The US Food and Drug Administration (FDA) has directed Glenmark's US arm, Glenmark Generics Inc, and three other manufacturers to stop the marketing of unapproved codeine sulphate tablets in the US market. The drug is an old narcotics product widely used to treat pain.
The USFDA said these products, marketed in 30mg and 60mg form, lack FDA approval and the agency has no evidence that they are safe and effective. Glenmark confirmed the company had received a warning letter yesterday in relation to the marketing of codeine sulphate tablets.
In March, FDA had warned Glenmark Generics not to sell another similar product, morphine sulphate, in the US market, citing the same reasons. Following the warning, Glenmark had withdrawn the product from the US market. A few weeks later, the regulator allowed Glenmark Generics to restart sales of one of the banned products, morphine sulphate solution immediate release concentrate, for up to a period of 180 days.
Sources said the decision stems from the FDA decision in 2006 to phase out unapproved drugs from the US market. Morphine and codeine belong to a category of 'grandfathered drugs', or drugs that were manufactured and sold in the US prior to the passage of the Food Drug and Cosmetic Act (FDAC) in 1938.
In accordance with an FDA policy issued in June 2006, FDA is transitioning grandfathered products to FDA-approved New Drug Application (NDA) products. In other words, manufacturers will have to provide safety, efficacy and clinical trial data of the drug to get marketing approval in the US.
Industry analysts said Glenmark's revenues would not be impacted much by the US FDA decision, as the US sales of this product are less than Rs 5 crore a year. A Glenmark spokesperson declined comment on the development.
"Consumers deserve and expect that their drugs meet modern FDA standards for safety, effectiveness, labeling, and quality. Removing unapproved products that do not meet those standards is an FDA priority," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER).
FDA said Roxane Laboratories, a US manufacturer, markets FDA-approved codeine sulphate tablets and the regulator does not anticipate a supply problem for codeine sulfate tablets in that market.
Indian pharma majors have faced trouble in the US on several occasions. Earlier this month, Dr Reddy's Laboratories had voluntarily withdrawn a few batches of four over-sized drugs from the US market.
Before that, on June 25, US marshals had seized drug products from Sun Pharmaceutical's US subsidiary Caraco's three production facilities in Michigan at Detroit, Farmington Hills and Wixom. Up to 33 different drugs were seized by the US marshals and the FDA banned Caraco from manufacturing and selling these drugs in the US, until there was an assurance that the firm complies with manufacturing standards.
The action followed Caraco's continued failure to meet the FDA's current good manufacturing practices requirements.
India's largest drug maker Ranbaxy Laboratories was banned last year by the FDA from selling more than 30 drugs in the US market, after the company's failure to comply with manufacturing standards at two of its production units in India.
