A Division Bench of the Bombay High Court comprising Justice GS Patel and Justice SG Dige on Wednesday set aside the order of the Food and Drug Administration (FDA) restraining Johnson & Johnson Private Limited to manufacture its baby powder after the PH value of the powder was found to be unstable.
The bench noted that it was not reasonable that if one sample of the batch is found not to be of a stable reading, the licence of the company should be cancelled. The court relied on the Wednesbury Principle and Doctrine of Proportionality and called the action of the FDA unreasonable and arbitrary. The court noted “The administrator cannot use a hammer to kill an ant.”
The court also expressed its displeasure over the delay in action by the FDA for three years. Further, the court said the tests to be done for checking the alkalinity of the sample take a few minutes and not days, months or a year.
The court observed, “It is necessary to have a watchdog like FDA but it must do a proper job, which is not achieved by delaying testing of samples and proceeding for months and years.”
Further, the court said delayed action by the FDA affects the consumer more than the manufacturer.
The Division Bench also observed that the excuse of Covid-19 pandemic cannot be taken by the government. It said, “The usual excuse of Covid will not do because this was before anyone could imagine Covid, then there was a delay which ran till 2022.”
The court, however, directed the company to not sell the tested sample in the market to the consumer and destroy the faulty batch of baby powder.
The Drug Regulator cancelled the licence of the company on September 15 which was to be effective from December 15. Earlier, the court had allowed the pharma company to manufacture the baby powder but had restrained them from selling the same.
During the earlier hearings, the bench had observed, “If you are dealing with infant health care, we expect you to take action within 48 hours, not 2 years. Did the world shut down during Covid? Did the Maharashtra government cease to exist from November 2019 till September 2022? You are champions of public health. Assuming that the product is a dangerous, third-grade product, this is how you approach it? This is your sense of urgency?”
Further, during the course of the hearing, the court also observed that it wants the regulator to act swiftly. The court said, “We want you to be vigilant with any kind of medicinal product in the market. Especially with the big pharmaceuticals, because of the sheer volume they manufacture. But we just want you to act swiftly considering the public interest.”
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