J&J files petition in Bombay HC against cancellation of Mulund plant licence

The company has also challenged the FDA's decision to serve a show cause notice for releasing an ad

Johnson & Johnson India has filed a writ petition in the Bombay high court against the Maharashtra government's decision upholding the Food & Drug Administration's (FDA) decision to cancel its licence to manufacture cosmetic products from its facility situated in Mulund, north east Mumbai. The company has also challenged the FDA's decision to serve a show cause notice for releasing advertisement titled "Your trust is in safe hands'' explaining its stand.

 

The hearing is underway for the admission of the petition in the high court. FDA official, who did not want to be identified, told Business Standard "J&J India has approached the high court challenging the state government's decision issued on June 20 upholding the FDA's order to cancel its licence to produce cosmetic products from its Mulund unit. Besides, the company has objected to the FDA's move to serve a show cause notice to it as per the provisions of Drugs & Cosmetic Act, 1940.''

 

J&J India spokesman in an email response said ''The matter is subjudice.''

 

FDA had taken action against J&J India in March this year based on 15 batches comprising 1,60,000 retail containers of baby powder produced in 2007, shelf life of which ended in July 2010. FDA had expressed serious concerns over the Ethylene Oxide used during sterilization which aimed to bring down microbial load in the same batch of baby powder produced in 2007. FDA had taken serious objection against J&J India's decision to sterilize those batches again by Ethylene Oxide without the submission of standard operating process.  

 

Further, FDA in its show cause notice served to J&J India on July 9 had said the company's advertisement was quite misliading. The company in its advertisement said that Ethylene Oxide treatment is internationally recognized as a safe method and is commonly followed for various categories of products including food products. The additional process was in fact followed to ensure complete safety of its products on babies by eliminating any harmful microorganisms on account of re-processing required on these batches.