Following the recommendation of the Drugs Technical Advisory Board (DTAB), rabbits may soon be spared the agony of drugs being tested on their skin and eyes.
Members of the DTAB were briefed about this decision in a meeting held on 1 August. The Drug Controller General of India has received representations to replace the Draize test that checks product safety by using living animals. An amendment to the Schedule-Y to Drugs and Cosmetic Rules, 1945 has been sought.
The Drug Controller General set up a panel in April 2016 to examine the feasibility of replacing the test with alternative methods. YK Gupta, the head of the Pharmacology Department at the All India Institute of Medical Science (AIIMS) headed the panel which met a couple of times during May and June 2016 to seek recommendations of various stakeholders.
The Draize test on rabbits goes back seventy years. Rabbits are put in captivity when the chemical is applied to their eye or shaved skin on the back. This is followed by a two week monitoring regime sans any pain killers to check signs of chemical damage including the likes of bleeding, blindness, swelling and ulcers.
The committee took into consideration reports from People for the Ethical Treatment of Animals (PETA), India, Mahatma Gandhi-Doerenkamp Centre for Alternatives to Use of Animals in Life Science Education, Blue Cross of India and Sun Pharmaceutical Industries Ltd, Humane Society International (India) and a pharmaceutical company, reported the Mint.
Except Sun Pharmaceuticals, all other organizations have given their opinion in favour of replacing the Draize test by non-animal test methods. However, Sun Pharma, which is a major Indian pharmaceutical house involved in new drug development including ophthalmic preparations, have requested not to mandate the alternative tests.Mint
The report also says “Indian regulatory system should adopt progressive nature in adopting the alternate methods to animals in toxicity testing as and where possible.” [sic]
After prolonged deliberation, the DTAB agreed to the proposed amendment to “use validated methods for selection of alternative non-animal test procedures which are available in international guidelines”, Mint report added.
A Sun Pharma representative said that this would require many resources which unfortunately our country lacks. The alternative tests would require procurement of new instruments, improved infrastructure, expertise and dexterity and in-house standardization of tests. The representative said that all this would take at least three years.
Animal rights activists, however, welcomed the news.
We welcome DTAB’s recommendation on a ban on the cruel Draize test. It’s not only the more humane option but also is in line with the legal requirement under the Prevention of Cruelty to Animals Act, 1960, which mandates the replacement of animal tests when alternatives are available. We hope the health ministry quickly notifies the ban so that the laboratories can then implement it as soon as possible.Gauri Maulekhi, Government Affairs Liaison, Humane Society International (India)
(Source: Livemint)
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