477 Pune Pharmaceutical Stores found Operational Without Pharmacists after FDA inspection
477 Pune Pharmaceutical Stores found Operational Without Pharmacists after FDA inspection
405 medical stores have temporarily been shut down.
30 April 2024
By Khushi Maheshwari
The Food and Drug Administration (FDA), which monitors such misdeeds, asserted that up to 477 retail and wholesale medical businesses in the city were operated without pharmacists.
According to the 1940 Drugs and Cosmetics Act, every medical business must hire a pharmacist to dispense prescription drugs. The FDA’s drug department is mandated by the Act to oversee the import, manufacture, distribution and sale of pharmaceuticals. It must guarantee that medications and cosmetics marketed in India are efficacious, safe and meet statutory requirements for quality.
The only way to purchase the scheduled medications is to present a valid prescription. This is a significant clause, and the FDA is in charge of putting it into practice and ensuring that it is followed. The government has identified a significant number of pharmaceutical enterprises in the micro, small and medium enterprise (MSME) sector as manufacturing pharmaceuticals that fall short of standard quality (NSQ). This has been seen by the FDA concurrently. As per an informed source, this was carried out as part of risk-based assessments of pharmaceutical businesses that have been carried out since December of last year.
The FDA supplied figures indicating that 477 actions were brought against city drug retailers in 2023–2024. 396 of these were retail establishments, and the remaining 81 were wholesalers. Subsequently, the FDA revoked the licences of 72 establishments, consisting of 24 wholesale outlets and 48 retailers. Up to 405 stores—348 retail and 57 wholesale—were told to close temporarily. In addition, the FDA carried out raids and gathered 22 medicine samples that were thought to be of inferior quality. In this context, up to 25 cases were reported.
Speaking with Pune Pulse, the Joint Commissioner of FDA’s Pune Division shed light on the situation and said, “The situation is under control. This is FDA’s regular activity… periodically our inspectors go and check the medical stores and see if they are complying with the regulations, in case they are not, we take action against them.”
He added that it is the FDA’s responsibility to monitor whether or not these stores are in compliance with their guidelines and how part of that responsibility is to provide the citizens of the country with safe, verified and authenticated medicines.
