HC questions delay in FDA notice to Johnson & Johnson

Bombay High Court (HC) asked Food and Drug Administration (FDA) Wednesday why it delayed show-cause notice to Johnson & Johnson India by a year-and-a-half for alleged use of a carcinogenic compound to sterilise a baby talcum powder produced at the Mulund factory of the company.

Production at the Mulund unit was stopped in 2007.

Johnson & Johnson, a leading manufacturer of baby products, has challenged the shutdown order issued on April 30, 2013, but which took effect on June 24, 2013.

FDA counsel Ashutosh Kumbhakoni said, "It is simply shocking. Ethyl oxide treatment is carcinogenic and results in cancer."

Johnson & Johnson counsel R A Dada, argued that FDA initiated action after a delay of one-and-half years and cancelled company licence for Maharashtra.

He said in 2009, the company tested three of 15 batches of the powder manufactured in 2007 as part of an internal audit. The company wanted to see if there was any residue after ethyl oxide treatment but found none.

The shelf life of the product was three years from the date of manufacture, he said.

Justices S J Vazifdar and M S Sonak also asked FDA why a complete shutdown of the factory was ordered.

They, however, felt it was necessary to ascertain if there was any breach on the part of the company.

The case will be heard further on July 26.

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