Has India informally agreed to make changes in its Intellectual Property Rights regime on the basis of US concerns? A sizeable section of the Indian pharmaceutical industry and some pro-health groups are worried that it has, following US Trade Representative Ambassador Michael Froman’s testimony to the Senate Committee on Finance less than a fortnight ago.

On January 27, Froman, in a written statement, said engagement between the two countries had helped “secure commitments from India in the 2014 Trade Policy Forum on a broad range of IP issues of concern to the US and its stakeholders.”

Industry worried Commenting on the development, DG Shah of the Indian Pharmaceutical Alliance, which represents large domestic Indian drug companies, said: “We are at a loss to understand, and are unaware on what has been committed. But when Ambassador Froman makes a statement to the Senate committee under oath, the Indian government needs to clarify what these commitments are.”

The controversy has erupted as India is in the midst of finalising a new policy on intellectual property rights.

After her meeting with US Commerce Secretary Penny Pritzker, Commerce and Industry Minister Nirmala Sitharaman had told the media: “We have invited the Americans to look at the draft policy (on IPR) and give their inputs. We will then see what we can do with it.”  Pritzker was part of President Obama’s delegation on his India visit.

On the face of it, the Centre’s position that Indian laws are already fully TRIPS compliant would rule out any major concessions to the US pharmaceutical lobby, which has been pressuring the American government to push for TRIPS-plus measures. TRIPS is short for Trade-Related Aspects of Intellectual Property Rights.

The US lobby is unlikely to make much headway with one of its main concerns – Section 3 (d) of the Indian Patent Act, which prohibits evergreening — given that India’s Supreme Court has upheld the constitutional validity of the provision, which prevents patenting of new forms of known substances unless they exhibit enhanced efficacy.

Anand Grover, former UN Special Rapporteur on the Right to Health and Director of Lawyers Collective, is concerned that India may be considering making concessions relating to data exclusivity and patent linkages. “From sources, it appears that the Centre is considering bringing these in through administrative measures. It must make its stand public and not do anything without parliamentary approval.”

Data exclusivity and patent linkage (see info-box) delay the entry of inexpensive generic medicines in the market, leaving the market open to high monopolistic pricing.

Different views? However, a top government official involved with bilateral talks during the Obama visit and a witness at the CEO forum the dignitaries addressed says that India has conveyed to the US that they were on different tracks on the IP issue.

The Prime Minister’s statement on accepting IP suggestions meant that India was ready to correct or rectify loopholes or loose ends in the implementation of the law. But India is not changing the law, the official said, adding emphatically that there was no softening of India’s stand on data exclusivity or patent linkages. 

 In fact, the official added, India was taking a cue from China in keeping the US at bay.

Deepak Parekh, another participant in the CEO forum, had told BusinessLine at the time that only piracy and counterfeiting had been discussed.

Public health concerns But pro-health groups have been cautioning that India is under pressure on the flexibilities it had been allowed and exercised under the TRIPS agreement.

 “All these flexibilities (such as opposition procedures, compulsory licences) are now under attack by the US government at the behest of their industry,” a Lawyers Collective note alleged, apprehending that India may adopt a TRIPS-plus IP regime.

 Last year, the US’ Special 301 report (on IP) stopped short of further downgrading India, though it called for “out of cycle” reviews. The year also saw trade-related investigations by the US International Trade Commission.

With inputs from Amiti Sen and Richa Mishra in New Delhi