FDA opposes Johnson & Johnson's plea to resume talc production


Mumbai, Jul 26 (PTI): Opposing grant of interim permission to Johnson & Johnson's to resume manufacturing of baby talcum powder at its factory here, Food and Drug Administration (FDA) today told the Bombay High Court that multinational companies shouldn't treat Indians as "guinea pigs".

Justifying state FDA's order directing closure of the J&J's Mulund facility for not checking some batches of talcum powder for ethylene oxide residue in 2007, FDA lawyer Ashutosh Kumbakoni said, "Multinationals should stop treating Indians like guinea pigs. If the same incident had happened in the US, the company would have faced worse (consequences)."

The division bench of Justices S J Vazifdar and M S Sonak was hearing a petition filed by J&J challenging FDA's order directing closure of suburban Mulund factory from June 24. The company has also sought a permission to reopen its factory as an interim relief.

In March, the FDA cancelled the licence of the factory after it found that 15 batches of baby talcum powder manufactured there in 2007 were sterilised using ethylene oxide, a chemical that is widely believed to cause cancer, apart from symptoms such as nausea, vomiting, and is considered `an irritant'.

FDA alleged that the company had not registered this process with it, and failed to conduct tests to check for traces of ethylene oxide in these batches of powder.

The company challenged the order before appellate authority, but the order was upheld, so it moved HC.

Senior counsel Rafiq Dada, appearing for the company, today sought interim relief and said the company was not using ethylene oxide treatment process anymore.

The FDA lawyer, however, opposed the request. "Even today the company is not admitting that treatment to check residue was not done. Absence of repentance and remorse is withholding the authorities," advocate Kumbakoni argued.

The hearing would continue on July 29.

  

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Comment on this article

  • KRPrabhu, Mangalore/Bangalore

    Sat, Jul 27 2013

    FDA should initiate strict checking of formulas of various composition of important drugs especially life savings drugs manufactured and marketted by the multinational companies in the light of penalisation of one of the biggest MNC by US govt, operating in India for supply of inferior quality of drugs.

    DisAgree Agree [2] Reply Report Abuse

  • Nanag Shetty, kinnigoly,Oman

    Sat, Jul 27 2013

    Ethylene oxide(EO) is one of the common raw material used in many products including Plastic ,Shampoo etc.
    Yes EO itself is carcinogen , but it is highly volatile ,no traces will be present in the finished products.
    Here issue may be other than Ethelene oxide , as FDA is still reluctant to approve in spite of company’s assurance not to use EO.
    In general Multinationals policy avoids bribing FDA officials and only multinational organized companies can afford to advanced R&D and highest quality standards,compared to local manufacturers.

    DisAgree Agree [1] Reply Report Abuse

  • Adv.pinto, Mlore

    Sat, Jul 27 2013

    BAN JOHN AND HIS SON AND GRANDSON....PLAYING ON THE LIVES OF INNOCENT INDIANS...THAT TOO BABIES , TRY YOUR STUNTS IN YOUR BIRTH PLACE .

    DisAgree Agree [1] Reply Report Abuse

  • Avinash, Kasaragod/Bangalore

    Fri, Jul 26 2013

    We common people think that products of multinational companies are the best and will buy it evenif these are costly and we will not think twice about it.

    But now the truth is coming out and we should be much careful before buying anything.

    DisAgree Agree [9] Reply Report Abuse

  • Jossey Saldanha, Mumbai

    Fri, Jul 26 2013

    Now we know why our FEKU wants to go to USA...........

    DisAgree [15] Agree [17] Reply Report Abuse


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Title: FDA opposes Johnson & Johnson's plea to resume talc production



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