Lagatar24 Desk
Mumbai, Jan 11: The directives of the Food and Drug Administration (FDA), Maharashtra prohibiting Johnson & Johnson Private Limited from producing baby powder in its facility in the Mumbai suburbs were overturned on Wednesday by the Bombay High Court.
After taking into account Johnson’s claim that only two of the 11 to 12 samples of baby powder that the FDA evaluated did not meet the relevant quality criteria, a bench of Justices GS Patel and SG Dige approved the product’s sale.
“There were altogether 11-12 results. Of these 2 are non-compliant. All others are within range. Is it either reasonable or proportionate on such a result that the product should be shut down in perpetuity, and the manufacturer of all other batches also. Would we want reasonablesness or proportionality to take such action that law permits on conforming batches?” the Court said.
The Court also considered it unfair that a particular batch’s noncompliance and a quality variation would only result in the suspension of all manufacturing.
“This seems to us to be extreme and there is nothing on record to show that FDA has consistently adopted such a stringent standard, with Johnson or other manufacturers. We rather believe that this kind of approach will result in considerable amount of commercial chaos and wastefulness. It is hard to imagine how any manufacturer will function” the Court remarked.
The FDA took too long to respond after receiving the test findings in 2018, according to the Court. The Court also objected to the laboratories’ delay in performing the pH test.
As a result, the order was voided and the company was free to sell its goods.
However, it was necessary to destroy the goods from the batch that had been tested in accordance with a co-ordinate bench ruling of the High Court on November 16, 2016. The business agreed to destroy it at its own expense and warned its distributors that the product would not be permitted to hit the market.
The decision was made in response to a petition by Johnson & Johnson, through Nishith Desai & Associates, submitted to contest the suspension of the baby powder facility’s cosmetic manufacturing licence in Maharashtra.
In the plea, it was noted that on September 15, the Joint Commissioner & Licensing Authority, FDA, Maharashtra, had issued an order cancelling the company’s licence, effective on December 15, 2022.
