Indian Pharma

The Constitution of India, the Golden Book under Article 21, guarantees Right to Life to all citizens. Article 39, assures good health to entire population and Article 47 stipulates raising of nutritional level and public health. The challenge to pharma research and to pharma industry lies in providing adequate medicines at affordable cost to Indian population and that too under the prevailing socio-economic conditions as mentioned earlier. At the same time, the industry has to compete globally, cost and quality wise, for exports.

Another challenge for Indian Industry emerges from the TRIPS Agreement. Introduction of product patent in drug sector, extension of Patent Life from 7 years to 20 years, changes in the provision of compulsory licensing, shifting of onus of proof to infringers and considering importation of patented items tantamount to working within the country are the main features of this agreement. All these facets pose challenge to drug industry. India being a party to TRIPS Agreement these changes are to be effected by January, 2005.

Incidentally, it may be mentioned that prior to 1970, Indian Patent Act provided for product patent. Since development of new molecule requires huge investment, which was beyond the capacity of pharma industry, the R&D activities did not pick up at desired pace. The 1970 Act provided for the Process Patent for certain areas including drugs and pharmaceuticals permitting making of the drugs through alternate process. Industry, thus gave lot of emphasis to reverse engineer the existing drugs with the intention to reduce the cost rather than focus on development of new molecules. This helped the industry in bringing drugs within a shorter time frame and also in reducing developmental costs.

This trend continued up to the TRIPS Agreement, which prohibits process patent. The drug industry therefore, is in transition to mount efforts towards development of new molecules rather than reverse engineering of the existing drugs.