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Page 1 of 11 INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre - Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare, Government of India ADRs Reporting Status, November 2019 The spontaneous ADRs reporting by the ADR Monitoring Centres (AMCs) under Pharmacovigilance Programme of India (PvPI), Revised National Tuberculosis Control Programme (RNTCP) & Anti- Retroviral Therapy (ART) centres under National Health Programmes, and Pharmaceutical industries to National Coordination Centre-PvPI for the month of November-2019 has been compiled. During the November month of 2019 a total 5615 ICSRs were reported to NCC-PvPI. The detail is given below. (I) Spontaneous ADRs reported by the AMCs , ART and RNTCP Centres as follows
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Page 1: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

Page 1 of 11

INDIAN PHARMACOPOEIA COMMISSIONNational Coordination Centre - Pharmacovigilance Programme of India (PvPI)

Ministry of Health & Family Welfare, Government of India

ADRs Reporting Status, November 2019

The spontaneous ADRs reporting by the ADR Monitoring Centres (AMCs) under Pharmacovigilance

Programme of India (PvPI), Revised National Tuberculosis Control Programme (RNTCP) & Anti-

Retroviral Therapy (ART) centres under National Health Programmes, and Pharmaceutical industries to

National Coordination Centre-PvPI for the month of November-2019 has been compiled. During the

November month of 2019 a total 5615 ICSRs were reported to NCC-PvPI. The detail is given below.

(I) Spontaneous ADRs reported by the AMCs , ART and RNTCP Centres as follows

Page 2: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

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Page 5: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

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Page 6: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

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Page 7: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

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Page 8: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

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Page 9: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

Page 9 of 11

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Name of AMCs

No. of ICSRs recieved from ART and RNTCP Centres in the month ofNovember 2019

Page 10: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

Page 10 of 11

(II) Spontaneous ADRs reported by the Pharmaceutical Industries as follows:

S.No. Industry Name Total

1 Abbott India Limited 202 Akums Drugs & Pharmaceuticals Limited 43 Alcon Laboratories India Private Limited 44 Alkem Laboratories 25 Allergan India Pvt. Ltd. 76 Astellas Pharma India Private Limited 57 AstraZeneca Pharma India Limited 108 Aurobindo Pharma Limited 439 Amgen India 4

10 Baxalta 1311 Baxter (India) Private Limited 27912 Bayer Healthcare Limited 2613 Biocon Limited 7214 Boehringer Ingelheim India Private Limited 2615 Bristol-Myers Squibb India 4416 Bharat Serums And Vaccines Limited 217 Cipla Limited 2618 Dr.Reddy's Laboratories 2119 EISAI Pharmaceuticals India Pvt. Ltd 3920 Eli Lilly & Company (India) Private Limited 5121 Emcure Pharmaceuticals Limited 322 Eris 223 FDC 524 Fresenius Kabi India Private Limited 725 Glaxo Smithkline Pharmaceuticals Limited 1326 Glenmark Pharmaceuticals 4627 Gufic Biosciences 128 Hetero Drugs Limited 3629 Intas Pharmaceuticals Limited (Lambda CRO) 530 Inventia 2131 IPCA Laboratories Limited 332 Johnsons & Johnsons Private Limited 3833 Kedrion Bio Pharma 334 Lupin Limited 3135 Lundbeck Pharmaceutical company 2

36 Emcure Pharmaceuticals Limited 3

Page 11: INDIAN PHARMACOPOEIA COMMISSION National …INDIAN PHARMACOPOEIA COMMISSION National Coordination Centre -Pharmacovigilance Programme of India (PvPI) Ministry of Health & Family Welfare

Page 11 of 11

37 Macleods Pharmaceticals Limited 338 MERCK Limited 6239 MSD Pharmaceuticals Ltd. 7240 MSN Labs 841 Mylan Laboratories Private Limited 1942 Novartis India Limited 86643 Novo Nordisk India 944 Nitin Life Sciences 545 Pfizer Limited 36046 Panacea Biotec Limited 847 Roche Products (India) Private Limited 11948 Reliance Life Sciences 349 Reckitt Benkiser 1350 Sanofi India Limited 13951 Serdia Pharmaceuticals (India) Limited 152 Sun Pharmaceuticals Industries Limited 1053 Serum Institute of India Limited. (Lambda CRO) 154 Synokem 155 Torrent Pharmaceuticals Limited 2456 UCB India Pvt. Limited 157 USV Private Limited 158 Vifor Pharma 159 Win Medicare 160 Wipro GE Healthcare Pvt. Ltd 161 Zydus Cadila 3562 Zuventus Healthcare Limited 1

Total 2678

Acknowledgement - NCC-PvPI acknowledges all the stakeholders for their contribution.


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