No coercive steps against drug firms for FDCs already in market, production to stop: HC

Pharma firms which challenged the Centre's decision to ban 328 fixed dose combination (FDC) drugs were Tuesday protected by the Delhi High Court from coercive action against them for the stock already in the market, provided they stop manufacturing the prohibited medicines.

Justice Vibhu Bakhru said the interim order would apply to the companies which have moved the high court and directed the Health Ministry to file an affidavit indicating the reasons for prohibiting manufacture and sale of the FDCs.

The court said it will test the government's assertion that the FDCs were risky to human health and listed the matter for further hearing on September 27.

It also asked the companies to give the batch numbers of the stock in the market.

The order came on a batch of pleas by several pharma majors including Glenmark, Wockhardt, Alkem Laboratories and Obsurge Biotech, challenging the Health Ministry's September 7 ban on 328 FDCs, which are two or more drugs combined in a fixed ratio into a single dosage form.

Coral Laboratories, Lupin, Mankind Pharma, Koye Pharmaceuticals, Macleods and Laborate have also moved the high court against the ban on their FDCs ranging from anti-inflammatory and pain killers to antibiotics and drugs for treating bacterial infections.

In a statement, Khaitan and Co partner Ajay Bhargava, who represented Glenmark, Lupin, Mankind, Coral and Koye, said: "The order will bring some respite to the pharma companies to protect them against coercive measures by the government in relation to the medicines which are already manufactured and in the distribution channel."