India’s drug regulator to probe J&J’s baby talc for asbestos post-US recall1 min read . Updated: 25 Oct 2019, 06:06 PM IST
The impending investigation by India’s apex drug regulator follows the US-based company initiating a voluntary recall of a single lot of its baby talc in the US last week, the official said
NEW DELHI : The Central Drugs Standard Control Organization (CDSCO) will investigate Johnson & Johnson’s baby talc powder for the presence of asbestos contamination after a similar issue was seen in the US, a senior government official said.
“The US FDA had found 0.00002% asbestos in a sample of baby talc. It is a very small amount but the drug controller will be looking at it," the official said, on condition of anonymity.
The impending investigation by India’s apex drug regulator follows the US-based company initiating a voluntary recall of a single lot of its baby talc in the US last week, the official said.
Mint sent a mail seeking clarification from Johnson & Johnson’s India arm on the matter. A reply to the email is awaited.
The recall was in response to a US Food and Drug Administration (FDA) test which indicated the presence of sub-trace levels of chrysotile asbestos contamination at a level of as much as 0.00002% in samples from a single bottle purchased from an online retailer.
Last week, US-based firm Johnson and Johnson Consumer Inc made a statement that it has “immediately initiated a rigorous, thorough investigation into this matter, and is working with the FDA to determine the integrity of the tested sample, and the validity of the test results".
Johnson & Johnson also said that the investigation was at an early stage, it could not confirm whether cross-contamination of the sample caused a false positive, of if the sample was taken from a bottle with an intact seal or whether the sample was prepared in a controlled environment. It also said that it could not confirm whether the tested product was authentic or counterfeit.
The Economic Times had first reported that the Indian drug controller had initiated an investigation into Johnson & Johnson’s baby talc powder, and that the CDSCO has asked the FDA asking to share its testing protocol to establish the presence of asbestos in talc.