By end April, an indigenously manufactured vaccine against the H1N1 (swine flu) virus may well be available.
Bangalore-based Bharat Biotech has started Phase I clinical trials to test the safety of HN-VAC, its cell-culture based H1N1 vaccine candidate, after getting a nod from the Drugs Controller General of India (DCGI) on January 8.
After Ahmedabad-basedpharma major Zydus Cadila, which started trials last week, Bharat Biotech is the second vaccine-manufacturer from India to take the step.
Two more pharmaceutical companies, Panacea Pharma-ceuticals and Serum Institute of India have also got DCGI approval and are close to beginning Phase-I trials, which take about six weeks.
“This is the first time that a flu vaccine is being developed in India, which now has the capacity to develop vaccines against all existing flu
strains, and new ones,” said health minister Ghulam Nabi Azad at the Editor’s Confe-
rence on Social Sector Issues on Tuesday.
“We won’t ever need to import flu vaccines again — as we did for bird flu and H1N1 — because our domestic industry will meet not just India’s vaccine requirements, but also the world’s,” Azad added.
Since April 2009, H1N1 has killed over 12,500 people in 210 countries, with India reporting 1,135 deaths till January 18.
“If the trials go as expected, the vaccines will be available between April 15 and 30,” said Dr Surinder Singh, drug controller general of India.
At present four multinationals (Glaxo, Novartis, Baxter and Sanofi Pastuer) manufacture the H1N1 vaccine.
India imports 1.5 million doses from Sanofi Pastuer to inoculate health workers testing and treating people infected with H1N1.