In 2018, samples of Johnson’s baby talcum powder were collected from Pune and Nashik which were manufactured at the Mulund (Mumbai) plant for regular checks. The test results that came out in 2019 stated that they were “not of the standard quality”. The report from the analyst revealed that the pH levels (9.285) were higher than what is permissible (5.5 to 8). On September 15th 2019, the Food and Drug Administration (FDA) cancelled the Johnson & Johnson License and instructed the company to call back the stock of the said product from the market.
The FDA during a random inspection in December 2018 took J&J’s sample of talc-based baby powder. The results concluded that the sample does not comply with the IS 5339: 2004 specification for skin powder for infants in the pH test. A Notice was served to the company under the Drugs and Cosmetics Act of 1940. But the company challenged the said result and demanded for a retest and the samples were sent to Central Drug Testing Laboratory (CDTL), Kolkata.
The State Government replied to the company’s plea saying it would be “a gross failure” on their part as they safeguard people’s health. Also, the affidavit filed by Ashok Rathod (Assistant Commissioner of FDA) said that the petitioner cannot manufacture the products for sale until it assures them of the quality. The use of this product could affect the baby’s skin and their health too.
A bench of Justices SV Gangpurwala and SG Dige on Thursday asked the State whether it had tested more samples of the same batch of baby powder. The Additional government pleader Milind More told the court that he will update on the same by Monday. The Court posted the further hearing in this matter to 14th November.