Cadila Pharmaceuticals’ plan to indigenously develop Influenza A HINI (swine flu) vaccine in collaboration with US-based Novavax is likely to be delayed as the government has shown caution in giving go-ahead for the clinical trials.
“We have not given approval (for clinical trials) to Cadila yet as they are using a new technology called virus like particles (VLP),” Drug Controller General of India Surinder Singh said.
"We are still studying the process… and it would take some more time before we decide on that," he added.
Last year, Cadila along with four other Indian companies, Zydus Cadila, Bharat Biotech, Panacea Biotech and Serum Institute, had applied for the health regulator's permission for conducting trials for vaccines in India.
All other Indian firms except Cadila Pharmaceuticals have got the permission and have started the clinical trials for the vaccine in India.
Singh said globally there was only one vaccine that used VLP technology. So, the company need to substantiate the new technology's credentials.
“We are still looking at data they gave us for the trials conducted in Mexico, but other Indian companies are using traditional methods to develop vaccines, it is already tested and certified … so we need to be very cautious,” Singh said.
An email query sent to the company remained unanswered.
According to industry officials, it will take around at least another three months for the Indian firms to develop the vaccines and their shots will be available in the market by April this year.
For meeting immediate requirements, the government has already placed the order for 1.5 million doses of imported vaccines in the country.
Ahmedabad-based Cadila Pharmaceuticals is one of the largest privately held pharma companies in India.