Pharma & Healthcare Update: Fast-Tracking Clinical Research: India’s New Approval Regime

Fast-Tracking Clinical Research: India’s New Approval Regime

• New Drugs and Clinical Trials Rules, 2019 amended to introduce a ‘prior intimation’ regime for specified categories of new drugs, investigational new drugs and unapproved APIs
• The amendments reduce regulatory timelines from 90 to 45 working days for grant of permissions and introduce deemed facilitation for analytical and non-clinical testing

INTRODUCTION

The Ministry of Health and Family Welfare has notified the New Drugs and Clinical Trials (Amendment) Rules, 2026 vide notification dated January 20, 2026¹ (“Amendment Rules”). The Amendment Rules introduce substantial amendments to the New Drugs and Clinical Trials Rules, 2019 (“NDCT Rules”), introducing a paradigm shift in the regulatory framework governing the manufacture of new drugs, investigational new drugs (“INDs”) and unapproved active pharmaceutical ingredients (“APIs”) for purposes of clinical trials, bioavailability, bioequivalence (BA/BE) studies, and analytical and non-clinical testing.

The Amendment Rules will come into force forty-five (45) days from the date of publication of the rules in the official gazette. The Amendment Rules fundamentally recalibrate the approval architecture by introducing a ‘prior intimation’ mechanism, enabling manufacturers to commence specified manufacturing activities upon mere acknowledgment by the Central Licensing Authority (“CLA”), rather than awaiting formal regulatory approval. In parallel, the timelines for regulatory decision-making have been halved from 90 to 45 working days, significantly compressing development cycles.

Collectively, these reforms reflect a conscious policy shift towards regulatory facilitation, accelerated innovation and global competitiveness, particularly in early-stage research, clinical development and API manufacturing.

REGULATORY BACKGROUND

Under the pre-amendment framework, manufacturers were required to obtain prior regulatory permission from the CLA in Form CT-11 (and analogous forms) under the NDCTR before manufacturing any new drug or IND for clinical trials or BA/BE studies or for examination, test and analysis even for analytical and non-clinical testing. Similarly, manufacture of unapproved APIs for formulation development required formal approvals under a permission-based regime.

While designed to ensure regulatory oversight and patient safety, this permission-heavy architecture often resulted in extended timelines, procedural complexity and operational inflexibility, particularly at early research and analytical stages, where rapid iteration and testing are critical.

The Amendment Rules represent a significant recalibration of this approach by segregating low-risk development activities from higher-risk clinical manufacturing and aligning regulatory scrutiny proportionately.

KEY AMENDMENTS: INTRODUCTION OF PRIOR INTIMATION REGIME

Manufacture of New Drugs and INDs for Analytical and Non-Clinical Testing

The Amendment Rules have amended Rule 52 of the NDCTR substantively to introduce a dual-track regulatory pathway:

• For manufacture of a new drug or investigational new drug to conduct clinical trial or BA/BE study for examination, test and analysis prior permission continues to be applicable from the CLA; or
• For manufacture of new drugs or INDs intended for analytical and non-clinical testing, manufacturers may now proceed based on ‘prior intimation’ submitted online in Form CT-10, without awaiting express regulatory approval. Manufacturing may commence upon acknowledgment of such intimation by the CLA.

However, this relaxation is not applicable to the following high-risk categories of INDs or new drugs:

• Sex hormones
• Cytotoxic drugs
• Beta-lactam antibiotics
• Biologics containing live microorganisms
• Narcotic and psychotropic substances

These categories continue to require formal prior regulatory permission, reflecting heightened safety and diversion risks.

This bifurcated approach introduces regulatory proportionality, enabling faster initiation of low-risk development activities while preserving robust oversight for sensitive drug classes.

REDUCTION IN REGULATORY TIMELINES: 90 TO 45 DAYS

The Amendment Rules have amended Rule 53 of the NDCTR to reduce the regulatory timeline for:

• Grant of permission;
• Communication of deficiencies in application; and
• Rejection of applications.

from 90 working days to 45 working days.

This change applies to permissions relating to:

• Manufacture of new drugs and INDs for Clinical trials and BA/BE studies;
• Manufacture for or new drugs or INDs for examination, test and analysis;
• Manufacture of unapproved APIs for formulation development.

