NEW DELHI––The Indian Ministry of Health & Family Welfare on May 6, 2014 introduced an amendment to the Drugs & Cosmetics Rules 1945 that will prohibit the import of cosmetic products tested on animals.
Implementing the Drugs & Cosmetics Act of 1940, adopted while India was a British colony, the Drugs & Cosmetics Rules 1945 had never before been substantively updated as regards animal testing. The potential penalties for violation include fines ranging from 500 to 10,000 rupees, or about $12 to $220, and/or three to 10 years in prison.
The amendment, titled clause 135-B, was recommended by the Drugs Technical Advisory Board, to help implement a national ban on animal testing of cosmetics ratified by the Bureau of Indian Standards on June 28, 2013. The ban brings Indian law governing cosmetics safety testing into alignment with the rules in effect in the 27-nation European Union, and in Israel, a leading cosmetics trader with India.
While most major cosmetics manufacturers have long had Indian divisions or subsidiaries, about 10% of the $1.5 billion Indian cosmetics market involves imported products or ingredients.
The Indian regulatory change, following the similar transitions in the EU and India, boosted the economic prospects of the Empiriko Corporation, of Newton, Massachusetts. Chief executive officer Pam Randhawa, originally from Rajasthan, India, and chief scientific officer and founder Mukund Chorghade, from Maharashtra, in March 2014 shared with the American Chemical Society and Science Daily particulars of their development of a “chemosynthetic liver technology” which will replicate the effects of product ingestion by animals without actually using animals.
Potentially useful in testing cosmetic products, the “chemosynthetic liver technology” is also expected to reduce animal use in drug development.
The first step in toxicity testing currently, Science Daily explained, is “metabolic profiling,” which involves identifying “minute amounts of molecular byproducts, or metabolites,” released as the liver of a test animal breaks down the substance under study.
“These metabolites,” Science Daily said, “are often responsible for causing nasty side effects.”
Chorghade, Science Daily continued, “has developed catalysts that act similarly to a group of enzymes known as cytochrome P450,” which break down substances in the liver. “So rather than using lab animals,” Science Daily summarized, “researchers could figure out metabolic profiles of drugs [and other substances] by mixing them in test tubes with chemosynthetic livers.
Said Chorghade, “These chemosynthetic livers not only produce the same metabolites as live animals in a fraction of the time, but also provide a more comprehensive metabolic profile, in far larger quantities for further testing and analysis.”
Concluded Science Daily, “The chemosynthetic livers aren’t yet approved to take the place of animal tests. But Chorghade is optimistic. His group has tested more than 50 drugs so far to show that the catalysts accurately mimic how the human body processes them. He said that they’re working to get that number up to 100, which is what the U.S. Food & Drug Administration requires for regulatory approval.”
(See also “China drops animal testing rule for cosmetics, shampoos & perfumes,” http://wp.me/p4pKmM-pa.)