After years of futile attempts, will global pharma majors finally succeed in getting India agree to introduce data exclusivity or similar provisions in the country’s drug regulatory framework to provide an additional protection to the ‘data’ innovative pharma firms generate to obtain marketing approvals for new drugs in India?

Well, two unrelated developments – one a recent communication from Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) and the other, a public statement by Union Commerce Minister Piyush Goyal, have triggered a fresh round of buzz over its possibility, at least among civil society groups that are consistently opposed to such amendments. The groups allege that introduction of data exclusivity provisions will delay the entry of affordable generic medicines and severely restrict access to lifesaving treatments in India and across the world.

In a letter to Health Minister J P Nadda and Commerce Minister Goyal on November 20, the groups said that the introduction of data exclusivity provisions will extend pharmaceutical monopolies beyond the 20-year patent term, and seriously undermine India’s ability to produce affordable medicines, and its established position as the “pharmacy of the world.”

The incidents that triggered the discussion was a CDSCO notice on October 8 on “Ensuring a Level Playing Field in New Drug Approval in India,” that hinted at the possibility of introducing data or market exclusivity provisions and a public statement made by commerce minister Goyal where he quoted a Swiss official as suggesting that India could attract $ 150 billion in investments from the European Free Trade Association (EFTA), if it adopted data exclusivity.

The letter explained that data exclusivity provisions prevent drug regulators from referring to or relying on the clinical trial and other related data of an originator company to approve any generic version of the same drug molecule for a certain period of time. “In other words, these provisions grant de facto monopoly to the originator companies during the period its data cannot be referred to. Usually, restrictions imposed by data exclusivity apply even in the absence of patent monopolies or when patents are invalid or unmeritorious. In effect, data exclusivity provisions allow large pharmaceutical companies to earn supernormal profits at the expense of people’s health”, the letter said.

The groups also illustrated the problem they foresee through an example: “On January 20, 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 April 7, 2025 and was launched on October 8 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 said.

The groups also emphasised that data exclusivity is not required under the TRIPS Agreement of the World Trade Organisation. “For the past three decades, India has rigorously implemented the TRIPS Agreement, which sets the multilaterally agreed standards on intellectual property protection, in both its letter and spirit. It has, therefore, consistently and justifiably resisted introduction of provisions like data exclusivity while negotiating bilateral trade agreements, with the European Union, Japan, and most recently with the European Free Trade Association (EFTA). Incorporating these provisions in India’s regulations, would weaken the policy space successive governments have worked hard to preserve, weathering all odds”, the letter pointed out.

The signatories of the letter to the ministers include the Association of the Persons Living with HIV & AIDS, Jan Swasthya Abhiyan, Third World Network- India and over a dozen others.