Civil society groups push back as govt agencies mull data exclusivity in drug rules

drugs

Patient groups and public health advocates have urged the government to abandon any proposed data exclusivity provisions out of drug regulatory framework to safeguard access to affordable medicines.

Civil society groups, in a letter to Health Minister J.P. Nadda and Commerce Minister Piyush Goyal, urged the government to reject the proposal, arguing it would extend monopolies beyond the 20-year patent term and inflate drug prices. They cited Jordan’s experience under a U.S. trade pact, where 79% of drugs without patent protection faced no generic competition due to DE.

Association of the Persons Living with HIV & AIDS, Jan Swasthya Abhiyan, National Coalition of People Living with HIV in India, Positive Women Network and Third World Network – India, among others, who wrote a letter to the government.

“Data exclusivity offers no public-interest benefit. Its only real effect is to delay generic entry and jeopardize India’s generic industry,” said Biswajit Dhar, former professor at Jawaharlal Nehru University.

The letter alleged that DPIIT and CDSCO are exploring data exclusivity provisions that would prevent regulators from relying on existing clinical trial data to approve generics or biosimilars.

Critics say this would create de facto monopolies for multinational drugmakers, forcing domestic firms to replicate costly trials or wait years before launching cheaper alternatives.

The debate intensified after Commerce Minister Goyal suggested India could attract $150 billion in investments from European Free Trade Association (EFTA) nations by adopting DE—a claim activists dismiss as misleading. They argue there’s no evidence linking DE to foreign direct investment inflows.

Advocates point to risdiplam, a spinal muscular atrophy drug priced at Rs.6.2 lakh per bottle by Roche.

A generic version launched this year at Rs 15,900 — 95% cheaper — due to India’s current bioequivalence-based approval system. “Had DE been in place, this affordable version would have been delayed for years,” said Dr. Purva Mittal, an SMA patient and activist.

Data exclusivity is intended to protect the innovator company's investment in research and development by preventing generic manufacturers from using innovator's data for a limited period, even if patents have expired or are invalid.

India has resisted data exclusivity for decades, even in trade talks with the EU and Japan, citing its TRIPS-compliant IP regime. Introducing DE now, public health activists warn, could erode policy space and weaken India’s leadership in supplying HIV, TB, and cancer drugs to developing nations.