The National Health Policy, which came into existence in December 1983, laid the foundations for health for all through the Universal Comprehensive Healthcare Services. There has been a phenomenal increase in the health status of the people in India as one can see from an increase in life expectancy, reduction in infant mortality and the decline in death and fertility rates. But more concrete efforts are required to improve the overall quality of life of the people. While on the one hand infections like tuberculosis, malaria, kalazar, HIV/AIDS, dengue and Japanese encephalitis are emerging, non-communicable diseases such as cardiac and psychiatric disorders are also rising as a result of the changes in lifestyles of the people. To meet the challenges of disease burden, the scientific and technological scenario in the country has undergone a sea-change in the last five years or so. In this rapidly moving world of innovative science and technology, biotechnology has emerged as a front-runner area of science with immense potential.

    Refined technologies, be it for early diagnosis for the therapeutic or for preventive purposes, are absolutely essential components of the modern health care system. Before the clinicians embark on treating a patient, proper diagnosis of ailment is critical. Although clinicians have their own judgements, specific and sensitive diagnostic procedures would essentially help to clinch precise diagnosis of infectious diseases like metabolic and cardiac disorders and cancer. A precise diagnosis indeed helps clinicians to consider specific line of treatment. Liberalisation of economy, free flow of international capital and state-of-the-art technology coupled with anticipated changes in patent laws paved the way to market several diagnostics developed outside the country for use in government-aided and private hospitals. But such diagnostic system may not be suitable for the country. Most of such diagnostic kits for infections being marketed in India are based on the detection of antibodies to a particular pathogen. However, in a developing country like ours where infections are rampant, an exposure to pathogen though leading to generation of antibodies may not necessarily produce the pathogens-specific clinical symptoms. In such a situation, a positive test would merely indicate exposure and can erroneously point to an active outgoing disease status. Moreover, a low degree of exposure to infections in community leads to "background noise" and the detection of certain levels of antibodies so generated especially in patients with concomitant microbial infections would yield a false result. Many of the diagnostics available therefore are not able to differentiate between an active ongoing infection from asymptomatic carrier status with no apparent pathogen-specific clinical symptoms. In addition, the genotypes of the pathogens in circulation in India in many instances are different. These point to the development of diagnostics relevant for India and other developing countries.. The Department of Biotechnology(DBT), under the Ministry of Science and Technology, has a very specific programme to develop easy-to perform, sensitive and specific indigenous diagnostics which are suitable for the country and which can differentiate an active infection from asymptomatic exposure at affordable cost. The diagnostic technologies which are either available or need to be developed must be perfected and structured in a way so that these could be absorbed and utilized to the fullest extent in the health care system. As a result of the DBT’s programme carried out in a contract mode, three diagnostic systems for HIV/AIDS have been developed, evaluated, validated and transferred to industries for upscaling and commercialization with the ultimate aim of their use in the health care system. One of the diagnostic test systems for HIV is based on what is commonly known as "while you wait" test system. This requires agglutination of one drop of blood by recombinant chimeric reagent. Such a system has potential use in screening of blood in blood banks. Similarly, a highly specific and sensitive western immuno blot assay utililizing antigen/protein from the Indian HIV virus strain as a confirmation test for HIV has also been commercialised. The programme has yielded 14 more diagnostic test systems for specific detection of dengue, Japense encephalities, leishmaniasis, malaria, rabies, toxoplasmosis and hepatitis A infection. In addition, the test systems have been developed for various hormones, alfafeto protein and acute lymphoblastia leukemia etc. An ELISA for hepatitis C has been commercialised not only for diagnostic purposes but also for screening of blood in blood banks. More refined methods based on the use of molecular probes especially for tuberculosis, typhoid and helicobacter pylori, are under-development. The Department recently organised a meeting of interested industrial partners and the scientists so that these technologies could be refined and upscaled for use.

    The market for diagnostic testes in India is estimated at Rs.3000 million. It is the highest for HIV-I and II and is of the order of Rs.450 million. This segment of diagnostic market is increasing at the rate of 100% per annum. There is a very big market for diagnostic for blood grouping, thyroid panel and fertility hormones dianostic reaqgents. The diagnostics thus have taken an important place in the logistics for better patient care. It is now gratifying that the Indian industries are coming forward to take up the indigenous technologies which are sensitive /specific as imported diagnostic kits, but would be available at affordable cost. The Department of Biotechnology believes that research and academic institutions and industry must join hands for developing joint ventures and new partnerships. It is through this effort that the product and processes and new diagnostic technologies would emerge for health care system in India.

*Adviser(Medical), Deptt of Biotechnology, Ministry of Science and Technology.