From 15th June, 2009 Office of Drugs Controller General (India) has made mandatory to register all clinical trials permitted on or after the said date to be registered with Indian Council of Medical Research (ICMR) registry at www.ctri.in before enrolling first patient in the study.
As per a report on ‘The Glorious Metamorphosis Compelling Reasons for doing Clinical Research in India’ published with a joint effort of FICCI and Ernst & Young Pvt. Ltd in 2009 the clinical trials market in India is sized at -USD250-275m.
Clinical trials are regulated under Drugs and Cosmetics Act and Rules there under by CDSCO. In order to strengthen / streamline the clinical trials, Govt. of India and Central Drugs Standard Control Organization (CDSCO) has taken various measures which includes:
1) Amendment of Schedule Y of Drugs and Cosmetics Rules in 2005;
2) Draft guidelines and requirements for registration of organization conducting clinical trials in the country have been developed and approved by Drug Technical Advisory Board (DTAB), which are proposed to be incorporated as new Schedule to Drugs and Cosmetics Rules, 1945.
This information was given by Minister of State for Health & Family Welfare, Shri Dinesh Trivedi in written reply to a question raised in Rajya Sabha today.
Source: PIB
