Laboratory services are an integral part of disease diagnosis, treatment, monitoring response to treatment, disease surveillance programmes and clinical research. The World Development Report 1993 regarded the provision of essential health technology as an important ingredient of essential clinical services. Use of diagnostic techniques aids early diagnosis, enabling appropriate and prompt intervention, thereby reducing overall disease burden and promoting health. All laboratories are not equipped with facilities for carrying out complex investigations. The structure and function of a clinical laboratory vary according to the level of health care facility. Peripheral laboratories carry out simple tests like urine analysis and hemoglobin estimation, whereas higher centers are equipped with sophisticated technology and trained manpower to carry out complex investigations. Establishing a network between peripheral and higher laboratories allows the collection of specimens at the periphery and their storage and transport for testing at higher centers, and communicating reports to the peripheral center efficiently without actually having to transfer the patient. In the event of patient transfer, the higher centers do not need to repeat investigations carried out at the peripheral health center, thereby saving crucial time as well as cost and providing continuity in patient care. Networking between laboratories is also essential in disease surveillance programs and outbreak investigations in order to obtain quick and reliable results.

The expert committee on revamping the public health system identified the surveillance and control of diseases as an important function of the public health system. This formed the conceptual framework of the Integrated Disease Surveillance Programme (IDSP), which was started in 2004 in a phased manner. The key components of IDSP are coordination and decentralization of disease surveillance activities, improvement of laboratory support, and strengthening data quality. Inclusion of private laboratories to act as sentinel sites and improve community participation are some other important features. The Reproductive and Child Health II program of the Government of India in 2005 indicated the need for developing public-private partnerships in health care, including outsourcing of health care, laboratory services, and others. It outlines the need for accreditation of service quality, including protocols for quality assurance and certification. In India, medical laboratories can volunteer for accreditation of one or more services offered by them. The National Accreditation Board for Testing and Calibration Laboratories (NABL) has been providing accreditation services to medical laboratories since 1998 and is currently following ISO 15189; 2007 standards.

In biomedical research too, achieving a set standard of quality produces credible results and allows comparison between studies carried out at different institutes nationally and internationally. This saves enormous time, money, and resources and prevents duplication of research work. The International Conference on Harmonization (ICH) provided Good Clinical Practices (GCP) Guidelines, which describe standards to be followed by researchers while designing, conducting, and reporting trials involving human participants. Realizing the rapid pace, wide spectrum, and potential for clinical research in our country, the Indian Council of Medical Research (ICMR) launched the Ethical Guidelines for Biomedical Research on Human Subjects in 2000 (revised in 2006), and Central Drugs Standard Control Organisation (CDSCO) released the Indian Good Clinical Practices (GCP) guidelines in 2002 to guide biomedical research in the country. To harmonize practices and generate mutually acceptable data for non-clinical health and environmental safety studies, the Organization for Economic Cooperation and Development (OECD) evolved Good Laboratory Practice (GLP) guidelines.

India is a signatory to OECD and National GLP Compliance Monitoring Authority established in the year 2002 by the Department of Science & Technology, Government of India, and provides GLP compliance certification to the test facilities involved in conducting safety studies on chemicals (viz., industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives, etc.). To ensure reliability of data quality, WHO/TDR (Research and Training in Tropical Diseases) has developed good practice guidelines for laboratories involved in clinical trials. However, standards have not yet been developed in India for this purpose. The proposed ICMR guidelines for Good Clinical Laboratory Practices (GCLP) aim to elucidate step-wise procedures which should be followed by laboratories to strengthen the quality of test results. These guidelines should be adopted by all ICMR laboratories engaged in research as well as patient care. ICMR carries out research activities through its own institutes as well as through approved research centers in the public and private health systems. It also provides financial support to projects submitted by individual researchers and institutes. Adopting these guidelines will lead to the generation of uniformly acceptable and good quality laboratory data. Subsequently, a checklist will be prepared to monitor these laboratories for compliance with these guidelines.