Bombay High Court directs fresh testing of Johnson & Johnson baby powder; allows company to manufacture but freeze on sale to continue

The Bombay High Court on Wednesday permitted Johnson & Johnson Private Limited to manufacture baby powder at its Mulund facility in Maharashtra but ordered that sale or distribution of the baby powder would not be permitted for the time being..A division bench of Justices SV Gangapurwala and SG Dige also directed the Food and Drug Administration (FDA) to send fresh samples of the baby powder from the Mulund facility to three laboratories for testing. The Court was hearing 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 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.During the hearing today, the Bench permitted Johnson to manufacture the baby powder at its own risk.The Bench also affirmed the order of the FDA that no sale of the product or handing it over to the distributor for sale would be permitted..During an earlier hearing, the Court had called for the re-examination of samples of baby powder manufactured by Johnson & Johnson in government or government-approved labs.Accordingly Additional Government Pleader Milind More submitted a list of laboratories to the Court today. From the list, the Court asked the parties to select three laboratories in order to avoid margin of error in the result. “We will direct that samples be sent to 2-3 labs. We do not want any margin of error. We will not send sample to just one”, the Court said. The three laboratories agreed upon by the parties are: Central Drug Testing Laboratory, Western ZoneFDA laboratory at Bandra-Kurla Complex, MaharashtraIntratech Laboratory (private lab).The Court in its order clarified that the samples will be collected from the manufacturing facility by the FDA officer in the presence of a representative of the petitioner company. The same was to be done within 3 days from today and thereafter the officer will send the samples to the laboratory within 3 days thereafter. The laboratory was directed to ensure the sample is tested and report is sent within a week from the date on which the sample is received.