HC quashes FDA order, allows J&J to sell baby talc manufactured at Mulund unit

The Bombay high court on Wednesday set aside an order of the Food and Drug Administration (FDA) which cancelled the licence of Johnson & Johnson Private Limited after a batch of its baby talcum powder was found to be of substandard quality

The Bombay high court on Wednesday set aside an order of the Food and Drug Administration (FDA) which cancelled the licence of Johnson & Johnson Private Limited after a batch of its baby talcum powder was found to be of substandard quality.

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The HC relied upon the reports of government-run and private testing laboratories to conclude that FDA’s decision, based on only one batch of the product, to halt the manufacturing at the company’s Mulund unit was arbitrary.

“It is necessary to have a watchdog like FDA but it must do its job properly which is to guard, a purpose which is not achieved by delaying the testing of samples and protracting proceedings for months. It is also not necessary for FDA to always adopt a one-size-fits-all approach. A manufacturer, who is a repeat offender, may receive a different treatment compared to a manufacturer whose product has occasional lapse,” a bench of justice G S Patel and justice S G Dige said.

The court asked FDA to conduct regular checks and permitted J&J to manufacture and sell the powder.

FDA had on September 15, 2022, issued a stop-work notice to the company on the grounds that samples of the baby powder collected in Pune and Nashik had higher pH (potential of hydrogen) levels. The samples were taken in 2018 but the tests were conducted in 2019. The results were conveyed to the company only in August 2022. Soon after, the company recalled the substandard product from the market and destroyed it.

The bench had been hearing the petition filed by J&J challenging the FDA order and the subsequent rejection of its appeal by the minister concerned.

Advocate Ravi Kadam, appearing for the company, argued that though 11 to 12 samples were tested, only two of them - belonging to the 2018 batch - were found to be of substandard quality.

The particular action was needlessly delayed by four years, the HC said. “It’s too late to fall back on the example of a single batch sample taken in 2018, not tested till 2019, and was acted on only in 2022, to justify the extreme action of stopping production of all batches. We don’t believe impugned orders can be sustained.”

The order further said the regulator had to have a more granular approach for different products and batches rather than cancelling the licence altogether and there was nothing to show that FDA consistently adopted such stringent standards with J&J or other manufacturers.

The bench also referred to the testing which was simple and would take a few minutes. “We find the state’s argument astonishing that the pH test takes two weeks. Even if it had to be done in sterile lab conditions it would not even take minutes. It is unreasonable not only from the point of view of the manufacturer, but also from the perspective of the consumer.”