"When it comes to intellectual property rights (IPR), I must firmly put on record that India is signatory to Trade Related Aspects of Intellectual Property Rights (TRIPS) and our laws are fully compliant with the agreement of the World Trade Organization (WTO). India has never deviated, never diluted (its law)," Commerce and Industry Minister Anand Sharma told reporters here.
Sharma was replying to a question that the US has alleged that India's IPR norms discriminates American companies particularly in the pharmaceutical sector.
The US had raised serious concerns over issuance of a compulsory license (CL) by India to Hyderabad-based Natco Pharma to manufacture and sell cancer-treatment drug Nexavar at a price over 30 times lower than charged by patent-holder Bayer Corporation.
Sharma said issuance of a CL is a flexibility available to all countries and India has used it only once after following a "due process" unlike the US which has issued such licences several times through executive authorities.
"India has never invoked (this facility) through an executive authority which India can. And in this (Nexavar) case also it was not the executive decision. The US has invoked executive decisions for CLs," he said.
The Minister said over 80 CLs have been issued worldwide so far through executive orders but till now India has never adopted this route.
"What is asked from India is TRIPS plus. India has made it clear that India will never accept TRIPS plus. India will adhere in letter and spirit to the multi-lateral agreement negotiated and signed," he added.
Under the Indian Patents Act, a CL can be issued for a drug if the medicine is deemed unaffordable by the government and grants permission to qualified generic drug makers to manufacture it.
As per the WTO norms, a CL can be invoked by a national government allowing a company to produce a patented product without the consent of the patent owner in public interest.
When asked whether the Ministry has received any proposal from the Health Ministry to issue a CL for anti-cancer drug 'dasatinib', he said: "So far, not".
However he added that if the Health Ministry would ask to issue a CL within the ambit of India's international commitments and obligations, "we will not be violating (any law) by accepting the formal recommendations of the health department".
He said the issue was raised by some American lobbyists in a particular sector "which is crucial not only for India but for every country of the world to ensure availability of life saving medicines at affordable prices to their citizens".
The US industry and trade lobbies are putting pressure on their government to put India under 'Priority Foreign Country' list for intellectual property rights.