Mumbai, Nov 16: The Bombay High Court on Wednesday approved Johnson & Johnson Private Limited’s request to manufacture baby powder at its Mulund factory in Maharashtra, but it also ruled that the company is not now allowed to sell or distribute the product.
The Food and Drug Administration (FDA) was also ordered to deliver additional samples of the baby powder from the Mulund factory to three laboratories for testing by a division bench comprising Justices SV Gangapurwala and SG Dige.
The court was considering a petition Johnson & Johnson filed through Nishith Desai & Associates to contest the suspension of the baby powder facility’s cosmetic manufacturing licence in Maharashtra.
In the appeal, it was noted that an order was issued on September 15 by the Joint Commissioner & Licensing Authority, FDA, Maharashtra, cancelling the company’s licence with effect from December 15, 2022.
After reviewing the decision five days later, the commissioner instructed the business to immediately halt producing and selling baby powder made at a plant in Mulund, Maharashtra.
The Bench gave Johnson permission to produce the baby powder at its own risk during the hearing today. The FDA’s order prohibiting the sale of the product or its transfer to a distributor for sale was also upheld by the Bench.
The Court had requested a reexamination of Johnson & Johnson baby powder sample at government or government-approved labs during an earlier hearing.
As a result, Additional Government Pleader Milind More today provided the Court with a list of laboratories. The Court instructed the parties to choose three laboratories from the list in order to reduce margin of error in the outcome.
“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 Zone
- FDA laboratory at Bandra-Kurla Complex, Maharashtra
- Intratech Laboratory (private lab)
In its order, the Court made it clear that the FDA officer would collect the samples from the manufacturing facility while a representative of the petitioner company was present.
The officer was to send the samples to the lab within 3 days of completing the same within 3 days starting from today. A week from the date the sample was received, the laboratory was instructed to make sure the sample was tested and a report was sent.