Biotechnology offers unique opportunity to create tools for prevention and treatment of diseases. Infectious diseases account for major part of the overall disease burden in the country, particularly, it affects the most vulnerable sectors of the society. It is the segment that has received our major attention in the research programmes of the department. In infectious diseases, a major thrust has been given on health care programmes such as new generation vaccines and diagnostics. In addition, programmes have been supported for stem cell research, genetics, genomics, clinical proteomics, nano-biotechno-logy and bioengineering for therapeutic applications.
R-VACCINE FOR CHOLERA IN PHASE 2
Efforts have been concentrated to develop new vaccines and diagnostics that are affordable and available at low cost. New vaccines/constructs have been developed indigenously for rotaviral vaccine for childhood diarrhoea, malaria, Japanese encephalitis, cholera, anthrax, rabies.
Some of these are at different stages of clinical trials. An immunomodulator developed for leprosy has already been marketed and its potential against Mycobacterium Tuberculosis is being ascertained. The recombinant oral cholera vaccine has completed phase II clinical trials in adults and phase I studies in children are ongoing. An anthrax vaccine based on protective antigen has been transferred to the industry and it is undergoing phase II clinical trial. Studies have been initiated for use of this vaccine in animals. The DNA rabies vaccine, first in the world, has already undergone animal trials at five centres in the country and human trials are being initiated.
Recombinant candidate vaccine both for Plasmodium vivax and P. falciparum malaria are undergoing GLP production for pre-clinical toxicology. The phase-I clinical trial for rotaviral diarrhoea vaccine has been completed in adults, older children and infants. A recombinant DNA-MVA vaccine candidate for HIV and a Vi-conjugate candidate typhoid vaccine have been developed. Both the technologies are being transferred to the industries for GMP production and pre-clinical toxicology. Tissue cultured Japanese encephalitis vaccine has been transferred to the industry for GMP production and pre-clinical toxicology and efforts are being made to develop the DNA vaccine. Recombinant DNA vaccine for tuberculosis is already undergoing animal studies. In addition, new initiatives have been taken to develop vaccines including recombinant DNA vaccines for filariasis and human papiloma virus, conjugate vaccines for pneumococcal and haemophilus influenzae and recombinant vaccine for dengue etc.
PCR TEST FOR TB
To help disease control and care of individual patient, a number of diagnostics have been developed. These are under different stages of technology transfer and commercialisation. The western blot technique as confirmatory and a quick to perform Naked Eye Visual Agglutination (NEVA) system for detection of HIV-1 & 2 have been developed. These technologies are already commercialised and launched in the market. Export of these technologies have received good response from the neighbouring countries.
Sensitive ELISA techniques developed for hepatitis C, leishmaniasis and alpha feto protein are already launched in the market. Specific lgM based ELISA tests for dengue, Japanese encephalitis, West Nile and hepatitis A have been transferred to the industry. PCR test systems have been developed for the diagnosis of tuberculosis. New initiatives have been undertaken to develop diagnostics for thyroid, toxoplasmosis, leishmania etc. New innovative technologies, easy to perform, affordable including those that detect multiple type of diseases through syndrome approach useful for medical practices and public health programmes are being developed including use of new platforms of quantum dots, optical thin film biosensors, Micro-Electro Mechanical System (MEMS) etc.
LIMBAL STEM CELLS FOR CORNEA REPAIR
Stem cell research is being promoted in the country in the view of its potential for clinical use within the existing policy of the Government of India. The strategy of the department for stem cell research is to encourage basic and translational research for therapeutic applications using adult cells from readily available sources such as bone marrow, peripheral blood and umbilical cord blood cells, support basic research in embryonic and adult stem cell biology, establish centers of excellence, create city clusters programmes etc. by involving basic researchers, clinicians and industry. The broader areas of research include limbal, haematopoeitic, neural, liver, cardiac, human corneal, embryonic stem cells, establishment of cell lines and stem cell preservation.
Limbal stem cells are being used at LV Prasad Eye Institute, Hyderabad to repair cornea surface disorders caused by limbal stem cells deficiencies. Over 200 patients have already been treated. First haploidentical stem cell transplantation has been carried out using CD34+ cells collected from the father of a child suffering from Glanzmann thrombasthenia with severe persistent bleeding. This type of transplantation is first of its kind in India. The technology has been established and is under use at Christian Medical College, Vellore. A network programme for clinical application of stem cells for cardiac disorders has been initiated.
GENETICS COUNSELLING CENTRES
The Department of Biotechnology has given major thrust to the post-genome era research in the areas of functional, microbial, comparative, struc-tural and computational genomics. The programmes have been supported in the areas of pharmmacogenomics for targeted therapy, microbial genomics for drugs, vaccines and diagnostics, clinical proteomics for biomarkers, drug target etc. and genome diversity. Eighteen genetics counselling units established have benefitted more than 25,000 families and 4,000 tribal population so far. Four new Genetic Diagnosis and Counselling Units are being created with a view to cover states having no such facilities.
Human resources development is being promoted in the area and a few centers are being considered for advanced molecular human genetics research and training. Carrier development program are being initiated.
SYNTHETIC MATRICES FOR DRUG DELIVERY
R & D programmes have been initiated in the tissue engineering, biomaterials & biomedical devices, bioinstrumentation and biomedical sensors for therapeutic applications. A number of studies conducted at National Centre for Cell Sciences (NCSS), Pune on cell culture, tissue banking and engineering have resulted in the development of biocompatible synthetic matrices suitable for controlled drug release and immunoisola-tion of islets and dermal equivalents for transplantation for burn patients.
- (The author is secretary, Department of Biotechnology (DBT), Ministry of Science & Technology , Government of India.)
- *Source: PIB Features