Mumbai: The Food and Drug Administration (FDA), the apex-drug regulatory body in Maharashtra, has cancelled the baby powder manufacturing licence of global pharmaceutical giant Johnson & Johnson’s (J&J) Mulund (Mumbai) plant.
The company has also been directed to withdraw the stock of the said product from the market, the FDA said in its order on Thursday.
In December 2018, FDA-Maharashtra had taken samples of J&J’s baby powder from Pune and Nashik for quality checks during a surprise inspection. The sample of baby powder manufactured at the Mulund plant was declared “not of standard quality”. The results of the 2019 trial concluded that “the sample test does not comply with the IS 5339:2004 (Second Amendment Amendment No. 3) specification for skin powders for infants in pH.”
Later, the firm was issued a show cause notice under the Drugs and Cosmetics Act-1940 and rules. But the firm challenged the result and sought a retest, which was later forwarded to the government-run Central Drugs Laboratory, Kolkata.
“As a result of the second trial which recently re-established our findings that the samples did not meet standard quality standards, there was no need to send them a show cause notice again. So, we directly cancelled its licence.”