During a random inspection in December 2018, the FDA-Maharashtra collected samples of J&J's talc-based baby powder from Pune and Nashik for product testing.
Digital Desk: The baby powder production license for the Mulund (Mumbai) facility of the multinational pharmaceutical firm Johnson and Johnson (J&J) has been revoked by Maharashtra's Food and Drug Administration (FDA), the state's top drug regulating authority.
The FDA stated in its decision on Thursday that the corporation has also been directed to remove the aforementioned product's stock from the market.
During a random inspection in December 2018, the FDA-Maharashtra collected samples of J&J's talc-based baby powder from Pune and Nashik for quality control. The Mulund plant's baby powder sample was deemed to be "not of standard quality."
"The material does not conform with IS 5339: 2004 (Second Revision Amendment No. 3) specification for Skin powder for newborns in test pH," was the test's conclusive finding in 2019.
Later, the firm received a show-cause notice pursuant to the Drugs and Cosmetics Act of 1940 and Rules. The government-run Central Drugs Laboratory in Kolkata was contacted when the company disputed the results and wanted a rerun.
There was no need to send them another show-cause notice because the most recent second test result confirmed our earlier conclusions that the samples didn't exceed the required quality standards. As a result, we immediately revoked their licence, according to an FDA representative.
According to an FDA press release, the product may have an impact on the newborns' skin's health. An FDA representative who wished to remain anonymous said, "For the safety of the public, we have cancelled the licence and directed them to recall the stock."
The FDA-Maharashtra received a letter from the All Food and Drug Licence Holders' Foundation in January 2020 highlighting the delay in taking action against J&J.
In general, an error in the manufacturing process and an impurity in an admixture element or ingredient during the manufacturing process are both indicated when the pH of baby powder is above average.
Babies' skin may be impacted if baby powder has an above-average pH level. As a result, I kindly request that you treat this situation seriously and carry out a thorough investigation, according to the letter.
When a message asking for a remark was sent to J&J, there was no response.
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