Govt to add non clinical tests to assess efficacy, safety of new drug

The non-clinical testing techniques specified in the draft to assess the efficacy and safety of a new drug or investigational new drug include animal studies, organ chips, micro physiological systems, advanced computer modelling, and cell-based assays.

The New Drugs and Clinical Trials Rules, 2019, First Schedule, paragraph 3, subparagraph (1), clause (b) states, "The detailed requirements of non-clinical studies have been specified in the Second Schedule."

However, in the draft rules, the Ministry has proposed to add the non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug in the New Drugs and Clinical Trials Rules, 2019, in First Schedule, in paragraph 3, in subparagraph (1), clause (b).

The government has released a draft of certain rules to amend the New Drugs and Clinical Trials Rules, 2019, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of fifteen days from the date on which the copies of the Gazette of India containing these draft rules are made available to public.

Further, the gazette notification stated that objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government.

"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in." the notification added.

As per the draft rules,

1. (1) These rules may be called the New Drugs and Clinical Trials (....Amendment) Rules, 2022.

(2) They shall come into force on the date of their final publication in the Official Gazette.

2. In the New Drugs and Clinical Trials Rules, 2019, in First Schedule, in paragraph 3, in subparagraph (1), clause (b) shall be substituted with the following, namely:—

"(b) The general requirements of non-clinical studies have been specified in the Second Schedule. The Non-Clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug may include the following:

(i) Cell-based assay;

(ii) Organ chips and micro physiological systems;

(iii) Sophisticated computer modeling;

(iv) Other human biology-based test methods;

(v) Animal studies.".

To view the Gazette Notification, click on the below link:

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTI4Nw==

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