DRUG TESTING. Animal rights activists cheer ban on repeat drug trials

It’s a good day for guinea pigs and other members of the animal kingdom as India will now not subject them to repeat testing of drugs meant for mammals of the homo sapiens species.

The Ministry of Health and Family Welfare has amended the Drugs and Cosmetics Rules to ban animal testing of drugs that have already been tested in another country that is part of the Organisation for Economic Cooperation and Development (OECD).

The amendment to Schedule Y of the Rule says, “Where the data on animal toxicity as per the specifications of Appendix III have 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 draft rules had been moved on January 6 and were finalised on March 16.

The move, which has earned cheer from animal rights activists, aims at preventing both economic and time loss from duplicated testing.

Dipti Kapoor, Research Associate, People for the Ethical Treatment of Animals (PETA) India, said, “This also enables drug companies to make medicines more easily available and also saves money since they don’t have to conduct tests to achieve data that is already available.”

This move, which is applicable only for drugs that have already been tested in countries whose regulatory requirements are in line with India’s, falls under the OECD decision of Mutual Acceptance of Data.

Gauri Maulekhi, Humane Society International (India), Consultant and a trustee at People for Animals, said, “The new amendment will not only save thousands of animals every year from being subjected to redundant animal testing, it also marks the beginning of a potential new era of sophisticated animal testing alternatives in India.”

However, animals would continue to be subjected to testing for new drugs being developed in India. But, there is hope that these, too, will come to an end soon as the Centre is looking at alternatives available.

This is the second victory for animal rights activists in as many years.

In January 2014, the Centre had amended the Drugs and Cosmetics Rule to ban animal testing of cosmetics as well, bringing India’s regulation on cosmetics at par with the European standards which had made animal testing of cosmetics illegal in 2013.

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