The Bombay High Court on Wednesday quashed the orders of the Maharashtra government restraining Johnson and Johnson from manufacturing and selling its baby powder observing that there has been a “needless delay of 2 years” which is not only “unreasonable” but also “arbitrary”.
The bench also remarked that swift action in such cases was necessary since “public purpose, welfare and consumer protection” is at the heart of the law.
A division bench of Justices Gautam Patel and SG Dige, while permitting Johnson from selling its product in the market, asked the company to destroy the stock of the tested batch which was found non-compliant with prescribed standards.
The HC was hearing a petition filed by Johnson challenging two orders of the state government – one dated Sept 15 by the Food and Drugs Administration (FDA) Joint Commissioner and Licensing Authority cancelling its license with effect from Dec 15, 2022; and second order dated Sep 20 by the FDA Commissioner directing the company to immediately stop manufacturing and sale of baby powder.
There was a harsh delay on part of FDA: Court said while pronouncing order
Quashing the orders of the FDA and the government, the HC said, “The particular action is needlessly delayed by 2 years. It is too late now to fall back on a single batch sample taken in 2018, not tested till 2019 and acted on only in 2022, to take extreme action of stopping all production of all batches of baby powder.”
"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 added.
The bench also said that the delay is unreasonable from the point of view of manufacturers. “It is also unreasonable from the view of consumers. If such substandard product is put in the market then every potential consumer has a right to be protected by FDA and from potential harm,” said the bench in its detailed order.
FDA collected samples in late 2018, testing only in 2019
The samples were collected by the FDA in late 2018 but sent for testing only in 2019. Even after receiving the report, it was not acted upon till 2022.
On a court query, the government pleader had earlier said that it would take time to test the samples afresh. Rubbishing the claim, the bench said that for testing merely pH balance, it barely takes few minutes. “It cannot take more than a few minutes (to conduct the test). Rest of the time would be probably to maintain records to maintain integrity of the tests. It cannot take months or years,” added the court.
Stressing on the importance of FDA, which acts as a watchdog, the HC said, "It is necessary to have a watchdog like FDA. But a watchdog must do its job properly which is to guard and protect. The purpose is not achieved by delaying testing of samples drawn and protracting proceedings for months and years.”
FDA must take stringent possible actions against suprious products
The court emphasised that the FDA “can take and must take stringent possible actions in a timely manner”, against spurious products considering there is a thriving industry making such products.
“In this country there is a thriving industry making spurious products. We come across several such matters filed by companies where their Intellectual Property Rights are being violated. More importantly the concern has always been of the consumers of these products especially of cosmetics, especially those used around eyes and on skin,” the bench averred.
FDA need not have 'one-size-fits-all' approach: Bombay HC said
Also, the FDA need not have a standardised approach for all the manufacturers. The order read: “It is also not necessary for FDA to always adopt a one-size-fits-all approach. A repeat offender may receive a very different treatment, more stringent and harsh punishment, then a manufacturer whose product has occasional lapse.
Permitting the company to sell its product, the HC said, “We are unable to understand why for a sample in mid 2018, no test result came for over a year. The now usual excuse of Covid will not do because this was before anyone could imagine Covid.
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