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IDMA Bulletin 21St August 2020

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PRICE LICENSED TO POST WITHOUT PREPAYMENT PER COPY LICENCE NO. MR/Tech/WPP-337/West/2018-20 ` RNI REGN. NO. 18921/1970 25/- REGN NO. MCW/95/2018-20 VOL. NO. 51 ISSUE NO. 31 (PAGES: 44) 15 TO 21 AUGUST 2020 ISSN 0970-6054 WEEKLY PUBLICATION Indian APIs & Formulations for Global Healthcare NPPA issues revised Guidelines regarding discontinuation of Scheduled Formulation under Para 21 (2) of DPCO, 2013 (Page No. 4) CBIC releases new Compliance Information Portal for Imports and Exports (Page No. 13) Prime Minister Narendra Modi launches platform for “Transparent Taxation - Honouring the Honest” (Page No.16) The new draft Environment Impact Assessment Bill is rubbing environmentalists the wrong way (Page No. 20) IDMA Bulletin LI (31) 15 to 21 August 2020 1 Explained: Will Trump’s order to buy American medicines impact Indian Pharma Industry? (Page No. 37) IDMA Bulletin LI (31) 15 to 21 August 2020 2 Founder Editor: Vol. No. 51 Issue No. 31 15 to 21 August 2020 Dr A Patani NPPA MATTERS: Editor: Dr Gopakumar G Nair Revised Guidelines regarding discontinuation of Scheduled Formulation under Para 21 (2) of DPCO, 2013 - reg. .......................................................................4 Associate Editors: J L Sipahimalani CUSTOMS MATTERS: Dr Nagaraj Rao Procedure to be followed in cases of manufacturing or other operations under- Dr George Patani taken in special warehouses under section 65 of the Customs Act - reg. ....................6 National President Mahesh H Doshi Manufacture and Other Operations in Warehouse (No.2) Regulations, st Immediate Past National President 2019 amended (1 Amendment of 2020) - reg. ..........................................................12 Deepnath Roy Chowdhury Special Warehouse (Custody and Handling of Goods) Regulations, Senior Vice-President 2016 amended (1st Amendment of 2020) - reg. .........................................................12 Dr Viranchi Shah CBIC MATTERS: Vice-Presidents: Bharat N. Shah CBIC New Compliance Information Portal for Imports & Exports ..............................13 (Western Region) CBIC notifies New Exchange Rates w.e.f. 17th July 2020 - reg. .................................15 Asheesh Roy GOVERNMENT PRESS RELEASE: (Eastern Region) B K Gupta Prime Minister Narendra Modi launches platform for (Northern Region) “Transparent Taxation - Honouring the Honest” .........................................................16 T Ravichandiran NEW DEVElopmENTS: (Southern Region) Scientists identify hundreds of drug candidates to treat COVID-19 ...........................18 Hon General Secretary Dr George Patani D614G: Malaysia detects new Coronavirus strain that is 10 times more infectious ...19 Hon Joint Secretaries NATIONAL NEWS: J Jayaseelan The new draft Environment Impact Assessment Bill is rubbing Atul J Shah environmentalists the wrong way ...............................................................................20 Hon Treasurer Vasudev Kataria MoU between CSIR and FSSAI for collaborative research on food & nutrition ..........21 For information contact IDMA Secretariat: (H.O.) Biological E signs pact with J&J for Covid-19 vaccine technology .............................22 Daara B Patel Bharat Biotech-ICMR developed Covaxin is safe, show preliminary Phase I results ...23 Secretary-General Spooked by Donald Trump, Indian pharma cos seeks T R Gopalakrishnan Deputy Secretary-General Government help to woo Capitol Hill ..........................................................................23 Melvin Rodrigues NPPA sets up Price Monitoring and Resource Unit in Karnataka ..............................24 Sr Manager (Commercial & Administration) Indian Consulate holds virtual meet to attract foreign investors for PLI scheme, C K S Chettiar bulk drugs and medical devices parks ........................................................................25 Asst. Manager (Publications & Administration) India’s shortage of Remdesivir is easing, Goa plant to ramp up production: Cipla ....27 Delhi Office: Ashok Kumar Madan DoP appoints IFCI as PMA to implement PLI scheme to promote domestic Executive Director manufacturing of key APIs & Medical devices ............................................................27 S Ranganathan Experts advocate need to assess risk profile of vaccines for COVID-19 amidst Asst Manager (Administration) WHO disapproving Russian vaccine due to lack of Clinical data ...............................29 IDMA STATE BOARDS CHAIRMAN NPPA issues final Guidelines for discontinuation of Scheduled Formulations ...........30 Gujarat State Board : Milan Patel Vaccine manufacturers Globally have capacity to produce 2-4 bn Haryana State Board : P K Gupta doses of COVID-19 vaccines till end