By Gunjan Bagla, Amritt Inc.
Extensive reforms to India’s clinical trial rules are slashing approval timelines in half and eliminating licenses that once took months to obtain — signaling a new era for pharmaceutical and drug development companies with India in their strategy.
For years, one of the most consistent frustrations cited by foreign pharmaceutical companies operating in India was the regulatory clock. Test licenses took months. Bioequivalence studies stalled at the permission stage. Clinical trial applications queued for 90-day reviews. India’s CROs have the science and the workforce, but the paperwork slowed everything down. In my own experience, some Amritt clients diverted critical studies away from India to other locations primarily due to such delays. One VP of product development joked with me that the approval delays reminded him of the extended traffic jams in Bangalore.
That calculus has now changed.
In January 2026, India’s Ministry of Health and Family Welfare published sweeping amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 — the governing framework for drug development and clinical research administered by the country’s Central Drugs Standard Control Organization (CDSCO) under the Drugs Controller General of India (DCGI). The amendments are now in effect, and their impact on the country’s pharmaceutical ecosystem is already being felt. According to the CDSCO Gazette Notifications, “the drug development life cycle will see a minimum saving of 90 days.”
From Licenses To Notifications
The centerpiece of the reform is a deceptively simple shift: replacing the requirement for a formal test license with an online “prior-intimation” mechanism for most low-risk drug development and manufacturing activities. Under the previous rules, any company wishing to produce small quantities of a new or investigational drug — for research, nonclinical testing, analysis, or bioequivalence studies — had to apply for and obtain a test license from CDSCO before work could begin. This process could take weeks or months and applied even to straightforward, low-risk activities.
The 2026 amendment, formalized through India’s Gazette Notification G.S.R. 46(E) dated January 20, 2026 (similar to the American Federal Register), replaces this with a streamlined notification system. Companies submit an online intimation through the National Single Window System (NSWS) and upon receiving acknowledgment, they may proceed. No formal approval. No waiting for a license to be issued. Once the regulator is informed, work can begin.
BA/BE Studies: A Bottleneck Removed
Bioavailability and bioequivalence (BA/BE) studies sit at the heart of India’s generics powerhouse. A large share of generic drug approvals — whether targeting the domestic market or the U.S. FDA, the European Medicines Agency, or other global regulators — requires BA/BE data demonstrating that the new product performs equivalently to the reference listed drug. India conducts thousands of these studies every year, making it one of the world’s leading hubs for this category of research.
Under the previous framework, even low-risk BA/BE studies required prior regulatory permission from CDSCO before they could commence. The 2026 amendment eliminates this requirement for specified categories. Companies may now initiate these studies on the basis of a simple online intimation — the same notification mechanism described above. CDSCO estimates it processes as many as 4,500 BA/BE applications annually; the new regime is expected to substantially reduce delays across this high-volume pipeline.
It is worth noting what has not changed. High-risk drug categories — including sex hormones, cytotoxic drugs, beta-lactam antibiotics, biologics containing live microorganisms, and narcotic and psychotropic substances — continue to require prior regulatory approval. The reform is explicitly risk-proportionate: lighter regulation for lower-risk activities and maintained oversight where the stakes are higher.
Timelines Cut In Half
For the categories where test licenses remain mandatory, the 2026 amendment delivers a separate but significant improvement: the statutory processing timeline has been reduced from 90 working days to 45 working days. This is not a target or an aspiration — it is a statutory deadline binding on the regulator. For sponsors working on accelerated development timelines, rare disease programs, or competitive generic launches, this change alone represents a material shift in planning assumptions.
The Ministry has indicated that across the full drug development life cycle, the combined effect of these changes represents a minimum saving of 90 days. For an industry where time-to-market drives billions of dollars in competitive advantage, that number commands attention. For venture-funded startups the accelerated timelines mean higher valuations for future funding rounds and sometime their very survival.
Digital Infrastructure To Match
Regulatory reform without implementation infrastructure has derailed previous Indian initiatives. The Ministry appears to have anticipated this. Dedicated online modules on the NSWS portals are being deployed to handle the new workflows, enabling companies to submit notifications, track acknowledgments, and maintain compliance records electronically. The digitization also creates audit trails and reporting obligations that preserve regulatory visibility even as the up-front approval burden is reduced — a meaningful concession to those concerned that faster processing could compromise oversight quality. In my experience there might be some initial snags in this process, but the streamlining should begin to show consistency very soon.
What’s Still Ahead
Two additional reform proposals published in February 2026 remain in draft and have not yet been enacted. The first, G.S.R. 97(E), proposes a structured, risk-based framework for handling post-approval manufacturing changes — classifying them into tiers that determine whether prior approval is required, similar to the ICH Q12 framework familiar to multinationals. The second, G.S.R. 98(E), targets the ethics committee registration process, proposing to eliminate the current two-step provisional-then-final registration in favor of direct final registration upon satisfactory document review. Both would, if enacted, further reduce friction for companies running multisite clinical trials in India.
What It Means For Life Sciences Companies Looking At India
India has long been an attractive proposition for pharmaceutical R&D — it has deep scientific talent, a large patient population, established CRO infrastructure, and cost structures that can be a fraction of Western equivalents. What has historically complicated the picture is regulatory unpredictability: not just the rules themselves but the time it takes to navigate them.
The 2026 NDCT amendments address that directly. For a company evaluating India as a site for Phase 1/2 studies, nonclinical work, BA/BE programs, or manufacturing partnerships, the practical effect is faster study initiation, reduced regulatory carrying costs, and a more competitive timeline relative to other global clinical research destinations.
The Ministry framed the initiative explicitly within India’s Ease of Doing Business agenda and the principles of the Jan Vishwas Siddhant or Principle to Engender Public Confidence — a trust-based regulatory philosophy that reduces presumptive requirements on lower-risk actors while maintaining rigorous oversight where it is genuinely warranted. That framing matters: it suggests these reforms reflect a durable policy direction rather than a one-off concession.
India’s regulator is signaling that the country wants to compete more aggressively — not just on cost but on speed. For pharma companies weighing where to place their next R&D bet, that signal is worth taking seriously.
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About The Author:
Gunjan Bagla is CEO of Amritt, Inc., a California-based consulting firm that helps Western companies do business in India. Organizations that have benefited from Amritt’s expertise include Becton Dickinson (BD), Biocom California, Combe, Clorox Healthcare, Johnson & Johnson, iHealth, and Roche. He writes about India for the Harvard Business Review and for Med Device Online. He holds a mechanical engineering degree from the Indian Institute of Technology Kanpur and an MBA with honors from Southern Illinois University, Edwardsville. Gunjan is a frequent speaker on subjects relating to India’s healthcare, biotech, and medical device ecosystem. You can reach him on LinkedIn.