In India, all clinical trials must be conducted in accordance with the Indian GCP guidelines, the Declaration of Helsinki (2013 or later versions as applicable), National Guidelines for Biomedical and Health Research Involving Human Participants (2017), the Drugs and Cosmetics Act (1940), and Rules (1945), and applicable amendments including the New Drugs and Clinical Trial Rules (2019), and other relevant regulations and guidelines.

A regulatory clinical trial can commence only after all necessary approvals and permissions are granted by the Licensing Authority (Central Drugs Standard Control Organisation, CDSCO) and the institutional ethics committee (EC). For an academic clinical trial, it is the ethics committee approval that is paramount.

Depending on the type of trial, approval from National Regulatory Agencies might be required in addition to an approval from CDSCO and EC(s). Section 7 of the National Guidelines for Biomedical and Health Research Involving Human Participants (2017), elaborate in detail the ethical and regulatory implications of clinical trials of drugs and other interventions (device trials, clinical trials with stem cells, trials of interventions in HIV/AIDS, trials of diagnostic agents, etc.). It is strongly recommended that trialists refer to the applicable sections in these guidelines, to ensure complete compliance.

In May 2017, ICMR and others signed a joint statement, under the aegis of WHO, on public disclosure of results from all international trials. In keeping with this, all clinical trials must be registered with the Clinical Trials Registry – India (CTRI).

The next sub-sections of this routemap provide information on regulatory approval, ethics approval, registration of clinical trials and other approvals that may be required depending on the type of trial.

Due to the time-consuming nature of these permissions, it is advisable that these processes are undertaken in a parallel manner and not sequentially.

References and Further Reading

• Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
• Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, October 2013, available online (last accessed on 26.02.2019).
• National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research, 2017, available online (last accessed on 26.02.2019).
• The Drugs and Cosmetic Acts and Rules, 1945, as amended up to the 30^th of June 2005, Ministry of Health and Family Welfare, Government of India, available online (last accessed on 26.02.2019).
• New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 01.04.2019).
• Joint Statement on Public Disclosure of Results from Clinical Trials, available online (last accessed on 26.02.2019).
• Clinical Trials Registry – India (CTRI), website (last accessed on 26.02.2019).