The government has moved Supreme Court seeking ban on 344 fixed-dose-combination drugs, after the Delhi High Court overturned this ban earlier last month. The government is challenging the Delhi High Court’s decision of revoking the ban of 344 fixed-dose-combination drugs.
The government is learnt to have told the Supreme Court that the pharmaceutical manufacturing companies have not followed proper procedures regarding drug licensing and clearances.
A fixed-dose-combination drug is a combination of two or more active pharmaceutical ingredients in a single drug. The government had banned 344 such drugs in March last year citing health risks, rise in antimicrobial resistance and lack of rationale in making these drugs.
The government has also maintained that it is following the lead of several other countries, which too have banned combination drugs as those are not safe.
Companies have been accused of sometimes bringing banned drugs into the markets using the garb of different combination drugs. However, the government says there is no therapeutic justification for use of such drugs.
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As many as 454 petitions were moved by various pharma and healthcare majors including Pfizer, Glenmark, Procter and Gamble and Cipla, who challenged the government’s ban on combination drugs, saying the decision was taken by the Centre in a haphazard manner without following the procedures prescribed in the Drugs and Cosmetics Act.
The Delhi High Court, while admitting the petition of the drug companies, clarified that the decision to overturn the government ban was only on the account of the government not following the proper procedure. It did not consider whether or not the combination drugs are risky to the patients.
Popular fixed-dose-combination drugs include Pfizer’s Corex, Abbott’s Phensedyl, P&G’s cold and cough drug Vicks Action 500 Extra, Piramal’s Saridon, Reckitt’s D Cold Total, Glenmark’s Ascoril-C, and many more.