The Association of Diagnostics Manufacturers of India (ADMI) is the most prominent organization, representing over 90% of India’s in-vitro diagnostics (IVD) manufacturers. Comprising around 90 members, the majority of whom are from the MSME sector, ADMI plays an indispensable role in shaping the IVD industry in the country. As the global IVD market continues to expand, with an estimated value of USD 80 billion by 2024, ADMI’s contributions to the national and international diagnostics landscape are more relevant than ever.

A Strong Interface Between Manufacturers and Government

In today’s rapidly evolving healthcare environment, a strong and coherent voice is essential for IVD manufacturers to navigate regulatory challenges and foster innovation. ADMI provides this unified voice, serving as the critical interface between manufacturers and various governmental bodies, ensuring that the industry’s concerns are heard and addressed effectively. As a member of several committees of the Government of India, ADMI is well-positioned to influence policies that impact the IVD sector, driving growth and ensuring compliance with global standards.

Driving the ‘Make in India’ Initiative

One of ADMI’s most notable contributions is its alignment with the Indian government’s “Make in India” initiative, which aims to bolster local manufacturing. By working closely with the government to develop industry standards and guidelines, ADMI ensures domestic manufacturers can compete globally. The association’s efforts in facilitating technology transfers and collaborations are vital for enhancing the capabilities of Indian IVD manufacturers. By providing access to advanced technologies, ADMI helps local manufacturers remain competitive while supporting India’s self-reliance and economic development goals.

Skill Development and Industry Growth

ADMI is committed to growing the Indian IVD industry through strategic partnerships with skill development councils. Collaborating with the Life Science Sector Skill Development Council (LSSSDC) and the Healthcare Sector Skill Development Council (HSSC), ADMI plays a crucial role in workforce development under the Ministry of Skill Development & Entrepreneurship (MSDE). By promoting skill enhancement, ADMI ensures that the Indian IVD sector remains at the cutting edge of global innovation and is equipped with the necessary expertise to tackle modern healthcare challenges.

Addressing Industry Challenges

Despite its growth, the IVD industry in India faces several challenges. One of the significant issues is the need for legislation that is more tailored to the unique nature of IVD products compared to other Vivo medical devices. Unlike other medical devices, IVD technologies are used outside the body—typically in labs, hospitals, or blood banks. Therefore, the regulatory framework needs to reflect this distinction. ADMI advocates for a separate chapter under the Medical Devices Regulations, with exemptions from stringent clauses that do not align with the nature of IVDs.

Another challenge is the need for more access to cutting-edge technologies within India. The industry’s current reliance on obsolete technology hinders its potential for growth. ADMI has been vocal about the need for governmental support in facilitating technology imports and fostering R&D collaborations to improve domestic production. In addition, the association is working to mitigate quality issues by advocating for a shared responsibility model, where intermediaries such as laboratories and hospitals are held accountable alongside manufacturers for product quality.

The Path Forward: A Balanced Approach to Regulations

ADMI’s ongoing dialogue with the government also addresses concerns about the pricing structure within the industry. While implementing a Price Control Order is a welcome step, it must account for all intermediaries in the supply chain for effective implementation. The current model, where manufacturers are solely responsible for pricing issues, overlooks the role of these intermediaries in driving up costs. ADMI advocates for a more balanced regulatory framework ensuring fairness across the IVD ecosystem.

As the IVD industry continues to expand in India and globally, ADMI’s role as the voice of diagnostics manufacturers has never been more critical. By facilitating technology transfers, advocating for regulatory reform, and driving skill development, ADMI is shaping the future of the IVD sector and ensuring that Indian manufacturers remain competitive on the global stage. In a landscape where technological advancements, aging populations, and increasing healthcare demands drive growth, ADMI’s proactive stance ensures that the IVD industry in India is well-positioned to thrive.

By continuing to work closely with the government, ADMI ensures that the industry’s interests are represented in policy discussions, fostering an environment where innovation and collaboration can flourish. For IVD manufacturers in India, ADMI is more than an association; It is a vital partner in managing today’s healthcare challenges and opportunities.