While the central authorities are introducing new strategies and support to boost the medical devices industry in the nation, certain factors are impeding its progress, according to industry insiders.
In early November, the Department of Pharmaceuticals (DoP), under the Union ministry for chemicals and fertilizers, initiated a Rs. 500 crore initiative called “Strengthening of Medical Device Industry (SMDI)” spanning from 2024-25 to 2026-27, to facilitate industry expansion.
However, later in the month, domestic industry representatives voiced concerns regarding delayed imports of essential components due to regulatory officials’ inconsistent decisions.
Delays in importing components for devices like x-ray machines arose after officials deemed certain components, such as flat panels, as medical devices, prompting challenges.
The Association of Indian Medical Device Industry (AiMeD), a collective of Indian medical device manufacturers, has requested a smooth transition in regulations to prevent market shortages or business interruptions.
“Such issues should be reviewed by the Medical Devices Technical Advisory Group before any amendments to rules or before providing guidelines to manufacturers, allowing ample preparation time,” stated Rajiv Nath, AiMeD’s forum coordinator.
Reportedly, significant industry players like Allengers and Trivitron faced disruptions as shipments were stalled at ports. Comment from these companies’ management was unavailable.
Regulatory bodies responded, remarking that Flat Panel Detectors (FPD), crucial to digital radiography devices, are classified as Class B devices, requiring import and manufacturing licenses as per the Medical Devices Rules, 2017. They further clarified that an import license in Form MD-14 is mandatory before import.
About 30 importers or producers have secured licenses for importing or manufacturing FPDs, authorities said.
“Whenever stakeholders need more information on regulatory necessities, the CDSCO offers clarification either through a PRO meeting or a Personal Hearing. For FPD devices, importers have been directed to secure an import license to meet import conditions,” noted a regulatory representative.
The import issue adds to an array of government choices contested by domestic manufacturers, despite government efforts supporting local production.
Industry groups recently praised the central plan for SMDI, intended to rejuvenate domestic manufacturing and potentially transition some players to exporting, while tackling the sector’s skill gap.
“Domestic companies, previously becoming traders or pseudo manufacturers, are now encouraged to become genuine manufacturers, producing products and components locally,” Nath remarked earlier.
Amid this assistance, certain sector leaders are wary of government support for importing pre-owned medical devices, contending it could undercut domestic industry, compromise patient safety, and harm the environment.
Similarly, the DoP introduced the National Medical Devices Policy to synchronize government ministry decisions with the goal of advancing the medical devices industry in line with the ‘Make in India’ initiative.
However, a lack of coordination and suspected inter-ministry lobbying is sending mixed messages to local and foreign manufacturers, mentioned an industry leader.
Another concern is that while the DoP is encouraging domestic manufacturing via the production linked incentive (PLI) scheme, the DGHS has allowed a Global Tender Enquiry (GTE) for around 354 medical devices, bypassing local procurement requirements, potentially harming domestic manufacturers.
Although local producers hold licenses for some of these products, losing public procurement preferences opposes the objectives of the Make in India policy.
Given that both the ministry of chemicals and fertilizers and the ministry of health and family welfare are overseen by the same minister, there is potential for collaborative efforts to fast-track the growth of the medical devices industry, benefiting the country’s healthcare sector and its patients in the future.