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. 23 (Pages: 44) 15 to 21 june 2021 ISSN 0970-6054 weekly publication
Indian APIs & Formulations for Global Healthcare
Implementation of Revised Gst for Covid Drugs : IDMA Submission on Draft Guidelines for dealing cases ofIDMA discontinuation representation of Scheduled to Formulations DoP (Page (PageNo. 15) No. 4) ‘Why Phytopharmaceutical Drug Discovery?’ by Dr S S Handa (PageCovid-19: No. 6) On vaccine interval, follow the science (Page No. 23) Advisory: COVID-19 – Amendments/Relaxations/Compliances (PageWatchdog No. 8) tells pharma firms to pass on rate cut Exportbenefits restrictions to consumers on Hydroxychloroquine (Page No. lifted25) (Page No. 19)
IDMA Bulletin DoP LII (23)comes 15 to 21 out June with 2021 draft Guidelines for Rs.6,940 crore PLI scheme1 Covid vaccination: The race against time (Page No. 34) to promote domestic production of Bulk Drugs (Page No. 32)
IDMA Bulletin LII (23) 15 to 21 June 2021 2
Founder Editor: Vol. No. 52 Issue No. 23 15 to 21 June 2021 Dr A Patani Editor: Dr Gopakumar G Nair Associate Editors: J L Sipahimalani Dr Nagaraj Rao Dr George Patani National President Mahesh H Doshi Immediate Past National President Deepnath Roy Chowdhury Senior Vice-President Dr Viranchi Shah Vice-Presidents: Bharat N. Shah (Western Region) Asheesh Roy (Eastern Region) B K Gupta (Northern Region) T Ravichandiran (Southern Region) Hon General Secretary Dr George Patani Hon Joint Secretaries J Jayaseelan Atul J Shah Hon Treasurer Vasudev Kataria For information contact IDMA Secretariat: (H.O.) Daara B Patel Secretary-General Melvin Rodrigues Sr Manager (Commercial & Administration) C K S Chettiar Asst. Manager (Publications & Administration) Delhi Office: Ashok Kumar Madan Executive Director S Ranganathan Asst Manager (Administration)
IDMA STATE BOARDs CHAIRMAN Gujarat State Board : Milan Patel Haryana State Board : P K Gupta Himachal Pradesh & Uttarakhand State Board : R C Juneja Karnataka State Board : S M Mudda Madhya Pradesh State Board : Paresh Chawla Tamil Nadu, Puducherry & Kerala State Board : J Jayaseelan Telangana State Board : Shaik Janimiya West Bengal State Board : Shiv Sagar Tewari A Publication of Indian Drug Manufacturers' Association 102-B, 'A-Wing', Poonam Chambers, Dr. A.B. Road, Worli, Mumbai - 400 018 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 e-mail: [email protected]/ [email protected]/ Website: www.idma-assn.org Published on 7th, 14th, 21st and 30th of every month Annual Subscription ` 1000/- (for IDMA members) ` 2000/- (for Government Research/Educational Institutions) ` 4000/- (for non-members) US$ 400 (Overseas) Please send your payment in favour of Indian Drug Manufacturers' Association IDMAOpinions Bulletin Expressed LIIXLIV By Th(23)e Au(38) t15ho rs08 to Of to21 Individu 14 June Octoberal Ar2021ticle s2013 3 Do Not Necessarily Represent The Official View Of Idma. Advertisements...... 2, 4, 33, 38, 39, 42, 43 & 44 IDMA Bulletin Advt. Tariff card...... 44
ADVERTISEMENT FOR NEW RECRUITMENT ADVERTISEMENT FOR NEW RECRUITMENT ADVERTISEMENTCOMPANYSITUATION FOR INTRODUCTION SNEW VACANT RECRUITMENT COMPANY INTRODUCTION COMPANY INTRODUCTION A reputed Group, engaged in manufactureCOMPANY of Pharmaceutical INTRODUCTION Formulations having Sales of over Rs 200 Cr (Exports constituteA reputed more Group, than engaged 50%) and in manufacturecurrently modernising/expanding of Pharmaceutical Formulationsits facilities to havingEU GMP Sales Standards of over is Rs looking 200 Crfor (Exportssuitable constituteA reputed more Group, than engaged 50%) and in manufacturecurrently modernising/expanding of Pharmaceutical Formulationsits facilities to havingEU GMP Sales Standards of over is Rs looking 200 Crfor (Exportssuitable AFDQGLGDWHV reputed Group, WR ߔOO XS engaged IROORZLQJ in YDFDQFLHV$OO manufacture ofVLWXDWLRQV Pharmaceutical ZLOO UHTXLUH Formulations WKH FDQGLGDWHV having WR Sales VWD\ QHDU of over WKH RsIDFWRULHV 200 Cr ORFDWHG (Exports LQ FDQGLGDWHVconstitute more WR ߔOO than XS IROORZLQJ50%) and YDFDQFLHV$OOcurrently modernising/expanding VLWXDWLRQV ZLOO UHTXLUH its WKHfacilities FDQGLGDWHV to EU GMP WR VWD\ Standards QHDU WKH is IDFWRULHV looking for ORFDWHG suitable LQ 0DUDWKL+LQGLDQG(QJOLVK/RRNLQJIRU5HVXOWRULHQWHGSHUVRQV more than 50%) and currently modernising/expanding its facilities to EU GMP Standards is looking for suitableڏconstitute0DKDUDVKWUDZLWKLQNPRI0XPEDL/DQJXDJHVNLOOV 0DUDWKL+LQGLDQG(QJOLVK/RRNLQJIRU5HVXOWRULHQWHGSHUVRQV WR ߔOO XS IROORZLQJ YDFDQFLHV$OO VLWXDWLRQV ZLOO UHTXLUH WKH FDQGLGDWHV WR VWD\ QHDU WKH IDFWRULHV ORFDWHG LQڏFDQGLGDWHV0DKDUDVKWUDZLWKLQNPRI0XPEDL/DQJXDJHVNLOOV 0DUDWKL+LQGLDQG(QJOLVK/RRNLQJIRU5HVXOWRULHQWHGSHUVRQVFDQGLGDWHV3URGXFWLRQ7DUJHWVDVZHOODV4XDOLW\RULHQWHGDSSURDFK WR ߔOO XS IROORZLQJ YDFDQFLHV$OO VLWXDWLRQV ZLOO UHTXLUH WKH FDQGLGDWHV WR VWD\ QHDU WKH IDFWRULHV ORFDWHG LQڏ0DKDUDVKWUDZLWKLQNPRI0XPEDL/DQJXDJHVNLOOV 0DUDWKL+LQGLDQG(QJOLVK/RRNLQJIRU5HVXOWRULHQWHGSHUVRQVڏ3URGXFWLRQ7DUJHWVDVZHOODV4XDOLW\RULHQWHGDSSURDFK0DKDUDVKWUDZLWKLQNPRI0XPEDL/DQJXDJHVNLOOV 0DUDWKL+LQGLDQG(QJOLVK/RRNLQJIRU5HVXOWRULHQWHGSHUVRQVڏ3URGXFWLRQ7DUJHWVDVZHOODV4XDOLW\RULHQWHGDSSURDFK0DKDUDVKWUDZLWKLQNPRI0XPEDL/DQJXDJHVNLOOV 3URGXFWLRQ7DUJHWVDVZHOODV4XDOLW\RULHQWHGDSSURDFK1. PRODUCTION MANAGER 1. PRODUCTION MANAGER 'FWECVKQPCN3WCNKſECVKQPU %3KDUP03KDUP1. PRODUCTION MANAGER 'FWECVKQPCN3WCNKſECVKQPU %3KDUP03KDUP1. PRODUCTION MANAGER 'FWECVKQPCN3WCNKſECVKQPU 1. PRODUCTION MANAGER 'FWECVKQPCN3WCNKſECVKQPUAge: 42-46 years %3KDUP03KDUP 'FWECVKQPCN3WCNKſECVKQPUAge: 42-46 years %3KDUP03KDUP Age 3RZGHUV LQ D UHSXWHG *03 &HUWLߔHG H[SHULHQFH LQ SURGXFWLRQ RI7DEOHWV&DSVXOHV ڕ \HDUV AgeWork: 42-46 experience years 3RZGHUV LQ D UHSXWHG *03 &HUWLߔHG H[SHULHQFH LQ SURGXFWLRQ RI7DEOHWV&DSVXOHV ڕ \HDUV WorkAge: 42-46 experience years Work&RPSDQ\6KRUWWHUPH[SRVXUHWRSURGXFWGHYHORSPHQWPD\EHDQDVVHW experience 3RZGHUV LQ D UHSXWHG *03 &HUWLߔHG H[SHULHQFH LQ SURGXFWLRQ RI7DEOHWV&DSVXOHV ڕ \HDUV Work&RPSDQ\6KRUWWHUPH[SRVXUHWRSURGXFWGHYHORSPHQWPD\EHDQDVVHW experience 3RZGHUV LQ D UHSXWHG *03 &HUWLߔHG H[SHULHQFH LQ SURGXFWLRQ RI7DEOHWV&DSVXOHV ڕ \HDUV Work experience \H[SHULHQFHDV$VVLVWDQWSURGXFWLRQPDQDJHURU3URGXFWLRQ0DQDJHULQDJRRGVL]HG*03&RPSDQ\SUHIHUDEOڕRPSDQ\6KRUWWHUPH[SRVXUHWRSURGXFWGHYHORSPHQWPD\EHDQDVVHW\HDUV& H[SHULHQFHDV$VVLVWDQWSURGXFWLRQPDQDJHURU3URGXFWLRQ0DQDJHULQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\&RPSDQ\6KRUWWHUPH[SRVXUHWRSURGXFWGHYHORSPHQWPD\EHDQDVVHWڕLQDQ(8*03RUHTXLYDOHQWXQLW\HDUV \H[SHULHQFHDV$VVLVWDQWSURGXFWLRQPDQDJHURU3URGXFWLRQ0DQDJHULQDJRRGVL]HG*03&RPSDQ\SUHIHUDEOڕLQDQ(8*03RUHTXLYDOHQWXQLW\HDUV \H[SHULHQFHDV$VVLVWDQWSURGXFWLRQPDQDJHURU3URGXFWLRQ0DQDJHULQDJRRGVL]HG*03&RPSDQ\SUHIHUDEOڕ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ſECVKQPU %3KDUP03KDUPZLWK'HJUHHRU'LSORPDLQ$GPLQLVWUDWLRQ0DQDJHPHQW2. FACTORY MANAGER 'FWECVKQPCN3WCNKſECVKQPU %3KDUP03KDUPZLWK'HJUHHRU'LSORPDLQ$GPLQLVWUDWLRQ0DQDJHPHQW2. FACTORY MANAGER 'FWECVKQPCN3WCNKſECVKQPU 2. FACTORY MANAGER 'FWECVKQPCN3WCNKſECVKQPUAge: 45-50 years %3KDUP03KDUPZLWK'HJUHHRU'LSORPDLQ$GPLQLVWUDWLRQ0DQDJHPHQW 'FWECVKQPCN3WCNKſECVKQPUAge: 45-50 years %3KDUP03KDUPZLWK'HJUHHRU'LSORPDLQ$GPLQLVWUDWLRQ0DQDJHPHQW Age H[SHULHQFHLQSURGXFWLRQRI)RUPXODWLRQVDWYDULRXVOHYHOVLQDUHSXWHG*03&HUWLߔHGڕ\HDUV AgeWork: 45-50 experience years H[SHULHQFHLQSURGXFWLRQRI)RUPXODWLRQVDWYDULRXVOHYHOVLQDUHSXWHG*03&HUWLߔHGڕ\HDUV WorkAge: 45-50 experience years Work&RPSDQ\([SRVXUHWR5 'PD\EHXVHIXO experience H[SHULHQFHLQSURGXFWLRQRI)RUPXODWLRQVDWYDULRXVOHYHOVLQDUHSXWHG*03&HUWLߔHGڕ\HDUV 'PD\EHXVHIXOWork experience RPSDQ\([SRVXUHWR5& H[SHULHQFHLQSURGXFWLRQRI)RUPXODWLRQVDWYDULRXVOHYHOVLQDUHSXWHG*03&HUWLߔHGڕ\HDUV Work experience H[SHULHQFHLQPDQDJHULDOFDSDFLW\LQ3URGXFWLRQPDQDJHPHQWODERXUPDQDJHPHQW*HQHUDODGPLQLVWUDWLRQDQGڕ'PD\EHXVHIXO\HDUV RPSDQ\([SRVXUHWR5& 'PD\EHXVHIXO H[SHULHQFHLQPDQDJHULDOFDSDFLW\LQ3URGXFWLRQPDQDJHPHQWODERXUPDQDJHPHQW*HQHUDODGPLQLVWUDWLRQDQG&RPSDQ\([SRVXUHWR5ڕKDQGOLQJ*RYHUQPHQWERGLHVLQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\LQD(8*03RUHTXLYDOHQWXQLW2XWRIWKLV\HDUV H[SHULHQFHLQPDQDJHULDOFDSDFLW\LQ3URGXFWLRQPDQDJHPHQWODERXUPDQDJHPHQW*HQHUDODGPLQLVWUDWLRQDQGڕKDQGOLQJ*RYHUQPHQWERGLHVLQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\LQD(8*03RUHTXLYDOHQWXQLW2XWRIWKLV\HDUV H[SHULHQFH LQ VHQLRU SRVLWLRQ DV *HQHUDO 0DQDJHU RU )DFWRU\ 0DQDJHU LQ PHGLXP VL]HG &RPSDQ\ LQ ڕH[SHULHQFHLQPDQDJHULDOFDSDFLW\LQ3URGXFWLRQPDQDJHPHQWODERXUPDQDJHPHQW*HQHUDODGPLQLVWUDWLRQDQGDW OHDVW \HDUVڕHDUV\ H[SHULHQFH LQ VHQLRU SRVLWLRQ DV *HQHUDO 0DQDJHU RU )DFWRU\ 0DQDJHU LQ PHGLXP VL]HG &RPSDQ\ LQ ڕDWKDQGOLQJ*RYHUQPHQWERGLHVLQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\LQD(8*03RUHTXLYDOHQWXQLW2XWRIWKLV OHDVW \HDUV KDQGOLQJ*RYHUQPHQWERGLHVLQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\LQD(8*03RUHTXLYDOHQWXQLW2XWRIWKLVSKDUPDFHXWLFDOV H[SHULHQFH LQ VHQLRU SRVLWLRQ DV *HQHUDO 0DQDJHU RU )DFWRU\ 0DQDJHU LQ PHGLXP VL]HG &RPSDQ\ LQ ڕSKDUPDFHXWLFDOVDW OHDVW \HDUV H[SHULHQFH LQ VHQLRU SRVLWLRQ DV *HQHUDO 0DQDJHU RU )DFWRU\ 0DQDJHU LQ PHGLXP VL]HG &RPSDQ\ LQ ڕ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ſECVKQPU %3KDUP03KDUP06F3. QUALITY CONTROL MANAGER 'FWECVKQPCN3WCNKſECVKQPU %3KDUP03KDUP06F3. QUALITY CONTROL MANAGER 'FWECVKQPCN3WCNKſECVKQPU 3. QUALITY CONTROL MANAGER 'FWECVKQPCN3WCNKſECVKQPUAge: 40-45 years %3KDUP03KDUP06F 'FWECVKQPCN3WCNKſECVKQPUAge: 40-45 years %3KDUP03KDUP06F Age \H[SHULHQFHLQ4XDOLW\&RQWURORI2UDO'RVDJH)RUPVLQDUHSXWHG*03&HUWLߔHG&RPSDQڕ\HDUV AgeWork: 40-45 experience years \H[SHULHQFHLQ4XDOLW\&RQWURORI2UDO'RVDJH)RUPVLQDUHSXWHG*03&HUWLߔHG&RPSDQڕ\HDUV WorkAge: 40-45 experience years Work6KRUWH[SRVXUHWR) ' experience \H[SHULHQFHLQ4XDOLW\&RQWURORI2UDO'RVDJH)RUPVLQDUHSXWHG*03&HUWLߔHG&RPSDQڕ\HDUV ' experience Work6KRUWH[SRVXUHWR) \H[SHULHQFHLQ4XDOLW\&RQWURORI2UDO'RVDJH)RUPVLQDUHSXWHG*03&HUWLߔHG&RPSDQڕ\HDUV Work experience H[SHULHQFHDV$VVLVWDQW4&0DQDJHURU4&0DQDJHULQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\LQDQ(8*03ڕ'\HDUV 6KRUWH[SRVXUHWR) ' (H[SHULHQFHDV$VVLVWDQW4&0DQDJHURU4&0DQDJHULQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\LQDQ(8*036KRUWH[SRVXUHWRڕRUHTXLYDOHQWXQLW\HDUV H[SHULHQFHDV$VVLVWDQW4&0DQDJHURU4&0DQDJHULQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\LQDQ(8*03ڕRUHTXLYDOHQWXQLW\HDUV H[SHULHQFHDV$VVLVWDQW4&0DQDJHURU4&0DQDJHULQDJRRGVL]HG*03&RPSDQ\SUHIHUDEO\LQDQ(8*03ڕHDUV\ RUHTXLYDOHQWXQLW6KRXOG SRVVHVV KDQGV RQ H[SHULHQFH LQ WHVWLQJ DQG KDQGOLQJ RI 4& HTXLSPHQW 6KRXOG EH H[SHUW LQ WURXEOH VKRRWLQJ DQDO\VLQJDQGVROYLQJFKDOOHQJHVLQWHVWLQJPHWKRGGHYHORSPHQW6KRXOGRUHTXLYDOHQWXQLW SRVVHVV KDQGV RQ H[SHULHQFH LQ WHVWLQJ DQG KDQGOLQJ RIVDQGYDOLGDWLRQV 4& HTXLSPHQW 6KRXOG EH H[SHUW LQ WURXEOH VKRRWLQJ DQDO\VLQJDQGVROYLQJFKDOOHQJHVLQWHVWLQJPHWKRGGHYHORSPHQW6KRXOG SRVVHVV KDQGV RQ H[SHULHQFH LQ WHVWLQJ DQG KDQGOLQJ RIVDQGYDOLGDWLRQV 4& HTXLSPHQW 6KRXOG EH H[SHUW LQ WURXEOH VKRRWLQJ 6KRXOG SRVVHVV KDQGV RQ H[SHULHQFH LQ WHVWLQJ DQG KDQGOLQJ RI 4& HTXLSPHQW 6KRXOG EH H[SHUW LQ WURXEOH VKRRWLQJ DQDO\VLQJDQGVROYLQJFKDOOHQJHVLQWHVWLQJPHWKRGGHYHORSPHQWFDA Approvals in Microbiology, Chemical and Instrumental VDQGYDOLGDWLRQV FDADQDO\VLQJDQGVROYLQJFKDOOHQJHVLQWHVWLQJPHWKRGGHYHORSPHQW Approvals in Microbiology, Chemical and Instrumental VDQGYDOLGDWLRQV FDA([SHULHQFHLQKDQGOLQJDXGLWVIURP)'$:+2(8*03RU8.0+5$DQGPXOWLQDWLRQDOFRPSDQLHVLVSUHIHUDEOH Approvals in Microbiology, Chemical and Instrumental ([SHULHQFHLQKDQGOLQJDXGLWVIURP)'$:+2(8*03RU8.0+5$DQGPXOWLQDWLRQDOFRPSDQLHVLVSUHIHUDEOHFDA Approvals in Microbiology, Chemical and Instrumental ([SHULHQFHLQKDQGOLQJDXGLWVIURP)'$:+2(8*03RU8.0+5$DQGPXOWLQDWLRQDOFRPSDQLHVLVSUHIHUDEOH'ZRGEVCVKQPU 0XVWEHZHOOYHUVHGZLWK4&HTXLSPHQWWKHLULQVWDOODWLRQVYDOLGDWLRQVDQGRSHUDWLRQV ([SHULHQFHLQKDQGOLQJDXGLWVIURP)'$:+2(8*03RU8.0+5$DQGPXOWLQDWLRQDOFRPSDQLHVLVSUHIHUDEOH'ZRGEVCVKQPU 0XVWEHZHOOYHUVHGZLWK4&HTXLSPHQWWKHLULQVWDOODWLRQVYDOLGDWLRQVDQGRSHUDWLRQV 'ZRGEVCVKQPUInterested 0XVWEHZHOOYHUVHGZLWK4&HTXLSPHQWWKHLULQVWDOODWLRQV candidates may please respond to [email protected]DQGRSHUDWLRQV with full details. 'ZRGEVCVKQPU 0XVWEHZHOOYHUVHGZLWK4&HTXLSPHQWWKHLULQVWDOODWLRQVYDOLGDWLRQVDQGRSHUDWLRQV
IDMA Bulletin LII (23) 15 to 21 June 2021 4
IDMA Activities Report on IDMA - ERNST & YOUNG Webinar on PLI Scheme for Pharmaceuticals: “What is in it for the Indian Pharmaceutical Industry!” held on Tuesday, 15th June 2021 from 3.00 pm to 5.30 pm
IDMA along with Ernst & Young organized a webinar delivered his Opening Remarks to the august on PLI Schemes for Pharmaceuticals: “What is in it for the gathering. Indian Pharmaceutical Industry” on Tuesday, 15th June 2021 from 3.00 p.m. to 5.30 p.m. Mr. Majmudar’s speech is reproduced below for your kind perusal and information. Mr. Mahesh Doshi, our National President, IDMA gave his good wishes to the organizers and participants. Mr. Hitesh Sharma and his team from Ernst and He thanked Mr. Hitesh Sharma and his team for organizing Young proceeded further with the webinar and conducted such an excellent webinar and requested the participants the technical sessions. They made a very interesting to reap benefits from the same. presentation which covered all the aspects of the PLI 1.0 and PLI 2.0 Schemes and the points were also very well Mr. Daara B Patel, our Secretary – General, IDMA explained. commenced the webinar by welcoming all the dignitaries, speakers and the participants for this informative, The presentation is reproduced for your kind interactive and excellent webinar. Mr. Patel thanked the organizers Ernst and Young, our National President, Mr. perusal and information. Mahesh Doshi and all the participants who were present The presentation was followed by a question and for this webinar. Approximately 130 participants attended answer session wherein many questions / clarifications this webinar. sought by the participants were answered. Mr. Patel’s speech is reproduced below for your kind perusal and information. Dr. George A Patani, Our Hon. General Secretary, IDMA & Chairman, Publications Committee, IDMA Mr. Yogin R Majmudar, Past National President summed up the proceedings in dept and proposed a vote and Chairman, Bulk Drugs Committee, IDMA of thanks.
IDMA Bulletin LII (23) 15 to 21 June 2021 5
Welcome Address by Mr. Daara B Patel, Secretary - General of IDMA
Good Afternoon Ladies and Gentleman! Chinese Government. For our manufacturers to compete with China, our costs need to be brought down. One of the Greetings from Indian Drug Manufacturers’ Association ways to achieve savings is by providing common facilities (IDMA) and Ernst & Young! to reduce cost on account of mass scale operations.
