Absence of NABL lab hampering growth of home grown healthcare industry

Guwahati: The absence of National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratories in the northeastern states has significant implications for the healthcare industry in the region.

Accreditation by NABL ensures that conformity assessment bodies (CABs), medical laboratories, calibration laboratories, proficiency testing providers, and reference material producers adhere to stringent technical competence standards.
This accreditation acts as a hallmark of quality, providing confidence to healthcare providers and patients alike.

However, despite the widespread presence of NABL-accredited laboratories in several states, a noticeable disparity exists in the northeastern region.

Dr. Subhash Khanna, a well known medical entrepreneur and MD of Swagat Hospital speaks on the subject to Business-Northeast , its importance, costing and health startups of NorthEast India. Here are the excerpts:

BNE: Dr. Subhash Khanna, could you elaborate on why NABL Labs are considered a basic necessity for testing medical devices and ensuring their usability for human needs?

Subhash Khanna: NABL Labs play a crucial role in the healthcare sector by providing accreditation to testing and calibration laboratories. When it comes to medical devices, it is essential to ensure their safety, accuracy, and reliability before they are used for human needs. NABL Labs conduct third-party assessments of the technical competence of these laboratories, ensuring that they meet the required standards.
For medical startups and entrepreneurs in the Northeast region, the absence of NABL Labs poses a significant challenge. Without access to these accredited labs, they face difficulties in testing and validating their medical devices, which are crucial steps before bringing their products to market. NABL accreditation instills confidence in the quality and reliability of the testing conducted, which is essential for both regulatory compliance and gaining the trust of potential customers.
Having NABL Labs in the Northeast region would not only support the local startups but also contribute to the overall healthcare infrastructure development in the area. It would ensure that the medical devices being developed and used in the region meet the necessary quality standards, enhancing patient safety and healthcare outcomes.

BNE: What steps can be taken to address this gap and promote the establishment of NABL Labs in the northeastern states?
Dr. Subhash Khanna: Several steps can be taken to address this issue. Firstly, there needs to be increased awareness among the stakeholders, including the government, industry associations, and healthcare organizations, about the importance of NABL accreditation and the benefits it brings. This can be done through workshops, seminars, and awareness campaigns specifically targeted at the northeastern region.

Secondly, the government can provide incentives and support to encourage the establishment of NABL Labs in the northeastern states. This can include financial assistance, infrastructure development, and streamlined processes for obtaining accreditation.
Collaboration between the central government, state governments, industry associations, and healthcare organizations is vital to create a conducive environment for the establishment and growth of NABL Labs in the northeastern region.

BNE: Dr. Khanna. Could you also tell us about the cost involved in obtaining NABL accreditation and how it may impact health startups in the northeastern region?
Dr. Subhash Khanna: The cost for obtaining NABL accreditation varies depending on the size and scope of the laboratory. There are several factors that contribute to the overall cost, including infrastructure requirements, equipment calibration and maintenance, documentation, training, and proficiency testing. It is essential to note that the cost is an investment in ensuring the quality and reliability of the laboratory's services.

For health startups in the northeastern region, the cost of obtaining NABL accreditation can be a significant consideration. However, it is crucial for these startups to recognize the long-term benefits of accreditation, such as enhanced credibility, increased customer trust, and access to a broader market. The government and industry associations can play a supportive role by providing financial assistance, mentoring, and guidance to health startups to help them navigate the accreditation process.

BNE: What is role of NABL Labs in the health sector?
Subhash Khanna: NABL Labs play a crucial role in studying various parameters of medical devices, including electro-thermal, thermal, fluid flow, radiological, and other relevant parameters. These labs provide a certification process after proper calibration and testing to ensure that the medical devices are suitable for human use.

For start-up entrepreneurs developing medical devices, the cost of getting their products tested in NABL Labs can be significant, amounting to around Rs. 3 lakhs. This cost includes the calibration and certification process necessary for validating the device's parameters and ensuring its safety and effectiveness.

By obtaining NABL accreditation, these labs offer a trusted and recognized certification for the tested medical devices. This accreditation instills confidence in the quality and reliability of the devices, both for regulatory compliance and for gaining the trust of healthcare providers and end-users.

