The Central Drugs Standard Control Organization has announced a relaxation in the requirement for toxicity studies for certain new drugs, subsequent new drugs, and fixed-dose combinations. This circular was issued on July 29, 2024.
The CDSCO aims to streamline the drug approval process without compromising safety. The New Drugs and Clinical Trials Rules, 2019 allow for the acceptance of preclinical toxicity data generated in other countries, provided the data is of high quality and meets specified standards.
Therefore, the CDSCO has decided that while review drug substance or drug product, it will accept already generated preclinical toxicity data. However, this acceptance will be based on the quality of the data and the credentials of the laboratory producing such data.
It is worthwhile to note that the requirement for sub-acute animal toxicity studies for intravenous infusions and injectables remains unchanged.
The decision is expected to expedite the drug approval process while maintaining stringent safety standards.
The CDSCO has clarified that this relaxation does not compromise patient safety and that the quality of data will be rigorously evaluated on a case-by-case basis.
