccine. The Pharmacovigilance plan includes vaccine and 18,325 received placebo. a plan to complete longer-term safety follow-up for The vaccine was 95% effective in preventing participants enrolled in ongoing Clinical Trials. The COVID-19 disease among these Clinical Trial participants Pharmacovigilance plan also includes other activities aimed with eight COVID-19 cases in the vaccine group and 162 at monitoring the safety profile of the Pfizer-BioNTech in the placebo group. Of these 170 COVID-19 cases, one COVID-19 vaccine and ensuring that any safety concerns in the vaccine group and three in the placebo group were are identified and evaluated in a timely manner. classified as severe. At this time, data are not available The FDA also expects manufacturers whose COVID-19 to make a determination about how long the vaccine will vaccines are authorized under an EUA to continue their provide protection, nor is there evidence that the vaccine Clinical Trials to obtain additional safety and effectiveness prevents transmission of SARS-CoV-2 from person to information and pursue approval (licensure). The EUA person. for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The EUA will be effective until the declaration The EUA Process: that circumstances exist justifying the authorization of the On the basis of the determination by the Secretary of emergency use of drugs and biologics for prevention and the Department of Health and Human Services on February treatment of COVID-19 is terminated, and may be revised 4, 2020, that there is a public health emergency that has a or revoked if it is determined the EUA no longer meets the significant potential to affect national security or the health statutory criteria for issuance. and security of United States citizens living abroad, and Source: US FDA Press Release, 12.12.2020 then issued declarations that circumstances exist justifying the Authorization of Emergency Use of unapproved l l l products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.
The issuance of an EUA is different than an FDA have you renewed your approval (licensure) of a vaccine. In determining whether to membership for the years issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and 2019-2020 & 2020-2021 any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available if not, please do so; kindly contact IDMA Secretariat at: Email: [email protected] / [email protected] during the emergency. Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723
IDMA Bulletin LI (48) 22 to 30 December 2020 36 Feature Five trends to watch out for in the Pharma Industry in 2021 feature Sanjeev Goel
Five trends to watch out for in the Pharma Industry in 2021 Sanjeev Goel Amongst the most contamination as well as variability. Also, with serum- significant trends to dependent processes with lot-to-lot variability, RPA mitigates watch out for in the any lack of proper cell characterization strategies. It has Pharma industry in further mitigated business setbacks in the transition of the 2021 is how consumer lab process to manufacturing or in the recurring failures b e h a v i o u r h a s during manufacturing runs. Developers and researchers are witnessed a significant integrating their knowledge to develop and have common acceleration towards access to phase appropriate Process Development (PD)
e-consultations through live video calls between doctors and Bio Assay Services (BAS), removing manufacturing
and patients, e-purchases of medicines by uploading bottlenecks, reducing their Cost of Goods (COGS), and
doctor’s e-prescriptions, and home-collection of blood preparing for commercial readiness in advance.
