Bombay High Court Reserves Order On Johnson & Johnson's Plea Against Cancellation Of Baby Powder License, Says FDA Action Must Be Time-Bound

“What we propose is this. Our view regarding 'prayer A' is that rule will have to be made absolute regarding the concerned batches,” to court said and subsequently reserved the petition for orders on Wednesday.

A division bench of Justice Patel and Justice SG Dhige expressed the need for FDA to act swiftly, within a certain time frame. The bench said it would only be dealing with the two batches of baby powder, which is the issue in the petition.

“We will say that to act against a batch or against full production capacity, you must exercise power reasonably and proportionately. You must act within a time frame because you are dealing with cosmetics especially drugs. There cannot be delays for months and years. We will set out that the speed at which you operate will be a factor to be considered, whenever there is a challenge. We are not saying anything so far as the product is concerned.”

The court was hearing Johnson and Johnson's petition against cancellation of its licence by the FDA in September 2022 to manufacture baby powder at its Mulund factory or sell it after the pH levels were found to be higher than the prescribed limit.

During the previous hearing, the court slammed the FDA for allegedly using defunct standards for testing and taking over 2.5 years for any action against Johnson and Johnson if it believed the baby powder was harmful.

While samples were collected in November 2019, the first show cause notice was issued in 2021 and the samples license cancelled on September 15, 2022.

“You are supposedly the torch bearers and champions of public health …Is this your sense of urgency?” Justice Gautam Patel had asked.

On Tuesday, Senior Advocate Ravi Kadam for Johnson finally argued the matter after FDA’s counsel said he didn’t have instructions to withdraw. But the court had several questions for the authority. Justice Patel wondered what could be done regarding the concerned batches of JBP already sold in the market due to FDA’s belated response.

“I have a question for the State. In Jan 2023, what order is required for the batches that were sold in 2019. It's not a car, it's a consumable. What do we? Were no babies born for three years?”

With any form of medicinal consumer product we want you to be vigilant, especially with big pharma companies because their production level is very high. But we want you to ask swiftly.”

The bench will now pronounce the order on Wednesday.

Johnson and Johnson Test Results After Bombay HC order

Following the Bombay High Court order, four fresh samples were collected and all the samples were tested by two government and one independent laboratory.

The pH Report of Intertek PTL found JBP samples at 7.58, 9.19, 6.37 and 7.59; The pH report of CDTL lab is 5.88, 7.80, 7.89 and 6.32; the pH report of FDA lab is 7.19, 8.52, 5.98 and 7.20. Intertek found that the pH reading was not stable even after five minutes.

The pH reading is ideally meant to be between 5-8.