From regulation to innovation – Navigating changes in India’s booming IVD sector

Over the next couple of years, the in-vitro diagnostic (IVD) industry in India is poised for significant developments, driven by evolving government policies, regulatory scenarios, import policies, and increased government spending. The landscape is characterized by a dynamic regulatory framework and a growing emphasis on domestic manufacturing under the Make in India initiative.

The regulatory oversight of medical devices and IVD medical devices in India is governed by the Drugs and Cosmetics Act and the Medical Devices Rules, 2017. Recent updates to IVD classification in October and November 2023 mandate registration through the ePortal or obtaining a Form MD-15 import license before importation. The changes reflect an updated categorization of IVD analyzers and instruments, as well as new lists for specimen receptacles and products like Covid, DNA, and mRNA Extraction Kits, considering point-of-care distinctions.

Oversight and inspections are conducted by the Central Drugs Standard Control Organization (CDSCO), state drug controllers, and central/state laboratories. Conformity assessment procedures ensure compliance with quality and safety standards, aligning with the Bureau of Indian Standards (BIS) and International Organization for Standards (ISO) specifications. As part of the Make in India initiative, specific recommendations for boosting the IVD sector include tariff reductions, collaboration with universities, improved training for medical staff, increased investments, global classification, clear product rules, essential post-market surveillance, export support, and a separate classification for accessories.

The central and state governments have shown a strong commitment to investing in the healthcare sector, particularly in medical devices. With an emphasis on promoting domestic manufacturing under the Make in India program, the government has identified the medical devices sector, including in vitro diagnostic (IVD) devices, as a priority area for investment and growth. This commitment is evident in policies promoting 100 percent foreign direct investment (FDI) and providing government incentives to encourage innovation and growth in the medical devices market. We can expect increased government spending and focus on the development and expansion of the IVD sector, aimed at enhancing domestic manufacturing, technological innovation, and accessibility to advanced diagnostic tools and devices.

For hospitals, ensuring a resilient supply chain amidst potential shifts in import policies involves a multifaceted approach. First and foremost, the emphasis should be on contingency planning and alternative sourcing to secure a stable supply of critical medical components. Diversifying the supplier base, both locally and internationally, becomes paramount to mitigate risks associated with disruptions in the global supply chain. Hospitals should actively engage with local manufacturers, advocating for the localization of medical product manufacturing within the country, aligning with the government’s policies. Concurrently, sustainability auditing is crucial to ensure that suppliers adhere to ethical and sustainable practices, particularly in the healthcare sector where reliability and quality are paramount.

Furthermore, building long-term partnerships with suppliers, and collaborating with research institutions, can enhance the hospital’s visibility into product availability, encourage innovation, and contribute to the development of advanced medical features. Considering the total cost of ownership is vital to evaluating the economic feasibility of localized or diversified supply chains, taking into account maintenance, consumable, and servicing costs. In adopting these strategies, hospitals can fortify their supply chains, guarantee a steady influx of medical supplies, and navigate the challenges associated with evolving import policies effectively.

In the IVD industry, the integration of AI holds significant promise for transforming healthcare practices. AI technologies can aid healthcare providers in collecting, storing, and analyzing vast amounts of patient information, enabling them to derive data-driven insights. This wealth of data facilitates improved disease treatment and management strategies, empowering healthcare professionals to deliver more personalized and effective care. Moreover, organizations within the industry are increasingly utilizing AI to enhance drug safety measures, contributing to a safer and more efficient healthcare landscape.

However, the application of AI in healthcare also presents challenges, particularly related to the quality, availability, privacy, security, and potential biases in the data that fuels these technologies. Safety concerns arise from the possibility of inaccuracies in AI algorithms, which could have adverse effects on patient well-being. Additionally, regulatory compliance becomes a paramount issue, especially for AI-powered telemedicine platforms, necessitating strict adherence to regulations to safeguard patient privacy and ensure data security. The inherent issues of incomplete, inconsistent, and inaccurate healthcare data further emphasize the importance of addressing biases and errors in AI models trained on such data, as these shortcomings can perpetuate healthcare disparities and impact patient outcomes.

The In Vitro Diagnostics (IVD) sector in India is set to grow significantly, with strong emphasis on meeting regulatory standards, driving innovation, and receiving government support. For the industry to progress steadily in the coming years, it is essential to navigate through regulatory updates carefully and to adopt AI effectively, while also addressing challenges such as data security and the need for investment in technology. Overcoming these issues is crucial for the sustained advancement of the IVD field, promising a future where diagnostics are more accurate and efficient, thereby enhancing healthcare outcomes in India.