Bombay HC Quashes FDA Order Against Johnson & Johnson, Allows Company To Sell Baby Powder
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Bombay HC Quashes FDA Order Against Johnson & Johnson, Allows Company To Sell Baby Powder

The Bombay High Court on Wednesday quashed and set aside the Maharashtra Food and Drug Administration (FDA) order that barred Johnson & Johnson from producing and selling its baby powder.

A division bench of Justice Patel and Justice SG Dhige allowed the product’s sale, noting that there were 11-12 results in total.

The FDA’s order was overturned by the court, which stated that the action was needlessly delayed by two years. “It’s too late to use a single batch to justify the extreme action of halting all production of all batches of baby powder,” the court remarked.

“The law is centred on public good, welfare, and consumer protection. There is a significant delay. They were deemed unreasonable and thus arbitrary by the bench. It is necessary to have a “watchdog” like the FDA, but it must do its proper job, which is to protect, which is not accomplished by delaying testing of samples drawn and protracting proceedings for months or years,” the court stated.

The court went on to say that it is not always necessary for the FDA to take a one-size-fits-all approach. A manufacturer who is a repeat offender may be treated differently than a manufacturer whose product has an occasional lapse. The court understands that the testing process may take a few days, but pH tests are important in this case. The court also observed that it was unbelievable  that it took two weeks. Even if it had to be done in a sterile lab, it would only take a few minutes.

The court was hearing a petition filed by the company, challenging the state government’s decision to revoke its baby powder manufacturing licence in Mumbai.

On 15 September 2022, the FDA, Maharashtra’s Joint Commissioner and Licensing Authority issued an order cancelling the company’s licence, effective 15 December, 2022. During a random inspection in December 2018, the FDA took samples of the baby powder and discovered it to be “not of standard quality.” The state then revoked the licence, citing public interest, and cancelled it in September 2022, ordering the company to remove the powder from the market.

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