Post-marketing surveillance (PMS) is the process of monitoring the safety, efficacy, and quality of medicines after they are released in the market. In India, PMS is governed by the Central Drugs Standard Control Organization (CDSCO) under the Pharmacovigilance Program of India (PvPI). The system collects data on adverse drug reactions (ADRs) to ensure patient safety and guide regulatory decisions. However, challenges remain, including underreporting of ADRs, lack of awareness among healthcare professionals, limited infrastructure, and delays in data analysis. Improving reporting mechanisms, training healthcare providers, and integrating digital tools are crucial to strengthen PMS and ensure safe use of medicines across the country.
MBH/AB
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It’s really important, recently what happened in M.P. where several children died due to ingestion of cough syrup is an important and sad reminder for us.
That’s a clear picture of how post-marketing surveillance works in India and the challenges it faces. It highlights the need for stronger monitoring systems to ensure drug safety and protect public health.
Excellent observations! For patient safety, PMS must be strengthened, particularly in a country with a diverse healthcare system like India. Its effectiveness is actually limited by underreporting and ignorance. Do you believe that including PMS education in pharmacy and medical programs could have a lasting effect? In what other ways can we motivate medical staff to promptly and actively report adverse drug reactions?