India will not go against the interests of its generic drugs industry in any of the Free Trade Agreements (FTA) it is negotiating with its partner countries, and has rejected the demand for ‘data exclusivity’ provision in the free trade pact with the European Free Trade Association (EFTA) bloc, a senior government official has said.

“The EFTA wanted that data exclusivity should be included in the proposed FTA with India. But India rejected the demand. We are with our generic industry,” Commerce Secretary Sunil Barthwal said in an interaction with the media on Thursday. The EFTA group includes Iceland, Liechtenstein, Norway and Switzerland.

The Commerce Secretary’s comment will come as a relief for the Indian generic industry especially because the country is in advanced stages of negotiating an FTA with the UK and is also carrying on parallel talks with the EU. Both want India to go beyond the commitments made in the multilateral TRIPS (Trade Related Intellectual Property Rights) agreement and grant more concessions to pharma biggies.

“There is no fear for generic industry in India. It is our important objective for country as a whole to see that generic drug industry flourishes. They are contributing significantly to our growth. They are also growing. So, we are there to protect the interest of generic drug industry throughout. There is no FTA agreement where we will go against the interests of generic drug industry,” Barthwal said.

Data exclusivity clause

Data exclusivity protects the clinical trial data of a pharmaceutical company for a particular drug. Generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator’s data for a specified number of years. Therefore, data exclusivity lengthens the monopoly for the original drug, and hits generic drug manufacturers.

Data exclusivity is not mandatory under TRIPS Agreement and India laws do not provide for it.

India is the largest supplier of generic medicines. It manufactures about 60,000 different generic brands across 60 therapeutic categories and accounts for 20 per cent of the global supply of generics, according to government figures. Access to affordable HIV treatment from India is one of the greatest success stories in medicine.