Pharmabiz
 

Maha FDA takes action against cos for supplying spurious products

Shardul Nautiyal, MumbaiTuesday, December 2, 2014, 08:00 Hrs  [IST]

To ensure compliance to the conditions of licence, Maharashtra Food and Drug Administration (FDA) has issued show cause notice to a Mumbai based stockist Alpha Enterprises and filed cases at Metropolitan Court, Sewri against marketing company for allegedly supplying spurious drugs to a reputed Mumbai based hospital and endangering patients life.

Licenses have also been cancelled for violating the conditions of license. FDA has also issued stop sale notice on the products and instructed hospitals to stop use of the products.

Cases of misbranding and duplication have been detected against Pharmadin Pvt Ltd for supplying Lysowash, the brand name for a sanitiser, as it was found to be of spurious quality on lab analysis done in an FDA lab. As per the analysis, it lacked an ingredient Propanol in the prescribed quantity. The company has been booked under Section 17 B of the Drugs and Cosmetics Act, 1940.   

FDA officials informed that another company Milan Cosmetics have been booked under section 17 C and punishable under 27 (A) (ii) of the Drugs and Cosmetics Act, 1940.     

Ever since the FDA intensified its drive two months ago 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. FDA had intensified the crackdown 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.

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. Clarifies an FDA official, "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 the D&C Act or the Rules made thereunder."

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.

 
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