Pharma Firms Move Delhi HC, Seek Quashing Of Notifications Banning 156 FDC

New Delhi: Pharma companies such as Alkem Laboratories and Entod Pharmaceuticals Pvt Ltd and others have moved the Delhi High Court seeking that the government’s recent notification banning 156 fixed-dose combination (FDC) drugs be quashed.

Taken up briefly for hearing before the division bench of Acting Chief Justice Manmohan and Justice Tushar Rao Gedela on Wednesday, the companies also pressed for interim relief, seeking that the existing stock of the now-banned drugs manufactured before the notification came into operation, and available with the stockists and retailers at present, be permitted to be exhausted.

The pharma companies, in their petitions, are also seeking an interim relief that no coercive action be taken against stockists and retailers until the stock is exhausted.

With senior advocate Rajsekhar Rao, appearing for the pharma companies, highlighting that the now banned drugs were approved earlier and have been on the market for a while, ACJ Manmohan, too, orally remarked that “existing stock has to be exhausted”.

However, the bench granted the government time till Monday (September 2) to come back with instructions.
ACJ Manmohan further remarked, “Experts will take the call…problem is you have made us the experts, which is not appropriate.”

In a sweeping crackdown on FDC drugs — combination of two or more known drugs in single dosage form — the Central government, earlier this month, banned 156 such drugs under section 26A of the Drugs and Cosmetics Act, 1940, thus prohibiting their manufacture for sale along with sale and distribution for human use, with immediate effect.

This means an immediate cease in sale, distribution and supply of these drugs as well as recall of all stocks available in the market.

The government has termed the use of these FDCs as irrational, noting that they do not have any therapeutic benefit.

Among the banned drugs were migraine medicine, anti-allergic medicines such as levocetirizine, decongestant syrups, and paracetamol.

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