Background & Rules
Global Clinical Trial means any clinical trial which is conducted as part of multi-national clinical development of a drug. Clinical Trial means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug.
No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority defined in clause (b) of Rule 21.
RULES GOVERNING CLINICAL TRIALS
The clinical trials are conducted in accordance with the Drugs and Cosmetics Rules. The specific Rules are-
- Rule 122 DA – Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;
- Rule 122 DAB – Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation;
- Rule 122DAC - Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of Drugs and Cosmetics Rules and other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance;
- Rule122 DD – Requirements and guidelines for registration of Ethics Committee;
- Rule122 E – Definition of new drug;
- Schedule Y - Detailed guidelines and requirements for conduct of clinical trial and approval of new drug
- Good Clinical Practice Guidelines issued by CDSCO, Directorate General of Health Services, Govt. of India
The Handbook for applicants and reviewer of clinical trials in India has been published by ICMR with CDSCO to provide clarity, enhance transparency, and facilitate understanding of review process.