Mumbai: Maharashtra Food & Drug Administration (FDA) has cancelled the manufacturing licence of Johnson Baby Powder manufactured by Johnson & Johnson India, the state government body said in a press note. The Maharashtra FDA had drawn samples of the company’s baby powder at Pune and Nashik for quality check purpose and those samples were declared ‘not of standard quality’ by the government.
“The sample does not comply with IS 5339: 2004 (Second Revision Amendment No. 3) Specification for Skin powder for infants in the test pH,” the statement said. The state government body issued show cause notice to the company under Drugs & Cosmetics Act, 1940. Maharashtra FDA also issued instructions to the company to recall the stock of the baby powder from the market.
The US based company did not accept the reports of the state FDA and challenged it in the court for sending to the referral laboratory i.e Central Drugs Laboratory (CDL) Govt., of India, Kolkata.
The note also said, “The director CDL, Kolkata confirms the report of Govt., Analyst, FDA Maharashtra and issued a final conclusive report stating the conclusion that “The sample does not conform to IS5339 : 2004 with respect to the test for pH.”
The state government body also said that the use of the product may affect the health of the skin of newborn babies. This comes after its parent-Johnson & Johnson Consumer Health announced in August the transition of its global baby powder portfolio to a cornstarch-based baby powder portfolio. It said in a statement while announcing its transition, “As a result of this transition, talc-based Johnson Baby Powder will be discontinued globally in 2023.
