Medical Biotechnology

The recombinant V. cholerae VAI.3 strain has undergone toxicology studies and
animal efficacy. The DCGI has permitted to carry phase-I volunteer clinical trials. After
due clearance from GEAC, the phase-I trials conducted at two centres have been
completed successfully with no side-effects. There have been no side effects. The phase
II/III clinical trials have been planned under Jai Vigyan Mission Programme. The DNA
vaccine for rabies has also shown a high degree of efficacy in animals. The pre-clinical
toxicological studies and efficacy trails in a phased manner will now be taken up. The
Japanese Encephalitis Virus has been adapted successfully in Vero cell utilising micro-
carrier technology, the required number of virion to produce tissue-cultured vaccines has
been achieved. Immunogenecity studies are being carried out. Primer combinations
targeting 16S rRNA/23S rRNA of pathogenic mycobacteria have been designed which
are able to identify M. tuberculosis. This can be used as a rapid and specific diagnostic
tool for tuberculosis. Another set of primers targeting spacer region has potential for
molecular epidemiology of tuberculosis. Unique mutations have been identified in genes
encoding for M. tuberculosis resistance to INH, streptomycin, rifampicin. Primers have
been perfected to identify multi-drug resistant mtb. The system is now being evaluated in
clinical samples i.e. sputum, CSF etc. For the first time, primers have been designed
targeting kinesin gene, which can differentiate L. donovani strain obtained from cases of
visceral leishmaniasis from post kala-azar dermal leishmanoid. Plant-derived flavonoid
has high degree of anti-leishmanial activity both in vitro & in vivo. One of the
compounds, Luteolin is ready for human clinical trials. Complete genomic mapping of
chromosome 5&10 of L. donovani is being attempted to identify new target for drugs.
The studies have revealed that HIV-I subtype C with quasi species C3 is the predominant
HIV-I strain in circulation in India. Genomic analysis has revealed these strains to be
closer to strains from sub-Saharan African Continent. No significant cross clade immune

response has been observed. Such observation has direct relevance on designing
candidate vaccine for the country. HIV-viral bank is operational and has about 60 strains
of HIV- I and 5 strains of HIV-2.

The NE part of India had unique Rota viral strain which produces diarrhoea in
adults. The nucleotide sequence indicated that these strains to be closer to Chinese
strains and unrelated to the suggested rotavirus strain in circulation in other parts of the
country. This has necessitated development of rotavirus candidate vaccine for specific
regions.
About fourteen diagnostic technologies for communicable and non-communicable
diseases, which have been validated, are ready for further refinement and upscaling.
Negotiations have been held with industries which are interested to take up the prototype
technologies for commercialisation.
On the First National Technology Day, May 11, 1999, Leprovac an
immunomodulator for leprosy and two HIV diagnostic test systems were launched.