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
the trial is approved by the Ethics
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
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.
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