US industry body says India agreed to not issue ‘compulsory’ drug licences

Mumbai, March 9

India has given private assurances that it will not grant licences allowing local firms to override patents and make cheap copies of drugs by big western drugmakers, a US business advocacy group said.

The comments were revealed in a submission last month by US-India Business Council (USIBC) to the US Trade Representative (USTR), which is reviewing global intellectual property laws for an annual report identifying trade barriers to US companies.

USTR has placed India on its ‘priority watch’ list for two years in a row saying India’s patent laws unfairly favour local drugmakers. A bone of contention has been a legal provision that allows the overriding of patents on original drugs and granting of ‘compulsory licences’ to local firms to make cheaper copycat medicines.

India can grant such licences under certain conditions, such as public health emergencies, to ensure access to affordable medicines. It granted the first such licence in 2012, allowing local firm Natco Ltd to sell a copy of German drugmaker Bayer’s cancer medicine Nexavar at a 10th of the price.

Since that ruling, big western pharmaceutical companies have criticised India’s patent law and lobbied for it to be changed.

In its submission to USTR, a copy of which was seen by Reuters, USIBC said the Indian government ‘privately reassured’ the group it would not grant such licences to firms for commercial purposes.

The Indian government has made no such statements publicly. Officials have said they are committed to protecting the interests of patients.

Commerce Minister Nirmala Sitharaman, her joint secretary in charge of pharmaceuticals, and USIBC did not respond to requests for comment. Under PM Narendra Modi, India has been undertaking a review of its intellectual property policy. A revised policy is due to be released imminently.