Maharashtra FDA minister to hear on Thursday J&J's appeal on cancellation of licence

Fate of Jhonson & Jhonson's licence depends on the outcome of Thursday's hearing

Maharashtra’s food and drug administration minister will hear on Thursday an appeal by Johnson & Johnson (J&J) against state Food and Drug Administration (FDA)’s move to cancel the company’s licence in April. The fate of the licence depends on the outcome of Thursday’s hearing.

FDA had issued the cancellation order on March 30 and J&J was given 90 days (up to June) to plead its case before the state. J&J’s licence for cosmetics at Mulund plant was cancelled by FDA, which expressed concerns over the ethylene oxide used during sterilisation that aimed to bring down microbial load in the same batch of baby powder produced in 2007.

FDA's had cancelled Johnson & Johnson India’s licence to manufacture cosmetics at its facility in Mulund, a Mumbai suburb.

Thursday's hearing was confirmed by both the office of Naik and FDA Commissioner Mahesh Zagde.  Zagde told Business Standard "Any action taken by licensing authority can be appealed to the state government. J&J has done so." However, J&J spokesman declined to comment.

It must be mentioned here that FDA's action was related to  a few batches of baby powder produced in 2007, the shelf life of which ended in July 2010. FDA had expressed concern over use of ethylene oxide for sterilization to bring down the microbial load.

FDA had said that the company did not conduct the mandatory test to ensure absence of traces of ethylene oxide, a carcinogenic substance before release of these batches. Since it was used in a product meant for infants, FDA observed, it was more objectionable. FDA had noted that  the company had carried out sterilization of 15 batches (of 160,000 retail containers) of baby powder by using ethylene oxide, against the normal practice of steam sterilization.