Maharashtra has upheld the state food & drug administration commissioner's decision cancelling the baby care major Johnson & Johnson India's licence to manufacture healthcare products from its facility at 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.
"The state government has given no relief and upheld the FDA move to cancel the J&J’s licence to manufacture cosmetics," FDA commissioner Mahesh Zagade said. 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 J&J 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, the company 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.
