The element of surprise

FDA to begin unannounced site inspections at Indian facilities

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In the wake of continued issues with manufacturing standards, the U.S. Food and Drug Administration (FDA) is purportedly considering adding unannounced inspections of facilities to its supervision practices in India. The regulatory body currently has such a same system in place in the United States and other countries. The FDA has had an office in New Delhi since 2008, and more recently has opened offices in Hyderabad and Mumbai and increased its India inspection team to 19.
The move to increased surveillance is not unwarranted, as several India-based companies have faced repeated manufacturing practice violations, issues of data falsification or failure to pass inspections.
On Sept. 16, the FDA announced an import alert by which U.S. officials can detain at the border any drug products manufactured at Ranbaxy Laboratories Ltd.’s facility in Mohali, India. The press release noted that Ranbaxy “will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP).” The FDA also ordered that the facility be subject to certain terms of the consent decree of permanent injunction leveled against Ranbaxy in January of last year, which contains provisions to ensure CGMP compliance and address data integrity issues at certain facilities, including Paonta Sahib and Dewas, India, two facilities that have been on FDA import alert since 2008. FDA inspections reported significant CGMP violations at the Mohali facility in September and December 2012.
The FDA’s decree prohibits Ranbaxy from “manufacturing FDA-regulated drugs at the Mohali facility and introducing drugs into interstate commerce, including into the United States, from the Mohali facility until the firm’s methods, facilities and controls used to manufacture drugs at the Mohali facility are established, operated and administered in compliance with CGMP.” Ranbaxy can resume manufacturing and distribution of FDA-regulated drugs at Mohali once a third-party expert has inspected the facility and certified to the FDA that “the facilities, methods, processes and controls are adequate to ensure continuous compliance with CGMP.”
In a Sept. 17 response to the FDA’s import alert, Ranbaxy issued a press release noting that it “will continue to fully cooperate with the U.S. FDA and take all necessary steps to resolve the concerns at the earliest.” Ranbaxy added that it “believes that it has made further improvements at its Mohali facility since the last inspection in 2012, and remains committed to addressing all concerns of the U.S. FDA. Ranbaxy is hopeful of an early resolution of these concerns.”
Ranbaxy isn’t alone in receiving censure. The FDA also placed an import ban on Wockhardt—which had been found to be falsifying data, among other issues—in May, and mid-October saw the UK Medicines and Healthcare Products Regulatory Agency withdrawing its good manufacturing practice certificate for Wockhardt’s plant in Chikalthana. The FDA has sent warning letters to other Indian drugmakers since 2011, including Cadila Healthcare, Strides Arcolab, Aurobindo and Lupin.
In a recent article, Business Standard reported that the Indian Pharmaceutical Alliance, which represents India’s domestic drug manufacturing industry—with members that include Ranbaxy and Wockhardt—has reached out to the FDA to initiate dialogue to discuss the recent issues and the FDA’s concerns. The FDA has agreed to the proposal.
Economically speaking, resolving these issues is in the interest of both the United States and India. The FDA notes on its website that in 2011, India represented the second largest drug exporter to the United States. It has emerged in recent years as a leading supplier of generic versions of drugs. The Pharmaceutical Export Promotion Council of India reported that there are 135 FDA-approved manufacturing sites in India, and in 2012, India exported $6.5 billion in medicines, 30 percent of which was exported to the United States.

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