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Indian Apis & Formulations for Global Healthcare PRICE LICENSED TO POST WITHOUT PREPAYMENT PER COPY LICENCE NO. MR/Tech/WPP-337/West/2021-23 ` RNI REGN. NO. 18921/1970 25/- REGN NO. MCW/95/2021-23 vol. NO. 52 ISSUE NO. 18 (Pages: 40) 08 TO 14 MAY 2021 ISSN 0970-6054 WEEKLY PUBLICATION Indian APIs & Formulations for Global Healthcare Unprecedented increase in the prices of Active Pharmaceutical Ingredients (API) : IDMA Representation to NPPA (Page No. 9) Press Release: IDMA Recommends Grant of “Voluntary Licenses (Vl)” IDMAfor Vaccines Submission by the on Patent Draft GuidelinesHolders to forIndian dealing Companies cases with ofSufficient discontinuation Expertise of in Scheduled this Field Formulations (Page No. 11) (Page No. 4) ‘WhyIDMA Phytopharmaceutical Representation to Minister Drug Discovery?’ of State for by Chemicals Dr S S Handa & Fertilizers (Pageon PLI No. 6)Scheme (Page No. 13) Advisory:Department COVID-19 of Pharmaceuticals – Amendments/Relaxations/Compliances Re-invites application for Production (PageLinked No. 8)Incentive (PLI) Scheme with the last date of Submission as th Export28 July restrictions 2021 (Page on No.Hydroxychloroquine 15) lifted (Page No. 19) Fight Covid with compulsory licensing (Page No. 20) IDMA Bulletin DoP LII (18)comes 08 to 14 out May with2021 draft Guidelines for Rs.6,940 crore PLI scheme1 toGST promote waiver domesticon Covid productionjabs, drugs ofwill Bulk backfire: Drugs FM (Page Nirmala No. 32) Sitharaman (Page No. 27) IDMA Bulletin LII (18) 08 to 14 May 2021 2 Founder Editor: Vol. No. 52 Issue No. 18 08 to 14 May 2021 Dr A Patani IDMA ACTIVITIES: Editor: Dr Gopakumar G Nair The Journey so far and the Roadmap Ahead .................................................................. 6 Associate Editors: Mr. Deepnath Roy Chowdhury, IDMA's Immediate Past National President J L Sipahimalani graces the cover page of QUALPHARMA April 2021 issue ............................................ 8 Dr Nagaraj Rao Unprecedented increase in the prices of Active Pharmaceutical Dr George Patani Ingredients (API) : IDMA Representation to NPPA ......................................................... 9 National President Current Issues In Exports of Pharmaceutical Goods: IDMA Representation Mahesh H Doshi to Minister of State for Ports, Shipping and Waterways & Minister of State Immediate Past National President for Chemical and Fertilizers – Reg. ............................................................................... 10 Deepnath Roy Chowdhury Press Release:IDMA Recommends Grant of “Voluntary Licenses (Vl)” for Vaccines by Senior Vice-President the Patent Holders to Indian Companies with Sufficient Expertise in this Field ............ 11 Dr Viranchi Shah Seeking kind intervention for creating a mechanism for making environmental Vice-Presidents: clearance (EC) and consent to establish (CTE) a one step process : Bharat N. Shah IDMA Representation to MoEFCC ................................................................................ 12 (Western Region) IDMA Representation to Minister of State for Chemicals & Fertilizers Asheesh Roy (Eastern Region) on PLI Scheme - reg ...................................................................................................... 13 B K Gupta GOVERNMENT COMMUNICATION: (Northern Region) Department of Pharmaceuticals Re-invites application for Production Linked th T Ravichandiran Incentive (PLI) Scheme with the last date of Submission as 28 July 2021 –reg. ........ 15 (Southern Region) GOVERNMENT PRESS RELEASES: Hon General Secretary DGFT’s COVID-19 Helpdesk coordinating and resolving International Dr George Patani Trade related Issues ...................................................................................................... 16 Hon Joint Secretaries DCGI approves anti-COVID drug developed by DRDO for emergency use ................. 17 J Jayaseelan Atul J Shah DGFT MATTER: Hon Treasurer Extension of validity of Registration cum Membership Certificate Vasudev Kataria (RCMC) beyond 31st March, 2021. ................................................................................ 18 For information contact IDMA Secretariat: (H.O.) IPR MATTER: Daara B Patel EU Split on Covid-Patent Waivers Casts Doubt on U.S. Plan ....................................... 18 Secretary-General Melvin Rodrigues DoPT MATTER: Sr Manager (Commercial & Administration) Appointment of Shri Vaibhav Bajaj, IRS(C&CE:2009) as Private Secretary to to the C K S Chettiar Minister for Health & Family Welfare (Dr. Harsh Vardhan) in the Ministry of Health & Asst. Manager (Publications & Administration) Family Welfare - reg. ..................................................................................................... 