The government’s plans to introduce data exclusivity provisions in the country’s drug regulatory framework pose a risk to the generics market, and could likely create monopolies in the pharma sector, an advocacy group said on Wednesday.
The Working Group on Access to Medicines and Treatment (WGAMT) said that the Department of Promotion of Industry and Internal Trade (DPIIT) and the Central Drugs Standard Control Organisation (CDSCO) are considering to introduce data exclusivity (DE) provisions which could delay access to lifesaving generic medicines, adversely impact the availability of affordable medicines, and threaten India’s position as the world’s leading supplier of affordable medicines.
Balancing global investment with public health access
As reported by FE earlier, last month, the central drugs controller issued a notice inviting public comment on “Ensuring a Level Playing Field in New Drug Approval in India”. Around the same time, the commerce and industry minister Piyush Goyal quoted Swiss State Secretary for Economic Affairs Helene Budliger Artieda as suggesting that India could attract $150 billion in investments from the European Free Trade Association (EFTA), if it adopted data exclusivity.
Why data exclusivity creates de facto monopolies
WGAMT also said that the data exclusivity would prevent India’s drug regulator from relying on existing clinical trial data to approve generic or biosimilar versions of medicines. “This would force generic manufacturers to either duplicate costly and ethically questionable clinical trials or wait years before entering the market, effectively creating de facto monopolies for multinational pharmaceutical corporations,” it said.
“For three decades, India has consistently resisted data exclusivity provisions in bilateral trade negotiations with the EU, Japan, and EFTA while rigorously implementing TRIPS obligations. India’s leadership in rejecting such harmful provisions has enabled millions of people across the developing countries to access affordable treatments,” said K.M. Gopakumar, co-convener, WGAMT.
Last week, the WGAMT wrote a letter to the Union Health and Family Welfare minister J P Nadda and Goyal to safeguard access to affordable medicines. In the letter, it said that data exclusivity provisions would extend pharmaceutical monopolies beyond the 20-year patent term, thus delaying the entry of affordable generic medicines and severely restricting access to lifesaving treatments in India and across the world.
As per the group, the current regulatory framework provides a fine balance between ensuring safety and promoting timely access to affordable medicines. For instance, the first applicant establishes safety and efficacy through clinical trials while the subsequent applicants rely on scientifically rigorous bioequivalence (BE) studies to seek regulatory approval. This approach, aligning with international regulatory norms, prevents duplication of clinical trials.
Data exclusivity is a regulatory shield given to new drugs that prevents drugmakers from using clinical trial data of the innovator company for a period of 5-10 years post the expiry of the drug patent. This protection mechanism is given to the innovator company to help recover the cost of developing a novel drug. Indian authorities have thus far denied data exclusivity as it is feared that it will make “ever-greening” of patents easier, besides undermining the generic industry.
While citing an example, the group said that on 20th January 2021, CDSCO granted approval to the originator company for Risdiplam oral solution, which was priced at Rs 6,20,000 per bottle. The generic version with maximum retail price of Rs 15,900, received marketing approval on 7th April 2025 and was launched on 8th October 2025 following a court order. “Had data exclusivity been in place, the generic version, which is more than 95% cheaper, would have been approved after several more years, denying a sizeable section of the population access to treatment,” the letter stated.
Meanwhile, the advocacy group members said that data exclusivity is not required under World Trade Organisation’s agreement Trade Related Aspects of Intellectual Property (TRIPS).
