Central Drugs Standard and Control Organization (CDSCO) announced it had removed the three study participation limit yesterday. It explained that investigators can now take part in more simultaneous trials if approved to do so by the ethics committee overseeing the research.
The decision overturns a 2014 rule introduced to limit investigator participation in the wake of criticism of Government oversight of drug research in India.
In a separate announcement, the regulator said it had decided to relax the requirement that clinical research must be conducted at a facility with more than 50 beds.
The document reads “As regards condition that no clinical trial shall be conducted at site having less than 50 bedded hospital, it has been decided to revise this condition & it is further decided that ethics committee shall examine & decide whether the clinical trial site is suitable for trial or not irrespective of the number of bed.”
Again, the agency handed responsibility for deciding to allow a smaller site to be included to the ethics committee overseeing the research.
The CDSCO did not say what prompted it to change the rules. However, it did say the decision followed meetings with stakeholders last year.
The organization did not respond to a request for more information.
Positive industry response
In an emailed statement, Indian Society for Clinical Research (ISCR) president, Suneela Thatte, welcomed the changes, telling us “the earlier restrictions impacted a sponsor’s ability to choose the best qualified investigators and sites for a study. Every investigator and site is unique in terms of their capacity, capability and infrastructure and, therefore, their ability to do quality clinical research.
"The new announcements vest this decision with the Ethics Committees who are best positioned to deliberate on this and take a well calculated decision. This is something we at ISCR have been making submissions on on behalf of all the clinical research stakeholders we represent and we are pleased that the regulators have responded positively to stakeholder feedback."
She predicted that: "Ultimately what this translates into is qualitatively better clinical trials as decisions will be guided by which investigator or site is best suited for a particular trial and not by any arbitrary limits."