Eli Lilly & Co (India) Pvt Ltd is one among the very few multinational drug majors that has active presence in clinical research operations in the country. While outsourcing is fast becoming a buzzword all over the world, Lilly believes that drug development is an essential part of its core activities.

When you hear the clinical research team of Lilly India say that "the thrill of developing a molecule or an indication which touches the lives of our patients cannot be described, only felt", its because Lilly as a company refers in-house research as "The heart of the business, the soul of the enterprise".

In less than a decade, Lilly has developed its clinical research strengths through its 30-plus team and with the active support of some of the most experienced members from the clinical research community in the country.

Commenting on the clinical research operations of Lilly India, Sanjiv Taneja, Director - Corporate Affairs, said the main focus of research in Lilly India has been in the field of cancer, diabetes and growth abnormalities. The company is also pursuing global registration trials in new molecules and new indications for some exis-ting molecules in the field of Oncology.

Says Dr Bhawana Awasthy, clinical research physician, Lilly India, "Our medical operations in India began way back in 1994 with a total of 3 people. The clinical research activities started soon after. Since class clinical research was still in a nascent stage and Lilly was also in its infancy in India, we had to identify the right kind of centers and investigators who were open to learn the methodologies and work hand in hand. Once the rapport was developed, there was no looking back. The investigators were trained in the conduct of GCP trials. Research directed to diseases and problems specific to the needs of India were carried out with the help of the global teams".

Lilly invests significant time and resources in conducting and maintaining clinical trial standards in India. The infrastructure and training is an integral and ongoing part of the clinical research process.

Recently, Lilly India launched Drotrecogin alfa (activated), a recombinant form of human activated protein C (Xigris), the first therapeutic intervention shown to reduce all-cause mortality in severe sepsis, within months of the global launch. Further Research on this molecule has already begun in India.

A registry on patients of severe sepsis worldwide is being developed for which 40 hospitals in India are working along with their counterparts in many countries around the world.

Dr Awasthy said that Lilly has been conducting Phase II, III and IV trials in India. "By conducting these trials, Lilly provides opportunity to Indian physicians to work hand in hand with their peers in the developed world and contribute to the world of medicine in bettering the therapeutic options available," she said.

Some of the innovative drugs on which clinical research is ongoing in India are an anti- sense DNA technology molecule (Affinitak) for the treatment of lung cancer, a multitargeted antifolate (Alimta) in various solid tumors, and expanding the role of the anti metabolite Gemcitabine (Gemcite) in cancers prevalent in the developing countries like India.

Eli Lilly and Company [India] Pvt. Ltd. [previously known as Eli Lilly Ranbaxy Limited] was set up in 1993 as a 50:50 joint venture between the Indian partner Ranbaxy and the US based, Eli Lilly & Company. In August 2001, Eli Lilly acquired the 50% equity stake of partner Ranbaxy Laboratories Limited in the JV after the latter decided to sell its stake converting the joint venture Eli Lilly Ranbaxy Limited (ELRL) into a 100% Lilly subsidiary, Eli Lilly & Company (India) Pvt. Ltd.

Eli Lilly & Company (Lilly) a fortune 500 company was founded in 1876.