As a part of its drive to ensure compliance to the conditions of licence as stipulated under Rule 65 of the Drugs and Cosmetics Rules, 1945, the Maharashtra Food and Drug Administration (FDA) has taken action against a number of wholesalers in Mumbai and Thane recently.
The state regulator is also in the process of scrutnising over 20 such cases with reference to violations of conditions of licence. As per officials, show cause notices were also served to the wholesalers for their explanations in these cases.
The FDA started the drive to inspect licences of around 18,000 drug wholesalers in the state from July, 2014 onwards 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 cases unfair practice of constraining the supply of medicines by a handful of drug dealers was rampant. 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.
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.
FDA started the drive to inspect premises of 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 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 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.
"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.