New Delhi: The Central drug regulator, the Central Drugs Standard Control Organisation (CDSCO) has decided to accept the preclinical toxicity data already generated and accepted by regulatory authorities of other countries for review of new drugs, subsequent new drugs (SNDs) and fixed dose combinations (FDCs), subject to certain conditions.
In a latest circular issued to the industry, the Drugs Controller General (India) (DCGI) Dr Rajeev Singh Raghuvanshi said that the CDSCO has reviewed the requirement of toxicity studies for new drugs, SNDs and FDCs, excluding biological products and Investigational New Drugs (INDs).
According to the New Drugs and Clinical Trials Rules, 2019, the regulator noted that, a repeated dose toxicity study in India may not be mandatory in certain cases including when a data on animal toxicity as per the specifications in the rule, has been submitted and the same has been considered by the regulatory authority of the country which had earlier approved the drug.
The animal toxicity data generated in other countries may be accepted and may not be asked to be repeated in India on a case to case basis depending upon the quality of data and the credentials of the laboratory where such data has been generated, noted the regulator pointing to the Schedules of the NDCG Rules, 2019.
“In view of the above, it has been decided to accept already generated preclinical toxicity data for review in the case of drug substance and drug product, based on the quality of data and the credentials of the laboratory where such data has been generated,” said the DCGI
However, the animal toxicity data needed in certain cases such as new claims namely, indications, dosage, dosage form or route of administration etc., should be determined on case by case basis depending on the nature of new claims as well as the mechanism of action etc., and the non-clinical data already generated with the drug in the approved claim, added the drug regulator.
Use of unapproved excipients in the formulation also will require relevant safety data.
Besides, as per the NDCT Rules, 2019, sub-acute animal toxicity studies for intravenous infusions and injectables data is still required to be submitted by an applicant for grant of permission to import or manufacture such new drug as mentioned in the Second Schedule of the Rules, added the drug regulator.