It gives me great pleasure and honour to address the Production Linked Incentive (PLI) Schemes for Bulk august gathering & on behalf of our National President, Mr. Drugs and Medical Devices have shown a very positive Mahesh H Doshi and Mr. Hitesh Sharma from Ernst and response from the pharmaceutical as well as the medical Young, I welcome you all to this very interesting webinar device industry. titled PLI Scheme for Pharmaceuticals – What is in it for the Indian Pharmaceutical Industry. As we are aware, in the Union Budget 2021-22, the Hon’ble Finance Minister announced an outlay of INR IDMA had envisaged this long ago and in 2014 IDMA 1.97 lakh crore to be utilized over 5 years for the PLI had prepared a white paper titled “Journey Towards Schemes in 13 key sectors. The thrust to reinforce India Pharma Vision 2020 and Beyond” wherein we had as the “Pharmacy of the world” is evident from the PLI presented our justifications and recommendations Schemes for this sector. for development of the API Industry in India to the Government. The Indian government announced a production- linked incentive (“PLI 1.0”) scheme on 21 July 2020 But as they say “Better Late than Never” and we are aimed at boosting India’s bulk drug security. This covered indeed very grateful to the Department of Pharmaceuticals identified Active Pharmaceutical Ingredients/Key Starting under the stewardship of Madam S. Aparna, IAS, Materials /Drug Intermediates. The financial outlay for the Secretary, Department of Pharmaceuticals to interact said PLI scheme was INR 6,940 Cr. with the Industry for the success of the PLI Scheme and to make our country Atma Nirbhar as envisioned by Hon’ble With the aim to further encourage the pharmaceutical Prime Minister. industry, to enhance its manufacturing capabilities, to diversify the product mix to complex generics, to enhance The Government has had several meetings since 2020 patented drugs, for going up the value chain, for bringing in regards to the PLI Scheme and even at IDMA we have investment and creating global champions from India, a discussed this issues in the special PLI meetings as well new scheme was notified by the government on 3 March as almost every monthly Executive Committee Meeting. 2021 (“PLI 2.0”) and its operational guidelines have since been announced on 1 June 2021. As you may be aware, India’s overdependence on China for APIs is a major geopolitical risk and has been DoP and Invest India had a meeting with all the flagged by the industry for over 10 years. With a view Associations in regards to PLI – 2 Scheme on 10th June to increase self-reliance (atma nirbharta) in production 2021 via an interactive video conference. Whilst the and availability of indigenously produced Medicines, the webinar was very successful and interesting as well as Government has come out with schemes like Production interactive not many questions were fielded due to paucity Link Incentive (PLI) Schemes 1.0 & 2.0, which will show of time. DoP has therefore requested the Associations to some results only after 2-3 years. Meanwhile, we have collate questions received from their members and forward been recommending to the Government to have a similar the same to DoP. scheme for existing manufacturers / plants also for quick results. The new scheme is more extensive in its coverage as compared to PLI 1.0 and is expected to offer a total of The main reason of our dependence on China has INR 15,000 cr in incentives to the selected applicants for been their low cost of production and active support of the the identified pharma products.
IDMA Bulletin LII (23) 15 to 21 June 2021 6
We have excellent speakers from Ernst & Young who more enlightened on “What is in it for the Indian will give us a meticulous & all-encompassing information Pharmaceutical Industry” on PLI Schemes. Not to forget our own Expert, Mr. Yogin R Majmudar. Till Then, Stay Safe, Stay Well and Stay Connected.
I wish you all fruitful deliberations and I am sure Thank you. at the conclusion of this webinar we would all be
Opening Remarks by Mr Yogin R Majmudar, Past National President and Chairman, Bulk Drugs Committee, IDMA
Mr. Yogin R Majmudar, Past National President and Indirectly this goal has been achieved by the value Chairman, Bulk Drugs Committee, IDMA and also, the addition (70 % & 90%) criteria. But it would have Managing Director of Bakul Aromatics and Chemicals been much simpler to have directly named the actual Pvt. Ltd. delivered his opening remarks to the august KSMs in the list gathering. He began with a few observations on the PLI This has also kept a loophole for someone to get the Schemes in general. KSM imported by another entity and then purchase them locally by still falling within the value addition Mr. Majmudar mentioned that it is a good initiative by Government to encourage local production in Pharma Intentionally or unintentionally in many of the Sector. He said that the Pharma has been one of the 41 products, only 1 applicant has been selected first Sectors chosen for PLI Schemes. PLI - 1 covered with the lurking danger of Monopoly with no local specific 41 products, while PLI - 2 is open ended with 55 competition participants for products covered under the 3 Mr. Majmudar then gave details of PLl - 2 Scheme. Categories. For PLI - 1, 41 products were identified He mentioned that as against PLl - 1 which was only for from import data as top imported products by APIs and KSMs, PLl - 2 Scheme also includes formulations value. Outlay for PLI - 1 was Rs.6940 crores while for and biologics along with APIs. He said that it was more PLI - 2 is Rs.15,000 crores. meant for “bigger players” with almost 90% of the incentive Mr. Majmudar further commented on the short comings amount allocated to companies with over Rs.500 crores in PLI – 1 scheme as per the below mentioned points :- Global t/o 3 Groups based on GMR levels.
Spare capacity of existing P & M was not covered He said that another focus was on manufacture of Complex Drugs which are Fresh investment was a necessity Original sole objective of the Scheme of becoming difficult to produce self-reliant and reduce dependence on China of high value was lost somewhere down the line with emphasis biologics shifting to investment and employment generation becoming the alternate goals disease specific drugs
In spite of our pointing out that the list should be made He further added that although the intention was to up of actual KSMs which are presently imported create global players, MSMEs also find a place in the and are being incentivised for local production, PLl - 2 with as many as 20 slots reserved out of total 55 mostly API names figure in the list of 41. This did participants from this sector. All sectors (including MSMEs) lead to confusion as the APIs are already being can apply for all 3 Categories. Although, it is not clearly produced by import of the KSMs, which the spelled out, the Scheme mentions only word 55 selected Government is looking at being produced indigenously applicants. This means that each of the applicant can apply
IDMA Bulletin LII (23) 15 to 21 June 2021 7
for a basket of products as a single application leading to He concluded by saying that the danger of Chinese few hundred products, unlike just 41 in PLl - 1. predatory pricing moves in future once production commences always exits. Just as in PLl-1 Scheme, PLl - 2 He said that further, there is no value addition criteria is also silent on how Government will proactively support as the emphasis is more on value creation, rather than the local manufacturer at the time. Along with PLl Schemes achieving self-reliance. This may be a major oversight, benefits, there is also need to simultaneously address the as after investing huge amount of funds, the selected subjects of high costs of utilities and transaction costs applicants will still be at the mercy of Chinese suppliers of in India as compared to our main competitor China for KSMs, if they have not fully backward integrated. success of these Schemes
Technical Sessions Presentation by Ernst & Young
Production Linked Incentives for Pharmaceuticals Sector Background
Objective Incentive component/ category Production Linked ► Specified pharmaceutical products – including Bio-pharmaceuticals, Complex generic drugs, Incentive Scheme for ► To enhance India’s manufacturing capabilities by Patented drugs or drugs nearing patent expiry, increasing investment and production in the sector Cell based or gene therapy drugs, Orphan Pharmaceuticals and contributing to product diversification to high drugs, Special empty capsules like HPMC, value goods in the pharmaceutical sector Pullulan, enteric, Complex excipients, Phyto- pharmaceuticals Gist of operational guidelines dated 1 June 2021 ► To create global champions out of India who have ► Active Pharmaceutical Ingredients / Key the potential to grow in size and scale using cutting Starting Materials / Drug Intermediates except edge technology and thereby penetrate the global for the 41 eligible products already covered June 2021 value chains under the earlier PLI Scheme of 2020 ► In vitro medical devices
Current status Scheme tenure ► Scheme approved with budget outlay of INR 15,000 Crores ► The tenure of the Scheme is from FY 2020-21 to ► Detailed operational guidelines published on 1 FY 2028-29 June 2021 ► Application window - 60 days starting from 2nd June, 2021 to 31st July, 2021
Page 2 Draft for discussion Page 1 16 June 2021
Pharma PLI scheme – products covered Eligibility conditions to qualify for the scheme
Category 1 products covered: Category 2 products covered: Global Manufacturing Revenue (‘GMR’) of How to compute GMR for 2019-20: pharmaceutical goods and/or in vitro Diagnostic Medical Consolidated Global Revenues of applicant and Group 1. Bio-pharmaceuticals Active Pharmaceutical Ingredients / Key Starting Materials / Drug Devices in 2019-20: Company, from manufacturing of pharmaceutical goods 2. Complex generic drugs Intermediates except for the 41 eligible products already covered 3. Patented drugs or drugs nearing patent expiry under the “Production Linked Incentive (PLI) Scheme for promotion and/or in vitro diagnostic medical devices 4. Cell based or gene therapy drugs of domestic manufacturing of critical Key Starting Materials (KSMs) / • G ro u p A – at least Rs 5,000 cr Revenues from any other source for instance R&D services, 5. Orphan drugs Drug Intermediates (DIs) / Active Pharmaceutical Ingredients (APIs) • Group B – at least Rs 500 cr but less than Rs 5,000 cr rental incomes, etc to be excluded 6. Special empty capsules like HPMC, Pullulan, enteric etc. in India” Group companies – 2 or more enterprises which, directly or 7. Complex excipients • Group C – less than Rs 500 cr (including MSME) (notified by Department of Pharmaceuticals (DoP) vide Gazette indirectly, exercise at least 26% voting rights in other 8. Phyto-pharmaceuticals Notification no.- 31026/16/2020-Policy, dated 21/07/2020) 9. Other drugs as approved* enterprise, or, appoint more than 50% board members
Category 3 products ((Drugs not covered under Category 1 and Category 2) Minimum cumulative investments to be made: Number of applicants to be selected:
1. Repurposed drugs • G ro u p A – Rs 1,000 cr over 5 years starting from Group A: 11 participants with maximum of 4 Foreign MNCs 2. Auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular 2021-22 – at least Rs 200 cr per annum Group B: 9 participants with maximum of 3 Foreign MNCs drugs, psychotropic drugs and anti-retroviral drugs • Group B – Rs 250 cr over 5 years starting from 2021- Group C: 35 participants, of which: 3. in vitro diagnostic devices 22 - at least Rs 50 cr per annum 4. Other drugs not manufactured in India Minimum of 20 MSMEs, subject to sufficient eligible 5. Other drugs as approved* • Group C (excluding MSME) – Rs 50 cr over 5 years applicants starting from 2021-22 – at least 10 cr per annum * Decision will be taken by DoP to include any drug based on requirement, CDSCO approvals, TC opinion which shall take into account the Minimum of 5 in vitro diagnostic medical devices current levels of production, availability, etc. The decision of DoP shall be aligned with the objectives of the scheme • Group C (MSME) – committed investment over 5 years manufacturers subject to sufficient eligible applicants – at least 20% per annum * Minimum percentage growth in sales of eligible products also required Page 3 16 June 2021 Page 4 16 June 2021
IDMA Bulletin LII (23) 15 to 21 June 2021 8
Selection criteria for pharmaceuticals (except in vitro Diagnostic Medical Devices) Selection criteria for in vitro Diagnostic Medical Devices
Group Selection parameter Weightage Group Selection parameter Weightage
A / B Gross manufacturing Investment (‘GMI’) of applicant/group company in India in 10 years during FY 2010-11 30% A / B / C Gross manufacturing investment of applicant/group company in India 30% to FY 2019-20 in 10 years during FY 2010-11 to FY 2019-20 Number of ANDA / NDA of applicant/group company from either USFDA / EDQM / UK MHRA / PMDA / Health 30% Number of manufacturing plants in India owned by applicant/group company having manufacturing 30% Canada / TGA as on 01.04.2021 license from CDSCO/SLA or approved by USFDA / EU (CE) / UK MHRA / PMDA / Health Canada / TGA R&D expenditure of applicant/group company as a % of GMR from pharmaceutical goods in FY 2017-18 to FY 40% / CDSCO as on 01.04.2021 2019-2020 GMR from in vitro diagnostic medical devices in FY 2019-2020 40% C Gross manufacturing investment of applicant/group company in India in 10 years during FY 2010-11 to FY 30% 2019-20 Number of ANDA / NDA of applicant/group company from either USFDA / EDQM / UK MHRA / PMDA / Health 30% Canada / TGA as on 01.04.2021. GMR from pharmaceutical goods in FY 2019-2020 40% C - MSME Number of manufacturing plants in India owned by applicant/group company and approved by USFDA / 50% EDQM / UK MHRA / PMDA /Health Canada/ TGA or having WHO-GMP compliance certification from a State Licensing Authority as on 01.04.2021 Total Investment Committed by the applicant under the scheme 50%
GMI will include gross capital investment in pharmaceutical and in vitro diagnostic medical device manufacturing facilities including capital investments for R&D facilities. Investment in corporate offices, sales offices, residential complex etc will not be included for the purpose of arriving at the GMI.
All eligible applicants shall be ranked on the basis of marks obtained on the basis of evaluation criteria
Page 5 16 June 2021 Page 6 16 June 2021
Incentives – eligibility and computation Incentives computation – illustrative example
Eligibility conditions for selected participants to claim Incentive rate to be applied on incremental sales: ► Sale of eligible pharmaceutical products ( from category 1 and 2) in 2019-20 was Rs 1000 cr incentives: Year 1: 2022-23 and year 6: 2027-28 ► Sale of eligible products from above in 2022-23 (year 1) assumed to Rs 1200 cr Minimum threshold sales of eligible products in 2022-23 to be For Category 1 and 2 products – 10% for first 4 years, 8% for year greater than Rs 50 cr for Group A, Rs 10 Cr for Group B, Rs 1 Cr 5 and 6% for year 6 ► Incentive for year 1 ie 2022-23 would be (1200 -1000)*10% = Rs 20 cr for Group C (except MSME) & Rs 50 lakhs for Group C MSME For Category 3 products – 5% for first 4 years, 4% for year 5 and ► In order to be eligible for year 2 ie 2023-24, minimum sales of eligible products in year 2 should be at least Rs 1284 Minimum threshold sales from year 2 onwards (2023-24 onwards) 3% for year 6 cr ie at least 7% growth over sales of year 1 – 7% over actual sales of eligible products in previous financial year ► Assume sale of eligible products in 2023-2024 (year 2) to be Rs 1300 cr
► Incentive for year e ie 2023-24 would be (1300 -1000)*10% = Rs 30 cr Computation of incentive: Group wise incentive allocation: ‘Net Incremental sales’ of eligible products * incentive rate ► Incentives for subsequent years to be computed on similar basis Incremental sales defined to mean sales of eligible products during Group A - Rs. 11,000 crore a financial year less sales in base year ie 2019-20 Group B - Rs. 2,250 crore Note; Incentive rate for category 3 products are different ‘Net’ means adjusting for sales returns of eligible product. For Group C - Rs. 1,750 crore example if sales of Rs 100 considered for claim processing in year In vitro medical devices are covered in category 3 1, and if sales returns of Rs 100 take place in year 2, sales of year 2 shall be adjusted for sales returns of year 1
If committed investment criteria is not met in any year, incentive will not be eligible for that year. However, the applicant will not be restricted from claiming incentive for subsequent years, provided criteria of minimum cumulative investment and threshold sales criteria are met for such subsequent year. If the incentive availed by an applicant is less than the maximum available incentive for that applicant in that financial yea r , the applicant shall not be entitled to claim the differential amount in subsequent financial years. Page 7 16 June 2021 Page 8 16 June 2021
Investment - Key considerations Incentives allocation and computation – additional considerations
► Eligible investments includes expenses incurred on the following in relation to eligible products: ► Selected applicant can change the product mix approved to them during the tenure of the scheme with the prior approval of the DoP - However, this option can be exercised up to 5 times only ► New Plant, Machinery, Equipment and Associated Utilities
► Research and Development (R&D) and product development including clinical trial costs in India only ► Participant shall be eligible to draw incentive within that annual allocation. However, any incentive unutilised by one
► Transfer of Technology (ToT) agreements - cost of technology and initial technology purchase in relation to the eligible product or more selected participant during a year may be used for paying additional incentive to other selected participants within that Group, provided that: ► Product registration - costs incurred for product registration both in India and in other countries in relation to the eligible product which includes renewal charges, bio-availability and bio-equivalence studies, plant inspection charges and patent filing; ► no participant shall receive additional incentive more than 40% of the allocated incentive to such participant for that year WHO pre-qualification charges in case of in vitro diagnostic medical devices ► no participant shall receive additional incentive more than 20% of the total incentive allocated to such participant over the entire ► Construction of building where eligible new plant and machinery are installed and expenditure on associated infrastructure tenure of the scheme, and limited to 20% of new plant and machinery ► all approvals of such additional incentive shall not exceed the budget allocated for the respective year and the budgetary outlay ► Associated utilities to include essential equipment required in operational areas such as Clean Rooms, cold chain, infrastructure at the for the Scheme manufacturing site, Air Curtains, Temperature and Air Quality Control Systems, Compressed Air, Water & Power Supply and Control Systems. Associated utilities shall also include ETP, incinerators, effluent lines / tanks / treatment, supply lines of water / sewerage / ► The ceiling for incentive and additional incentive shall be (Rs Cr) solvents / gases, solvent recovery, solid waste treatment plant, solvent storage tanks, LPG storage tanks, warehousing, electricity Group Incentive ceiling Ceiling of Additional Incentive, if any Total incentive lines, power generation facility and communication lines for telephone-internet within the establishment Ceiling A 1000 200 1200 ► Investments made on or after 1.4.2020 to be considered B 250 50 300 C 50 10 60 ► All non creditable taxes and duties to be included in the expenditure
► Second hand plant and machinery, raw materials and consumables for manufacturing, not eligible, investment on land excluded ► Additional incentive is not an entitlement and is contingent upon savings available from unutilized incentive of other ► Date of purchase invoice considered as date of Investment, heads of eligible investment should be capitalised in the books except participants in that year expenditure on R&D, product registration in the nature of capital / revenue expenditure ► Annual disbursement claims with supporting documents after end of financial year by 30 April ► Investments already considered for PLI Scheme for Bulk Drugs or any other PLI Scheme not to be considered again for the purpose of ► 75% claim amount to be released if claim found in order and balance 25% to be released after submission of final eligible investment under this Scheme audited accounts
Page 9 16 June 2021 Page 10 16 June 2021
IDMA Bulletin LII (23) 15 to 21 June 2021 9
We have done a preliminary analysis, basis historical data, on the implications Excluding MNCs, 17 Indian pharma cos have a high likelihood of being Group A; for pharma cos, across the Groups and qualify as one of 7 to 11 Indian cos selected for the PLI
Tracked Sales A. Domestic FDF B. FDF Exports C. API Exports ANDAs APIs Please note: Company (A+B+C) (Rs Cr) (Rs Cr) (Rs Cr) (Orange Book) (US DMF) ( R s C r ) Sun Pharma 11,784 6,792 1,175 867 247 19,751 ► The analysis is based on publicly available data, with no inputs from individual pharma cos Cipla 6,705 6,045 780 286 139 13,530 Lupin 5,463 3,712 778 382 198 9,953 Dr Reddy's 3,501 4,678 1,799 425 220 9,978 ► It is a “conservative” point of view, assuming a constrained vs. a liberal interpretation of the Zydus Cadila 5,987 3,644 333 532 123 9,964 guidelines Intas 4,337 3,078 270 33 7,415 Glenmark 3,274 3,124 733 296 112 7,132 Alkem 5,092 1,524 203 28 6,615 Macleods 4,136 2,415 163 105 6,551 ► The objective is to illustrate processes in assessing Aurobindo 4,933 1,585 848 236 6,517 ► Likelihood of qualifying for the scheme T o r r e n t 4,485 1,999 150 35 6,484 ► Indicative realization of incentives Mankind 5,484 47 19 5,531 Hetero 866 1,738 1,842 172 209 4,447 These cos report revenues Jubilant 40 384 1,529 114 97 1,953 of more than Rs 5,000 cr; however, clarity is needed D i v i ’ s Labs 1,667 37 1,667 o n t h e 3 rd party manufacturing revenues Biocon 481 90 794 16 46 1,365 being part of GMR – this Serum Inst 358 934 1,292 can make a difference between A & B The “Tracked Sales” is a useful public domain data point to compare companies; the actual sales, both formulations and APIs, from internal data is critical to specifically arrive at The 30% weightage for # of regulated Gross Manufacturing Revenues (GMR), accounting for 3rd party manufacturing and market approvals (ANDAs / DMFs services, both in-bound and out-bound equivalent) will impact scores of Torrent and Mankind, and even Alkem and Intas, Page 11 16 June 2021 Page 12 16 June 2021 if the scheme is revised to include a combined # of ANDAs and DMF
Interestingly, Group B is very competitive, with only 9 slots, between the next The right starting product mix is critical to maximize year 1 i.e. 2022-23 set of formulations cos, as well as the large regulated market focused API cos incentives; the following criteria may be used in a company-specific assessment
Tracked Sales A. Domestic FDF B. FDF Exports C. API Exports ANDAs APIs I. In-market products (FDFs and APIs, domestic and exports) Company (A+B+C) (Rs Cr) (Rs Cr) (Rs Cr) (Orange Book) (US DMF) ( R s C r ) ► Rs 50+ cr products (in 2019-20) with high growth potential, at least for 2022-23 vs. 2019-20 Emcure 3,704 1,113 18 98 4,817 ► New introductions (say, 2019 or later), likely to scale to Rs 50+ cr in 2022-23 Alembic 1,698 1,860 676 251 116 4,234 Ipca 2,092 1,061 973 47 51 4,127 Micro Labs 2,553 1,414 80 37 3,968 II. Products not launched yet, but likely to be commercialized by 2022-23 and scale up to Rs 50+ cr in 2022-23 Domestic & RoW focused Aristo Pharma 3,748 110 3,858 formulators have lesser ► Approved ANDAs / DMFs or equivalent, as qualifying for PLI (say, 2017 or later) likelihood of selection USV 2,844 328 124 12 27 3,296 ► Submitted ANDAs / DMFs or equivalent (typically not public information) MSN’s vast US approvals in MSN Labs 541 1,933 63 395 2,474 APIs positions them as a front-runner in Group B ► Upcoming high potential pipeline e.g. biosimilars, NCEs, innovative products, not necessarily in US / EU (typically Aarti 2,319 36 2,319 not public information) Ajanta 876 1,184 101 2,061
Granules 1,507 503 63 30 2,010 API companies will have higher sales, once the For both sets above, how intense is the competition? Therefore, are our growth assumptions justified? E.g. Cadila Pharma 1,073 423 452 110 32 1,947 domestic API sales are Natco 1,090 161 286 43 38 1,536 factored in; for example, ► IQVIA sales for commercialized products (global incl. India) companies like SMS, Wockhardt 1,291 181 122 30 1,473 Enaltec, MSN, Symbiotec etc. also have large non- ► Orange Book entries or EMA entries for approved products, not yet commercialized (likewise, for APIs) Piramal 273 505 632 32 36 1,410 US, non-EU APIs ► Portfolio (approvals, not submissions) and sales of other Indian companies competing in the PLI e.g. which other Indoco 950 276 19 19 1,226 e.g. Laurus Labs reported > Rs 4,700 cr in FY21 Indian companies are anticipated to list the same product in their PLI application? Nectar 204 825 21 1,029 Laurus Labs 946 10 51 946 Hikal 911 8 26 911 Solara Active 794 90 794 Orchid has been listed given large Orchid 491 97 74 491 US approved portfolio Page 13 16 June 2021 Page 14 16 June 2021 A: 50+ cr, B: 10+ cr, C: 1+ cr, C-MSME: 50+ L
ILLUSTRATIVE, SIMULATION How much incentive are we likely to actually convert? Example of a large Group A co. (randomly selected)
► “What if” simulation… say, PLI was announced in 2016 for incentives in the period 2017-20; applying the current Of the 34, 17 brands also get PLI guidelines to two domestic formulations businesses, one in Group A and the other in Group B, how much incentive in Year 2 incentives do the companies get? + 2 new brands qualify 16 brands that got incentives in year 1 or 2, also get incentive in ► High level assessment basis historical data, for illustration only 34 brands qualify for T o t a l 19 brands get incentive in Y e a r 3 27 brands that got incentives in xx brands > 50 Cr incentive in Year 1 year 2 year 1 or 2 or 3, also get in Year 1 (2016-17) incentive in Year 4 Sales: Rs ~3,000 Cr Sales: Rs ~ 2,000 Cr + 10 new brands qualify Rs x,xxx Cr sales ► “Product” = molecule or composition, separately for formulations and API Incentive: Rs 25-30 Cr Incentive: Rs 30-35 Cr + 4 new brands qualify Total 26 brands get incentive in ► All SKUs or brands within molecule / composition, considered single product e.g. a 100 mg strength and a 200 year 3 Total 31 brands get incentive in mg strength are the same “product”, but a mono and a fixed dose combination are two different products Sales: Rs ~ 2,500 Cr year 4 Incentive: Rs 60-70 Cr Sales: Rs ~3,500 Cr Incentive: Rs 80+ Cr ► Every eligible product needs to be Rs 50+ cr (Group A) in the year of claiming incentive INSIGHTS ► A less stringent interpretation is that the entire applied-for eligible portfolio needs to be Rs 50+ cr ► Had the PLI taken 2016 as base year and awarded incentives in 2017, 2018, 2019, 2020, then XX’s domestic portfolio would have achieved ~ Rs 200+ Cr in cumulative incentives ► All products in the portfolio and pipeline, are expected to have been applied for ► Of this, the top 5 molecules would have contributed 35-40% of the incentives: Molecule 1 (Rs 21 cr incentives), Molecule 2 (17 cr), ► This is a critical activity as you fill the form with the first product mix during application Molecule 3 (16 cr), Molecule 4 (Rs 16 cr), Molecule 5 (13 cr) ► Similar analysis needs to be conducted on sales projections, product-wise, for the PLI period (2019-20 as base, and 2022-23 as year 1, …) ► Each eligible product needs to meet 7% growth requirement – criteria applied to each product, not at category or ► Additionally, the formulations exports, by products (molecule / composition) need to be added to their domestic sales, for the right overall portfolio, therefore Product A and Product B both need to grow at 7% estimation of incentives from formulations
► Similar analysis needs to be done on the API portfolio and pipeline
Page 15 16 June 2021
IDMA Bulletin LII (23) 15 to 21 June 2021 10
ILLUSTRATIVE, SIMULATION Example of a Group B company (randomly selected) INPUTS for portfolio selection
Of the 29, only 6 brands also get ► Complete list of products and SKUs, and sales in 2017-18, 2018-19, 2019-20, 2020-21 incentive in Year 2 + 3 new brands qualify 22 brands that got incentives in ► Sales projections, for products and SKUs, for as many future years, as available year 1 or 2, also get incentive in 11 brands that got incentives in 29 brands qualify for T o t a l 9 brands get incentive in Y e a r 3 year 1 or 2 or 3, also get ► List of submitted (not approved) ANDAs and DMFs and equivalent xx brands > 10 Cr incentive in Year 1 year 2 incentive in Year 4 in Year 1 (2016-17) Sales: Rs ~600 Cr Sales: Rs ~150 Cr + 10 new brands qualify ► List of pending submissions, with indicative year of submission, and target markets, say US, EU, domestic and RoW Rs x,xxx Cr sales Incentive: Rs 5-10 Cr Incentive: Rs 2-5 Cr + 4 new brands qualify Total 32 brands get incentive in + 4 new brands qualify5 ► Products and SKUs that we manufacture as third party, for others; incl. sales value year 3 Total 16 brands get incentive in year 4 Sales: Rs ~700 Cr ► Products and SKUs that we get manufactured by third parties; incl. sales value Incentive: Rs 10-15 Cr Sales: Rs ~600 Cr Incentive: Rs 10-15 Cr ► Point of view of R&D / new product development / strategy etc., for working sessions to align on key assumptions INSIGHTS
► Had the PLI taken 2016 as base year and awarded incentives in 2017, 2018, 2019, 2020, then XX’s domestic portfolio would have achieved Rs 25-35 Cr in cumulative incentives
► Similar analysis needs to be conducted on sales projections, product-wise, for the PLI period (2019-20 as base, and 2022-23 as year 1, …)
► Additionally, the formulations exports, by products (molecule / composition) need to be added to their domestic sales, for the right estimation of incentives from formulations
► Similar analysis needs to be done on the API portfolio and pipeline
Page 18 16 June 2021
OUTPUTS for portfolio selection
► Product mix to be submitted as part of the PLI application
► High level estimation of the incentive that this product mix is likely to yield, in 2022-23 Fast tracking
► Assessment of the competitive intensity in key products commercialization
► List of 5-10 products that are not likely to be part of the PLI application, for 2022-23 incentives, but may be included in the product mix subsequently Overview
Page 19 16 June 2021 Page 20 16 June 2021
EY can support in individual workstreams including PMO from facility design to We will ensure that activities run in parallel so that end to end timeline is commercialization enabling reduction in overall lead time to commercialization… reduced… and EY can help in specific areas…
Facility Layout & Lean Manufacturing Lean Quality Lean Supply Chain M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 Design ACTIVITY
• Capacity • Plant Site • RM-PM supplier Finalization basis • Capacity planning Work Stream 1 Facility Layout & Design 10 to 12 months Finalization finalization the demand for RM, In-process, • Approvals for • V e n d o r projections FG testing and thus manufacturing qualification Work Stream 2 Lean Manufacturing 6 to 8 months • Equipment lab design • Lean Layout • ERP and Systems Finalization which • Lab instruments Finalization Setup Work Stream 3 Lean Quality 6 to 8 months are Digitally finalization • Plant Construction • Integrated demand enabled for Smart • Finalizing • Utilities set up and supply Factory & Apps Productivity norms Work Stream 4 Lean Supply Chain 8 to 10 months • Plant Validation planning process • Finalizing • Digital Lab – LIMS, • We will use the setup with digital Productivity norms QMS, Lab Planning expertise of SMEs enablement (Equipment & and Lab Analytics PMO End to End PMO for 10 to 12 months who are empaneled • Distribution and Manpower) • Installation, with us for knitting logistic partner • Installation, Validation & all the aspects onboarding Validation & Approval together to ensure • Digitally Enabled Approval • Digitally Equipped Strategic Partnership Lean and Digital best possible Supply Chain • Digitally Equipped Smart Lab PMO timeline • Commercialization Tie ups with trusted CRO Deployment Smart Factory Support project management partners quicker turn through increased and around in development Support in implementing lean structured governance phase, Tie ups with principles and Digital in areas of Time Line – 8 to 10 Time Line – 6 to 8 Time Line – 6 to 8 Time Line – 8 to 10 process to reduce timeline to technology partner for manufacturing line set up, months months months months commercialization ERP and planning tool set Quality, better plant layout, up supply chain planning and KPIs finalization PMO across all workstream to reduce time to market (End to End) – 10 to 12 months
Page 21 16 June 2021 Page 22 16 June 2021
IDMA Bulletin LII (23) 15 to 21 June 2021 11 Manufacturing and Other Operations Warehousing Regulations, 2019
Generally, Customs duty is payable at the time of import of goods into India . However, MOOWR, 2019 provides for duty deferment in case of imports, subject to various compliances and procedures.