19 Delhi Office: NATIONAL NEWS: Ashok Kumar Madan Fight Covid with compulsory licensing ........................................................................... 20 Executive Director S Ranganathan Zydus’ wrapping up Phase-III trials of three dose vaccine ............................................ 21 Asst Manager (Administration) Pfizer-BioNTech vaccine is highly effective against variants, studies find .................... 21 India to receive between 190-250 million fully subsidised Covid vaccines; IDMA STATE BOARDS CHAIRMAN $30 million financial assistance: Gavi ............................................................................ 23 Gujarat State Board : Milan Patel Govt relaxes procurement norms for health, pharma ministries, DRDO ....................... 23 Haryana State Board : P K Gupta Himachal Pradesh & Vivimed Labs gets DGHS nod to manufacture, market Favipiravir tablets in India ....... 24 Uttarakhand State Board : R C Juneja Centre still meandering on Covid-19 vaccine strategy .................................................. 25 Karnataka State Board : S M Mudda Madhya Pradesh State Board : Paresh Chawla Budget heading for vaccination expenditure does not inhibit Centre Tamil Nadu, Puducherry from using funds: FinMin ............................................................................................... 25 & Kerala State Board : J Jayaseelan DCGI approves anti-COVID drug developed by DRDO for emergency use ................. 26 Telangana State Board : Shaik Janimiya West Bengal State Board : Shiv Sagar Tewari Bharat Biotech commences direct supply of ‘Covaxin’ to 14 states .............................. 27 A Publication of GST waiver on Covid jabs, drugs will backfire: FM Nirmala Sitharaman ...................... 27 Indian Drug Manufacturers' Association Russia’s Sputnik V jabs set to make India debut at private hospitals ............................ 28 102-B, 'A-Wing', Poonam Chambers, Dr. A.B. Road, Worli, Mumbai - 400 018 As demand soars, health & wellness brands expect 35-50% Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 revenue growth in FY22 ................................................................................................ 29 e-mail: [email protected]/ [email protected]/ Website: www.idma-assn.org Jab shortage forces health startups to defer plans to vaccinate India Inc ..................... 30 Published on 7th, 14th, 21st and 30th of every month Fixing the vaccine crunch .............................................................................................. 31 Annual Subscription Get Pfizer in, work out indemnity ................................................................................... 32 ` 1000/- (for IDMA members) FEATURE: ` 2000/- (for Government Research/Educational Institutions) ` 4000/- (for non-members) US$ 400 (Overseas) How Indian pharma companies should have dealt with Remdesivir crisis .................... 33 Please send your payment in favour of A tale of two cities .......................................................................................................... 34 Indian Drug Manufacturers' Association IDMAOPINIONS Bulletin EXPRESSED LIIXLIV BY TH(18)E AU(38) T08HO RS08 to OF to14 INDIVIDU 14 May OctoberA L2021 ARTICL E S2013 North Carolina’s Bio-Pharma Advantage: (Advertisement)..............................................3 4 DO Not NECESSARILY REPRESENT THE OFFICIAL VIEW OF IDMA. IDMA Bulletin Advt. Tariff card ......................................................................................36 IDMAAdvertisements Bulletin Advt. ............................................................. Tariff card ................................................................................................................................ 2, 35, 38, 39 & 4440 April 14, 2021 Dear Pharmaceutical Leader: As North Carolina’s newly appointed Secretary of Commerce, allow me to introduce you to our state’s esteemed business-friendly environment, including one of the leading pharmaceutical and manufacturing clusters in the United States. It is supported by a top-rated college and university system and is immersed in a rich and diverse culture. North Carolina has invested in building its life sciences sector since the mid-1980s. The results are apparent today with 775 companies and a diverse and talented workforce of 67,000. This robust ecosystem also includes approximatively 2,500 specialized support companies and suppliers, and several private-sector organizations. Pharmaceutical and medicine manufacturing is the largest part of our life sciences cluster, with 30,000 skilled people making specialized pharmaceutical and biological products. We’re proud to count Accord Healthcare, Aurobindo, Glenmark, and KriGen among those companies, alongside other major pharmas including Baxter, GSK, Novo Nordisk,
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