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MedTech industry calls for tougher regulatory controls on import of pre-owned products
The last few weeks have been “eventful”, says a medical device entrepreneur, discussing the multiple policy directives that have come their way.
Over a week ago, the Union Ministry of Chemicals and Fertilizers announced a ₹500 crore scheme to strengthen the medical device industry — a small but affirmative push for those looking to produce locally.
However, mid-October, a directive from the Ministry of Environment, Forest and Climate Change (MoEFCC) — taking forward earlier ones from the Directorate General of Health Services and the Union Health Ministry — had upset a section of the domestic industry. This involved the import of pre-owned or refurbished medical devices into the country.
The medical devices industry speaks in different voices on whether the two recent developments send out conflicting signals, or whether they, in fact, help build the sector.
Between the two, though, they walk a fine line to build local strength.
Mixed signals
The Centre’s financial scheme for medical devices will help small and mid-sized enterprises, encouraging them to manufacture locally and not follow the path of importing and becoming a “pseudo-manufacturer”, says Rajiv Nath, on behalf of the Association of Indian Medical Device Industry (AiMed).
The MoEFCC’s communication appears to work at cross-purposes to the ‘Make in India’ campaign, he says.
If refurbished products are imported, then the companies that have invested in making some of these products locally cannot compete, he adds.
Outlining the concerns voiced by other local associations as well, Nath calls for tougher regulatory controls on the import of pre-owned products as they are used products and may have safety issues.
“Those regulations are not in place,” he says.
Moreover, there is no clarity on whether patients treated with these refurbished products (MRI or CT machines, for example) will be charged less.
Calibrated approach
Himanshu Baid, Managing Director of Poly Medicure, echoes the prevailing sentiment on financial support to medical device makers. It is an “enabler”, he says, for small and mid-sized companies with aspirations to grow and export.
India’s medical device market is valued at approximately $14 billion and expected to grow to $30 billion by 2030.
On the move to import refurbished medical devices, Baid says this can go hand-in-hand with the campaign to make products locally, until local industry is able to make such high-end products.
Presently, the local industry cannot make some of the high-end equipment “at one go”, he says, adding that there should be a transition period during which imports of pre-owned products are allowed.
There should be a calibrated approach, so patients can have access to these products, and the local industry is able to meet the local requirement, he says.
Companies importing these products should be restricted to OEMs (original equipment manufacturers), who can take responsibility for the product if something goes wrong, rather than any random trader, he adds.
Regulatory clarity
Shobha Mishra Ghosh, Director and Head, Government Affairs and Policy (India & South Asia), WIPRO GE Healthcare, points out that “even the developed countries like the US and EU have about 30 per cent of import dependencies for medical devices and 7-9 per cent dependency on pre-owned medical equipment vis-à-vis the total medical equipment market”.
India imports about 80 per cent of the higher-end medical products such as cancer diagnostics, medical imaging tools, ultrasonic scans, PCR technologies, and robotic surgeries, she says. And the pre-owned market currently accounts for about 10 per cent of the total medical equipment market and supports access to high-quality medical technology in the hinterland.
The refurbishment of pre-owned medical devices by OEMs or their authorised third party follows a stringent process that adheres to all quality and patient safety norms, thus performing as good as a new medical device, and are 25-50 per cent cheaper, she says.
Healthcare push
But there are challenges too, says Ghosh. The import of refurbished medical equipment by OEMs and authorised third parties has been “severely disrupted” in the absence of a clear regulatory path for approvals.
She calls for a comprehensive regulatory framework for refurbished medical devices enabling the Central Drugs Standard Control Organisation (CDSCO) to grant licences and ensure only high-quality, compliant devices are imported.
Affordable high-end technologies are crucial for screening, diagnosis, prognosis, treatment and post-care in smaller cities, and rural and semi-urban centres, she points out, especially for the country to achieve universal healthcare. The Hindu Business Line