Pharmaceutical giant Johnson & Johnson (J&J) on September 20 said it "strongly disagrees" with the Maharashtra Food and Drug Administration (FDA)'s order cancelling the license of its baby powder, and would legally challenge the decision.
“We are aware of the Maharashtra FDA order on our manufacturing license. This order was issued on the basis of the pH test result of a single batch of our cosmetic talc. We strongly disagree with this order and will appeal to the authorities within the 90 days’ time given to us," a spokesperson of the company told Moneycontrol.
The Johnson and Johnson spokesperson further said that the identified batch of product 'should no longer be available on shelves as it expired in September 2020'.
"The health of the people who use our products is of utmost importance to us. We stand by the safety of our product,” the J&J spokesperson added.
The statement comes after Maharashtra FDA asked the company to recall from the market the baby powder produced at its plant in Mumbai's Mulund.
The regulatory body, which has cancelled the product's manufacturing license, said it had collected samples of J&J's baby powder at Pune and Nashik for a quality check. “The samples were declared Not of Standard Quality by the government analyst as the pH test failed to comply with IS 5339:2004 (second revision, amendment no. 3) specifications for skin powder for infants,” a press note issued by the Maharashtra FDA noted.
The pH values were higher than specified.
A senior Maharashtra FDA official responsible for granting licence to pharma companies told Moneycontrol that J&J had not replied to the state regulator on the notice sent.
When asked if the company can appeal against the notice, the officer, requesting anonymity, said the pharma giant has a three-month window to challenge the notice issued.
“If they wish to appeal, they can. They have 90 days of time to appeal in front of Sanjay Rathor, FDA Minister, Maharashtra. The minister may decide the fate of the appeal,” the officer said.
According to a state FDA official who spoke to Moneycontrol, J&J had rejected the government analyst’s reports and challenged it in court, requesting that the samples be sent to the Central Drugs Laboratory (CDL), Kolkata.
“The Director, CDL Kolkata, confirmed the government analyst’s assessment and issued a report concluding that the sample does not conform to the standards laid down in India with respect to pH test,” the officer added.
The Maharashtra FDA press note further said that 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 has cancelled the manufacturing licence of Johnson’s Baby Powder vide order dated 15/09/2022," it added.
The J&J spokesperson, however, said the company "would like to assure consumers that the identified batch should no longer be available on shelves as it expired in September 2020".
"The health of the people who use our products is of utmost importance to us. We stand by the safety of our product," the spokesperson added.
It is important to note that the notice cancelling J&J’s license to manufacture the product is for failing the pH test. It does not mention anything about the use of asbestos in the product, which many have complained about.
Moneycontrol had reported in August that J&J is discontinuing its talc-based baby powder in the face of lawsuits claiming that it contains asbestos, a carcinogen. However the company has no plan to take the product off Indian shelves.A J&J executive had confirmed this. “There is no recall. We continue to stand by the safety of the product. We will continue to manufacture it till quarter one of next year. After that, we will stop manufacturing,” the executive had said.