HC quashes J&J baby powder manufacture ban over FDA test delay

MUMBAI: Observing an “unreasonable delay” in the watchdog’s actions, the Bombay high court on Wednesday set aside a Maharashtra Food and Drugs Administration (FDA) on September 15, 2022, order to ban the manufacture of Johnson’s Baby Powder at the Mulund facility of the leading fast moving consumer goods (FMCG) giant Johnson & Johnson Pvt Ltd citing “unstable” sample from a batch of 2018, tested in 2019.
“A pH test cannot conceivably take weeks let alone months and years. That is unreasonable,” said the HC. It said, “The failure of FDA to act with utmost dispatch is contrary to provision of the Drugs and Cosmetics Act.’’
The FDA last year cancelled the company’s licence to manufacture baby talcum powder at its Mulund plant and sell, after a sample was found to have a pH of 8.4 when the standard was between 5.5 and 8. On October 19, 2022, the FDA minister, in an appeal by the company, upheld the ban, citing a report from a central laboratory in Kolkata.
The HC also said, “Shutting down all manufacturing seems to be extreme.” It added, “Nothing to show from state that FDA has adopted such stringent approach for other J&J products or other cosmetic products... Would result in considerable degree of commercial chaos and wastefulness.”
The HC questioned the delay in testing and enforcement of the ban action in 2022 after the baby powder sample was taken in 2018. “It is too late now to fall back on a single batch sample of 2018 not tested till 2019 and not acted on till 2022 to stop manufacture of all batches of baby powder,” it ruled.