Maharashtra cancels Johnson & Johnson’s baby powder production license


Maharashtra Cancels Johnson & Johnson Baby Powder Production License


Maharashtra’s Food and Drugs Administration (FDA) on Friday canceled Johnson & Johnson Pvt Ltd’s baby powder production license “in the interest of public health at large”.

In a press release, the government agency said the company’s product, Johnson’s Baby Powder, can affect the skin of newborn babies.

Samples of the powder for babies did not meet standard pH levels during a lab test, the regulator said.

The release said the action was taken following the conclusive report from the Kolkata-based Central Drugs Laboratory concluding that “the sample does not comply with IS 5339:2004 with regard to the test for pH”.

According to the release, the FDA had taken samples of Johnson’s baby powder from Pune and Nashik for quality control purposes.

The government analyst had declared the samples “not standard grade” because they do not meet the IS 5339:2004 specification for infant skin powder in the test pH, it said.

Thereafter, the FDA gave Johnson and Johnson a cause of action notice under the Drugs Cosmetics Act 1940 and Rules, in addition to directing the company to withdraw its stock of said product from the market, the release said.

The company “did not accept” the report from the government analyst and is challenging it in court for sending it to the Central Drugs Laboratory, it added.

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