Manufacturing and Other Governing provisions Basic operational mechanism Benefits 1 Duty-deferment on import of Inputs/ Operations Warehousing ►Section 58 of the Customs Act, 1962, ► Application to be filed for private bonded Capital goods provides for grant of license by the warehouse and manufacturing and other Principal Commissioner/ Commissioner operations before the Principal Regulations of Customs for private warehouse, for Commissioner/ Commissioner of Customs deposit of dutiable goods No Customs Duty 2 ► Goods to be imported into India can be on direct exports ►Section 65 of the Customs Act, 1962 deposited in the private warehouse, by Overview provides for an owner of any way of filing a bill of entry for from warehouse warehoused goods to carry on any warehousing, but without payment of any manufacturing or other operations in a Customs duty warehouse, subject to permission of 3 the Principal Commissioner/ ► Further, manufacturing or other Pay Customs Duty on Commissioner of Customs and various operations can be carried out on such goods in the private warehouse domestic clearance conditions thereon of capital goods/ ► Clearance of goods can be done for home finished or consumption or export manufactured goods Procurement 4 ► The applicant would be required to maintain records with respect of from DTA warehoused goods permissible*
• Unlike Project Import Scheme, import of old machinery is also included under MOOWR, 2019 for deferment/ non payment of Duty
• Deferment/ non payment of GST on imported machinery which would otherwise be available as input credit in 10 to 15 years * GST implications may arise in case of domestic procurement
Page 24 Page 23 16 June 2021
Manufacturing and Other Operations Warehousing Regulations, 2019
Figures in INR Crores
Savings on import of CAPEX under MOOWR Benefit on import of Raw Material under MOOWR State level incentives in Particulars Amount Particulars Amount India
Duty payable at the time of domestic clearance 8.25 Cost of imported raw material 100 Overview Less: Present value of duty payable in future (20th year) 1.47 Stock holding period 2 years
Immediate savings under the MOOWR Scheme - A 6.78 Duty paid on domestic clearance 27.74
Interest cost saving on BCD and SWS over the period of time (20 years) –B 3.95 Net Savings on material on account of 3.24 MOOWR,2019 Interest cost saving on IGST over the period of time (20 years) – C 11.34
Total Savings on CAPEX on account of MOOWR,2019 (A+B+C) 22.07
For an investment of 100 Cr. in Plant & Machinery, tentative benefit of 22 Cr. can be achieved through MOOWRs ► Investment of 100 cr. relates to Plant & Machinery scheme ► Life of assets - 20 years
► Estimate stock holding period – 2 years
► BCD –rate assumed as 7.5%, IGST assumed 18%
► Internal rate of return assumed as 9%
Page 25 Page 26 16 June 2021
State incentives in India Types of fiscal incentives - indicative Nature and key parameters
Key considerations Single window approval and sanction across States Comparison Parameters to be ► Incentives vary based on of general vs. considered location, scale of Incentives overview specific investment, classification policies in a ► Location & amount of as to new or expansion State goods and services tax (SGST) reimbursement, sales State investment: To evaluate project subsidy Comparison Fiscal Incentives Incentive the maximum benefits of policies/ Capital subsidy claim framework that can be availed ► Investment period is a incentives implementation period within which the Electricity duty exemption/tariff concession * across States ► Sector: To identify the investment made is incentives under sector Competitive Capital Linked Expenditure Linked Sales Linked considered for eligibility Stamp duty exemption specific policies of incentives federalism Interest subsidy across States ► Sales pattern: To ► Operative period is the Negotiating identify and quantify Skill subsidy * Opting for minimum number of for a incentives available Cash back Exemption/ Cash back Domestic sales - GST subsidy suitable years for which a unit Land concessions including concessional land allotment * structured under foreign trade incentive has to be in commercial package of policy and state framework industrial policy production Infrastructure support incentives Evaluation of Vendor ecosystem ► Expenditure: To quantify ► Tailor-made incentives for other the incentives linked to projects with substantial *Relevant for manufacturing and services locational expenditure investment (usually parameters referred to as Mega Projects) Possibility of negotiating for over 100% of CAPEX investment as incentive
Page 27 16 June 2021 Page 28 16 June 2021
IDMA Bulletin LII (23) 15 to 21 June 2021 12
State incentives Sample Calculation for Group A Company Recent developments Renewal of state incentives policies has also picked up pace recently, with several more expected in the near future Particulars Value Remarks Maharashtra Excludes revenue in international locations from 1 No of companies with greater than 5000 Cr. tracked revenue in India 14 Maharashtra Industrial Policy, international plants 2019 offers Investment Promotion Average of tracked revenue for such 14 companies 8985 Cr. Madhya Pradesh 2 Subsidy by way of gross SGST reimbursement Less: 30% sourcing from TP for Dom Form Revenue 1493 Cr. Incentives are de-linked from taxes and offered on the basis Expected average GMR for these 14 companies ~ 7500 Cr. of a formula based on employment generation, 3 Karnataka Maximum incentive for a Group A company in 6 years 1000 Cr. manufacturing capacity, exports etc Erstwhile incentive of interest free Average incentive rate across Cat 1/2/3 Products 7.5% Assumed mix Cat 1: 25%, Cat 2: 25%, Cat 3: 50% loan has has been replaced with Gujarat turnover based capital subsidy 4 under the new policy Capital subsidy as a percentage Growth Rate Maximum Y1 Y2 Y3 Y4 Y5 Y6 Total of Fixed Capital Investment FY 22 to 28 Possible introduced in place of erstwhile Tamil Nadu net SGST reimbursement 5 7% 101 148 197 250 307 368 1,372 1000 Investors to choose incentives 8% 107 161 219 281 349 422 1,538 1000 mode from GST reimbursement/capital 9% 113 174 241 313 392 478 1,711 1000 Jammu and Kashmir 6 subsidy/formula based incentive 10% 120 188 263 345 436 536 1,888 1000 etc Subsidy linked to GST liability to 11% 126 202 286 379 482 597 2,072 1000 the extent of 300% of investment
Page 29 16 June 2021 Page 30 16 June 2021
Ernst & Young LLP EY | Assurance | Tax | Transactions | Advisory
About EY EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities. EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more information about our organization, please visit ey.com.
Ernst & Young LLP is one of the Indian client serving member firms of EYGM Limited. For more information about our organization, please visit www.ey.com/en_in.
Ernst & Young LLP is a Limited Liability Partnership, registered under the Limited Liability Partnership Act, 2008 in India, having its registered office at 22 Camac Street, 3rd Floor, Block C, Kolkata – 700016
© 2020 Ernst & Young LLP. Published in India. All Rights Reserved.
This publication contains information in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Neither EYGM Limited nor any other member of the global Ernst & Young organization can accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any material in this publication. On any specific matter, reference should be made to the appropriate advisor.
l l l Questions / Clarifications Sought in Regards to Industry Outreach webinar for PLI 2.0 on 10.06.2021: IDMA representation to DoP – reg.
The Association has submitted following Accordingly, our members have sent a few questions representation to Dr. Sumit Garg, IRS, Deputy which are given below : Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers on 17th June 2021 on 1) What happens when KSM is manufactured by one the above subject: Group Company and the end API by another? Can investment of both companies will be clubbed, or Dear Sir, company has to apply for 2 products as separate ones? We refer to the very informative and very interactive 2) Currently company is manufacturing APIs and webinar organized by Invest India and Department of intermediates under loan-license/job work. Pharmaceuticals on Industry Outreach for PLI 2.0 on 10th Production of the product to be applied will start only June 2021. We thank you for giving IDMA an opportunity to in 2022-23 in the new plant to be constructed post interact and also raise questions and seek clarifications.
IDMA Bulletin LII (23) 15 to 21 June 2021 13
September 2021 as MSME. Whether the product can Need clarity on expenses incurred for exhibit batches be considered as eligible to apply under the scheme? manufactured for getting ANDA etc. from regulated market will be considered as R&D expenditure? 3) The scheme indicates minimum investments for various Groups for the company to be eligible for Whether cost of employee’s and Chemicals used in incentives. R&D will be considered for eligible investment. If the company due to certain reasons beyond its control is unable to complete the required investment 2.15.3 EXPENDITURE ON TOT but has already committed the investment by way Only TOT cost incurred initially is allowed. Normally of issuance of PO's for purchase of P&M and have for a TOT subsequent improvements are also transferred also opened LC's / paid advances, then the company at a cost. If such improvements are not available to the should not be denied incentives. Indian company, they may lose out to competition in the 4) (a) If some new product are manufactured for the first International market. Hence all subsequent cost for the time by company in the year 2022-23 with no sales eligible product should be allowed. in base year 2019-20, will it be eligible under PLI 2 scheme? 2.15.4 EXPENDITURE ON PRODUCT REGISTRATION (b) Can examples be provided of Drugs which are Here it indicates that WHO pre-qualification charges included in Bio-pharmaceuticals, Orphan Drugs, are allowed in case of in vitro diagnostic medical devices. Complex Excipients, Phyto-pharmaceuticals? As you are aware all major formulations procured by 5) Along with PLI Scheme benefits, there is also need global agency for commutable diseases such as, TB, to simultaneously address the subjects of high costs AID etc. insist on WHO pre-qualification. Hence to target of utilities and transaction costs in India as compared international market WHO pre-qualification expenses to our main competitor China for success of the PLI should also be allowed. Schemes. 6.1.5 6) The scheme indicates minimum investment of R. 200 crores per year for 5 years for Group A bidders and The heads of investment based on which eligibility is minimum 50 crores per year for 5 years for Group B being determined should be capitalised in the books of bidders. If the required investment is not made then, accounts. Many a time though the invoice date prior to the company is not eligible for incentives. closing date, the same is not capitalised as the P&M has 7) The company due to certain reasons beyond their not commenced operation. It is declared in Capital Work control could not complete the required investment In Progress. Hence the policy needs to be clear whether but have already committed the investment by way of Invoice date would be considered Or Capitalisation issuance of PO's for purchase of P&M and have also date. opened LC's / paid advances should be considered as investment and the company should not be denied 6.2.3 incentives. 8) ELIGIBLE INVESTMENT (2.15) Plant & Machinery once invested will be utilised for a long period. Additional investment would be 2.15.2 EXPENDITURE INCURRED ON R&D. required only for capacity expansion or modification. In that case insisting on cumulative investment only The scheme objective is to create manufacturing on eligible products will make the incentives scheme capacities and create global champions. However clinical a dampener. trials expenses are limited to India only. To be a global player as per the various laws in the respective countries, 7.1.1 many countries specifies local clinical trials. Hence all clinical trials relating the eligible product should be Clarity on cumulative investment required? Whether considered. Also cost of patent charges if any and other only for eligible product or company as a whole in pharma registration charges to enter any market. business?
IDMA Bulletin LII (23) 15 to 21 June 2021 14
7.2.2 We have collated the questions / clarifications forwarded by our members as above and we look forward CHANGE OF PRODUCT MIX to your prompt response on the same. a) When the applicant can request for a product mix? Looking forward to your support and co-operation in b) Whether the product deleted will be considered for regards to the above. YOY growth % for incentives? Yours sincerely, c) After application, in how many days the approval will be given? For Indian Drug Manufacturers’ Association, d) If approved, from when the new status will be Mahesh H Doshi effective? National President e) If the whole list of product approved get changed in product mix request, how YOY% of growth will be determined?
l l l Implementation of Revised Gst for Covid Drugs : IDMA representation to DoP – reg.
The Association has submitted following We refer to the OM File No. 19(175)/2019/DP/NPPA/ representation to the Secretary, Department Div.II dated 15th June, 2021 issued by NPPA in reference of Pharmaceuticals, Ministry of Chemicals and to the lower GST announced for COVID drugs. Fertilizers on 18th June 2021 with the copy to Smt. Shubhra Singh, IAS, Chairperson, National We have been approached by many of our members Pharmaceutical Pricing Authority on the above seeking clarification, with respect to Serial No. 5 of subject: Medicines as per the PIB notice dated 12/06/2021 relating to “Recommendation of 44th GST Council Meeting.” (Copy Respected Madam, enclosed). Greetings from IDMA! The serial No. 5 reads as under :-
Sr. Description Present GST GST Rate No. Rate recommended by GST Council 5 Any other drug recommended by Ministry of Health and Family Welfare Applicable 5% (MoHFW) and Dept. of Pharma (DoP) for Covid treatment Rate
Since the list of drugs has not been explicitly specified, Thanking you, it can lead to a lot of confusion on account of interpretation of COVID drugs by different States Health Authorities. Yours sincerely, Hence we request your office to kindly list out the drugs For Indian Drug Manufacturers’ Association, covered under Serial No. 5, so that there is no ambiguity in interpretation. Mahesh Doshi National President Looking at the facts referred to above, we seek your clarification at the earliest so that our members are not Encl : Recommendation of 44th GST Council Meeting put into any hardship on account of overcharging and (reproduced below) GST violation. l l l
IDMA Bulletin LII (23) 15 to 21 June 2021 15
Ministry of Finance Ministry of Finance
RecommendationsMinistry of 44th of Finance GST Council Meeting Recommendations of 44th GST Council Meeting Recommendations of 44th GST Council Meeting Change in GST Rates on goods being used in Covid- Change in GST Rates on goods being used in Covid- 19 relief and management Change in GST19 Ratesrelief andon goods management being used in Covid- 19 Postedrelief On: 12and JUN 2021 management 3:39PM by PIB Delhi Posted On: 12 JUN 2021 3:39PM by PIB Delhi
Posted On: 12 JUN 2021 3:39PM by PIB Delhi The 44th GST Council met under the Chairmanship of Union Finance & Corporate Affairs Minister Smt TheNirmala 44th SitharamanGST Council through met under video theconferencing Chairmanship here today.of Union The Finance Council & in Corporateits meeting Affairs has decided Minister to reduce Smt Nirmalathe GST Sitharaman rates on the through specified video items conferencing being used inhere Covid-19 today. Therelief Council and management in its meeting till 30hasth decidedSeptember, to reduce 2021. theThe GST 44th rates GST on Council the specified met under items thebeing Chairmanship used in Covid-19 of Union relief Finance and management & Corporate till 30 Affairsth September, Minister 2021. Smt NirmalaThe meeting Sitharaman was also through attended video by conferencing Union Minister here today.of State The for Council Finance in &its Corporate meeting has Affairs decided Shri to Anuragreduce ThetheThakur GST meeting ratesbesides wason Financethe also specified attended Ministers items by ofUnionbeing States used Minister & in UTs Covid-19 ofand State senior relief for officers Financeand management of & the Corporate Ministry till 30 Affairs thof September, Finance Shri & Anurag 2021.States/ ThakurUTs. besides Finance Ministers of States & UTs and senior officers of the Ministry of Finance & States/ UTs.The meeting was also attended by Union Minister of State for Finance & Corporate Affairs Shri Anurag ThakurThe details besides of recommendationsFinance Ministers ofare States given & below UTs :and senior officers of the Ministry of Finance & States/ UTs.The details of recommendations are given below : GST Rate S. Present The detailsDescription of recommendations are given below : GSTrecommended Rate by S.No. PresentGST Rate Description recommendedGST Council by No. GST Rate GST Rate S. A. Present GST Council MedicinesDescription recommended by No.A. Medicines GST Rate 1. Tocilizumab 5% GSTNil Council 1. Tocilizumab 5% Nil 2.A. MedicinesAmphotericin B 5% Nil 2. Amphotericin B 5% Nil 1.3. TocilizumabAnti-Coagulants like Heparin 5%12% Nil5% 3. Anti-Coagulants like Heparin 12% 5% 2.4. AmphotericinRemdesivir B 5%12% Nil5% 4. Remdesivir 12% 5% 3. Anti-CoagulantsAny other drug recommendedlike Heparin by Ministry of Health 12%Applicable 5% 4.5. RemdesivirAnyand otherFamily drug Welfare recommended (MoHFW) by and Ministry Dept. of HealthPharma 12%ApplicableRate 5%5% 5. and(DoP) Family for Covid Welfare treatment (MoHFW) and Dept. of Pharma Rate 5% Any other drug recommended by Ministry of Health Applicable B. (DoP) for Covid treatment 5. Oxygen,and Family Oxygen Welfare generation (MoHFW) equipment and Dept. and of Pharma related medicalRate devices5% B. Oxygen, Oxygen generation equipment and related medical devices 1. (DoP)Medical for GradeCovid Oxygentreatment 12% 5% 1. Medical Grade Oxygen 12% 5% B. Oxygen,Oxygen Oxygen Concentrator/ generation Generator, equipment including and relatedpersonal medical devices 2. 12% 5% Oxygenimports Concentrator/ thereof Generator, including personal 2.1. Medical Grade Oxygen 12% 5% imports thereof 3. OxygenVentilators Concentrator/ Generator, including personal 12% 5% 3.2. Ventilators 12% 5% 4. importsVentilator thereof masks / canula / helmet 12% 5% 4. Ventilator masks / canula / helmet 12% 5% 3.5. VentilatorsBiPAP Machine 12%12% 5%5% 5. BiPAP Machine 12% 5% 4.6. VentilatorHigh flow masks nasal canula/ canula (HFNC) / helmet device 12%12% 5%5% 6. High flow nasal canula (HFNC) device 12% 5% 5. C. TestingBiPAP MachineKits and Machines 12% 5% C. Testing Kits and Machines 6.1. HighCovid flow Testing nasal Kits canula (HFNC) device 12%12% 5%5% 1. Covid Testing Kits 12% 5% C. TestingSpecified Kits Inflammatory and Machines Diagnostic Kits, namely D- 2. 12% 5% SpecifiedDimer, IL-6, Inflammatory Ferritin and Diagnostic LDH Kits, namely D- IDMA2.1. BulletinCovid LII (23) Testing 15 to Kits 21 June 2021 12% 5% 16 D. Dimer, IL-6, Ferritin and LDH OtherSpecified Covid-19 Inflammatory related Diagnosticrelief material Kits, namely D- 2. D. 12% 5% OtherDimer, Covid-19 IL-6, Ferritin related and relief LDH material D. Other Covid-19 related relief material Ministry of Finance Recommendations of 44th GST Council Meeting
Change in GST Rates on goods being used in Covid- 19 relief and management
Posted On: 12 JUN 2021 3:39PM by PIB Delhi
The 44th GST Council met under the Chairmanship of Union Finance & Corporate Affairs Minister Smt Nirmala Sitharaman through video conferencing here today. The Council in its meeting has decided to reduce the GST rates on the specified items being used in Covid-19 relief and management till 30th September, 2021. The meeting was also attended by Union Minister of State for Finance & Corporate Affairs Shri Anurag Thakur besides Finance Ministers of States & UTs and senior officers of the Ministry of Finance & States/ UTs. The details of recommendations are given below :
GST Rate S. Present Description recommended by No. GST Rate GST Council A. Medicines 1. Tocilizumab 5% Nil 2. Amphotericin B 5% Nil 3. Anti-Coagulants like Heparin 12% 5% 4. Remdesivir 12% 5% Any other drug recommended by Ministry of Health Applicable 5. and Family Welfare (MoHFW) and Dept. of Pharma Rate 5% (DoP) for Covid treatment B. Oxygen, Oxygen generation equipment and related medical devices 1. Medical Grade Oxygen 12% 5% Oxygen Concentrator/ Generator, including personal 2. 12% 5% imports thereof 3. Ventilators 12% 5% 4. Ventilator masks / canula / helmet 12% 5% 5. BiPAP Machine 12% 5% 6. High flow nasal canula (HFNC) device 12% 5% C. Testing Kits and Machines 1. Covid Testing Kits 12% 5% Specified Inflammatory Diagnostic Kits, namely D- 2. 12% 5% Dimer, IL-6, Ferritin and LDH D. Other Covid-19 related relief material 1. Pulse Oximeters, incl personal imports thereof 12% 5% 2. Hand Sanitizer 18% 5% 3. Temperature check equipment 18% 5% Gas/Electric/other furnaces for crematorium, 4. 18% 5% including their installation, etc. 5. Ambulances 28% 12%
These rate reductions/exemptions shall remain in force upto 30th September 2021. ***** l l l RM/MV/KMN
COMPANIES LAW AMENDMENTS
(ReleaseAmendment ID: 1726525) of Companies (Meetings of Board and its Powers) Rules, 2014
Ministry of Corporate Affairs Notification G.S.R. 409(E), dated 15th June, 2021
In exercise of the powers conferred by sections Note: The Principal Rules were published in the Gazette of 173, 177, 178 and section 186, read with section 469 India, Extraordinary, Part II, Section 3, Sub- section (i), vide notification number G.S.R. 240(E), dated the 31st March, 2014 of the Companies Act, 2013 (18 of 2013), the Central and subsequently amended as follows:- Government hereby makes the following rules further to 1. G.S.R. 398 (E), dated the 12th June, 2014; amend the Companies (Meetings of Board and its Powers) th Rules, 2014, namely:— 2. G.S.R. 590 (E), dated the 14 August, 2014; 3. G.S.R. 206 (E), dated the 18th March, 2015; (1) These rules may be called the Companies 1. 4. G.S.R. 971(E), dated the 14th December, 2015; (Meetings of Board and its Powers) Amendment 5. G.S.R. 309 (E), dated the 30th March, 2017; Rules, 2021. 6. G.S.R. 880 (E), dated the 13th July, 2017; (2) They shall come into force on the date of their 7. G.S.R. 429 (E), dated the 7th May, 2018; publication in the Official Gazette. 8. G.S.R. 777 (E), dated the 11th October, 2019; 2. In the Companies (Meetings of Board and its 9. G.S.R. 857 (E), dated the 18th November, 2019; Powers) Rules, 2014, rule 4 shall be omitted. 10. G.S.R. 186 (E), dated the 19th March, 2020; F.No. 1/32/2013-CL-V-Part 11. G.S.R. 395 (E), dated the 23rd June, 2020;
th K.V.R. Murty, Joint Secretary, Ministry of Corporate Affairs, 12. G.S.R. 590 (E), dated the 28 September, 2020; and New Delhi. 13. G.S.R. 806 (E), dated the 30th December, 2020.
