The government today said every member of the WTO, including India, has the right to grant compulsory licences (CL) and also decide the grounds for issuing them.
As per the WTO norms, a CL can be invoked by a government allowing a company to produce a patented product without the consent of the patent owner in public interest.
Under the Indian Patents Act also, 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.
The government's clarification comes against the backdrop of a statement issued by the US-India Business Council in which it had stated that the Indian government privately reassured that it would not use CL for commercial purposes.
The Commerce and Industry Ministry said that there have been recent reports that India privately assured that it will not issue any more compulsory licence.
"It is hereby clarified that such reports are factually incorrect. In this regard, it may be noted that India has a well-established TRIPS compliant legislative, administrative and judicial framework to safeguard IPRs.
"Under the Doha Declaration on the TRIPS Agreement Public Health, each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licenses are granted," the ministry said in a statement.
Trade Related aspects of Intellectual Property Rights (TRIPS) is a WTO agreement which deals with intellectual property related issues including CL.
It said "even as India is conscious of the need to spur innovation and protect individual rights, it retains the sovereign right to utilise the flexibilities provided in the international IPR regime".
So far India has issued only "one case" of compulsory licence and "that too after a well-thought out and laid down process, which was subsequently upheld right up to the highest court of the land," it added.
Multi-national companies mainly in the pharmaceuticals sector have raised concerns of India issuing CL.
In a submission made last month by USIBC to the Office of the US Trade Representative, it had said: "Despite CL denials, industry continues to be concerned by the potential threat of compulsory licensing. The Government of India has privately reassured... (that) it would not use Compulsory Licenses for commercial purposes".
