Prolonged delays in clearing imports of essential components has resulted in disruptions in the manufacture of medical devices, people in the business said, adding that this could affect the government’s Make-in-India scheme in the long run.
“Despite full regulatory compliance, a lack of policy clarity among regulatory authorities has led to stalled shipments, severely affecting production timelines and jeopardizing health care services,” said a manufacturer of X-ray device, requesting anonymity.
According to the manufacturers of critical devices such as X-ray and C -Arm machines, even though they are equipped with valid so-called MD- 9 certifications as required under India’s Medical Devices Rules, they are encountering unexpected demands for additional import licenses.
“It is being sought for components such as flat panel detectors (FPDs), which is contrary to the certification’s established scope as these components are integral to manufacturing and not standalone devices,” said the manufacturer cited above.
These delays have persisted for nearly three months, causing production disruptions, missed delivery deadlines and restricted availability of life saving diagnostic tools , manufacturers claimed.
Last year, the Union Cabinet approved of the National Medical Devices Policy 2023. MD-9 certification is required for manufacturers of class C and D— moderate to high risk— medical devices such as implants, dialysis catheters, and heart valves.
“MD-9 certification should suffice for importing essential components, but the demand for additional approvals has created unnecessary bottlenecks,” said another manufacturer, who too asked not to be named
The manufacturers are asking the government for immediate and long-term resolution to their concerns.
Among the immediate measures, they are asking to be permitted imports of essential components on valid MD-9 certification until a long-term solution is implemented.
“This will prevent further production disruptions. In addition, the government should provide clear guidelines on MD-9 certification and its applicability, distinguishing between manufacturing components and fully built medical devices and also a proper demarcation between manufacturers and traders,” said the second manufacturer cited above.
The manufacturers are also asking for a fast-track customs clearance process for MD-9-certified manufacturers, a centralized grievance redressal mechanism for swift dispute resolution, and improved coordination between the Central Drugs Standard Control Organisation (CDSCO), customs authorities, and industry stakeholders to avoid misinterpretation of regulatory requirements.
However, people familiar with the matter in the government, said there is no ambiguity and the rules in this regard are crystal clear.
“The demands have no substance; everything is clear in regulations. Major components of medical devices, when being imported, are categorized as medical devices. This is the practice world over that you need a separate import license to import not just medical devices but also major components. The license required to import devices or parts is MD-14; and MD-9 certification is to manufacture devices,” said a senior official in the government, requesting anonymity.
The official explained that FPDs, for example, are used in digital radiography such as digital X-rays, CT scan, mammograph, andb also to replace radiographic film or screen systems in all general-purpose diagnostic procedures to detect X-rays. It captures X-rays and transforms them into digital signals for producing digital X-ray images.
FPD is one of the major parts of the digital radiography imaging device whose quality and performance may impact the performance or safety characteristics or the intended purpose of the medical device.
“We have had discussions with the importers on this and explained things to them threadbare. This regulation has been put in place because the quality of the component determines the overall quality of the medical device that’s being manufactured. It’s crucial to check where you are importing from to ensure the quality of equipment in market. We have already issued 28 similar licenses. It stems from the earlier practice— before 2022 when medical devices rules were implemented— of importing components randomly. It seems some importers want to by-pass current rules and keep following the earlier pattern.”