The Food and Drugs Administration of Maharashtra has revoked Johnson & Johnson Pvt Ltd’s production license for baby powder “in the interest of public health in general.”
In a press release issued on Friday, the state agency stated that Johnson’s Baby Powder may harm the skin of newborn infants.
During laboratory testing, samples of baby powder did not adhere to the standard pH value, the regulator stated, as reported by Press Trust of India.
According to the announcement, the action was initiated after the Central Drugs Laboratory in Kolkata issued a report concluding “the sample does not adhere to IS 5339:2004 regarding the pH test.”
Press Trust of India stated that the FDA had gathered samples of Johnson’s Baby Powder from Pune and Nashik for quality control purposes.
According to the document, the government analyst determined the samples to be “not of standard quality” since they do not meet the IS 5339:2004 criterion for skin powder for infants in the pH test.
According to the announcement, the FDA then issued Johnson and Johnson a show-cause notice under the Drugs and Cosmetics Act of 1940 and Rules, as well as instructions to recall the product from the market.
In addition, the company “refused to accept” the government analyst’s report and contested its submission to the Central Drugs Laboratory in court.
The public awaits company’s statement in great detail.