4. IMA ends debate: Nimesulide is safe Arun Kumar and Sutirtho Patranobis New Delhi More than 50 doctors country-wide participated in an opinion poll organised by the IMA and submitted data on the use of nimesulide on nearly 5.3 lac patients. The data clearly showed that the side-effects of the drug were nothing more than common GI problems … January 13, 2003
5. January 14, 2003 Nimesulide not safe, insist doctors By Kalpana Jain Times News Network New Delhi: Doctors have questioned an “opinion poll” conducted by the Indian Medical Association (IMA) to declare the controversial fever drug, Nimesuilde, “safe”. … a leading paediatrician who is the former head of the pediatrics department at the All India Institute of Medical Sciences, told The Times of India … that severe side effects of the drug have been documented and it needs to be used with caution.
6. Pharmacovigilance in India Fresh strategy: Collaborative Approach Requisite Resources Team Mates Agreed performance benchmarks Willingness to Learn Political Will The rule of “farming” (preparing / tilling the soil, sowing the seeds, nurturing the seedlings, providing resources for fostering growth, harvesting the benefits)
12. National PVig Programme E Regional N Regional W Regional W Regional NE Zonal SW Zonal National PVig Center
13. The Road Ahead Protocol > Validate Protocol > Formal agreements with centers > Center & Staff Identification > Prepare & Distribute Material > Web link > Collate feedback > Review Progress > Make mid-course corrections > Close non-performing / non complying sites > Identify fresh sites > Eventually broaden the programme base
14. The Road Ahead National Pharmacovigilance Center : Office of the Drugs Controller General of India Central Drugs Standard Control Organization, (Directorate General of Health Services), Ministry of Health & Family Welfare Government of India
15. The Road Ahead Zonal Center 1 : for North and East Regions All India Institute of Medical Sciences, New Delhi Coordinator: Dr. S. K. Gupta Regional Pharmacovigilance Centres Northern Region Lady Hardinge Medical College, New Delhi Coordinator: Dr. Kamlesh Kohli Eastern Region NRS Medical College, Kolkata Coordinator: Dr. S. K. Tripathi
16. The Road Ahead Zonal Center 2 : for West and South Regions SGS Medical College, Mumbai Coordinator: Dr. Nilima Kshirsagar Regional Pharmacovigilance Centres Southern Region Madras Medical College Coordinator: Dr. Annabelle Western Region KEM Medical College, Mumbai Coordinator: Dr. Urmila Thatte Central Sub-Region (under Western Region) Indira Gandhi Medical College, Nagpur Coordinator: Dr. Meena Shrivastava
17. Regulatory Pharmacology Regulatory decisions are generally based on “cases”. Regulators can’t wait for epidemiological data or evidence.
18. Acknowledgments: Indian Council of Medical Research World Bank WHO – India Country Office UMC Uppsala Professional Colleagues
