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The Drugs Technical Advisory Board (DTAB) has recommended doing away with such tests on animals. Photo: AFP
The Drugs Technical Advisory Board (DTAB) has recommended doing away with such tests on animals. Photo: AFP

DTAB backs plan to scrap drug tests on animals

The recommendation would bring cheers to animal rights activists, who say non-animal alternatives to the Draize test have been available for years now

New Delhi: Rabbits may soon be spared the pain of drugs being tested on their eyes and skin. The Drugs Technical Advisory Board (DTAB), India’s highest health advisory body, has recommended doing away with such tests.

At a meeting on 1 August, members of DTAB were briefed that the Drug Controller General of India had received representations to amend Schedule-Y to Drugs and Cosmetics Rules, 1945, to replace the Draize test in which products are tested for safety using live animals.

A panel was formed by the Drugs Controller General in April 2016 to examine the feasibility of replacing the test, named after toxicologist John Henry Draize, with alternative methods not involving animals.

The panel was led by Y.K Gupta, head of the Pharmacology department at the All India Institute of Medical Science (AIIMS). The panel sought comments from different stakeholders and met twice—in May and July 2016—to examine the issue.

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 an eye or to shaved skin on the 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.

According to the minutes of the DTAB’s meeting reviewed by Mint, the committee received comments from five organizations, including one pharmaceutical company, People for the Ethical Treatment of Animals (PETA), India; Humane Society International (India), Mahatma Gandhi–Doerenkamp Centre for Alternatives to Use of Animals in Life Science Education; Blue Cross of India and Sun Pharmaceutical Industries Ltd.

“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," according to the minutes.

As per the minutes, the panel recommended that considering the current global scenario, the “Indian regulatory system should adopt progressive nature in adopting the alternate methods to animals in toxicity testing as and where possible."

“Based on the recommendations of the committee, it is proposed to amend the Schedule Y to Drugs and Cosmetics Rules, 1945, appropriately by inserting provisions so that acute dermal toxicity study and ocular toxicity study, wherever required, may be replaced by validated non-animal alternative tests to Draize test, wherever possible," according to the minutes of the DTAB meeting.

“DTAB, after detailed deliberations, agreed to the proposed amendment and stated that the draft rules are appropriately worded, which emphasizes to use validated methods for selection of alternative non-animal test procedures which are available in international guidelines," the minutes added.

A Sun Pharma spokesperson said pre-requisites for alternative tests would include procurement of instruments, establishment of infrastructure and development of expertise, “along with in-house standardization and validation of tests and demonstration of proficiency."

“Considering that no one in our country has the infrastructure and feasibility for implementation of such alternatives, we believe the implementation of these alternative tests will take at least three years," the spokesperson said.

The recommendation would bring cheers to animal rights activists, who point out that a variety of validated and globally recognized non-animal alternatives to the Draize test have been available for years now.

“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," said Gauri Maulekhi, government affairs liaison at Humane Society International (India), a non-governmental organization.

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