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The medical device manufacturing industry is divided over the recent order by the Central Drugs Standard Control Organisation (CDSCO) to stop import of pre-owned, refurbished medical devices into India until a proper policy framework comes into place.
While a section of companies, especially domestic manufacturers, have welcomed the idea as a push for ‘Make in India’, others say that the step could lead to irreversible damage to both healthcare providers and the workforce without a policy for refurbished devices in place.
The CDSCO, in a letter to the Principal Commissioner of Customs dated January 10, clarified that refurbished medical devices cannot be imported into the country for sale and distribution, as there is no specific regulation for such devices under the Medical Devices Rules, 2017.
The letter, reviewed by Business Standard, added that no licence is issued for the import of such devices.
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMED) said that the clarification by the regulator is welcome and a huge Make in India investment enabler.
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“By eliminating ambiguity, CDSCO has strengthened the push towards self-reliance, innovation, and quality in India’s medical technology sector, perfectly aligning with the Make in India and Atmanirbhar Bharat initiatives,” Gaurav Agarwal, Managing Director, Innvolution Healthcare said.
Domestic manufacturers also added that the order will also stop the unregulated influx of second hand medical devices which could have been detrimental to the patient safety in India.
Last year, the Patient Safety and Access Initiative of India Foundation (PSAIIF), a Delhi-based not-for-profit organisation, had filed a public interest litigation in the Delhi High Court, highlighting concerns about reliability of these devices and the risks to patient safety.
“Now our next logical step should be to recall all such illegally imported medical devices from every corner of the country and destroy them in the interest of patient safety,” Prof Bejon Kumar Misra, founder of PSAIIF said.
Industry experts, however, added that the import of such devices may remain suspended until a regulation is passed by an expert committee of the health ministry.
Expressing shock over the move, a spokesperson representing a multinational corporation (MNC) device manufacturer said that the imports were stopped without any prior notice or a transition time.
“The imports for such devices was happening after permission from the Union Environment Ministry, and included 38 high end and high value (HEHV) medical devices approved by the Directorate General of Health Services (DGHS),” the person said on the condition of anonymity.
Valued at around Rs 1,500 crore, the pre-owned medical equipment market currently constitutes around 10 per cent of the total medical equipment industry in India.
Another industry expert stated that these devices play a critical role in meeting the growing demand in hospitals in the Tier-II, -III, and -IV cities, as well as rural and underserved areas.
Meanwhile, several device and healthcare bodies have called for the need of a regulation within a stipulated time frame to support the industry.
Commenting on the same, Siddhartha Bhattacharya, Secretary General, Nathealth added that there is a need to ensure that proper guardrails for safety and efficacy are in place to ensure no dumping, benefiting both domestic and global manufacturers.
“For a country like India, Nathealth suggests that a well-considered policy and guidelines with cross value chain feedback linking to patients be swiftly implemented to facilitate the creation of a well-regulated refurbished medtech market for appropriate beneficiaries and product segments,” he added.
The Medical Technology Association of India (MTaI) also added that it is imperative that the expert committee expedites the creation of a policy for refurbished devices and allow imports through necessary approvals by DGHS and the environment ministry to avoid any disruptions.
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