The regulatory framework relating to clinical trial of drugs is governed under the Drugs and Cosmetics Act, 1940 ("Act") and the Drugs and Cosmetics Rules, 1945 ("Rules"). Further, Part X-A and Schedule Y of the Rules deal with the statutory provisions applicable for clinical trial of drugs in India. Clinical Trial is defined as a systematic study of 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 drug1.

The term new drug is defined under Rule 122-E of the Rules, which inter alia includes a drug already approved by the licensing authority (Central Drugs Standard Control Organisation) for certain claims, which is proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dose form) and route of administration. Therefore, if already approved drug is marketed with modified or new claims or dosage etc. such drug would be considered a new drug and thus require clinical trial of such drug by obtaining permission from the licensing authority under the Act.

Prior to 16 March 2016, all the clinical trial of new drugs were required permission from the licensing authority and accordingly researchers were required to seek approval from the licensing authority for clinical trials for academic purposes, in the same manner as pharmaceutical companies' application for approval of new drugs. However as per Ministry of Health and Family Welfare Notification G.S.R. 313 (E) dated 16 March 2016, no permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where,-

  1. the trial is approved by the Ethics Committee; and
  2. the data generated is not intended for submission to licensing authority.

However, the Ethics Committee is required to inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trial for academic and regulatory purposes. It is further provided that if the licensing authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.

The aforesaid exemption from obtaining permission from the regulatory authorities to conduct clinical trial would definitely boost clinical trials of already approved drugs for academic purpose which could not see light of the day due to existence of red tape. It has been seen that various medical institutions/hospitals are willing to conduct clinical trials/studies in collaboration with pharmaceutical companies and this recent move from the Government will pave the way for future clinical studies/trials of drugs for academic purpose and reduce start up timelines due to exemption from the licensing authority while maintaining vigilance through Ethics Committee.


1 Rule 122 DAA – (Definition of Clinical Trial) of the Drugs and Cosmetics Rules, 1945.

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.