India to review US FDA’s ban on antibacterial soap

The US FDA ruled that manufacturers failed to show efficacy of any of 19 active compounds that go into over-the-counter antiseptic washing products


Manufacturers have been given a year to change formulations or pull their products from the market.
Manufacturers have been given a year to change formulations or pull their products from the market.

New Delhi: A week after the US Food and Drug Administration (FDA) banned the use of certain compounds in antibacterial hand and body wash products, India’s Central Drug Standard Control Organization (CDSCO) is set to deliberate whether their use in India poses a public health hazard that requires a closer look, two CDSCO officials said on condition of anonymity.

The FDA ruled on 2 September that manufacturers had failed to show the efficacy of any of 19 active compounds that go into many over-the-counter consumer antiseptic washing products. As a result, the FDA banned the use of these 19 compounds, including triclosan and related triclocarban.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, director of the FDA’s centre for drug evaluation and research. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long term.”

Manufacturers have been given a year to change formulations or pull their products from the market.

In India, soaps and hand-washes are classed as cosmetics, subject to the Drugs and Cosmetics Act, 1940.

“Any review would depend on the importance of the FDA’s ruling in an Indian context of public health impact. Also, since the ban is owing to a lack of data, it’s unclear how we should proceed just yet. However, we do intend to review the ruling soon,” said one of the two CDSCO officials cited earlier.

Calls, texts and emails sent to a CDSCO spokesperson did not elicit a response.

Multiple products in India use triclosan and triclocarban, including some popular soaps and hand-washes such as Hindustan Unilever’s Lifebuoy, ITC’s Savlon, Wipro’s Santoor and Godrej’s Cinthol.

An HUL spokesperson said, “In 2015, we started replacing triclosan and triclocarban in our Lifebuoy soap. We no longer manufacture antibacterial soaps and personal wash products with triclosan. We will complete the phase-out of triclocarban across all markets in 2017. None of the other compounds mentioned in the FDA rule are used in Unilever antibacterial soap bars.”

Queries to the other companies named above had not elicited responses by the time of going to press.

While antibacterial products are an over $1 billion industry in the US, the market size in India is fairly small.

“The antibacterial liquid hand-wash market is a little over Rs.500 crore in India and growing 15% annually. Any order by the government banning certain compounds may not entail any significant disruption in the market,” said Rajat Wahi, partner and head (consumer markets) at consultancy KPMG in India.

To be sure, the US FDA did not say that the products were inherently harmful. The onus of proof, however, lay on the manufacturers, who had to show that the long-term use of their products would be advantageous, a claim which they failed to substantiate. Additionally, in 2015, a study published in the Journal of Antimicrobial Chemotherapy found that antibacterial formulas were ineffective at killing any more bacteria than traditional soap and water for hand washing, something the FDA stressed.

“Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the US Centers for Disease Control and Prevention recommends that it be an alcohol-based hand sanitizer that contains at least 60% alcohol,” it said.

A 2011 study by The Journal of Hazardous Materials on the risk assessment of triclosan and two other compounds (carbamazepine and parabens) in three Indian rivers—Cauvery, Vellar and Tamiraparani—and the Pichavaram mangrove in Tamil Nadu found that the mean concentration of triclosan found in the three rivers was “among the highest detected in surface waters”, with industrial effluents a major contributor.

“Hazard quotients suggest greater environmental risks for triclosan than for carbamazepine and parabens,” the study reported. A greater hazard quotient translates to significantly higher adverse health effects as a result of exposure to a compound or agent—in this case triclosan.

According to a health ministry official, who declined to be named, “While the US FDA’s decision needs to be looked into by the states and deliberated upon, it’s still a long-term public health concern when it comes to India. I would be surprised if there’s any movement by the states beyond looking at the central drug regulator.”

Emails sent to the health ministry went unanswered.

The long-term public health concern, however, is potentially blowing up into a full-fledged worry across the world. Pathogens, or microorganisms, are developing antibiotic resistance, or immunity, owing to continuous and systematic exposure to non-lethal quantities of antibacterial compounds. The implication being most antibiotics, even the strongest class of them—carbapenems—are useless against such pathogens.

The FDA, for instance, revealed in 2013 that some data suggested that “long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.”

“The cosmetics division of CDSCO will take a call on it, if need be. It basically depends on whether there’s a public health issue at stake here,” said the second of the two CDSCO officials cited earlier.

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