The IVD industry in the past few years has brought around a massive transformation in the medical technology in India. From mergers and acquisitions to regulatory changes, the industry has seen its fair share of challenges and opportunities. However, as we move into the future, we can only expect the industry’s growth to continue, with new drug development, sophisticated analytics, and personalized medicine paving the way.
In India, the various stakeholders, including the industry-the key players, government officials, industry associations, and manufacturers are continuously working toward streamlining operations and addressing challenges. Further, they are also enhancing the quality and efficacy of IVD products to meet international standards.
The Indian government support has been instrumental in the growth of the IVD industry. The Make in India initiative, regulations enforced by the CDSCO, and affordability and accessibility-based pricing policies have encouraged the industry to flourish over the past few years. However, certain challenges, such as inadequate funding, competition from multinational corporations, and lack of trained personnel still persist in the IVD industry.
The regulatory landscape of the IVD industry in India is governed by various bodies, the most predominant of which is the Central Drugs Standard Control Organization (CDSCO). The regulatory framework for IVDs is primarily defined by the Medical Device Rules, 2017, which govern the manufacture, import, distribution, and sale of medical devices, including IVDs. In addition, to regulate the import of IVD instruments and ensure their safety and efficacy, the Indian government has implemented several policies and regulations. The CDSCO regulates the import of IVD instruments under the Drugs and Cosmetics Act, 1940. Further, all IVD instruments imported into India must be registered with the CDSCO and comply with the relevant standards and guidelines. Additionally, the government has implemented various policies, such as the National Health Policy (2017) and the Digital Health Blueprint (2018) to promote the growth of the IVD industry.
The year 2020 will always be remembered due to the outbreak of Covid-19 pandemic and the subsequent impact it had on the healthcare industry. In 2020, the Ministry of Health and Family Welfare allocated ₹300 crore for certain research projects in the IVD industry. The government’s focus on promoting research and development has been critical in the industry’s growth, given that innovation plays a crucial role in the development of new diagnostic tests. In addition, the government spend on the IVD industry has also increased over the years. In 2021, the Ministry of Health and Family Welfare has allocated ₹94.452 crore for the National Health Mission’s diagnostic program. A significant chunk of this funding will go into supporting the IVD industry over the coming years. Moreover, the government has also taken steps to promote domestic manufacturing of IVD kits and reagents, and schemes such as the Production Linked Incentive (PLI) program have been initiated to incentivize local manufacturing. This is expected to reduce the dependence on imports and make essential diagnostics tests more affordable.
The industry standards are necessary to ensure that products are manufactured to a high level of quality, are consistent in their performance, and are safe and effective. It can also help to facilitate international trade and promote interoperability between products. Moreover, in India the Bureau of Indian Standards (BIS) is responsible for developing and maintaining national standards. However, the standards developed by BIS are not mandatory, and compliance is voluntary. This lack of mandatory compliance can lead to a lack of uniformity in the products that are being produced, resulting in varying levels of quality and safety.
The future of the IVD industry in India looks promising, with several growth drivers, such as ease of access to affordable healthcare, growing elderly population, rising demand for early diagnosis, and an increase in lifestyle disorders. Further, the emergence of innovative technologies, such as portable and handheld devices that provide accurate and reliable diagnostic results will significantly contribute to the growth of the IVD market in India. In addition, advancements in artificial intelligence and machine learning techniques are also expected to revolutionize the IVD industry in India, resulting in a reduction in the testing time and improvement in accuracy over the coming years.