STOCK MARKET BSE NSE

Centre Bans Repeat Drug Tests on Animals

Animal testing of new drugs already tested abroad is now banned as per a ruling by the Ministry of Health and Family Welfare.

Published: 19th March 2016 05:06 AM  |   Last Updated: 19th March 2016 05:57 AM   |  A+A-

Centre Bans

NEW DELHI: Animal testing of new drugs already tested abroad is now banned as per a ruling by the Ministry of Health and Family Welfare. This move comes after 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 aligned with India’s regulatory requirement, no further toxicity testing shall be required. Both committees are also 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”.



Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp