SC allows sale of Saridon, three other drugs

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

A bench of Justices RF Nariman and Indu Malhotra issued 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 immediately known.

The top 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 by 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 Indian pharma major Wockhardt to sell its Ace Proxyvon tablets, which is a mixture of three salts — aceclofenac, paracetamol and rabeprazol — a combination that is banned.

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 (DTAB) 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 reportedly prescribed for people with painful rheumatic conditions, such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The Health Ministry had, through a notification of March 10, 2016, prohibited 349 FDCs for manufacture, sale and distribution under Section 26 A of the Drugs and Cosmetics Act, 1940. The notification was then contested by the pharma companies in the Delhi High Court and the Supreme Court.

The high court in December 2016 had quashed the ban on the FDCs, which was challenged by the Centre in the apex court.

The top court had in December last year set aside the high court order and referred the banned FDCs to DTAB for re-examination.

Complying with the apex court direction, an expert panel set up by DTAB, in its report to the Centre, had stated that there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to humans.

The Board had recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in larger public interest.

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