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IDMA Bulletin 14Th April 2021

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IDMA Bulletin 14Th April 2021 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. 14 (Pages: 48) 08 TO 14 APRIL 2021 ISSN 0970-6054 WEEKLY PUBLICATION Happy Navratra Baisakhi Cheti Bohag Bihu Chand Nav Varas Poila Boishakh Gudi Padwa Ugadi Pana Sakranti Puthandu Vishu Indian APIs & Formulations for Global Healthcare Clarivate alongWebinar: with IDMA Trends and in global BDMAI API aremanufacturing jointly organising and the webinar strategic success in regulatory affairs Webinar: TrendsFriday, 16th April in 20 2global1 3:30PM – 5:00 APIPM IST manufacturing and strategic In collaborationsuccess with Indian in Drug regulatoryManufacturers’ Association affairs (IDMA) and Bulk Drug Manufacturers’ Association India (BDMA) th Friday, 16 April 2021 3:30PM – 5:00PM IST Register here>> (More details on Page No. 4) IDMA Submission on Draft GuidelinesMr. forYogin Majmudar dealing cases Past President 3:30 – 3:35 pm Opening Address Indian Drug Manufacturers’ of discontinuation of Scheduled FormulationsAssociation (IDMA) (Page No. 4) 5 min. Ms. Jo Butlin VP Sales, Life Sciences R&D 3:35 – 3:40 pm Welcome Address ‘Why Phytopharmaceutical Drug Discovery?’Clarivate, United Kingdom by Dr S S Handa Government bans export of Remdesivir till5 min. COVID-19 situation improves (Page No. 6) (Page No. 38) Ms. Madhurima Datta Manager – Pharma, South Asia 3.40 – 3.45 pm Introduction Clarivate, India 5 min. CBIC imposes anti-dumping duty on imports of Polyethylene Terephthalate Advisory: COVID-19 – Amendments/Relaxations/Compliances (Page No. 8) Trends in global API manufacturing Dr. Leticia Fereira Terra (PET) resin originating in or exported fromSolution China Consultant PR for a period of 5 years - An overview of the global API industry, Clarivate, Brazil 3.45 – 4.10 pm - A deep dive into top API manufacturers 25 min. (Page No. 18) - A look at the impact COVID-19 - Tips to identify potential portfolio candidates Export restrictions on Hydroxychloroquine lifted (Page No. 19) Insolvency and Bankruptcy (prepackaged insolvency resolution process) IDMA Bulletin Rules,DoP LII (14)comes 2021 08 to 14notified out April with 2021 (Page draft No. 21) Guidelines for Rs.6,940 crore PLI scheme1 DCGIto promote directs domesticSLAs to monitor production availability of Bulk of RDrugsemdesivir (Page injections No. 32) & prevent its hoarding (Page No. 30) IDMA Bulletin LII (14) 08 to 14 April 2021 2 Founder Editor: Vol. No. 52 Issue No. 14 08 to 14 April 2021 Dr A Patani ETIZOLAM ADVISORY: Editor: Etizolam API and Formulations: classified as Psychotropic substance and Dr Gopakumar G Nair brought under the NDPS Act, 1985, effective from 23rd March 2021 – reg. ........................................ 8 Associate Editors: GoverNMENT NOTIFICatioNS: J L Sipahimalani Government notifies Inclusion of Tapentadol in Schedule H1 - reg. ................................................. 11 Dr Nagaraj Rao Government Appoints Dr Raghuram Reddy Adidala as Analyst at Central Dr George Patani Drugs Testing Laboratory, Hyderabad - reg. ..................................................................................................... 12 National President Amendment to the Notification Number No.G.S.R.578(E), dated 23rd July, 1983 ............................. 12 Mahesh H Doshi DGFT matterS: Immediate Past National President Late cut for MEIS applications for exports made in the Financial Year 2019-20 - reg. ..................... 14 Deepnath Roy Chowdhury Amendment in Export Policy of Injection Remdesivir and Remdesivir API - reg. ............................. 14 Senior Vice-President NPPA matterS: Dr Viranchi Shah Revised Ceiling Price of 1 Scheduled Formulation of Sch-I under Vice-Presidents: (Prices Control) Order, 2013 based on review order ....................................................................... 15 Bharat N. Shah NPPA notifies revised Ceiling Prices (WPI adjusted) of 2 Sch. (Western Region) formulations of Schedule-I under DPCO 2013 - reg. ......................................................................... 16 Asheesh Roy NPPA notifies Extension of Price of Medical Oxygen - reg. ............................................................. 17 (Eastern Region) CUSTOMS matterS: B K Gupta CBIC rescinds Notification No.10/2016-Customs (ADD) dated 29th March, 2016 - reg. .................... 18 (Northern Region) CBIC imposes anti-dumping duty on imports of Polyethylene Terephthalate (PET) T Ravichandiran resin originating in or exported from China PR for a period of 5 years - reg. ................................... 18 (Southern Region) Government issues amendment for self approval under Section 149 Hon General Secretary of the Customs Act, 1962 - reg. ......................................................................................................... 