The halving of statutory timelines represents one of the most significant regulatory accelerators introduced under the clinical trials regime and materially impacts product development velocity, investor confidence and global trial competitiveness.

EXTENSION OF VALIDITY TO PRIOR INTIMATION

The Amendment Rules have amended Rule 54 of the NDCTR to extend the three-year validity period (and potential one-year extension in exceptional cases) not only to permissions, but also to acknowledgments issued under the prior intimation route.

This provides regulatory certainty and operational continuity to manufacturers, ensuring that the shift to a facilitative framework does not dilute compliance expectations or regulatory traceability.

CONDITIONS OF MANUFACTURE AND COMPLIANCE OBLIGATIONS

The Amendment Rules have expanded Rule 55 of the NDCTR to impose uniform compliance obligations on both:

• Holders of regulatory permissions; and
• Holders of acknowledgments under the prior intimation regime.

Key conditions include:

• Manufacture of new drugs and INDs strictly limited to clinical trials and BA/BE studies or analytical and non-clinical testing purpose;
• Absolute prohibition on commercial sale or third-party supply;
• Small-quantity manufacturing at licenses premises aligned with Good Manufacturing Practices (“GMP”); and
• Maintenance of detailed records of the new drugs manufactured and details of persons to whom such drugs have been supplied for specific purposes.

This ensures that regulatory relaxation does not translate into regulatory dilution, preserving robust oversight over investigational and developmental drugs.

API MANUFACTURING REFORMS: EXTENDING PRIOR INTIMATION TO UNAPPROVED APIs

Parallel amendments have been introduced under Rules 59 to 64 of the NDCTR to streamline the manufacture of unapproved APIs and API ingredients intended for development of pharmaceutical formulations for purposes of examination, test and analysis, clinical trials, and BA/BE studies.

Manufacturers may now proceed via prior intimation route in Forms CT-12 (manufacturer of pharmaceutical formulation) and Form CT-13 (manufacturer of API), subject to acknowledgment by the CLA, except for the same excluded high-risk drug categories discussed above. The manufacturing activities are required to be in compliance with the conditions stipulated under the Amendment Rules.

This reform directly addresses long-standing industry concerns regarding development bottlenecks in early-stage formulation research, particularly for generic and biosimilar development pipelines.

LABELLING AND TRACEABILITY ENHANCEMENTS

The Amendment Rules have amended Rule 66 of the NDCTR to mandate enhanced labelling requirements for the holder of a permission/prior intimation on behalf of another person to indicate the following information on the label of the drug, including:

• Name and address of manufacturer;
• Name and address of the recipient;
• Scientific name or identification reference of the drug; and
• Purpose of manufacture.

These measures strengthen regulatory traceability, audit readiness and pharmacovigilance oversight, reinforcing compliance even under the relaxed approval framework.

POLICY IMPLICATIONS AND INDUSTRY IMPACT

The 2026 amendments represent a decisive policy pivot from regulatory gatekeeping to regulatory enablement, particularly for early-stage research and development, analytical testing and formulation development. By enabling manufacturing based on prior intimation and sharply reducing regulatory approval timelines, the amendments are expected to compress development cycles, reduce regulatory uncertainty, improve the global competitiveness of Indian clinical research, and encourage early-stage innovation and investment.

At the same time, the continued exclusion of sensitive drug categories from the prior intimation framework reflects a calibrated, risk-based regulatory approach, ensuring that public health safeguards and patient safety considerations remain uncompromised despite the broader push towards regulatory facilitation.

From an industry perspective, these reforms are likely to accelerate clinical trial readiness timelines, improve throughput for bioavailability and bioequivalence studies, enable faster transitions from API development to formulation manufacturing, and strengthen India’s positioning as a global hub for clinical development and pharmaceutical research and development.

KEY TAKEAWAYS

The Amendment Rules introduce a fundamental restructuring of India’s regulatory framework for clinical research and drug development, anchored in regulatory agility, proportional oversight and industry facilitation.

The introduction of a prior intimation regime, coupled with reduced statutory timelines, marks a significant shift towards ease of doing business, without diluting compliance or safety imperatives. For pharmaceutical manufacturers, API producers and formulation developers, the amendments offer tangible operational, financial and strategic advantages, particularly in early-stage development and global trial integration.

Shlok Siddhant, Tanya Kukade and Dr. Milind Antani
You can direct your queries or comments to the authors.

¹Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4MjE=