Pune-based Serum Institute of India will soon become the second company to get manufacturing approval for a vaccine for the H1N1 virus (swine flu) . The company's intra-nasal swine flu vaccine is expected to get regulatory clearance by the month-end, health ministry officials said.
Anticipating the approval, Serum has produced 10 batches of vaccines, now undergoing quality inspection at the Central Research Institute, Kasauli, company officials said. The product will be priced lower to vaccines that are manufactured by foreign multinationals.
Last month, Zydus Cadila had announced the launch of its version of H1N1 vaccine, the first Indian firm to do so. While Cadila's vaccine is an injectable, Serum has changed the vaccine delivery route to the less 'painful' nasal route.
"We are going for WHO pre-qualification as these vaccines have an export market," a Serum official said.
Panacea, Bharat Biotech and Cadila Healthcare are also on the verge of completing clinical trials for their swine flu vaccines. Ministry officials said these companies may also be ready with their vaccines by September.
The development of H1N1 vaccine has allowed Indian vaccine makers to foray into the area of flu vaccine production, a space they had ignored until now. Industry officials said they can use the technology platform they are developing to make swine flu vaccine enter into the broad flu (influenza) vaccine business -- an area monopolised by global drug majors such as GSK, Sanofi-Aventis and Novartis.
The move has the potential to trigger a price war among established vaccine players, as Indian vaccines are expected to be priced lower than the existing brands.
