Now in Maharashtra no one can use Johnson’s Baby Powder. The same product that had become almost mandatory to be present in a house where a baby was present was found to be not meeting the required quality standards.
The Food & Drugs Administration of Maharashtra has cancelled Product manufacturing Licence of Johnson’s Baby Powder manufactured by M/s Johnson’s & Johnson’s Pvt. Ltd., Mulund, Mumbai.
The FDA, Maharashtra had drawn samples of Johnson’s Baby Powder at Pune & Nashik for quality check purpose. The drawn samples were declared Not of Standard Quality by the Govt. The FDA issued a press note and stated, “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 Administration issued a show cause notice to the firm under Drugs & Cosmetics Act, 1940 and Rules there under as to why actions like suspension or cancellation of manufacturing licence or product manufacturing licence should not be taken. FDA also issued instructions to recall the stock of the said product from the market.
According to the statement issued by FDA, Johnson’s had not accepted the reports of the Government Analyst and challenged it in the court and asked for sending to the referral laboratory i.e Central Drugs Laboratory Government of India, Kolkata. “The Director CDL, Kolkata confirmed the report of Government Analyst, FDA Maharashtra and issued final conclusive report stating the conclusion that, the sample does not conform to IS5339 : 2004 with respect to the test for pH,” read the statement.
The product Johnson’s Baby Powder is popularly used for new born babies. The sample declared Not of Standard in pH and the use of the product may affect the health of the skin of the new born babies.
“Hence in the interest of the public health at large the FDA, cancelled the manufacturing licence of the Johnson’s Baby Powder of M/s Johnson’s & Jonson’s Pvt., Ltd., Mulund, Mumbai vide order dated 15/09/2022,” concluded the statement.