l l l
IDMA Bulletin LII (23) 15 to 21 June 2021 17 Government communication
ATTENTION MEMBERS IDMA has received the below communications from Department of Pharmaceuticals requesting IDMA Members to provide requisite information, if any, on the below subjects. Interested members are requested to kindly forward your comments urgently to IDMA Secretariat at [email protected] and/or [email protected]
18th Session of India-Switzerland Joint Economic Commission (JEC) to be held shortly in India or on virtual platform - reg.
F. No. 35022/14/2021-Policy, dated 4th June 2021
To India-Switzerland Joint Economic Commission Pharmexcil, IPA, IDMA and AIMED (JEC) urgently (latest by 6th June, 2021) for onward submission to Department of Commerce. 1. I am directed to refer on the above mentioned subject and to say that Department of Commerce 3. This issues with the approval of Competent has informed that 18th Session of India-Switzerland Authority. Joint Economic Commission (JEC) to be held shortly Yours faithfully, in India or on virtual platform. Sanjay Meena, Section Officer, Department of Pharmaceuticals, 2. You are requested to provide issues/points for Ministry of Chemicals and Fertilizers, Shastri Bhawan, inclusion in the agenda of the 18th Session of New Delhi .
l l l 11th Session of India-Turkey Joint Committee on Economic and Technical Cooperation (JCETC) to be held shortly on virtual platform - Reg.
F.No. 35022/15/2021-Policy, 17th June, 2021
To Turkey Joint Committee on Economic and Technical Pharmexcil, IPA, IDMA and AIMED Cooperation (JCETC) urgently (latest by 21st June, 2021) for onward submission to Department of 1. I am directed to refer on the above mentioned subject and to say that Department of Commerce Commerce. has informed that 11th Session of India-Turkey Joint Sanjay Meena, Committee on Economic and Technical Cooperation Section Officer, (JCETC) to be held shortly on virtual platform. Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, 2. You are requested to provide issues/points for Shastri Bhawan, inclusion in the agenda of the 11th Session of India- New Delhi .
l l l
IDMA Bulletin LII (23) 15 to 21 June 2021 18
NDPS Matters Temporary Provisions for issue of Provisional CBN Registration Number to the firms dealing in Psychotropic Substances - reg.
Public Notice dated 17th June, 2021
1. Reference is invited towards Rule 65 sub rule 1, 2. The Provisional CBN Registration Number issued of NDPS Rules, 1985 wherein, it is directed to shall be valid only for the period of one year from the all the firms dealing in Psychotropic Substances date of its issue or till restoration of the CBN Online to get themselves registered with the Narcotics Portal, whichever is earlier. Commissioner of India, in the form and manner as 3. After restoration of the CBN Online Portal, the specified by the Narcotics Commissioner.Also, as per companies to whom Provisional CBN Registration Rule 65 sub rule 2, of NDPS Rules, 1985, the firms Number has been issued shall be required to having registered with the Narcotics Commissioner or apply on CBN Online Portal for Temporary CBN CBN are mandatorily required to submit their quarterly Registration Number and thereafter shall send returns in the form and manner as specified by the the self-attested copy of the print out bearing Narcotics Commissioner. system generated Temporary CBN Registration Number along with a forwarding letter. However, 2. For filing an application for issuance of CBN the previously issued Provisional CBN Registration Registration Number & facility for submitting online Number should specifically be mentioned in their quarterly returns, this office had already provided forwarding letter. After receipt of the same, after the CBN Online Portal https:\\www.cbnonline.gov. due scrutiny, this office will issue Permanent CBN in.However, due to some technical issues the above Registration Number to the applicant company. An said website/ online portal is currently not functional intimation in this regard shall be sent to the applicant and it is expected that it may take some time to company, accordingly. become operational. B. Submission & Management of Quarterly 3. Due to the reason above, the user companies are Returns:- facing difficulty in submitting their application as well 1. The applicant company should have to file the as their quarterly returns. In order to facilitate the user quarterly returns (in manual forms by post or by hand companies during the period of breakdown of the or by e-mail) strictly in accordance with the time frame CBN Online Portal, the Central Bureau of Narcotics, given under Rule 65 of NDPS Rules, 1985, failing, Gwalior has initiated some temporary arrangements which, their registration will be liable to be cancelled. as under: - In addition, the company shall ensure preserving the quarterly returns submitted in manual form as record A. Issue of Provisional CBN Registration Number: for the period up to the completion of two years from 1. The firms, not having any temporary CBN the date of restoration of the CBN Online Portal. Registration Number, may apply for the CBN registration, manually. The proforma of the 2. The companies who have been registered during the application and list of documents to be submitted period when CBN Online Portal is not functional, shall have to preserve their manually/ offline sent quarterly is attached herewith as Annexure-I. (After due scrutiny of the application and documents returns up to the period 2 years after restoration of submitted by the firms, this office may issue these the CBN Online Portal. The companies shall provide the information/ detail with regard to their CBN firms a Provisional CBN Registration Number which will facilitate them to continue their business Registration or their quarterly returns, as and when till restoration of the CBN Online Portal. they are directed to do so.
IDMA Bulletin LII (23) 15 to 21 June 2021 19
3. immediately after restoration of the CBN Online F. No. XVI/5/138/Online/ Psy/ 2019-127 Portal, all the firms having Permanent CBN Central Bureau of Narcotics, Ministry of Finance, 19,The Mall, Registration Numbers shall file/ update their quarterly Morar, Gwalior (M.P.) returns on the CBN Online Portal which were filed manually/ in offline mode. Annexure - I
IDMA Bulletin LII (23) 15 to 21 June 2021 20
l l l
For Advertising in the Classified Columns and also for series advertisements Please Contact: Geeta Suvarna (+9820161419) Publications Department IDMA BULLETIN Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723/ E-mail: [email protected], Website: www.idma-assn.org, www.indiandrugsonline.org
IDMA Bulletin LII (23) 15 to 21 June 2021 21
IPR Matter WTO talks on Trips waiver from June 30
At the informal meeting of the Trips Council on some proposals could Thursday, it was also decided that other issues such be very expensive as as duration and implementation of the waiver will be they unfold over the next discussed at a later stage depending on the first stage of 5-10 years. talks, officials said. The discussions World Trade Organization (WTO) members will on on the proposal will June 30 begin talks on the scope and coverage of the continue on July 6, 14 waiver of provisions of the Trade-Related Aspects of and 20 between which Intellectual Property Rights (Trips) agreement proposed meetings among small by India and South Africa for Covid-related medicines. groups would be held. The first consultation At the informal period will start soon, meeting of the leading up to the first Trips Council on open-ended session and Thursday, it was stock taking meeting on also decided that June 30. other issues such as duration and The General Council implementation of of the WTO will check the waiver will be the progress of the “There was agreement on regular Trips Council discussed at a later negotiations on July 27- sessions to push negotiations,” said an official. stage depending 28, instead of July 21-22 as planned earlier, the official on the first stage of talks, officials said. said.
Differences remain on how to ensure rapid and EU seeks parity equitable access to vaccines and Covid-related medical products for all as the European Union and a few others The European Union, which has backed the use of are still opposing a revised proposal by India and South flexibilities within existing frameworks such as compulsory Africa seeking patent waivers on Covid-related medical licences instead of new ones, sought its submission to be products for three years, with a provision to review the treated on a par with the waiver proposal though India and duration annually. South Africa argued that the two be discussed separately in parallel tracks. “There was agreement on regular Trips Council sessions to push negotiations,” said an official. “While the India and South Africa proposal is based on Article 9 of the WTO Agreement, what the EU has made The meeting was the first after the WTO members is not a formal proposal. They can’t be treated equally,” agreed to engage in text-based discussions on the said an expert on WTO issues. proposal for waiver of intellectual protection rights for Covid medication. South Africa argued that from the legal point of view of the discussions, the waiver proposal and the At the Thursday meeting, the US expressed doubts communication by the EU should be addressed on about starting a discussion on the scope of the waiver different tracks. instead of focusing on common objectives and said Source : By Kirtika Suneja, ET Bureau, 18.06.2021
l l l
IDMA Bulletin LII (23) 15 to 21 June 2021 22
national News
Covid-19: On vaccine interval, follow mind, the Delta variant is widely held to have been one the science of the primary factors behind India’s deadly surge. Data from Public Health England analysed by researchers, as Dr Review of Covishield dose-interval is welcome; to Srinath Reddy of PHFI has pointed out in this newspaper, quell controversy, let independent experts appraise show a single-dose of AstraZeneca—with caveats on evidence cited the sample size—registers a very low efficacy against Right now, the Centre can’t afford further trust deficit Covid-19. Two doses, on the other hand, offer reasonable over vaccines. protection, making a strong case for shortening the dose- gap. Thus, if the government is indeed considering a Against the backdrop of senior scientists saying the review of the interval, it is good news. In the interim, it NTAGI didn’t have enough data to back the recommendation must consider narrowing the interval for those who are to increase the gap between two doses of the Covishield more vulnerable to the disease, because of their age or vaccine from 8-12 weeks to 12-16 weeks, chairman NK immunocompromised status. Those arguing against further Arora has said the government is reviewing the move. The categorisation for targetting vaccines would do well to keep scientists were quoted on the inadequate data in a Reuters in mind the government only recently created a category for report earlier this week. The government has denied this, prioritisation of vaccines: students up for admission abroad. saying the decision was unanimous and there were no The INSACOG episode—Reuters reported how the ministry dissenting scientists. It has cited the minutes of meetings and some scientists within INSACOG were not on the same of the Covid-19 working group of the NTAGI on May 10 page initially regarding the seriousness of the threat from and the Standing Technical Sub-Committee of NTAGI on the Delta variant—and now the NTAGI episode underscore May 13. While the working group’ recommendation was the need to let science drive the response to the pandemic, “based on real-life evidences particularly from the United not concerns of the politically-minded. Kingdom”, increasing the interval between the two doses to 12-16 weeks, the technical sub-committee had talked Source : The Financial Express , 18.06.2021 of “an interval of a minimum three months” (or roughly l l l 12 weeks), as per a government release. The government is yet to clarify whether it had endorsed a gap of 12-16 Now, PETA urges govt to not use calf weeks, and if it didn’t, how it settled on 16 weeks as the serum in Covaxin production maximum interval. The example of Spain has been cited with regards to the 16-week gap. However, the fact is Covaxin does not contain calf serum, but the serum Spain recommended the 16-week interval only for those is used in the labs to boost the growth of Vero cells, both the government and Bharat Biotech clarified under 60 years of age. The controversy can be quelled if independent experts can examine real-life evidence that Peta has now urged the Drug Controller of India to find the government says corroborates the scientific strength of an alternative to calf serum for Covaxin production. India’s decision. Right now, the Centre can’t afford further A day after the government clarified that Covid-19 trust deficit over vaccines. The deadly second wave has had vaccine Covaxin does not contain calf serum, People for the unfortunate consequence of stoking vaccine hesitancy the Ethical Treatment of Animals (PETA) India on Thursday because of breakthrough infections, despite these being wrote to the Drugs Controller General of India urging him to a very small number. As such, even if it manages to get replace newborn calf serum with an animal-free chemical NTAGI scientists to put up a ‘unanimous front’, it needs solution, reports said. The government on Wednesday to do much more to engender trust. explained that Covaxin does not contain calf serum, but calf Around the time the Indian government announced serum is used at the very first step of the production. the 12-16 weeks gap, the UK had reduced the interval In its letter, PETA said the calves required for this between two doses of the AstraZeneca vaccine from 12 purpose are taken away from their mother shortly after weeks to 8 weeks at the maximum. This was done in light birth which traumatises both the mother and the calf. It of the increasing prevalence of the Delta variant—it now also said that there are animal-free alternatives already accounts for 98% of the cases in the country. Bear in available.
IDMA Bulletin LII (23) 15 to 21 June 2021 23
What is the controversy all about? Ocugen ties up with Jubilant to make Congress’s Gaurav Pandhi has recently shared an RTI Covaxin for US, Canada reply document on social media which says that newborn HYDERABAD: Bharat Biotech’s US partner Ocugen Inc calf serum is used for the growth of Vero cells. has entered into a partnership with Jubilant HollisterStier The government said that claiming that vaccine LLC, a step-down subsidiary of Jubilant Pharmova, for contains calf serum is twisting and misrepresenting the the manufacture of indigenously developed Covid-19 fact as the final product does not contain any aminal vaccine Covaxin for the United States and Canadian part. It explained that to ensure the growth of Vero cells, markets, Jubilant Pharmova said in a regulatory filing. calf serum is used as the serum has some properties which boost the growth of Vero cells. These Vero cells, after growth, are washed with water many times to make them free from the calf serum, which is only used as a growth agent.
