Government to phase out Draize testing for drugs on rabbits
New Delhi: Drugs Technical Advisor Board, which comes under the Health Ministry, has recommended a ban on Draize test on Rabbits. The drive came after Union Minister for Women and Child Development, Menaka Sanjay Gandhi, wrote to the Health Ministry with representations of animal welfare organizations regarding this matter.
The animal welfare organizations opposed to the testing done on animals saying it as notoriously irrelevant and painful.
The representations of animal welfare organizations suggested that “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.”
A meeting in this respect was held on August 1, in which amendment of schedule y to drugs and cosmetic rules, 1945 (inserting non-animal test methods as alternate options for the draize test for eye toxicity study and skin toxicity study) has been recommended.
The Board thus, suggested replacement of Draize test in which chemicals are applied on the eyes and skin of rabbits for potential toxicity of pharmaceutical products by alternative methods. It is suggested that the phase out period is for carrying such tests remain two years.
The Indian Express reports that a working committee constituted under the chairmanship of Dr. Y K Gupta, Prof. and Head, Dept of Pharmacology, AIIMS, New Delhi, had earlier commented “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.
The committee suggested that an application should be sent to the regulator for conduct of in-vitro alternate methods in lieu of Draize test by the applicant of a new drug. However, the committee has accepted the use of draize test for two years as a phase out time.
“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 of the meeting of working committee, according to the Indian Express.
The animal welfare organizations opposed to the testing done on animals saying it as notoriously irrelevant and painful.
The representations of animal welfare organizations suggested that “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.”
A meeting in this respect was held on August 1, in which amendment of schedule y to drugs and cosmetic rules, 1945 (inserting non-animal test methods as alternate options for the draize test for eye toxicity study and skin toxicity study) has been recommended.
The Board thus, suggested replacement of Draize test in which chemicals are applied on the eyes and skin of rabbits for potential toxicity of pharmaceutical products by alternative methods. It is suggested that the phase out period is for carrying such tests remain two years.
The Indian Express reports that a working committee constituted under the chairmanship of Dr. Y K Gupta, Prof. and Head, Dept of Pharmacology, AIIMS, New Delhi, had earlier commented “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.
The committee suggested that an application should be sent to the regulator for conduct of in-vitro alternate methods in lieu of Draize test by the applicant of a new drug. However, the committee has accepted the use of draize test for two years as a phase out time.
“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 of the meeting of working committee, according to the Indian Express.
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