NEW DELHI: The Drugs Technical Advisory Board (DTAB) under Ministry of health has recommended replacing Draize test where chemicals are applied on rabbit eyes and skin for potential toxicity of pharmaceutical products by alternative methods. The phase out period is two years.
The Board in its meeting held of August 1 recommended amendment of Schedule Y to Drugs and Cosmetics Rules, 1945 inserting non-animal test methods as alternate option for Draize test for ocular toxicity study and dermal toxicity study.
The decision was taken based on the comments received from a committee constituted under Chairmanship of Dr Y K Gupta, Prof. and Head, Department of Pharmacology, AIIMS, New Delhi. It included members of animal welfare organsiations and a pharmaceutical company.
“The Indian regulatory system should adopt progressive nature in adopting the alternate methods to animals in toxicity testing as and where possible. The alternate methods should be validated as sufficient alternative for equal predictability of potential toxicity of pharmaceutical products,” said the minutes of the meeting.
This move comes after Union Minister of Women & Child Development Maneka Sanjay Gandhi, wrote to the Ministry regarding the practice, followed by representations from animal welfare organizations.
According to animal welfare organizations, Draize test is used to measure irritation or corrosion caused to the eye or skin, but it is notoriously unreliable, producing highly variable results and is also extremely unpleasant and painful, causing eye reddening, swelling, ulceration, even blindness, or skin cracking and bleeding.
The committee was of the view that the applicant of new drug should be encouraged to make application to the regulator for conduct of in-vitro alternate methods in place of Draize test.
Emphasizing that the intent should be to gradually phase out the Draize test by replacing it with in-vitro tests, the committee recommended that the Draize test should be accepted for two years.
“During this interim period, all the testing laboratories should develop the capacity for in vitro testing facility and validate them. After one year, a stock taking of progress in capacity building should be reviewed,” said the minutes.
The Committee also recommended that in rare situation where alternate test is not acceptable for acute dermal and ocular toxicity test and with specific reasons, the Draize test is asked for with certain principles.