Delay in approving imports hits India’s medical industry

Prolonged delays in processing imports of critical components have disrupted medical device manufacturing, according to industry sources, and this might have long-term implications for the government’s Make in India initiative.According to the producers of crucial items such as X-ray and C-Arm machines, even though they have legitimate so-called MD-9 certificates as needed by India’s Medical Items Rules, they are receiving unexpected requests for additional import licenses. These delays have lasted nearly three months, resulting in production disruptions, missed delivery dates, and limited availability of life-saving diagnostic tools, according to manufacturers.

Last year, the Union Cabinet approved the National Medical Devices Policy 2023. MD-9 certification is necessary for producers of class C and D medical devices, which are moderate to high risk. Examples include implants, dialysis catheters, and heart valves. Among the urgent measures, they want to be able to import crucial components with valid MD-9 certification while a long-term solution is created.

The manufacturers also want a faster customs clearance process for MD-9-certified manufacturers, a centralized grievance redressal mechanism for quick dispute resolution, and better coordination between the Central Drugs Standard Control Organization (CDSCO), customs authorities, and industry stakeholders to prevent regulatory requirements from being misinterpreted.

However, sources acquainted with the situation in the government claim there is no uncertainty and the regulations are plain clear. The official explained that FPDs are utilized in digital radiography, such as digital X-rays, CT scans, and mammograms, as well as to replace radiographic film or screen systems in all general-purpose diagnostic processes for detecting X-rays. It takes X-rays and converts them into digital signals, resulting in digital X-ray images. FPD is a crucial component of digital radiography imaging devices, and its quality and performance can have an impact on the device’s performance, safety, and intended purpose.