Will direct re-examination of J&J’s baby powder samples, says Bombay High Court – The Indian Express

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 a report from the Food and Drug Administration (FDA), the apex drug regulating body of Maharashtra, which found that the sample of baby powder manufactured at the company’s Mulund plant was ‘not of standard quality’. On September 15, the FDA cancelled the licence and later the company was also instructed to recall the stock of the 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 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.

The state 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, Additional Government Pleader Milind More informed the bench that another such case was found against the company in Delhi where the samples had not matched with statutory requirements.

After senior advocate Ravi Kadam, for the company, said that the said case was before a jurisdiction not governed by the Bombay High Court, the bench inquired why there were so many matters taking place against the company.

Kadam 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.

“You (company) have grievances against the minister, but if there is reconsideration then we will send it back to him. We do not want that, but we want to have fresh samples tested,” the bench said.

The bench asked the state government to give the names of its labs along with those approved by the government. It also said that the company can manufacture the products, however, the court would not permit it to hand over the product for sale or even for distribution. The bench will hear the state’s response on Wednesday and pass further orders.