Bombay High Court allows Johnson and Johnson to manufacture, sell baby powder; sets aside FDA orders

The Bombay High Court on Wednesday set aside the orders of the Food and Drug Administration (FDA), Maharashtra restraining Johnson & Johnson Private Limited from manufacturing baby powder in its facility in Mumbai suburbs..A bench of Justices GS Patel and SG Dige allowed the sale of product after noting the submission of Johnson that of the 11 to 12 samples of the baby powder which were tested by the FDA, only two were non-compliant with the concerned quality standards. "There were altogether 11-12 results. Of these 2 are non-compliant. All others are within range. Is it either reasonable or proportionate on such a result that the product should be shut down in perpetuity, and manufacturer of all other batches also. Would we want reasonablesness or proportionality to take such action that law permits on conforming batches?" the Court said.The Court also found unreasonable how non-compliance of a particular batch and deviation from a standard quality would only lead to shut down all manufacturing."This seems to us to be extreme and there is nothing on record to show that FDA has consistently adopted such a stringent standard, with Johnson or other manufacturers. We rather believe that this kind of approach will result in considerable amount of commercial chaos and wastefulness. It is hard to imagine how any manufacturer will function" the Court remarked. .The Court also noted that there was delay by FDA in taking action after the test results had come in 2018."We are unable to understand why for a sample in mid 2018, no test result came for over a year. The now usual excuse of Covid will not do because this was before anyone could imagine covid, then there was a delay which ran till 2022," the Court said.The Court also took exception to the delay of the laboratories in carrying out the pH test. "We find it astonishing that a pH test takes 2 weeks. A ph test cannot take weeks, or months let alone years. It is unreasonable. Not only for manufacturer. But it is unreasonable from perspective of consumer", the Court said. .It, therefore, allowed the company to sell its product and vacated the order staying the same.The company also undertook to destroy the stock from the batch which had been tested after the order of High Court..The High Court while disposing off the petition set aside the two orders passed by the Joint Commissioner of FDA restraining the company from selling stock of the baby powder and recalling the stock from the market and the appellate order of the Minister of FDA upholding the commissioner's order..The order was passed on a petition filed by Johnson & Johnson through Nishith Desai & Associates challenging the cancellation of cosmetic manufacturing license of its baby powder facility in Maharashtra.The petition pointed out that the Joint Commissioner & Licensing Authority, FDA, Maharashtra had issued an order on September 15 cancelling the company’s license, effective from December 15, 2022.Five days later, the commissioner reviewed the order and directed the company to stop manufacture and sale of the baby powder manufactured at a facility in Mulund, Maharashtra with immediate effect.Senior Advocate Ravi Kadam for the company had requested the Court to permit them to sell the accumulated stock. The Court ordered for re-testing of samples and after perusal of the report 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.