Amongssamples.t the most At significant the trendssame to watchtime, out for the in the combined power of the Pharma industry in 2021 is how consumer behaviour has Biologics including Genetic Susceptibility and witnessedInternet, a significant data acceleration science, towards connected e-consultations devices and AI have through live video calls between doctors and patients, e- expedited the pace of digital transformation in Pharma Pharmacogenetics, Epigenetics & Genomes: organisations to improve quality and productivity. Skilled Instead of developing medicines (Small Molecules and manpower in Artificial Intelligence (AI), Machine Learning Generics) which start at the point when a disease disrupts (ML), cloud computing, Robotic Process Automation (RPA), the normal healthy life of an individual, the move towards and other technological areas are helping speed up drug biologics which studies how diseases are expressed or repurposing and development of biomarkers. contracted through genetic susceptibility and/or prevented through genetic resistance have spawned a new and rapidly Faster time-to-market for drug discovery: growing interest in Pharmacogenetics, Epigenetics and Al algorithms, Big Data and early-stage experiments Genomes – e.g. Covid-19 research papers have primarily using new technologies are helping substantially lower focused on studies of the virus at the protein levels and time and costs in bringing new drug formulations to how they interact with RNA and DNA. Genetics is expected market. The entire Research and Development cycle to generate the maximum amount of new Research and spanning data management, Clinical Trials and testing are Development in the pharmaceutical industry moving now so technology oriented that Pharma companies are forward. increasingly on boarding ‘health-tech’ partners and tech Connected virtual & self-monitoring in patient care: start-ups in the journey to drug discovery, hitherto a pure science domain. The advent of connected devices, wearables and IoT have ushered in a new trend in self-monitoring without Digitization & Automation: having to physically visit a clinic or a doctor. Instead, The manufacturing shop floor in Pharma was amongst they have the necessary equipment available at their the first to embrace digitization and automation. It was homes at a fraction of the cost for most self-monitoring not just about paperless processes, but also to ensure that needs. The readings are transmitted to a central console quality processes were robust and scalable, with minimal of the monitoring healthcare provider or doctor for scope for human error. It ensured CGMP compliance in their review and analysis. Diagnostic healthcare is fast the manufacturing process. Besides, robotic technology moving towards such connected devices, with AI and the and AI have been reducing manufacturing downtime and Internet providing the first level diagnostics followed by substantially reducing product wastage. a prognosis and final review by an expert doctor before actual prescription. This is empowering both patients From a quality point of view, automation has curbed (customers) and doctors to be connected virtually and human intervention associated with increased risk of has spawned a whole system of healthcare integrators
IDMA Bulletin LI (48) 22 to 30 December 2020 37 and aggregators bringing experts and patients on a Regulatory bodies like US FDA, and EMA are going to self-monitoring virtual healthcare platform. strengthen the WHO in its ways of working. Automation Governments across the globe are realising how such software for common standards and compliances are going connected healthcare systems are not only more flexible but to be universally implemented since it impacts humanity also extremely efficient. AI-enabled diagnosis and prognosis at large. for review by consulting expert doctors has already gained As the world rapidly takes to the convenience of substantial traction even in hospitals and clinics where the healthcare solutions through technology, the Pharma number of patients is high. Connected healthcare is going industry is presented with the challenge to ensure that their to be the new normal from 2021. workforce is as adept at addressing this demand and can Global collaboration in compliance & regulatory conditions: keep up with the speed of adoption by customers. Pharma companies need to up skill and train their personnel in the Covid-19 has ushered in collaboration, and not latest developments and ways of working with customers competition, amongst each country’s pharmaceutical at various touch points. regulatory bodies. And though the US Government has voiced its displeasure with the WHO, this global collaboration in (Disclaimer: The writer - Sanjeev Goel is Business Head, Manipal ProLearn. Views expressed are a personal opinion.) healthcare – both Research and Compliance – is only going to get more deeply entrenched moving forward. Source: E-Health Network, 08.12.2020 (Excerpts)
l l l Slowing sales a concern for Indian Pharma Companies Clifford Alvares Sales of Covid-19 drugs are also seen moderating due to the lower number of Coronavirus cases in November
Having Covid-19 drugs in the portfolio is proving useful in November. “Excluding the contribution from covid-19 for some drug makers. With the Indian Pharma Market once drugs, growth for Glenmark, Cipla and Cadila were at -0.4%, again showing signs of slowing sales, drugs such as 3.9% and -1.1% respectively,” said analysts at Nomura Favipiravir, Remdesivir and Toclizumab helped Glenmark Financial Advisory and Securities (India) in a note. Pharma Ltd, Cipla Ltd and Cadila Healthcare Ltd, with
November sales rising 7-15% from a year ago. Overall Sales Growth, however, decelerated considerably in November, which is a surprise given that it had bounced back in October. Sales growth decelerated to about 1.3% year-on- year in November as against 9.8% in October. Note that growth in September stood at 4.7%, suggesting that the recovery has been short-lived. One of the main reasons has been slower volume growth, which is showing signs of tapering off after monsoons. Volumes declined by 6.9% y-o-y in November as against a 0.6% growth in October. In the past eight months, volumes declined 7.6% on an average.
