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India bans Cruel Eye & Skin Test on Rabbits for Drug Testing

Monday, November 7, 2016 Drug News J E 4
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In a major victory for Humane Society International/India’s campaign to end cruel and obsolete animal testing, the Ministry of Health & Family Welfare has prohibited the use of “Draize” irritation tests using rabbits. The notification dated November 4, 2016 recommends the use of OECD (Organisation for Economic Cooperation and Development) validated non-animal alternatives. The Health Ministry’s decision comes after a series of representations made by HSI/India, People for Animals and other stakeholders, informing the Central Drug Standard Control Organization and the Drug Controller General (India) regarding internationally recognized alternatives.

The Draize test was developed more than 70 years ago to measure eye and skin irritation using rabbits, who are locked in restraints while a test chemical is applied to one eye or to the shaved skin on their backs. Animals are monitored for up to two weeks, without pain relief, for signs of chemical damage, which can include swelling, ulceration, bleeding and blindness. In addition to its obvious cruelty, the Draize test is not reliable or relevant to humans. A variety of validated and internationally recognized non-animal alternatives, including reconstructed human skin and corneal tissues, have been available for years -- some since 2004. These 21st century technologies, deployed as part of a sequential testing strategy, allow for complete replacement of the Draize eye and skin tests with methods that are more reproducible and reflective of human responses.

“This is a historic decision by the health ministry. Thousands of rabbits will now be spared from one of the most cruel and infamous experiments on rabbits known to mankind.” said Alokparna Sengupta, Deputy Director of HSI/India. “This, in addition to the cosmetic testing ban will provide the much needed impetus for India to move towards more humane and advanced 21st century science. We laud the Health Ministry for acting swiftly to notify the rule change and hope that the companies follow this in letter and spirit.”

This move comes after Union Minister of Women & Child Development, Smt. Maneka Sanjay Gandhi, wrote to the Ministry regarding the practice, followed by representations from HSI/India and PFA. India has been a full adherent to the Organization for Economic Cooperation and Development decision regarding Mutual Acceptance of Data since 2011. As a consequence, the data generated following OECD test guidelines and using Indian Good Laboratory Practice laboratories must be accepted in all the OECD member countries, and vice versa. The OECD estimates that adherence to MAD saves more than €150 million and scores of animals per year by avoiding needlessly duplicative testing.
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