The traditional research and development model of large pharmaceutical companies is arguably unsustainable in current times. For example, estimated research and development costs increased as much as twelve percent over the last year while pharmaceutical sales grew only seven percent over the same period. Current estimates put the price to develop a new drug and bring it to market between $800 million and $1.5 billion per drug. These costs are increasing, driving large pharmaceutical companies to find more cost-effective research and development models. One cost-saving initiative is to globalize the system. In particular, companies have increasingly outsourced the required investigational drug trials from developed countries in which the drugs would be sold, such as the United States, to developing countries, such as India.
Outsourcing Drug Investigations to India: A Comment on U.S., Indian, and International Regulation of Clinical Trials in Cross-Border Pharmaceutical Research,
Nw. J. Int'l L. & Bus.