The FDA-Maharastra had taken the samples of J&J’s talc-based baby powder from Pune and Nashik for quality check during a random inspection in December 2018.
The drug regulating body Food and Drug Administration (FDA) has cancelled the license for the baby powder manufacturing of the global pharmaceutical giant Johnson & Johnson (J&J)’s plant in Mulund, Mumbai. The FDA also instructed the company in its order on Thursday to recall the stock of the concerning product from the market.
The FDA-Maharastra had taken the samples of the talc-based baby powder from Pune and Nashik for quality check during a random inspection in December 2018. The sample from the Mulund plant was declared as not of standard quality with the test result that came in 2019 which concluded that the sample does not comply with IS 5339 (2004) Indian Standard Skin Powder For Infants – Specification (Second Revision Amendment No.3) in the test pH.
Afterwards, a show-cause notice was given to the company under the Drugs and Cosmetics Act – 1940 and rules. In response, the company challenged the results and demanded a retest. So, it was then referred to the government-run Central Drug Laboratory in Kolkata.
Going further, an official from FDA said in a statement that a second test result that came recently had reestablished their findings that the samples did not meet the standard quality parameters and there was no need to send a show-cause notice again to them. So, they’ve cancelled their licence directly.
According to FDA, the said product may affect the health of the skin of the babies.
In January 2020, the All Food and Drug Licence Holders’ Foundation wrote FDA-Maharastra pointing out the delay in initiating an action against the company J&J.
According to the letter, if the pH of baby powder is above average level, it indicates a mistake in the manufacturing process and the presence of an impurity in the admixture element or ingredient during the manufacturing process. The above-average pH level of baby powder can affect the skin of babies. The letter requested FDA to take this matter with utter sincerity and conduct a fair investigation.
Related: Johnson & Johnson has to stop their sales of baby powder in 2024
