Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022
Ministry of Health and Family Welfare issued a Notification regarding Draft New Drugs and Clinical Trials (……Amendment) Rules, 2022 on 11th May 2023 to amend the New Drugs and Clinical Trials Rules, 2019. They shall come into force on the date of their final publication in the Official Gazette unless otherwise specified.
in rule 2, in sub-rule
(1), after clause (i), the following clause shall be inserted, namely:—
“(ia) ‘Clinical Research Organization’ means a body commercial or academic or of other category owned by an individual or an organisation having status of legal entity by whatsoever name called to which the sponsor may delegate or transfer some or all of the tasks, duties and/or obligations regarding clinical trial, such transfer or delegation of contractual transfers or obligations must be in writing.”
After Chapter V, the following Chapter shall be inserted, namely:— CHAPTER VA CLINICAL RESEARCH ORGANISATION
38A. Registration of Clinical Research Organisation
38B. Application for Registration of Clinical Research Organisation
38C. Grant of registration to Clinical research organisation
38D. Validity period and renewal of registration of Clinical Research Organisation
38E. Conditions of registration
38F. Inspection of Clinical Research Organisation registered with Central Licencing Authority
38G. Suspension or cancellation of registration of Clinical Research Organisation
In the Eighth Schedule, after Form CT-07A, following Forms shall be inserted, namely
Form CT-07B Application for Registration / Renewal of Clinical Research Organisation
Form CT- 07C Grant of Renewal of Registration of Clinical Research Organisation
After the Eighth Schedule, following Schedule shall be inserted, namely NINTH SCHEDULE – REQUIREMENTS AND GUIDELINES FOR REGISTRATION OF CLINICAL RESEARCH ORGANISATION
Objections and suggestions which may be received from any person within 15 days from the date on which the copies of the Gazette of India containing these draft rules are made available to public;
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare,Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.
