Johnson & Johnson baby powder: HC prima facie says its Mulund facility adheres to legal requirements on quality

A division bench of Justices SV Gangapurwala and SG Chapalgaonkar made the observation based on reports submitted by three laboratories in sealed envelopes.

Urvi MahajaniUpdated: Friday, December 02, 2022, 08:46 PM IST
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Picture for representation | PTI

Mumbai: The Bombay High Court on Friday prima facie observed that the Johnson & Johnson (J&J) baby powder manufactured at the company's Mulund facility adhere 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 November 16, had directed the Food and Drug Administration (FDA) to send samples of the baby powder from the Mulund facility to three laboratories -- two government labs and a government approved private lab -- for testing.

The judges noted that 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.

Ravi Kadam, counsel for J&J, 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 sale,” 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 December 6.

The court was hearing a petition filed by J&J challenging two orders of the state government – one dated September 15 by FDA’s Joint commissioner & Licensing Authority cancelling its licence, effective from December 15, 2022; and second order dated September 20 by 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 containing higher pH level than prescribed.

J&J has contended in tis 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 was renewed in January 2020.

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