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Soon, Animal Testing will be history in India

 

Clinical courses

Government of India is considering to replace some animal tests with alternative methods in rabbits, guinea pigs or mice with respect to the approval of new drugs and therefore they are looking for replacements in Indian situation.

For this purpose, A committee has been constituted to give its recommendation for taking necessary action to replace Draize test which is applied on Rabbit eyes and skin by alternative methods for testing of eyes and skin irritation or corrosion.

The committee in its first meeting held on 23rd May, 2016 deliberated the issue and perused the related literature applicable globally vis-a-vis Schedule-Y requirement. It noted that several alternative tests are being evolved and validated to different stages. The OECD guidelines have also suggested use of alternative methods. The committee also noted that US FDA and European Union have initiated the process of use of alternative methods.

The committee opined that as there is international trend towards replacing tests on animals with alternatives it may be considered in Indian context, after obtaining assessment of feasibility, validation, preparedness of Indian laboratories etc.

The main contentions are;

  • Are Indian pre clinical testing laboratories equipped for such change?
  • Have the alternative methods been validated particularly in India?,
  • Do we have adequate number of laboratories to undertake the toxicity testing of all required substances by alternative methods ?

If the answer is NO or PARTIAL, how much time and what efforts will be required for capacity building for using alternate methods?

It is further decided to seek the feedback/opinion from different stakeholders viz. laboratories involved in carrying out preclinical toxicity tests from public, private sector and related organisation from pharmaceutical industry before taking the final decision in the matter.

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