Central Drug Research Institute (CDRI), Lucknow is in an advanced stage of negotiations with major pharmaceutical companies including Pfizer and Ranbaxy for out-licensing its new drug leads for further R&D and possible commercialization.

Of the three synthetic and four herbal molecules CDRI has recently developed, Pfizer is known to be interested in an anti - osteoporosis molecule. Ranbaxy is in the process of signing final legal agreement for the further clinical trials and commercialization of an anti-diabetic drug molecule. While the anti-osteoporosis molecule is nearing completion of basic studies, CDRI has already completed large animal efficacy studies for anti-diabetic molecule.

Among the other companies include a Hungarian firm, which is planning to take up the clinical trials of an herbal drug (derived from turmeric) for cerebral stroke. The drug has already been licensed to Themis, which has completed the animal studies and CDRI is party to the discussions to include the Hungarian company for expensive clinical trials.

According to Dr C M Gupta, director CDRI, the decision to outsource potential lead molecules to the industry is part of its current strategy to minimize the risk in drug R&D. "Earlier we used to initiate the clinical trials on our own. Today we approach the drug companies as soon as we optimize the lead. It helps us reduce the cost, as we will be proceeding with further research only after we signs contracts with pharmaceutical companies. The companies will be asked to fund the later stage R&D activities. They will also conduct the clinical trials. If every thing goes well, we would be receiving a 5 - 7 per cent royalty and also the rights to choose the domestic manufacturer," he said.

CDRI has at least six research products that are currently being marketed in the country. This includes Saheli, the world's first non-steroidal oral contraceptive pill, marketed by Hindustan Latex Limited.

Equipped with the latest drug discovery tools, CDRI is focusing on diseases that are of special significance to the country. Diabetes, obesity, osteoporosis, breast cancer, malaria, tuberculosis etc are some of the disease areas of high priority. The biggest research team in CDRI is focusing on malarial drugs, Dr Gupta said.

CDRI has strengths in areas like fermentation technology, toxicology, molecular and structural biology, medicinal and process chemistry, pharmacology and lab animals.