GSR Notification #227: Paving the Way to Clinical Research in India (Part II)

GSR Notification #227: Paving the Way to Clinical Research in India (Part II)

The application for permission to conduct clinical trial of a new drug or investigational new drug has to be made in Form CT-04 in place of Form 44. The following are the new provisions to be followed during trial conduction.

Enrolment status

The enrolment status of the trial subjects should be submitted on quarterly basis to the central licensing authority. Six monthly status report, pertaining to whether the trial is on-going, completed or terminated, should be submitted in SUGAM portal.

Serious adverse event reporting timeline

Serious adverse event (SAE) reporting timeline for sponsor has been changed to 14 calendar days of the “knowledge of occurrence” of SAE and not “occurrence/onset of SAE”.

Termination of clinical trial

In cases where the clinical trial is terminated early, the same should be reported to central licencing authority within a period of 30 working days. If there is occurrence of study related injury or death, compensation should be provided within 30 calendar days of receipt of orders from licencing authority.

Provision of Post-Trial Access

If the drug is beneficial, and there is no alternative therapy, investigator can recommend post trial access for the patient. In such cases ethic committee (EC) approval and patient/legal heir’s consent is required. The rule also states that there is no liability on sponsor for post-trial use of the drug by patient.

Provisions for bioavailability and bioequivalence (BA/BE) studies

Provisions like application process, inspection process, suspension or cancellation of permission have been defined in the new regulations. The permission to conduct bioequivalence studies is valid for a period of one year from the date of its issue, unless suspended or cancelled by the central licensing authority. The new rules have also laid down requirements of bioavailability and bioequivalence study centres registrations.


There are no significant changes in payment of compensation and the process of determination of causality assessment. Requirement of medical management (in clinical trial or BA/BE study of new drug or investigational new drug) to be provided by the sponsor has been clearly defined. The sponsor has to provide free medical management to the subject as long as required “as per the opinion of investigator”, or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.

A provision for pre and post submission meetings

With the provision of pre-submission meetings, the applicant can seek guidance about the requirements of law and procedure applicable for their projects before making actual submission to the regulator. The applicants can discuss their projects with the regulators and subject experts by paying a certain amount of fee. In the provision of post-submission meetings, the applicant can seek clarification in person with regards to pending application and can discuss related queries. For this the applicant has to apply for a post-submission meeting with the officer designated by the central licencing authority within a period of fifteen days (from the date the query was received) for seeking guidance with regards to the queries concerning pending application.

Phase IV and Post Marketing Surveillance

The new rules make certain clear requirements for phase IV and post marketing studies. Phase IV (Post marketing) trial include additional drug-drug interactions/dose-response/safety studies & trials designed to support use under the approved indications. Such trials have to be conducted under an approved protocol comprising definite scientific objectives, inclusion/ exclusion criteria, safety/ efficacy assessment etc. in approved indication in approved patient population. While conducting such studies, all ethical guidelines (including compensation rule) have to be followed and drug may be given free of cost. For post marketing surveillance (or observational or non-interventional study) regulatory provisions and guidelines of clinical trial are not applicable as drugs are already approved for marketing. However, they need to be conducted as per an approved protocol with scientific objective and should follow inclusion/ exclusion of subjects as per approved package insert.


New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

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