India emerges as new drug proving ground

Western drug companies are bringing a new form of outsourcing to India: clinical trials on the country's more than one billion potential patients. India's huge population allows new-drug studies to be completed much faster, say experts.

Beyond the sheer size of the population, India offers clinical researchers other distinct advantages: The population is genetically diverse. Every disease, from tropical maladies to "lifestyle" ailments, is present. There are also plenty of English-speaking physicians and nurses, some of whom are familiar with international clinical-trial practice.

Perhaps most importantly, clinical trials in India are considerably cheaper:
 

• Phase I (normally tests on small groups of healthy humans) clinical trials have an average cost of $20 million in the United States; in India, they cost 50 percent less.
   
• Phase II (tests on individuals afflicted with the condition for which the drug was developed) clinical trials have an average cost of $50 million in the United States; in India, they cost 60 percent less.
   
• Phase III (tests on large groups of afflicted patients) clinical trials have an average cost of $100 million in the United States; in India, they cost 60 percent less.
  
  The result is that India is garnering attention from Western companies looking to contain rising research-and-development costs for new drugs. For U.S.-approved drugs, such costs averaged $900 million per drug in the 1990s.
  
  Last year, the Indian government added to the allure by removing a regulatory barrier to performing more clinical trials there. And next year, India will adopt a stricter, Western-style patent regime, long a demand of large global pharmaceutical companies.
  
  Source: Joanna Slater, India Is Emerging As Proving Ground For New Drugs, Wall Street Journal, February 19, 2004.
  
  For WSJ text (subscription required) http://online.wsj.com/article/0,,SB107713895963332997,00.html
  
  For more on Regulatory Issues (Drug Approval) http://www.ncpa.org/iss/reg/
  
  FMF Policy Bulletin\24 February 2004