USFDA bans imports from Sun Pharma’s Gujarat plant, shares hit

The US Food and Drug Administration (FDA) has imposed a ban on imports from generic drugmaker Sun Pharmaceutical Industries’plant at Karkhadi in Gujarat, in the latest quality blow for India’s drug sector.

The Karkhadi plant makes both drug ingredients and formulations, according to Sun’s 2013 annual report.

An “import alert” results in the detention without physical examination of drugs from firms that have not met so-called good manufacturing practices, according to the FDA website.

Sun Pharma, India’s biggest drugmaker by value, saw its shares fall as much as 6.4 per cent on Thursday after the FDA’s “import alert”, which appeared on Wednesday on the agency’s website.

A spokesman for Sun was not available for comment.

The FDA action against Sun Pharma comes amid a rash of regulatory sanctions against Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by India’s $14 billion drug industry to countries including the United States, the biggest market.

USFDA has banned all the India plants of Ranbaxy Laboratories, India’s No.1 drugmaker by sales, due to lapses in production quality. Rival Wockhardt has also been barred by regulators from exporting drugs from some of its plants to the United States and the United Kingdom.

India is second only to Canada as a drug exporter to the United States, where it supplies about 40 per cent of generic and over-the-counter drugs.