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Indian Pharmaceutical Industry Challenges and Opportunities in New Patent Era

Pradeep Kumar
Associate Professor Institute of Pharmacy HCPG College, Bawan Beegha Varanasi-221002 E.mail: pkiitbhu@gmail.com

The pharmaceutical production in India began in 1910s when private initiatives established Bengal Chemical and Pharmaceutical Works in Calcutta and Alembic Chemicals in Baroda and setting up of pharmaceutical research institutes for tropical diseases like King Institute of Preventive Medicine, Chennai (Tamil Nadu), Central Drug Research Institute, Kasauli (Himachal Pradesh), Pastures Institute, Coonoor (Tamil Nadu), etc. through British initiatives. The Indian pharmaceutical industry, which had little technological capabilities to manufacture modern drugs locally in the 1950s, has emerged as a successful hightechnology-based industry that has witnessed consistent growth over the past three decades. It is a highly organized sector.

Current Scenario:
The Indian Pharmaceutical Industry is estimated to be about $ 6.0 billion (Rs. 300.00 billion) of the $550 billion global pharmaceutical industry. In terms of the global market, the Indian Pharmaceutical Market currently holds a modest 1-2% share It is growing at about 10 percent annually. It ranks high amongst all the third world countries in terms of technology, quality and vast range of bulk drugs and formulations. It is also now the 3rd largest in the world in terms of volume and stands 14 th in terms of value. It produces from simple pain killer pills to sophisticated vaccines, antibiotics and highly complex biotech products. Theorganizedsector of India's pharmaceutical industry consists of 250 to 300 companies, which account for 70 percent of products on the market, with the top 10 firms representing 30 percent. However, the total sector is estimated at nearly 20,000 units, some of which are extremely small. Approximately 75 percent of India's demand for medicines is met by local manufacturing It faces severe price competition and government price control. The major players are-Multinational Pharmaceutical Companies (MNC) -Indian Pharmaceutical Companies -Public Sector Units (PSU) -Small Sector Units India has carried out three Amendments in March 1999, June 2002 and April 2005 on the Patent Act 1970 to bring Indian Patent Regime in harmony with the WTO agreement on Trade Related Intellectual Property Rights (TRIPS). The third and the final one, known as the Patent (Amendment) Act, 2005 came into force on 4th April 2005 and introduced

product patents in drugs, food and chemicals sectors. The term of patenting has been increased to a 20 year period. These changes in the policy regime in 1990s, thus, stared a new chapter in the history of Indian Pharmaceutical Industry where free imports, foreign direct investment (FDI) and technology superiority would determine the industry performance.

Challenges & Opportunities:

The Indian pharmaceutical industry is looking at this era of globalization as both a challenge and an opportunity. The major challenges are-Patents and Intellectual Rights -Pricing Issues -Regulatory Reforms -R & D Spending Whereas the major opportunities are-Generic Drugs -Biotechnology Derived Drugs -Outsourcing -Contract Manufacturing -Contract Research

There has never been a more important time for Indian Government and its drug producers, both multinational and domestic, to work together in partnership for the good of the industry and the nation. India has got advantages, of a large, well-educated skilled and English-speaking workforce, low operational costs and improving regulatory infrastructure, India has the potential to become the region's hub for pharmaceutical and biotechnology discovery research, manufacturing, exporting and health care services within the next decade. However, in order for this to happen, it is important to note that the Indian Regulatory Environment continues to improve. Otherwise, India needs to look to the achievements of China, where the government's strong commitment pro-industry policies have produced a positive environment that not only offers drug manufacturers a product patent regime but also, and crucially, data protection. India's continuing failure to do so needs to be urgently rectified The future of Indian pharmaceutical sector looks extremely positive. India is an attractive global sourcing destination for Pharmaceuticals due to availability of low-cost, high-quality production and regulatory compliance, large and growing US FDA approved plant capacity synthetic chemistry talent for early stage compound development, low cost of research and world-class testing facilities.