New drug discovery and development in India

This is the story of my quest to jump-start new drug development activities in India at the custom synthesis, animal models, bulk drug production, toxicology and preclinical stages. A snapshot of research and evaluation during the 1995-1999 period is given and compared with the much-improved present situation. Practical experience of managing contract research and avoiding pitfalls are described. Drug discovery and biological development are still in early stages, but are growing. New drugs are being developed for serious and life-threatening diseases, needs are being met and safety and efficacy are improving. However, a project is often started in India solely for licensing-out purposes and develops its own momentum due to weak regulatory oversight and are rarely terminated due to lack of safety or efficacy. Drug discovery is targeted at diseases of the Western world, and not towards the endemic diseases prevalent in India such as malaria, tuberculosis, leishmaniasis, filariasis, leprosy, malnutrition, vitamin deficiencies, blindness, conjunctivitis, and so on. A few licensing deals for new chemical entities from India have been signed; however, some were discontinued and others are ongoing.