India's Food & Drugs Administration in the state of Maharashtra announced through a press note on Friday that it has cancelled the product manufacturing license of Johnson's Baby Powder, manufactured by Johnson & Johnson Private Limited.
The press note said that the samples of Johnson's Baby Powder were declared "Not of Standard Quality". FDA Maharashtra had taken the samples of Johnson's Baby Powder at Pune and Nashik for quality check purposes.
"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 press note stated.
As per the press note, the Maharashtra administration had issued a show-cause notice to the firm under Drugs & Cosmetics Act, 1940 and also issued instructions to the firm to recall the stock of the said product from the market.
However, Johnson & Johnson has stood firmly behind the product and said, "Johnson and Johnson stand firmly behind the decades of independent scientific analysis by medical experts around the world that confirms talc-based Johnson's Baby Powder is safe, does not contain asbestos, and does not cause cancer."
As per the press note, the firm also challenged the quality tests to be sent to the Central Drugs Laboratory (CDL) Government of India. However, the Director of CDL also issued the final conclusive report in line with the Maharashtra FDA.
"Since Johnson's Baby Powder is used in newborn babies, the sample being declared "Not of Standard in pH" may affect the health of the skin of the newborn babies. Hence, in the larger public interest, FDA Maharashtra is cancelling the manufacturing licence of the Johnson's Baby Powder, with the order dated September 15," the press note further said.
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