HC seeks J&J reply on plea over FDA order for unit closure

Bombay High Court today sought an affidavit from Johnson & Johnson (J&J) on a former employee's application supporting Maharashtra health regulator's order to shutdown its facility here for not checking for traces of a harmful chemical residue in a batch of baby talcum powder.
Ajit Telang, employed with J&J from 1996 to 2010, filed the application stating that the multinational firm had not followed due procedure while sterilising the 2007 batch baby powder with ethylene oxide, a chemical widely believed to cause cancer, nausea, vomiting and is considered an irritant.
The plea was filed before a Bench of Justices S J Vazifdar and K R Shriram, which was hearing a petition of J&J challenging the Food and Drug Administration's (FDA) order directing closure of its unit at suburban Mulund from June 24.

Telang has said in 2006 he worked on a sterilisation project for elimination of ethylene oxide and is hence well versed with harmful effects of the chemical.
According to the application, in December 2008 Telang, then Technical Services Manager at the US healthcare giant, came across information that 15 batches of baby powder had undergone sterilisation process by usage of ethylene oxide as they were found to have microbial contamination.
"This sterilisation was done without following the procedure prescribed by law. Being aware of the extremely harmful side effects of ethylene oxide sterilisation I spoke to my immediate superior and sought recall of those batches. However, I was brushed aside following which I filed an online complaint with the head office in America. However, no action was taken," Telang alleged.

He claimed in March 2010 he met with Managing Director of the company and explained the issue but still no steps were taken. "In August 2010, when the said batch completed its expiry date, my contract was terminated," he said.
In February 2011, Telang approached FDA and in April 2013 he learnt the regulator had issued closure orders which the company had challenged in the High Court.
The HC today directed the company to file its reply to the application on September 16.