Maha FDA prohibits Mankind from selling, distributing drugs worth Rs.2 cr until further notice

Mumbai, 24 July: The Maharashtra Food and Drugs Administration (FDA)-Pune division issued a notice to Mankind Pharma, prohibiting them from selling and distributing drugs worth Rs.2 crore in the state until further notice. The notice was issued to the company for not complying to the storage conditions as required under the Drugs and Cosmetics (D&C) Act while storing their drugs in the godown of Sheetal Distributors in Pune. During the initial investigation that was carried out last month, the FDA officials found the company to be flouting the rules and provisions listed under D&C Act 1940 and rules 1945, thus prompting the officials to seize, Mankind's drugs worth Rs.2 crore, for improper storage of goods. B R Masal, joint commissioner (drugs), FDA, Pune division informed that they found that the goods having tags stating to be stored below 25 degree centigrade where stored below 30 degree centigrade whereas drugs that needed to be stored in cool place were stored at 36 degree centigrade. Following the investigation, the Pune FDA have sent 30 samples to the government laboratory in Mumbai for test analysis to check on the stability and efficacy of the drugs in question. “With a view to ensure public safety and to promote the use of safe medicine across the state, we have issued a notice to the company, as a precautionary measure, prohibiting them from selling the drugs that were stored in warehouse in Pune. The ban on sale and distribution will be valid till we receive the test results which have been send for analysis on top priority basis,” Masal stated. A show cause notice has also been sent to Mankind regarding the same on June 25 by the FDA Authorities. The investigation on the company was carried out on the complaint filed by Narendra Jain, who runs an NGO, Pharma Gladiator, which stated that Mankind Pharma was not complying to the required storage condition as per the D&C Act and Rules. Narendra Jain who is also the general secretary of Maharashtra Chemists & Distributors Federation (MCDF) stressed that the data that they had passed on to the FDA officials was received after an independent study conducted by Pharma Gladiator showed that many pharma top companies were not complying to proper storage conditions, leading to the possibility of supply of sub standard drugs in the market. “After recent investigation, we have come across some very serious issues regarding pricing and storage conditions which needs to be addressed urgently. To bring a stop to such practices we will be handing over all the researched cases to the the FDA authorities so that proper action can be taken against such companies.” Earlier based on a similar complaint by Jain, the FDA Pune had done an investigation on Cipla as well wherein even Cipla was found to be flouting the rules. Test analysis on the samples collected from both Cipla and Mankind are expected to be received any time now after which further action will be taken.

Pharmabiz