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September 2015

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Changes to Toxicity Testing Regulations in India


Recent decisions by India's Drug Technical Advisory Board  will reduce the numbers of animals used for toxicity testing and likely stimulate the development and use of alternative test methods.

At its August 18 meeting, the Board announced it was ending the requirement that drugs already tested and approved in other countries be re-tested on animals in India before marketing, provided manufacturers present adequate toxicological data and evidence that the drug otherwise meets existing Indian cosmetics and drugs regulations (the 1940 Drugs and Cosmetics Act and the 1945 Drug and Cosmetics Rule, Schedule Y). The Board also encouraged the use of non-animal alternative methods "wherever such robust validated methods are available for small or large animals."

The decision furthers India's efforts to reduce animal-based toxicity tests. In 2014, India's Ministry of Health and Family imposed bans on the domestic use of animals in cosmetics testing, and on importing cosmetics that have been tested on animals. More recently, just weeks after the announcement ending the re-test requirement, the Committee for the Purpose of Control and Supervision of Experiments on Animals announced that it was taking steps to ban the testing of soaps and detergents on animals, as well.

India is a signatory on the Organisation for Economic Co-operation and Development’s (OECD) Mutual Acceptance of Data agreement, which states that “test data generated in any member country in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) shall be accepted in other member countries for assessment purposes and other uses relating to the protection of human health and the environment.” These decisions bring India's toxicology regulations into closer alignment with OECD member countries, and are sure to accelerate the development and use of alternatives.
 

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SSCT-Swetox Workshop: Mechanisms, markers and models – the 3M strategy in risk assessment
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9th Congress of the Turkish Society of Toxicology with participation of Hellenic Society of Toxicology
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SETAC North America 36th Annual Meeting: Buzzing With Science: Cross-Pollination for Environmental Progress
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