The Indian pharma sector has succeeded to a great extent in the recent past due to practices like reverse engineering. But now the product patent regime brings along the challenge of thriving on "discovery based", which involves huge investments and time. The article throws light on the patent regime and its impact on the Indian pharma sector.

The dawn of 2005 has opened doors for a new patent regime. The new patent regime is based on the provisions agreed to by the member countries during the TRIPS Agreement. The economy in general, the pharma industry in specific, is being exposed to multidimensional challenges in legal and business spheres under the new regime. Most of the medicines produced under the new regime in India and medicines patented outside the country may face complex problems. New patent monopolies may come into being and hinder the growth of the pharma industry in the country. Of course, new opportunities will open up in the global market. The pharma industry in India, which began from a scratch in 1970, was swift in reaching the global market. It now occupies the 4^th position in terms of volume and 13^th position in terms of the value of pharma business. The industry has achieved a compound annual growth rate of 19.8%.¹ With the export of bulk drugs, intermediaries and fine chemicals and finished formulations, the industry has shaped up into an export-oriented industry. The success of the industry is possible, only when inventions are efficiently protected by the patents law across the globe with well-defined legal system and strong enforcement mechanisms. The law, in the new patent regime, has to cater to the needs of the global markets and move further by complying with the guidelines laid down in the TRIPS Agreement. Harmonization of existing law of the land with that of the provisions in the TRIPS Agreement is inevitable, particularly during that phase when the industry has to face crucial and complex business and legal environments created by the developed countries. The industry should be facilitated to work in the well-defined new regime of the patent law.

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