Coherent medtech policy urgently needed to enable domestic manufacturing : AiMeD

The Association of Indian Medical Device Industry has said that it would be tabling a strategic roadmap for promoting indigenous manufacturing of medical devices to the government, based on key strategic ‘Make In India’ enablers


New Delhi: While inaugurating the ‘3rd Global Conference on Pharma Industry and Medical Devices’ recently at Bengaluru, the union minister for chemicals and fertilizers, Mr Ananthkumar reiterated that the government’s flagship programme, “Modicare” will unleash huge growth opportunities and challenges for the Indian pharma sector through explosive demand. The minister also announced that the Government was considering setting up a separate ministry of pharmaceutical and medical devices to serve the sector in a more integrated manner.

Reacting to the ministers’ promises, Mr Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMed) mentioned, “We are enthused to hear the minister’s announcements. Yes, there is a huge growth opportunity but, if this growth is fuelled and demand met by imports to the order of 70-90 percent, it will be a shame. We await a coherent medical device policy to enable manufacturing in India.”

Mr Nath also said that AiMed would be tabling a strategic road map for promoting indigenous manufacturing of medical devices to the government, based on key strategic ‘Make In India’ enablers, which include predictable tariff strategy for investors. “We have been asking for a phased manufacturing plan and predictable tariff structure linked with manufacturing capacity and international competitive capabilities as evidenced by exports performance. This would include basic custom duty (BCD) on medical devices having export turnover of more than
Rs 100 crore (in any one of last three financial years), should be at least 15 percent, (WTO bound rate is 40 percent), Rs 10 crore to Rs 100 crore, BCD should be 7.5 percent, and for less than Rs 5 crore, BCD could be at 5 percent or higher instead of NIL.”

“The linkage of growing exports is to demonstrate growing capability and international competitiveness of these devices to silence critics or India will forever remain import dependent on unaffordable medical devices, Mr Nath added.

As per AIMeD, the MOH and FW must expedite a buy Indian policy of preferential pricing for Indian medical device and have weightage for ICMED/ISO Certification and Design India Certification for promoting quality and indigenous development. Make IS/ISO 13485 standard mandatory for medical devices under BIS Act as an interim regulatory measure for patient safety till we get a medical device law. Till we have regulations enforce restrictions on refurbished medical equipment of over 3 years for ensuring patient safety.

The Department of Pharmaceuticals should accelerate trade margin capping proposal in the range of 50- 100 percent, depending on the value of the devices or ask Department of Revenue to introduce a tax based disincentive to discourage importer/ manufacturer from labeling high MRP, the AIMeD has demanded.

The inaugural session at ‘India Medical Devices 2018’ witnessed the launch of two major initiatives for medical device industry – the world’s first unique e-Auction Tech Transfer Portal exclusively dedicated for Medical Technologies and world’s first Med Tech Enterprise Resource Planning (ERP) software for Medical Device manufacturers which is free and developed on open source.

“We welcome these new initiatives. But, these are a small part of the whole well defined, integrated, conducive policy and regulatory framework that we are looking forward to, without which the ‘Make in India’ dream will remain on paper,” Mr Nath said adding further, “The government needs to realize that medicines are just one component of healthcare cost and very often not its major component. Medical devices can be equally if not more as critical part of overall healthcare cost as medicines and diagnostics. If the government had focused on giving major boost to medical device manufacturing in the country and also ensured a robust MRP regime, then it would have served many purposes with one shot – i.e. lower the overall healthcare cost and lead to sharp reduction on import dependency.”