Post-marketing surveillance
Also called: Pharmacovigilance · Topic: Consumer Rights and Consumer Protection · NCERT: Beyond NCERT
Meaning
Post-marketing surveillance is the checking of medicines after they are already on sale. Officials take samples from the market, test them in labs and publish alerts. If a batch fails, they order a recall, which means taking it off shop shelves. This matters because a factory can pass its approvals and still send out a bad batch later. In India, CDSCO, the central drug regulator, does this together with the State Drugs Controllers under the Drugs and Cosmetics Act 1940. A drug that fails a lab test is declared Not of Standard Quality (NSQ), meaning a real product that does not meet its quality specifications. CDSCO publishes NSQ results every month as drug alerts.
Example
In 2024-25, State and UT labs tested 1,16,323 drug samples. Of these, 3,104 were NSQ (about 2.7%) and 245 were spurious or adulterated. When a sample is declared NSQ, the manufacturer is told to recall the product right away and stop distributing it.
Don't confuse with
- Pharmacovigilance: this is the narrower part that tracks harmful side effects (adverse reactions) that patients report. Post-marketing surveillance also covers lab testing of quality, alerts and recalls.
- Schedule M (Good Manufacturing Practice): these are rules followed inside the factory before a drug is sold, so they prevent bad batches. Post-marketing surveillance finds problems only after the drug is on the market.