The Bombay High Court (HC) has overturned a Maharashtra Food and Drug Administration (FDA) order prohibiting Johnson & Johnson from selling baby powder in the state. The ruling came in response to a plea submitted by the business, which contested the Government's termination of J&J's license to manufacture the powder in its Mumbai Plant.
The issue began in 2018, when an FDA inspector discovered that a sample of the powder was not of standard quality for use. Specifically, the pH level of the powder was found to be higher than what is prescribed by regulatory standards. In response, the FDA issued an order cancelling J&J's license to manufacture the powder on September 15.
However, the court found that the FDA's action was unreasonable. In its judgement, the bench, which featured Justices Patel and Dhige, stated, "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 manufacturer of all other batches also? Would we want reasonableness or proportionality to take such action that law permits on conforming batches?"
The court went on to say, "The particular action is needlessly delayed by two years. 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 also emphasized the importance of proportionality in regulatory action, stating, "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 court's decision highlights the delicate balance that regulators must strike between protecting public welfare and ensuring that companies are not unduly burdened by strict regulations. As the court stated in its order, "The executive cannot use a hammer to kill an ant. Is it always inevitable that when there is a single case of deviation or non-compliance (to prescribed norms) by a product the only option left with the regulatory authority is to cancel or revoke the license of the manufacturing company?"
In light of the court's decision, Johnson & Johnson is now able to resume the sale of its baby powder in the state. However, the court did order the company to destroy the complete batch of powder that had tested unfit for use.
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