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17
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USFDA Bans Imports from Mumbai-Based Polydrug Laboratories for Quality Control Concerns Read more: USFDA Bans Imports from Mumbai-Based Polydrug Laboratories for Quality Control Concerns
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USFDA Bans Imports from Mumbai-Based Polydrug Laboratories for Quality Control Concerns

The FDA’s “import alert” on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the same site, citing data integrity issues. Europe also barred imports from the plant in early June citing critical deficiencies, including that staff deliberately did not record customer complaints.

Polydrug makes drugs to treat hypertension, fungal diseases, and muscle relaxants, and exports them to more than 70 countries across Europe, North America and Asia, according to its website.

The FDA action comes less than two weeks after Svizera Labs, a major Indian supplier of tuberculosis drugs to developing countries, was criticised by the World Health Organization for inadequate manufacturing standards and poor testing procedures.

Several Indian drugmakers, including some of the country’s largest, have faced FDA bans in the last few years over issues ranging from sanitation to data manipulation, as the FDA stepped up efforts to regulate the generic drugs industry.

The ban on Polydrug takes the total number of Indian drug manufacturing facilities that currently stand barred from exporting to the United States to 44 between 2011 and now, according to the FDA website.

The sanctions have hurt India’s image as a reliable supplier of cheap generics, and slowed the growth of India’s $15 billion pharmaceutical industry that supplies 40 per cent of the generic and over-the-counter medicines sold in the United States.

Indian drugmakers have said they have been working towards upgrading their systems and improving quality control procedures at their manufacturing plants, but many are still struggling to get their facilities cleared by regulators.

Read more: USFDA Bans Imports from Mumbai-Based Polydrug Laboratories for Quality Control Concerns http://www.medindia.net/news/usfda-bans-imports-from-mumbai-based-polydrug-laboratories-for-quality-control-concerns-153584-1.htm#ixzz3lxqtuE6r



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