Delayed import clearances are severely impacting the production of medical devices in India, according to industry experts, who caution that this could have far-reaching consequences for the government's flagship Make-in-India program.

An anonymous industry expert revealed that X-ray device manufacturer’s, despite meeting all regulatory obligations, are struggling due to vague policy guidelines, which are causing shipment delays and hindering healthcare services.

Manufacturers of vital medical devices, such as X-ray machines and C-Arm systems, are facing unexpected hurdles in India. Despite possessing valid MD-9 certifications, which meet the requirements of India's Medical Devices Rules, they're being asked to obtain additional import licenses, causing disruptions in their operations.

"The additional license request targets specific components, including flat panel detectors (FPDs), which fall outside the scope of the existing certification. These components are essential parts of our manufacturing process, not standalone devices," explained the manufacturer.

Manufacturers claim that these delays, which have lasted almost three months, have severely impacted their operations, resulting in production disruptions, missed delivery deadlines, and limited availability of life-saving diagnostic equipment.

The Union Cabinet formally approved the National Medical Devices Policy in 2023. Under this policy, manufacturers of medical devices falling under Class C and D categories, which comprise moderate to high-risk devices, must obtain MD-9 certification. This regulation applies to medical devices including implants, dialysis catheters, and heart valves.

An anonymous manufacturer expressed frustration, stating that holding MD-9 certification is insufficient for importing crucial components, and that securing additional approvals poses a significant challenge.

Manufacturers are urging the government to address their concerns through both immediate and long-term solutions. In the short term, they are requesting that imports of critical components be allowed based on valid MD-9 certification, pending the implementation of a more permanent fix.

"The government must provide clear and detailed guidelines on MD-9 certification to minimize the risk of future production disruptions. Specifically, these guidelines should clearly delineate the application of MD-9 certification to the manufacture of individual components versus fully assembled medical devices. Additionally, a clear distinction should be made between manufacturers and traders to ensure a smoother process for all parties involved," emphasized the second manufacturer.

Manufacturers are seeking several key reforms to streamline their operations. These include:

1. To minimize delays, manufacturers holding MD-9 certification should be eligible for expedited customs clearance.

2. A centralized grievance redressal mechanism to quickly resolve disputes.

3. Enhanced coordination between the Central Drugs Standard Control Organization (CDSCO), customs authorities, and industry stakeholders to prevent misinterpretation of regulatory requirements and ensure a smoother compliance process.

Government insiders countered that the regulations are unequivocal and leave no room for confusion, dismissing claims of ambiguity.

According to the official, Flat Panel Detectors (FPDs) play a crucial role in digital radiography, including applications such as digital X-rays, CT scans, mammography, and general-purpose diagnostic procedures. FPDs convert X-rays into digital signals, enabling the production of high-quality digital X-ray images and replacing traditional radiographic film or screen systems.

FPD is a critical component of digital radiography imaging devices, and its quality and performance can significantly impact the overall safety, effectiveness, and intended use of the medical device.

Government officials have engaged in detailed discussions with importers to clarify the new regulations. The rules are in place to ensure the quality of medical devices, which is heavily dependent on the quality of their components. It is essential to verify the source of imported components to guarantee the quality of equipment in the market.

To date, 28 similar licenses have been issued. The current regulations aim to correct the previous practice of random component imports, which was prevalent before the implementation of the medical device’s rules in 2022. However, it appears that some importers are attempting to circumvent the new rules and continue with the earlier practices.

(Input from various sources)

(Rehash/Sai Sindhuja K/MSM)