HSI/India and PFA laud historic decision that could save thousands of animals
NEW DELHI (March 26, 2016)—Repeat animal testing of new drugs already tested abroad is now banned per a ruling dated 18 March 2016 by the Union Ministry of Health and Family Welfare.
The ban falls under amendment Schedule Y, in the Appendix I, under item 4 where after sub-item 4.8, the following note shall be inserted - “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.”
Leading animal welfare groups Humane Society International/India and People for Animals welcomed the decision.
Gauri Maulekhi, HSI/India consultant and a trustee at People for Animals, said, “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.”
This move comes after Union Minister of Women & Child Development, Smt. Maneka Sanjay Gandhi, wrote to the Ministry regarding the practice. The Investigational New Drug Committee, which considered the matter before the Drug Technical Advisory Board, states 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. Both committees also are encouraging the use of internationally accepted non-animal alternatives where available.
India has been a full adherent to the Organization for Economic Cooperation and Development 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. The OECD estimates that adherence to MAD saves more than €150 million and scores of animals per year by avoiding needlessly duplicative testing.