Challenges and gaps in regulating medical laboratories in India

Abstract

Accurate diagnosis is an essential component of healthcare delivery. However, research on the delivery of diagnostic services is lacking in low- and middle-income countries. This article examines the issues related to the provision of medical laboratory services in India, including licencing, geographic distribution, charging practices, quality, personnel requirements, information sharing, and newer technologies that impact the sector. The challenges and gaps in regulatory mechanisms governing these services are discussed, highlighting the need for improvements. Legislation to regulate medical laboratories in many Indian states is either outdated or non-existent, with some states recently updating or enacting their laws. A registry of medical laboratories in the country will assist in assessing and meeting the shortfall. Universal adoption of external and inter-laboratory quality control mechanisms will help in standardization and ensuring quality. Clarity and consensus on who can operate medical laboratories and the responsibility of different cadres of technical staff are required. The provision for making information on registered laboratories publicly available under the Central and some state legislations can be very useful to the users in choosing laboratories. Mandatory reporting to the government by both public- and private-sector laboratories will help in maintaining data on disease burden and in planning health services. However, the lack of data protection laws in the country creates the potential for violation of the users’ privacy when laboratories store data digitally and report it online on government web portals. Caution is warranted in the use of newer technologies until the regulations governing these matters are strengthened. A combination of voluntary and statutory mechanisms such as accreditation and regulation would be useful instruments for ensuring quality in diagnostic services. Research on the effectiveness of existing provisions at the state level would help in understanding their impact and suggest ways of further improvement.