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, 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
