After Ranbaxy Laboratories, Caraco Pharmaceutical Laboratories, the US subsidiary of Sun Pharmaceutical, is facing the heat of US FDA regarding the product quality issue. As per the request of US FDA, US Marshals have seized drug products manufactured by Caraco's Michigan facilities in Detroit, Farmington Hills and Wixom. The seizure also includes ingredients held at these same facilities.
As a result of US FDA action, Sun Pharmaceutical scrip plunged by Rs 155 to Rs 1,143 in the morning session and touched to its intraday low of Rs 1070 on the BSE.
The US FDA's most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. The seizure is intended to lead to major changes at Caraco's facilities.
If the US FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public.
"The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public."
This action follows Caraco's continued failure to meet the US FDA's current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the US FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.
Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.
The US FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The US FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective.
"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.
Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.