HC questions Food and Drug Administration’s delayed action in Johnson case:

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The Maharashtra Food and Drug Administration (FDA) had suspended the licence for manufacturing cosmetics of Johnson and Johnson after residues of carcinogenic substances were found in baby talcum powder produced by it.

The licence had been suspended as the FDA expressed serious concern over the presence of ethylene oxide in a batch of baby powder produced in 2007.

Ethylene oxide was used to bring down microbial load in the powder by sterilisation.

Consumers need not worry as the shelf life of the batch ended in July 2010 and it would not be available for sale in the market.

Justifying its order directing the closure of the Johnson & Johnson (J&J) Mulund facility, the Food and Drug Administration (FDA) on Wednesday told the Bombay high court that the ethylene oxide treatment (EtO) it had applied to 15 of its batches of baby talcum powder in 2007, was carcinogenic.

The HC asked the FDA why it waited for more than a year after issuing a show-cause notice to initiate action.

A division bench of Justice S J Vazifdar and Justice M S Sonak heard J&J’s petition challenging the FDA’s order on April 30, 2013, to close down the facility from June 24.

Its appeal before the appellate authority was also rejected.

Senior counsel Rafiq Dada argued that in 2009, J&J subjected three samples from the 15 batches for testing as part of an internal audit.

“We wanted to check if there was any residue after the EtO treatment. We found none,” he said. The plea said the treatment was given to sterilize the product.

In March, the state FDA cancelled the licence of the Johnson & Johnson (J&J) facility after it found that 15 batches of baby talcum powder manufactured at the Mulund plant were sterilised using ethylene oxide, a chemical that is widely believed to cause cancer, nausea, vomiting and is considered an irritant.

The state FDA alleged that the company did not register the process with it, and failed to conduct tests to check for traces of ethylene oxide in the batches of talcum powder.

In June, the Maharashtra government upheld the FDA commissioner’s decision to cancel J&J India’s licence to manufacture healthcare products from its facility in Mulund.

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