Navigating the future – Growing footprints of India’s MedTech & IVD industry

The MedTech and IVD (in vitro diagnostics) industry of India has been a vital player in the country’s healthcare ecosystem, with growing emphasis on innovation, accessibility, and affordability. As the world grapples with challenges brought on by the Covid-19 pandemic, the Indian healthcare sector has witnessed significant changes in government policies, regulatory scenarios, import policies, government spending, and the adoption of standards.

There is no doubt that the Indian MedTech & IVD industry is poised to evolve and grow by 2025, offering insights into the industry’s growth trajectory and the challenges it faces. With government policies playing a crucial role in shaping the future of the MedTech & IVD industry, over the last few years, the government has been proactive in promoting the growth of the MedTech & IVD sector by promoting domestic manufacturing and reducing dependency on imports. Initiatives like Make in India and Atmanirbhar Bharat – all aimed at boosting local manufacturing, fostering innovation, and reducing reliance on foreign-made medical devices – have created conducive environment for indigenous production.

While both the Make in India initiative and the Atmanirbhar Bharat campaign have paved the way for a favorable business environment, the production-linked incentive (PLI) scheme, with specific provisions for the MedTech industry, offers financial incentives to companies that manufacture medical devices within India. The implementation of the Medical Devices Rules 2017 and the Medical Devices (Amendment) Rules 2020 have brought in much-needed clarity and uniformity to the regulatory landscape.

While these regulations aim at streamlining the approval process for medical devices and IVDs, making it faster and more transparent, the Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in ensuring that products meet the necessary quality and safety standards. The onus of remaining vigilant and adaptable, however, remains on manufacturing companies since regulatory changes are an ongoing process. Import policies have also been a key area of focus, with a push toward reducing reliance on foreign-made medical devices. The Atmanirbhar Bharat campaign has encouraged indigenous manufacturing, subsequently reducing the need for imports. Moreover, the government has implemented measures to promote the export of Indian-made medical devices to other countries, strengthening India’s position in the global market.

We have also noticed how the imposition of tariffs and trade restrictions on certain medical devices has been met with mixed reactions, which although may offer a boost to domestic manufacturers, there have been concerns from within the industry about the potential impact on prices of essential medical equipment. Balancing the need for self-reliance with the necessity of ensuring affordability is a delicate task that policymakers must navigate in the coming years.

Here it is important to mention that the allocation of funds and resources by the government is a decisive factor, which determines the growth and stability of the MedTech & IVD industry. While the Covid-19 pandemic brought this into sharp focus, we have noticed a visible rise in increased funding for healthcare infrastructure and medical devices, along with investments in medical technology, including ventilators, diagnostic equipment, and personal protective gear. The pandemic has taught us crucial lessons and we have been refreshing our skills and re-learning behavioral patterns that we believed to be beyond reproach before 2020.

The National Health Mission has been central to driving healthcare spending at the national and state levels, with expansion of healthcare infrastructure, establishment of new medical colleges, and procurement of advanced medical equipment being identified as areas that will need continued financial support. There remains no doubt that the government’s commitment to improving healthcare infrastructure will provide a significant boost to the MedTech & IVD industry.

While it is essential to adopt international quality standards for our MedTech & IVD industry to gain global recognition, even though the regulatory framework is evolving, it is equally important for manufacturers to adhere to stringent quality control processes and standards, even as the Bureau of Indian Standards and the Indian Pharmacopoeia Commission have set guidelines for product quality and safety. The adoption of international standards, such as ISO 13485 and WHO Prequalification Standards, can not only help enhance the sector’s competitiveness in the global market, it is also important to take note that consistency in product quality and adherence to international standards are critical aspects that the industry should prioritize over the next few years.

Even though the outlook is mostly positive, the Indian MedTech & IVD industry faces several challenges, the foremost concern being the huge demand and gap in skilled manpower. If the shortage of skilled professionals in R&D, manufacturing, and regulatory affairs poses a hurdle to the industry’s growth, developing a skilled workforce is an essential aspect that the industry and educational institutions must address collaboratively. Even after so many years of liberalization, the education sector is yet to fill the noticeable knowledge gaps, which can only be addressed with continued dialogue between the industry and the academia, taking into consideration on-ground realities and their assimilation in educational curricula.

Another significant concern is the need for continued innovation as it is vital for the MedTech & IVD industry to focus on R&D and invest in cutting-edge technology to stay competitive globally. While a robust ecosystem for start-ups and innovation hubs can stimulate innovation and entrepreneurship in MedTech & IVD, intellectual property protection and enforcement have also become crucial. It is necessary to foster an environment that will ensure adequate protection for innovators and companies have their innovations.

The Indian MedTech & IVD industry is at a pivotal juncture, with promising growth prospects as favorable policies, regulatory reforms, increased budgetary allocation and spending, regulatory reforms, and a strong focus on quality standards, present a unique opportunity for the industry to thrive. As the industry navigates its way over the next couple of years, it needs to maintain a balance between self-reliance and affordability.

While the government’s role in providing a supportive policy environment and financial backing will remain crucial, manufacturers and stakeholders should remain agile, ready for adapting to changing regulations, and focused on innovation to stay competitive on the global stage. There is no doubt that with a growing emphasis on self-reliance, innovation, and quality, the future of the Indian MedTech & IVD industry is bright. With the right strategy and collaboration, India can position itself as a global hub for medical technology and diagnostics.