FDA’s move to cancel Johnson & Johnson licence upheld by Maharashtra Government

After finding residues of carcinogenic substances in 15 batches of Johnson & Johnson baby powder, Maharashtra Food and Drug Administration (FDA), the apex body for food and drug products in the State, had, in March, cancelled  the licence of Johnson & Johnson, the multinational healthcare and consumer products major, to manufacture cosmetic products at their Mulund plant. On Monday, The Maharashtra Government also upheld the Food & Drug Administration (FDA) Commissioner’s decision to cancel the same.

FDA suspends licence of Johnson & Johnson

The FDA had cancelled the company’s licence after finding that the carcinogenic residue was found because the batches were sterilised using ethylene oxide, a chemical that is widely believed to cause cancer, nausea, vomiting and is considered an irritant.

“The State Government has given no relief and upheld the FDA move to cancel the Johnson & Johnson India”s licence to manufacture cosmetics,” FDA Commissioner Mahesh Zagade said.

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.”

The State FDA alleged that Johnson & Johnson did not register the process with the local FDA and failed to conduct 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.

A J&J India spokesman was quoted in Business Standard saying that, “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.”
He further 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.”

What all consumers should learn from this is that  blindly following a brand is not wise. The contents of the products should be carefully checked by them to prevent themselves from such things.