New Delhi: India’s drug regulator has allowed Johnson and Johnson Pvt. Ltd to resume production of its iconic baby talc at its plants at Baddi, Himachal Pradesh, and Mulund, Mumbai, after tests affirmed it is of “standard quality".
Samples of J&J’s baby powder were sent to a government laboratory in Chandigarh on 18 December after allegations that it contains asbestos. The Drug Controller General of India (DCGI) issued Form 15 (under the Drugs and Cosmetics Act) to J&J’s manufacturing plants in Mulund and Baddi, barring the company from using raw material for talcum powder.
J&J was earlier barred from using about 200 tonnes of raw material at the Mulund plant. “They were issued Form 15, which means that they could not dispose of stocks of raw material used for making talc till further orders and hence could not manufacture their talc till further orders," said a senior government official.
J&J has now been allowed to resume production after the test report suggested that the talc is of standards quality, the official said.
“This conclusion reinforces the findings of decades of independent tests by universities, research labs and government regulators around the world that have consistently found that our talc is safe," a J&J spokesperson said in a statement.
J&J makes a range of toiletries for toddlers, including shampoo, lotion, talc and soap.
Market researcher Euromonitor International predicts baby and child toiletries in India to grow at an average annual rate of 16.5% till 2022. J&J continues to dominate this segment in India.
Government officials said, during the probe, the drug inspectors found that the company was testing the raw material in contravention of the Drugs and Cosmetics Act. “Under the Act, it is mandatory to test every batch of the raw material. However, drug inspectors found that J&J was randomly testing its raw material," another official said, requesting anonymity.
Ubiquitous in many Indian homes, Johnson’s baby powder has been in the news for all the wrong reasons. In July, too, India’s drug regulator asked J&J in India to reveal the composition of its talc following a report that the US parent was ordered to pay $4.7 billion to 22 women who claimed that asbestos in its talc had caused them ovarian cancer. In a 19 July email, the Central Drugs Standard Control Organisation asked the company to share the composition of its powder sold in India and the US.
The spokesperson said other countries have also reaffirmed the purity of J&J’s product. “In recent months, regulatory authorities from Singapore, Thailand, Saudi Arabia, Jordan, Kuwait, and Egypt have also reaffirmed the purity of Johnson & Johnson’s talc. We stand behind the safety of our talc, which is routinely tested by both suppliers and independent labs to ensure it is free of asbestos. Johnson & Johnson has cooperated fully and openly with global regulators, providing them with all the information they have requested dating back to the 1960s, and has made its cosmetic talc sources and processed talc available to regulators for testing".