Why calf serum is used in vaccine production Calf serum’s biological properties make it crucial for rapid cell growth as newborn calf have fewer antibody properties. The announcement comes less than a week after On the allegation of animal cruelty Ocugen informed bourses in the US that it had In his tweet, Gaurav Pandhi claimed newborn calves dropped plans to seek an emergency use approval are slaughtered for obtaining serum, which many on social (EUA) from US Food & Drug Administration based on media contested and said there are many ways to get the the regulator’s recommendation and would be taking serum. Importing is also one of them. the BLA (biologics licence application) route to bring Covaxin to the US market. Ocugen had also said it Bharat Biotech has not specified how they procure calf would be filing an EUA with Health Canada for taking serum for their vaccine production, but it has clarified that Covaxin to Canada. the use of newborn calf serum is not a secret. The company has been in the vaccine-making business for decades and Ocugen’s senior vice president of manufacturing this is the standard process of producing vaccines. and supply chain, JP Gabriel, said in a statement that Ocugen was fully committed to bringing Covaxin If calves are not killed, why PETA is opposing to the US and Canadian markets because it has the PETA said the Prevention of Cruelty to Animals potential to save lives by adding a weapon to the arsenal. (Slaughter House) Rules, 2001, prohibits the slaughter “Securing US-based manufacturing capability is a critical of pregnant animals and animals under three months step as we prepare to submit our regulatory submissions to of age. “Therefore, the use of serum obtained by the FDA and Health Canada. slaughtering a calf younger than 20 days of age for Based on Bharat Biotech’s strong track record vaccine production should also not be allowed,” it said. of developing and commercializing vaccines globally But even if they are not killed, they are traumatised for and Jubilant’s proven track record in manufacturing,” being snatched from their mothers just after their birth, Gabriel added. Jubilant Pharma Ltd CEO Pramod Yadav PETA said. said: “With two facilities in North America working to It also raised the issue of the risk of contamination in manufacture multiple Covid-19 vaccines and therapies, the vaccine, which Bharat Biotech has already addressed we remain committed to supporting efforts to eradicate and said that Covaxin is pure and there is no trace of calf this global pandemic.” serum in the finished product. Source : Swati Bharadwaj , TNN, 17.06.2021
Source: Poulomi Ghosh, Hindustan Times, 17.06.2021 l l l l l l
IDMA Bulletin LII (23) 15 to 21 June 2021 24
Watchdog tells pharma firms to pass on covid items will experience temporary accumulation of tax rate cut benefits to consumers credit proportionate to the unsold stocks,” he added. In India, remdesivir is manufactured by seven • Since drug prices are inclusive of taxes, producers and companies, including Hetero Drugs, Cipla, Dr Reddy’s marketing firms should lower the maximum retail price, Laboratories and Zydus Cadila, through a voluntary taking into account the GST rate cut announced last licence issued by Gilead Sciences. Sun Pharmaceutical Saturday Industries also makes the drug in partnership with Syngene • The government had last week lowered the GST on International Ltd. Tocilizumab and Amphotericin B to zero from 5% The Centre has recently said remdesivir must be The National Pharmaceutical Pricing Authority (NPPA) used only in select covid-19 patients on supplemental has urged manufacturers of medicines and medical devices oxygen as it is a reserve drug approved under emergency used in treating covid-19 to slash product prices and pass use authorization based on limited scientific evidence on the benefit of tax rate cuts to consumers. globally. In an order on Wednesday, the drug pricing watchdog The government has also asked amphotericin B said since the prices are inclusive of taxes, producers and manufacturers to increase production in view of the rise marketing firms should lower the maximum retail price, in cases of mucormycosis, or black fungus, among covid taking into account the reduction in goods and services patients. tax (GST) rates announced on 12 June. Tocilizumab, which is being imported from Switzerland However, NPPA said that in case of products that have by Cipla, costs ₹40,000- 50,000 for a single dose in India, already been dispatched, there was no need to change and helps reduce the inflammatory storm in the respiratory the price tag on the package, but producers must ensure system of severe covid patients. compliance of the new low price at the retail level by sending a revised price list. Source: Neetu Chandra Sharma & Gireesh Chandra Prasad, HT Mint, 17.06.2021 The government had lowered GST on tocilizumab used l l l in treating inflammatory and autoimmune conditions, and anti-fungal drug amphotericin B to 0% from 5%, and COVID-19 Has Created An anti-viral injection remdesivir and blood thinner heparin to “Ecosystem” Of Innovation In India: 5% from 12% earlier. The tax cuts covered 18 categories, including medical oxygen and oxygen concentrators. NPPA’s Kiran Mazumdar-Shaw order was addressed to both pharmaceutical companies as “The whole intent (of the more than a decade old annual well as medical device makers. India-US bio pharma summit) is to catalyse an innovation Following the NPPA order, the All India Organisation of ecosystem in India. I think, COVID has actually created the Chemists and Druggists (AIOCD) also advised its members ecosystem,” Mazumdar-Shaw told in an interview. to revise MRPs. “We have requested all pharmaceutical The ongoing COVID-19 public health crisis has resulted companies manufacturing remdesivir, tocilizumab, in the creation of an “ecosystem” of innovation in India, heparin and amphotericin B to send us the new prices Biocon chief Kiran Mazumdar-Shaw has said ahead of urgently so that we can inform the trade to follow the the annual India-US bio-pharma summit in Boston next gazette notification,” said Rajiv Singhal, general secretary, week. AIOCD. Mazumdar-Shaw, 68, is one of the key speakers at NPPA mandated pharmaceutical manufacturers and the 15th edition of the annual virtual summit on June marketing companies to pass on GST rationalization 22 hosted by the USA India Chambers of Commerce. benefits on covid items, including oxygen concentrators, The other star-studded speakers include Dr Albert Bourla, said Rajat Mohan, senior partner at chartered accountant Chairman and CEO of Pfizer; Dr Francis Collins, Director, firm AMRG and Associates. “In case of unsold stocks National Institutes of Health; Dr Janet Woodcock, Acting in the market, manufacturers are made liable to ensure Commissioner, US Food and Drug Administration; and prices are reduced by every retailer with immediate effect, Amitabh Kant, CEO of NITI Aayog. irrespective of the old MRP tags. Large stockists of the
IDMA Bulletin LII (23) 15 to 21 June 2021 25
“The whole intent (of the more than a decade old The nasal vaccine that Bharat Biotech is developing annual India-US bio pharma summit) is to catalyse an has been licensed from the University of Wisconsin. A lot innovation ecosystem in India. I think, COVID has actually of that kind of partnership and collaborations are ongoing, created the ecosystem,” Mazumdar-Shaw told PTI in an she said, adding, “COVID has definitely brought a lot of interview. spotlights on to those kinds of opportunities”. COVID, she, noted, has actually resulted in innovative One of the major challenges of the global bio- vaccines being produced, such as Covaxin, Genova mRNA pharmaceutical industry was the disruption of global supply programme, and many other programmes that the Indian chains. And one of them was the raw material supply chain vaccine makers have licensed and developed in the required for vaccine production, the Biocon head said. country. India, she said, was dependent on the US for raw “Then, of course, the whole clinical research ecosystem materials for vaccine manufacturing. Recently, the US has been created because we’’ve had so many clinical trials and India came together and the ban on supply of the raw in India, whether it is for new repurpose drugs or vaccines... materials was revoked, paving the way for Indian vaccine basically bridging trials, a lot of clinical trials have also manufacturers to produce the jabs required for global happened in India,” said the executive chairperson and markets. founder of Biocon, a top biotechnology company based in “Today, India has been recognised as one of the largest Bangalore, noting that clinical trials were banned in India producers of vaccines in the world. They (the Indian pharma at one stage. companies) were limited in terms of their vaccine capacity “And then when the whole environment opened up for because of some of these constraints. But now with the clinical trials, there were not enough trials going on. Now US opening up that kind of supply of products to vaccine suddenly, a whole bunch of clinical trials have gone on. manufacturers, they have also enabled the production of A lot of clinical sites have opened. A lot of investigator- vaccines for global markets,” Mazumdar-Shaw said. initiated studies have started. Responding to a question, she said India and the US “I think the whole understanding that you’’ve just got need to make sure that there is free sharing of knowledge to get into clinical trials and clinical research, to actually on technologies and products and any kind of export ban address a large number of unmet needs is now beginning be lifted. That would be a very good policy for both the to dawn on the Indian innovation system,” Mazumdar- countries to adopt. Shaw said. “The fact that there’’s already a natural collaboration She noted that India has a large number of happening between Indian companies and the US incubators, where they are developing some very innovative companies and academic institutions. Ultimately it is really programmes. about having access to each other’’s markets, because India is a huge market and so is the US,” she said. “There is VC funding now getting into those programmes. So slowly, that ecosystem has been created,” Mazumdar-Shaw said while most Indian genetic the billionaire entrepreneur said, adding that companies companies are dependent on the US market, a lot of from India have started US operations to raise funding and American companies are also looking at India as a market are becoming a part of the US’’ innovation ecosystem. that is important in the future. The COVID-19 crisis, she observed, has also brought “From that point of view, it’’s a symbiotic and win-win the pharma companies from India and the US together. kind of an opportunity for both the countries,” she said. Citing examples, she said, Novavax has partnered with Observing that the second wave of COVID-19 is Serum Institute. The Baylor Institute has partnered with receding and the numbers are coming down very rapidly, Biological-E, Johnson and Johnson has partnered with Mazumdar-Shaw said India has learned many lessons from Biological-E and contracted manufacturing their vaccine. this public health crisis. Then there are many other programmes that have been “Every country has learned lessons in COVID-19. One is licensed from US academic centres, Mazumdar-Shaw that you cannot be complacent. Secondly, there are going said. to be waves of the pandemic. So just because one wave
IDMA Bulletin LII (23) 15 to 21 June 2021 26
recedes, doesn’’t mean that another wave won’’t happen. There are many different types of the condition, Thirdly, you got to be in a state of preparedness all the although little is known about what causes this variation time. You cannot be complacent. and the best way to manage the different versions of the disease. “Fourthly, you must have very strong surveillance measures. Because that is something which every country According to data from IQVIA, Tiotropium DPI had a has not done very well, and it has got surprised by an market size of US$ 450 million in the European Union in outbreak, which has suddenly led to another wave,” she the 12 monthAperiod ended September 2020. said. Glenmark’s subsidiary, Glenmark Pharmaceuticals Mazumdar-Shaw said any government needs to make Europe Limited had entered into a strategic, exclusive in- sure that it calibrate the opening up of the economy and licensing arrangement for marketing generic Tiotropium adopt COVID appropriate behaviour. Bromide DPI in Western Europe and UK in August 2018. “You must be very vigilant about any outbreaks anywhere. Because small outbreaks can really start Glenmark is planning subsequent launches of the becoming very serious if you ignore them. These are some product across markets in Western Europe under the brand of the learnings. But most importantly, the world has name Tiogiva in Ireland, Sweden, Finland and Norway; realised that by vaccinating dense populations that have Tavulus in Denmark, Spain and Netherlands and Tiotropium high caseload, they’’re able to basically bring down and Glenmark in Germany. manage the pandemic much better than if you just tried Tiotropium Bromide DPI is a bioequivalent version of to vaccinate everyone,” she said. Boehringer Ingelheim’s Spiriva Handihaler and is used in Noting that healthcare costs are very challenging right the treatment of COPD, Glenmark said. now, Mazumdar-Shaw said products like generics and According to Glenmark, this is the second inhalation biosimilars are going to be very helpful and they will also product in-licensed by Glenmark for the European market contain the healthcare costs. after StalpexA(Fluticasone/ Salmeterol) dry powder “Indian pharma companies will continue to basically inhaler. address these healthcare needs... From that point of Source: IANS, 16.06.2021 view, I see that right now all the focus has been on COVID, but we’’ve also neglected a lot of other disease l l l areas. Now that the economy has opened, hospitals have opened...you’’re going to see a huge demand for many, Bharat Biotech officials to meet WHO many of these products (generics and biosimilars),” assessors next week she said. A pre-submission meeting provides an opportunity to the Source : PTI, 15.06.2021 company for advice and guidance before submission of the l l l final dossier, as well as an opportunity for them to meet WHO assessors who will be involved in assessing their product. Glenmark launches dry powder inhaler The World Health Organization (WHO) will hold a Tiogiva in UK ‘pre-submission’ meeting with Hyderabad based Bharat Biotech regarding the approval of its Covid-19 vaccine Pharma major Glenmark Pharmaceuticals Ltd on Covaxin on June 23. Tuesday said it has launched a bioequivalent version of Tiotropium Bromide dry powder inhaler (DPI) under the In May, Bharat Biotech said its Emergency Use Listing brand name - Tiogiva, in UK for the treatment of chronic (EUL) application had been submitted to WHO, Geneva, obstructive pulmonary disease (COPD). and regulatory approvals are expected between July and According to Glenmark, COPD is a long-term condition September. that causes inflammation in the lungs, damaged lung A pre-submission meeting provides an opportunity to tissue and a narrowing of the airways, making breathing the company for advice and guidance before submission difficult. of the final dossier, as well as an opportunity for them to
IDMA Bulletin LII (23) 15 to 21 June 2021 27
meet WHO assessors who will be involved in assessing At present, several countries have imposed restrictions their product. on international travel from India but this can become a thorny issue for those who have taken the Covaxin jab once The WHO Emergency Use Listing/Pre qualification these restrictions are lifted. evaluation process guidance document dated May 18 posted on the WHO website said Bharat Biotech had Source: Teena Thacker, Economic Times, 18.06.2021 submitted its Expression of Interest on April 19 and that l l l more information is required. “The final dossier and the results of Phase III will be Delta, Delta Plus variants and their submitted after next week’s meeting,” a person aware of response to vaccines the development told ET. While virologists say theoretically the vaccine Submission of Phase III data along with data on that works on Delta should work on the Delta Plus manufacturing quality is mandatory for Emergency Use variant as well, more research is needed Listing (EUL). The EUL pathway involves a rigorous Delta and assessment of clinical trial data as well as additional Delta Plus variants data on safety, efficacy, quality, and a risk management of Sars-CoV-2 are plan. causing concern Bharat Biotech has released an interim analysis of among doctors and its phase 3 data, but it has not yet published full results researchers as the from phase 3 study in an internationally recognised peer world tries to map review journal. the spread, virulence and potential risks Bharat Biotech had earlier said it will make Covaxin’s of these mutations. Phase-3 trial data public during July, following which the Bharat Biotech had earlier said it will make Covaxin'sIndiaDelta and Phase hasDelta Plus said- variants3 trial that of Sars data Delta-CoV - 2 Plusare causing is concern not yetamong a doctors variant and of company will be applying for full licensure of the Covid-19 researchers as the world tries to map the spread, virulence and potential risks of these public during July, following which the company willconcern.mutations. be Indiaapplying Buthas said what that forDelta are Plusfull these is not yet variants,a variant of concern. where But what did are they vaccine in India. It also said it was conducting Phase-4 these variants, where did they originate and are vaccines effective against them? Let’s licensure of the Covid-19 vaccine in India. It also saidoriginatefind out. it was and conducting are vaccines effective against them? Let’s trials to check the “real-world effectiveness” of the vaccines find out. Phase-4 trials to check the “real-world effectiveness”What of is thethe Delta vaccines variant of Sars -andCoV-2 and what is its origin? and to meet scientifically approved standards for safety to meet scientifically approved standards for A safetyll viruses, including and SARS efficacy.-CoV-2 that causes Covid-19, change over time. Most and efficacy. Whatchanges ishave the little Deltato no impact variant on the virus’of Sars-CoV-2 properties. However, and some what changes is mayits affect how easily the virus spreads and the associated severity of the disease, the origin?performance of vaccines, therapeutic medicines, diagnostic tools, or other public health and social measures. All viruses, including SARS-CoV-2 that causes Covid- The earliest documented examples of the Delta variant, officially named B.1.617.2, are 19,from India, change according over to the time. World MostHealth Organizationchanges (WHO). have little to no impact onIn Apr theil this virus’ year, the properties. WHO classified However,the Delta variant some as a “variant changes of interest” may (VOI) affect — a variant that warranted close monitoring because of its potential risk. But in May, it howreclassified easily it as athe “variant virus of concern” spreads (VOC) —and to signify the that associated it posed additio nalseverity risks to ofpublic the health. disease, the performance of vaccines, therapeutic medicines,This strain is thought diagnostic to be behind the tools, second wave or otherof infections public in India. health and socialWhat is the measures. Delta Plus variant? The Delta Plus, or Delta-AY.1 variant, is a mutated version of the B.1.617.2 variant or strain.The This strain earliest is character documentedised by the K417N examples mutation in theof spikethe proteinDelta of variant,the SARS-CoV2 virus that causes the Covid-19 disease. officially named B.1.617.2, are from India, according to According to reports, the K417N mutation has been associated with “immune escape”, which basically means that the virus is less susceptible to — or less responsive to — An emergency approval from the WHO will allow the World Health Organization (WHO). An emergency approval from the WHO will allow the company to export the company to export its vaccines, and enable easy its vaccines, and enable easy international travel of IndianIn April citizensthis year, whothe WHO classified the Delta variant international travel of Indian citizens who have been as a “variant of interest” (VOI) — a variant that warranted administeredhave Covaxin.been administered Covaxin. close monitoring because of its potential risk. But in May, it reclassified it as a “variant of concern” (VOC) — to signify TheThe EU EU and and some some countries like like Saudi Saudi Arabia Arabia have have made it mandatory that it posed additional risks to public health. madefor travelers it mandatory to takefor travelers approved to take vaccines approved vaccines(those cleared by WHO or the (thoseUS, UK, cleared and by EU WHO regulators) or the US, UK, before and EU they regulators) can step footThis on strain their is thought shores. to be behind the second wave of before they can step foot on their shores. infections in India. At present, several countries have imposed restrictions on international travelIDMA Bulletinfrom India LII (23) but 15 this to 21 can June become 2021 a thorny issue for those who have 28 taken the Covaxin jab once these restrictions are lifted.
Delta, Delta Plus variants and their response to vaccines While virologists say theoretically the vaccine that works on Delta should work on the Delta Plus variant as well, more research is needed Topics Coronavirus | Coronavirus Vaccine | Coronavirus Tests Sohini Das | Mumbai Last Updated at June 17, 2021 06:10 IST
What is the Delta Plus variant? Chandrashekhar said that it is believed to be 60 per cent more transmissible than the B.1.1.7 variant (or the The Delta Plus, or Delta-AY.1 variant, is a mutated alpha variant) and may be associated with an increased version of the B.1.617.2 variant or strain. This strain disease severity such as hospitalisation risk. is characterised by the K417N mutation in the spike protein of the SARS-CoV2 virus that causes the Covid-19 Are Covishield, Covaxin, Pfizer, Sputnik and other vaccines disease. effective against the Delta and Delta Plus variants? According to reports, the K417N mutation has been According to Public Health England, Pfizer and associated with “immune escape”, which basically means AstraZeneca vaccines offer protection against the Delta that the virus is less susceptible to — or less responsive variant. The protection is more than 90 per cent against to — any drug therapy. The Indian government has said hospitalisation or getting severe disease. that the Delta Plus variant is not a variant of concern. Covaxin, the Bharat Biotech vaccine, also offers Where did Delta Plus originate and in which countries do protection against the Delta variant, the company and the we find it now? Indian Council of Medical Research have claimed. The Indian government has said that the variant has Sputnik V’s official Twitter handle claimed it works been seen in Europe since March. against the Delta variant, too. It said it was more “efficient” than any other vaccine. Public Health England, an executive agency of the Department of Health and Social Care in the United A study conducted by the All India Institute of Medical Kingdom, has said that the Delta Plus variant has been Sciences, Delhi, and the National Centre for Disease identified in six genomes from India till June 7. These Control recently said that the Delta variant can infect sequences have been found in genomes from 10 countries partially or fully vaccinated people. The infection does not so far, some scientists have said. US, Canada, UK, Japan, become severe, however. Portugal, Poland, Russia, Turkey, Nepal and Switzerland While virologists say theoretically the vaccine that are among the countries that have reported this strain. works on Delta should work on the Delta Plus variant as “The variant prevalent in the US is called Alfa; the well, more research is needed. one prevalent in South America is Beta and the one in Source: Sohini Das, Business Standard, 17.06.2021 Africa is Theta. And the European countries have seen the prevalence of Gamma, besides Theta,” explained l l l Chandrashekhar T, chief intensivist, Fortis Hiranandani Hospital, Vashi, Mumbai. Indians spent Rs 15,000 crore on He added that Delta was by and large prevalent in immunity boosters in a year India and Asia, and has now spread to other nations, Data from the All India Organisation of Chemists & too. The Kappa variant was prevalent in Australia. “The Druggists (AIOCD) showed that in the June 2020-May Delta variant was there in the first wave as well. However, 2021 period, Indians bought Rs 1,220 crore of antiviral the coronavirus is in constant mutation, with increasing drug Favipiravir and Rs 833 crore of Remdesivir. Sales transmissibility and virulence,” the doctor said. of antibiotic Azithromycin stood at Rs 992 crore, 38% How virulent are these variants? higher on-year. Sales of Doxycycline almost tripled to Rs 85 crore. Sales of anti-parasitic drug Ivermectin surged The Delta Plus variant is said to be resisting the over 10 times to Rs 237 crore. monoclonal antibody cocktail — Casirivimab and Imdevimab — treatment given to high-risk Covid-19 Indians bought nearly Rs 15,000-crore of vitamin patients in the early stages of this disease. This treatment supplements and other immunity boosters in the twelve recently got the nod in India from the drug regulator. months to May, up about a fifth from the same period the Scientists, however, are not certain if this resistance preceding year, as sales of drugs related directly or indirectly means that the new variant has a higher transmission rate to Covid-19 treatment surged. Prescription antivirals or that it causes more severe infection compared to the and antibiotics, such as Favipiravir, Remdesivir and other predominant strains. Azithromycin, were also in demand.
IDMA Bulletin LII (23) 15 to 21 June 2021 29
Data from the All India Organisation of Chemists & increased demand due to infections triggered by Druggists (AIOCD) showed that in the June 2020-May compromised immunity, said Sapale. 2021 period, Indians bought Rs 1,220 crore of antiviral Medicines are largely an out-of-pocket expense item for drug Favipiravir and Rs 833 crore of Remdesivir. Sales of Indians, and the share of wellness and prescription drugs antibiotic Azithromycin stood at Rs 992 crore, 38% higher on-year. Sales of Doxycycline almost tripled to Rs 85 crore. in total expenses increased for the average household since Sales of anti-parasitic drug Ivermectin surged over 10 times the onset of the pandemic. to Rs 237 crore. For several companies that rolled out such products on Indians also bought immunity-boosting vitamin drugs time, sales through the period under review were robust. and mineral supplements worth Rs 14,587 crore, about Glenmark Pharma, the first to introduce Favipirvir in India 20% more than in the preceding year. Sales of vitamin in June last year, earned Rs 975 crore until May, accounting D alone stood at Rs 817 crore, about 40% higher. Zinc for four-fifths of the drug’s total sales in the country until supplements sold nearly three times more at Rs 183 last month. Glenmark’s domestic sales stood at Rs 3,536 crore.Indians also bought immunity-boosting vitamin drugs and crore for FY21. mineral supplements worth Rs 14,587 crore, about 20% more Directthan in Dispatchesthe preceding not year. Included Sales of vitamin D alone stood at Cipla and Cadila Healthcare earned Rs 309 crore Rs 817 crore, about 40% higher. Zinc supplements sold and Rs 215 crore, respectively, from Remdesivir nearlySales three of plain times vitamin more C on at the Rs other 183 hand crore. nearly sales. Similarly, sales of leading vitamin and minerals quadrupled to Rs 340 crore. Direct Dispatches not Included supplement brand Zincovit of Apex Labs nearly tripled to SalesTo of be plain sure, vitamin sales C onof thethese other categories hand nearly of quadrupleddrugs could to Rs 340 crore. Rs 585 crore. Limcee, a vitamin C supplement marketed be even higher as AIOCD data do not include company by Abbott Healthcare, saw its sales quadruple to Rs 192 dispatchesTo be sure, salesdirectly of these to large categories hospitals of drugs or institutions. could be even crore. higher as AIOCD data do not include company dispatches directly“AIOCD to sources large data hospitals from stockists. or Thus, institutions. sales of Vitamin D brand Uprise D3 of Alkem Labs almost drugs that pharma companies directly sell to the hospitals “AIOCD sources data from stockists. Thus, sales of drugs doubled its sales from Rs 72 crore to Rs 132 crore. and other institutions may not get captured in the AIOCD that pharma companies directly sell to the hospitals and other Multivitamin brands A to Z grew 58% and Supradyn 76%. data,”institutions said may Krishnanath not get captured Munde, in Associate the AIOCD Director, data,” said India Health supplement brands Revital and Protinex witnessed RatingsKrishnanath and Munde,Researc Associateh. Director, India Ratings and Research. on-year jumps of 52% and 64%, respectively.
Incidentally, the latest Director General of Health Services (DGHS) guidelines published late last month have dropped Favipiravir, Ivermectin, Azithromycin, Doxycycline and Hydroxychloroquine from the list of drugs to be directly used in Covid treatment. Zinc supplements and multivitamins, too, do not find mention in the guidelines. Also, the use of Remdesivir and Tocilizumab has been restricted to select cases. Still, experts believe that would not immediately change prescription patterns.
“Lancet or health ministry guidelines do not get widely read and it becomes difficult for physicians to delete Multivitamins were in demand because of their immunity these drugs from their prescriptions after it has developed booster properties, said Sheetal Sapale, President – into a deep-rooted ritual,” said Dr SP Kalantri, Director Marketing, AIOCD AWACS. Antivirals Favipiravir and and Professor of Medicine, Mahatma Gandhi Institute of Remdesivir were also in high demand through the second Medical Sciences. wave because of their direct role in Covid treatment. Source: Economic Times, 17.06.2021 Antibacterials such as Doxycycline and Azithromycin and anti-parasitic agents such as Ivermectin reported l l l
IDMA Bulletin LII (23) 15 to 21 June 2021 30
Covid-19 vaccine pricing accounts for Medical Research, and its adjuvant supplier Virovax last-mile delivery, say firms of Kansas. The cost of logistics is built into the final price Vaccine logistics has to take into account a few things of the vaccine, especially when supplying to the —Covid spoilage-19 vaccine freezersand integrityfrom hospitals of and the institutions. cold It chain. is now set Vaccinesto start exports ofdo not private sector holdthese freezers their to potencyvarious countries, for i ncludinglong and Japan. thus have to be transported to the last mile within a certain time frame, maintaining The two Indian vaccine makers —Bharat Sputnik V requires a temperature range of -18 degrees Celsius to keep the vaccine stable and thepotent. temperature requirements. As a result, commercial Biotech and Serum Institute of India — bear the cost of cold chain players are seeing an opportunity. last-mile delivery of their Covid-19 vaccines, executives said. While supplying to the government this means movement from their plants to states’ cold chain points, but for private hospitals, it is delivered at the doorstep. The cost of logistics is, thus, built into the final price of the vaccine, especially when supplying to the private sector. A senior executive of Bharat Biotech explained: “When we supply to the government, we dispatch the doses to the state-wise cold chain points. Each state would have more than one such point. The government takes it from there and ensures distribution to vaccination centers.” According to PTI, the government has invited bids for last-mile delivery of vaccines to remote areas through For Sputnik V, which is now available at private drones. hospitals, Hyderabad’s Rockwell Industries has partnered
However, in case of delivering to private hospitals, the with Dr Reddy’s Laboratories. Rockwell Industries has got vaccine makers have to send it to the specific hospital itself. orders for 750 Covid-19 vaccine freezers from hospitals and “Nothing extra is charged from hospitals. This logistics institutions. It is now set to start exports of these freezers cost, which is significant, is built into the pricing,” the to various countries, including Japan. executive mentioned. Sputnik V requires a temperature range of -18 degrees Cost of logistics is largely determined by the volumes. Celsius to keep the vaccine stable and potent. Supplying a few thousand doses to hospitals thus becomes Source: Sohini Das, Business Standard, 17.06.2021 a challenge, say the vaccine makers. l l l Pune-based SII too follows the same model, sources confirmed. Bharat Biotech charges private hospitals Rs How Biological E could emerge as game 1,200 per dose for Covaxin, while SII charges them Rs 600 per dose for Covishield. changer in India’s vaccine race Company scales up its ambition after government The cost for the government is much lower at Rs 150 advanced it Rs 1,500 crore for 300 million doses of per dose, and the vaccine makers have indicated that this its vaccine candidate. is not sustainable. A few weeks ago, Hyderabad-based Biological Bharat Biotech said on Tuesday that supplying at Rs E made headlines by becoming the second created-in- 150 per dose is not sustainable in the long run. India vaccine player with the government announcing an It has invested Rs 500 crore from internal accruals advance of Rs 1,500 crore for 300 million doses of its for development and production of the vaccine and candidate Corbevax, which is awaiting the drug regulator’s has to pay royalties on sales to the Indian Council of approval. This order is part of a larger vaccine plan by this
IDMA Bulletin LII (23) 15 to 21 June 2021 31 How Biological E could emerge as game changer in India's vaccine race Company scales up its ambition after government advanced it Rs 1,500 crore for 300 million doses of its vaccine candidate. 73-year-oldTopics company, currently the world’s largest producer conducted due diligence on Biological E’s proposal before Biological E | Coronavirus Vaccine | Vaccination ofSohini tetanus Das | Mumbai vaccines. Last Updated at June 17, 2021 08:59 IST approving the advance payment.
