[Johnson & Johnson license cancellation] Bombay High Court calls for re-examination of baby powder samples in government lab

The Bombay High Court on Monday called for the re-examination of samples of baby powder manufactured by Johnson & Johnson in government or government-approved labs..A Division Bench of Justices SV Gangapurwala and SG Dige asked Additional Government Pleader Milind More to submit names of such labs by November 16. The Bench stated that it would pass an order on Wednesday, after receiving the names of the labs..In the previous hearing, the Court had asked the State whether it had tested more samples from the same batch of baby powder which was under challenge in the petition, or from any other batch. Counsel for the State informed the Court today about a case in Delhi, where one of the samples had not matched the statutory requirement under the Drugs and Cosmetics Act and Rules.Appearing for Johnson & Johnson, Senior Advocate Ravi Kadam pointed out that the Minister of Food and Drug Administration (FDA) in Delhi had not issued a show cause notice and had considered what the company had to submit, which was contrary to what the company faced in Maharashtra. “Here, we made all these submissions and the Minister has only looked at Central Drugs Laboratory (CDL) report not any other material. There was a report we submitted (of a private laboratory),” he said..The Court deduced that the company was not seeking an order directing the Minister of FDA to reconsider the matter afresh. Thus, it decided to hear the issue themselves.It also asked counsel to take instructions on whether the State would be willing to allow the company to begin manufacturing the powder at the facility. “Let them be allowed to manufacture, we will not permit them any handover for sale or even distribution,” the Court assured..The Bench 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 stated that the order was passed despite the company having provided stability reports and test reports of the latest batches of the talcum powder. The company had also allegedly assured that it would submit pH reports of the product. The order failed to refer to the alleged lab report on the basis which the orders under challenged came to be passed, it contended. It also claimed that the orders by the FDA authorities referred to two samples of the powder submitted in 2018 and 2019..The State government justified it decision to cancel the manufacturing license of the baby powder in the State, reasoning that the same was done for the health and welfare of the consumer, which was most important.In its affidavit, the State said that it will be gross failure on its part if it fails to enforce the statutory provisions under the Drugs and Cosmetics Act and Rules meant to safeguard the health of people.