Last Updated on January 6, 2024 by The Health Master
Download draft notification GSR No. 835(E) dt 22-11-2022, the link is given below: The Ministry of Health and Family Welfare (MoHFW) has issued a draft notification amending the New Drugs and Clinical Trials Rules (NDCTR), 2019 to include specific requirements on non-clinical studies to assess the safety and efficacy of a new drug or investigational new drug.
The proposed amendment shall come into effect on the date of their final publication in the Official Gazette, which would be after considering the objections and suggestions from all persons likely to be affected by the notice.
The draft elaborates that in the New Drugs and Clinical Trials Rules, 2019, in the First Schedule, which is about the general principles and practices for clinical trials, clause (b) of sub-paragraph (1) of paragraph 3, at present states that the detailed requirements of non-clinical studies have been specified in the Second Schedule.
However, this will be amended to substitute that while the general requirements of non-clinical studies have been specified in the second schedule, clause (b) will have additional details on the specifics required for such studies.
It proposes that the non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug may include cell-based assays, organ chips, microphysiological systems, sophisticated computer modeling, other human biology-based test methods, and animal studies.
The draft notification has been published in the Official Gazette as “Induced pluripotent Cell Technique for pre-clinical studies”.
The third paragraph of the First Schedule details the development methodology, with sub-paragraph (1) elaborating on the requirements of nonclinical studies.
It states that the nature of non-clinical studies and their timing with respect to the conduct of clinical trials should be determined by taking into account aspects such as:
- The characteristics of the new drug or investigational new drug;
- Disease or conditions for which the new drug or investigational new drug is intended to be indicated;
- Duration and exposure in the clinical trial subject;
- The route of administration.
It also states that for the first time in human studies, the dose should be carefully calculated based on the non-clinical pharmacological, and toxicological data generated.
The Ministry stated that the draft rules are published for the information of all persons likely to be affected thereby, and notice is given that the said draft rules shall be taken into consideration on or after the expiration of a period of 15 days from the date on which the copies of the draft rules are made available to the public.
“Objections and suggestions that may be received from any person within the period specified above will be considered by the central government,” it said, directing that the objections and suggestions be addressed to the Under Secretary (Drugs) under the MoHFW or be sent in the designated email ID.
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