Bombay HC allows Johnson & Johnson to manufacture baby powder but freeze on sale to continue
The High Court also ordered that the samples of the product, which was banned in Maharashtra for not meeting quality standards, be sent for re-testing.
The Bombay High Court on Wednesday allowed healthcare company Johnson & Johnson to manufacture its baby powder at the Mulund plant in Maharashtra but prohibited its sale or distribution, reported Bar and Bench.
A division bench of Justices SV Gangapurwala and SG Dige also directed the state Food and Drug Administration to send fresh samples of the baby powder from the facility to three laboratories for re-testing.
The product samples will be sent to Central Drug Testing Laboratory, Western Zone, Food and Drug Administration laboratory at Bandra-Kurla Complex, and a private lab called Intratech Laboratory, reported Bar and Bench.
Johnson & Johnson faces about 38,000 lawsuits that claim its talcum products cause cancer due to contamination with asbestos. The product had been discontinued in the United States and Canada in 2020. On August 11, the company had announced that it will stop selling its baby talcum powder globally from 2023.
The High Court passed the order on Wednesday after hearing Johnson & Johnson’s plea challenging the state government order on September 15 cancelling the company’s license to manufacture the product, effective from December 15, reported Bar and Bench.
The order banning the product came after the Food and Drug Administration during a random inspection took samples of the talc-based baby powder for a quality check in December 2018.
The government then revoked the licence citing “public interest” following a Food and Drug Administration report which found that the sample from the the company’s Mulund plant was “not of standard quality,” reported The Indian Express.
The company was also asked to stop the manufacture and sale of the baby powder manufactured at the facility with immediate effect and directed to recall the product from the market.
The state government had issued a show cause notice to the company under the Drugs and Cosmetics Act, 1940 and Rules. Johnson & Johnson then challenged the result and demanded a retest, after which the samples were referred to the Central Drug Testing Laboratory in Kolkata, reported The Indian Express.
In its previous hearing on Monday, Additional Government Pleader Milind More had informed the court that a similar case was found against the company in Delhi where the samples had not matched with statutory requirements.
Senior advocate Ravi Kadam, appearing for the company, had contended that the Maharashtra food and drug administration minister had not issued a show cause notice to Johnson & Johnson and did not consider the supporting material submitted by the company before passing the order.