Bombay HC allows Johnson & Johnson to make and sell baby powder, lifts ban
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Mumbai: The Bombay High Court has quashed three orders of the Maharashtra government preventing Johnson & Johnson's baby powder business. The court has permitted the American company to manufacture, sell and distribute its baby powder.
The court said it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products. "Such an approach will result in a considerable amount of commercial chaos and wastefulness." The government order was on the basis of a lab report which found the baby powder contained higher pH levels than prescribed. The court noted that the fresh tests showed all batches of baby powder products were compliant with the norms.
The division bench of Justices Gautam Patel and S G Dige said the government revoking the company's licence was "stringent, unreasonable, and unfair." They also criticised the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company's baby powder seized in December 2018. The test was done in December 2019. The bench called the delay unreasonable, unacceptable, and arbitrary.
"The executive cannot use a hammer to kill an ant. Is it always inevitable that when there is a single case of deviation or non-compliance (to prescribed norms) by a product the only option left with the regulatory authority is to cancel or revoke the licence of the manufacturing company?," said the HC order.
"This seems to us as an extreme approach. There seems to be unfairness and unreasonableness in the executive action. There is also nothing to show that the FDA has adopted such a stringent approach for any other product of the petitioner company or any other company," it added.
Johnson & Johnson had challenged three orders of the state government - one dated September 15, 2022, cancelling the licence and the second dated September 20, 2022, ordering it to immediately stop the manufacturing and sale of the baby powder product. The third order was passed on October 15, 2022, by the state minister upholding the earlier two orders.
