Maharashtra Food and Drug Administration (FDA) has served show cause notices to 13 wholesalers from Thane division related to violation of conditions of licence. FDA is in the process of scrutinising certain 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.
According to officials, show cause notices have been 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.
The FDA started the drive to inspect licenses of around 18,000 drug wholesalers in the state from July, 2014 on wards to detect malpractices related to violations of conditions of license. The state as of today has 18000 wholesalers including those who export and import. Out of this, there are around 4000 stockists who supply to the retail trade.
FDA has intensified the crackdown on the errant wholesalers considering the fact that until last year unfair practice of constraining the supply of medicines by a handful of drug dealers was rampant. C&F agents are also mandated as per Schedule 5 of DPCO to share the price list with the stockists or wholesalers to ensure that consumers or patients are not overcharged in accordance with DPCO -2013.
Drug wholesalers have however alleged that FDA officials have been seeking irrational data like bank statements, annual turnover and profit margins which is not in accordance to officials' enquiry rules. A senior FDA official maintains that a drug inspector is empowered to inspect the wholesaler's premises also under Section 22 of the Drugs and Cosmetics Act and can ask for details like bank statements, annual turnover and profit margins for the sake of verification and clarity.
The duties of a drug inspector for inspecting the premises of a licensed 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.