Experts opine recalling illegally imported medical devices from every corner of the country and destroy them

Medical device manufacturers have hailed the clarification by the Central Drugs Standard Control Organization (CDSCO) that current law does not provide for granting of licenses for import of refurbished devices.

Pointing out that the healthcare security of the country is already compromised with about 70 per cent of the current medical device requirements being met through imports, the Association of Indian Medical Device Industry (AiMeD) said that ongoing import of used medical devices without any regulatory controls had further jeopardised it as nearly 60 per cent of the Rs 40,000 crore of imports of medical electronic equipment were estimated to be of preowned equipment being dumped into India.

“A stop to import of refurbished medical equipment is a true policy intervention that will guard the domestic industry against dumping of equipment with uncertain quality and will also help the patients in receiving appropriate medical care thereby bringing the best value of cost for them and the payers, including insurance agencies. This is a welcome and much-awaited long-due intervention," said Dr Jitendra Sharma, MD, AMTZ, Visakhapatnam.

“We welcome MNCs to invest in India and make high technology equipment and make these affordable to the Indian patients as is being done in mobile phones and the automobile sector. A healthy competition is welcome. There is a Policy review of the need for imports underway and we have sought related regulations for refurbished or remanufactured Indigenous medical equipment that has lived beyond the extended warranty terms, with adequate and additional patient safety safeguards to bring in the necessary discipline," Rajiv Nath, Forum Co-Ordinator, AiMeD said.

"The circular issued by CDSCO regarding refurbished medical devices imported into India has shown Modi 3.0 is awake and ready to listen to a common consumer. 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'," said Prof Bejon Kumar Misra, Founder of Patient Safety and Access Initiative of India Foundation.

“We applaud the CDSCO in removing the confusing signals we had been getting as on one side we had been supported by GoI excellent PLI scheme to manufacture high-end cath labs and imaging equipment in India but were despondent when we had to compete against low-priced second-hand imports. The medical device rules do need a provision for extra safeguards needed for refurbishing or re-manufacturing of equipment beyond the extended warranty period and the existing informal sectors that had been repairing and refurbishing imported pre-owned equipment can now use their skills to do so for the indigenously produced equipment. With a growing market expected from stable and competitive domestic manufacturing, this sector will also have ample opportunities to grow as a support to the healthcare industry," mentioned Gaurav Aggarwal, MD, Innvolution Healthcare.