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Delhi HC denies interim relief to pharma firms on fixed dose drugs ban

LiveMint logoLiveMint 21-06-2017 Priyanka Mittal

New Delhi: The Delhi high court on Wednesday denied interim relief to three pharmaceutical companies that sought a stay of a central government notification banning certain fixed dose combination (FDC) drugs.

Three companies—Mankind Pharmaceuticals, Akum Drugs and Pharmaceuticals Ltd and JB Chemicals and Pharma Ltd had approached the court.

Justice Sanjeev Sachdeva who was hearing the case sought the Centre’s reply on the issue before the next hearing.

“The injections using the drug combination have been in use since the last 8-9 years and the Centre’s decision to ban them is invalid and without application of mind,” counsel Sandeep Sethi told the court.

This was refuted by the Centre, which said any hearing before prohibition of the FDCs would be extended to the innovator and not the manufacturer of generic drugs.

Under an 8 June gazette notification, fixed dose combination of Ofloxacin with Ornidazole injection; combination of Etodolac with Paracetamol and certain other combinations were banned with immediate effect.

An FDC contains two or more active drug ingredients in a fixed ratio of doses.

In March last year, the Centre had banned 344 FDC drugs citing health risks and lack of therapeutic justification.

The ban covered about 6,000 brands and major pharma houses including Pfizer Ltd, Sun Pharmaceutical Industries Ltd, Cipla Ltd, Sanofi India Ltd, Alkem Laboratories Ltd and Wockhardt Ltd. The ban was imposed following a report by a six-member committee headed by Chandrakant Kokate, vice chancellor of KLE University, Karnataka.

Justice Rajiv Sahai Endlaw of the Delhi high court had quashed the notification, holding that the government had failed to consult statutory authorities like the Drug Testing Advisory Board and the Drugs Consultative Committee for the ban. The court, however, did not rule on whether FDC drugs are harmful to consumers.

Proceedings in all high courts against the ban on 344 FDC drugs are stayed by the Supreme Court where the matter is pending.

The case will be heard next on 30 June.

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