For Immediate Release:
8 November 2016
Following Efforts by PETA and Others, New Gazette Notification Calls for Use of Non-Animal Skin and Eye Toxicity Tests
Delhi – Through a recently released notification in The Gazette of India, the Ministry of Health & Family Welfare has progressed towards humane drug-products testing by mandating the use of currently available non-animal test methods instead of forcing rabbits to endure eye and skin irritation and corrosion tests. The change follows efforts by People for the Ethical Treatment of Animals (PETA) India, Union Cabinet Minister Maneka Gandhi, and others. PETA India has been pushing for Draize tests on rabbits to be banned, including via the expert committee formed by the Drug Controller General of India to consider the matter. Draize tests involve restraining live rabbits while chemicals are applied to their eyes or shaved skin. The animals often suffer from ulcers, bleeding, and even blindness. But that is changing.
The Gazette notification, which can be found at http://egazette.nic.in/WriteReadData/2016/172505.pdf, reads in part:
In the Drugs and Cosmetics Rules, 1945, in Schedule Y, in Appendix III relating to Animal Toxicology (non-clinical toxicity studies), in paragraph 1, in sub-paragraph 1.4 relating to Local Toxicity,
- In Note (i) relating to Dermal toxicity study, for the words and brackets “Daily topical (dermal) application of test substance in its clinical dosage form should be done”, the words and brackets “the initial toxicity study shall be carried out by non-animal alternative tests as given in Organisation for Economic Cooperation and Development Guidelines”, shall be substituted.
(B) In Note (vi) relating to Ocular toxicity studies (for products meant for ocular instillation), after the words “need to include a recovery group.” the words “such initial toxicity studies shall be carried out by non-animal alternative tests as given in Organisation for Economic Cooperation and Development Guidelines.” shall be substituted.
“By moving away from the archaic and cruel Draize tests, India will improve product safety and spare countless animals’ lives”, says PETA India Research Associate Dr Dipti Kapoor. “PETA looks forward to a day when all animal tests are replaced with superior, humane non-animal methods.”
PETA India – whose motto reads, in part, that “animals are not ours to experiment on” – notes that experimenters have a variety of modern, non-animal in vitro methods at their disposal to test for skin and eye irritation and corrosion. These methods have been adopted by the Organisation for Economic Co-operation and Development, an international body responsible for publishing international test guidelines. The non-animal methods may also be more human-relevant and faster than tests on animals.
For more information, please visit PETAIndia.com.