The Commerce Ministry statement comes weeks after Reuters and media
in India quoted the U.S. business advocacy group, U.S.-India
Business Council (USIBC), as saying India had given private
assurances that it would not grant such "compulsory licenses".
"There have been recent media reports that the Government of India
has privately assured that it will not issue any more compulsory
licenses. It is hereby clarified that such reports are factually
incorrect," the ministry said in the statement late on Tuesday.
"In this regard, it may be noted that India has a well-established
TRIPS compliant legislative, administrative and judicial framework
to safeguard IPRs (intellectual property rights). 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."
India is party to TRIPS, or the Trade-Related Aspects of
Intellectual Property Rights, a World Trade Organization agreement
that sets down minimum standards for intellectual property
regulation.
The USIBC's comments were revealed in a submission it made last
month to the U.S. Trade Representative (USTR), which is reviewing
global intellectual property laws for an annual report identifying
trade barriers to U.S. companies.
The USTR has placed India on its "priority watch" list for two years
in a row, saying the country's patent laws unfairly favor local drug
makers. A legal provision that allows granting of "compulsory
licenses" has been a key bone of contention.
India can grant such licenses under certain conditions, such as
public health emergencies, to ensure access to affordable medicines.
It granted the first such license in 2012, allowing local firm Natco
Ltd to sell a copy of German drugmaker Bayer's cancer medicine
Nexavar at a tenth of the price.
Since that ruling, big Western pharmaceutical companies have
criticized India's patent law and lobbied for it to be changed.
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The medical charity Medecins Sans Frontieres (MSF), which banks on
India's robust generic drugs industry to supply cheap medicines to
many parts of the world, weighed in last week saying it was "deeply
concerned" about the USIBC's submission.
"Such a commitment will encourage multinational drug companies to
start charging unaffordable prices to Indian patients and
governments across the developing world, further undermining access
to critical, and life-saving products," MSF said.
India's commerce ministry statement did not comment directly on the
USIBC's submission.
"Even as government of India is conscious of the need to spur
innovation and protect individual rights, it retains the sovereign
right to utilize the flexibilities provided in the international (IP
rights) regime," the ministry said.
"It may be noted that to date, there has been only one case of
compulsory license in India 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."
(Reporting by Zeba Siddiqui in Mumbai; Editing by Nick Macfie)
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