U.S. FDA officials visiting India laid out a new approach to facility inspections that would reward Indian devicemakers whose quality management systems exceed the minimum.
Under the proposal, high-performing facilities would be rewarded with less-frequent inspections and less scrutiny when proposing postapproval manufacturing changes, the agency says.
“To put it simply, the inspections can yield also carrots, and not just sticks,” says Howard Sklamberg, deputy commissioner for global regulatory operations.
The FDA plans to pilot a program — using a questionnaire that will standardize the inspection process — to uniformly gather quality metrics and target Indian plants most likely to have compliance issues. But aggressive enforcement will remain an important part of the agency’s efforts to ensure product quality, especially in cases where it finds devicemakers have tampered with or failed to protect the data they show investigators.
The India trip, which began in mid-March, included site visits in New Delhi, Goa, Chennai and Mumbai, FDA spokesman Jeff Ventura says. Cynthia Schnedar, director of the Office of Compliance, is also part of the delegation, which hopes to build on cooperative quality agreements launched last year when Commissioner Margaret Hamburg visited the country ().
Information exchange and knowledge sharing would be beneficial for devicemakers and exporters and help with capacity building, says Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry. He adds that the Central Drugs Standard Control Organization has been reluctant to regulate the vast field of medical devices.
At the same time, the U.S. regulatory model may not be the best model for India, Nath ventures, noting that regulation in India needs to be layered to separate the roles of legislator from those of regulator and of supervisory accreditation bodies from those of third-party conformity assessment bodies. — Jonathon Shacat