‘Repeat’ animal testing not needed: drug board

Often messages pop up on the social media seeking homes for beagle dogs rescued from being used as lab animals.

Relief may be on hand for the animals and the pharmaceutical industry thanks to a recent recommendation by the Drugs Technical Advisory Board (DTAB) against “repeat animal testing”.

DTAB committee members have recommended that pre-clinical toxicity tests for a drug need not be repeated on animals in India if the drug has been tested and approved from a lab that follows Good Laboratory Practices (GLP) in another country.

OECD commitment This is in line with India’s OECD commitment on mutual acceptance of data.

After deliberation, the committee agreed that “for drugs approved in other countries where complete toxicological data generated in GLP certified laboratory and in alignment with the requirements prescribed under Drugs and Cosmetics Act, 1940 and Rules, 1945 (Schedule Y), further toxicity study may not be required if complete data as per prescribed requirements is submitted during application for new drug approval.”

Global practices “It may also be explored, in line with international practices, to encourage the use of other alternative methods than animal studies, wherever such robust validated methods are available for small or large animals,” the DTAB said, according to the minutes of the meeting.

The development follows a letter from Women and Child Development Minister Maneka Gandhi to Health Minister JP Nadda.

As a signatory to the OECD Council Act, India is required to respect data generated by another country on pre-clinical/toxicity studies and “therefore there is no need for CDSCO (Central Drugs Standard Control Organisation) to undertake further studies,” it was pointed out to the committee.

 “The molecules of interest have been those that are approved by multiple regulatory agencies and have been through many animal studies which have been made available on sites and published in scientific journals,” the committee was told.

The recommendation will save lab animals from being put through unnecessary drug trials, said an official familiar with the DTAB proceedings. 

It also helps the pharma industry, which now has to take one step less in bringing a product to the market, the official added.

 Urging the Health Ministry to notify this recommendation at the earliest, Gauri Maulekhi, a consultant with Humane Society International/India, said that in addition to the animals’ welfare, the move would bring relief to pharma companies, which would not have to invest in such tests.

Lab tests involve small animals such as rodents as well as larger ones like dogs and monkeys.

The DTAB recommendation would be relevant in any situation where pre-clinical toxicity data are required, explained Chaitanya Koduri, Science Policy Adviser with the People for the Ethical Treatment of Animals.

Faster, cheaper Koduri pointed out that non-animal testing is the new trend, as it is both faster and cheaper. However, a government notification is necessary, he said, as companies may otherwise still resort to outdated animal testing.

He gave the example of rabbits being used in rapid progressive testing despite the availability of mono site activation tests involving blood samples.

 Chinny Krishna, Vice-Chairman, Animal Welfare Board, further cautioned that the Committee for the Purpose of Control and Supervision of Experiments on Animals will have to be vigilant about companies that seek permission to perform animal tests to sell products overseas.

 The attention now shifts to the Health Ministry, and how it will take forward the DTAB recommendation.