Drug Technical Advisory Board (DTAB), 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. DTAB’s recommendation comes following a series of representations made by Humane Society International/India (HSI/India), People for Animals (PFA) and other stakeholders to the Central Drug Standard Control Organization (CDSCO) and the Drug Controller General of India (DCGI).

The Draize test was developed more than 70 years ago to measure eye and skin irritation using rabbits, which are locked in restraints while a test chemical is applied to one eye or to the shaved skin on their back. 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 complete replacement of the Draize eye and skin tests with methods that are more reproducible and reflective of human responses.

“The DTAB’s recommendation to phase out the cruel Draize test is a step in the right direction,” said Gauri Maulekhi, Government Affairs Liaison for HSI/India and PFA trustee. “However, an immediate ban would have been a more appropriate response to companies that have for years smugly disregarded the ever-growing toolbox of non-animal testing methods and their legal mandate under the Prevention of Cruelty to Animals Act, to replace animal tests when alternatives are available. We expect the health ministry will act swiftly to notify the rule change so that companies are required to implement it as soon as possible.”

This move comes after Union minister of women & child development, Maneka 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 (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.