Issues facing the Indian Pharmaceutical Industry Idealistic, Ineffectual Defense or Pragmatic Penetration ?

The Indian Pharmaceutical Industry stands at a crossroads today with the advent of the impending challenges thrown up by the WTO product patent regime. 

Transnational companies are now once again looking to expand their horizons in the phenomenally growing markets of Asia, this time, armed with weapons of protected research technologies, having secured their home markets by the non-tariff barriers of extended patent protection and complicated regulatory approval mechanisms.

An increasing number of developing countries are also adopting such measures and are insisting on products that have been previously approved by either US, Canadian or European regulatory agencies in response to pressures linked directly with economic and defense aid packages.

Even though the Indian industry's achievements have been impressive over the past 50 years, India accounts for only 1.2% (US$ 3.8 billion) of the US$ 320 billion global pharmaceutical market, (Rs. 17,000 crore, of which only Rs. 4000 crore - US$ 0.9 billion - was exported in 1999).

Today, over 80% of the global pharmaceutical market is concentrated in three different zones: North America (35%), the European Union (26%) and Japan (21%), where less than 20% of the world's population actually resides.

Despite the advent of the product patent regime, over 85% (US$ 270 billion) of global pharmaceutical sales revenues come from drug products free from patent protection, and over US$ 5 billion worth of products will go off patent between 2000-2005.

Considering the limitations of the Indian Pharmaceutical Industry with respect to its new product development capabilities, the most pragmatic and lucrative option for Indian companies to enhance their reach in the global pharmaceutical market is to invest in penetrating the patent-free US$ 200 billion segment of the vast and profitable markets of North America and Europe. It requires only moderate levels of investments to upgrade manufacturing facilities, and obtain the necessary regulatory approvals to penetrate these markets.

The objective of this seminar is to provide a platform for the Indian Pharmaceutical Industry to interact with top-level industry and regulatory experts from India and abroad and gain an insight into penetrating these markets.