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 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. “We hope this will lead to more stability and growth in clinical research being done in India which will ultimately ensure that our patients have access to faster and more effective treatment.”
India has the second largest population in the world and the highest disease burden, but conducts less than 1.2 per cent of global clinical trials. 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. For drugs developed outside the country, the approval time has been fixed to 90 days.
Claiming that the new rules will provide clarity to various applicants and help to smooth the application process, Dr Trivedi said, clinical trials in India went through a very challenging few years and is still in the process of rebuilding the trust and confidence of sponsors in placing trials in India. 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. He pointed out that this step is important in ensuring initiation of approved studies and quicker access to new treatment for patients.
For the first time, orphan drugs have been defined as intended to treat conditions which affects not more than five lakh persons in India. In addition, fee waivers for orphan drug trials is likely to encourage more trials for rare diseases in India.