Mumbai HC raps Maharashtra for 2-year delay in action against J&J baby powder manufactured at Mulund plant

After the bench asked the state’s lawyer to explain the delay in taking action though the results of the tests on samples were made available in 2019, Additional Government Pleader Milind More said there were difficulties due to the Covid-19 pandemic and the concerned department could not take swift action.

However, the bench expressed displeasure over the reasoning and orally observed,  “If you are dealing with infant health care, we expect you to take action within 48 hours, not in two years. Did the world shut down during Covid-19 pandemic? Did the Maharashtra government cease to exist from November 2019 till September 2022? You (state) are champions of public health. Assuming that the product is a dangerous or a third-grade product, this is how you (state) approach it? This is your sense of urgency?”

Senior advocate Ravi Kadam, for the company, submitted that the lab reports, which the high court had taken on record after it had ordered a fresh examination, had cleared the samples as compliant with standards.

The bench then perused the reports and the government decision under challenge and noted that the state’s decision and the reports relied on rules which had been declared defunct by the Central government in 2021, and indicated that the said decision can be set aside on the said ground alone. “You want to proceed further and take fresh samples, then the authorities will have to maintain the standards based on the prevailing rules. You can even carry out testing today (Tuesday). But this order (the state’s decision) has to go,” the bench said.

After the state’s lawyer sought time to take instructions on whether it wanted another examination of the samples, the bench adjourned the hearing to January 6 and said it will pass the orders on the said day.

The high court had allowed the company to continue manufacturing its baby powder though its licence expired on December 15. However, the order was only for manufacturing and the firm could not sell the products.

In December 2018, the FDA, during a random inspection, took samples of J&J’s talc-based baby powder from Pune and Nashik for a quality check. The sample manufactured at the Mulund plant was declared “not of standard quality”. The result of the test that came in 2019 concluded: “The sample does not comply with IS 5339: 2004 (Second Revision Amendment No. 3) specification for skin powder for infants in the test pH.”

Later, a show-cause notice was served to the company under the Drugs and Cosmetics Act, 1940. But it challenged the result and demanded a retest, which was then referred to the Central Drug Testing Laboratory (CDTL) in Kolkata.

The government had revoked the licence citing “public interest” following an FDA report which found that the sample of baby powder manufactured at the company’s Mulund plant was “not of standard quality”. On September 15, 2022, FDA cancelled its licence and later, the company was instructed to recall the product from the market.