The government has supported Biological E’s candidate since the pre-clinical stage. The Department of Biotechnology extended a grant-in-aid of over Rs 100 crore, and partnered with Biological E to conduct all anim al challenge and assay studies through its research centre Translational Health Science and Technology Institute, Faridabad. In December last year, the Coalition for Epidemic Preparedness Innovations (CEPI), which is backed by 14 governments, the Bill and Melinda Gates Foundation, and UK’s Wellcome Trust, chipped in with an initial $5 million and an option to provide more to produce 100 million doses of the vaccine in 2021. CEPI’s interest in Biological E’s vaccine candidate is crucial because it is one
A few weeks ago, Hyderabad-based Biological E made headlines by becoming the of the three global institutions that are part of the Covax secondThe created sheer-in-India volumes vaccine player could with makethe government Biological announcing E, consideredan advance of Rs 1,500 crore for 300 million doses of its candidate Corbevax, which is awaiting the alliance that aim to secure poor countries fair access to adrug dark regulator’s horse approval. in theThis orderbusiness, is part of a largera game-changer, vaccine plan by this 73more-year-old so Covid-19 vaccines. Gavi, the Vaccine Alliance, and the company, currently the world’s largest producer of tetanus vaccines. because Corbevax is not its only bet. Last year, Mahima World Health Organization are the other two. Datla is a The sheer volumes could make Biological E, considered a dark horse in the business, a Datla,game-changer, MD more and so because CEO andCorbevax granddaughter is not its only bet. Last of year, the Mahima founder, Datla, Gavi board member. toldMD and Business CEO and granddaughter Standard thatof the founder,the company told Business plans Standard to that make the 1.5 company plans to make 1.5 billion doses of Covid-19 vaccines in 2021. Of this, 500-600 The global vaccine alliance’s interest in Biological E’s billion doses of Covid-19 vaccines in 2021. Of this, 500- candidate is due to its scalability. CEPI had indicated that 600 million doses will be contract manufactured for the Biological E’s vaccine candidate has “the potential to be single shot candidate of US major Johnson and Johnson produced at scale, and characteristics which could make under the Quad Vaccine Partnership, an alliance between it suitable for broad distribution in developing countries”. India, the US, Japan and Australia. The Indian government is betting on Biological E for the By 2022, there is a plan to make an mRNA- same reason. technology vaccine, for which it has tied up with V K Paul, member (health) of the Niti Aayog, has said Canadian firm Providence Therapeutics. The vaccine, recently that Biological E will have the capacity to make named PTX-COVID19-B, is under development in Canada 75 million doses per month from September, though and the plan includes conducting clinical trials in India. the Centre’s expectation of 300 million doses between The financial terms of the deal were not disclosed, but August and December assumes a more modest 60 million Providence will sell up to 30 million doses of PTX- a month. In comparison, it expects 550 million doses COVID19-B to Biological E and transfer technology to from Bharat Biotech, and 950 million doses from SII make the vaccine in India, with a minimum production (both AstraZeneca’s Covishield, which is already being capacity of 600 million doses in 2022 and target administered, and Covovax, the candidate from US-based capacity of one billion doses. biotech company Novavax) for the same period. To put these plans in perspective, Pune-based Serum Senior virologist T Jacob John, former head of the Dep Institute of India (SII), the world’s largest vaccine maker artment of Clinical Virology and Microbiology at Christian by volume, manufactured 1.5 billion doses in FY 2019-20. Medical College, Vellore, said that science is predictive. This financial year, SII has scaled up annual capacities to This platform has been used to make the hepatitis B vaccine over 2 billion doses. and the pichia pastoris (a species of yeast) platform has But it is Corbevax that is attracting attention as shown good results so far. “Therefore, we can expect that India’s vaccine programme gathers momentum. Currently Corbevax will also work. What needs to be seen is whether undergoing Phase 3 clinical trials, the National Expert this is able to induce cell-mediated immune response, or Group on Vaccine Administration for Covid-19 had long-term immune response,” he said.
IDMA Bulletin LII (23) 15 to 21 June 2021 32
SeniorThese virologist areT Jacob “The John, technology former headplatform of thethe Depcompany- is using is highly artmentcertainly of big Clinical gambles Virology scalable, and Microbiologyand also it does at notChristian require a BSL-3 (biosafety Mforedical the College, Rs 900- Vellore,level) said facility that scienceto manufacture. is predictive. This makes the huge volumes This1,000-crore platform unlisted has been theyused are to talking make aboutthe hepatitis achievable. B But, we do not see that vaccinecompany and to take.the pichia Are pastorishappening (a byspec December,”ies of yeast) said the senior official who platformthey too has ambitious? shown good requested results anonymity.so far. “Therefore, He added wethat the challenge will be canT h expect e c o that m p Corbevax a n y bigger will whenalso wit ork.comes What to the needs mRNA to technology platform, becertainly seen is whether has the this whichis able is tonew induce to India. cell “The-media mRNAted platform, too, is scalable immuneexperience. response, Vaccines or longwith-term high yields.immune And response,” thus, once he the company masters the said.account for 80 per technology, it would be able to make large volumes here cent of Biological as well,” he added. These are certainly big gambles for the Rs 900-1,000- E’s revenues, the crore unlisted company to take.John Areadded they that too any ambitious? Covid-19 vaccine that comes result of a strategic The company certainly outhas now the isexperience. like an “also-ran” Vaccines candidate, given that many reorientation in 2000 account for 80 per cent vulnerableof Biological people E’s haverevenues, already the succumbed to the disease with McKinsey, five result of a strategic reorientationfor want of in vaccine 2000 withprotection. McKinsey, fiveyears years after after UK’s UK’s GSK GSK sold its 25 per cent stake to thesold Datla its 25family. per centThe companyAnother had industry forayed insiderinto vaccines pointed out that the risks instake 1962 towith the diphtheria, Datla Biologicalpertussis Eor haswhooping taken with cough, Corbevax are also limited, andfamily. tetanus The companyvaccines, butprincipally they formed because an it insignificant is based on a similar platform as the parthad of forayedits revenues. into Thenhepatitis Datla vaccine,decided whichto exit the highly company has been making competitivevaccines in 1962 businesses with for such years. as tuberculosis All the same, drugs Datla and is taking a jab at a new consumerdiphtheria, health, pertussis and focusopportunity. on the The opportunities year 2022 willthrown be the real test. up by the government’s decision to introduce hepatitis, or whooping cough, Source: Sohini Das, Business Standard, 17.06.2021 H1and influenza tetanus vaccines, and pentavalent (or 5-in-one) vaccines. l l l but they formed an Today,insignificant Biological part E ofhas seven WHO-prequalified vaccinesits revenues. in its kitty Then and supplies to more than 100 countries.It has seven manufacturing facilities — of Datla decided to exit which two are neighbours of Bharat Biotech at Genome highly competitive Valley in Hyderabad, and three are in Telangana. businesses such as Buttuberculosis it’s the timeline drugs that’s a question mark. A vaccine makera n d felt c o that n s uBiological m e r E may miss the 1.5 billion dose manufacthealth, uring and focusplan by calendar 2021, but would be able toon make the opportunitiessignificant volumes by the end of the financial year.thrown “The up technology by the platform the company is using is highlygovernment’s scalable, decision and also it does not require a BSL-3 (biosafetyto introduce level) hepatitis, facility to manufacture. This makes the hugeH1 influenzavolumes they and are talking about achievable. But, we pentavalentdo not see (orthat 5-in-one) happening vaccines. by December,” said the senior official who requested anonymity. Today, Biological E has seven WHO-prequalified vaccinesHe added in that its thekitty challenge and supplies will be to bigger more whenthan 100 it comes to the mRNA technology countries.Itplatform, which has seven is new manufacturing to India. “The facilities mRNA — platform,of which too, is scalable with high yields. twoAnd are thus, neighbours once the of companyBharat Biotech masters at Genome the technology, Valley in it would be able to make large Hyderabad,volumes here and as three well,” are he in Telangana.added. But it’s the timeline that’s a question mark. A vaccine John added that any Covid-19 vaccine that comes out now is like an “also-ran” maker felt that Biological E may miss the 1.5 billion dose candidate, given that many vulnerable people have already succumbed to the disease manufacturing plan by calendar 2021, but would be able to for want of vaccine protection. make significant volumes by the end of the financial year.
IDMA Bulletin LII (23) 15 to 21 June 2021 33
Feature Covid vaccination: The race against time
Battered by the second wave of covid-19, the government recalibrates its vaccination strategy in the hope of inoculating India’s 900 million adult population by December 31. How realistic is this target? Raj Chengappa & P.B. Jayakumar
When word came people’s anger and anguish. Their loss of faith and trust that Prime Minister in the ability of both the central and state governments Narendra Modi would to handle the pandemic was evident. Worse, a third wave, address the nation possibly as devastating as the second, seemed imminent as at 5 pm on June the vast majority of Indians remained unprotected without 7, the pandemic- inoculation. afflicted nation was at The writing was on the wall when Modi began his PM Narendra Modi in his address to the a critical crossroads. nation on June 7, 2021 broadcast. The vaccination strategy needed course On a positive note, correction before the situation spiralled completely out the Second Wave was clearly on the wane, with new cases of Covid-19 infection dropping from the daily peak of of control. Many states did demand that the vaccination 400,000 to under 100,000 by June 1. Yet, they were still be expanded to younger age groups and the procurement higher than at the height of the first wave, which meant that decentralised to permit them to directly purchase vaccines the red signal remained on, and the unlockdown process from manufacturers. But the Centre clearly erred in had to be gradual. On the negative side, the carefully- acceding to their requests given its own experience in calibrated Covid vaccination programme was threatening procuring vaccine doses in the preceding months. So, to descend into a self-inflicted anarchy. Modi made a virtue out of necessity and announced that the Centre would now handle the entire procurement of The liberalised vaccine regime that the central government had announced on April 21 allowing states vaccines (which it was doing before it announced the their own purchase and pricing for vaccinating the 18-44 liberalised regime) and in addition would make vaccines year age group was failing. Even the Supreme Court termed available for free for the 18-44 age group as it was for the it “irrational and arbitrary” and asked the Centre to roll it 45 years and above group. Quoting from the scriptures, he back. As the blame game between the Centre and states said: “Vijeta aapada aane par usse pareshaan hokar haar intensified, the month of May saw a substantial drop in nahin maante balki udyam karte hain, parishram karte vaccinations compared to April due to a shortage of doses. hain aur paristhiti par jeet haasil karte hain (Winners do While the Centre boasted that India was among the top not give up in the face of disaster. They work on it and three nations in terms of total number of vaccinations— conquer the situation).” behind only China and the US—the fact remained that Mission Impossible? even after 136 days of vaccinations, as of June 1 only 41 million people, or 3 per cent of the country’s population Much remains to be conquered in India’s mission had received both their doses. vaccination. The Centre had announced a target of inoculating the country’s 940 million adult population by The Modi government had also come under flak for its December 31. This means vaccinating 900 million people poor handling of the Second Wave. State governments, from June onwards at the rate of 8.4 million daily—triple too, were not spared, especially over the collapse of critical the current rate of 2.7 million. At this rate, the entire care facilities for severe Covid patients in major cities and population of the US of 300 million would get vaccinated in in rural areas. The situation was compounded by a deadly 71 days. The US, which began its vaccination programme shortage of medical oxygen that saw fatalities double in on December 14, had as on June 8 covered 143 million, comparison to the First Wave. The long queues outside or 42.3 per cent of its population with a daily vaccination crematoriums to dispose of the dead only added to the rate of less than a million.
IDMA Bulletin LII (23) 15 to 21 June 2021 34
Getting 900 million adult Indians vaccinated by US-based Baylor College of Medicine’s National School of December-end is indeed a humungous task. Not only does Tropical Medicine developed it. In mid-April, Biological E the central government have to procure nearly 2 billion got approval to start Phase III clinical trials from India’s doses, it must also mobilise the health infrastructure of Central Drugs Standard Control Organisation, or CDSCO, the country to inject the numbers required to meet the Subject Expert Committee (SEC), following successful target. A senior government official says, “It is like a T-20 completion of previous stage trials. The Phase III clinical match where if the side batting second doesn’t score the study is to be conducted in 15 sites across India in about necessary runs in each over, the asking rate mounts.” So, if 1,268 healthy subjects in the age range of 18 to 80 years, for some reason, the vaccination effort flags in any month, and there are plans to conduct a larger global Phase III as it did in May, the number of daily vaccinations required study. could go up to as many as 10 million. Is India’s vaccine Meanwhile, the government is also expected to target a Mission Impossible then? purchase close to 150 million doses of Russia’s Sputnik 5 Dr Vinod K. Paul, chairperson of the National Expert vaccine. Dr Reddy’s Laboratories has exclusive marketing Group on Vaccine Administration for Covid-19 (NEGVAC), and distribution rights for the first 250 million doses of the the premier body overseeing vaccine procurement and Russian vaccine in India. The Russian Direct Investment distribution in the country, is confident of accomplishing Fund (RDIF), which owns the vaccine, has also entered into the target. “It is a mission difficult but it is not a mission manufacturing agreements with Indian manufacturers such impossible,” he says. “We have been able to secure the as Gland Pharma (for 252 million doses), Strides Arcolab’s vaccine doses we require to meet the target by December- Stelis (200 million), Virchow Biotech (200 million), end and are putting in place the wherewithal to treble our Panacea Biotec and Hetero Drugs (100 million each) to daily capability for inoculations, including in rural areas.” make over 850 million doses a year from India. SII too got Paul has reason to be sanguine. From the perilous position permission recently to make Sputnik V in India. India found itself in May with vaccine shortages being the With all these deals, the central government has got rule, NEGVAC has worked in the past two months to boost India an assured supply of 1.62 billion doses for the next availability to levels that give the country some comfort. seven months—just enough to inoculate the entire adult For June and July alone, 280 million doses have been population of the country. purchased already. The government seems to have paid heed to the The new vaccines on the block criticism that it failed to place sufficient orders, like the Meanwhile, the Modi government is already working US, UK and Europe did, before launching the vaccination on procuring a host of newer vaccines to make up for any programme on January 16. That lapse was responsible delays or shortfalls in its assured procurement. That’s for the subsequent shortage of vaccines. In a significant because one of the major hiccups in India’s vaccination move, a day after Modi’s announcement, the government plans has been the inability to mass produce and scale placed orders for 250 million doses of Covishield with the up India’s first indigenously developed Covid vaccine, Serum Institute of India (SII) and 190 million doses of ‘Covaxin’, made by Bharat Biotech. So far, only 20.7 Covaxin with Bharat Biotech Limited (BBL), giving both million Covaxin jabs have been given since January 16, or of them 30 per cent advance payment. As an official said, an average of 5.4 million vaccines a month. The company, “This should address the carping about the Centre being though, claims that it has made 60 million doses since stingy and disincentivising domestic manufacturers by not March. That confusion caused Bharat Biotech to clarify that placing orders in advance.” The supply of this stock should its vaccine has a lag time of four months, from beginning begin from August onward. In addition, the government is of production to distribution for vaccination. It means that expected to place orders for another 250 million doses of production batches of Covaxin that were initiated in March Covishield and an additional 200 million doses of Covaxin this year will be ready for supply only this month. The later this year. company is scaling up its production facilities in Hyderabad Earlier, the central government, in a departure from and Bengaluru to meet the additional requirements. the past, paid Rs 1,500 crore in advance to purchase 300 As Covaxin was co-developed with the support of the million doses of Corbevax. This is a vaccine being produced Indian government, the Centre entrusted its production to by the Hyderabad-based Biological E after scientists at the three PSUs—Indian Immunologicals Ltd (IIL), Haffkine
IDMA Bulletin LII (23) 15 to 21 June 2021 35
Another Indian government-funded vaccine project is from the Pune-based Emcure Pharmaceuticals’ biotech subsidiary Gennova Biopharmaceuticals. It is working on India’s first mRNA Covid-19 vaccine (similar to Pfizer BioNTech and Moderna vaccines). The vaccine candidate is in Phase I trials, which will be completed in two months. The Phase II and III trials are likely to take another two months and the vaccine is expected to be launched later this year. The government expects Gennova to make 60 million doses available this year and has granted Rs 250 crore for the vaccine development, based on milestones. Institute and Bharat Immunologicals and Biologicals As exciting is BBL’s intranasal vaccine BBV154 which Corporation Ltd (BIBCOL)—in a bid to boost production. is now undergoing the first phase of clinical trials. It will But these will not yield immediate results. The Maharashtra be a game-changer, as the vaccine can create an immune government-owned Haffkine Institute wants to make 228 response at the site of infection and block both infection million doses of Covaxin a year. The state government and transmission of the virus. “I can easily make one billion says it will require eight months’ time to set up the BSL-3 doses, as large-scale production is easy,” says Dr Krishna biosafety laboratory, critical in making Covaxin. IIL and Ella, BBL’s chairman. The government plans to purchase BIBCOL are together expected to make 10-15 million doses 100 million doses of this nasal vaccine this year. per month, starting from August or September. Reaching out to big pharma The good news is that several new vaccines being made in India are showing tremendous potential and could The Centre is also in talks with top foreign pharmaceutical provide the necessary back-up in India’s vaccine quest. One companies, including Pfizer, Moderna and Johnson & of the most exciting developments is the made-in-India Johnson, who have successfully launched Covid vaccines Covid vaccine from the Ahmedabad-based Zydus Cadila. in the US, UK and Europe. The import of vaccines is It is a three-dose DNA vaccine and the final phase trial expected to gather pace as the Drugs Controller General of data for the vaccine will be submitted soon to the drug India (DCGI) further relaxed rules for importing Covid-19 regulator, with plans of launching it in August. Zydus plans vaccines last week. The regulator exempted mandatory post- to start with 10 million doses a month initially and double approval bridging clinical trials and testing of each batch capacity in the following months. The Indian government’s of imported vaccines at India’s Central Drug Laboratory calculation is to get 50 million doses before December. (CDL) at Kasauli in Himachal Pradesh. The earlier rules for “Since it is a DNA vaccine, scale-up is easy and it can new drugs and vaccines had stipulated that those products resist virus mutations to a large extent,” says Pankaj Patel, which had completed Phase III vaccine studies outside the the group’s chairman. The vaccine is also being tested on country should undergo ‘bridging’ or limited clinical trials adolescents aged 12-17 years. This vaccine has a unique on the Indian population to know how the drug works on advantage—it does not needles to be administered; instead, people of Indian origin. it is injected intradermally with a special device. Since the country has severe shortage of Covid-19 Next is a protein-based Covid vaccine, Covovax, from vaccines, this clause was seen as a major impediment and SII and US biotechnology company Novavax. Its Phase a delaying factor in bringing overseas vaccines into India. III trial is to begin soon and plans are to launch by On April 15, as per the recommendation of NEGVAC, the September. The vaccine has undergone Phase III trials DCGI had relaxed the rules to some extent. It allowed in Europe. “It has been tested against the African and Covid-19 vaccines already approved for restricted use by UK variants of the virus and has an overall efficacy of 89 regulatory agencies such as US FDA, EMA (Europe), UK’s per cent,” says Adar Poonawala, owner and CEO of SII. MHRA, PMDA of Japan or other agencies listed in the WHO The firm plans to make about 750 million doses a year Emergency Use Listing (EUL). in India and ‘at risk’ trial production has begun. India According to sources, companies like Cipla and hopes to get 200 million doses of this vaccine in the first Wockhardt are talking to counterparts like Moderna and year of production. Pfizer to import and to manufacture their vaccines in India.
