Bombay High Court indicates it will set aside FDA order cancelling license of Johnson & Johnson baby powder

The Bombay High Court on Monday 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 Justices GS Patel and SG Dige stated that aside from setting aside FDA order, it will also try and elaborate on the following three aspects:Set out the legal principles of proportionality;State that power must be exercised reasonably and proportionally; The manner in which licenses and production can be cancelled as per rules in future cases. The Court specified that it would insist the FDA authorities to act within a time frame since they are dealing with cosmetics, and there ought to be urgency to test samples. The Court also clarified that as far as the present case by Johnson &Johnson is concerned, it would not go into the issues beyond the orders under challenge and the batches from which samples were taken for testing. The verdict will be pronounced on January 11, Wednesday. .The division bench stated so while hearing Johnson and Johnson's petition filed through Nishith Desai & Associates. .The bench indicated outright its inability to come up with any possible solution in the petition since it was dealing with an order passed by a regulator on the basis of a defunct guidelines. "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 powders has not 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 consumer," the Court observed..The Court also enquired about the dangers posed to the public in using a product which the State had decided was non-compliant with the quality guidelines. "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 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", the Court said..Before concluding the hearing, the Court also clarified that it did not want any misunderstanding to ensure from its line of questioning."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," the Court concluded. .Senior Advocate Ravi Kadam for the company requested the Court to permit them to sell the accumulated stock. The bench posted the matter for pronouncement of judgment on January 11 and stated it will decide on this request on that date..Kadam had in the previous hearing informed the Court about the three laboratory reports which a co-ordinate bench of the High Court had called for on November 16 last year.After perusal of the report and the orders under challenge, the Court questioned the State why there had been a delay of over two years in passing an order cancelling the cosmetic manufacturing licence of the company's baby powder facility in Maharashtra.Additional government pleader Milind More appeared for the State.