Introduction
In January 2026, the Ministry of Health and Family Welfare introduced amendments to the New Drugs and Clinical Trials Rules, 2019 through the New Drugs and Clinical Trials (Amendment) Rules, 2026 and the New Drugs and Clinical Trials (Second Amendment) Rules, 2026 (collectively, the “2026 Amendments”).
The 2026 Amendments introduce a ‘prior intimation’ mechanism for certain regulatory activities relating to bioavailability/bioequivalence (“BA/BE”) studies and the manufacture of drugs for analytical and non-clinical testing. Under this framework, certain specified activities may proceed upon intimation to the regulatory rather than requiring prior approval. In addition, for activities that continue to require regulatory approval, the 2026 Amendments reduce the approval timelines for manufacturing drugs for clinical trials or BA/BE studies from 90 days to 45 days.
The amendments appear intended to streamline regulatory processes for certain low-risk activities, while continuing to maintain regulatory oversight over higher-risk clinical research activities.
These changes may therefore, have practical implications for sponsors and clinical research organizations that conduct clinical trials and BA/BE studies on behalf of sponsors (“CROs”), and for investors evaluating India as a destination for clinical research and contract manufacturing.
These changes also come at a time when India is seeking to strengthen its position as a competitive jurisdiction for clinical research and pharmaceutical manufacturing within global development and supply chains.
This article examines the amendments, outlines the shift in India’s regulatory approach under the NDCT Rules, and considers their implications for clinical research and the pharmaceutical industry.
Analyzing the Policy Shift
The 2026 Amendments introduce a limited departure from the earlier regulatory approval model by introducing a prior intimation route for certain specified activities (“Prior Intimation Route”). Under this framework, applicants may proceed with specified activities upon filing an intimation to the Central Drugs Standard Control Organization (“CDSCO”) and receiving an acknowledgment, without requiring substantive prior approval.
The New Drugs and Clinical Trials (Amendment) Rules, 2026 (“First Amendment Rules”) introduce this Prior Intimation Route by amending Rule 52 of the NDCT Rules, which governs the manufacture of new drugs or investigational new drugs for clinical trials or BA/BE studies. Under the amended Rule 52, the manufacture of a new drug or investigational new drug intended for analytical and non-clinical testing may proceed upon submission of prior intimation in the prescribed form to the Central Licensing Authority and receipt of acknowledgement, instead of requiring prior permission.
However, the Prior Intimation Route does not apply to certain restricted category of drugs like sex hormones, cytotoxic drugs, beta-lactam compounds, biologics containing live microorganisms, and narcotic or psychotropic substances (“Restricted Categories”).
Where a drug falls within the Restricted Categories, or where manufacturing is intended for clinical use rather than analytical or non-clinical purposes, the traditional approval route continues to apply. However, even under the approval route, the regulatory timeline has been reduced from ninety working days to forty-five working days.
The New Drugs and Clinical Trials (Second Amendment) Rules, 2026 (“Second Amendment Rules”) extend the Prior Intimation Route to certain BA/BE studies, although within a narrower scope. To qualify for the prior intimation route, the BA/BE study must:
be conducted for export purposes
follow a standardized single-dose, two-period, two-sequence, two-treatment crossover design
involve normal healthy adult volunteers
have a minimum sample size of eighteen subjects
relate to drugs already approved in India or in specified jurisdictions, including the United States, the European Union, Japan, Australia, Canada, or the United Kingdom.
Drugs falling within the restricted categories described above, as well as drugs with narrow therapeutic indices or highly variable pharmacokinetics, remain outside the scope of this Prior Intimation Route framework.
Taken together, these amendments appear intended to introduce a more risk-based regulatory approach, under which relatively lower-risk analytical and export-oriented activities may proceed more efficiently while higher-risk clinical research activities continue to require prior regulatory scrutiny.
Implications for the Industry
Clinical research in India is frequently conducted through specialized service providers known as CROs, which undertake activities such as management of clinical trials, BA/BE studies, data collection, and regulatory documentation on behalf of pharmaceutical sponsors.
As a result, regulatory changes affecting the approval process for clinical research activities may have operational implications not only for sponsors but also for the CROs responsible for conducting such studies.
Greater Operational Responsibility for CROs
The shift toward an intimation-based framework may also have implications for CRO accountability.
Where regulatory approvals will no longer be the principal gatekeeping step for certain research activities, greater reliance will be placed on internal compliance processes, documentation standards and institutional governance adopted by CROs.
CROs may therefore need to ensure that their internal procedures and compliance systems are sufficiently robust to withstand potential post-hoc regulatory scrutiny, particularly where the prior intimation pathway is relied upon.
Sponsors evaluating CRO partners may also place greater emphasis on governance standards and compliance credibility, in addition to technical capability.
Effect on Sponsor Strategy
For both domestic and international sponsors, the amendments primarily address timing uncertainty rather than removing substantive regulatory requirements.
Under the earlier regulatory framework, even relatively low-risk activities were often planned conservatively in anticipation of regulatory approval timelines. This often resulted in delay of project initiation and affected the integration of Indian studies within global development programmes.
The introduction of the Prior Intimation Route together with shorter approval timelines, may allow sponsors to better align research initiation with manufacturing and development schedules.
For global pharmaceutical companies and generics manufacturers, this may make it easier to incorporate India-based studies within global development strategies and export-oriented supply chains.
Contractual and Transactional Considerations
Although these 2026 Amendments simplify certain regulatory procedures, they are also likely to introduce new considerations for investors, sponsors and CROs in transactional contexts.
In a domestic or global investment or M&A transaction involving Indian CROs, this may require sellers to represent that studies conducted under the Prior Intimation Route were properly classified, complied with eligibility requirements, and were supported by the necessary Ethics Committee approvals and documentation. Also, the investors and acquirers in the M&A context may require verifying (as a part of the regulatory due diligence) whether the qualifying conditions for adopting the Prior Intimation Route were in fact satisfied by the target/investee companies.
The amendments may also affect contractual arrangements between sponsors and CROs. In many Sponsor–CRO agreements, payment milestones are linked to regulatory events such as submissions and approvals.
The accelerated timelines associated with the Prior Intimation Route may therefore require reconsideration of such milestone structures. Sponsors may also face greater upfront financial exposure if payments are triggered upon regulatory acknowledgment of an intimation, but the study is subsequently found not to meet the eligibility criteria for the Prior Intimation Route.
The framework may also lead to certain regulatory issues emerging at a later stage. For example, the Second Amendment Rules provide that records of BA/BE studies conducted under the Prior Intimation Route may be reviewed by the regulator at the time of renewal of the relevant Ethics Committee’s registration. As a result, compliance issues relating to earlier studies could potentially surface during later regulatory inspections or renewals.
Conclusion
The 2026 Amendments to the NDCT Rules reflect a shift toward a more risk-based regulatory framework for clinical research in India.
By replacing prior approval requirement with the Prior Intimation Route for qualifying low-risk activities, and by reducing approval timelines from 90 to 45 working days for prescribed activities that continue to require regulatory permission, the amendments are promising to enhance regulatory predictability across both tracks and support India’s role as a destination for clinical research, contract manufacturing and export-oriented pharmaceutical development.
At the same time, sponsors, CROs and investors may need to adapt their compliance practices, contractual frameworks and diligence processes to address the evolving regulatory landscape.
Authors:
Ananda Malhotra Martin, Partner
Taskeen Pirani, Associate Partner
Disclaimer:
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.