India is an attractive place to run clinical trials, but overseas sponsors often ask the same first question: what approvals do we need, and who issues them? This overview explains the main steps.
The rules that apply
Clinical trials of new drugs and investigational new drugs in India are governed by theNew Drugs and Clinical Trials Rules, 2019 (NDCT Rules), issued under the Drugs and Cosmetics Act, 1940. The rules replaced the earlier framework in Schedule Y of the Drugs and Cosmetics Rules, and set out requirements for trial permission, ethics committees, informed consent, safety reporting and compensation.
The regulator is the Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), which acts as the Central Licensing Authority.
Step 1: Permission from CDSCO
The sponsor, or its authorised Indian representative, applies to CDSCO for permission to conduct the trial. The application includes the protocol, investigator's brochure, informed consent documents and supporting data.
The NDCT Rules set decision timelines for these applications, with a shorter timeline for drugs discovered and developed in India. In some cases, CDSCO can waive the requirement for a local trial for drugs already approved in certain other countries. Whether that applies depends on the product, so it should be confirmed early.
Step 2: Ethics committee approval
Each participating site needs approval from an ethics committee registered with CDSCO. Ethics committees review the protocol, informed consent documents and the site's suitability, and continue to oversee the trial until close-out.
Step 3: CTRI registration
Trials must be registered on the Clinical Trials Registry – India (CTRI), run by the Indian Council of Medical Research, before the first participant is enrolled.
Obligations once the trial starts
- Informed consent must follow the NDCT Rules, with additional safeguards for vulnerable participants.
- Serious adverse events must be reported to the regulator, ethics committee and sponsor within set timelines.
- Medical management and compensation must be provided for trial-related injury, as the rules specify.
- Records must be kept and the trial run to Good Clinical Practice, ready for inspection.
How ACRS helps
ACRS acts as the local regulatory and operational partner for overseas sponsors: preparing and submitting applications, managing ethics committee approvals and CTRI registration, and keeping the study compliant through to close-out. See our regulatory affairs services.
This article is a general overview, not legal or regulatory advice. Requirements change and depend on the product and study design, so confirm the pathway for your study with us or your regulatory advisers.