Bombay High Court: Setting aside the impugned order of the Joint Commissioner and Licensing Authority- Food and Drug Administration, the Court granted a major relief to the petitioner, whose baby powder facility at Mulund had been shut down following the revocation of license by the FDA on the grounds that the company sterilized 15 batches of baby powder boxes with "carcinogenic" ethylene oxide without checking for residue. The petitioner in its reply told the Court that the 15 batches were brought back to its facility and tested according to a validated process (ETO Treatment) before its release into the market. The division bench of Hon’ble S J Vazifdar and M S Sonak, JJ held that although incorrect procedure had been followed in the case of 15 batches but the petitioner had ensured, to the satisfaction of the Court, that only tested samples were released in the market. Regarding revocation of licence, the Court held that as the product continues to be manufactured at other units, revoking the license to manufacture the powder at the Mulund unit would not serve any purpose whatsoever except by way of a penalty. The Court remanded the case to the appellate authority-the FDA minister-for reconsideration and it has also stated that it is open to former employee, Dr Ajit Telang, who claimed to be a whistle-blower, to approach the appellate authority. [Johnson & Johnson Limited vs. State of Maharashtra, Writ Petition No. 1714 of 2013, decided on 19th September, 2013]
Posted on: Thu, 03 Oct 2013 06:54:38 +0000
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