20 Dr George Patani CBIC matterS: Hon Joint Secretaries CBIC notifies New Exchange Rates w.e.f. 02nd April 2021 - reg. ...................................................... 20 J Jayaseelan COMPANIES laW AMENDMENTS: Atul J Shah Insolvency and Bankruptcy (prepackaged insolvency resolution process) Hon Treasurer Rules, 2021 notified - reg. ................................................................................................................. 21 Vasudev Kataria Insolvency resolution process of the corporate debtor under Chapter III-A For information contact IDMA Secretariat: (H.O.) of the Insolvency and Bankruptcy Code, 2016 (31 of 2016) - reg. .................................................... 22 Daara B Patel PARLIAMENT NEWS: Secretary-General In Lok Sabha & In Rajya Sabha ........................................................................................................ 23 Melvin Rodrigues NEW DeveloPMENTS: Sr Manager (Commercial & Administration) Study discovers crucial step in formation of deadly brain diseases .................................................. 26 C K S Chettiar COVID-19 causes 'unexpected' cellular response in the lungs ......................................................... 27 Asst. Manager (Publications & Administration) NatioNAL NEWS: Delhi Office: Indian Pharma Market registers 10.3% growth in March 2021 .......................................................... 28 Ashok Kumar Madan Centre bans export of Remdesivir & its active ingredients till Covid Executive Director situation improves in country ............................................................................................................. 29 S Ranganathan Demand for Covid vaccines, hydroxychloroquine pushes India’s Asst Manager (Administration) pharma exports to 5-year high ........................................................................................................... 29 DCGI directs SLAs to monitor availability of Remdesivir injections IDMA STATE BOARDS CHAIRMAN & prevent its hoarding ........................................................................................................................ 30 Gujarat State Board : Milan Patel Digital transformation a major challenge for healthcare sector in India: Vishal Jain ......................... 31 Haryana State Board : P K Gupta IPC invites bids for supply of reference standard, pharma impurities from manufacturers ............... 32 Himachal Pradesh & WHO says no to extending Covishield shelf-life to 9 months ............................................................ 33 Uttarakhand State Board : R C Juneja Container shortage, rising freight rates hit pharmaceutical exports .................................................. 33 Karnataka State Board : S M Mudda Madhya Pradesh State Board : Paresh Chawla Pharma firms to track drug supply ..................................................................................................... 34 Tamil Nadu, Puducherry IPC releases draft chapter on "Approach to alternative rapid microbiological methods” ................... 35 & Kerala State Board : J Jayaseelan Mankind Pharma may partner RDIF for Russian Covid-19 vaccine Sputnik V .................................. 36 Telangana State Board : Shaik Janimiya Exporters remain optimistic with weaker rupee and low interest rates .............................................. 37 West Bengal State Board : Shiv Sagar Tewari As Covid cases rise, Zydus to scale up Remdesivir production ........................................................ 37 A Publication of Indian Drug Manufacturers' Association Covid-19 vaccine: Panacea Biotec to begin Sputnik V manufacturing within 90 days ...................... 38 102-B, 'A-Wing', Poonam Chambers, Government bans export of Remdesivir till COVID-19 situation improves ........................................ 38 Dr. A.B. Road, Worli, Mumbai - 400 018 Bharat Biotech to raise Covaxin’s production to 12 million a month by July ..................................... 39 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 Explained: Why there’s a shortage of remdesivir, and what is being done about it .......................... 40 e-mail: mail_ [email protected]/ [email protected]/ Website: www.idma-assn.org INTERNatioNAL NEWS: Published on 7th, 14th, 21st and 30th of every month US FDA OKs first new ADHD drug in over a decade for children ..................................................... 41 Annual Subscription FeaturE: ` 1000/- (for IDMA members) Global Psychedelic Drugs Market Growing Tends in Global Regions with COVID-19 ` 2000/- (for Government Research/Educational Institutions) Pandemic Analysis, Development
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