of 2021: CEPI survey .......................................31 Himachal Pradesh & Uttarakhand State Board : R C Juneja CSIR-IICT urged to promote Industry-Academia Partnership Karnataka State Board : S M Mudda to boost research in Bulk Drugs .................................................................................31 Madhya Pradesh State Board : Paresh Chawla Tamil Nadu, Puducherry The MSME Concern: Pharmabiz-Editorial ...............................................................32 & Kerala State Board : J Jayaseelan AIOCD seeks PM’s intervention to streamline Telemedicine Guidelines Telangana State Board : Shaik Janimiya as per D&C Act & Pharmacy Act to curtail abuse of prescription drugs .....................33 West Bengal State Board : Utpal Moitra A Publication of INTERNATIONAL NEWS: Indian Drug Manufacturers' Association Coronavisus: Gilead seeks US Approval for Drug that 102-B, 'A-Wing', Poonam Chambers, shortens Covid recovery time .....................................................................................34 Dr. A.B. Road, Worli, Mumbai - 400 018 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 Companies test antibody drugs to treat, prevent COVID-19 ......................................34 e-mail: mail_ [email protected]/ FEATURE: [email protected]/ Website: www.idma-assn.org Published on 7th, 14th, 21st and 30th of every month Explained: Will Trump’s order to buy American medicines Annual Subscription impact Indian Pharma Industry?: Prabha Raghavan ..................................................37 ` 1000/- (for IDMA members) We need to build a ‘digital culture’ for Pharma Research: Sauri Gudlavalleti, ` 2000/- (for Government Research/Educational Institutions) Global Head, IPDO, Dr Reddy’s Laboratories Ltd ......................................................38 ` 4000/- (for non-members) US$ 400 (Overseas) Please send your payment in favour of Now Available ! IDMA-APA Guidelines / Technical Monographs ................................. 17 Indian Drug Manufacturers' Association Subscription Form ................................................................................ 36 IDMAOPINIONS Bulletin EXPRESSED LIXLIV BY (31)THE AU(38) 15THO RS08to OF 21to INDIVIDU 14August OctoberAL AR 2020TICLE S2013 IDMA Bulletin 3 DO Not NECESSARILY REPRESENT THE OFFICIAL VIEW OF IDMA. IDMA Bulletin Advt. Tariff Card..................................................................................... 41 Advertisements .............................................................. ..................2, 19, 40, 42, 43 & 44 NPPA MATTERS Revised Guidelines regarding discontinuation of Scheduled Formulation under Para 21 (2) of DPCO, 2013 - reg. NPPA Office Memorandum dated 14th August, 2020 The Authority in its 209th (overall) and 77th meeting held F No.31(170)/2020/Div.III/NPPA on 06.08.2020 has approved the guidelines for dealing with cases of discontinuation of scheduled formulations Vinod Kotwal, Member Secretary, National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of under Para 21(2) of DPCO, 2013. These guidelines will Chemicals & Fertilizers, New Delhi. be effective with immediate effect and be applicable to all cases under consideration and future cases. Enclosed: Revised Guidelines* *Revised Guidelines for dealing intimations of discontinuation of Scheduled Formulations under Para 21 (2) of DPCO, 2013 1. Paragraph 21(2) of the DPCO, 2013 provides that via return e-mail. Incomplete intimation without any manufacturer of scheduled formulation, intending the requisite documents would be returned for to discontinue any scheduled formulation from the re-submission and the same shall be informed to market shall issue a public notice and also intimate the applicant via email within 10 working days. the Government in Form-IV of this order at least six iii) Wherever Moving Annual Turnover (MAT) of months prior to the intended date of discontinuation the company is 1% or less than 1% of total and the Government may, in public interest, direct MAT value, company has to inform at least six the manufacturer of the scheduled formulation to months prior to the proposed/intended date of continue with the required level of production or discontinuation and to issue public notice in at import for a period not exceeding one year, from the least one newspaper. Such cases will be noted intended date of such discontinuation within a period without issuing any direction to the company and of sixty days of receipt of such intimation. A copy of case will be except where the draft public notice is attached. deemed approved intimation has not been submitted six months prior 2. Taking the above into consideration, the Authority to the proposed/ intended date of discontinuation th th in its 209 (overall) and 77 meeting held on or
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