Friday, May 31, 2013

FDA warning Indian drug manufacturing units - Is it a retaliation to court ruling against Novartis

One after other drug manufacturing units of India getting warning letters or getting banned to manufacture licenses getting cancelled. Is this a systematic fight back (to the set back of patent disputes in favor of local generic manufacturers)  by big pharma by their arm twisting techniques or is it real the plants are not following procedures.

Today Hospira's manufacturing unit in India received a warning letter from FDA concerning the drug safety i.e contamination of drugs manufactured at its facility in India.

Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy Laboratories and Wockhardt Ltd faced issues related to manufacturing practices. Incidentally Indian court's ruling against Novartis came in April and after that FDA is finding issues and issuing warning letters. Or is it simply they have not followed the procedures.

Ranbaxy earlier this month agreed to pay $500 million in civil and criminal fines under a settlement agreement with the U.S. Department of Justice, after it pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations.

The FDA imposed an "import alert" on a plant operated by Wockhardt in the western state of Maharashtra on May 22.

As in the case of Hospira plant which is bought by Hospira from India-based Orchid Chemicals & Pharmaceuticals Ltd , the FDA said it found that surfaces in the facility were not always sanitized prior to use and that sterile drug products were not protected from contamination

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