Repeat animal testing not required, says drugs advisory board

Every now and then messages circulate online seeking homes for beagle dogs rescued from labs where they are used for the purpose of testing human medicines.

But a recent recommendation by the Drugs Technical Advisory Board (DTAB) against “repeat animal testing” could bring some relief not just to these lab animals but also the pharmaceutical industry.

The DTAB has recommended that pre-clinicial toxicity tests for a drug need not be repeated on an animal in India if the drug has been tested and approved from a lab that follows Good Laboratory Practices (GLP) in another country. This is in line with India’s OECD commitment regarding mutual acceptance of data.

The committee deliberated and agreed that “for drugs approved in other countries where complete toxicological data generated in a GLP certified laboratory and in alignment with the requirements prescribed under the 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.”

“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 from their meeting.

The development follows a letter from Maneka Gandhi, Minister for Women and Child Development to the Health Minister on the issue. “India being a signatory of the OECD Council Act related to mutual acceptance of data is under obligation to respect the data generated by another country regarding 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.

Good for science too

The recommendation will save lab animals from being put through unnecessary drug trials, besides helping the pharma industry who will have to undertake one less step in bringing a product to market, said an official familiar with the DTAB proceedings. 

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

Animal tests involve small animals like rodents to large ones like dogs and monkeys. And the recommendation would be relevant in any situation where pre-clinical toxicity data is required, explains Dr Chaitanya Koduri, Science Policy Adviser with People for the Ethical Treatment of Animals.

In fact, Koduri points out that non-animal testing is the new trend in science as it is both faster and cheaper.  However, a Government notification is necessary, he says, as otherwise outdated animal testing would still be done by companies. He gives the example of rabbits used in Pyrogen testing (for fever), when science has moved on to monocyte activation tests involving blood samples.  

Chinny Krishna, Vice-Chairman, Animal Welfare Board, further cautions that the CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals) will have to be vigilant on companies seeking permission to do animal tests to sell products overseas.

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

jyothi.datta@thehindu.co.in

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