Indian state government cancels Johnson & Johnson India’s cosmetics license

The Maharashtra government in India has upheld an order of the state Food and Drug Administration (FDA) regarding the cancellation of Johnson & Johnson India’s (J&J) cosmetics making license.

In March 2013, Maharashtra FDA cancelled J&J’s license to make cosmetics at its facility located in Mulund, in Mumbai, after it raised concerns regarding the sterilisation of 15 batches of baby powder produced by the company in 2007.

The shelf life of the 15 batches comprising 160,000 retail containers of baby powder ended in July 2010, reported Business Standard.

J&J was held responsible for the violation of the Drugs and Cosmetic Act, 1940, and the rules framed in 1945.

FDA expressed its concerns over the use of ethylene oxide during the sterilisation process to reduce microbial load.

After the FDA order, the company appealed against the license cancellation to the state FDA ministry.

Following the state government’s decision on J&J’s cosmetics license, the company will have to halt manufacturing these products at the Mulund plant.

However, the company can continue to make non-cosmetic products at the facility. The company manufactures J&J Baby Powder, Stayfree sanitary napkins, and Band-Aid adhesive bandages at the plant.

Johnson & Johnson India spokesman said the company is disappointed with the outcome.

"Nothing is more important to us than the safety of our products and the health of the consumers who use them," the spokesman added.

"We would like to reaffirm that we have been manufacturing Johnson’s Baby Powder at the Mulund plant for more than four decades with a strong record of safety, quality and regulatory compliance, and that product safety was not compromised at any point."