Health ministry bans “Draize” test in rabbits for eye irritation tests, dermal toxicity tests for skin irritation

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In line with the international trend towards replacing tests on animals with alternative methods, the Union health ministry has prohibited the use of “Draize” test in India which has been in vogue for the last more than 70 years for eye irritation tests and dermal toxicity tests for skin irritation/corrosion tests in rabbits. The ministry has now recommended the use of OECD (Organisation for Economic Cooperation and Development) validated non-animal alternatives.

According to the amended notification, GSR 897(E) dated 21.09.2016, 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, “the initial toxicity study shall be carried out by non-animal alternative tests as given in Organisation for Economic Cooperation and Development Guidelines”.

Likewise, in note (vi) relating to ocular toxicity studies (for products meant for ocular instillation), the notification states, “such initial toxicity studies shall be carried out by non-animal alternative tests as given in Organisation for Economic Cooperation and Development guidelines.”

India has been a full adherent to the Organization for Economic Cooperation and Development (OECD) decision regarding Mutual Acceptance of Data (MAD) 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.

The health ministry’s decision comes after a series of representations made by HSI/India, People for Animals and other stakeholders, informing the ministry regarding internationally recognized alternatives to “Draize” test.

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.
Earlier this year, the Drugs Controller General India (DCGI) had constituted a committee to examine the feasibility of replacing the Draize test with alternative methods in Indian situation. The committee in its first meeting held on May 23, 2016 deliberated the issue and perused the related literature applicable globally vis-a-vis Schedule-Y requirement. It noted that several alternative tests are being evolved and validated to different stages. The OECD guidelines have also suggested use of alternative methods. The committee also noted that US FDA and European Union have also initiated the process of use of alternative methods.

Later in August this year, the Drug Technical Advisory Board (DTAB) had also recommended a two-year phase out period for the “Draize” irritation tests using rabbits. During this transition period, validated non-animal alternatives may be accepted in place of the previously mandatory animal tests, it recommended.

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