J&J's Mulund facility adheres to legal requirements on quality: Bombay High Court

The Bombay High Court (HC) on Friday prima facie observed that the Johnson & Johnson (J&J) baby powder manufactured at the company's Mulund facility adheres to the legal requirements on quality.

Urvi MahajaniUpdated: Saturday, December 03, 2022, 02:48 AM IST
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Bombay High Court | Wikimedia Commons

Mumbai: The Bombay High Court (HC) on Friday prima facie observed that the Johnson & Johnson (J&J) baby powder manufactured at the company's Mulund facility adheres to the legal requirements on quality. However, the court refused to grant it permission to sell the baby powder.

A division bench of Justices SV Gangapurwala and SG Chapalgaonkar made the observation based on reports submitted by three laboratories in sealed envelopes. The court, on Nov 16, had directed the Food and Drug Administration (FDA) to send samples of the baby powder from the Mulund facility to two government labs and a government-approved private lab for testing.

The judges noted that the report of the FDA laboratory at Bandra-Kurla Complex stated that the sample complied with the statutory requirement and the report from the Central Drug Testing Laboratory (Western Zone) also stated that the sample conformed to the requirements laid down. However, the report received from the Intratech Laboratory (private lab) stated that the reading was not stable as per the procedure.

Counsel for J&J, Mr Ravi Kadam stated that since the reports showed that the sample complied with the statutory requirements, the company ought to be permitted to sell their product. “The reports make it clear. The Court may just permit us to sell,” he said. However, the court said it will hear the government pleader before passing any order.

The court clarified that as per earlier order, the company can continue to manufacture the product, but would not be permitted sale or distribution of its baby powder till the next date of hearing. The HC has kept the plea for hearing on Dec 6.

The court was hearing a petition filed by J&J challenging two orders of the state government – one dated Sep 15 by FDA's Joint Commissioner & Licensing Authority cancelling its licence, effective from Dec 15, 2022; and second order dated Sep 20 by the FDA commissioner directing the company to immediately stop manufacturing and sale of baby powder.

The government based its orders on the report of the Central Drug Laboratory in Kolkata, which found the powder contained a higher pH level than prescribed. J&J has contended in its plea that it tested samples from 14 random batches of February, March and September 2022 at an independent public testing laboratory and all were found to be well within the prescribed pH value. It said that it has been making the baby powder at its Mulund plant for the last 57 years and its licence had been renewed in Jan 2020.

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