PRICE HON’ble LICENSED TO POST WITHOUT PREPAYMENT PER COPY SUPREME COURTLI CENCE NO. MR/Tech/WPP-337/West/2018-20 JUDGEMENT - 25/- RNI REGN.RN INO. REG 78921/1970N. NO. 18921/1970 GLEEVEC Regn No.R EMCW/95/2015-2017GN NO. MCW/95/2018-20 Supreme Court VOL. NO. 51 ISSUE NO. 36 (PAGES: 44) 22 TO 30 SEPTEMBER 2020 ISSN 0970-6054 WEEKLY PUBLICATION Indian APIs & Formulations for Global Healthcare DGFT extends implementation date of Track and Trace for Pharma Export Packs to 1st April 2021 (Page No. 12) Indian Pharma sector set to emerge stronger due to higher Exports (Page No. 28) India’s World Bank Executive Director S Aparna, IAS named New Pharma Secretary (Page No. 30) DCGI’s new Guidelines for Covid-19 vaccine: At least IDMA Bulletin50 LI percent(36) 22 to 30 efficacy September 2020 in Phase 3 Trials (Page No. 31) 1 Union Minister Gowda lauds contribution of Indian Pharma Industry amid COVID-19 crisis (Page No. 36) IDMA Bulletin LI (36) 22 to 30 September 2020 2 Founder Editor: Vol. No. 51 Issue No. 36 22 to 30 September 2020 Dr A Patani IDMA ACTIVITIES: Editor: Dr Gopakumar G Nair IDMA Representation to DCG(I) re. Inclusion of ‘Marketer’ in D&C Rules – reg. ........... 4 Associate Editors: IDMA Representation to DCGI for extension of validity of Form 10 Licence J L Sipahimalani along with Form 41 Registration Certificate – reg. ........................................................ 6 Dr Nagaraj Rao Dr George Patani IDMA Representation to FSSAI for Clarification of status of Methylcobalamin National President as Ingredient under FSS Regulations 2016 – reg. ......................................................... 7 Mahesh H Doshi NPPA MATTERS: Immediate Past National President Deepnath Roy Chowdhury NPPA order for submission of data by manufacturers and re-fillers of medical oxygen - reg. ............................................................................ 9 Senior Vice-President Dr Viranchi Shah CBIC MATTERS: Vice-Presidents: CBIC notifies Administrative Instructions for recovery of Interest Bharat N. Shah on Net Cash Tax Liability w.e.f. 01.07.2017 - reg. ........................................................ 10 (Western Region) th Asheesh Roy CBIC notifies New Exchange Rates w.e.f. 18 September 2020 - reg. ........................ 10 (Eastern Region) DGFT MATTERS: B K Gupta (Northern Region) DGFT extends implementation date of Track and Trace for Pharma Export st T Ravichandiran Packs to 1 April 2021 – reg. ........................................................................................ 12 (Southern Region) Publication of Revised ANF-7A – reg. .......................................................................... 12 Hon General Secretary PARLIAMENT NEWS: Dr George Patani Hon Joint Secretaries In Lok Sabha & In Rajya Sabha ................................................................................... 20 J Jayaseelan Atul J Shah NEW DEVELOPMENTS: Hon Treasurer T cells take the lead in controlling SARS-CoV-2 and reducing Vasudev Kataria COVID-19 disease severity .......................................................................................... 27 For information contact IDMA Secretariat: (H.O.) Kochi-based Company to start Phase 2b trials of COVID Daara B Patel Secretary-General drug next week ............................................................................................................. 28 T R Gopalakrishnan NatiONAL NEWS: Deputy Secretary-General Indian Pharma sector set to emerge stronger due to higher Exports ........................... 28 Melvin Rodrigues Sr Manager (Commercial & Administration) Incentives not enough, Bulk Drug industry seeks level playing C K S Chettiar field to make India ‘Atma Nirbhar’ ................................................................................. 29 Asst. Manager (Publications & Administration) India’s World Bank Executive Director named New Pharma Secretary ....................... 30 Delhi Office: DCGI’s new Guidelines for Covid-19 vaccine: At least Ashok Kumar Madan 50 percent efficacy in Phase 3 Trials ........................................................................... 31 Executive Director S Ranganathan Indian Pharma needs regulatory surveillance system for disposal Asst Manager (Administration) of unused & date expired drugs: Dr Jagashetty ........................................................... 31 IDMA STATE BOARDS CHAIRMAN Ayurveda offers myriad approaches to pandemics and Gujarat State Board : Milan Patel all infectious diseases: Dr Ram Manohar ..................................................................... 32 Haryana State Board : P K Gupta Haryana showcases readiness to bid for Bulk Drugs and Himachal Pradesh & Uttarakhand State Board : R C Juneja Medical Device Parks at PHDCCI webinar .................................................................. 