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DTAB recommends two-year phase out for Draize irritation tests using rabbits
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Our Bureau, Mumbai
August 27 , 2016
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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.
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