Draft National Policy for the Medical Devices, 2022

In News 

• Recently, the Ministry of Chemicals and Fertilisers has released an Approach paper for the Draft National Policy for the Medical Devices, 2022.

Salient features of Policy 

• Regulatory streamlining in order to optimise regulatory processes and multiplicity of agencies for enhanced ease of doing business, along with harmonisation with global standards to ensure standardisation.
• Quality Standards and Safety of the Devices in order to provide safe devices to the consumers, in harmony with the global standards.
• Building Competitiveness through fiscal and financial support for stimulating the development of the local manufacturing ecosystem with private sector investments.
• Infrastructure Development to provide best-in-class physical foundation, including medical devices parks with common facilities such as testing centres, to improve cost competitiveness and enhance attraction of domestic manufacturers.
• Facilitating R&D and Innovation with a focus on enhanced collaboration in innovation and R&D projects, global partnerships, and joint ventures among key stakeholders to bridge the gap between academic curriculum and industry requirements.
• Human Resource Development to ensure relevant curriculum at higher education level, skilling of various stakeholders, creation of future-ready HR with required skill sets across the innovation value chain.
• Awareness Creation and Brand Positioning in creating awareness and positioning India as a hub for manufacturing of medical devices as part of the “Make in India, Make for the World” initiative.
• This Policy envisions that by 2047, our country
  • will be having few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs;
  • Will be home & originator to 25 high-end futuristic technologies in MedTech
  • will have a MedTech Industry of $100-300 Bn size with 10-12 percent of Global Market Share.

Aims and Objectives

• The proposed policy strives to put in place a comprehensive set of measures for ensuring sustained growth and development of the sector and addressing the further challenges of the Sector such as regulatory streamlining, skilling of human resources and lack of technology for high end equipment and lack of appropriate infrastructure, through a coherent policy framework.
• It aims to facilitate an orderly growth of the sector for the coming years. 
  • This policy, while addressing the core objectives of accessibility, affordability, safety and quality, focus on self-sustainability and innovation .

Medical Devices Sector in India 

• It is an essential and integral constituent of the Indian  healthcare sector, particularly for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities. 
• It forms an important pillar in the  healthcare delivery system along with healthcare providers, pharmaceuticals and health  insurance industry, thereby helping achieve the key values enshrined in the National Health Policy  (NHP) 2017 in terms of provision of good quality, affordable, and comprehensive healthcare to all  citizens. 
• The medical device is a multi-product sector, with the following broad classifications: (a)  Electronics Equipment; (b) Implants; (c) Consumables and Disposables; (d) IVD reagents; and  (e) Surgical Instruments.

Market size and Potential 

• The current market size of the medical devices sector in India is estimated to be $11 bn  and  its share in the global medical device market is estimated to be 1.5%. 
• India is counted amongst  the top 20 global medical devices market and is the 4th largest medical devices market in Asia  after Japan, China, and South Korea.
• The Indian medical device market has a significant presence of multiple multi-national  companies with about 80% of the sales generated from imported medical devices backed by  multiple approvals, certification of accredited organisations and capacity to produce verified  clinical trial records.
• The growth of the medical device sector in India is primarily driven by growing and ageing  population, increased per capita and disposable income, demand for healthcare infrastructure,  rise in preventive testing and spread of healthcare services and insurance . 
• Recently, the Indian medical devices sector’s contribution has become  even more prominent as India supported the global battle against COVID-19 pandemic through  the production of medical devices & diagnostic kits, e.gVentilators, RT-PCR kits, IR  Thermometers, PPE Kits & N-95 masks.
• The Sector is expected to grow in market size from the present $11 Bn to $50 Bn by 2025.

Initiatives undertaken by the Government:

• Foreign Direct Investments (FDI):
  • In order to attract  investments in this sector, the Government has allowed 100% foreign direct investments (FDI) in the medical devices sector.
  • In 2019, under the Scheme “Assistance to Medical Device industry for Common  Facility Centre, financial assistance of Rs 25 crore was approved to Andhra Pradesh  MedTech Zone (AMTZ) for a superconducting magnetic coils project which is under  implementation. 
• Production Linked Incentive PLI Scheme: 
  • The Production Linked Incentive PLI Scheme for Medical devices was  introduced with an outlay of Rs. 3,420 crores to incentivize manufacturers in four target  segments of high-end medical devices based on achieving investment and incremental  production targets over a period of FY 2020-21 to FY 2027-28. 
• Medical Devices Rules:
  • The Medical Devices Rules, 2017 notified by the Ministry of Health and Family  Welfare under the Drugs and Cosmetics Act 1940, laid out the regulatory framework in  terms of quality, safety and efficacy for medical devices.
    •  This expanded the regulatory  oversight from 15 specified devices to the entire gamut of devices, categorised into four  classes for regulation as per their risk categorisation. 

• The National Pharmaceutical Pricing Authority (NPPA) has stepped up price  monitoring of essential medical devices and made interventions to cap margins on retail  prices, where warranted in the case of some medical devices such as stents, oxygen  concentrators and other Point of care devices.
• To improve access, the Government has made available 240 types of surgical  supplies in over 8500 stores or Jan Aushadhi Kendras at highly affordable prices under  the Pradhan Mantri Bharatiya Jan Aushadhi Pariyojana. 
  •  Health and Wellness Centres are being equipped with medical devices required  for primary diagnostic services under Ayushman Bharat program. 

Challenges 

• The domestic medical devices industry faces challenges related to considerable cost of  manufacturing disability, among other things, on account of lack of adequate infrastructure,  domestic supply chain and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities and low investments on R&D and skill development.
• The Indian medical device industry is facing regulatory/legal issues, unfavourable duty structure for imports and exports,

Way Forward 

• Policy makers in India will need to set out an action plan to reduce the country’s dependency on medical devices/technology imports.
•  At present, NITI Aayog is reportedly drawing up a strategic road map for medical devices similar to the incentive package that gives sizable capital subsidies for the electronics business, which helps boost local production of cell phones in the country.
• Medical device companies should develop India as a manufacturing hub for domestic and international markets, undertake India-based innovation in combination with indigenous manufacturing, collaborate across the Make in India and Innovate in India schemes, and produce Low to Medium technology products to cater to the underpenetrated domestic markets.
• The sector requires special coordination and communication among industry and stakeholders because of its diversified nature, continuous innovation & variation.

Source:ET