33 Karnataka State Board : S M Mudda Hyderabad soon to emerge as leading API Hub of India as more firms Madhya Pradesh State Board : Paresh Chawla seek land to set up their API units in Pharma City ....................................................... 34 Tamil Nadu, Puducherry & Kerala State Board : J Jayaseelan SCTIMST signs MoU with Tynor Orthotics for joint R&D in orthotics Telangana State Board : Shaik Janimiya and rehabilitation devices ............................................................................................. 34 West Bengal State Board : Utpal Moitra Punjab Government receives encouraging response from A Publication of Pharma industry for Bathinda Bulk Drug Park ............................................................. 35 Indian Drug Manufacturers' Association 102-B, 'A-Wing', Poonam Chambers, Industry approaches Centre to urgently notify methylcobalamin Dr. A.B. Road, Worli, Mumbai - 400 018 for neurological disorders ............................................................................................. 36 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 e-mail: mail_ [email protected]/ Union Minister Gowda lauds contribution of Indian Pharma [email protected]/ Website: www.idma-assn.org Industry amid COVID-19 crisis .................................................................................... 36 th th st th Published on 7 , 14 , 21 and 30 of every month Can’t directly deal with complaints of Unethical Practices: Department Annual Subscription of Pharmaceuticals ....................................................................................................... 37 ` 1000/- (for IDMA members) ` 2000/- (for Government Research/Educational Institutions) InternatiONAL NEWS: ` 4000/- (for non-members) US$ 400 (Overseas) Please send your payment in favour of Russia to supply Avifavir drug to 17 nations for Coronavirus Treatment .................... 38 Indian Drug Manufacturers' Association FEATURE: IDMAOPINIONS Bulletin EXPRESSED LIXLIV BY (36)THE AU(38) 22THO RS08to OF 30to INDIVIDU 14September OctoberAL ARTICLE S20202013 3 DO Not NECESSARILY REPRESENT THE OFFICIAL VIEW OF IDMA. Why Vaccines are a better bet against Coronavirus than Drugs: Michelle Cortez ...... 39 Advertisements .................................................................... ..................2, 41, 42, 43 & 44 IDMA ACTIVITIES IDMA Representation to DCG(I) re. Inclusion of ‘Marketer’ in D&C Rules – reg. The Association has submitted the following by another manufacturer under an agreement for representation on 23rd September 2020 to Dr V G marketing of such drug by labeling or affixing his name Somani, Drugs Controller General of India, Central on the label of the drug with a view for its sale and Drugs Standard Control Organisation, New Delhi distribution;’ (in response to Gazette Notification No.GSR 101(E) dated 11th February 2020) on the above subject: The term ‘Agent or in any other capacity’ in the definition of 'Marketer' have wider meaning and are not “Greetings from Indian Drug manufacturers’ specific. Be sides, as explained below, Marketer not being Association. a manufacturer or an agent gets an exemption under We refer to the Gazetted Notification as above for Section 19(3). The definition thus needs to be revised defining “Marketer’ under Drugs and Cosmetics Rules that accordingly. places certain responsibilities for quality and regulatory compliance on the marketer for the products marketed by In fact, provisions under Section 19(3) of the Act him. The Rule comes into force on the 1st day of March, provide safeguard to the person not being either a 2021. manufacturer or agent of the drug. Since the Section is not being amended, it would have conflicting implications We had made a detailed submission on 24th July for making marketers responsible for quality as well as 2019 (copy enclosed for immediate reference)* on other regulatory compliances. Any Rule contrary to the the draft Notification amendment [GSR 447(E) dated provisions under the Act or having overriding effect will 24th June 2019]. While IDMA had welcomed in principle not withstand judicial scrutiny. the sharing of responsibilities for quality by the marketer, we had brought out the issues of: 84E. Responsibility of marketer of the drugs - Any marketer who sells or distributes any drug shall be a) lack of clarity related to responsibilities for quality responsible for quality of that drug as well as other and compliance with regulations; and regulatory compliances along with the manufacturer under b) requirements being inconsistent with the law as a these rules.” challenge for implementation of the Notification in it's draft form. As stated in