Why has J&J lost its Mulund cosmetic license? All you need to know

The FDA had cancelled the licence of J&J facility in March after it found that 15 batches of baby talcum powder manufactured at the Mulund plant were sterilised using ethylene oxide, a chemical that is widely believed to cause cancer, nausea, vomiting and is considered an irritant.

FP Staff December 20, 2014 22:03:07 IST
Why has J&J lost its Mulund cosmetic license? All you need to know

The Maharashtra government on Monday upheld the Food & Drug Administration (FDA) Commissioner's decision to cancel Johnson & Johnson India's licence to manufacture healthcare products from its facility in Mulund in suburban Mumbai.

The FDA had cancelled the licence of J&J facility in March after it found that 15 batches of baby talcum powder manufactured at the Mulund plant were sterilised using ethylene oxide, a chemical that is widely believed to cause cancer, nausea, vomiting and is considered an irritant.

Why has JJ lost its Mulund cosmetic license All you need to know

In a big blow for cosmetics major Johnson & Johnson, Maharashtra FDA has decided to cancel the company's licence to manufacture cosmetics at its Mulund plant.

The state FDA alleged that Johnson & Johnson did not register the process with it and failed to conduct mandatory tests to check for traces of ethylene oxide in the batches of talcum powder.

In its appeal, Johnson & Johnson explained the circumstances under which it had to use ethylene oxide to sterilise the 15 batches - which comes to about 1,50,000 bottles of baby powder.According to the pharma giant, the 15 batches of powder had a pH level (the balance between alkalinity and acidity) that were higher than the prescribed limit set by the Bureau of Indian Standards. Therefore, the pH levels had to be brought down manually. The manual process involved human intervention which raised the susceptibility of the product to microbial content.

The company has also admitted its failure to register the process with the local FDA and test the batches of powder to check for traces of ethylene oxide.

However, the Maharashtra FDA had stuck to its ground, saying that they were looking to cancel this licence not only because the company had failed to register the process with a local FDA but had also not conducted mandatory tests to check for residues in these 15 batches.

"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,"FDA Commissioner Mahesh Zagade was quoted as saying by the Business Standard.

The licence suspension comes into affect immediately.

J&J's appeal was heard by the Maharashtra Minister of Food and Drugs Administration, Manohar Naik, on June 20.

The state government in its order ruled that "J&J has violated section 18 of the Drugs & Cosmetic Act, 1940 and rule 142 (c) of 1945 rules. The appeal stands rejected. FDA directives issued in this regard on March 30 are upheld. The licence stands cancelled from June 24."

J&J would continue to manufacture non-cosmetic products at the same site. The factory was making J&J Baby Powder, Band-Aid adhesive bandages and Stayfree sanitary napkins.

A J&J India spokesman told the Business Standard: "We appreciate that the Maharashtra state FDA has given us a hearing on the matter of our Mulund plant. However, we are deeply 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.

Sources told CNBC-TV18 that the company is looking to explore more legal options such as moving the Bombay High Court and the production of baby products could be shifted to another plant as well as to third-party manufacturers.

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