NEW DELHI: Repeat animal testing of new drugs already tested abroad is now banned as per a ruling by the Union Ministry of Health and Family Welfare. This move comes after Union Minister of Women & Child Development Maneka Gandhi wrote to the ministry regarding the practice.
The amendment said that “where the data on animal toxicity as per the specifications 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”.
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.
The new amendment also says that “no permission for conduct of clinical trials intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form if the trial is approved by the Ethics Committee and the data generated is not intended for submission to licensing authority”.
India has been a full adherent to the Organization for Economic Cooperation and Development (OECD) decision regarding Mutual Acceptance of Data (MAD) 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.
“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,” said Gauri Maulekhi, Humane Society International, India consultant and a trustee at People for Animals