Savvy Thakur
Published on: 16 November 2022 at 22:07 IST
On Wednesday, the Bombay High Court granted Johnson & Johnson Private Limited permission to manufacture baby powder at its Mulund facility in Maharashtra, but it also stipulated that the baby powder would not be sold or distributed at this time.
Additionally, a division bench composed of Justices SG Dige and SV Gangapurwala ordered the Food and Drug Administration (FDA) to send fresh baby powder samples from the Mulund facility to three laboratories for evaluation.
Johnson & Johnson, had brought a petition to the Court challenging the denial of the cosmetic manufacturing license for its baby powder facility in Maharashtra.
The petition noted that the company’s license had been revoked by an order from the Joint Commissioner & Licensing Authority, FDA, Maharashtra, on September 15 and would no longer be valid until December 15, 2022.
After reviewing the order five days later, the commissioner ordered the company to immediately cease manufacturing and selling the baby powder produced at a facility in Mulund, Maharashtra.
The Bench granted Johnson permission to manufacture the baby powder at its own risk during today’s hearing.
The FDA’s order that the product could not be sold or given to the distributor for sale was also upheld by the Bench.
The Court had requested that samples of Johnson & Johnson’s baby powder manufactured in government or government-approved laboratories be reexamined at an earlier hearing.
As a result, Additional Government Leader Milind More presented the Court today with a list of laboratories.
In order to avoid a margin of error in the result, the Court asked the parties to choose three laboratories from the list.
The Court stated, “We will direct samples to be sent to two to three labs. There should be no room for error for us.”
The parties came to an agreement on the following three labs:
Central Drug Testing Laboratory, Western Zone FDA laboratory at Bandra-Kurla Complex, Maharashtra Intratek Laboratory (private lab)
The Court clarified in its order that the FDA officer will collect the samples from the manufacturing facility in the presence of a petitioner company representative.
The officer will then send the samples to the laboratory within three days. The same was to be done within the next three days.
The laboratory was instructed to ensure that the sample was tested and that a report was sent within a week of receiving it.