On the 29th of July 2024, the Central Drugs Standard Control Organization (CDSCO) released new circular on the requirement for toxicity studies for New Drugs, Subsequent New Drugs (SNDs), and Fixed Dose Combinations (FDCs) reiterated from the New Drugs and Clinical Trials Rules (NDCT Rules 2019) as followed:
According to the clause 2, 1.1 of the NDCT Rules 2019, repeated dose toxicity study is required for new drugs but may not be mandatory for certain cases as stated below:
Animal toxicity studies shall not be required to be conducted in India if the animal toxicity data, as per the specifications of Clause 2, has been submitted and reviewed by the regulatory authority that previously approved the drug. However, this regulatory easing does not apply to special cases with documented written concerns. (Second Schedule, Table 1, 4(note))
Animal toxicity data generated in other countries may be accepted on a case-by-case basis, depending on the quality of the data and the credentials of the laboratory that produced it, and may not need to be repeated or duplicated in India. (Second Schedule, Clause 2 (1.8 Note (1)) of NDCT Rules)
So, CDSCO decided to accept preclinical toxicity data that has been generated earlier for review in the case of Drug Substance and Drug Product, depending on the data quality and laboratory credentials.
However, the toxicity data needed in certain cases such as new claims for namely, indications, dosage, dosage form, or route of administration, will be determined on case-by-case basis depending on the nature of the new claims and the non-clinical data generated with the drug in the approved claim. While for sub-acute animal toxicity studies for intravenous infusions and injectables data is still required to be submitted for permissions grants to import or manufacture the new drug.
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