BENGALURU: THE Indian drug industry will no longer be able to use rabbits for pre-clinical toxicity tests for a variety of pharmaceutical products. Currently, eye and skin irritation tests are conducted to assess the quantity of chemical damage on mammals. Known as the Draize irritation tests, these cruel tests on rabbits will now be phased out over a period of two years during which validated non-animal alternatives can be used.
The Drug Technical Advisory Board’s recommendation comes in the wake of a series of representations made by Humane Society International (HSI) India, People for Animals (PFA), PeTA India and other animal welfare organisations.
Welcoming the move, HSI said this will remove outdated, obsolete animal testing methods in India.
Gauri Maulekhi, Government Affairs Liaison for HSI/India and PFA trustee said, “This is a step in the right direction. However, an immediate ban would have been a more appropriate response to companies that have for years disregarded the ever-growing toolbox of non-animal testing methods and their legal mandate under the Prevention of Cruelty to Animals Act, 1960 to replace animal tests when alternatives are available. We expect the Health Ministry to act swiftly and notify the rule changes so that companies are required to implement it as soon as possible.”
Animals activists say a variety of validated and internationally recognised non-animal alternatives, including reconstructed human skin and corneal tissues, have been available since 2004. In fact, currently available technologies allow complete replacement of the Draize tests with methods that are reproducible and reflective of human responses.
According to Dr Deepti M Kapoor, Research Associate, PeTA India, the Drug Board has recommended an amendment to Schedule Y of Drug and Cosmetics Rules, 1945 to specify that validated non-animal tests may be used instead of the Draize test for initial studies whenever non-animal alternatives are available.
She adds, “Luckily, experimenters have a variety of modern, non-animal in vitro test methods for skin and eye irritation and corrosion at their disposal. These methods have been adopted by the Organisation for Economic Co-operation and Development, an international body responsible for producing and validating international test guidelines, and they are humane, more human-relevant and faster than tests on animals,” she said.