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Lab reports clear J&J baby powder made at Mulund plant; HC seeks FDA’s response

In 2018, the FDA, took samples of J&J’s talc-based baby powder from Pune and Nashik for a quality check and sample manufactured at the Mulund plant was declared “not of standard quality”.

The court had permitted Mulund plant to manufacture its baby powder at its Mulund plant at the firm's “own risk”(Photographer: Justin Sullivan/Getty Images)

The Bombay High Court on Friday prima facie observed that the Johnson & Johnson Private Limited baby powder being manufactured at its Mulund plant in Mumbai had conformed with the statutory requirements in at least two of the three lab reports submitted to it.

On November 16, the bench had ordered fresh examination of samples of the company’s baby powder to be completed within two weeks, directing Food and Drug Administration (FDA), the top drug regulating body of Maharashtra, to collect four samples of the product and submit them to two government laboratories and one private lab for fresh testing.

The court had also permitted the company to manufacture its baby powder at its Mulund plant at the firm’s “own risk”, but said it cannot hand over the product for sale or distribution as the state FDA has prohibited it.

The government had revoked the licence citing “public interest” following an FDA report which found that the sample of baby powder manufactured at the company’s Mulund plant was “not of standard quality”. On September 15, FDA cancelled its licence and later, the company was instructed to recall the product from the market.

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In December 2018, the FDA, during a random inspection, took samples of J&J’s talc-based baby powder from Pune and Nashik for a quality check. The sample manufactured at the Mulund plant was declared “not of standard quality”. The result of the test that came in 2019 concluded: “The sample does not comply with IS 5339: 2004 (Second Revision Amendment No. 3) specification for skin powder for infants in the test pH.”

Later, a show-cause notice was served to the company under the Drugs and Cosmetics Act, 1940 and Rules. But it challenged the result and demanded a retest, which was then referred to the Central Drug Testing Laboratory (CDTL), Kolkata.

On Friday, the reports were submitted to a division bench of Justice S V Gangapurwala and Justice S G Chapalgaonkar.

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The court observed that the report of FDA laboratory at Bandra-Kurla Complex (BKC) had stated that the samples complied with the statutory requirements, while the report of the Intratech laboratory, a private testing facility, stated that the Ph value was not stable as per procedure. The Central Drug Testing Laboratory (CDTL), Western Zone, found that the samples conformed with the requirements.

Senior advocate Ravi Kadam representing the company said that it should now be permitted to sell the product.

The court said that it would hear the government’s stand through Additional Government Pleader Milind More on the reports during the next hearing. The bench maintained that the company would not be permitted to sell or distribute its baby powder produced at Mulund plant till the next date of hearing on December 7.

First published on: 02-12-2022 at 21:21 IST
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