India Ends Re-Testing Of Drugs on Animals for New Drug Registrations

For Immediate Release:
18 March 2016

Sachin Bangera; [email protected]

Efforts by PETA and Union Minister Maneka Gandhi Prompt Amendments to the Drugs and Cosmetics Rules

Delhi – Following appeals from People for the Ethical Treatment of Animals (PETA) India and Union Minister Maneka Gandhi, the Ministry of Health & Family Welfare has passed an amendment to Schedule Y of the Drugs and Cosmetics Rules, 1945, that will prevent testing on animals for new drug registrations when complete data from earlier toxicity experiments already exist for drugs approved abroad.

The Gazette notification, which can be found here, reads:

  1. In Schedule Y to the said rules, in Appendix I, in item 4, after sub-item 4.8, the following note shall be inserted, namely:

“Note.- Where the data on animal toxicity as per the specifications of Appendix III 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.”

Last year, upon reviewing the requests from PETA and Union Minister Gandhi, the Indian Investigational New Drugs Division recommended to the Drug Technical Advisory Board (DTAB) that animals be spared cruel duplicative tests for new drug registrations when relevant data from other countries already exist. PETA supporter and X-Files star Gillian Anderson, who was in India filming for Gurinder Chadha’s Viceroy’s House, also penned a letter to the Minister of Health & Family Welfare requesting that he quickly remove the requirement for redundant toxicity testing on animals by amending the relevant rules.

“By ending redundant and painful tests on animals, the Indian government will spare the lives of potentially hundreds of thousands of animals each year”, says PETA India Research Associate Dr Dipti Kapoor. “PETA India will continue to work to save other animals from being painfully and lethally poisoned for outdated, unreliable tests.”

PETA India – whose motto reads, in part, that “animals are not ours to experiment on” – notes that because of the vast physiological and biochemical differences between humans and the rats, mice and other animals used in toxicity tests, the results are often misleading, but regulators still typically require that drugs be tested on animals. However, progressive scientists are developing sophisticated, non-animal methods that are more effective, produce faster and more human-relevant results, and are more economical in the long run – such as “organs-on-chips” that replicate human physiology, diseases and drug responses more accurately than animal experiments.

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