'Indian pharma companies lag in molecule discovery'

The fact that almost all the 35-odd drug molecules discovered in the pharmaceutical industry have been by multi-national companies, is an indicator that the Indian pharmaceutical industry has concentrated its efforts on working around known molecules instead of discovering new molecules, experts opined.

However, this trend has been changing rapidly over the past couple of years, with Indian pharmaceutical companies investing heavily in research and development even as the product patent regime comes into force with effect from January 1, 2005.

Companies have now begun to sizably hike up their research and development expenditure, with the intention of discovering new molecules and patenting them to enjoy monopoly post January 1, 2005.

"In the past five years or so, between 30 and 35 new molecules have been invented in the pharmaceutical industry across the world and not more than 1,000 patent applications have been filed for these molecules. Indian companies figure almost nowhere as far as discovering these molecules is concerned," said Manoj Pillai, partner of Lex Orbis, a New Delhi-based intellectual property practice firm.

When a New Chemical Entity (NCE) is discovered, there is a broad NCE patent that is done, but several other patents too are possible, he explained.

"A NCE patent is the broadest form, but there are other patents possible like if a pharmaceutical company derives a pharmaceutical formulation, it could be patented. Also, the dosage pattern and other treatment benefits can be patented."

Pillai said that pharmaceutical companies in India will require to spend between Rs 10 and 15 crore only on research and development of a single NCE every year. "In India, only Dr Reddy's Laboratories seems capable of seriously pursuing NCE research," said Pillai.

Discovery of new molecules in the product patent regime will be a tremendous boost to the fortunes of pharmaceutical companies, as they will acquire the sole manufacturing and marketing rights of the product.