After banning import of animal-tested cosmetics, the Government has taken yet another animal-friendly step by exempting the repeat tests on animals for drugs which have already been approved by other countries.
The Union Health Ministry recently amended Schedule Y of the Drugs and Cosmetics Rules, 1945, which states that animals will be spared the cruel tests for new drug registrations where complete data from similar toxicity experiments already exists for drugs approved abroad.
“Where the data on animal toxicity... 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,” said a notification signed by the Ministry’s Joint Secretary, Kl Sharma.
The amendments follow repeated appeals by People for the Ethical Treatment of Animals (PETA) India and Union minister Maneka Gandhi, a well-known animal rights activist.
Explaining the amendment, a senior PETA official said if a particular drug, which is being introduced in India, has been approved in a particular country after tests on animals, then conducting such tests again for the same drug here will not be required.
The notification says that no permission will be required to conduct clinical trial intended for academic purposes in respect of approved drug formulation for “any new indication or new route of administration or new dose or new dosage form where the trial is approved by the Ethics Committee and subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority”.