The Maharashtra FDA has cancelled the baby talcum powder manufacturing licence of Johnson & Johnson (J&J), from its sole plant in the state at Mulund, officials said.
The FDA said that the licence was cancelled after samples of the fast-moving Johnson`s Baby Powder collected from Nashik and Pune have failed quality checks, and has ordered the company to recall all its stocks from the markets.
These samples were declared by the FDA as `Not Of Standard Quality` after it failed to comply with IS5339:2009 (Second Revision Amendment No. 3) Specification for Skin Powder for infants in the test pH.
The powder samples were collected in November 2019, followed by a show-cause notice issued to the company after the FDA report.
However, J&J challenged the FDA`s notice in court even as the report of the Central Drugs Laboratory (CDL), Kolkata, was awaited.
The CDL Kolkata confirmed the government analyst`s earlier report and issued its final conclusion in the matter after which the FDA swung into action and revoked J&J`s licence.
In a statement on its Sepember 15 order, the FDA said: “The product Johnsons Baby Powder is popularly used in new born babies. The sample declared Not of Standard in pH and the use of the product may affect the health of the skin of the new born babies.”
Experts, activists and pediatricians have expressed concern over the delay in the FDA licence cancellation order after its first notice to J&J as millions of infants may have used the Johnsons Baby Powder in the intervening period.