Bombay HC allows J&J to manufacture baby powder at Mulund plant at ‘own risk’, no sale or distribution allowed


The Bombay High Court Wednesday permitted Johnson and Johnson Pvt Ltd to manufacture its baby powder at the Mulund plant in Maharashtra at the company’s “own risk,” but said it cannot hand over the product for sale or distribution as the state Food and Drug Administration (FDA) has prohibited the same.

The high court also ordered the re-examination of samples of Johnson and Johnson’s baby powder, which is to be completed within two weeks, and directed FDA, the top drug regulating body of Maharashtra, to collect samples of the product and submit them to two government laboratories and one private lab for the re-testing.

A division bench of Justice S V Gangapurwala and Justice S G Dige was hearing the company’s plea challenging the government order that cancelled its baby powder manufacturing licence.

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 had cancelled the licence and later the company was instructed to recall the stock of the said product from the market.

In December 2018, during a random inspection, FDA 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. But it challenged the result and demanded a retest, which was then referred to the Central Drug Testing Laboratory (CDTL), Kolkata.

The Maharashtra Government in its reply had told the high court that the decision was taken as the “health and welfare of the consumer is most important”. The state government had claimed that it will be “a gross failure” on its part if it fails to enforce the provisions under the Drugs and Cosmetics Act and Rules stipulating safeguards for the health of people.

On Monday, after the state had informed the HC about another such case found against the company in Delhi where the samples had not matched statutory requirements, the bench inquired why there were so many matters taking place against the company.

Senior advocate Ravi Kadam, representing Johnson and Johnson, submitted that the Maharashtra FDA minister had not issued a show-cause notice to the company and did not consider the supporting material submitted by the company before passing the order and only relied on the CDTL report, which was not proper. The bench had said it will direct the fresh samples to be tested

On Wednesday, after Kadam said the samples should be also sent to Central Drug Testing Laboratory (CDTL), which has a branch in Maharashtra, the bench said it will direct the samples to be sent to more than one lab as it did not want any “margin of error.”

As per the court’s direction of November 14, Additional Government Pleader Milind More for the state government submitted the names of three labs for re-testing agreed upon by Johnson and Johnson, which included CDTL, Western Zone, FDA Laboratory at Bandra-Kurla Complex (BKC) in Mumbai, and private Intertech Labs.

The bench then directed the FDA to collect samples within three days and send them to the concerned labs within three days thereafter. The labs will have to complete testing and send their reports within seven days thereafter.

The HC will hear the plea and peruse the report during the next hearing on November 30.





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