MedTech associations discuss new policy with the govt, seek inclusion of their suggestions

New Delhi: The Federation of Chambers of Commerce and Industry (FICCI) hosted Department of Pharmaceuticals’ day long workshop on Draft National Medical Device Policy on 24^th August, attended by several other medical device stakeholders and senior Government representatives. The workshop witnessed Department of Pharma leading the dialogue and discussion under the chairmanship of  Pharmaceuticals Secretary, Jai Priye Prakash.

The industry and importers were represented by the Association of Indian Medical Devices Industry (AiMeD), Medical Technology Association of India (MTaI), Confederation of Indian Industries (CII), FICCI, Association of Diagnostics Manufacturers of India (ADMI), PHD Chambers of Commerce and Industry etc and other government departments were National Health Systems Resource Centre (NHSRC), National Pharmaceutical Pricing Authority (NPPA), Central Drugs Standards Control Organization (CDSCO), MInistry of Health and Family Welfare (MoH&FW), Department of Electronics and IT (DeitY) and National Institute of Pharmaceutical Education and Research (NIPER).

Each of the Association got an opportunity to make a presentation on what was needed to boost manufacturing of medical devices and to provide affordable access of medical devices in the country.

While the top associations representing various sections of medical devices industry gave their inputs on the various points within the draft policy, the FICCI suggested the government to adopt a four pillar balanced approach while drafting the policy to assure the sustainable growth of this nascent industry.

The important topics that were discussed during the conference included the management of imports of finished medical devices and their components by tariff review. Other topics were addressing patient safety and quality needs by regulations etc and need for separate medical devices law. Also, having possibly biomedical engineers to play the corresponding role of pharmacists in hospitals to ensure healthcare providers abided by law in ensuring single use of devices where they are so labelled and proper storage and upkeep of equipment and its calibration.

FICCI suggests way forward through a 4 Pillars Medical Devices Policy

FICCI has said that it is committed towards an appropriate and balanced National Medical Device Policy that is designed to enable a quick and well planned acceleration of the sector.

Prioritizing on Universal Health Care Access:FICCI strongly proposed that a careful evaluation based selection be made on manufacturing of certain targeted medical devices that can fit the current Indian manufacturing skills and manufacturing ecosystem, along with prevalence of disease that they address, and that the Government facilitates local manufacturing of them in a targeted manner towards the Make In India Program. FICCI suggested that targeting all complex medical devices for Make In India will neither find success nor will make healthcare cost effective in the country.The current consumption levels of medical devices in India at $3 per capita is far lower than the $50 to $70 per capita consumption of China, Brazil and Russia, thus making Make in India a challenge. Universal Healthcare  Provision, by significantly enlarging India’s healthcare market from its currently abysmal 0.8 beds per 1000 population will expand the supply side market size of medical devices.

Focusing on export promotion, rather than purely seeking import substitution: Since it is proven that the world over medical device is a global supply chain, as evidenced by the fact that even China is more than 70% import dependent in this sector, FICCI suggested that the Government focus on building India’s global medical devices export competitiveness without seeking to curb imports. Importing low volumes of high quality and novel medical devices will facilitate market adoption, and scale the Indian market, which will eventually benefit domestic manufacturing to acquire both skill and scale. If this strategy is not adopted, India will have to direct far larger resources towards novel innovation, for which both funds and medical research capability is currently in short supply.

Adopting a sub-segmented policy approach for medical devices: FICCI observes that, in the absence of a cogent policy, currently all medical devices are treated the same from a policy standpoint.Since both technology and market adoption vastly varies from such low risk devices as a syringe, I.V. catheter or a blood bag, to high risk – high complexity devices as pacemakers and equipment such as MRI machines,  FICCI urged the Government not be make a blanket un-segmented policy. The policy should acknowledge the sub-segmentation of medical devices into simple engineering and complex engineering, and apply distinct policy treatment, wherever applicable.

Facilitating an innovation centric approach: As the medical device is a fast innovation driven industry, it will be of utmost importance for the Government to promote an innovation ecosystem approach. This can be driven by keeping innovative devices outside price control, scaling currently an abysmal number of innovation incubators such as School of Biodesign to several such institutes, and launching a fiscal incentive mechanism for attracting top global medtech innovators to India.

MTaI hopes for a balanced approach

Medical Technology Association of India (MTaI) welcomed the initiative of Department of Pharmaceuticals to engage most of the important stakeholders to invite views and comments.

The views of the stakeholders have been welcomed and taken on board. MTaI hopes that the NMDP will facilitate the development and manufacturing of those products which can be made in India, the import of those products which cannot be made here at a cost which is not prohibitive, continue to fuel FDI and inflow of technology, lead to increased R&D investment and activity, Healthcare Worker (HCW) training, increased patient access to quality healthcare and demand generation.

AiMeD lists its recommendations 

 “We are happy that productive discussions took place and hope based on inputs an updated draft policy will be finalised next week for enabling other stakeholders like NGO ‘s healthcare care providers, consumer groups and insurance companies could be involved for consensus,” said Mr Rajiv Nath, Forum Coordinator, Association of Indian Medical Devices Industry (AiMeD).

As per AiMeD, the five main factors highlighted by the Secretary and around which most discussions were focused were:

1) Recommendations for Basic Import Tariff to be 10% for Medical Devices (whose Export is over 5 Crores) and Duty on Components to be 5% Next Year and 7.5% thereafter as a Make in India Enabler. Concessional Duty on Raw Material may be retained at 2.5% for now and to cover the devices which had not been addressed in Jan 2016 notification.

2) Expedite Medical Devices Law to regulate all devices and ensure:

i) Definition of ‘Manufacturer’ needs to disallow legalization of Pseudo Manufacturers and Traders to pass themselves off as Manufacturer

ii)  Voluntary Compliance backed by 3rd Party ICMED Certification to be considered as a Compliance option / reduced oversight.

3) Buy Indian Policy of Preferential Market Access and Preferential Pricing (as per World Bank Terms) for Indian Medical Device for Indian Public Healthcare Tenders and have weightage of 5% for ICMED Certification, 2% for ISO 13485 Certification and 3% for Design India Certification for promoting quality and indigenous development.

4) Ban on Refurbished Medical Equipment for Next 5 Years till such time we have a strong Regulatory Regime to ensure validated and calibrated Equipments for limited access for enabling Patient Safety.

5) MRP to be enforced on Unit of Sale of Medical Devices. We requested that No NPPA/DPCO for Medical Devices other than a case of Stents (Combination Device, having Drug). We recommended to Introduce Price Cap Mechanism of Ex-Factory / Import Landed Price in a Phased Manner or bring in a 1% Cess on GST to act as Disincentive for putting Exorbitant MRP and to incentivize ethically correct Low MRP.

6) Medical Device Promotion Council – to focus on aspects of Sectoral Export Promotion and indigenization, to address India’s 70% Import Dependency, 90% on Medical Electronics.

While the basis was the earlier Task Force Recommendations Report published in April, 2015 and the earlier Draft Policy released in June 2015 it was conceded that much water has flown under the bridge with many policy initiatives in interim period e.g. addressing inverted duty structure for many devices and release of Medical Devices Rules by MoH&FW and Notification for enforcing MRP on all medical devices and price capping of stents and orthopaedic implants.