Some of this could be attributed to the slower patient inflows at clinics, say analysts. In fact, almost all therapies Another reason for the decline is the lower sales of including derma, pain, gynaecological and neuro have acuteSome therapy of this drugs could due be attributedto better hygiene. to the slower Within patient acute shown a dip in sales growth. Sales of Covid-19 drugs are therapies,inflows at anti-infective clinics, say growth analysts. fell to In 0.2% fact, in almostNovember all also seen moderating due to the lower number of cases againsttherapies 6.6% including in October. derma, In pain,addition, gynaecological there was some and neuro have shown a dip in sales growth. IDMA Bulletin LI (48) 22 to 30 December 2020 38 Sales of Covid-19 drugs are also seen moderating due to the lower number of cases in November. “Excluding the contribution from covid-19 drugs, growth for Glenmark, Cipla and Cadila were at -0.4%, 3.9% and - 1.1% respectively," said analysts at Nomura Financial Advisory and Securities (India) in a note.
Another reason for the decline is the lower sales of acute therapy drugs due to better hygiene. Within acute
stocking at user ends in October too, which led to a lower expenses. It is likely that cost savings of 1-1.5% are take-off in November, note analysts. However, chronic sustained beyond the pandemic,” said analysts at Nomura therapies such as cardiac have shown a growth of 8.7% in in the note. November, while anti-diabetic registered a modest growth While this should continue to support the sector, note of 1.9% in November. that the valuations of the Nifty Pharma index have been For now, Pharma companies may not see growth expanding due to the sharp increase in stock prices. The normalize in the next few months. This could impact their index’s one-year forward price-earnings multiple is at 27 revenue growth in the second half. But profits could still times as against 19 times a year ago, as per data from increase. “While top-line growth for the Indian formulation Bloomberg. business may disappoint, profitability may remain high due Source: Live Mint, 07.12.2020 (Excerpts) to lower costs—particularly for travel, sales and marketing
l l l Pharma Industry has a new drug: Artificial Intelligence Priya Dialani AI-controlled platforms permit companies to change how they lead and screen Clinical Trials
It’s almost difficult to talk about the future of any and screen Clinical Trials. They incorporate everything from industry without referencing Artificial Intelligence (AI). options for conducting smart, hybrid and virtual trials, digital Regardless of whether it’s retail, health care industry, study design tools, ability to provision devices and concierge manufacturing, etc the conversation around the advantages on a unified platform — complete with automated information proceeds. Increasingly, Pharma and Biotech Organizations collection and organization, analytics and cognitive AI. are embracing more effective, automated processes that integrate data-driven decisions and utilize predictive Drug Recalls: analytics tools. The next development of this approach Drug Recalls happen when a prescription in the supply to deal with cutting-edge data analytics fuses machine chain is tainted or traded off, making the resulting drug learning and AI. risky for recommending. Drug recalls are another significant The absolute most discussed issues incorporate drug trouble spot for the Pharma business and can have intense deficiencies, Clinical Trials, and the opioid epidemic, all ramifications for suppliers and patients. within the difficulties of the COVID-19 pandemic. Despite Drugs are reviewed to shield patients from tainting the fact that these issues appear to be inauspicious and or unfavorable impacts, yet patients may require that huge, AI is deliberately positioned to help us better address medication to endure, leaving suppliers in an exceptional all challenges. predicament. Using AI, we can possibly pinpoint precisely where any contamination or deformity began in the Development in Life Sciences: inventory network, permitting teams to address or work The power and capability of AI-based innovation in around the issue more effectively than would be possible Life Sciences have apparently never been more significant. utilizing manual research-based processes. The value of speedy and safe clinical advancement is With AI-empowered item level visibility software clear, particularly since the crucial work of pharmaceutical solutions, the