The Holy Grail Of New Drug Development

The announcement by Zydus Cadila in early June that their new drug to treat diabetics who also suffer from high cholesterol has passed all stages of clinical trials is an important landmark for the Indian pharmaceutical industry. This is not the first new chemical entity (NCE) developed by an Indian company. Ranbaxy, DRL, and Biocon are some of the companies that developed NCEs earlier. But none of these NCEs reached the market (so far), mainly due to hiccups faced at one of the later stages of trials.

Zydus Cadila reports that it has already spent $250 million on development of this drug and estimates that it will spend another $150-200 million on approvals and marketing in developed markets. Their hope is that this drug will be a $1billion blockbuster.

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Some diseases, which are of serious concern to India like tuberculosis and malaria, are not on the agenda of multinational drug companies because of the limited purchasing power of people in developing countries who suffer from these diseases.

The Government has started an unprecedented effort to apply the principles of open source innovation to pharmaceuticals in the form of an Open Source Drug Discovery Programme. This programme networks research institutions and individual researchers across the country in an effort to find new cures to combat tuberculosis. Any new drug created will be licensed to multiple manufacturers so as to keep the cost of the drug low. This programme should help sharpen drug-related research skills in India.