Maharashtra Food and Drug Administration (FDA) is in the process of scrutinising 23 cases of wholesalers from Mumbai and Thane with reference to violations of conditions of licence as stipulated in Rule 65 of Drugs and Cosmetics Rules, 1945.
The state had earlier served show cause notices to the wholesalers from Thane and Mumbai division related to violation of conditions of licence.
According to officials, show cause notices were served to the drug wholesalers for their explanations. Cases of violation under scrutiny are 13 from Thane division and 10 from Mumbai on the inspections carried over a period of past few months. Stockists were being inspected for compliance to schedule 65 of Drugs and Cosmetics (D&C) Act, 1940 and Schedule 5 of Drug Price Control Order (DPCO) - 2013.
FDA had recently cancelled licences of stockists for violating the conditions of licence. FDA has also issued stop sale notice on the products and instructed hospitals to stop use of the products.
Informs S T Patil, joint commissioner, FDA, "The crackdown on the errant wholesalers is an ongoing exercise considering the fact that until last year unfair practice of constraining the supply of medicines by a handful of drug dealers was rampant."
FDA started the drive to inspect licences of 18,000 drug wholesalers in the state from July, 2014 onwards to detect malpractices related to violations of conditions of licence.
Ever since the FDA intensified its drive against people stocking and selling drugs illegally, FDA had also filed FIRs against four such people at Dongri Police Station in South Mumbai for illegally selling and stocking medicines. According to an FDA official, action was taken against them for violating the conditions of licence under Section 18 of the Drugs and Cosmetics Act, 1940.
The arrested persons were also selling prescription drugs at exhorbitant prices in contravention to DPCO- 2013, Section 7 of Essential Commodities Act (EC Act) and Drugs and Cosmetics Act.
The state as of today has 18,000 wholesalers including those who export and import. Out of which, there are around 4,000 stockists who supply to the retail trade.
The duties of a drug inspector for inspecting the premises of a licenced drug wholesaler are prescribed under Rule 51(1) of the D&C Rules, 1945. It empowers the drug inspector to inspect, not less than once a year, all establishments licenced for the sale of drugs within the area assigned to him, to satisfy himself that the conditions of the licences are being observed and to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act.