drug production network can monitor each organizations and healthcare organizations has been vial and needle from producer to patient, guaranteeing a fundamentally disrupted by the Covid-19 pandemic. Right review is executed as fast as possible and without making off the bat in the pandemic, at least 440 Clinical Trials in the falling barriers to patient care. US had been ended due to logistical challenges, wellbeing concerns or raised exposure risks to participants. Processing Biomedical and Clinical Information: Some forefront solutions offer extensive AI-controlled May be the most evolved utilization of AI so far is in platforms that permit companies to change how they lead algorithms intended to read, group and decipher enormous
IDMA Bulletin LI (48) 22 to 30 December 2020 39
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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 Gate,early as possible KARNAL- as our understanding 132 of001 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 / (HARYANA) 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 safetyEmail:Year while [email protected]. not slowingIDMA Bulletin IDMAdown & Bulletin LIaccess2020-2021 (11) 15LI to (11)to critical21 15 March to 21 new 2020 March 2020 5 Indian5 DrugsWebsite online, kindly: www.idma-assn.org, arrange to E-mail us your updated email ID on YearYear 2019-2020 2019-2020 & 2020-2021 & 2020-2021 [email protected] / [email protected] Iftools. not, YpleaseearPhone: do 2019-2020so; kindly contact IDMA & Secretariat2020-2021 at: If not, please do so; kindlyIDMA contact+98961 IDMA BULLETIN Secretariat 16000 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 do MAINTAIN so; do kindly so; PUBLIC / [email protected] contact CONlDENCE/ [email protected] contact IDMA INI DMA Secretariat THE APPROVAL 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 IDMAMarch April Bulletin 20202020 LI (37) 01 to 07 October 2020 IDMAIDMA IDMA BulletinBulletin Bulletin XLVIII11 LIXLVII (12) (04)(44) 22 5 to22 30 to March30 NovemberJanuary 2020 2017 2016 39 403829 IDMA BulletinIDMAIDMA LIBulletin Bulletin (18) 08 LI LI to(21) (22) 14IDMAIDMA 01 May08 to to 2020 07 BulletinBulletin14 June June 2020 LI2020LI (28)(48) 2222 toto 3030 JulyDecember 2020 2020 IDMAIDMA BulletinBulletin LI24LI (11)(16) 152285 toto 2130 MarchApril 2020 2020 3640 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? 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IDMA Bulletin XLVII (48) 22 to 30 December 2016 48 IDMA Bulletin XLIV (14) 08 to 14 April 2013 43
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Date : ______To The Subscription Department Indian Drug Manufacturers’ Association , 102-B, Poonam Chambers, Dr. A. B. Road, Worli, Mumbai – 400 018, India. Email: [email protected] /[email protected] / Web: www.idma-assn.org Kindly enter my subscription to “IDMA Bulletin”. The details are as follows: Name of the subscriber …………………………………………….……………….….……...... ……………...... Current institutional attachment …………………………………………..……………….….…………………………...... Designation ……………………………………………..……………….….……………………………..……...... Delivery Address ……………………………………………..…………….….……………………………..……...... City ……………………………………………..……… Pin code …………………………….State …………………………………..….. Country …………….……...... …Phone no. (with STD/ISD code) …………………… E-mail address …………………………………..….. Subscription details Subscription Period: One year Subscription Type: India / Foreign Subscription starts from: Month ……………….…. Year……………… Payment details Cheque No …….…………………… Dated .……………. Drawn on ..…..……...... … Amount ……………Date: ………………… Signature of the subscriber Annual subscription rates: India (INR)
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USD 400 Kindly note: IDMA Bulletin is Published on 7th, 14th, 21st and 30th of every Month. (IDMA GSTIN:27AAATI3594D1ZO) • Subscriptions are for calendar year only • Please return the filled form to the above mentioned address. • Cheque should be issued in favour of “Indian Drug Manufacturers’ Association”, payable at Mumbai. • Please allow at least two weeks for commencement of new subscription. • Claims for missing issues can be made only within fifteen days of publication IDMA Bulletin LI (02) 08 to 14 January 2020 30 IDMA Bulletin LI (48) 22 to 30 December 2020 41
