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Bombay HC allows Johnson & Johnson to manufacture and sell baby powder

The court noted the fresh tests conducted showed all batches of the product were compliant with the norms prescribed

The Bombay High Court has permitted Johnson & Johnson to manufacture, sell and distribute its baby powder and quashed three orders of the Maharashtra government revoking the company's license and asking it to stop the product manufacture and sale, terming them as “stringent, unreasonable and unfair”.

According to a report by Newsdrum, the court in its order on Wednesday noted the fresh tests conducted showed all batches of the product were compliant with the norms prescribed.

A division bench of Justices Gautam Patel and S G Dige noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time 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 would result in a considerable amount of "commercial chaos and wastefulness", it said.

The bench also came down heavily on 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.

“Since 2018, when the sample was taken for test, the company has been manufacturing and selling its product till 2022 when its license was revoked. It is necessary to have a watchdog like the FDA but a watchdog must do its job of guarding. This is not achieved when there is a delay in testing samples,” the bench said.

The HC said a “more granular approach” would be available to the FDA under the provisions of law.

“It does not seem reasonable to us to accept that the moment a product is found to be deviant or non-conforming to the prescribed standards, then the only possible consequence is to shut down all manufacturing,” the court said.

The orders of suspension and revoking of the license were passed based on the report of a lab which found the baby powder contained a higher pH level than prescribed.

The court passed its order on a petition filed by the company challenging three orders of the state government – one dated September 15, 2022, cancelling the license, the second dated September 20, 2022 ordering it to immediately stop the manufacturing and sale of the baby powder product, and the third passed on October 15, 2022 by the state minister concerned upholding the earlier two orders.

"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 license of the manufacturing company?" the HC in its order stated.

"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.

The company had in its plea said 14 random batches of February, March and September 2022 were tested by an independent public testing laboratory and all were found to be well within the prescribed pH value.

The leading FMCG manufacturer said it has been making the baby powder in its Mulund plant for the last 57 years and its license was renewed in January 2020.

The company also said due to the license revocation, it suffered a daily loss of Rs 2.5 crore based on the market value of the goods sold.

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