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Hundreds of drug units in state under grip of fear as FDA embarks on surprise inspection spree

Ramesh Shankar, Mumbai
Wednesday, December 3, 2014, 08:00 Hrs  [IST]

Hundreds of WHO certified pharmaceutical units in Maharashtra are under the grip of fear and anger as the Maharashtra Food and Drug Administration (FDA) has embarked on a surprise inspection spree on these units in the state, which the industry terms as 'unnecessary and without any logic' as these units were issued the WHO certification after a joint inspection by CDSCO and state FDA.  

According to the industry, which is running from pillar to post to put an end to this surprise inspection drive, Maharashtra FDA has already inspected more than 50 of total 450-plus WHO certified units for schedule M compliance.  “It is surprising to note that these inspections seem to be targeted to units that already have WHO certification jointly inspected and issued by CDSCO and State FDA”, industry sources said.

Some of the units, which have been inspected by the Maharashtra FDA recently, included Wockhardt, Glenmark, Ajanta, Indoco Remedies, Cipla, Piramal, Sandoz, FDC, Manish Exports, Arti Drugs, to name only a few.  The FDA has issued show cause notices to most of the inspected units and in some cases the FDA has asked the units to close down. Interestingly, show cause notices have been issued even for minor faults, industry sources said.

Sources further said that the inspections are being conducted by drug inspectors and assistant commissioners other than from respective company's jurisdiction. Even the units which have been recently inspected either for WHO or schedule M compliance are being inspected again.

“We fail to understand the reason for the drive as these units have been cleared by the same department.  So if there seems to be any doubt on the permission given to these units then it should have been taken up with the CDSCO on validity of WHO grant given to them. If the drive is taken on compliance issues logically then it should be done across the board and should start with the units that are not WHO certification”, an agitated industrialist told Pharmabiz.

Interestingly, the Maharashtra FDA's rather unwarranted inspection spree comes at a time when the pharmaceutical exports have already taken dip a of 6 per cent on YOY basis and a cabinet secretarial level meeting was called on this issue on November 28, 2014 to understand the issues faced for the dip in exports.  The industry further says that the Maharashtra FDA's latest move is in total contradiction to Prime Minister Narendra Modi's avowed efforts to bring India from no. 144 to no. 50 for doing business in India which he plans to achieve by April 2015.

Meanwhile, annoyed over the issue, an industry delegation will soon meet the state chief minister Devendra Fadnavis to find a lasting solution to the issue.


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