J&J manufacturing license restored at Indian plant

The facility recently had its manufacturing license cancelled after an inspection found that 15 batches of powder had been sterilized with ethylene oxide, an irritant and carcinogenic. 

This judgment was based on all available evidence, including the fact that no carcinogens were found in the baby powder tested.

A Johnson & Johnson India spokesperson said: “Nothing is more important to us than the well-being of consumers, and we see this outcome as a significant step in restoring their confidence.”​

“We will continue to work closely with Maharashtra FDA and provide India with safe, high quality products that help people care for themselves and their families.”​

“Objectionable, irresponsible and illegal”​​

The company’s license was cancelled in May when an investigation found that 15 batches of powder produced at the Mulund plant in 2007 were contaminated with ethylene oxide.  

Ethylene oxide can legally be used to sterilize cosmetics in India, however it is also considered a possible carcinogenic, neurotoxin and sensitizing agent according to the US Occupational Safety and Health Administration (OSHA).

The Indian FDA contended that Johnson & Johnson failed to register this process with them and also did not carry out mandatory checks for traces of ethylene oxide in the powder.

In an interview with the Business Standard in June, FDA Commissioner Mahesh Zagade was quoted as saying: “The company did not have data to check whether traces of Ethylene Oxide did not remain in the powder, as it is highly carcinogenic.” ​

“The company released about 1,60,000 small packs in the market and in effect exposed equal number of babies to carcinogenic substance. This is highly objectionable, irresponsible and illegal.”​

Chain of events​

The cosmetics giant claims that the contamination was the result of a chain of events in which the manufacturers needed to lower the pH level of products manually.

This raised the risk of bacterial infection and forced J&J to use ethylene oxide to sterilize the powder.

A spokesperson from J&J noted: “​Product safety was not compromised at any point, and there were no adverse events or product complaints related to this issue.” ​

“There is no scientific foundation supporting claims by certain sections of the media that there were carcinogenic substances present in our product.” ​

J&J also stated that the products concerned expired in 2010.