FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 352:1633-1636 April 21, 2005 Number 16 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

	Full Text PDF PDA Full Text Purchase this article Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

In January 2005, the government of India enacted a new rule that allows foreign pharmaceutical companies and other interested parties to conduct trials of new drugs in India at the same time that trials of the same phase are being conducted in other countries. This new rule supersedes a directive of India's Drugs and Cosmetics Rules that required a "phase lag" between India and the rest of the world. According to the old rule, if a phase 3 study had been completed elsewhere, only a phase 2 study was permitted in India. Even under the new rule, phase 1 trials . . . [Full Text of this Article]

Source Information

Dr. Nundy is a consultant in the Department of Surgical Gastroenterology, Sir Ganga Ram Hospital, and Dr. Gulhati is the editor of the Monthly Index of Medical Specialties — both in New Delhi, India.

This article has been cited by other articles:

• Ali, R., Raina, V. (2008). Developing innovative models for North-South cooperation in clinical research--experience from the INDOX Cancer Research Network. Ann Oncol 19: 831-833 [Full Text]  
• Raina, V. (2005). Doing cancer trials in India: opportunities and pitfalls. Ann Oncol 16: 1567-1568 [Full Text]