India’s drug regulatory force conducts third round of raids on manufacturers

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The regulatory agency found both firms were producing new drug formulations without regulatory approval. (Yann Forget/Wikimedia Commons)

India’s drug regulatory force, the Central Drugs Standards Control Organization, pulled off a third round of raids on drug facilities that were manufacturing products without approval.

In the latest round of raids, the agency focused on manufacturing firms in Sikkim that resulted in the cancellation of one license and suspension of another, The Wire reported.

The raids last week, which come in the wake of similar actions in Uttarakhand and Daman, targeted drug manufacturing firms Savi Healthsciences and Savi Pharma.

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The regulatory agency found both firms were producing new drug formulations of ulipristal, dienogest and azilsartan without regulatory approval. Ulipristal is an emergency contraceptive, dienogest is a hormonal drug used to treat endometriosis in women, and azilsartan is used to treat high blood pressure.

The agency cancelled Savi Pharma’s license and ordered it to dispose of all processed tablets, capsules and sterile products.

In the case of the raid on Savi Healthsciences, inspectors found the firm was manufacturing drugs in areas of the plant that were under construction. The company was also cited for not keeping appropriate records of their manufacturing process.

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