Supreme Court allows sale of Saridon, 3 other drugs

PTI New Delhi | Updated on September 17, 2018 Published on September 17, 2018

Popular painkiller Saridon will be available on medical stores across the country, with the Supreme Court on Monday allowing the sale of the drug and three other banned fixed dose combinations (FDCs).

A Bench of Justices RF Nariman and Indu Malhotra issued a notice to the Centre and sought its reply on the plea filed by some drug makers and pharma associations.

The medicines whose sale was allowed were Piramal Healthcare’s Saridon, GlaxoSmithKline’s Piriton, Juggat Pharma’s Dart and another drug, the details of which could not be ascertained.

The court, however, did not grant any relief to the other medicines falling in the list of 328 FDC drugs which were banned by the Health Ministry in its September 7 notification. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

The Delhi High Court had earlier allowed pharma major Wockhardt to sell its Ace Proxyvon tablets, which is a banned combination of three salts — aceclofenac, paracetamol and rabeprazol.

The pharma company, which claimed to have been manufacturing and selling the drug for over 11 years, had contended that it has not been provided with the Drugs Technical Advisory Board report based on which the decision was taken. It had claimed that the only reason given in the September 7 notification was that the combination had no therapeutic value. The medicine is prescribed for painful rheumatic conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The Health Ministry in 2016, prohibited the manufacture, sale and distribution of 349 FDCs under Section 26A of the Drugs and Cosmetics Act, 1940. The notification was then legally contested by the pharma companies.


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Published on September 17, 2018
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