The state government agency said the company’s product, Johnson’s Baby Powder, may affect the skin of newborns.
The state government agency said the company’s product, Johnson’s Baby Powder, may affect the skin of newborns.
The Food and Drug Administration (FDA) of Maharashtra has revoked the baby powder manufacturing license of Johnson & Johnson Pvt Ltd “in the interest of public health at large”. The state government agency said in a release issued on Friday that the company’s products, johnson baby powderCan affect the skin of newborns.
The regulator said the samples of powder for infants did not conform to the standard pH value during laboratory testing.
The release said the action was taken following a conclusive report from the Kolkata-based Central Drugs Laboratory, which concluded that “the sample does not conform to IS 5339:2004 with respect to the test of pH.” According to the release, the FDA had collected samples of Johnson’s Baby Powder from Pune and Nashik for the purpose of quality testing.
The government analyst had declared the samples as “not of standard quality” as they do not comply with the IS 5339:2004 specification for skin powder for infants at test pH, it said.
Subsequently, the FDA issued a show cause notice to Johnson & Johnson under the Drugs Cosmetics Act 1940 and regulations, in addition to directing the company to withdraw stock of the said product from the market, the release said.
The firm “did not accept the report” of the government analyst and challenged it in court to send it to the Central Pharmaceutical Laboratory.