Indian state annuls J&J’s cosmetic manufacturing license

Indian state of Maharashtra’s Food & Drug Administration (FDA) has barred Johnson & Johnson (J&J) India from manufacturing cosmetics at its facility in Mumbai.

It follows certain batches of baby powder produced by J&J in 2007 seeing their shelf life ending in July 2010.

FDA was concerned over ethylene oxide use for sterilisation to reduce the microbial load, according to Business Standard.

An investigation by FDA discovered that the company did not conduct the mandatory test to make sure absence of traces of ethylene oxide, a carcinogenic substance, before release of these batches.

According to FDA, this was alarming as this product was meant for toddlers.

The authority issued an order cancelling the frim from producing cosmetics at this unit on March 30.

J&J has, however, been given a period of three months to plead its case before the state government.

This move comes on the heels of an FIR lodged against one of J&J’s subsidiaries for supply of faulty hip joints.

FDA Commissioner Mahesh Zagde was quoted by the newspaper as saying that the company had carried out sterilisation of 15 batches (of 160,000 retail containers) of baby powder through use of ethylene oxide, instead of steam sterilisation that is normally done.

Confirming the receipt of the FDA order, a J&J spokesman said it was concerned with cosmetic products only.

The company would continue manufacturing non-cosmetic products at the same site.

"The matter in question as cited by the FDA order relates to a limited number of batches produced in 2007. FDA raised concern about ethylene oxide treatment, which was not included as part of the manufacturing process submitted to FDA," added the spokesperson.