The Union Ministry of Health and Family
Welfare has banned repeat animal testing of new drugs that have been already
tested abroad. Animal protection organizations such as Human Society
International (HSI) and People for Animal (PFA) have lauded the decision.
The animal welfare organizations in the
country have recommended banning repeat animal
so that animals be spared
cruel tests for new drug registrations. Animal testing involves rodents,
rabbits, dogs and monkeys. In India, animals are killed during repeat
pre-clinical toxicity experiment for drugs that are already approved abroad.
‘Indian Health Ministry has banned repeated pre-clinical toxicity tests for a drug on an animal if the drug has been tested and approved abroad.’
The ban on
repeat animal testing falls under Amendment Schedule Y, in Appendix I, under
item 4 where after sub-item 4.8. "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
HSI/India consultant and a trustee of People for Animals, said, "We welcome and
laud this move by the Health Ministry. The new amendment will not only save
thousands of animals every year from being subjected to redundant animal
testing, but it also marks the beginning of a potential new era of
sophisticated animal testing alternatives in India. We look forward to
continuing our association with the Ministry to ensure that use of validated
alternatives is encouraged as the Drug Technical Advisory Board has
Sanjay Gandhi, Union Minister of Women & Child Development, wrote to the
Ministry regarding repeat animal testing. Upon reviewing the request, the
Investigational New Drug Committee recommended the Drug Technical Advisory
Board, (DTAB) that if the new drugs were tested elsewhere under Good Laboratory
Practice conditions and align with India's regulatory requirement, repeat drug
toxicity testing shall not be required.
India is adherent to the Organization for Economic Cooperation and Development
(OECD) decision regarding Mutual Acceptance of Data (MAD). The data generated
by the Indian Good Laboratory Practice laboratories must be accepted in all the
OECD member countries, and vice-versa. The OECD estimates that adherence to MAD
saves more than €150 million and thousands of animals per year by avoiding
duplicative animal testing.
The ban on
repeat animal testing of new drugs will save thousands of animals from painful
and lethal poisoning during drug toxicity
tests. The ban will also help the pharma
industry who will have to undertake one less step in bringing a new drug to the
market. The move towards the prohibition of repeat animal testing for drugs
comes under The Drugs and Cosmetics Act, 1945.
To Animal Testing
committee encouraged the use of internationally accepted non-animal
alternatives such as "organs-on-chips". Scientists around the world are
developing non-animal testing methods which can replace the use of animals.
Non-animal testing is both faster and cheaper. Scientists at Harvard
University's Wyss Institute have created "organs-on-chips" that contain human
cells that mimic the structure and function of human organs and systems. These
chips can be used instead of animals in drug testing and toxicity testing.
Organs-on-chips have been shown to replicate human physiology, diseases, and
drug responses more accurately than animal testing.