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Health Ministry move to Supreme Court to challenges the revocation of the drug ban by FDC

 

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Clinical courses

The health ministry asked the Supreme Court to challenge an order of the Delhi High Court that had quashed its ban on more than 300 fixed-dose drugs. The health ministry last year had banned 344 FDCs, estimated to affect about 6,000 drug brands and shave over Rs 3,000 crore on the Indian pharmaceutical market, which is estimated to be over Rs 100,000 crore.

The Delhi High Court canceled on December 2 the government notification banning hundreds of fixed-dose combination drugs (FDCs), or drugs made by combining two drugs in a single dose. And now, after about two months, the Ministry of Health has filed the petition.

The Delhi High Court had already allowed 454 applications from a number of pharmacy and health specialists such as Pfizer, Abbott, Cipla, P&G who challenged the government's ban on FDCs.

Combination drugs or fixed dose combination (FDC) drugs are those with two or more active pharmaceutical ingredients combined in a fixed dose to form a single drug.

The ban had impacted several popular brands including Corex, Phensedyl, Saridon, D'Cold Total and Vicks Action 500 Extra.

 

Government and industry disagreed, with the Department of Health arguing that it was acting in the public interest based on a experts committee that found these drugs "irrational" and "dangerous" for consumption.

And Industry also claiming that marketing approvals for these combo drugs were granted after following all the procedures.

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