In January 2005, the government of India enacted a new rulethat allows foreign pharmaceutical companies and other interestedparties to conduct trials of new drugs in India at the sametime that trials of the same phase are being conducted in othercountries. This new rule supersedes a directive of India's Drugsand Cosmetics Rules that required a "phase lag" between Indiaand the rest of the world. According to the old rule, if a phase3 study had been completed elsewhere, only a phase 2 study waspermitted in India. Even under the new rule, phase 1 trials. . . [Full Text of this Article]
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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.
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