INDIAN DRUG MANUFACTURERS’ ASSOCIATION 102, Poonam Chambers, A Wing, 1stFlr., Dr A B Road, Worli, Mumbai–400018 Tel: +91-22-24944624/24974308 Fax: +91-22-24950723 Email :[email protected]/[email protected]: www.idma-assn.org ATTENTION MEMBERS Invitation to participate in ‘IDMA MARGI MEMORIAL BEST PATENT AWARDS 2019-20’ As you will be aware, the IDMA Margi Memorial Best Patent Awards recognize the ‘Best Patent of the Year’, both national and international. We request you to kindly send us details of your patent/s granted in the last 12 months period (01.04.2019 to 31.03.2020). An Expert Panel will examine and evaluate the applications received and recommend their selection for the Award. A copy of the Patent granted should also be enclosed to enable the Panel to evaluate the Patent for the Award. Applications should be forwarded in a closed and sealed envelope marked ‘IDMA Margi Memorial Best Patent Awards 2019-20’ along with an ENTRY FEE of `10,000/- + GST @18% (Total `11,800/-) per Member Company immediately to reach us latest by 07th January 2021. For the convenience of the panelists, soft copies of the application along with relevant supporting patent documents may also be sent separately. Applications for the Award will need to comply with certain criteria as enumerated in the Guidelines (Do’s and Don’ts) for IDMA Margi Memorial Best Patent Awards 2019-20 (as mentioned below). Kindly peruse the same before applying for the Award. The winners will be notified by email after the Expert Panel finalizes selection of Award Winners. The Awards will be presented at the IDMA 59th Annual Day Celebrations to be organized by end of February 2021 at Online Web. ======GUIDELINES FOR SUBMISSION OF APPLICATIONS FOR PATENT AWARDS The Expert Panel, constituted to scrutinise the Applications, has set the following DOs and DON’Ts for consideration for Awards as below: DOs: 1. Applications must include Patents granted only during the financial year 2019-20 (1st April 2019 to 31st March 2020) for evaluation. 2. A Member-Company can apply for more than one Patent. Multiple Patents can be listed in a single application. 3. The Application is to be submitted both as Soft Copy as well as Hard Copies with Summary of the Patents. However, details of Patents may please be sent preferably only in Soft copy. 4. All Family Patents belonging to same invention will be considered as one patent. Country-wise validations for EU or ARIPO patents will not be considered as independent patents. Divisional patents granted with similar inventions will be considered along with parent patent. 5. Different inventions having same title with common priority document will be identified and considered as One Patent. 6. Group companies (including Research Centres) applying independently may indicate if they wish to be considered together or separately. If patent is granted to other than the applicant, the documents justifying the inclusion of such patents (group status) need to be attached. 7. Applications for Awards for Patents granted to individuals will be considered with documentary support of rights transferred to the Applicant (Member Company) 8. Applicants are requested to self-certify the authenticity of information submitted to minimise the review and verification work by IDMA. 9. The Application must be forwarded under a covering letter/or by email duly signed by an authorised signatory along with name, designation and contact details. 10. The covering letter should carry a declaration that “We have read ‘The Guidelines and Criteria for Evaluation of Patents submitted for IDMA Margi Memorial Patent Awards 2019-20 and abide by the same”. DON’Ts: 1. Please do not apply for Patents granted earlier than 1st April 2019 or after 31st March 2020. It will not be considered for this year’s Awards. 2. Please do not apply for a pending patent. It will not be considered and will be disqualified. 3. Please do not apply for Patents which are already withdrawn, abandoned, not maintained or revoked will obviously not be considered. 4. An Application of a patent of the same family (of an invention which has already qualified for award in earlier years), even if granted in another country in the relevant year will not be considered. 5. If the data submitted is found to be not correct or factual, the applications will be disqualified. (Note: The Decision of the Expert Panel will be Final).
IDMA Bulletin LI (48) 22 to 30 December 2020 42
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
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IDMA Bulletin LI (48) 22 to 30 December 2020 43
IDMA Bulletin LI (48) 22 to 30 December 2020 44
IDMA Bulletin LI (48) 22 to 30 December 2020 45
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