Import Delays Disrupt India's Medical Device Industry

India’s medical device industry faces delays in component imports, disrupting production and healthcare services. Manufacturers seek streamlined licensing and policy clarity, citing excessive regulatory demands. Government officials insist quality checks are essential. Prolonged issues could undermine the Make-in-India initiative and delay life-saving medical tools' availability, affecting healthcare delivery nationwide.

India's medical device industry is grappling with significant disruptions due to delays in clearing imports of critical components. Manufacturers of high-risk medical equipment, including X-ray and C-arm machines, cite policy ambiguities and additional licensing requirements as major obstacles, despite possessing MD-9 certifications mandated under the 2023 National Medical Devices Policy.

These delays, persisting for over three months, have hindered production timelines, reduced the availability of diagnostic tools, and raised concerns about the government’s Make-in-India initiative. Manufacturers argue that components like flat panel detectors (FPDs), integral to device production, should not require separate MD-14 import licenses. Instead, they advocate for streamlined processes and clarity in distinguishing between manufacturing components and standalone devices.

The manufacturers have proposed interim measures, including permitting imports based on MD-9 certification and establishing clear guidelines. Long-term recommendations include fast-tracking customs clearance for certified manufacturers and enhancing coordination among regulatory bodies like the Central Drugs Standard Control Organisation (CDSCO) and customs authorities.

Government officials, however, contend that the rules are clear. They argue that separate licensing ensures component quality, crucial for maintaining the safety and efficacy of medical devices. According to officials, 28 licenses have already been granted under the MD-14 requirement, emphasizing that quality control safeguards cannot be compromised.

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Despite regulatory reassurances, industry stakeholders warn that prolonged disruptions could undermine domestic manufacturing and delay the availability of critical medical tools, impacting healthcare delivery nationwide.

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