Mumbai based Polydrug Laboratories Ambernath manufacturing plant is now facing a ban from USFDA; exactly 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 US Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action.
The company did not immediately respond to a request seeking comment on Monday, after the FDA posted a notice of the ban on 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.