Maharashtra FDA cancels Johnson & Johnson's production license as 2018 samples test hazardous

The Maharashtra Food and Drug Administration (FDA) has cancelled the production license of Johnson & Johnson's Mulund plant in Mumbai and ordered it to recall its stock from the market. The serious steps come as a result of the FDA's sample tests that were conducted in 2018 and 2019, which found that the talc-based baby powder has a pH value above the mandated levels.

So what did the Maharashtra FDA find? 

• The Maharashtra FDA collected two samples of the Johnson & Johnson baby powder, one from Pune and another from Nashik in December 2018.
• The test results came out in 2019 and as per the results, the samples from the Mumbai plant were ''not of standard quality'' as they did not comply with the IS5339:2004 specification for skin powder for infants in the test pH. 
• J&J was issued a show-cause notice (SCN) under the Drugs and Cosmetics Act 1940. But J&J challenged the results and demanded a retest, thus causing the retest to occur at the government-run Central Drugs Laboratory, Kolkata.
• The results of the second test came in recently and confirmed the results of the first test. Therefore, the FDA directly cancelled the manufacturing plant's license without sending a second SCN. This means that J&J's Mulund plant can no longer manufacture baby powder.
• But as per Economic Times, the firm "didn't accept the report" of the government analyst and challenged it in court for sending it to the Central Drugs Laboratory. 

Some context: You might remember how pharma giant Johnson & Johnson (J&J) decided in August 2022 to stop selling its legacy product globally: its talc-based baby powder. This announcement came two years after J&J stopped selling baby powder in the US, UK, and Canada, thanks to numerous lawsuits that were filed against the company. This massive shift came after thousands of consumer safety lawsuits were filed against J&J for knowingly selling asbestos-laced talcum powder, which led to lung and ovarian cancer in many customers globally. 

On August 22, 2022, a J&J representative told Moneycontrol:

“We will work with retailers to keep the product on the shelves until our supply of talc-based powder runs out”

This caused some outrage in the country since questions were raised about why J&J was selling its talcum powder in India when it had stopped producing and selling it across the world. Since J&J had switched to corn-based powder in the US, UK and Canada, why was it not following suit with the same strategy in India? Also, there was some outrage over the silence of drug administrators in India, who had not taken any action over J&J. 

On August 30, 2022, J&J announced that it would stop production in India by the first quarter of 2023. That meant that it would continue to sell its already produced products and dump them into India till it exhausted its supplies. 

It is surprising how Indian drug regulators are slow to act on J&J even when they know that J&J's hazardous products impact the Indian population just like they do all over the world.