Govt revokes suspension of Anti-Diabetic Drug

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The Government had suspended the manufacture for sale, sale and distribution of the drug Pioglitazone and formulations containing Pioglitazone for human use vide Gazette Notification GSR 379 (E) dated June 18, 2013 as certain reports, published in medical journals raised the issue of safety concerns on continued use of the drug.

However, the Drugs Technical Advisory Board (DTAB) recommended for revocation of the suspension of the manufacture and sale of the drug on the opinion of an Expert Committee constituted for the purpose.

DTAB also recommended that the drug should however be allowed to be marketed with a box warning and should also be put under focus Pharmcovigilance Programme.

Accordingly, the Government has issued a Gazette Notification GSR 520 (E) July 31, 2013 revoking the suspension of the manufacturing and sale of the drug subject to the condition that the manufacturer shall mention on their package insert and promotional literature of the drug.

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Story first published: Wednesday, August 21, 2013, 12:30 [IST]
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