Public comments invited on the draft amendments to the New Drugs and Clinical Trials Rules by 5th Feb, 2022; proposes to introduce deemed approval w.r.t. registration of Ethics Committee, conducting all clinical trials etc.

The Ministry of Health has proposed a draft of the New Drugs and Clinical Trials (……Amendment) Rules, 2022 (“Draft Rules“) to further amend the New Drugs and Clinical Trials Rules, 2019.

Objections and suggestions on the Draft Rules, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, A Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in by 5th February, 2022.

Key Highlights of the Draft Rules:

1. In the event the ethics committee receives no communication from the Central Licensing Authority within the forty-five working days from making the application for grant of registration, the same shall be deemed to be gr Further, the committee shall be authorized to initiate clinical trials after informing the Central Licensing Authority in Form CT-02A;

2. In the event the person or institution or organisation who may have applied for permission to conduct clinical trials, receives no communication from the Central Licensing Authority within ninety working days, the same shall be deemed to have been granted. Further, such applicant shall be authorized to initiate clinical trials after informing the Central Licensing Authority in Form CT-06A;

3. In case a person or institution or organisation makes an application for permission to conduct clinical trial of a new drug already approved outside India, and receives no communication from the Central Licensing Authority within ninety working days period, the same is proposed to have been granted and legally valid for all purposes. Further, such person or institution or organisation shall be authorized to initiate clinical trials in accordance with these rules after informing the Central Licensing Authority in Form CT-06A;

4. In case any person or institution or organisation applying for permission to conduct bioavailability or bioequivalence study receives no communication from the Central Licensing Authority within ninety working days period, the same shall be deemed to have been granted and be legally valid for all purposes. Further, such person or institution or organisation shall be authorized to initiate bioavailability or bioequivalence study of the new drug or investigational new drug in accordance with these rules after informing the Central Licensing Authority in Form CT-07A;

5. In case any person applying for permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study, or for examination, test and analysis, receives no communication from the Central Licensing Authority within ninety working days period, the same shall be deemed to have been granted and be legally valid for all purposes. Further, such person shall be authorized to manufacture the new drug or investigational new drugs for the said purposes after informing the Central Licensing Authority in Form CT-11A.

6. In case a manufacturer of a pharmaceutical formulation applying for permission to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study, receives no communication from the Central Licensing Authority within the period, the same shall now be deemed to have been granted and legally valid for all purposes. Further, such manufacturer shall be authorized to manufacture new drug or investigational new drugs for the said purposes after informing the Central Licensing Authority in Form CT-15A.

A copy of the Draft Rules is hyperlinked below for your ease of reference.

Source: Ministry of Health and Family Welfare