Maharashtra News: Maharashtra’s apex-drug regulation body Food and Drug Administration (FDA) has granted baby powder manufacturing license to the Mulund (Mumbai) plant of global pharmaceutical giant Johnson & Johnson (J&J). has been cancelled. The FDA said in its order on Thursday that the company has also been directed to withdraw the stock of the said product from the market. In December 2018, FDA-Maharashtra took samples of J&J’s baby powder from Pune and Nashik for quality checks during a surprise inspection. The sample of baby powder manufactured at Mulund plant was declared ‘not of standard quality’. The test results in 2019 concluded that "Specimen test pH does not comply with IS 5339:2004 (Second Amendment Amendment No. 3) specification for Skin Powder for Infants."
Cancellation of license immediately after second result
difference in pH has this effect
According to an FDA release, the product may affect the health of babies’ skin. An FDA official said, "For the safety of the public, we have canceled the license and directed them to take back the stock." In January 2020, the All Food and Drug License Holders Foundation wrote to FDA-Maharashtra, pointing out the delay in initiating action against J&J. The letter to the company states that “generally, when the pH of baby powder is above average, it indicates a mistake in the manufacturing process and an impurity in an admixture element or ingredient during the manufacturing process.” If the pH level in baby powder is above average, it can affect the skin of babies. Therefore, I request you to take this matter very seriously and conduct a fair investigation”