The Bombay High Court on Wednesday permitted Johnson & Johnson Private Limited to manufacture their baby powder at “its own risk” in Mulund but withheld the permission for its sale and distribution as the Food and Drug Administration (FDA) had revoked the licence.
A Division Bench of Justices S.V. Gangapurwala and S.G. Dige was hearing a petition filed by Johnson & Johnson challenging the order by the State government, cancelling the manufacturing licence of its baby powder in Mumbai. The plea mentions: “On September 15, the Joint Commissioner and Licensing Authority, FDA Maharashtra, issued an order cancelling the company’s licence, effective from December 15, 2022. In December 2018, the FDA during a random inspection took samples of the baby powder and found it to be “not of standard quality.” The State had then revoked the licence citing public interest and in September 2022, cancelled it and directed the company to recall the stock of the powder from the market.
On Wednesday, senior advocate Ravi Kadam, appearing for the company, said the FDA did not issue a showcause notice to his party and urged that the product samples be sent to the Central Drug Testing Laboratory. The court then directed the samples to be sent to more than one lab as it did not want any margin of error. The State counsel suggested the names of the three laboratories. The court directed the FDA to collect the samples and send them to the labs within three days and posted the matter to be heard on November 30.
Meanwhile, the court permitted the company to manufacture the product at its own risk and also directed the FDA to send fresh samples of the baby powder from the Mulund facility to three laboratories for testing.