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Gireesh Babu, New Delhi November 24 , 2022
The Union 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, the clause (b) of the sub-paragraph (1) of the 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, the 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 assay, organ chips and micro physiological 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 the sub-paragraph (1) elaborating the requirements of non clinical studies. It states that the nature of non-clinical studies and their timing in respect of conduct of clinical trial should be determined taking the aspects such as the characteristics of the new drug or investigational new drug; disease of conditions for which the new drug or investigational new drug is intended to be indicated; duration and exposure in clinical trial subject; and the route of administration.

It also states that for first in human studies the dose should be calculated carefully based on the non-clinical pharmacological, toxicological data generated.

The Ministry stated that the draft rules is published for information of all persons likely to be affected thereby and a notice is given that the said draft rules shall be taken into consideration on or after the expiry of a period of 15 days from the date on which the copies of the draft rules in the Gazette of India are made available to public.

“Objections and suggestions which 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 shall be addressed to the Under Secretary (Drugs) under the MoHFW or to be sent in the designated email ID.

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