Civil society groups have sounded a sharp warning against what they describe as a "dangerous move" by the Union government to introduce data exclusivity (DE) provisions into India's drug regulatory framework. They say the proposal could delay access to affordable medicines, weaken India's generic industry, and undermine its role as the 'pharmacy of the world'.
In a statement issued on Wednesday, the Working Group on Access to Medicines and Treatment said the Department for Promotion of Industry and Internal Trade (DPIIT) and the Central Drugs Standard Control Organisation (CDSCO) are considering amendments that would bar the regulator from relying on existing clinical trial data to approve generic or biosimilar drugs. Such a shift, it warned, would effectively create "parallel monopolies" even after patents expire, as generic manufacturers would be forced to repeat costly and ethically fraught trials or wait years to enter the market.
The press release notes that the push appears tied to commercial overtures from foreign governments. Recent comments by the Union commerce and industry minister cited Swiss suggestions that India could attract $150 billion from the European Free Trade Association (EFTA) if it adopted data exclusivity. However, public-health experts argue that this narrative is misleading and ignores the lack of evidence linking DE with higher foreign investment.
"Data exclusivity offers no public-interest benefit," said Biswajit Dhar, trade economist and former Jawaharlal Nehru University professor. "Its only real effect is to delay generic entry and raise medicine prices beyond the reach of most citizens. We examined these arguments two decades ago… the evidence has not changed. What has remained constant is the push by multinational corporations to secure control through mechanisms outside the patent system."
Patients' groups also stressed that the consequences would be immediate and devastating. Citing her own experience accessing treatment for Spinal Muscular Atrophy (SMA), public health activist Dr Purva Mittal pointed to Risdiplam, initially priced at over ₹6 lakh a bottle by Roche, whose generic version now costs about ₹12,000. "Had data exclusivity been in place, this affordable version would have been delayed for years," she said, calling DE "a direct threat to the survival of many people like us."
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Experts emphasise that data exclusivity is not required under the WTO's TRIPS Agreement, and India has consistently rejected such provisions in negotiations with the EU, Japan and EFTA. A recent CDSCO notice on 'Ensuring a level playing field in new drug approval,' has raised concerns that the government is now reconsidering this position.
Leena Menghaney, public health lawyer, said that the introduction of DE "would mark the beginning of the end of India as the pharmacy of the world. It betrays millions in the Global South, who depend on Indian medicines and contradicts India’s stated global-health leadership."
The working group urged the Union health ministry to intervene and reject any move toward data exclusivity, warning that it would not only delay access to newer treatments but also erode the technological capabilities of India’s domestic pharmaceutical sector.
