INDIA. Mumbai: The Bombay High Court on Wednesday set aside the orders of the Maharashtra Food and Drug Administration (FDA), restraining Johnson & Johnson Private Limited from manufacturing baby powder at its facility at Mulund in North East Mumbai.
The order was passed on a petition filed by Johnson & Johnson challenging the cancellation of the cosmetic manufacturing license of its baby powder facility by the Maharashtra FDA.
The petition pointed out that the Joint Commissioner & Licensing Authority, FDA, Maharashtra, had issued an order on September 15, 2022, cancelling the company’s license, effective December 15, 2022.
Five days later, the commissioner reviewed the order and directed the company to immediately stop the manufacture and sale of the baby powder manufactured at its Mulund plant.
On Wednesday, a division bench comprising Justices GS Patel and SG Dige allowed the sale of the product after noting the submission of Johnson that of the 11 to 12 samples of the baby powder tested by the FDA, only two were non-compliant with the concerned quality standards.
The Court also noted that the FDA took too long to act after the test results were released in 2018. The Court also questioned how non-compliance with a particular batch and deviation from a standard quality, can lead to a shutdown of all manufacturing activities.
In its order dated November 18, 2022, a division bench comprising Justices S V Gangapurwala and S G Dige, had directed the FDA to send fresh samples of the baby powder to three laboratories for testing. It also agreed with the FDA’s demand that the sale or distribution of baby powder should not be permitted for the time being. As per the order, the samples were tested in three different laboratories.
J&J vs FDA
The action against the company began when the FDA tested the samples of the powder at its laboratories in Pune and Nashik on December 20, 2018, and June 27, 2019, respectively. The Government Analyst, FDA, Maharashtra, issued a report stating that “The sample does not conform to IS5339: 2004 concerning the test for pH”. The FDA then sent samples to the Government of India’s Central Drugs Laboratory (CDL) in Kolkata, which confirmed the report.
However, J & J challenged the decision of the FDA to send the samples to the CDL.
Then the FDA referred the samples to the Central Drugs Standard Control Organisation (CDSCO), West Zone, which too confirmed the report of the government analyst. As such the Maharashtra FA issued a final report stating that “the sample does not conform to IS5339: 2004 concerning the test for pH”.
Also Read: Bombay High Court Directs Fresh Testing of Johnson & Johnson Baby Powder