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Animal toxicity data generated in other nations is likely to be accepted, and the regulator may not seek fresh tests 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. This won’t, however, be applicable for biological and investigational new drugs, the regulator said. It said also that the use of unapproved excipients in formulations will require relevant safety data.
A recent circular by the Drugs Controller General (India) (DCGI) says the Central Drugs Standard Control Organisation (CDSCO) has reviewed the requirement of toxicity studies for new drugs, SNDs and FDCs, excluding biological products and Investigational New Drugs (INDs).
As per 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 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 approved the drug previously, the regulator said in the circular.
Officials said this will speed up the approval process as toxicity studies take a few months to even a few years. “This will reduce the wastage of resources and even time. The added advantage is that it will help avoid duplicate testing of the drug in India, thereby cutting short the time to get approval,” an official said.
“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 circular.
