The Authority had cancelled the licence back in March after it carried out an investigation on some batches of baby powder produced in 2007, the shelf life of which ended in July 2010, that revealed J&J did not conduct mandatory tests to ensure the absence of traces of ethylene oxide before the release of those certain batches.
On the news, a company spokesperson told Business Standard 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."
Elsewhere other reports are speculating that J&J will explore more legal options such as moving to the Bombay High Court or shifting production to another plant or third-party manufacturers.
Ruling comes after internal investigation
Back in March FDA Commissioner Mahesh Zagde revealed the company had carried out the sterilisation of 15 batches (of 160,000 retail containers) of baby powder by using ethylene oxide, against the normal practice of steam sterilisation. And that since it was used in a product meant for infants, the FDA observed, it was more objectionable.
In an initial appeal, a Johnson & Johnson spokesman confirmed it had received the FDA order, which pertained to cosmetic products only, and explained the circumstances under which it had to use ethylene oxide.
Those batches of powder were found to have a pH level (the balance between alkalinity and acidity) that were higher than the prescribed limit set by the Bureau of Indian Standards.
However, the Maharashtra FDA is standing by its decision, stating that it is 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.
“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.”