Johnson and Johnson to appeal against licence cancellation

Company yet to shut down plant at Mulund near Mumbai, says discussions are on

GN Bureau | May 4, 2013



Even though Johnson and Johnson recently lost the manufacturing licence for its Mulund plant for using an unauthorised process for sterilising baby powder, the company is yet to shut the unit in the outskirts of  Mumbai.

The company, on Friday, has however said that it is in "ongoing discussions" with the regulators here and assured that the matter would be resolved soon.

According to Peggy Ballman, spokesperson, J&J, “We understand their concerns and are diligently working with them to resolve the issue.” Ballman further said that till date the company had neither received any consumer complaints nor were there any adverse events being reported due to its use of the process in question. Ballman said that the company will be appealing the decision.

The matter came to light following an investigation undertaken by the Maharashtra Food and Drug Administration which revealed that J&J, at its Mulund plant was making use of ethylene oxide in its baby powder. The authorities have contended that the company had not carried out mandatory tests to ensure that there were no traces of the substance, which is used to manufacture industrial chemicals and to sterilise medical equipment used in the killing of bacteria, in the powder.

Acute exposure to ethylene oxide, according to the U.S. Department of Labor, can lead to lung damage, nausea, vomiting and cancer.

Ballman has denied all charges saying that the company, in 2007, was conducting an experiment of using the sterilization process in question only on a limited amount of baby powder, which is usually sterilized using steam. “For a brief time in 2007, we used an alternative sterilization process,” she said.

Justifying the experiment terming it a “widely accepted and safe practice of sterilization”, Ballman assured that the substance left no harmful residue. “However, the process was not registered with the local food and drug administration and they viewed this step as out of compliance,” she said.

In the recent times, J&J has been plagued by several quality control issues, the last one involving its consumer healthcare division with the company having to recall millions of bottles of Motrin and children's Tylenol from counters.

 

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