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Delhi HC quashes ban on 344 fixed dose combination medicines

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In a major development and big relief to pharma majors, the Delhi High Court on Thursday set aside the Union government’s decision to ban 344 fixed-dose combination (FDC) drugs, including well known names like Corex, a cough syrup, Vicks Action 500 and D’Cold.

The court was hearing a plea filed by pharmaceutical companies challenging the March 10, 2016 order which banned 344 FDC drugs. The ban included several common cough syrups, analgesics (pain killers) and anti-diabetes combinations.

The pharmaceutical companies’ argued that the government’s action had been ad hoc in nature and not in keeping with the procedures mentioned under Section 26A of the Drugs and Cosmetics Act, 1940. They went on to argue that the decision was taken without considering clinical data and based on an ‘absurd’ claim that there are safer alternatives available in the market now.

Drug makers immediately challenged the ban at high courts across the country, with Delhi receiving over 450 petitions asking for a stay on the decision. Pfizer was the first to get interim relief from the Delhi court for its cough syrup ‘Corex’.

Sanjay Jain, a lawyer representing the central government, told that the government was evaluating the decision and planned to appeal at a higher court. The exact reasons for the stay are not yet known, as the order has not been made public yet, but is expected to be uploaded on the court website.

Thursday’s decision provides interim relief to several local and multinational drugmakers operating in India’s $15 billion drugs industry whose business had been hit by the ban. Many, however, had obtained stay orders days after the ban was announced in March.

The move covered fixed-dose combination drugs, which are cocktails of medicines that are used worldwide to improve patients’ compliance in complicated courses of treatment, especially for conditions such as HIV, tuberculosis and malaria.

As per the March 10 notification, “On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country.”

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