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Govt bans manufacture, sale of 35 fixed-dose combination drugs

The regulator issued the directions after it found that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy, posing a serious risk to public health and safety

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Apex drugs regulatory body CDSCO has directed controllers of all states and Union territories to stop the manufacture, sale and distribution of unapproved 35 fixed-dose combination drugs that include painkillers, nutrition supplements and anti-diabetics, reported news agency PTI.

They have also been asked to review their approval process for such fixed dose combination drugs (FDC) and ensure strict compliance with the provisions of the Drugs and Cosmetics Act 1940 and rules.

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