India’s drug board brings cheer to animal lovers

Almost paradoxically, India's animal lovers and its pharmaceutical industry – often at loggerheads – may both have cause for cheer, thanks to a recent recommendation by the Drugs Technical Advisory Board (DTAB) against ''repeat animal testing''.

The DTAB committee has 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 by a lab that follows Good Laboratory Practices (GLP) in another country.

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''.

And this is not all. ''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 J P 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, while also helping the pharma industry, which now has to take one step less in bringing a product to the market.

It is now to be seen how the health ministry takes forward the DTAB recommendation, as a government notification is still required to make it effective.