The pre-investigational new drug application (pre-IND) centres on a monoclonal antibody (mAb). If accepted by the US Food and Drug Administration, Shantha hopes to begin a Phase I clinical trial at the start of next year, according to a web report on Daily News & Analysis, India (DNA India).

Although several pharma companies have conducted research, including clinical trials in India - taking advantage of lower costs, this could prove to be the first time the trend has been reserved. The move could be down to the fact that a French healthcare company Merieux Alliance bought a 60 per cent stake in Shantha last November.

At the time, the managing director of Merieux Alliance India, Rekha Khanna, said: "The stake will help us strengthen our presence within the country, which has strong potential in the field of biology and significant needs in public health."

The Indian pharma company has developed four fully human monoclonal antibodies against Lung cancer, Melanoma, Pancreatic and Breast cancer, called RM1 to RM4 respectively. A monoclonal antibody against lung cancer could potentially be a $1bn (€740m) blockbuster drug.

However, DNA India reports that although the company has spent $15m on the drug so far, it needs a further $7m.

Antibodies represent one of three areas that Shantha is focussing research and development. Its pipeline also consists of therapeutic proteins and, thirdly, vaccines. The company has already commercialised three biosimilars based on interferon alpha 2b, streptokinase and erythropoietin.

In the vaccine part of its business, Shantha claims to be the first company to produce a vaccine based on recombinant DNA technology; Shanvac-B is based on the hepatitis B surface antigen vaccine. Subsequently, the company also launched a tetravalent (DPT-Hepatitis B) vaccine.