Multi-nationalS should stop treating Indians as guinea pigs, Food and Drug Administration (FDA) counsel Ashutosh Kumbhakoni told Bombay High Court Friday. He was defending an FDA order to shut the Mulund factory of Johnson & Johnson (J&J) that manufactured baby talcum powder for allegedly using the carcinogenic ethyl oxide to sterilise 15 batches in 2007.
Kumbhakoni said the delicate skin of babies would be affected.
If this was US,I cant imagine what would have happened.
He said the company cannot take advantage of tolerant and considerate authorities.
Kumbhakoni said the usual method of steam was not used to sterilise the contentious batch. The company sent the bottles to Microcontrol laboratory in Saki Naka,which used ethyl oxide to remove contamination.
J&J did not test it for residue before packaging for release into market,as pointed out to FDA by a whistleblower in 2010.
The rules require them to test each batch. To save money you cannot expose public (to danger), Kumbhakoni said.
Arguing for J&J,senior counsel R A Dada said the FDA order of shutting down the factory permanently was totally disproportionate as sterlisation in ethyl oxide was a one off incident.
He said FDA penalised Microcontrol laboratory with a three-month suspension of licence whereas J&Js facility with 250 employees was permanently closed.
Dada also said over a hundred laboratories in India used ethyl oxide. The tests are not for oxidation but for removal of contamination.
Kumbhakoni countered,Microcontrol is a service provider. They did not push the product into the market.