Were babies not born for three years, a division bench of the Bombay High Court, comprising Justice GS Patel and SG Dige, asked during the hearing on Johnson & Johnson Baby Powder’s plea against the Food and Drugs Administration’s (FDA) order cancelling their licence, on Monday. The HC is likely to pronounce its order on Wednesday.
Government Pleader Milind More told the court that the tests on baby powder samples could not be conducted as per the new rules, as ordered by the court, due to shortage of time. Moreover, Ravi Kadam, Senior Advocate, informed the court that the samples were collected in 2019 and a show-cause notice was issued to the company in 2022.
The division bench asked More as to what they had done to stop the sale of baby powder after the samples were tested in 2018. The bench said that it was difficult for them to come up with a solution as they were deciding on an order passed by the authorities under the old rules which are not in force today.
The HC said the batch of samples tested, which are allegedly dangerous, was out in the market between 2019 and 2023 and has already reached the consumers. Justice GS Patel said, “Were babies not born for three years?”
The court questioned the counsel on the cancellation of the licence of the company to which Kadam said that the licence was not revoked, but the company was directed to manufacture the powder.
The counsel informed the court that under the old cosmetic rules, there was a provision for cancellation of the licence, however, under the 2020 Rules, the perpetual licence is granted by the authority. The bench, however, clarified the counsel should not misunderstand the questions of the court.
The court said, “We are not saying whether it is safe or unsafe. We are testing your action. You have to justify saying you have acted properly in the manner given in the safeguard. Do not misunderstand us. 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.”
Kadam requested the court to allow the sale of the baby powder which was rejected by the court. The court said it will pronounce its judgment on Wednesday on the principle of proportionality and how licence or production can be cancelled in future cases.
During the previous hearings, the court has said that in case there is a problem with a product of the pharmaceutical company, the government should act swiftly because there is public interest involved.
When More informed the court that the government wants to test the samples again, the bench had said the government can take the sample and send it for testing, but the government was ordered to take action within one week of getting the reports from the labs. The bench had also asked the AGP to test the samples as per the new guidelines.
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