The Indian government has amended its Drugs and Cosmetic Rules (DCR), 1945, and done away with the repeat tests on animals for drugs which have already been approved by the other countries.
- People for the Ethical Treatment of Animals (PETA) India and Union Minister Maneka Gandhi, who is also an animal rights activist, had appealed the health ministry to scrap the tests on animals for drugs that are already approved by other countries.
- 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 align with India’s regulatory requirement, no further toxicity testing shall be required.
- Both committees also are 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 and the data generated is not intended for submission to licensing authority”.
