The Food and Drug Administration (FDA) in Pune has claimed to crack down on as many as 477 retail and wholesale medical stores in the city that were run without pharmacists.
According to the regulations outlined in the Drugs and Cosmetics Act of 1940, each medical store is required to have a pharmacist on staff to dispense medicines prescribed by doctors.
The drug department of the FDA is responsible for overseeing the entire process of importing, manufacturing, distributing, and selling medicines. Its mandate includes ensuring that all drugs and cosmetics available in India meet stringent safety, effectiveness, and quality standards set by the state.
Scheduled drugs can only be sold with a valid prescription, a pivotal regulation enforced by the FDA.
Ensuring compliance with this provision falls under the FDA's jurisdiction. Concurrently, the FDA has observed that numerous pharmaceutical companies within the micro, small, and medium enterprise (MSME) sector have been flagged by the government for producing drugs of substandard quality (NSQ). This determination was made during risk-based inspections of pharmaceutical companies conducted since December of the previous year.
Statistics provided by FDA
According to statistics provided by the FDA, in 2023-24, a total of 477 actions were initiated against medicine stores in the city. Out of these, 396 were retailer stores while 81 were wholesalers. Later, the FDA cancelled licenses of 72 stores, out of which 48 were retailers and 24 wholesale stores. As many as 405 stores, 348 retail and 57 wholesale, were directed to temporary closures. Besides, the FDA conducted raids and collected 22 samples of drugs suspected to be of substandard quality. As many as 25 cases were registered in this regard.
SV Pratapwar, Assistant Commissioner of FDA (Drug), said, “During our routine surprise inspections, a total of 477 medical stores in the city were found not abiding by the rules. We took action against them for lacking fare bills, proper audit, manpower, and a pharmacist. We randomly conduct these inspections and issue notices if any unfair trade practices are found.”
