Patients’ rights groups warned on Wednesday that the Centre’s plans to introduce "data exclusivity" provisions into Indian drug regulations will delay the launch of new generic medicines and adversely impact access to affordable drugs if implemented.

The concerns have emerged amid what the groups have described as “signals” from both India’s apex drug regulatory authority and the Union commerce and industry ministry favouring the incorporation of data exclusivity into Indian drug regulations.

Data exclusivity will mean Indian drug-makers seeking to produce generic versions of new or off-patent medicines will need to generate their own data from clinical trials to demonstrate safety and efficacy of their products, disregarding data generated earlier by original drug makers.

Such a provision would “force generic manufacturers to either duplicate costly and ethically questionable clinical trials or wait years before entering the market", the Working Group on Access to Medicine and Treatment, a network of patients’ rights advocates, said in a statement.

Foreign drug makers in India have long sought regulatory data protection, asserting that it recognises the investments needed to generate the original clinical data.

The Central Drugs Standard Control Organisation (CDSCO), the regulatory authority, last month issued a notice flagging what it called “the lack of a level playing field” between the first company seeking approval to introduce a new drug into the country and companies that follow.

Under existing rules, only the first company must submit safety and efficacy data from clinical trials — evidence that industry executives say is expensive and time-consuming.

Later entrants need to show only that their product is bioequivalent to the original drug, without repeating the clinical trials.

As a result, the CDSCO said, the regulatory burden on later entrants is "much lower as they are not required to conduct clinical trials". The agency has invited comments from stakeholders on possible changes.

Union commerce and industry minister Piyush Goyal said at a public event last month that the Swiss state secretary for economic affairs Helene Budliger Artieda had indicated that Switzerland would consider foreign direct investment of $150 billion once India finalises a data exclusivity provision in its drug regulations.

The Working Group on Access to Medicines said the push for data exclusivity appears driven by external commercial pressures rather than by India’s public health needs.

“Data exclusivity offers no public interest benefit — its only real effect is to delay generic entry and jeopardise the future of India’s generic pharmaceuticals industry,” Biswajit Dhar, a trade economist and former professor at Jawaharlal Nehru University, said in a statement.

“Introducing data exclusivity would place an even greater burden on patients who are already paying high prices for essential medicines,” Dhar said.

Multiple patients’ rights groups have also urged the Union health ministry, in a November 20 letter, to reject demands for data exclusivity, saying such a provision would block early entry of affordable generic medicines.

They have argued that the current absence of data exclusivity has sped up access to cheaper drugs, citing risdiplam for spinal muscular atrophy. The originator version approved by the CDSCO in 2021 cost ₹600,000 per bottle, while a generic priced at ₹12,000 received approval in 2025. If data exclusivity had been in place, they said, the generic would likely have been delayed for years.

But sections of industry have earlier cited challenges in creating original products.

“Drug discovery is a long, expensive and risky path,” the Organisation of Pharmaceutical Producers of India (OPPI), a body representing foreign drug makers, said in an August 2024 document. It noted that fewer than 14 per cent of drug candidates entering safety trials gain regulatory approval and that successful ones can take 10 to 25 years and about $2.5 billion to reach the market.

Industry executives who support data exclusivity have argued that without such a provision, generic manufacturers can enter the market without conducting their own clinical trials.