Quality Systems

A. Nair is a freelance writer based in Mumbai, India.

Articles

The $6.3 billion Indian pharmaceutical industry is at a crossroad. Aiming to be the international home for quality drugs, which could in itself propel India's market to $20 billion by 2015 according to recent estimates, the generic hothouse is clearly moving beyond its earlier low-cost mindset.

Report from: India, January 2008

The tightening of intellectual property rights in India under GATT/TRIPS was a crucial inflection point for pharmaceutical outsourcing in India.

Dynamics of India's Life Sciences Outsourcing Industry

May 24, 2007 Notes: AAI Acquires Brazilian CRO, Biovail Investigated by SEC, Pall Opens Center of Excellence, more

Forty years ago, investors and business speculators shuddered at the prospect of working with India's pharmaceutical industry. The industry was plagued by archaic patent laws and insufficient infrastructure, and only multinational companies (MNCs) were able to exploit its crude resources and monopolistic legal framework. Struggling in the shadows of these MNCs were the Indian pharmaceutical entrepreneurs and a handful of producers. Because more than 70% of the pharmaceutical market value was in the hands of MNCs, India's indigenous pharmaceutical industry was floundering. Its amount of exports was negligible, and the domestic market outlook was bleak because of onerous government regulation.

India: the Gateway to Pharma

The enactment of the Indian Patents Act of 1970, implemented in 1972, provided an open platform to the Indian pharmaceutical industry to adopt process patents to manufacture active pharmaceutical ingredients (APIs) and formulations without fear of infringement of product patents. This resulted in a phenomenal growth in the number of pharmaceutical manufacturing units, from 2257 in 1970, to 5156 in 1980, 16,000 in 1990, and more than 23,000 in 2005. This was accompanied by a steep increase in investment from Rs. 2.25 billion (approx. $250 million US) in 1973, to Rs. 45 billion (approx. $1 billion US) in 2002–03. The prices of the most advanced drugs dropped significantly in India, leading the Indian pharma sector to become more competitive while remaining extremely cost effective in the global market.

Indian Pharma Sector: Evolving to Innovation

Indian pharmaceutical machine manufacturers (IPMMs) are exceptional among their foreign counterparts. Historically similar to the Chinese with regard to copycat practices, patent infringements, and substandard quality, the IPMMs have made great strides in innovation and collaboration to break free from the shackles of this paradigm.

India's Pharmaceutical Machine Manufacturers: From Imitation to Innovation

Warning: Brazilian Diet Pills Found to Contain Active Drug Ingredients

India and China: Outsourcing Beyond the Comfort Zone

Hemant N. Joshi, PhD, is associate director of pharmaceutical research and development at Barr Laboratories.

India's pharmaceutical industry, which is one of the country's major economic sectors, is poised to make signficant gains on the global market.

Regulatory/GMP Compliance, Emerging Markets