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The Maharashtra’s Food and Drug Administration (FDA) has scrapped Johnson & Johnson India’s licence to make cosmetics at its unit in Mulund, a Mumbai suburb. The order was issued by the joint commissioner on March 15 while giving time till April 21 to appeal the decision.
The authority has upheld the order by the state’s appellate authority in June. The company has been held responsible for the violation of the Drugs & Cosmetic Act and the rules framed in 1945.
An FDA official said, “The action is with regard to a few batches of baby powder made in 2007, the shelf life of which had ended in July 2010. The FDA, in its first order in April to cancel the licence, and the subsequent ruling by the appellate authority, had claimed 1.6 million were exposed to cancer following the overuse of ethylene oxide for sterilisation.’’
A J&J India spokesman said, ‘’It is inappropriate to comment since the matter is sub judice.’’
The authority has upheld the order by the state’s appellate authority in June. The company has been held responsible for the violation of the Drugs & Cosmetic Act and the rules framed in 1945.
An FDA official said, “The action is with regard to a few batches of baby powder made in 2007, the shelf life of which had ended in July 2010. The FDA, in its first order in April to cancel the licence, and the subsequent ruling by the appellate authority, had claimed 1.6 million were exposed to cancer following the overuse of ethylene oxide for sterilisation.’’
A J&J India spokesman said, ‘’It is inappropriate to comment since the matter is sub judice.’’
The official said the J&J India's facility to produce cosmetics at Mulund plant was closed for more than 78 days after the first order to cancel the license was issued in April last year.
However, the manufacturing was restored after the high court in September last year on a petition filed by J&J India to approach it to the licensing authority.
The official added that notwithstanding the March 15 order issued by the licensing authority the production will continue as J&J India has been given time till April 21 to explore legal course of action.
However, the manufacturing was restored after the high court in September last year on a petition filed by J&J India to approach it to the licensing authority.
The official added that notwithstanding the March 15 order issued by the licensing authority the production will continue as J&J India has been given time till April 21 to explore legal course of action.
