Industry Asks Govt. To Withdraw Memorandum Allowing Import Of Pre-used Medical Devices

On Friday, an industry body of Indian medical device manufacturers, AiMeD expressed its gravest concerns over an Official Memorandum (OM) issued by the government to its various Ministries enabling the import of pre-owned or pre-used and refurbished medical devices in India from MNCs. 

The request was allegedly promulgated by FICCI seeking the import of pre-used devices post which the government issued the OM and a copy of that has been accessed by BW Healthcare World. The OM includes a list of 50 medical devices. 

Among them are top diagnostic devices like MRI, CT, PET CT, Mammograms, C- Arm, Radiotherapy Devices and interventional devices like Robotic Assisted Surgical Systems, Endoscopes and 4K Laparoscopy Surgery Systems etc.

This AiMeD said is in direct contradiction to India's Make In India push and is a huge blow to Indian manufacturers at a time when they are already dealing with high competition against foreign manufacturers.  

The Indian medical device manufacturers have written multiple letters to the Union Ministry of Health and Family Welfare, Ministry of Environment, Forest and Climate Change and Department of Pharmaceuticals urging the Union Government to withdraw the official memorandum permitting the import of pre-owned medical devices.

In a letter dated 06 July 2023 written to the Secretary of the Union Health Ministry, Rajesh Bhushan, the device makers have called for immediate intervention to stall and recall the inter-ministry policy issue stating that India should not be a dumping ground for unsafe pre-owned medical equipment and have patients exposed to non calibrated equipment. 

The letter written by Rajiv Nath, Forum Coordinator Association of Indian Medical Device Industry (AiMeD) and under-signed by as many as 10 domestic manufacturers noted that manufacturers of medical electronics and equipment already find it very challenging to compete with imports. The letter added that if the Union Health Ministry permits the additional imports then it becomes virtually impossible to address the 90 per cent import dependency on medical electronics.

“Nothing could have been worse than what FICCI Medical Devices Division is doing at the behest of MNCs lobby. Much to our dismay and disappointment, FICCI Medical Devices Division is working against the interest of domestic medical device manufacturers,” said Nath on Friday.

Nath added that the OM is a regressive step that has confused the investors who have been putting up manufacturing capacity in the last few years in response to Prime Minister Narendra Modi’s call for self-reliance.

Cautioning against the repercussions of the move by the government, Gaurav Agarwal, Managing Director, of Innvolution Healthcare said that the utilisation of refurbished equipment under the guise of C-arms and advanced X-ray systems for performing catheterization procedures is both misleading and potentially hazardous. 

"Against the need of 500 Cath Labs a year to serve the Indian population, Indian Manufacturers have the capacity to manufacture more than 600 indigenized Cath Labs which play a critical role in diagnosing and treating cardiovascular diseases, and it is essential that these facilities meet the highest standards of quality, reliability, and patient safety,” he said. 

Agarwal added that by importing refurbished equipment, India misses the opportunity to nurture a robust ecosystem of innovation, research, and development in the medical technology sector.

Nath further pointed out that the entire development smacks of a larger conspiracy, as the move to finish the domestic medical device industry raises concerns for the safety of patients, e-waste dumping, and the affordability and reliability of foreign make equipment. "The quality and affordability of healthcare are going to be a sure shot casualty for which FICCI Medical Devices Division has conspired with their MNC friends,” Nath stated. 

Suresh Vazirani, Chairman of India's largest IVD company, Transasia Bio-Medicals said “The use of old, discarded medical equipment can not only be dangerous for the lives of our fellow Indians but it will destroy our PM Modi's dream of making India Atma Nirbhar in medical technology."

Vazirani further explained that India's retrograde policy will allow Western countries to ship all old equipment to India and thereby prevent their own countries from getting environmentally polluted with discarded pollutants in medical equipment.