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Pharmacovigilance in India: Present Scenario and Future Challenges
V Kalaiselvan1, Sushma Srivastava2, Abhishank Singh3
1Indian Pharmacopoeia Commission, Sector 23, Raj Nagar, Ghaziabad, 201002, India. vivekarts@gmail.com.
Drug Safety
|October 1, 2018
Summary
India
Area of Science:
- Pharmacovigilance and Drug Safety
- Public Health Surveillance
- Pharmaceutical Regulation
Background:
- India's formal adverse drug reaction (ADR) monitoring began in 1986.
- The Pharmacovigilance Programme of India (PvPI) was established in 2010, evolving from earlier initiatives.
- The program aims to ensure medicine benefits outweigh risks for the Indian population.
Purpose of the Study:
- To outline the evolution and current status of pharmacovigilance in India.
- To highlight achievements in establishing a robust drug safety monitoring system.
- To identify ongoing challenges and future directions for the PvPI.
Main Methods:
- Evolutionary analysis of pharmacovigilance initiatives in India.
- Description of the organizational structure, including the National Coordination Centre at the Indian Pharmacopoeia Commission (IPC).
- Overview of the PvPI's operational scope, including ADR reporting, training, and collaborations.
Main Results:
- Successful establishment of 250 adverse drug monitoring centers across India.
- PvPI designated as a WHO Collaborating Centre for Pharmacovigilance.
- Significant progress in fostering a culture of ADR reporting and enhancing patient safety.
Conclusions:
- The Indian pharmacovigilance system has made substantial progress but faces challenges.
- Key challenges include monitoring generic drugs, biosimilars, and specific drug classes.
- Continued efforts are needed for public awareness, counterfeit drug detection, and antimicrobial resistance surveillance.
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