Healthcare activists added that data exclusivity would prevent India’s drug regulator from using existing clinical trial data to approve generic or biosimilar versions of medicines. Image for representation.
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As the Central Drugs Standard Control Organisation (CDSCO) considers introducing data exclusivity provisions into India’s drug regulatory laws, healthcare activists warned that the move could delay access to lifesaving generic drugs, reduce the availability of affordable medicines, and threaten India’s position as the world’s leading supplier of such drugs.
They added that data exclusivity would prevent India’s drug regulator from using existing clinical trial data to approve generic or biosimilar versions of medicines.
Members of Indian civil society organisations, patient groups, and concerned individuals working on public health and access to medicines have written to the Union Ministries of Health and Commerce, seeking to keep data exclusivity provisions out of India’s drug regulatory framework.
‘Don’t extend pharma monopolies’
In their letter, they said they are not opposed to the inflow of foreign investments in the pharmaceutical sector but cautioned that the introduction of data exclusivity would seriously undermine India’s ability to produce affordable medicines.
“Data exclusivity provisions would, in effect, 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. We would also like to point out that there is no evidence of any link between foreign direct investment inflows and introduction of data exclusivity provisions in any jurisdiction,’’ the activists said.
They pointed out 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.
“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,’’ they said in the letter.
‘Will delay generic entry’
The push for data exclusivity appears to be driven by external commercial interests rather than public health needs, noted activists, adding that recent statements by the Ministry of Commerce and Industry referenced suggestions from Swiss officials that India could attract ₹150 billion in investments from the European Free Trade Association (EFTA) by adopting data exclusivity.
“However, this framing dangerously misrepresents both India’s international obligations and the evidence on foreign direct investment,’’ the group said.
Biswajit Dhar, trade economist and former Professor at Jawaharlal Nehru University, said that data exclusivity offers no public-interest benefit. Its only real effect is to delay generic entry, jeopardising the future of India’s generic pharmaceutical industry, which is widely known as the pharmacy of the world.
‘Threat to survival’
Purva Mittal, a health activist living with Spinal Muscular Atrophy (SMA), added that before pharmaceutical giant Roche’s drug risdiplam was approved by the Indian regulator, it was priced at over ₹6 lakh a bottle.
“The only reason we have a generic today priced at ₹12,000 a bottle is because India’s regulatory system allows timely approval based on bioequivalence. Had data exclusivity been in place, this affordable version would have been delayed for years, denying countless SMA patients access to this life-saving treatment. Data exclusivity will not be just a technical tweak; it will be a direct threat to the survival of many people like us,” she said.
The activist added that data exclusivity is not required under the World Trade Organisation’s agreement on Trade Related Aspects of Intellectual Property (TRIPS). “Currently, there is no international obligation on India to introduce data exclusivity,’’ said public health lawyer Leena Menghaney.
Published – November 26, 2025 07:42 pm IST
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