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A senior government official said that central drug licensing inspectors will draw samples of J&J's baby powder and start its probe
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New Delhi: Johnson and Johnson (J&J) Pvt. Ltd is under scrutiny again. India’s drug regulator has decided to investigate J&J’s baby powder following recent reports that said J&J knew for decades about the presence of cancer causing asbestos in the product.
A senior government official said that central drug licensing inspectors will draw samples of J&J’s baby powder and start its probe. “The inspectors will visit J&J’s manufacturing facility, draw samples for further investigation," the official told Mint.
The drug licensing inspectors have also been told to lift samples of raw material used by J&J in talcum powder, as well as the finished product from retail stores across the country.
“They will be tested at the central drug laboratory," said another official, on condition of anonymity.
Ubiquitous in many Indian homes, J&J’s talcum powder has been in the news for wrong reasons.
In July, following a report that the US parent was ordered to pay $4.7 billion to 22 women who claimed asbestos in its talc had caused them ovarian cancer, India’s drug regulator had at the time asked J&J to reveal the composition of its talcum powder.
In an email dated 19 July, the Central Drugs Standard Control Organization (CDSCO) wrote to J&J to share the composition of its powder sold in India and the US.
On 12 July, a Missouri court had ordered the pharmaceutical giant to pay compensation and damages in the asbestos case.
J&J insists that its baby powder is safe and asbestos-free. “Studies of more than 100,000 men and women show that the talc does not cause cancer or asbestos-related disease. Thousands of independent tests by regulators and the world’s leading labs prove our baby powder has never contained asbestos," the spokesperson for the company said in a statement.
This is, however, not the first time that the product has come under the scanner.
In 2013, the Maharashtra Food and Drug Administration cancelled the licence of J&J’s facility after it found that 160,000 packets of baby talcum powder manufactured at the Mulund plant were sterilized at another plant using ethylene oxide, a chemical that is widely believed to cause cancer.
“It was found that J&J deviated from their normal practice of sterilizing its baby powder. In our investigations, we found that J&J sent batches of its talcum powder to another plant in Thane to sterilize the powder. The powder was sterilized with ethylene oxide, which is carcinogenic. The facility where they sent the powder was not licensed to treat powder. The company was charged for multiple violations and their licence was cancelled, facility shut for three months after which they went to the court and got the relief," said Mahesh Zagade, former FDA commissioner, Maharashtra.
According to market researcher Euromonitor, the talcum powder category is shrinking in India, with a decline in compound annual growth rate by 5.7%.
In its defence, Johnson and Johnson said the Reuters report that has put the spotlight on its talcum powder “ignores that thousands of tests by J&J, regulators, leading independent labs, and academic institutions have repeatedly shown that our talc does not contain asbestos".
“The article ignores that Johnson and Johnson has cooperated fully and openly with the US Food and Drug Administration and other global regulators, providing them with all the information they requested over decades. We have also made our cosmetic talc mines and processed talc available to regulators for testing. Regulators have tested both, and they have always found our talc to be asbestos-free," said the company spokesperson.
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