Supreme Court lifts ban on Saridon, 3 other FDCs

Sep 18, 2018 10:11 IST
Supreme Court lifts ban on Saridon, 3 other FDCs

The Supreme Court of India on September 17, 2018 allowed the sale of popular painkiller Saridon and three other banned fixed-dose combinations (FDCs) in medical stores across the country.

The ruling was delivered by a bench of judges comprising Justices R F Nariman and Indu Malhotra. The bench was hearing a plea challenging the ban on the drugs following a recent notification by the Union Health Ministry. The bench also issued a notice to the centre and sought its reply on the plea filed by some drug makers and pharma associations.

Key Highlights

The apex court has allowed the sale of Piramal Healthcare's Saridon, GlaxoSmithKline's Piriton, Juggat Pharma's Dart and another drug, the details of which are not known.

The petitioners contending the ban argued that the medicines were manufactured before 1988 and thus should be exempted from the banned list of 328 fixed-dose combination (FDC) drugs.

The pharma company, which claimed to have been manufacturing and selling one of the drugs- Saridon 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 Health Ministry’s notification was that the combination had no therapeutic value.

However, it contended that Saridon is prescribed for people with painful rheumatic conditions, such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The top court hasn’t, however, granted any relief to the other medicines falling in the banned list of FDCs.

What are FDCs?

The Fixed Dose Combination drugs are two or more drugs combined in a fixed ratio into a single dosage form.

The fixed-dose combinations reduce the number of pills taken by a person each day. These drugs are majorly used to simplify disease management for chronic diseases such as HIV, asthma, diabetes, lipid regulation and hypertension.

The FDCs include anti-diabetic drugs, HIV drugs, antibiotics and analgesics such as Saridon, Panderm Plus and Taxim AZ.

Health Ministry prohibits manufacture, sale and distribution of Fixed Dose Combinations

Background

The Union Health Ministry issued a notification last week prohibiting the manufacture, sale and distribution of 328 Fixed Dose Combinations (FDCs) for human use with immediate effect.

The Ministry also restricted the manufacture, sale and distribution of six FDCs subject to certain conditions. The action was taken by the Ministry under the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940.

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 rabeprazole -a combination that is banned.

Prior to that in March 2016, the Health Ministry had prohibited the manufacture, sale and distribution of 349 FDCs 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 Delhi 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 then in December 2017 set aside the high court order and referred the banned FDCs to a Drugs Technical Advisory Board (DTAB) for re-examination.

The 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.

Hence, the board 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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