Indian drug manufacturers are working on their game plans to improve quality following several notable regulatory failings, this week adding details to their action at a confab with domestic and international regulators.
Business leaders from Sun Pharma, Dr. Reddy's Laboratories ($RDY), Cadila, Lupin and others converged on Mumbai to meet with regulators from India, the U.S., Britain and other European countries, the Business Standard reported. The Indian Pharmaceutical Alliance hosted the gathering and announced its plans there to track of the quality progress of Indian companies against global competition.Thomas Cosgrove
The meeting came as many of India's largest drugmakers have had their U.S. business operations interrupted as they deal with concerns raised by FDA inspectors. At the gathering, the FDA's India office director Mathew Thomas said many of India's issues are no different than problems the FDA encounters at plants in the U.S. or Europe, the Economic Times reports. The FDA's office of manufacturing quality director Thomas Cosgrove urged the industry to deal with problems, such as data integrity, where the FDA has often found test results that have been changed or deleted, and employees with unfettered access to computers that allow such violations.
Cosgrove also urged plant management to put the responsibility where it belongs. Simply firing low-level employees who did not create the situations "will not help," he said.
The meeting allowed companies to talk up their strategies to improve manufacturing quality, with many planned or underway. Sun Pharma is setting up a quality management training institute, while Cipla is asking employees to report "pain points" openly, the heads of each company said. Cipla, as well as Zydus Cadila and Torrent, plan to incorporate automation into their manufacturing as well as boost their talent pools and establish "quality cells," the newspaper reported.
Additionally, the Indian Pharmaceutical Alliance (IPA) has hired consultants McKinsey & Company to help it form "data integrity guidelines" and effect other sectorwide change. McKinsey director Vikas Bhadoria told the Business Standard the "key focus" for Indian drug firms will be to implement data controls.
The IPA hopes the moves can bring about change as many of its companies have seen sales hits recently stemming regulatory action on quality shortfalls. Many inspections, notably by the FDA, have led to warning letters, import alerts and other disciplinary actions until the issues can be fixed and the plants reinspected. In some cases, regulators have found rampant data falsification and manipulation, while in other cases they have found contamination potential, among a host of other recorded problems.