Amid concerns that more domestic pharma companies could seek compulsory licences to replicate patented drugs, the government today said no such application was pending for approval.
In March, the government had allowed Hyderabad-based Natco Pharma to manufacture and sell a generic version of cancer-treatment drug Nexavar at a price, over 30 times lower than charged by its patent-holder Bayer Corporation.
In a written reply to the Rajya Sabha, Minister of Commerce and Industry Anand Sharma said: "No application for compulsory licence is pending at present".
The Minister said only one such licence has been granted in India since the amendment of the Patents Act in 2005.
The only compulsory licence has been granted to Natco Pharma for Sorafenib Toylate, a drug used for treatment of liver and kidney cancer, he said.
As per WTO agreement, a compulsory license can be invoked by a national government allowing someone else to produce a patented product or process without the consent of the patent owner in public interest.
The compulsory licence was granted to Natco by India Patents Office under Section 84 of the Indian Patent Act, which is in compliance with the TRIPS agreement of the World Trade Organisation.
Natco was allowed to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets required for a month's treatment as compared to a staggering Rs 2.80 lakh per month charged by Bayer for its patented Nexavar drug.
