Sun Pharma, India’s largest drugmaker, has announced the recall of almost 400,000 bottles of anti-depressant and antihistamine medications in the U.S. because the pills failed to dissolve properly.
About 128,000 bottles of Sun Pharma’s antihistamine cetirizine, known by the brand name Zyrtec, “may not meet the drug release specification through expiry,” the FDA said in a statement, according to Bloomberg News. Caraco Pharmaceutical Laboratories Ltd., Sun’s U.S. division, has recalled 252,000 bottles of generic Effexor (venlafaxine), an anti-depressant, which it manufactures in Gujarat, India.
A recent series of recalls of prescription and over-the-counter medicines made by Indian drug companies has led to increased scrutiny from U.S. regulators, concerned that the drugs fail to meet U.S. standards, Bloomberg News reports. Dr. Margaret Hamburg, the commissioner of the U.S. Food and Drug Administration (FDA), made a nine-day visit to India in February to meet with pharmaceutical makers to discuss production quality and safety issues. Indian companies supply about one quarter of the medicines used in the U.S. The U.S. is increasing scrutiny of generic drugs made in India. In 2013, the FDA banned imports from four plants belonging to Ranbaxy Laboratories Ltd. and Wockhardt Ltd.
The FDA plans to expand its offices in India, train Indian regulatory officials, and increase inspections of overseas plants, Hamburg said in a February television interview in Mumbai, Bloomberg News reports. “If a company wants to do business in the United States, the responsibility is on them to understand the rules and requirements,” Hamburg said. Hamburg has agreed to a plan that will allow Indian regulators to shadow FDA inspectors on plant visits to observe FDA practices.