These proposed draft rules have been issued 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), after consultation with the Drugs Technical Advisory Board (DTAB). The draft has been published for information of all persons likely to be affected.
Point 4.2 of Table 2 in the Second Schedule of the New Drugs and Clinical Trials Rules, 2019 normally requires applicants seeking approval for intravenous infusions and injectable drugs to submit data from sub-acute animal toxicity studies.
These studies involve giving repeated doses of the drug to animals over a short period to evaluate potential toxic effects on organs, overall safety, and tolerability, which is considered especially important for injectables because they enter directly into the bloodstream and can produce rapid systemic effects.
However, the proposed amendment introduces a conditional exemption: if the test product has excipients (inactive ingredients) that are qualitatively (same type) and quantitatively (same amount) identical to those in an already approved reference product, the need to repeat such animal toxicity studies may be waived. This change is intended to avoid unnecessary duplication of animal testing, reduce regulatory burden and costs, and support a more ethical, science-based approach while maintaining safety, since the excipient profile has already been established as safe.
The draft amendment states:
"1. (i) These rules may be called the New Drugs and Clinical Trials (...... Amendment) Rules, 2025.
(ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.
2. In New Drugs and Clinical Trials Rules, 2019, under the para 4.2 of 4 of Table 2 of Second Schedule, after the words “intravenous infusion and injectables” the words “except when the test product, in respect of its excipients, is qualitatively and quantitatively same as reference product” shall be inserted.
The draft rules will be taken into consideration after the expiry of thirty days from the date on which copies of the Gazette of India containing the draft rules are made available to the public.
"Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government," the notification states.
"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at drugsdiv-mohfw@gov.in.," the gazette added.
To view the official gazette, click the link below:
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