The Role of Regulation in Strengthening India's Diagnostic Industry

by Anand K

Over the past 50 years, laboratory medicine has evolved significantly. Sophisticated diagnostic techniques and laboratories emerged during the 19th century, coinciding with global industrial revolutions. Automation and robotics have streamlined processes and enhanced treatment speed. Molecular diagnostics, including techniques like PCR and genomics, have allowed for personalized medicine approaches, tailoring treatments based on genetic markers. Data analytics and informatics have become crucial for managing the increasing volume of data, while interdisciplinary collaboration and global connectivity have enhanced healthcare delivery. These changes have collectively improved diagnostic accuracy, treatment efficacy, and patient outcomes, shaping the landscape of laboratory medicine for the future.

Diagnostics is expected to be more and more significant in the care journey of patients. According to the US Centers for Disease Control and Prevention (CDC), 70% of medical decisions depend on laboratory test results, which shows the important role clinical laboratories play in healthcare diagnosis. Therefore, the lack of an exhaustive, all-encompassing regulation to govern labs has serious implications on patient care and safety. Lack of minimum standards results in lack of uniformity in quality.

Laboratories in India currently have to comply with the Shop & Establishments Act that governs standards of cleanliness and number of hours. There are other ancillary regulations under the Biomedical Waste Management Rules and approval of diagnostic kits under CDSCO.

If you look at developed nations like the US and the UK, there exist detailed advisories and regulatory standards for medical laboratory testing. The US operates under the Clinical Laboratory Improvement Amendments (CLIA) act and UKAS is a national accreditation body run by the Department of Health of the UK and most laboratories are accredited by the UKAS. Thailand is a great example of a country that reinforced regulatory standards for its labs in response to the HIV/AIDS epidemic in the 1990s.

The approach followed by Thailand for improving the quality standards of health laboratories is novel because of its flexibility, ease of implementation in a step-wise fashion and the participatory approach of the laboratory staff to achieve national standards. Pathology laboratories in Korea are rigorously regulated by the Ministry of Food and Drug Safety (MFDS) to uphold standards of quality, safety, and accuracy. These regulations encompass licensing, accreditation, and adherence to stringent quality control measures, ensuring that laboratory facilities, equipment, and personnel meet specified criteria. Pathology laboratories in Vietnam are overseen by the Ministry of Health, ensuring adherence to stringent regulations aimed at maintaining high standards of quality and safety. These regulations encompass licensing requirements, often supplemented by accreditation from organizations like VILAS or ISO, to ensure compliance with quality standards. While developing nations have already set an example, even developing economies like Korea and Vietnam are progressing ahead in laboratory medicine and its role in the overall healthcare system.

The National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation is a key success factor for the diagnostics industry as it signifies adherence to proper standards and instils confidence among healthcare providers as well as patients regarding the reliability of the diagnostic services offered. Estimates suggest that India has over 1, 00,000 laboratories and as of January 2023, there were total of 2,394 accredited labs in India. If we consider accreditation as a measure of good quality processes, then we have a long journey ahead. As the largest network of accredited labs in the country and also as the first diagnostic lab to have been accredited by NABL and CAP, we have always prioritized and maintained high-quality standards in diagnostic processes.

The diagnostic services sector, being a crucial component of the healthcare industry, plays a pivotal role in recommending essential treatments and monitoring patients' recovery post-treatment. Over the past few years, the industry has experienced robust growth, showing a healthy upward trend. The diagnostics industry is poised for substantial growth between FY23 and FY28. The overall industry is expected to reach a market size of Rs 1,150-1,250 billion, logging a CAGR of 8-10%. The ‘omics’ era in laboratory medicine represents a transformative period marked by the widespread adoption of high-throughput technologies, enabling comprehensive analysis of biological molecules at various levels, such as genomics, transcriptomics, proteomics, and metabolomics. This revolution is pivotal for precision medicine, as it facilitates the identification of genetic variations, biomarkers, and molecular signatures associated with diseases, leading to personalized treatment strategies and improved patient outcomes. Moreover, omics approaches contribute to a deeper understanding of disease mechanisms, biomarker discovery for diagnosis and prognosis, accelerated drug development through target identification etc. Through translational efforts, the omics era bridges the gap between basic science discoveries and clinical applications, driving innovation in diagnostic tools, therapeutic interventions, and personalized medicine approaches, ultimately shaping the future of healthcare towards precision and individualized care.

Considering the industry is expanding steadily, the need for effective regulation of medical laboratories cannot be overemphasized. A combination of voluntary and statutory mechanisms such as accreditation and regulations would be useful instruments for ensuring quality in diagnostic services. A greater push towards updating outdated legislation and its implementation in letter and spirit is warranted.

Anand K, Managing Director & CEO, Agilus Diagnostics

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