New Delhi, 5, February: The Ministry of Health and Family Welfare (MoHFW) has proposed a regulatory amendment to allow a conditional exemption from sub-acute animal toxicity studies for specific injectable and intravenous drugs in India. The proposal was published as a draft notification (GSR 45(E)) in the Gazette of India on 20 January 2026, inviting public feedback before finalisation.
The draft seeks to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, which currently mandate animal toxicity data as part of the approval process for injectable formulations.
According to the draft, animal sub-acute toxicity studies may be waived when the injectable drug under review contains excipients that are identical in both type and quantity to those used in an already approved reference product in India.
Excipients are inactive substances added to medicines to ensure stability, solubility, or delivery. While they do not produce therapeutic effects, excipients can influence safety, especially in injectable products that directly enter systemic circulation.
The Health Ministry has proposed this exemption to avoid repetition of animal studies where sufficient safety data already exist for identical excipient compositions. Regulatory authorities note that repeating such studies does not add new scientific value when formulation components remain unchanged.
The proposal aligns with broader efforts to reduce unnecessary animal testing, lower regulatory burden for manufacturers, and streamline drug approval timelines without altering safety standards.
If implemented, the amendment will primarily affect pharmaceutical manufacturers and applicants developing injectable or intravenous drugs. Companies seeking approval for products with unchanged excipient profiles could benefit from reduced preclinical requirements.
Regulatory bodies, ethics committees, and clinical research organizations will also be involved in evaluating whether applications meet the exemption criteria under the NDCT framework.
The waiver will apply only under defined conditions. Manufacturers must demonstrate that their product’s excipients are qualitatively and quantitatively identical to those of an approved reference drug. Any variation in excipient type or amount will disqualify the product from exemption and trigger the standard toxicity testing requirements.
Importantly, the proposed rule does not eliminate other safety or efficacy requirements under the NDCT Rules. Applicants must continue to submit all other mandated data for regulatory review.
The draft notification was issued in New Delhi on 20 January 2026. The Ministry has allowed a 30-day public consultation period, during which stakeholders can submit objections or suggestions.
The amendment will come into force only after the Central Government reviews the feedback and publishes a final notification in the Gazette of India, specifying the effective date.
Stakeholders, including industry representatives, researchers, and members of the public, may submit written comments to the Under Secretary (Drugs), MoHFW, via post or email, as outlined in the Gazette notification.
The feedback received during this period will inform the final regulatory decision.
The proposal was issued under powers granted by the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board (DTAB). By focusing on formulation equivalence rather than repetitive testing, the draft reflects a risk-based regulatory approach within India’s drug approval system.
If adopted, the amendment would apply nationwide and mark a significant procedural change in preclinical requirements for injectable drug approvals.
1. Ministry of Health and Family Welfare. Draft Notification G.S.R. 45(E): Exemption of Animal Toxicity Studies with Respect to Certain Conditions. Gazette of India. https://www.cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4Mjc=
(Rh/SS/MSM)
