NEW DELHI — Cadila Pharmaceuticals’ plans to manufacture H1N1 flu vaccines has hit a roadblock as the drug regulator has expressed concerns over the technology to be used.
The company intends to use the virus-like particle technology to develop the vaccine, but the Drug Controller General of India has not yet given approval for clinical trials.
“We have not given approval to Cadila as they are using a new technology called VLP and there is only vaccine that uses VLP technology right now. So the company needs to substantiate its credentials. We are still looking at the data they gave us and trials are also on in Mexico. It is being seen as new pathway for the vaccine, but on the other hand, we already have traditional vaccines … so we need to be very cautious,” DCGI chief Surinder Singh told DNA on Jan. 29.
Cadila has signed an agreement with Novavax to develop vaccines based on VLP technology.