On January 11, the Bombay High Court division bench led by Justice Gautam Patel and Justice SG Dhige quashed the Maharashtra Food and Drug Administration's orders cancelling Johnson & Johnson's licence to manufacture baby powder at the Mulund factory. Johnson & Johnson will now be able to produce and sell baby powder. A division bench was unreasonable in its delay and thus arbitrary. "An administrator cannot use a hammer to kill an ant," said the court.

The court ruled that it is not reasonable to cancel the licence because one sample from a batch was found to be of poor quality. "It's an extreme approach. [There is] nothing to show FDA has adopted such a stringent standard with other J&J products or manufacturers," said the bench.

While acknowledging the importance of a watchdog such as the FDA, the court stated that proceedings cannot be delayed for weeks or months."But a watchdog must do its job properly which is to guard and protect. Public purpose, welfare and consumer protection is at the heart of the law. There is a harsh delay. It is unreasonable not only from the point of view of the manufacturer but even for consumers," it added.

The investigation against Johnson and Johnson began in November-December 2018 following a random FDA check on J&J's powder in Pune and Nashik. When the October 2018 batch sample was re-tested 11 months later, the pH levels were slightly higher. The company was notified in January 2020 and requested re-testing. A show cause notice, however, was issued only in February 2021, and a personal hearing was held in July 2022.

On November 16, 2022, a coordinate bench ordered new powder testing at two government labs and one private lab. According to the court, the FDA laboratory at Bandra-Kurla Complex and the Central Drug Testing Laboratory, Western Zone found the sample to be within the permissible limit of 5-8 pH level. The pH reading, however, was deemed unstable by Intratech Laboratory, a private laboratory. Intertek PTL's pH report found JBP samples at 7.58, 9.19, 6.37, and 7.59; CDTL lab's pH report is 5.88, 7.80, 7.89, and 6.32; and FDA lab's pH report is 7.19, 8.52, 5.98, and 7.20. Even after five minutes, Intertek discovered that the pH reading was not stable.
The pH reading should ideally be between 5-8.