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Friday, 17 June 2016

Maharashtra FDA suspends Sequent Scientific’s Mahad unit licence

MUMBAI: The Maharashtra Food and Drug Administration has ordered suspension of the manufacturing licence of the Mahad unit of Sequent Scientific, a maker of drug raw materials and veterinary products. The company has appealed against the decision — taken in May last week — to Girish Bapat, state food and civil supplies minister. In its appeal, Sequent has pleaded that the decision to suspend the operations will lead to serious financial losses, hamper exports
and cause loss of foreign currency besides leading to unemployment, said a person close to the matter. The suspension is to be effective from July 1 to July 15, 2016. The Maharashtra FDA officials did not comment on the issue. n response to questions from ET, Sequent said the observations made by Maharashtra FDA were general in nature except for the procedural lapses which the company is addressing. While the granular details could not be obtained, the people mentioned above said the issues detected are not too serious and mostly related to late submission of documents to the FDA. "The state regulator exercised its rights. The appeal to the minister is not an exception and part of the official procedure if the aggrieved party disagrees on regulatory action. A resolution may be expected soon," a source told ET. Sequent and its affiliate companies have a total of seven manufacturing sites mostly spread across Maharashtra, Andhra Pradesh, Karnataka, and also a unit in Turkey. Most of these facilities make raw materials and formulations, used both for human health and veterinary care. 

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