IDMA Bulletin LII (23) 15 to 21 June 2021 36
J&J was planning to make its single-shot vaccine in India placed than most to execute one of the world’s largest under the Quad Vaccine Partnership, an alliance by India, Covid vaccination programmes. “State governments have the US, Australia and Japan to make over a billion doses for expressed tremendous confidence in achieving their use in the Asia region by the end of 2022. Biological E was targets,” he says. Already, during the current round of looking to contract manufacture about 600 million doses vaccinations, Uttar Pradesh, India’s largest state, has of the J&J vaccine annually, but so far has not revealed showed that it could do about a million vaccinations in June plans on starting of manufacturing. and so is well positioned to meet the demand. Other states like Maharashtra, Andhra Pradesh, Gujarat, Rajasthan and With all these measures, the Centre believes it will Madhya Pradesh, too, have exhibited similar capabilities. deliver on the vaccine front. Dr P.K. Mishra, principal The vast rural health infrastructure has to be galvanised secretary to the prime minister, says, “Vaccinating 130 to engage in the vaccine programme. This includes the crore people is a massive undertaking, not just in terms 1 million ASHA workers and 300,000 ANMs, apart from of scale and speed, but also in terms of ensuring efficient the 700-odd community health officers. As Bhramar and sustained last-mile delivery across multiple supply Mukherjee, a professor of epidemiology at the University chains and local constraints. We must recognise that Covid of Michigan, points out, “We should take vaccines to the vaccination is under emergency use authorisation and is people right up to the doorstep if needed so that they don’t a more complex operation than the regular immunisation have to scramble and fight to get vaccines.” Paul concurs programme, such as for polio. We are looking into several and says that what is needed is a Jan Andolan to get strategies for scaling and diversifying production and people to overcome vaccine hesitancy—to induce the same encouraging new vaccines approved elsewhere. We are patriotic fervour witnessed when the country is at war. confident that we will achieve the goal of vaccinating all adults by the end of this year and will leave no stone As important is transparency in procurement and unturned to do so.” distribution of vaccines for states. The Centre has worked out a formula for distribution of vaccines by the states Overcoming vaccine hesitancy based on population and age groups. It also needs to ensure While the bottleneck for vaccine supply seems to vaccine equity. Mukherjee says the Cowin platform for have been removed, the real issues will be to beef up the registering requests for vaccination should be made more number of daily inoculations being done from the current flexible so that those who are not tech enabled will not be 2.7 million to around 8 million to meet the December 31 turned away. The private sector is now stepping up to the deadline. This is, without doubt, an enormous challenge task. Though the government opened up the private vaccine given the inherent vaccine hesitancy in the population. market in May, it has not gained momentum mainly due Modi in his speech pointed out that even till 2012, the to vaccine shortage and the inability of small and medium Universal Immunisation Programme (UIP) for children hospitals to negotiate directly with the manufacturers. covered around 60 per cent of the total population. After This has led to a drop in private hospitals involved in his government came to power, the prime minister made vaccinations from 7,000 to around 2,000. Overall, the it a point to mention, it had been pushed to 90 per cent. private sector accounted for around 23 per cent of the Now, both the Centre and the state governments have to total vaccinations and it is important it maintains that ensure that at least 90 per cent of the adult population is pace. Industry, too, must put its shoulder to the wheel. vaccinated. This will provide the herd immunity required T.V. Narendran, CEO and managing director of Tata Steel to check the spread of a possible third wave. It will also and the current president of the Confederation of Indian reduce the severity of the illness in those afflicted and Industry, says, “Retaining 25 per cent of the vaccine thereby lessen the burden on the health infrastructure. procurement for the private sector will enable industry to As a senior officer points out, “There are two ways to contribute to the vaccination drive and target workers.” develop herd immunity. The bad way is for the population The key to avoiding a third wave as devastating as to get the disease and build immunity. The best way is to the second is to step up the vaccination drive and ensure build immunity through a systematic and comprehensive that as many people as possible get their shots during the vaccination programme.” lull before the next storm. “We should not get nationally Dr Paul of NEGVAC believes that given the experience jubilant as the second wave subsides,” says Mukherjee, of conducting elections and the UIP, India is better “but work hard towards preventive measures like vaccines,
IDMA Bulletin LII (23) 15 to 21 June 2021 37
apart from strictly observing Covid-appropriate behaviour.” The warning comes after massive crowds began mingling again soon after Delhi announced a graded unlockdown. Contact The virus, as an official put it, hasn’t gone away. It is still lurking around searching for susceptible people and For Purchase and could cause another surge. The second wave also showed that even if only a couple of states are initially affected, Sale of it easily spreads to the rest of the country. So, not only do we need early warning systems, but states also undertake graded lockdown measures. Equally important is testing, Pharma Units tracking and isolating those found to be infectious. The medical infrastructure needs to be beefed up, especially to ensure the availability of oxygen and drugs. Variants will remain a challenge and have the potential of undermining Korporate vaccination programmes and causing a fresh surge. Everything rests on our ability to control the virus and Consulting prevent a third wave before it overwhelms us. Vaccinations are our only effective shield. The price of failure is just too high for us to be complacent. Enterprise
Source: India Today Magazine, Cover Story Vaccines, 21.06.2021 (Excerpts) M: 9712829295
l l l
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 PHARMACEUTICAL PReFORMULATION SPECIFICATION (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 LII (23) 15 to 21 June 2021 38
IDMA ACTIVITIES CDSCO MATTERS CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on its Regulatory Members Pathway – reg. DCG(I) Circular Ref.X-11026107/2020-PRO, dated 20th March 2020
To, for sale and distribution would be processed on All Stakeholders through CDSCO web site Copy for priority though expedited review/accelerated Information, approval. IDMA ACTIVITIES PS to JS(R), Ministry of Health and Family Welfare, Nirman IDMA ACTIVITIES Bhawan, New Delhi. 4. Any firm having DrugNaccine already approved for IDMA ACTIVITIES CDSCO MATTERS COVID-19 in any otherCSR country Initiatives can directly by approach IDMA with the support of its Members Novel Corona-virus DiseaseCSR I (COVID-19)nitiatives hasby spreadIDMA with the support of its Members IDMA ACTIVITIES CDSCO MATTERSDCG(I) through Public Relations Office regarding over 118 countries with now more than 191,127 cases and expedited review/accelerated approval for marketing CSR Initiatives7807 people CDSCOby haveIDM lostA theirprovides with lives as the on 18.03.2020. guidancesupport World of on its Regulatory Members Pathway – reg. CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on its Regulatory Min embersIndia. Pathway – reg. Health Organization (WHO)DCG(I) has declaredCircular it Ref.X-11026107/2020-PRO,as pandemic. dated 20th March 2020 At present there is no current evidence from randomized 5. Data requirement for animal toxicity study, clinical DCG(I) Circular Ref.X-11026107/2020-PRO, dated 20th March 2020 clinical trials to recommend any specific treatment for study, stability study etc. may be abbreviated, To, for sale and distribution would be processed on suspected or confirmed patients with COVID-19. deferred, or waived on case to case basis depending To, All StakeholdersIDMA through ACTIVIT IES CDSCO web site Copy for for salepriority and distribution though expedited would be review/acceleratedprocessed on NOT FOR PROlT SUPPLY OR EQUITY BASED tiered pricing based vaccinesCII further byupon ensuring suggested the robust type the safetyof adoption vaccine, and efficacy of nature wide reviews scale of drug, clea plant“Forrances example, from for API cartons parks, protect boosting the product drug formulations from light All StakeholdersInformation,InWhat order are tothe encourage next through steps in research the CDSCO trial? & development web site Copy of drug forSrias will URGENTLYLanka peoplepriority pharmawho areapproval. deemed though firms REQUIRED at highsay expedited risk no from shortage Covid-19 review/accelerated on countries’ needs and capabilities.” dueE-ICU/tele-consultationand to their removing agewhich or unwarrantedmedical the todrug conditions. tackle is political extracted the spread considerations & of its COVID- experience whichfrom indigenous in can case USED otherwise API and degrade PHARMAIDMA its intermediates ACT theIV IT product;IES and sometimes providing Information,PS toThe JS(R), results so Ministry far are promising, of Health but and their Family main purpose Welfare, Nirman ofIDMA drugs, ACTIVITIES not to panic buy CSR Initiativesor vaccine by forIDM preventionA with or treatmentthe support of COVID-19, of anyits19, from especiallyM theseembersapproval. indiscussions its phase 3and and the 4. approvalCII has already process. set up Bhawan, New Delhi. USED R4.of Phyto-phar&Any D firmEQUIPMENTSmaceuticals. having DrugNaccine alreadydesiccantsincentives approved arefor usednewIDMA toproductfor ACT protect IVITIES development, the product from processes moisture,” and PS toSupportis JS(R),to ensure effective Ministry the vaccine and of Healthequitable is safe andenough distribution Family to give Welfare, toof people. these Nirman However,IDMA ACTIV widespreadITIES vaccination is likely to be, at the MACHINERY FOR SALE application submitted to CDSCO will be processed on highs the %NHANCESricontrol Lanka’s centre COUNTRY pharmaceuticals and READINESS the backend AND firms systemsIN COUNTRY said CthererequiredSR DELIVERY is I nitiativesnofor shetechnology, said. by among IDM others.A with the support of its Members Bhawan,innovationsThe New study Delhi. cannotglobally: show whetherC SR the vaccineInitiatives can either by earliest, IDM4.A next withAny year firm eventheCOVID-19 havingif supporteverything DrugNaccine in any goes of other to its plan. country Malready Borisembers can approved directly for approach priority. NovelCDSCO Corona-virus will also provide Disease guidance (COVID-19) on regulatory hasshortage E-ICUspread SYSTEMS and6. of drugsthese BYApplications ENSURING incan the be country ADEQUATE scaled to and upmanufacture EXPERTISE withurgedC SRthe the ANDsupport publicInitiatives RESOURCES or notimportof the to DrugNaccine by IDMA with the support of its Members prevent people from becoming ill or even lessen their Johnson said:WeCOVID-19 “Obviously areDCG(I) an I’min established any hopeful, through other I’ve country Public got my can Relationsfingers directly Officeapproach“SriCII stated Lanka regarding that is athe small outbreak market could and lead the to significant excellent pathwayNovelh7E onCorona-virus WILL such STRIVE matter. TOWARDS DiseaseCSR EQUITABLE I (COVID-19)nitiatives ALLOCATION hasbyOF OUR spreadIDM engageGovernment,A arewith in placepanic the foras for buying necessary. test, supporteffective afteranalysis country two ofdomestically andplanning, its further Members distribution, transmitted use BA/BE orComplete Clinical tablet section in good oversymptoms 118 countriesof Covid-19.CBIC with MATTE nowRS more than 191,127 casescrossed, and but to say I’m 100% confident we’ll get a vaccine relationships that our Chamber members have with treatment, which boosts “innatePRODUCTS immunity”, AND SUPPORTwas initially GLOBAL IDMAHow MECHANISMS doesACTIVITIES Sepsivac LIKE work? #/6!8 and follow-upDCG(I) forexpedited new through diagnostics, review/accelerated Public therapeutics, Relations and Office approval shortage regarding for of marketingsupply in the medical technology sector as well, over7807 118 countries people have with nowlostNATIO theirmoreNAL NEWS lives than (SPECIAL) as 191,127 on 18.03.2020. cases andcasesthis World pharmaceutical year,On of pharmaceuticals, Coronavirus or indeedTrial nextmay was year, CIIdiscovered.be company said is,processed alas, that just the ancurrenthaving within exaggeration. situation 7 days. condition (GMP and Standard) approved by the Drug ControllerRECOGNISING MoreGeneral than THEof India MOST10,000 (DCGI) EFFECTIVE people APPROACH will take TO EQUITABLEpart in the ACCESS next vaccines.expedited review/accelerated approval formultinationalespecially marketing for critical pharmaceutical medicines manufacturers and medical devices worldwide, such IDMA donated medicines to 7807theThe following detailspeople arehave as lost under their - lives2.It as contains onBliss 18.03.2020. heat-killed GVS Pharma mycobacterium World“We’remakes L manufacturingtd. anot compelling w there (Mw), yet.” incase India. facilityfor Indian Governmentin Navsari, to declare for gram negative sepsis whichHealthwillstageCBIC vary is of a theOrganization diseaseacross trialsnotifies vaccines, caused in the UK. by (WHO) Newtherapeutics, However, Exchangehas the declaredtrialand hasdiagnostics. also it been as pandemic. “There7. is currentlyIn case enoughof emergency, stock to meet Import three license months (Form willashaving thermometers, 10)ensure would that Rotary we nebulizers, will 27not runStn. glucometers, out and of stock,” 16 etc. Stn., Chellaraja Institutions: IDMA congratulatesIDMA-TNPKSB Dr Kiranan immunomodulator, CSR Mazumdar-Shaw Activities which is API a non-pathogenic as on a strategic beingSource:in India. Expresssector asPharma, most 01.10.2020inputs are (Excerpts)imported. bacteria. HealthAtWeexpanded presentOrganizationalso will to use otherthere our countries (WHO)collective is noth current becausehas voice3. declared alongside levelsevidenceCachet of itother Coronavirus asP fromharmaceuticals pandemic.global randomized of normal Pdemandvt.5. L td. andDataGujarat. we willrequirement makeIDM sureA donated that for the animalmedicines supply toxicityto thesaid. following study, clinical 2. Bliss GVS Pharma Ltd. 1. RatesAny firm w.e.f. having 17 a IDMDrug AApril mycobacterium.donated Vaccine medicines2020 under “Normally to- reg.thedevelopment following when you WhatIndustry developAssociation-Tamil progress a alsovaccine,2.be is suggests Bgrantedbeing liss Nadu, GVS made that Pwithoutharma with firms Lothertd. Registration for vaccines? which capacity Certificate (FormBlisterThe medical 41) 300 devices and 150, market Mass too is Mixer heavily import namedAt presenthealthare low EY stakeholders therein theWorld UK,is no making tocurrent Entrepreneur advocate it hard evidence forto knowthe fromstrengthening if theO randomized fvaccine The Yearchain is 5.2020 not Datadisrupted,” requirement Kasturi Chellaraja, Institutions: for animal Chairperson toxicity study, clinical 1. Sai Seva But Mandal the scientists – found which thatclinical the organises pathological trials symptoms to walking recommendInstitutions: you grow the any organism specific and kill treatment it. It is calledPuducherry for heat killed. & Kerala study, State stability study etc. may be abbreviated, 3. Cachet Pharmaceuticals Pvt. Ltd. for COVID-19 can directly4. approach Fourrts DCG(I)th (India) through Laboratoriesutilization The Oxford is 3. 40%P vt. vaccineC achetmay Ltd. be P harmaceuticals ispermitted not the to first produce Pvt. toLtd. reach API which this dependent,The chamber at around was monitoring70-80%, with supply imaging chains equipment and was Notificationofis effective.health No.39/2020-Customs systems and distribution (N.T.), networksdated 16 so April, crucial 2020 of the Sri Lankasubject Chamber to ofapproval the Pharmaceutical1. ofSai Central Seva Industry Mandal Government. – which200 organises kg and walking 100 kg, Fluid bed dryer pilgrimageof this from disease Mumbai and Covid-19clinical to were Shirdi trialsquite everysimilar. to recommend And year given for Here any we heat specific killed the treatment bacteria. It forisare a Boardstandard beingWe (IDMA-TNPKSB)imported.are vaccinestudy, looking Approvals stability for for used studynew investments R etc. & mayD should be abbreviated, 4. Fourrts (India) Laboratories Pvt. Ltd. suspectedPublic Relations or confirmedIDMA ACT 1. Office I V ITISaiES patients Seva for seekingMandal with – COVID-19. which guidance organises stage, for walking with groups4. Fourrts indeferred, the (India) US andL aboratoriesor waivedChinapilgrimage also P vt.on publishingL casetd. from Mumbaito caseconfident (CT to basisShirdi & MRI everythere depending scanners), yearwould for cardiac be no interruption. stents, orthopedic implants, the urgency of finding a solutioninnovations toDr the Kiran reach rapidly Mazumdar-Shaw, everyone rising concept,”who5. needs My VishwakarmaI ndbusiness them. Swift focusIn said,L doingaboratories is addingglobal (SLCPI)healththatis the glad careL bacterium saidimited toand informin the a is statement.provision that on 60 kg, Tray dryer, Strip Packing approximatelyIn exercise 500 pilgrimsof the suspectedpowers conferredThere or willbyconfirmed section be a 14large ofpatients trialpilgrimage10. involving withNorwegian from COVID-19. 30,000 Mumbai topeople Shirdi7.40 everysimilarbe C yearfast-tracked.ON forresults.7.15 SULTANCYdeferred, TheCII has US proposed orCompany waived FO that RModerna on blanketFINANCEapproximately case was environment to casefirst 500 out basispilgrims depending 5. Ind Swift Laboratories Limited Executive Chairperson of India- of universal access to life savingEquipmentsth medicine;For5. however, Ianynd uponSwiftmainly additionalmy L aboratoriesthe fortype informatiTablet Lofimited vaccine, onand kindly nature contact glucometersof drug, Public plant and criticalfrom care equipment cornering a large Covid-19the Customs cases Act, across 1962 the (52 world, ofso,in 1962),regulatory the wethe USscientistsandsupport asin supersession wellpathway. thoughtevidence-based 2,000 of inapproximatelyproduced South prioritisation Africaby fermentation.500 andpilgrims 5,000 so that in 8 June 2020, we donated Europe was the largest manufacturer of drugs CSR Initiatives basedby I DM BioconA with Limited, the was support6. responsibilitySaiKroner Mirraof its as I nnopharmM an embers entrepreneurofpermission the “WeP is vt. blocks greaterneed Ltd. upon beto an than beprovidedd sensible itsthe simply vaccine type andto ofmanufacture judiciouscan vaccine,2. produce M. in C.our nature anyneutralising Damanwalla reaction API of ontodrug, CharitablegastrointestinalCombi plant from Dispensary, Pack, medicines UV 6.Spectrophotometer, etc. Sai is slowingMirra Innopharm down, with Pvt. people L td. 2. M. C. Damanwallatestingof the the Notification treatment No.37/2020-Customs(N.T.),against Charitable the currentIn order pandemic Dispensary, to encourage caused dated research & development ofRs.18.00 drugRelations Liquid 6. Lakhs AN Sai DOffice Mirra worth Departments.SUB I nnopharm throughSID IEP tollvt.S L td.free number 1800andshare. 11 Sri 1454Many Lanka raw& imported materials pharmaceuticals and components mostlyare imported from healthcareBrazil. There workers, are also high-risk calls2. M. toindividuals,11. C.perform“The DamanwallaPound treatment “challenge and Sterling other Charitable we priority aretrials” 97.40 testing Dispensary,submission According against94.05 Covid-19 to dataof self-certification from whichmarket research the todrug firm comply AIOCD isUdvada extracted AWACS,with - This pollution Calpol institution & its aimsexperience at helping and in treating case st 2. In Anyordernamed firm to ‘EYencourage or World research Entrepreneur research institute delivering & development having value protocolto shareholders. of drug theantibodies. for current situation and not panic.” The pharma chamber staying indoors, eating home-cooked food and taking care by1 - April,theThis SARS-CoV-2 2020 institution except virus. as aims respectsor at vaccine helping things done forand or prevention treatingomitted U dvada or treatment- This institution of aims COVID-19, at helping andsawof treating any sales these of `which 317.9 medicines, crore the in December,drug is whenextracted itthe was poor the & andnumber its needy experience 3 patients,India.from villagers China. in case Multi-mill.and Adivasis M. CShifter. Damanwalla etc. Charitable Dispensary, Udvada: Udvada groupsin whichof Theidentified vaccinated Year 2020’ by WHO people at a and ground- areis 12. other designed deliberately healthQatari to Riyal enhanceauthorities infected innate withare21.75 immunity load requirement.Capital whichwrite20.45 isM. toInvestment, very C .startupinnovPcdsco.nicin Damanwalla of Phyto-phar Interest, Charitable maceuticals.GMP, Dispensary, GLP, Udvada: to be done before suchor supersession, vaccinerepurposing for the prevention Central of existingBoard orthe treatment drugs/vaccines poorM. andC. needyDamanwallaShe of added, patients,COVID-19, for “Wealth villagerstreatment C haritablecreationany andsaid Adivasis they can were Dispensary,be a urging catalyst drugcalm for in because theUdvada: category therewho were live reports in and from around Udvadaof their and health. also supplies“The industry expects the value growth this the poor andCSIR needy got the patients, approval applicationprotectedCoronavirus. tovillagers test “Sepsivac” for and However,thesubmitted durationAdivasis against there toof critical.aretheCDSCO13. ethicalpandemic,Saudi People willconcerns Arabian who beregardless are processed dueweak to 21.10inof a innate onInterested immunityin Theyhigh the19.80 presenceare willof injecting getPhyto-phar parties of our Coronavirus maymaceuticals. contact RNA (its our genetic 1. Alkem Laboratories Ltd. of Indirect Taxes and Customs breaking, hereby determines virtual award that ceremony. who live in and around Udvada and also WHO-GMP,supplies 1. ERP,Alkem LICT,aboratories Electrical Ltd. freeConnection, medicines to them. DespiteWhile the China real impact making on about industry 60 is percent likely to of be the visible raw Covid-19 in a Phase 2application clinicalof trial COVID-19 aboutsubmitted 10 days will to ago.also CDSCO bethe giveninfection willcha be prioritynge, faster,” processed and heforall said. entrepreneursreview on high andpharmaciescode), Deputy haveThe which a CII Drugresponsibility that recommendationsthen Controller-some starts customersto making to wereviral strengthen buyingproteins up APIin two order and to Dryear V G to Somani, slow down For to 1.5-3 Enquiry:2. per C centachet if P theharmaceuticals crisis continues. Pvt. Ltd. who live in and around Udvadapriority.THElack COUNTRYKiran ofand treatments. wasCDSCO alsoTHEY picked suppliesLIVE from will IN among also7Efree WILL 46 medicinesprovide1. ADVOCATEARiyallkem to guidance them. FOR L EQUITABLEaboratories on regulatoryMumbai ElectricityLtd. 