SC may pronounce judgement on fixed dose combination drugs ban today

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The government had filed a transfer petition asking for all pending FDC petitions to be transferred to the Supreme Court. In all 294 FDCs which were banned way back in 1997 also got transferred to the apex court. Photo: Pradeep Gaur/Mint

New Delhi: The Supreme Court is expected to pronounce the judgment against the ban of over 600 fixed dose combination drugs (FDCs) on Wednesday.

The health ministry last year had banned 344 FDCs, estimated to affect around 6,000 brands, after an expert committee declared them unsafe for human health. The expert committee found these drugs to be “irrational” and “unsafe” for consumption and, hence, banned them. However, drug makers immediately challenged the government’s ban in high courts across the country, with Delhi receiving over 450 petitions seeking interim relief on their specific brands.

In January this year, the ministry of health and family welfare moved the apex court challenging a Delhi high court order that revoked its ban of over 300 FDCs.

The petition was filed after the Delhi high court on 2 December last year set aside the government notification that had banned hundreds of FDC drugs, made by combining two drugs into a single dose.

The government previously had also filed a transfer petition asking for all pending FDC petitions to be transferred to the Supreme Court.

In all, 294 FDCs that were banned way back in 1997 also got transferred to the Supreme Court.

“In total, fate of 643 FDCs which include 349 FDCs which were banned by the government last year and 294 banned in 1997. The Supreme Court is expected to deliver the judgement tomorrow,” said a member of a pharma lobby group on Tuesday on condition of anonymity.

The government and the industry have been at loggerheads over the move since then.

While the health ministry argued that it acted in public interest, the industry claims marketing approvals for these combo drugs were granted after following due procedures.

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

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