Bombay High Court Slams Maharashtra Govt For Using ‘Defunct’ Standards To Test Baby Powder, Trashes COVID Excuse

“You are supposedly the torch bearers and champions of public health… I will assume the reverse side. That a baby product is of third-rate quality and may cause fatalities…Is this your sense of urgency?” Justice Gautam Patel asked.

“Don’t argue COVID again. We will impose costs if you use Covid as an excuse,” the judge said, when the State cited COVID in response.

A division bench of Justice Patel and Justice SG Dhige granted FDA time till next Friday to file an affidavit and specify if it wanted to continue to contest the petition or withdraw the orders against J&J and undertake fresh testing.

The court was hearing the company's petition against cancellation of its licence by the Food and Drug Administration (FDA) in September 2022 to manufacture baby powder at its Mulund factory.

During the last hearing, and pursuant to earlier orders, the HC received samples from two independent laboratories and the FDA which found some samples below the permissible pH level but on the higher side.

On Tuesday, Senior Advocate Ravi Kadam informed the bench that even after collecting fresh samples and re-testing them, the FDA had used an outed IS5339 2004 standing of testing instead of IS 5339 2021 standard for testing.

The draft standard prescribes the requirements and methods of sampling and test for skin powder for infants below three years age.

The FDA originally collected samples from Pune and Nashik in the November and December 2019, the first show cause notice was issued in February 2021 and Johnson’s response was received a couple of weeks thereafter. However, the company was given a personal hearing only in July 2022 and the license was suspended on September 15, 2022.

“Your order is from September 15, what were you doing? If you are dealing with infant health care products, we expect a response within 48 hours, not two years…Using a defunct standard to test.. how do you justify this?" the court asked.

The State’s counsel reasoned that the FDA's functioning suffered because of the COVID pandemic.

“Did everything shut down during COVID? If you say COVID, we are going to impose costs on the State of Maharashtra [Government],” Patel said.

The court added that the fresh reports on testing - wherein defunct standards were used, have come pursuant to court orders.

“You want to withdraw these orders, ok. In compliance with the statute you can carry out fresh testing,” the court said and adjourned the matter to Friday.

Johnson and Johnson Test Results

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

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.  

Background

JJB's licence was cancelled by the apex drug regulatory body of Maharashtra on September 15 last year on the ground that a batch of the powder was found to be of slightly higher pH than prescribed on testing at the Central Drugs Testing Laboratory. The company was later also told to recall their stocks. Investigations had started in December 2018, after a random check by the FDA on J&J's powder in Pune and Nashik.