Animal testing of new drugs already tested abroad is now banned as per a ruling by the Ministry of Health and Family Welfare. This move comes after Minister of Women & Child Development Maneka Gandhi wrote to the Ministry regarding the practice.
The amendment said that “where the data on animal toxicity as per the specifications 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 studies shall not be required to be conducted in India except in cases where there are specific concerns recorded in writing”.
The Investigational New Drug Committee, which considered the matter before the Drug Technical Advisory Board, states that if the drugs were tested elsewhere under Good Laboratory Practice conditions and aligned with India’s regulatory requirement, no further toxicity testing shall be required. Both committees are also encouraging the use of internationally accepted non-animal alternatives where available.
The new amendment also says that “no permission for conduct of clinical trials intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form if the trial is approved by the Ethics Committee”.