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This document discusses pharmacovigilance in India and proposes a new collaborative approach. It notes that India's large population could potentially provide a large adverse drug reaction database. It then outlines a proposed structure for a national pharmacovigilance program in India with zonal and regional centers coordinated by a National Pharmacovigilance Center run by the Drugs Controller General of India.
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The document discusses pharmacovigilance in India, including its history, current challenges, and future goals. It outlines the pharmacovigilance process, including adverse drug reaction reporting procedures. The future of pharmacovigilance in India needs to address issues like increasing awareness, improving reporting rates, and strengthening oversight of medical devices and herbal products. The successful outcome of an effective national pharmacovigilance program would be to improve patient safety, public health, and rational drug use through ongoing monitoring, education, and risk assessment activities.Basic aspects of Pharmacovigilance (Clinical Research & Pharmacovigilance).pptx
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Pharmacovigilance aims to detect, assess, monitor, understand, and prevent adverse drug reactions. It has evolved over time in response to drug safety issues. Key events include the Thalidomide disaster in the 1960s which led to clinical trials, and the establishment of reporting systems in the UK, US, and Europe. India launched its national pharmacovigilance program in 2010 to monitor adverse drug reactions, but progress in expanding monitoring centers has been slow. Increased funding and commitment are needed to fully establish nationwide pharmacovigilance in India.Hospital Pharmacy Chapter -11 Pharmacovigilance
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The document provides an overview of pharmacovigilance, highlighting its definition, importance in drug safety, historical milestones such as the thalidomide disaster, and advancements in systems and technology. It emphasizes the role of international collaboration, regulatory frameworks, and the integration of pharmacovigilance throughout the drug development lifecycle. The future of pharmacovigilance is characterized by ongoing innovations and challenges that require adaptation to new medical paradigms and technologies.Ad
Pv india dcgi presentation r3
- 1. Pharmacovigilance in India Contemporary Perspectives Ashwini Kumar Drugs Controller General of India
- 2. INDIA Worlds largest democracy Population: 10,00,00,00,00 Area: 3,287,263 sq. km. Age distribution: <14 yrs=33% 15-64 yrs=60% >65%=7% +
- 3. Pharmacovigilance in India Gains so far: Knowledge about how not to do it!
- 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)
- 7. Pharmacovigilance in India Fresh Tool: Collaborative Protocol Pharmacovigilance cant be anyones personal agenda! EVERYONES INVITED!
- 8. Pharmacovigilance in India Fresh Team: Involving all health-care professionals Physicians, Surgeons, Dentists, Pharmacists, Nurses Form on the Web Interactive Reporting
- 9. Pharmacovigilance in India Clear goals & milestones: Step 1 : Notification culture Debriefing, Interaction, Training Step 2 : Data management Debriefing, Interaction, Training Step 3 : Data analysis Debriefing, Interaction, Training
- 10. Advantage India Large population > Potentially large world scale ADR database
- 11. Emerging Scenario (Clinical Research & Industry) Vigilant Ethics Committees Ongoing reviews AE Reporting GCP QC Regulatory Inspections Trained Investigators Credible Data Safe Pharmaco-therapeutics
- 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 cant wait for epidemiological data or evidence.
- 18. Acknowledgments: Indian Council of Medical Research World Bank WHO India Country Office UMC Uppsala Professional Colleagues