- A Divi's Laboratories manufacturing facility has found itself on the Food and Drug Administration's import ban list, yet another example of ongoing quality and regulatory control issues at Indian drug production sites.
- The facility, located in the Chippada village of Andhra Pradesh, India, underwent an agency inspection between Nov. 29 and Dec. 6, which led the agency to issue a Form 483 based on five observations. Such forms are only given when there is a safety concern about the products made at a plant.
- While Divi's pledged at the end of last quarter to get its manufacturing facilities into compliance, the FDA clearly isn't sold on the company's corrective strategies. Since the ban listing was released on March 20, Divi's shares, which trade on the National Stock Exchange of India, have fallen nearly 20%.
The FDA has been cracking down on foreign drugmakers, particularly in China and India where violations of current good manufacturing practices (cGMP) have been more common. Last April, the CEO of Dr. Reddy's Laboratories, one of India's largest pharmaceutical businesses, cited FDA oversight as a contributing factor to lower export growth.
Dr. Reddy's has reason to complain too; the FDA sent the company a warning letter in November 2015 for a Miryalaguda, India production site of active pharmaceutical ingredients (APIs). By February 2017, the agency had issued a Form 483 after a re-inspection found three instances of violations.
The FDA isn't the only regulatory agency on the offensive.
Germany's Federal Institute for Drugs and Medical Devices, for example, flagged an API facility in Hyderabad, India, owned by Artemis Biotech after identifying more than 30 safety or regulatory violations.
The Indian government has also been increasing oversight. The country's Drug Controller General, who's responsible for approving medications for market, revealed last June plans to inspect roughly 200 domestic and international pharmaceutical companies.
Amid the ongoing regulatory turmoil, as well as an industry-wide trend of consolidation, drugmakers have been pulling the plug on their Indian plants.
Japanese pharma Daiichi Sankyo announced in January it is shuttering a facility in the city Gurgaon that employs about 170 people. Five months earlier, Pfizer disclosed plans to temporarily close a production center in Chennai. The center was formerly owned by Hospira and had a history of manufacturing woes.
In response to the FDA's observations, Divi's sought outside support to help get manufacturing infractions in check. The company wrote in a Feb. 4 statement about third quarter results ended Dec. 31 that it was working toward an "enhanced culture of compliance."
"Divi's Labs has always adopted consistent practices to ensure that its products are safe and meet the applicable standards," the company wrote. "The company's quality and regulatory teams continually strive to comply with the cGMP guidelines and are committed to ensure supply of quality products to its customers and partners across the globe."