How the MedTech & IVD industry will pan out over the next couple of years

Serving as the Medical Director of a renowned network of super specialty hospitals, Ujala Cygnus Healthcare Services has allowed me to personally observe how medical technology (MedTech) and in vitro diagnostics (IVD) have revolutionized patient care. Over the next few years, the MedTech and IVD business in India is expected to grow and evolve significantly due to a variety of factors, including government policies, regulatory changes, import tactics, greater government investment, and the establishment of strict standards. This is a thorough examination of the variables influencing this course.

Government policy and regulatory scenario
The Indian government has taken the initiative to create an atmosphere favorable to the expansion of IVD and MedTech industries. Important programs like the Make in India campaign and the Atmanirbhar Bharat (self-reliant India) objective aim to promote indigenous production and lessen reliance on imports. A crucial step in this direction is the Medical Devices Production Linked Incentive (PLI) plan, which provides financial incentives to businesses that increase domestic production.

Regulatory organizations are also changing, most notably the Central Drugs Standard Control Organization (CDSCO), to expedite the approval procedure for novel diagnostics and medical equipment. The Indian government has been attempting to simplify regulations so businesses can more easily launch new goods into the market. The Medical Devices (Amendment) Rules, 2020, are being implemented to more effectively regulate the MedTech industry.

Import policy and international collaboration
Even with the effort for home production, a sizable amount of cutting-edge MedTech and IVD equipment is still imported. The government’s import strategy is continuously changing to strike a balance between the objective of building local skills and the requirement for top-notch equipment. The significance of a flexible strategy is highlighted by tariff modifications and import duty exemptions for essential medical items during the Covid-19 pandemic.

International cooperation is still essential. In addition to improving local manufacturing capabilities and facilitating technology transfer, partnerships with international MedTech businesses can guarantee that Indian healthcare providers have access to state-of-the-art technologies. As Indian businesses look to capitalize on international experience, joint ventures and strategic alliances are probably going to become increasingly prevalent.

Government spending and infrastructure development
The expansion of MedTech and IVD industries depends critically on higher government spending on healthcare. Two important moves toward universal healthcare are the National Health Policy of 2017 and the Ayushman Bharat initiative, which intends to cover over 500 million people. Significant expenditures in healthcare infrastructure, including cutting-edge medical technology and diagnostic instruments, are required to support these endeavors.

The need for MedTech and IVD products is rising due to the opening of new medical colleges, AIIMS-like establishments, and modern district hospitals. Additionally, new opportunities for remote monitoring and diagnostics are being made possible by the advent of telemedicine and digital health initiatives, which are driving industry growth even more.

Standards and quality assurance
As the sector grows, upholding high standards and guaranteeing quality assurance becomes increasingly important. The Association of Indian Medical Devices Industry (AiMeD) and the Bureau of Indian Standards (BIS) collaborate to create comprehensive standards that meet global benchmarks. Following these guidelines improves the competitiveness of India- made goods on the international market while also guaranteeing patient safety.

Quality control covers every stage of a medical device’s lifecycle, from design and manufacture to upkeep and disposal, going beyond manufacturing. Gaining the trust of patients and healthcare professionals will depend heavily on implementing global best practices and maintaining strict adherence to regulatory requirements.

Challenges and the way forward
Although MedTech and IVD industries in India have a bright future, there are still a number of obstacles to overcome. Concerns include a high reliance on imports, regulations-related obstacles, and the requirement for large investments in research and development. Furthermore, it is still important to guarantee that urban and rural communities have equal access to cutting-edge diagnostics and medical equipment.

To tackle these obstacles, a multifaceted strategy is needed. Essential efforts include bolstering public-private partnerships, promoting innovation through specialized research hubs, and improving skill development initiatives for the MedTech workforce. Furthermore, it is imperative that policymakers and industry stakeholders have an ongoing discussion to guarantee that rules progress in lockstep with technical improvements.

Outlook
The Indian MedTech and IVD sectors are about to undergo a dramatic upheaval. The industry is well-positioned for strong growth thanks to encouraging government policies, changing regulatory frameworks, selective import policies, higher spending on healthcare infrastructure, and strict standards. Our priority must always be to ensure that these developments result in better patient outcomes and fair access to high-quality healthcare for everyone as we negotiate this changing environment.