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Pharmacovigilance Programme of India: Recent developments and future perspectives
Vivekanandan Kalaiselvan1, Prasad Thota1, Gyanendra Nath Singh2
1National Coordination Centre, Pharmacovigilance Programme of India, Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, India.
Indian Journal of Pharmacology
|January 10, 2017
Summary
The Indian Pharmacopoeia Commission
Area of Science:
- Pharmacovigilance and Drug Safety
- Public Health Initiatives
- Pharmaceutical Regulation
Background:
- The Indian Pharmacopoeia Commission (IPC) prioritizes safe medicine use, operating as the National Coordination Center (NCC) for the Pharmacovigilance Programme of India (PvPI).
- Effective pharmacovigilance is crucial for monitoring drug safety and protecting public health.
- A robust adverse drug reaction (ADR) reporting system is essential for regulatory action and patient safety.
Purpose of the Study:
- To outline the initiatives undertaken by the NCC for the Pharmacovigilance Programme of India (PvPI) to enhance drug safety monitoring.
- To highlight the current status of ADR reporting and India's contribution to global drug safety databases.
- To detail strategies for improving ADR reporting rates and ensuring the PvPI serves as a vital resource for Indian regulators.
Main Methods:
- Monitoring of adverse drug reactions (ADRs) through a network of 179 centers reporting to the NCC.
- Analysis of India's contribution to global drug safety databases and completeness scores.
- Implementation of capacity-building programs, surveillance activities, and collaborations with national health programs and other organizations.
Main Results:
- Currently, 179 centers actively report ADRs to the NCC.
- India's contribution to the global drug safety database stands at 3%, with a completeness score of 0.93.
- The Central Drugs Standard Control Organization issued safety label changes for carbamazepine and piperacillin + tazobactam in 2015, with ongoing monitoring for other drugs.
Conclusions:
- The NCC is actively implementing measures to strengthen the Pharmacovigilance Programme of India (PvPI) and enhance patient safety.
- Increased ADR reporting and enhanced surveillance are key to improving drug safety in India.
- Collaborative efforts and regulatory interventions are vital for ensuring the safe use of medicines.
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