6.office Duty, Applications CLCSS, with relevant Finance to manufacture & details: Gujarat or importonly after DrugNaccine April 2020, the local manufacturer’s capacities the rate of exchange of conversion of each of the foreign the world around them andthreeforintermediates the DrApril communitiesmonths 6. Manivanan, is even 2.Applicationsof productiondrugs. grimmer. Cinachet IDMA-which Pharma P harmaceuticals“For in tothe firms the manufacture country anti-infectives store P drugs vt.include Ltd. in or specially segmentcreation import DrugNaccinematerial, the risk of Sri Lanka running out of medicines is free medicinesThe trial is tobeing them. conducted priority. on approval.50 awardCDSCO patients winners at thewill from All also India 41 countriesprovide 14. guidanceSingapore on regulatory54.60 to trigger 52.80 an immune response. The companiesWeDrugs are thankful ControllerBioNtech to the following GeneralApart members from (India), whonewMob: donated launches 09827152837 3. and C entaursmaller P harmaceuticalsbrands getting L hit,td. currencies specified in columnpathwaydistribution, (2) of each on recognizing of such Schedule matter. that We sovereignareVishwakarma thankfulthey nationsto operate.the following explained have Women members final that also itwho(antibioti is play donated a non-specific a hugelycs primarily), important& Centralfor the test, sales Subsidies. analysis in the first and15 days further of April use slim,will BA/BE needthe chamber toor beClinical bolstered, said. which would likely become Institute of Medical SciencesWhen (AIIMS),and will territories New I get Delhi, a vying vaccine? AIIMS for the world2. CDollarachet Pharmaceuticalsbuiltandof largeTNPKSB-Chairman- Pfizer warehouses. API P havevt. parks3.for L alsotest,td.C entaur Incorrectlywith ha analysisdfiscal PpositiveCentralharmaceuticals benefits overstocking results andDrugsmedicines for further L usingexistingStandardtd. medicinesfor thistheir use API noble ControlRNA BA/BEand atcause: logisticsOrganization, or Clinical challenges will also affect overall sales,” said CEO I and Schedule II annexedpathway decision-makinghereto, on into such Indian matter.authority,” currencymedicines theyvaccine for stated this role which noble. in couldeconomic cause: be used development, to both cure and and for protecttoo long their reliable sources amidst global4. C oronashortages, Remedies said PCII.vt. Ltd. Bhopal, and Post Graduate3. InstituteApplicationstitle. of Medical Inth the Education award’s for Clinical 20-year15. SouthTrial African permission 4.25 andareintermediatesMr downMeridian Jayaseelan,3.95 by 4.67 plants,perC oronaEnterprises Trialcent Vice- supportiveRemedies compared may be P vt. regulatoryto processedPvt. Lthetd. first Ltd. 15 framework withindays of 7 days. Email: We are thankfulor vice versa, to the shall, following with effect members from 17 April,who 2020,donated be people. He explained that there are homegenerallyvaccine. canContact: Directoratethree affect types Shashank the Generalefficacy Tatu, of of medicines HealthM:Sai 9879919438, Seva Services, she Mandal: said. Public Relationof a drug Office, major on conditionSource: of Economyanonymit Next,y. 13.03.2020 IDMA donated medicines to the Itfollowing is possible a Coronavirus3. vaccinecontribution2.CRand entaur willBliss behas P GVSharmaceuticalsproven been ignored.P harmaChairman-Mr It’s L importanttd. Ltd.Trial Sathish thatmay we &be processed within 7 days. IDMA is thankful to the above members for their help andthe rateResearch history,mentioned (PGIMER), Kiran against becomes Chandigarh. Theit inapplications thethe details thirdcorresponding EY are World to as import entryEntrepreneur underSai Seva or - manufactureMandal: Drug VaccineMarch,”and Email: common said [email protected] the infrastructure senior official facilitating of a Mumbai-based single window drug [email protected] Delhi. Source: Pharmabiz, 21.03.2020 IDMmedicinesA donated for this medicines noble cause: to the followingMaintaineffective publicbefore confidencethe end of theinof ourvaccines.2.year, innovations: usehoweveB lissthe platformr, GVS it will Pofnotharma EY be World LEntrepreneurSource:td. Email: James of [email protected],IDMA Year is thankful to Health to and the1. aboveScience Alkem members Correspondent, Laboratories for their help Ltd. and support. Institutions: of The Year AwardThe winner details from are India. as She under follows - former16. Swedish Kroner 7.75 major. Members He7.50 reasoned 7. Mr Pandian thatIn case demand of emergency, for antibiotics, Import and even license (FormSource: 10) wouldSohini Das, Business Standard, 25.04.2020 in column“We expect (3) thereof, the results for the from purpose this Phase of the 2said trial section, within1. Alkem4. L aboratoriesCorona Ltd. Remedies Pvt. 7.LContacttd. andIn case support. No.: of emergency, BBC022-66084217 News, 20.07.2020 Import license (Excerpts) (Form 10) would Institutions: Indian world title winnerswidely “We Uday available. will Kotak continue ofHealth Kotak makingandMahindra care17. “Therethe workers Swissencouragesafety3. are will therapeuticFranc Cof be achetmoreindividuals prioritised women vaccines, P80.85harmaceuticals to participate where& you Mr77.80 ingive Rajesh.entrepreneurial them Pvt. L Wetd. IDMA donated medicines to the following 2. Bliss GVS Pharma Ltd. 30-45relating days to imported from now. and And export if1. the goods. resultsAny are firm encouraging, having a IDMDrug3.A donated VaccineCachet medicines under Pharmaceuticals to thedevelopment following P vt. Ltd.2.be Bgrantedliss GVS PwithoutIDMharmaA donated Ltd. Registration medicines to Certificatethe following (Form 41) 2. Bliss GVS Pharma Ltd. 1. Any firm having a IDMDrugA donatedas Vaccine18. a drug medicinespursuits.Turkish for under curing. Lira I’mto thedevelopment truly There following honoured 11.45 are prophylactic to were receive 10.75 fortunate vaccines, this2.be prestigious Bgrantedliss to GVS have P without harma L td.RegistrationInstitutions: Certificate (Form 41) 3. Cachet Pharmaceuticals Pvt. Ltd. Sai1. Seva Sai Mandal: Seva Bank Mandal (2014) and– Narayana whichwho receive Murthy organises ofproducts Infosys Technologies walkingwe areInstitutions: developing or supporting Institutions: 1. SaiI DM SevaA wedonated will Mandal seek medicines approval – whichSCfrom Hto EDUthe the Drug organisesL followingE-for IController COVID-19 because walkingInstitutions: ofcan directly2. Baward.”IDMA4.liss approach GVS Fourrtsis thankful Pharma DCG(I) (India) Ltotd. the through L aboveaboratories members3. subjectP vt. Cforachet L theirtd. to Pharmaceuticals approval help of P Centralvt. Ltd. Government. 3. Cachet Pharmaceuticals Pvt. Ltd. LimitedThe (2005). Adyar Cancer Shethe foralso Institute highest COVID-19 becomes (WIA), priority. the as second can you Adherence are directly woman aware,which19. 4. to istoapproach youtheUAEFourrts givestrictest Dirham to DCG(I)people (scientificIndia) to protectthrough21.60 L aboratories them. And20.25 there3. subjectP vt.areCachet Ltd. to Pharmaceuticals approval of P Centralvt.1. L td. Sai Government. Seva Mandal – H whichave you organises renewed your walking Membership 4. forFourrts the (India) Laboratories Pvt. Ltd. pilgrimageemergency from and keep Mumbai on continuing to the Shirdi Phase 3 every trial. That’s year 1. for Sai Seva Mandal – which organises walking 1. Sai Seva Mandal – which organises walking 4. Fourrts (India) Laboratories Pvt. Ltd. 1. pilgrimageAlkemInstitutions: Laboratories fromholda public Mumbai the title,charitable Ltd. following to voluntary Shirdi OliviaPublic institute Lum every of dedicated RelationsHyflux year Limited for to the somefrom Office 20.careand which support.US for Manny haveDollar seeking – both Stul, which the Chairman organises properties,guidance77.65Have you and renewed walking which Co-CEO for 75.95 your are of calledM embershipMoose 4. Toys Fourrtsfor the (India) Laboratoriespilgrimage Pvt. Ltd. from Mumbai to Shirdi every year for howSr. it happens,”Foreign Ram Vishwakarma,RateandPublic ofethical exchange Director, Relations standards Integrativeof one 1. Office in Saiproduct 3. Seva for pilgrimage Cdevelopment seekingMandal5.achet fromI ndPharmaceuticals guidance MumbaiSwift and in toL aboratories Shirdi for P everyvt. L td. year4. L forimitedFourrts (India) Laboratoriespilgrimage Pvt. Ltd. from Mumbai to Shirdi every year for 5. Ind Swift Laboratories Limited approximatelySingaporeof cancer 500 forin pilgrims 2011.the last 60 years. During these Covidpilgrimage Times,immunomodulators.5. fromInd MumbaiSwift toL aboratories Shirdi every year L forimited For any additional informatiapproximatelyon kindly 500 pilgrims contactYear 2019-2020 Public 5. & I2020-2021nd Swift Laboratories Limited approximatelyNo. 500Currency pilgrims– whichunitmanufacturing of foreignregulatory organises currency processes walking pathway. will remainapproximatelyand the Chair top of priority500 the pilgrims EY Worldover Entrepreneur of The Year 5.judging Ind Swift Laboratoriesapproximately Limited 500 pilgrims 1. SaiMedicine Seva (Council Mandal of Scientificregulatory & Industrial pathway. Research), approximately4. Fourrts 500 pilgrims (India)SC HLEDUaboratoriesYearLE- II2019-2020 Pvt. ForL5.td. & Iany2020-2021nd Swift additional Laboratories informati Limited on kindly contact Public 6. Sai Mirra Innopharm Pvt. Ltd. the Drinstitute Mazumdar-Shaw, is badlyequivalentspeed in need 67, or to ofpolitics,” founded funds/materialsIndian rupees Bangalore-based guaranteed (as Covid the drug panel,6. makers. says:Sai “Kiran Mirra is Iannnopharm inspirational entrepreneurPvt.Relations Ltd.6. whoSai Office Mirra Innopharm through2. P tollvt.M. L td.free C. Damanwalla numberIf not,1800 Charitable please 11 do 1454so; kindly Dispensary, & contact 6. Sai IDMA Mirra Secretariat Innopharm at: Pvt. Ltd. 2. M. C.pilgrimageJammu, Damanwalla told. from Mumbai Charitable to Shirdi every Dispensary, year for 2. 6.“SepsivacM. C.Sai Damanwalla will Mirra be an immunomodulator,InnopharmI f Charitablenot, please do so;P Dispensary, whichvt.kindly L willcontacttd. have IDMA Secretariat at: 2. M. C. DamanwallaThis Charitable institutionEmail: [email protected] aims Dispensary, at helping and treating / [email protected] 2. M. C. Damanwalla(1) materials(2) to Charitable each health2. warriorAny Dispensary,(3) in firm the hospital or research2. is anM. extra C. Damanwalla institutedemonstrates having Charitable that determination, protocol Dispensary, forRelations perseverance 6. Sai Office Mirra and aInnopharm through P tollvt. L td.free numberUdvada - 1800 11 1454 & Biocon Limited2. in 1978Any with firm just or two research employees protective instituteSr.and5. U dvadaInd Foreigneffect having Swift- This and institution L therapeuticaboratories protocolEmail:Rate aims [email protected] ofeffect at exchangefor helpingLimited both,” and heof treating 100said. / [email protected] Udvada - This institution aims Tel.:at helping 022 - 2494 and 4624 treating / 2497 4308 / Fax: 022M. -C 2495. Damanwalla 0723 Charitable Dispensary, Udvada: Udvadaapproximately - This institution 500 pilgrims aims at helping and treating - This institution aims at helping and treating writeFor Advertising to startupinnovPcdsco.nicin in the Classified Columnsthe poor and and needy also patients,for series villagers and AdivasisM. C. Damanwalla Charitable Dispensary, Udvada: Udvada - ThisVishwakarma currentlyinstitutionburden to saidleads such aimsthat thecharitable onceT companyathe(a) helping itC ollaborationhospital,applies, that andis butthe now (b) stilltreatingapproval hasworth many also close patientsU dvada No. called tothe poorwillingness Currency upon and Governments, needy to innovate patients,Tel.:units 022 can ofvillagers- 2494 foreign create 4624 and /writecurrencylong-term 2497 Adivasis 4308 to /startupinnovPcdsco.nicinvalue. Fax:M. 022 CThe. - Damanwalla2495 0723 Charitablethe poor and Dispensary, needy patients, Udvada: villagersHave andyou Adivasis renewed your membership for the repurposingrepurposingFor Advertising of existingin theof Classifiedexistingthe drugs/vaccines poor6. Columns and drugs/vaccinesSaiM. needy Mirra andC. patients,alsoDamanwalla Innopharm for series villagerstreatment for treatment Pandvt. C Adivasis Lharitabletd. M. C .Dispensary, Damanwallaadvertisements Charitable Udvada: Dispensary, pleasewho contact: 525/- liveUdvada: in and around Udvada and also supplies 1. Alkem Laboratories Ltd. the2. poorM.from C. theand Damanwalla areDrug needy dependent Controller patients, on(For is Charitable expectedthem), Imported H villagersasave toall come patients you(For Dispensary, fast Exportedrenewedand are as treateditAdivasis is your thereM. VishwakarmaMwho Cembership .live Damanwalla in and is hopeful aroundfor equivalentthe that Udvada C theharitable Phase andto Indian also2 clinical suppliesDispensary, rupees trials Udvada: who live in and around Udvada and also supplies 1. Alkem Laboratories Ltd. the poor andIDM needyRsA donated 50,000 patients, medicines crore by multilateralto villagersmarket-cap the following and andinstitutions, employsadvertisementsAdivasis morecompanies,2. who B thanpleaseliss live GVS in contact: judging Nand PGharmaO s,around andpanel Ltd. othersUdvada were impressed to:and also suppliesby her ability to build1. andAlkem Laboratories Ltd.free medicines to them. of COVID-19 will also be given priority for review and 1. MrAlkem Chettiar Laboratories (+9820629907) LIDMAtd.free Bulletin medicines Publications LI (11)250/- to 15them. Departmentto 21 March 2020 2. Cachet Pharmaceuticals Pvt. Ltd. 5 who Uanlivedvada emergency Institutions:in11,000 either -and This situation. free aroundinstitutionpeople. or at Soa very ifUdvadaaimsGoods) ofthe minimal COVID-19 Phaseat helpingMr cost.and2Chettiar trial Goods) Onand alsoshows will(+9820629907) the treating mass alsothatsupplies request beof(1) Publicationsthegivenfree treatmentsustain medicines1. priority (2) Department growthwillAlkem to providefor them. over review L positivetheaboratories past and results.30(3) years And and L becausetd. by her integrity Dr V G Somani,DrC Vurrent G Somani, Year 2. C2016-2017?achet Pharmaceuticals Pvt. Ltd. who live in and around Udvada and also suppliesIDMA3. free BulletinC achetM.medicines1. C P.LI harmaceuticalsDamanwallaA (11)lkem to 15them. to L21 aboratories MarchPvt. C Lharitabletd. 2020 LDispensary,td. Udvada:2. Cachet Pharmaceuticals Pvt. Ltd. 5 the1. poorAustralian and needy Dollar patients,s 49.30 0ROVIDEvillagersapproval. SUFlCIENT and47.10 Adivasis DEDICATED the drug SUSTAINABLE is already AND in use TIMELY for sepsis or septic2. shock Cachet Pharmaceuticals Pvt. Ltd.WeDrugs are 45/-thankful Controller to the following General members (India), who donated 3. Centaur Pharmaceuticals Ltd. free medicines“Sepsivac”1. bySai theis Sevaeffectiveto Hospital them. Mandal againstfor donors– approval. which Covid-19,Y & organisesearon a specific the 2019-2020 walkingworld request may for drugs & and 2020-2021 passion for philanthropy(a) that has delivered(b) huge global WeDrugs are thankful Controller to the following General members (India), who donated 3. Centaur Pharmaceuticals Ltd. free medicines to Onthem. being anointed as the EY World Entrepreneur4.We areFourrtsWe thankful are (India) thankful to theLaboratories following to the following members Pvt. Ltd. members who donated who donated 3. Centaur Pharmaceuticalsmedicines Ltd. for this nobleIf not, cause: Forplease Advertising do so Kindly Contact in the I DMAClassified Secretariat at: whohave2. livea vaccineBahrainifrom pilgrimagein and the against Dinar mostaround from respectedthe Mumbai diseaseUdvada206.20 tofunding Chairman Shirdias andearly every for also asof 200.90 thetheone year supplies Hospital procurementmonth for treatment,1. andA 2.deliverylkem “human CLaboratories achetof safety the tools isP alreadyharmaceuticals Ltd. assured,” he3. said, PCentaurvt. L td.PharmaceuticalsIDMACentralmedicines LBULLETIN td.Drugs for this Standardnoble10/- cause: ControlFor Advertising Organization, in the Classified Columns of the Year, Dr Mazumdar-Shaw said,IDMA “At itsPadma BULLETINmedicines core,2. impact. Cforachet this Shenoble Phas harmaceuticalscause:(For built Imported India’s largest (For Pbiopharmaceutical Exportvt. Ltd. Central Drugs Standard Control Organization,Email: [email protected]. Corona / Remedies Pvt. Ltd. free3. medicinesCanadianapproximately Dollarto them. 500 pilgrims I3.f55.30 not, necessary Applicationsplease doto53.45 end so; kindlythemedicines for5.COVID-19 addingIcontactnd Clinical for Swift this that pandemic.L aboratoriesInobleDMA it willTrial cause: beSecretariat Lapplicableimited permission at:for all age and groups. 4. Corona Remedies Pvt. Ltd. Columns and4. alsoCorona for Remedies series Pvt. Ltd. from now,Vibhushan at least for Dr emergency3. V Shanta,Applications use. weTel.: volunteered 022 - 2494 for to 4624 contribute Clinical / 2497 the4308 Trial/company Fax: 022 permission on- 2495 a foundation 0723/Goods) of and compassionate DirectorateGoods)4. capitalism DirectorateCorona General and Remedies General of Health Pvt. ofLtd. HealthServices, Services, 325/-Public Relation Public Relationand Office, also Office, for series advertisements WeWe are arethankful thankful4. Chinesetoentrepreneurship the to following theYuan following is membersabout11.00 members solving who problems.10.70 whodonated The donated6. greatest Sai2. Mirra C DrI3.nnopharmachet Shanta C Pentaur inharmaceuticalsPvt. Person Ltd. atP theharmaceuticals time P ofvt. donating Ltd. Tel.: the medicines.022Ltd. - 2494 4624 /Sai 2497 Seva 4308Sai Mandal: Seva/ Fax: Mandal: 022 - 2495 0723/ E-mail: [email protected] IDMA is thankful to the above members for their help 2. listM. of C. 3 DamanwallamedicinesEmail: requested Charitable [email protected] by Dispensary,them.E-mail: Namely [email protected], to importSai1.3. Seva/ , [email protected] manufactureCMandal:entaur patient Yen P needsharmaceuticals Drug72.40 before Vaccine profits.” 69.80 Ltd. advertisementIDMA discount is thankful to the above members for their help Meanwhile,opportunities Vishwakarma often arises applications informed $IVERSIFYat the toughest that REPRESENTATION to CSIR times, import Sai has andNeukine Seva IN orthat’s CRITICAL manufactureMandal:“We are SheDECISION MAKING keeping was very ourDrug thankful fingers ANDVaccine crossedto IDMA and & all hoping its members. for the MayIDMA our [email protected], thankful to the above members85/- for theirTel.:New help 022 Delhi.P- 2494leaseNew 4624 Delhi. C /ontact: 2497 4308 Geeta / Fax: 022Suvarna - 2495 0723 medicinesmedicines forWe thisfor 5.are this thankfulnobleDanishU dvadanoble cause:Kroner to - theThis cause: institutionfollowingTel.:11.40 aims members 022Website: at helping - 2494 www.idma-assn.org,and who11.00 4624treating donated / 2497 4308 www.indiandrugsonline.org / Fax: 022 - 2495 0723 IDMA is thankful to the1. above Alkem members1. LaboratoriesAlkem for their Laboratories help Ltd. Ltd. and support.and support. beenPegastathe poor my experienceand & needyPeg-Grafeel patients, throughoutcoordination villagers. Indian my entrepreneurialand Drug Adivasis bodies Manufacturers’ withM. journey. C1.. Damanwallaspecial 2.3. A lkemKoreanC emphasisentaur L aboratoriesCharitable Won Pharmaceuticals on Dispensary, voices Ltd.6.45 Udvada: Ltd. 6.05 Website:and www.idma-assn.org,support. www.indiandrugsonline.orgplease contact: Mr Chettiar medicinesalso6. got for approval thisEURO noble for conductingcause:85.00 Phase 3 clinical81.95 trial1. of Alkembest,”4. L aboratoriesVishwakarmaservice4.Corona Cto L oronaHumanity td.said. Source:Remedies As Moneycontrol,developingRemedies Continue P vt. asa PRNewswire,vaccine ever...L Ptd.vt. againstand Ltd. 04.06.2020support. (+9820161419) Publications Department who live in and around Udvada and also supplies 1. Alkem Laboratories Ltd. “Sepsivac”7. Hong against Kong Covid-19. 10.10representing9.75 low-income a new4. and disease lower-middle-incomeC orona takes Remedies time, researchers P vt. L td.the world over are 425/- (+9820629907) Publications Department free medicines to them. F.No . 468 / 01 /2020-Cus.V SaiSai Seva Seva Mandal: Mandal:Dollar countries. 2. rushingCachet Ptoharmaceuticals repurposeIDMA existing Pisvt. thankful Ltd. drugs, vaccines to the against above the members for their help Sai Seva“The Mandal: Phase 3 trials will be done on 1,100 people IDMA is thankful to the above members for their help IDMA Bulletin 8.LI (11)KuwaitiWe are15 thankful Dinarto 21 to IDMAtheMarch following254.65 Bulletin 2020 members whoLI238.80 donated(12) 22 3. to disease.PramodC30entaur MarchIDMA P Kumar,harmaceuticals is2020 Director,thankful L td. Centralto the Boardabove of members Indirect Taxes for their help 5 Have you16 renewedHave you your renewed Membership your M forembership the for the 1. 1. AlkemAlkem L600aboratories L medicinesaboratories will be for those this Ltd. noble whoL td.cause: s have #ONTINUE tested positiveQUICKLY DEVELOPING but and AND support.COMMUNICATINGand support. CLEARHave youH renewedave you renewedyour Membership your Membership for the for the 1. Alkem9. NewLaboratories Zealand Ltd.46.95 44.75 4. andCoronaand Customs, support.Remedies Ministry Pvt. L oftd. Finance, Department of Revenue, Guidance on product needs in lower resource Source: settings IANS, IndiaTVNews, 02.05.2020 IDMA BULLETIN non-symptomatic,Dollar and 500 will be those who are out of New Delhi. 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 early as possible as our understanding of 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. Tel.: 022 - 2494 4624 / 2497 4308 / 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 / For AdvertisingFor Advertising in the Classified in the Classified Columns Columns and alsoTel.: andfor 022 series also - 2494Tel.: for 4624I 022 NDIANseriesFax: /- 24942497 022 46244308 / D/- 2497Fax:2495RUGS 4308022 - 0723/ 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 E-mail:are pleased to [email protected] that INDIAN DRUGS – our monthly magazine - is , processesHave you for renewed all stakeholders your Membership involved, for the which prioritize Mr ChettiarMr Chettiar (+9820629907) (+9820629907) Publications Publications Department DepartmentE-mail:available ONLINE. In order to enable you to have access of please contact:Mr Chettiar (+9820629907) Publications Department IDMA BulletinIDMA LI Bulletin (11) 15 LIto (11)21 March 15 to 202021 March [email protected], 2020 : www.idma-assn.org, 5 5 safetyYear while 2019-2020 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 Year 2019-2020 & 2020-2021 [email protected] / [email protected] IYftools. not,ear Ypleaseear 2019-2020 do 2019-2020so; kindly contact & IDMA2020-2021 & Secretariat2020-2021 at: If not, please do so; kindlyIDMA contact IDMA BULLETIN Secretariat at: IDMAIDMA BULLETIN BULLETIN For morewww.indiandrugsonline.org details, please contact: Publications Department : Ifs not,Email:Email: "UILD please [email protected] [email protected] AND do MAINTAIN so; kindly PUBLIC / [email protected] contact CONlDENCE/ [email protected] IDMA IN Secretariat THE APPROVAL at: Tel:022-24944624/ 24974308 / Fax: 022-24950723 / E-mail: mail_idma@ Tel.: 022 - 2494IfTel.: not, 0224624 -please 2494 / 2497 4624 do/ 43082497 so; 4308 / kindlyFax: / Fax: 022 022 contact - 2495 0723 0723/ IDMA E-mail: Secretariat [email protected], at: Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723 Tel.: 022Tel.: - 2494 022 4624- 2494 / 2497 4624 4308 / 2497 / Fax: 4308 022 / Fax: - 2495 022 0723/ -idmaindia.com 2495 E-mail: 0723/ / web: E-mail:www.idma-assn.or g / www.indiandrugsonline.org Email:Email: [email protected] Website:[email protected] www.idma-assn.org, for diagnostics, / [email protected] www.indiandrugsonline.org /therapeutics, [email protected] and [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 l l l 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) 14IDMA 01 May08 to to 202007 Bulletin14 June June 2020 LI2020 (28) 22 to 30 July 2020 IDMAIDMA BulletinBulletin LI24LI (11)(16) 152285 toto 2130 MarchApril 2020 2020 36 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? Mumbai “We are a leading job placement 25% discount applicable only for IDMA members consultant working for the Pharma Industry IDMA 15% discount is applicableBULLETIN on Annual Contract for Non IDMA Members with excellent candidate profiles Please provide Banner Artwork as per the size for advertisements before the deadline to suit all your requirements.” Tel.:Advertisement 022 - material 2494 must 4624 reach / us 249710 days before the date of release Contact: 4308 / Ext.:For more103 details please contact Publications Department Gargi Mukherjee: 9987799131/02232261414 Indian Drug Manufacturers’ Association email: [email protected] Fax: 022102-B, - 2495 Poonam Chambers,0723 Dr/ A E-mail:B Road Worli, Mumbai 400 018. Tel: 24944624/24974308 Fax: 24950723 Candidates can also register their resume at Email: [email protected]/ [email protected]. / Website: www.idma-assn.org / www.indiandrugsonline.org email: [email protected] [email protected]
IDMA Bulletin XLVII (48) 22 to 30 December 2016 48 IDMA Bulletin LII (23) 15 to 21 June 2021 39 IDMA Bulletin XLIV (14) 08 to 14 April 2013 43
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
Position Rate per Insertion ` B/W Colour Full Page (18 cm wd x 23.5 cm ht) : 9,000 12,500 Half Page (18 cm wd x 11.5 cm ht) (Horizontal) 5,000 8,500 Half Page (8.5 cm x 23.5 cm) (Vertical) : 5,000 8,500 Quarter Page (8.5 cm wd x 11.5 cm ht) : 2,500 6,000 Strips Advts (4 cm ht x 18 cm wd) : 2,500 - Inside Cover Pages : - 18,000 Back Cover : 25,000 Centre Spread (double spread) Print area (40cm wd x 27cm ht) : 25,000 30,000
Terms and Conditions: • All payments by Cheque/ Demand Draft/RTGS in advance only to be made in favour of “Indian Drug Manufacturers’ Association”, Payable at Mumbai The RTGS details are as follows:- BANK: BANK OF BARODA Account Name : Indian Drug Manufacturers’ Association, Bank A/c No. : Current A/c 76080200000242 Bank : BANK OF BARODA, Branch Address : Worli Branch, Mumbai-18, IFSC : BARB0VJWORL MICR CODE : 400012339 • GST will be charged extra, as applicable. (Current Rate is @5%) • SPECIAL DISCOUNTS for Series Advertisements • For colour advertisements, positives to be supplied otherwise processing charges to be paid. • Advertisement material must reach us 7 days before the date of publication. • Positioning of the Advt other than Cover Positions will be at our discretion. • Only Colour Advts will be entertained on Cover Positions.
Classified Advertisements Upto 80 words — `2,000/- 50% extra for Advt Box Number 50% extra for indent/layout spacing, bold captions, etc. `50/- extra for voucher copy Series discount not applicable for classifieds
For further details such as series discounts etc, please contact: Melvin Rodrigues — Cell: +9821868758 (Email: [email protected])/ Geeta Suvarna — (Email: [email protected]) PUBLICATIONS DIVISION INDIAN DRUG MANUFACTURERS’ ASSOCIATION 102-B, Poonam Chambers, Dr. A. B. Road, Worli, Mumbai 400 018. Tel: 022-2494 4624/2497 4308 Fax: 022-2495 0723 Website: www.idma-assn.org www.indiandrugsonline.org
IDMA Bulletin LII (23) 15 to 21 June 2021 40
IDMA BULLETIN SUBSCRIPTION FORM
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)
Members Government Research/Educational Institutions Non-Members
1000 2000 4000 Overseas (US$) :-
Individual
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 LII (23) 15 to 21 June 2021 41
IDMA Bulletin LII (23) 15 to 21 June 2021 42
IDMA Bulletin LII (23) 15 to 21 June 2021 43
LICENSED TO POST WITHOUT PREPAYMENT LICENCE NO. MR/Tech/WPP-337/West/2021-23 RNI REGN. NO. 18921/1970, REGN.NO.MCW/95/2021-23 Published and Posted on 7th, 14th, 21st and 30th of every month This issue posted at Mumbai Patrika Channel Sorting Office on 21.06.2021
Turning helpless into help
Unit Dose System, the single shot nasal drug delivery device from Aptar Pharma
You may recognize our UDS as the delivery device for NARCAN®, the first and only FDA-approved nasal form of Naloxone, used for the treatment of an opioid emergency. What you may not recognize is that there is so much more to this device than just for emergency situations.
UDS was designed to enable the systemic delivery of drugs without the need for injection or administration by a healthcare professional. Primeless, with one-handed actuation and 360˚ functionality, this device is approved with multiple drug products by the FDA and is used by thousands of people every day in a range of scenarios from migraine medication through to breakthrough pain relief in end-of-life situations.
All delivered with the certainty of science and safety you’d expect from Aptar Pharma, one of the world’s leading providers of drug delivery systems.
To find out more about how Aptar Pharma can help you make a positive impact on patients’ lives, call Herve Pacaud, Business Development Director at Aptar Pharma on +33 1 3917 2020 or email [email protected]
Delivering solutions, shaping the future.
IDMA Bulletin LII (23) 15 to 21 June 2021 44