GSR Notification #227: Paving the Way to Clinical Research India (Part I) · Cliniexperts

Yes. The status of enrolment of the trial subjects shall be intimated to the CLA on quarterly basis or as appropriate as per the duration of treatment in accordance with the approved clinical trial protocol, whichever is earlier. Further, six monthly status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted in SUGAM portal. In case of termination of any clinical trial the detailed reasons for such termination shall be communicated to CLA.

An “investigational new drug (IND)” means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.

SUGAM portal is an e-Governance solution for CDSCO. SUGAM enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committee, medical devices, vaccines and cosmetics. SUGAM has facility for users to possess multiple roles on the same registered ID. Applicant can register with different purposes with the assigned roles and forms.

A “clinical trial” in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its, clinical or; pharmacological including pharmacodynamics, pharmacokinetics or; adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug

For drugs that are discovered in India, or research and development of the drug are being conducted in India, and if the drug is intended to be manufactured and marketed in India, the applications to conduct clinical trials will be considered approved if there are no queries raised by Drugs Controller General of India (DCGI) within 30 days of the application. However, the sponsor will still have to notify the DCGI prior to initiation of the clinical trial in Form CT-4A.

As per the new provision of pre-submission meetings, applicants can discuss their projects with the regulators and subject experts by paying a certain fee, before making actual submission to the regulator, for seeking guidance about the requirements of law and procedure applicable for their projects.

No fee shall be chargeable in respect of application for conduct of clinical trial for orphan drugs as defined in clause (x) of rule 2 of the New Drugs and Clinical Trial Rules, 2019. The Rules exempt local clinical trials for orphan drugs permitted to be imported for sale or distribution. The phase IV study requirement could also be reduced in case of orphan drugs.

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

Yes, drug Clinical Trial at each site shall be initiated after the approval of the Clinical Trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.