Will lead re-examination of J&J baby powder samples, says Bombay High Court

The Bombay High Court said on Monday it would lead the re-examination of samples of baby powder made by Johnson and Johnson Pvt Ltd and asked the state government lawyer to hand over the names of the government and laboratories state-approved by November 16.

A divisional bench of Judge SV Gangapurwala and Judge SG Dige was hearing the company’s plea challenging the government order which revoked its license to manufacture baby powder.

The government had revoked the license citing ‘public interest’ following a report by the Food and Drug Administration (FDA), Maharashtra’s apex drug regulator, which found that the sample of baby powder manufactured at the company’s Mulund factory was ‘not of standard quality’. On September 15, the FDA revoked the license and later the company was also instructed to remove the stock of said product from the market.

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

Later, a show cause notice was served on the company under the Medicines and Cosmetics Act 1940 and Rules. But he disputed the result and demanded a retest, which was then sent back to the Central Drug Testing Laboratory (CDTL), Kolkata.

The state government, in its response, had told the High Court that the decision had been made because “the health and welfare of the consumer is most important”. The state government had claimed it would be “a gross failure” on its part if it did not enforce the provisions of the Drugs and Cosmetics Act and Rules stipulating safeguards for people’s health.

On Monday, the government’s additional litigant, Milind More, informed the bench that another such case had been found against the company in delhi where the samples did not meet the legal requirements.

After Senior Solicitor Ravi Kadam, for the company, said the said case was before a court not governed by the Bombay High Court, the bench questioned why there were so many cases pending against the company.

Kadam argued that the Maharashtra FDA minister failed to issue a show cause notice to the company and did not consider the supporting documents submitted by the company before issuing the order and s was only relied on the CDTL report, which was not appropriate.

“You (the company) have grievances against the Minister, but if there is a reconsideration, we will refer it to him. We don’t want that, but we want to have new samples tested,” the bench said.

The bench asked the state government to give the names of its labs as well as those approved by the government. He also said that the company can manufacture the products, but the court would not allow it to release the product for sale or even distribution. The bench will hear the state’s response on Wednesday and make further orders.

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