Health ministry cancels repeat animal testing for new drugs already tested abroad

Mumbai, March, 2016
The Union Health Ministry has done away with the practice of repeat animal testing for new drugs already tested abroad which will save a large sum of money and scores of animals per year by avoiding needlessly duplicate testing.

In Schedule Y to the Drugs and Cosmetics Rules, 1945, in Appendix I, in item 4, after sub-item 4.8, the following note shall be inserted, namely:- “Note- Where the data on animal toxicity as per the specifications of Appendix III has been submitted and the same has been considered by the regulatory authority of the country which had earlier approved the drug, the animal toxicity studies shall not be required to be conducted in India except in cases where there are specific concerns recorded in writing,” a notification from the health ministry said. 

The ministry's latest move comes after Union minister of women & child development, Maneka Gandhi, wrote to the health ministry regarding the practice. The Investigational New Drug Committee, which considered the matter before the Drug Technical Advisory Board, stated that if the drugs were tested elsewhere under Good Laboratory Practice conditions and align with India’s regulatory requirement, no further toxicity testing shall be required.

India has been a full adherent to the Organization for Economic Cooperation and Development (OECD) decision regarding Mutual Acceptance of Data since 2011. As a consequence, the data generated by Indian Good Laboratory Practice laboratories must be accepted in all the OECD member countries, and vice-versa. 

Meanwhile, leading animal welfare groups Humane Society International/India and People for Animals welcomed the health ministry's decision.

“We welcome and laud this move by the Health Ministry. The new amendment will not only save thousands of animals every year from being subjected to redundant animal testing, it also marks the beginning of a potential new era of sophisticated animal testing alternatives in India. We look forward to continuing our association with the ministry to ensure that use of validated alternatives is encouraged as the Drug Technical Advisory Board has recommended,”said Gauri Maulekhi, HSI/India consultant and a trustee at People for Animals.