Pharmaceutical Laboratory Equipment

Impact of Product Patent on FDI in Indian Pharmaceutical Industry
By Arvind Singhatiya

An Ordinance on Patents (Third) Amendment was promulgated by the Government on December 26, 2004 to make the Indian patents law WTO compliant and to fulfill India’s commitment under TRIPS to introduce product patent protection for Drugs, Food and Chemicals with effect from January 1, 2005.

An overview of Indian pharmaceutical industry

The Indian pharmaceutical industry, with US$4 billion in domestic sales and over US$3 billion in exports, is showing satisfactory progress in terms of infrastructure development, technology base and product use. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing processes and has also developed excellent ‘good manufacturing practices’ (GMP) compliant facilities for the production of different dosage forms. The strength of the industry is in developing cost-effective technologies in the shortest possible time for drug intermediates and bulk actives without compromising on quality. This is realized through the country’s strengths in organic synthesis and process engineering. The focus under the R&D effort is to encourage development of new molecules. A provision of Rs. 150 crore has been made under the Pharmaceutical Research & Development Support Fund. A Drug Development Promotion Board under the Department of Science & Technology has also been set up for the utilisation of this fund. Feasibility of setting up a Mega Chemical Industrial Estate in the country with world class infrastructure facilities is also being studied. For the first time in many years, the international pharmaceutical industry is finding great opportunities in India. The process of consolidation, which has become a generalised phenomenon in the world pharmaceutical industry, has started taking place in India.

The pharmaceutical industry, with its rich scientific talent and research capabilities, supported by Intellectual Property Protection regime, is well set to take a great leap forward. As regards product patents for drugs, an amendment to the Indian Patents Act has been carried out through the Patent (Amendments) Ordinance, 2004 on December 26, 2004. The Ordinance amends the Indian Patents Act, 1970 for the third time with a view to introducing product patents for drugs, food and chemicals. Apart from manufacture of drugs, the product patent regime will help the pharmaceutical industry to tap outsourcing of clinical research. By participating in the international system of IPR protection, India, with its vast pool of scientific and technical personnel, and well-established expertise in medical treatment and health care, has unlocked vast opportunities in both exports and outsourcing and has the potential to become a global hub in the area of R&D based clinical research. The Patent Ordinance also provides adequate safeguards to protect the interest of the domestic industry, and the citizen from any increase in prices of drugs.

Impact of product patent on Indian Pharma industry

With a regulatory system focused only on process patents, helped to establish the foundation of a strong and highly competitive domestic pharmaceutical industry which in the grip of a rigid price control framework transformed into a world supplier of bulk drugs and medicines at affordable prices to common man in India and the developing world. Introduction of product patents will, however, mark the end of a golden age for IPI (Indian Pharmaceutical Industry). The new regulations will reshape the landscape of IPI forcing significant changes and divide within the industry.