Sanofi Pasteur and Panacea Biotech have approached the central drug control organisation for grant of marketing permission to conduct clinical trial of dengue vaccine in India, Lok Sabha was informed today.
"Sanofi Pasteur and Panacea Biotech approached Central Drug Standard Control Organisation (CDSCO) for grant of marketing authorisation and permission to conduct clinical trial respectively," Minister of State for Health Faggan Singh Kulaste said in a written reply.
He was asked whether several India and foreign pharmaceutical companies have approached the government to develop or introduce dengue vaccine in India.
He said that the dengue vaccine (DSV4) development programme is being supported through Indo-US Vaccine Action Programme of department of Biotechnology.
The International Centre for Genetic Engineering and Bio-Technology (ICGEB) has filed an international patent on this unique vaccine which "seems safe, efficacious" against all four dengue viruses.
"This candidate vaccine is being produced using recombinant DNA technology in Yeast in an affordable manner.
"Sun Pharma and ICGEB signed an agreement in October 2016 for clinical development for this Indian vaccine candidate that is being monitored by global dengue experts," he said.
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