HC asks DCGI to grant licence to Cipla’s anti-cancer drug

HC asks DCGI to grant licence to Cipla’s anti-cancer drug

New Delhi: The Delhi high court on Friday directed the drug regulator of the country to go ahead with the process of granting a licence to Cipla for producing a generic version of the anti-cancer medication ‘Nexavar´ against which global drug maker Bayer Corp is fighting a legal battle.

However, the court has asked Cipla not to launch its product without its permission.

The court’s direction comes in response to Bayer’s petition before the court challenging an earlier single bench order that had rejected its plea to restrain Cipla from producing the generic version of Nexavar.

A division bench headed by chief justice A P Shah directed the drugs controller general of India (DCGI) to proceed with its process of granting licence to Cipla for the cancer drug, but said the licence would be subject to the outcome of its order.

Meanwhile, the High Court has directed all parties, including Bayer, Cipla and the government, to file their written submission in two weeks. The court has also allowed the application of the Indian Pharmaceutical Alliance for making it a party in the ongoing case.

The matter will come up for hearing on 6 October.In its petition Bayer had said it was granted the sole patent right to manufacture, sell and distribute the cancer drug Nexavar and that the Indian patent authorities in March 2008, had also granted it exclusive rights for manufacturing.

Bayer had requested the court to direct DCGI not to give a licence to Cipla to manufacture, sell and distribute the drug.