Comments
The Bombay High Court has allowed Johnson & Johnson to resume its manufacturing activities at the Mulund plant in Mumbai. Johnson & Johnson (J&J) had lost its license to manufacture cosmetics at the plant, with the Maharashtra Food and Drug Administration finding the company guilty of using ethylene oxide in a limited number of batches of baby powder in 2007.
Ethylene oxide is known to be a chemical that causes cancer. On the basis of a complaint, the Maharashtra Food and Drug Administration (FDA) had cancelled the company's Mulund plant licence.
In 2007, 15 finished batches of Johnson baby powder were found to have higher pH levels than the prescribed limits. These batches were reprocessed for pH correction, to meet the quality specification. However, due to the excessive manual handling of these 15 batches during reprocessing, the batches at the finished goods stage were treated with ethylene oxide to reduce the anticipated increase in bio-burden. The product had an expiry date of 2010.
However, on April 10, 2013, J&J received an order from the Maharashtra FDA cancelling its Cosmetic Manufacturing license at the Mulund plant, with effect from June 24. The company said the FDA did not issue a show cause notice to J&J before cancellation of the license.
An appeal against the order was filed with the Ministry of FDA in Maharashtra, requesting for an immediate stay, but was rejected by the FDA Minister of Maharashtra. The company subsequently filed a writ petition on July 12, 2013 in the Bombay High Court challenging the FDA order.
With the Bombay High Court setting aside the Maharashtra FDA order, the company has said it would resume cosmetic manufacturing at its Mulund plant in Mumbai in due course. ``We will continue to work closely with Maharashtra FDA, and provide safe, high quality products,'' said a J&J India spokesperson.
The FDA action was specific to the cosmetics production at the Mulund plant in India and did not impact global manufacturing or any other plants in India, the company said.
Comments
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.