Maharashtra FDA cancels Johnson & Johnson baby powder licence over poor quality

The Maharashtra Food and Drug Administration (FDA) has revoked Johnson & Johnson's baby powder production license for its Mulund factory and ordered the corporation to remove the product from the market.

The judgment was made after the Central Drugs Laboratory in Kolkata agreed with the Maharashtra FDA's 2019 report deeming the goods sub-standard.

In 2019, the state FDA had checked the product samples from Pune and Nashik for quality and declared them ‘not of standard quality’ as per the government’s test pH guidelines for infants.

The FDA had issued a show cause notice to the firm under the Drugs and Cosmetics Act (1940) and Rules, asking why action such as suspension or cancellation of manufacturing licence should not be taken. It had also issued instructions to recall the product stock from the market.

However, the company did not accept the reports of the government analyst and challenged it in court, seeking to send the samples to the referral Central Drugs Laboratory in Kolkata.

"When I learned about Johnson and Johnson baby powder sample failure, I immediately contacted the state FDA to take necessary steps in this matter because it's one of the most selling baby powders in the market and incorrect pH can harm infants," said Abhay Pandey, president of All Food and Drugs Licence Holders Foundation.

The Director CDL, Kolkata also confirmed the report of Maharashtra FDA and issued final conclusive report stating that the sample does not conform to IS5339 : 2004 with respect to the test for pH.

(With inputs from agencies)