Summary:
Advertising“The new rules seek to protect the rights, safety and well-being of patients, while ensuring a strong scientific base for conducting clinical trials,” Dr Chirag Trivedi, ISCR president, said in a statement issued Tuesday. The validity of clinical trial approval has been determined as two years to initiate a study, which is extendable by one year, the ISCR president said. In addition, fee waivers for orphan drug trials is likely to encourage more trials for rare diseases in India. Welcoming the New Drugs and Clinical Trial Rules, 2019, which were notified by the Ministry of Health and Family Welfare and made public on March 25, the Indian Society for Clinical Research (ISCR) said that the new guidelines are well-balanced and will further the conduct of ethical and quality clinical trials in the country that in turn will benefit patients. The new Clinical Trial Rules, the ISCR said, has reduced the time for approving applications to 30 days for drugs discovered in India or whose research and development has been done in India and are proposed to be manufactured and marketed in India..