Bombay HC quashes FDA ban on production and sale of Johnson & Johnson baby powder
The High Court noted that the two-year delay in imposing the ban on the product was unreasonable and arbitrary.
The Bombay High Court on Wednesday set aside an order of the Maharashtra Food and Drug Administration that restrained pharmaceutical company Johnson & Johnson from manufacturing and selling its baby powder, reported Live Law.
Johnson & Johnson had moved the High Court against the Food and Drug Administration’s September 2022 decision to cancel its licence to manufacture baby powder at its factory in Mumbai’s Mulund area.
The decision came after the regulator claimed that tests on samples of the baby powder revealed that the pH levels were higher than the prescribed limit. The pH levels determine whether a substance is acidic or alkaline in nature.
The Food and Drug Administration had collected the samples of the product in November 2019, and issued a show cause notice to the company in 2021. On September 15 last year, the product’s licence was cancelled.
On Wednesday, a division bench of Justices Gautam Patel and SG Dhige allowed Johnson & Johnson to manufacture and sell its baby powder. The High Court also pulled up the drug authority for cancelling the licence two years after an order was passed in the case.
“The particular action is needlessly delayed by two years,” the court said, reported The Hindu. “It’s too late to fall back on example of single batch to justify extreme action of stopping all production of all batches of baby powder. We don’t believe impugned orders can be sustained.”
The court added: “Public purpose, welfare and consumer protection is at the heart of the law. There is a harsh delay. We find them to be unreasonable and for that reason arbitrary. It is necessary to have watchdog like FDA but it must do its proper job which is to guard, purpose which is not achieved by delaying testing of samples drawn and protracting proceedings for months and years.”
The High Court also said the batch that was tested in 2019 should be re-called and destroyed as two of the 11 samples examined were found to be of a higher pH level.
At an hearing on Tuesday, the High Court had said that the authorities could carry out fresh testing of samples according to new guidelines of the Centre and take swift action if they violate safety standards.
Notably, Johnson & Johnson faces about 38,000 lawsuits that claim its talcum products cause cancer due to contamination with asbestos. The product had been discontinued in the United States and Canada in 2020. On August 11, the company had announced that it will stop selling its baby talcum powder globally from 2023.