Days ahead of Budget 2026, the Union Health Ministry amended the New Drugs and Clinical Trials (NDCT) Rules (2019) to “reduce the regulatory burden” and enable faster clinical research and development in the country.
These amendments simplified regulatory processes, collapsed approval timelines and “dispensed with” the requirement of prior permission for low-risk bioavailability/ bioequivalence (BA/BE) studies.
But this was just a trailer. Three days later, the Finance Minister’s Budget speech spoke of creating a network of 1,000 accredited clinical trial sites across the country, besides strengthening the central drug regulatory authority — the Central Drugs Standard Control Organisation — to meet global standards and approval time-frames through a dedicated scientific review cadre and specialists.
The announcements injected enthusiasm into the clinical trial industry, which has been ambling alongside the pharmaceutical industry.
Never in recent memory have clinical trials got a mention in the Union Budget, straight off the bat, in a sense, they point out. Public health advocacy groups, meanwhile, stress the need to keep the patient/ subject’s voice at the heart of these discussions, which, they worry, is not being done enough.
Echoing the industry’s upbeat sentiment, Anirban Roy Chowdhury, General Secretary, Indian Society for Clinical Research (ISCR), points out: “For the first time ever in the Union Budget, within the first five or 10 minutes, clinical research, drug development… has been mentioned.” The Centre’s acknowledgment of the need for more clinical trial sites recognises the industry as the backbone of drug development, he adds.
This, alongside strengthening the regulatory body and the National Institute of Pharmaceutical Education and Research would bolster translational science and help bring concepts to market faster, he adds. Besides global clinical trials, this would help local biopharma companies, med-tech, and digital health companies/ startups that need clinical evaluation for their products, he explains.
While industry awaits a clear roadmap on these announcements, Chowdhury says states like Uttar Pradesh are already making announcements on having about 200 sites.
Innovations base
Connecting the dots between collapsed approval timelines, trial sites and enhanced government funding for biopharma, Dr Chirag Trivedi, Global Clinical Early Operational Strategy Head, Sanofi, and ISCR executive committee member, observes that it would help build India as a base for innovative research. He recalls the Indian Council of Medical Research’s announcement, in 2024, on creating a network of institutes to improve clinical research focused on certain diseases. With participation from organisations such as the ICMR, All India Institute of Medical Sciences and KEM, for example, a strong human resources base can be developed, he says, responding to a query on existing shortage of clinical trial investigators and experts for ethics committees.
Dr Jogin Desai, Co-founder and Chief Executive with Eyestem, a cell therapy company, says the trial sites announcement, along with the Research Development and Innovation (RDI) fund, were a healthy push for innovation, with the quality mindset. Eyestem undertakes trials in India for age-related dry macular degeneration, a global unmet medical need. As RDI grants get underway and other processes are implemented, it is a journey in the right direction, he says, adding that the ecosystem should ensure the patient’s decision-making is not “clouded” by any other factor.
Stringent monitoring
The clinical trial segment has come a long way, under the watch of the Supreme Court (SC), which had clear directions to protect patients through informed consent, registration of institutional ethics committees, and other stringent measures.
Amulya Nidhi of Swasthya Adhikar Manch (SAM), a non-profit advocating for safe clinical trials, calls for stringent monitoring of ongoing trials, including consent practices, recruitment of patients/ subjects, and compensation for adverse events. Messaging apps are used to call for healthy volunteers for a small payment, he alleges. SAM is a petitioner in the SC clinical trials case. Instead of adding trial sites, upgrade public hospitals as research centres, he says, so the overall hospital facilities improve. Besides, he adds, clinical research should address unmet medical needs in the country.
ISCR’s Chowdhury observes that the regulatory framework is stringent with features like audiovisual recordings of informed consent, provision for the regulator to debar investigators, and an ethics committee. The law has a ‘carrot-and-stick’ approach, with incentives for doing things right, besides deterrents, he says, adding that the patient’s voice is increasingly being heard through advocacy groups and joint meetings with industry representatives.
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Published on February 9, 2026