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Maharashtra FDA cancels 58 MFG licenses and suspends 145 licenses for GMP non-compliance

In a recent attempt to scrutinize and curb malpractices in Good Manufacturing Processes, Maharashtra FDA cancelled 58 manufacturing licenses and suspended 145 licenses of manufacturing units across the state since April 2016 till date. The strict action taken by Maha FDA is response to malpractices followed at manufacturing units contravening the provisions of Schedule M and Schedule T of Drugs and Cosmetics Act, 1940 and Rules thereunder.

State regulator’s announcement on assessing compliance levels, manufacturing units were warned to upgrade to the standards followed by regulated markets. However, failing to which, the units faced suspensions and cancellations. The State FDA and Central Drugs Standard Control Organisation (CDSCO) will jointly assess and follow the preparedness of the units towards GMPs and will assist them in inspections carried out by other regulated markets. This will be a big boost to several Indian drug makers and will eventually benefit the pharmaceutical market to get a strong hold in international market.

Recently, many Indian drug makers have come under the scanner of the global regulatory authorities over a range of issues like data integrity, including production quality, sanitation standards and alleged data manipulation.

Focussed at maintaining uniform inspection procedures across the country related to GMP, Union health ministry has instructed manufacturers to self-assess their systems and procedures as part of CDSCO's new draft checklist and evaluation tool.

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