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| home > epc > autumn 2004 > will india become the outsourcing capital for the global pharmaceutical industry? |
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European Pharmaceutical Contractor
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India's stance in relation to intellectual property protection has played a vital role in the evolution of the domestic pharmaceutical industry. It has also affected the development of local capabilities that form the basis for contract services to the global pharmaceutical industry. The Indian Patents Act (1970) that replaced British colonial laws related to intellectual property rights did not recognise pharmaceutical product patents. Instead, the manufacturing process patents were recognised for a seven-year period.
The Act's objectives were to encourage the development of an indigenous pharmaceutical industry and to provide Indian consumers with low cost medicines. During the 70s and 80s, the Indian pharmaceutical industry enjoyed tremendous growth to become the world's largest producer of formulations (in volume terms) and bulk drugs. Furthermore, the industry structure changed such that Indian-owned companies took over the industry's leading positions from multinational subsidiaries. Having developed expert synthetic chemistry 'reverse engineering' skills and world class manufacturing plants, India's leading pharmaceutical companies have become major exporters of pharmaceutical products to the world's regulated and unregulated markets.
Winds of change were heralded when India agreed to uphold the Trade-Related Intellectual Property Rights (TRIPS) agreement finalised during the Uruguay round of multilateral trade negotiations in 1995. As a signatory to the TRIPS Agreement, India is committed to amending her patent legislation so as to recognise and enforce product patents in all fields of technology including pharmaceuticals by 2005. The dramatic change in Indian patent legislation is already having, and will continue to have, a major impact on the Indian pharmaceutical and ancillary industries by creating new opportunities for some players and delivering the death knell for others.
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By Dr Nermeen Varawalla, Vice President, Business Development International at PRA International
Dr Nermeen Y Varawalla, MD, DPhil (Oxon), MBA is Vice President of International Business Development at PRA International, UK. Responsible for leading PRA's European business development team, Dr Varawalla has a strong interest in 'emerging world' clinical development with a particular emphasis on India. Prior to joining PRA, she was the founder of PerinClinical, a niche India-focused CRO. Before that, she worked with Accenture's Business Strategy Consulting Practice where she focused on the area of drug development. Dr Varawalla received her medical training at the KEM group of hospitals, Mumbai, India. She was awarded the Rhodes Research Fellowship to Oxford University for her doctoral research and then practiced as an NHS specialist. Dr Varawalla obtained her MBA at INSEAD and is Chairman of the INSEAD - Wharton Alumni Health & Pharma Group.
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