Overall, the role of NABL Labs in the health sector is to provide an independent and impartial assessment of the technical competence of testing and calibration laboratories, ensuring that medical devices meet the necessary standards and are suitable for human use.

BNE: Could you shed light on the role of entrepreneurs in the health sector? And how are entrepreneurs stepping up?
Subhash Khanna: During challenging times like the COVID-19 pandemic, entrepreneurs, local startups developing innovative solutions such as home-based oximeters and other medical devices entrepreneurs have been a helping hand.
Entrepreneurs in the health sector have a vital role to play in driving innovation, improving healthcare delivery, and addressing the specific needs of the population. They have the potential to bring forth new ideas, technologies, and business models that can contribute to advancements in the healthcare industry. They can collaborate with NABL Labs by utilizing their services for testing and validating their medical devices and technologies. By seeking NABL accreditation for their laboratories, entrepreneurs can ensure that their testing and calibration facilities meet the required technical competence standards.

Additionally, entrepreneurs can explore partnerships with NABL Labs to foster innovation, research, and development of new medical devices and technologies.

The availability of NABL Labs in all state would make the process of testing medical devices more accessible and cost-effective for entrepreneurs. This, in turn, would promote local manufacturing, reduce dependency on imports, and contribute to the vision of achieving self-reliance (atmanirbhar) in the healthcare sector.

Regarding the presence of testing labs at institutions like IIT and NIPER, it is important to pursue NABL accreditation to ensure that these labs are recognized for their technical competence and reliability. NABL certification adds credibility to the testing results and helps establish trust among stakeholders in the health sector. This collaboration can contribute to the growth of the health sector and the realization of a self-sufficient healthcare ecosystem in India.

BNE: What is the number of entrepreneurs in the health sector in India and the distribution of NABL Labs across states?
Subhash Khanna: There are several hundred startups in the health sector in India. These startups play a vital role in driving innovation, addressing healthcare challenges, and contributing to the overall growth of the sector.

Regarding NABL Labs, while most states in India have NABL Labs, it is unfortunate that the northeastern region still lags behind in terms of their presence. Among the northeastern states, only a few startups have emerged in the health sector, with one from Tripura and the rest from Assam.

The absence of NABL Labs in the northeastern region has been a significant factor contributing to the challenges faced in obtaining ISO certification for laboratories in the area. Establishing NABL Labs in the northeastern states would not only support the growth of startups but also contribute to the overall development of the healthcare infrastructure in the region.

It is important to bridge this gap and promote the establishment of NABL Labs in the northeastern region to ensure that startups and healthcare organizations have access to accredited testing and calibration facilities, fostering innovation and development in the health sector.

BNE: Have you brought this in notice to the government?
Subhash Khanna: As the Chairperson of ICC NE (Indian Chamber of Commerce NorthEast), I have a unique opportunity to advocate for the establishment of NABL Labs in the region and bring about positive changes in the medical services offered. By raising awareness about the need for NABL Labs and their potential impact on the healthcare sector in the region, you can create a strong case for the government's support and investment in building these labs. As a surgeon and Chairperson of ICC NE, I believe I can drive significant change in the medical services of the northeastern region by bringing NABL Labs to the area, and positively impacting healthcare innovation and delivery.

BNE: Dr. Khanna, what would be your next step that can be taken to bridge the gap in the healthcare sector?
Subhash Khanna: Startups and research scientists have been continuously working towards the sector's development. However, between startups and research scientists in the healthcare sector there is a huge gap between the work and actual needs of the region.

I propose a valuable approach by suggesting a meeting that brings together various stakeholders, including research scientists, startups, clinicians, surgeons, healthcare workers, members of the ICC Board, financiers, and government officials. Such a meeting would provide a platform for collaboration, dialogue, and understanding of the specific healthcare needs and challenges faced in the region.

This collaborative effort will help align the work of startups and research scientists with the actual requirements of the healthcare sector, leading to more targeted and impactful innovations.

And we hope that such a meeting can be organized to drive positive change in the healthcare landscape of the northeastern region.

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