Health Ministry to phase out Draize test

June 13, 2016: Most cosmetic preparations, including face creams, lotions, foundations, and toners, are subject to animal testing in order to evaluate their irritant effects on delicate parts of the body. The most commonly employed technique is the Draize test, which was approved in 1944 by the FDA.


This test entails applying a dilute solution of the cosmetic preparation to the skin of restrained animals such as rabbits, guinea pigs or mice, and recording effects of flushing or erythema. Often times, these solutions are instilled into the animal’s eye to check the extent of redness or smarting. Euthanizing the animal is typically the fate, if there is permanent damage caused to the eye or their skin.


These tests have caused uproar over the decades, with animal activists claiming them to be inhumane, and often unnecessary to subject animals to torture.


Keeping this in mind, the Indian Union Health Ministry is actively seeking measures to completely eliminate these tests and have them replaced by non-invasive toxicological screens. This could involve additional in vitro tests using cell-based assays in order to determine if the new drug or product causes any irritation to cultured retinal or dermal tissue.


The Drug Controller General of India (DCGI) has set up a committee to look into the matter and also devise novel methods which would help eliminate the need to use animals for testing unknown products. The European Union and USFDA have already implemented the eradication of Draize test and other traumatic skin tests in animals.


Several tests are being adapted and tried in Indian laboratories to evaluate feasibility, reproducibility, and validation of these alternate methods of product testing. The committee is also in talks with pharmaceutical organizations and biotech firms to design suitable preclinical tests which would help them arrive at a conclusive decision.

Dr. Jay Shinde

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