Bombay High Court likely to revoke FDA order cancelling Johnson & Johnson baby powder license

Bombay High Court likely to revoke FDA order cancelling Johnson & Johnson baby powder license

The verdict will be pronounced on 11 January

The Bombay High Court has indicated that it would set aside the order of the Joint Commissioner & Licensing Authority, Food and Drug Administration (FDA), Maharashtra restraining Johnson & Johnson Private Limited from manufacturing baby powder in their facility in Mumbai suburbs.

A division bench of Justice GS Patel and Justice SG Dige stated that apart from setting aside the order, it would also elaborate on the aspects of - the legal principles of proportionality; a state that power must be exercised reasonably and proportionally; and the manner in which licenses and production could be cancelled as per the rules, in future.

The court specified that it would insist the FDA authorities act within a time frame since they were dealing with cosmetics, and it required urgency to test the samples. Also, it would not go into the issues beyond the orders under challenge and the batches from which samples were taken for testing.

The bench observed, "Assuming the samples produced after this test batch is dangerous as they say, it was out in the market between 2018 to 2022. If the powder was been stopped expeditiously, what is a writ court supposed to do? In January 2023, when batches between 2019 to the "stop production" notice have already been sold? They have reached the consumer."

The court enquired about the dangers posed to the public in using a product that the state had decided was non-compliant with the quality guidelines.

The bench stated, "A writ court cannot speculate. We want someone to tell on affidavit that this is the danger, this is why we acted; that there is an element of detriment to the public safety. We cannot assume that if the pH is too high, it is alkaline, so it is unsafe. It may be safe too. But show us how it is unsafe. If you are non-compliant, you stop production. If we put this in the judgment, it will look ridiculous."

Clarifying that they did not want any misunderstanding, the judges said, "We are not saying whether it is safe or unsafe. We are testing your action. You have to justify saying you have acted properly in the manner given in the safeguard. Do not misunderstand us. We want you to be vigilant with any kind of medicinal product in the market. Especially with the big pharmaceuticals, because of the sheer volume they manufacture. But we just want you to act swiftly considering the public interest."

Johnson and Johnson had filed a petition through Nishith Desai & Associates.

Appearing on behalf of the company, senior advocate Ravi Kadam requested the court to permit them to sell the accumulated stock. Thus, posting the matter for the judgment on 11 January, the bench stated it would decide on the request on that date.

Earlier, Kadam had informed the court about the three laboratory reports that a co-ordinate bench of the high court had called for on 16 November. The court questioned the state on the delay of over two years in passing an order cancelling the cosmetic company's manufacturing licence for baby powder.