The Central Drugs Standard Control Organisation (CDSCO) on July 29, 2024, issued the notification regarding the requirement for toxicity studies for New Drugs, Subsequent New Drugs (SNDs), Fixed Dose Combinations (FDCs) excluding biological products and Investigational New Drugs (INDs).
The following has been stated namely: -
• A repeated dose toxicity study is required for new drugs, this is however not mandatory in certain cases namely: -
o Where the data on animal toxicity has been submitted and the same has been considered by the regulatory authority
o Animal toxicity data generated in other countries
• The sub-acute animal toxicities studies for intraventions infusions and injectables data is still required to be submitted for grant of permission to import or manufacture of new drug
[Notifications No. F.No. 12-01/24-DC(Pt-104)]
