Maharashtra FDA cancels manufacturing license of Johnson and Johnson’s baby powder for its Mulund plant

The decision was taken after the referral Central Drugs Laboratory in Kolkata agreed with the Maharashtra FDA’s report of 2019, declaring the product sub-standard

Swapnil Mishra Urvi MahajaniUpdated: Thursday, November 10, 2022, 10:15 PM IST
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Maharashtra FDA cancels manufacturing license of Johnson and Johnson’s baby powder for its Mulund plant | PTI

The Maharashtra Food and Drug Administration (FDA) has cancelled the manufacturing licence of Johnson and Johnson’s baby powder for its Mulund plant and has asked the company to withdraw the product from the market.

The decision was taken after the referral Central Drugs Laboratory in Kolkata agreed with the Maharashtra FDA’s report of 2019, declaring the product sub-standard.

In 2019, the state FDA had checked the product samples from Pune and Nashik for quality and declared them ‘not of standard quality’ as per the government’s test pH guidelines for infants.

The FDA had issued a show cause notice to the firm under the Drugs and Cosmetics Act (1940) and Rules, asking why action such as suspension or cancellation of manufacturing licence should not be taken. It had also issued instructions to recall the product stock from the market.

However, the company did not accept the reports of the government analyst and challenged it in court, seeking to send the samples to the referral Central Drugs Laboratory in Kolkata.

Abhay Pandey, the president of All Food and Drugs Licence Holders Foundation said, “When I came to know about Johnson and Johnson baby powder sample failure, I immediately contacted the state FDA to take necessary steps in this matter as it’s one of the most selling baby powders in the market and incorrect pH can harm infants.”

Govt justifies cancellation of manufacturing licence  

The Maharashtra government has filed an affidavit before the Bombay High Court justifying its decision to cancel the manufacturing licence of Johnson & Johnson baby powder in the State saying that the “Health and welfare of the consumer is most important”. 

The government also refuted claims by Johnson & Johnson that pH values did not impact the health of the consumer. 

The government filed an affidavit in response to the petition filed by Johnson & Johnson challenging the cancellation of the licence to manufacture cosmetic products at a facility in Maharashtra.

The affidavit filed by the Assistant Commissioner, of Food and Drugs Administration (FDA) opposing the petition states that it will be a gross failure on its part if it fails to enforce the statutory provisions under the Drugs and Cosmetics Act and Rules meant to safeguard the health of people. “It is submitted that the health and welfare of people/consumers are to be the highest while examining the cosmetics products in the instant case. It is statutory duty apart from the moral responsibilities of the petitioner to manufacture and supply the product that is absolutely safe for the consumers particularly infant babies in this case,” read the affidavit. 

It further said that Johnson & Johnson, without assuring the quality of their baby powder till its final use, cannot manufacture products for sale as per norms. 

Refuting the company’s claim that the pH values did not impact the health of the consumer, the government said that the samples of baby powder sent for testing from two different samples were reported to be “not of standard quality” as the pH was of 8.42. This conclusion had been upheld by the Central Drugs Laboratory (CDL) at Kolkata. 

“Action by the FDA authorities is more concerned with public health at large, and nothing else matters when it comes to public health at large,” the officer underscored. 

The HC on Thursday asked the government whether it had tested more samples from the same batch of baby powder which was under challenge in the petition, or from any other batch. 

The HC has kept the matter for hearing on November 14. 

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