India's Commerce Ministry has shot down claims by the U.S.-India Business Council that compulsory licenses for drugs are a thing of the past.
Press Trust of India reports that the government's rumored private assurances to a lobby group representing U.S. business stating it will not issue any more compulsory licenses were not correct.
"It is hereby clarified that such reports are factually incorrect. In this regard, it may be noted that India has a well-established TRIPS (Trade Related aspects of Intellectual Property Rights) compliant legislative, administrative and judicial framework to safeguard IPRs," the ministry said in a statement carried by Press Trust of India.
"Under the Doha Declaration on the TRIPS Agreement Public Health, each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted."
Talk of an informal agreement surfaced this month that put Indian drugmakers and the U.S. trade representative on watch for policy signals on compulsory license applications pending that include Bristol-Myers-Squibb's ($BMY) dasatinib (Sprycel), and Onbrez respiratory treatment from Novartis ($NVS) after no such approvals were granted in 2015.
Dilip Shah, secretary general of the Indian Pharmaceutical Alliance that represents domestic firms had earlier called on the government to "confirm or deny" the informal arrangement.
Médecins Sans Frontières had also criticized the implications of stopping compulsory licenses in India, saying it would hit access and costs for the poor.
India's Patent Office, backed by rulings on appeals by the India Supreme Court, has granted notable compulsory licenses, including on Novartis cancer drug Glivec/Gleevec under Section 3(d) of the Indian Patent Act (1970).
It has as well denied such applications as it did recently with Onglyza (saxagliptin) from AstraZeneca ($AZN), rejecting case filed by Hyderabad-based Lee Pharma.
The issue however has vexed multinational firms and led to concern in India that access to innovative drugs may suffer and that companies would shun manufacturing in the country.
Press Trust of India said the Commerce Ministry noted that "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."
- here's the Press Trust of India story