The new rules to regulate clinical trials, notified by the Union health ministry earlier this week, will encourage research and "benefit patients", a section of experts say. On February 18, THE WEEK had reported that the rules that had been long in the making would be notified this month.
According to the Indian Society of Clinical Research, an association of clinical research professionals, the new rules will pave the way for more clinical trials in India by easing certain procedures. As of now, India's contribution to clinical trials stands at 1.2 per cent, which is low for a country with 17 per cent of the world's population and 20 per cent of the world's disease burden.
“For drugs discovered in India or for whom the research and development is done in India, and are proposed to be manufactured and marketed in this country, the approval for trial is considered given if no communication is received from the Central Licensing Authority. This is a huge push towards encouraging local drug development,” said Chirag Trivedi, president of ISCR. "Earlier, the approval process would take anywhere from three-six months,” Dr Easwara Reddy, Drug Controller General of India had told The WEEK on an earlier occasion.
The approval timelines for global clinical trials stands at 90 working days. “This will support India’s participation in global drug development as these timelines are globally competitive and in line with timelines in developed countries,” said Trivedi.
In a statement, the ISCR also pointed to other “positive” developments in the new rules—pre- and post-submission meetings to provide clarity to various applicants and help smoothen application process. Conditions for providing post-trial access of drugs to patients who require it have been defined for the first time, and the validity of clinical trial approvals has been determined as two years to initiate a study which is extendable by one year. “This step is important in ensuring initiation of approved studies and quicker access to new treatment for patients,” the ISCR has said.
In another first, orphan drugs (used to treat rare diseases) have been defined as a “drug intended to treat conditions which affects not more than five lakh persons in India”. Fee waivers for orphan drug trials will encourage more trials for rare diseases in India, ISCR experts say.
The rules also specify the conditions under which data from a local clinical trial may not be required to be submitted along with the application for permission to import a new drug for sale or distribution. These include conditions such as if the new drug is approved and marketed in countries specified by the Central Licencing Authority, and no serious unexpected adverse events have been reported; no probability or evidence of a difference of the enzymes or gene involved in the metabolism of the new drug in the Indian population or, any other factor affecting the safety and efficacy of the drug. “This clause will help provide early access to Indian patients to drugs already approved in the specified countries,” according to ISCR.
In case of rare diseases, and diseases such as extreme drug resistant tuberculosis, dengue, malaria and HIV, the condition for a Phase 4 trial may also be waived off.
The new rules have been introduced in the backdrop of a huge dip, and subsequently, a small rise in the number of clinical trials in India. In 2010, the number stood at 500, in 2013, it came down to 17. This happened in the wake of two PILs in the Supreme Court over the issue of illegal clinical trials, and consequently, stricter rules.