MUMBAI: Bombay high court is slated to hear today John & Johnson's plea against the order of the Food and Drugs Administration directing closure of its Mulund factory on the allegation that the ethylene oxide treatment applied to its batches of baby talcum powder in 2007 is carcinogenic.
A division bench of Justice S J Vazifdar and Justice M S Sonak will hear petition by the company challenging the FDA's April 30, 2013 order for closure effective from June 24, 2013. Their appeal before the appellate authority was also rejected. At the previous hearing on July 24, 2013 FDA's advocates Ashutosh Kumbhakoni and Ashutosh Gavnekar opposed the petition. It is simply shocking. Ethyl oxide treatment is carcinogenic and results into cancer. It is a mutagen,'' said Kumbhakoni.
Senior counsel Rafiq Dada argued that in 2009 the company subjected samples of 3 out of 15 batches of 2007 for testing as part of an internal audit requirement. We wanted to check if there is any residue left after the ethyl oxide treatment. We found none,'' said Dada, adding that a year and half later a show cause notice was issued in March 31, 2012 stating that FDA was kept in the dark. . The penalty is we are closed forever,'' said Dada, adding that the ethyl oxide treatment is also carried in cases of foodgrains, spices and medical devices.
He said the shelf life was over three years from date of manufacture. Here the problem is they initiated action after everything is over,'' said Dada. He said also informed that the laboratory Microtoll , where the test was carried, was also served a three month suspension. He said FDA officer who passed order for closure had also appeared before the minister in appeal saying the company had not obtained a license to carry out the tests to check residue of ethyl oxide outside its manufacturing premises.
Dada said since the license was cancelled permanently in Mahrarashtra, the company recently conducted a simulation in Haryana and has found no residue. What is relevant is not whether there is a breach earlier or today, but if at all there is a breach,'' said Justice Vazifdar. The judges questioned what was the point in FDA barring the the company from producing. What is the point of closing down the whole factory? Why did your officer take a year and half (after show cause notice) to decide the issue,'' asked Justice Vazifdar.
Anda sedang membaca artikel tentang
HC to hear Johnson & Johnson's plea against factory closure
Dengan url
http://cegahkeropostulang.blogspot.com/2013/07/hc-to-hear-johnson-johnsons-plea.html
Anda boleh menyebar luaskannya atau mengcopy paste-nya
HC to hear Johnson & Johnson's plea against factory closure
namun jangan lupa untuk meletakkan link
HC to hear Johnson & Johnson's plea against factory closure
sebagai sumbernya
0 komentar:
Posting Komentar