The Medical Technology Association of India (MTaI) has sought reduction in customs duty and Goods and Services Tax (GST) on finished medical devices towards affordable patient care as part of Budget 2022-23 expectations.

MTaI has sought reduction of customs duties to 0% to 2.5% on both finished medical devices and components. It has also sought reduction in GST on medical devices from 12% to 5%.

MTaI is an association of research-based medical technology companies which have set-up R&D centres and manufacturing plants in India.

According to Pavan Choudary, Chairman, Medical Technology Association of India (MTaI), “These measures will help in increasing affordability of medical devices for patient care in compliance with National Health Policy (NHP) 2017 and to meet UN Sustainable Development Goal (SDG)-3.”

MTaI has also urged the Government to create budgetary provisions for skilling and up-skilling of healthcare workers (HCWs) at primary, secondary and even tertiary care centers. This will help in creating a reserve of skilled human resources ready for deployment in any emergency and develop strong and efficient referral system.

These will also further the efforts of the private sector which is already pushing this agenda. MTaI companies give training to more than 2.5 Lakh healthcare workers (HCW’s) annually and make them patient-ready.

Pavan Choudary further explained that MTaI has also sought budgetary provision to help MSME manufactures adopt to globally harmonized Medical Device Rules and Tax Holiday to set up medical device research and development centers under the Transfer Pricing Act (TPA). Providing tax incentives on exports has also been sought as currently there are no tax benefits on export income.

“Presently medical device market is 1.6 % of the global market only. By achieving the targets set in the National Infrastructure Pipeline (NIP) 2020, to build state of the art 73 apex medical colleges/ hospitals, tertiary medical centers in every district, secondary care center in every sub-division and primary centers in every block level, will help meet patient care and enhance domestic market of medical devices,” Choudary further added.

Another policy which needs a thorough rework is the implementation of Public Procurement Order (PPO) for medical devices. As per NITI Aayog and Pharma Bureau estimates, 86 % of medical devices are imported. This is even higher for critical class C and D medical devices of which 90% are imported.

“Therefore, the PPO in its current form would greatly limit the access of our Public health systems and government academic hospitals to lifesaving newer generation medical devices, affecting patient care, research and academic activities. However, through a timely course corrective measure – Department of Pharmaceutical has identified a list of around 500 medical devices which do not have sufficient local manufacturing capacity, for exemption from PPO. We believe a comprehensive exercise to ascertain the real on-ground capacity is required along with more stake-holders consultations between Medical Fraternity and Industry,” MTaI stated.

The year 2021 brought some very positive developments for the MedTech sector, with some historic decisions taken like implementation of Trade Margin Rationalization (TMR) from the first point of sales to control high margins. This mechanism of trade margin rationalization in medical devices (Viz Oxygen concentrators, Pulse Oximeter, Glucometer, BP monitor, Nebulizer and Digital Thermometer) has showed that patient affordability can be ushered in without affecting innovation.

“The year 2021 also saw various stakeholder engagements for emergency procurement of COVID essential products, R&D policy for medical devices and equipment, Uniform Code for Medical Device Marketing Practices (UCMDMP). These policies when implemented will greatly benefit the healthcare eco-system,” MTaI stated.

“Even on the regulatory front, we took positive strides towards adoption of globally harmonized Medical Device Rules, with ISO 13485 been made mandatory. Adoption of regulatory pathway as suggested by Central Drugs Standard Control Organization (CDSCO) will help local manufacturers achieve greater acceptability of their products in global markets,” Choudary concluded.

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