To ensure compliance to the conditions of wholesale licence and Drug Price Control Order (DPCO-2013), the Maharashtra Food and Drug Administration (FDA) is in the process of inspecting wholesalers on aspects like maintaining proper invoicing and purchasing in the Konkan Division of Maharashtra.

Around 3803 wholesalers in areas like Thane, Mira - Bhayander, Bhiwandi, Navi Mumbai and Ulhasnagar of the division are 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.

C&F agents are 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. However, it has been observed that C&F agents fail to share the price list in 80 per cent cases to either the stockist or the retailer, which might lead to overcharging, sources informed. A request on the same has been sent to the state FDA by city based retailers.

FDA started the drive to inspect licenses of around 15,000 drug wholesalers in the state from July, 2014 onwards to detect malpractices related to violations of conditions of license. 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 request has been sent to the state FDA to give instructions to the drug inspectors to perform their duties in accordance with the D&C Rules.

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 licensed 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.

A senior FDA official however 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 D&C Act empowers the drug inspector to examine any record, register, document or any other material object found and seize the same if he has reason to believe that it may furnish evidence of the commission of an offence punishable under this Act or the Rules made thereunder," the official concludes.