India bans animal testing for cosmetics

Standards for alternative tests to be set; amendments to acts and laws required

India has become the first country in South Asia to ban animal testing for the manufacture of cosmetics. G N Singh, the Drug Controller General of India, announced the decision at a Cosmetics Sectional Committee meeting of the Bureau of Indian Standards (BIS) on June 28.

The ban is based on an application by non-profit People for Ethical Treatment of Animals (PETA) which has been campaigning for the ban on animal testing for a long time. PETA in its application also argued for the relevant alternatives to the tests.

The ban is effective on wide range of products that include lipsticks, eye make-up, and toothpaste. However, India is yet to ban marketing of animal tested products manufactured in other countries. BIS will now have to set down standards to meet the new requirements while the DCGI will make relevant amendments in acts and laws.

Alternative tests and technologies available

Between August and December 2012, India banned several tests on animals. The current ban pertains to the two remaining tests, namely acute oral toxicity limit test and oral mucosal irritation test. “These tests can easily be replaced by computer simulations and tests on human or animal cells,” says the marketing-director of an Indian manufacturer which stopped using tests on animals a few years ago (see box).

According to Chaitanya Koduri, scientific advisor with PETA, new technologies are available which provide conclusions even more accurate than those from animal testing. The alternative tests are approved and endorsed by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the Organisation for Economic Co-operation and Development (OECD).

In 2010, Israel enacted a law banning the import and marketing of cosmetic products tested on animals, and the ban came to effect in January this year. The EU, comprised of 27 countries, banned the marketing of cosmetic products tested on animals in March 2013. India is yet to follow their example.

Alternatives to tests on animals

Acute oral toxicity limit test

Balb/c 3T3 neutral red uptake (3T3 NRU) assay and Normal human keratinocyte neutral red uptake (NHK NRU) assay: Certain cells can take in and store red coloured dye. In event of cell death or inhibition in cell growth, red colour in the specific region will decrease, indicating impact of the chemical on the cell.
AcuteOralTox-LD50 in vitro screen: This analysis considers pharmacological and physio-chemical properties of a substance. Evidence so far suggests 75 per cent success rate. The sensitivity and specificity of the tested substances were 85 per cent and 89 per cent respectively.
EvaTOX assay: The test is based on DNA alterations in cultured human cells. EvaTOX predicted 82 per cent of toxic chemicals. It is currently awaiting acceptance from ECVAM to enter their validation programme.
Quantitative structure-activity relationship (QSAR) models: QSAR models can be used to estimate the likelihood of toxicity of chemicals. For example, the combined use of two or more software can be used to predict the toxicity of an unknown substance or its major metabolites.

Oral mucosal irritation test

Epi oral model: This is a human inner-cheek tissue equivalent. Evidence suggests it provides a quick, reproducible method for evaluating the irritation potential of oral care products.
Reconstructed human oral epithelium (RHOE) model: This too is a human inner-cheek tissue equivalent. The model has been in use to examine oral mucosal irritancy of teeth whitening products.

People for Ethical Treatment of Animals (PETA)