Believes it will allow for better quality of clinical research in India and benefit patients
On August 2, 2016, CDSCO released two circulars by the DCGI regarding the conduct of clinical trials in India. As per the revised rules, the cap on the number of trials an investigator can undertake at any point in time has been removed and the Ethics Committees have been empowered to decide on how many trials an investigator can undertake after examining the risk and complexity involved in the trials being conducted. The cap on a minimum number of 50 beds for a clinical trial site has also been revised with the Ethics Committees now being vested with the responsibility of examining and deciding whether a clinical trial site is suitable for a trial or not, irrespective of the number of beds.
Welcoming the recent announcements by the DCGI with regard to the cap on the number of trials per investigator and number of beds per site, the Indian Society for Clinical Research (ISCR) has said that it is a welcome move that will enhance the overall quality of clinical research being done in India. ISCR also acknowledged the collaborative approach by the regulators in making the changes in response to stakeholder feedback.
“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,” said Suneela Thatte, President, ISCR. “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.”
ISCR also acknowledged the efforts and contribution of late Prof Ranjit Roy Chaudhury, who headed the Expert Committee constituted by the Ministry of Health & Family Welfare in February 2013 to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. One of the recommendations in a report by the Executive Committee submitted to the government was that any clinical trial of a new or existing drug or medical device should be carried out at a centre where facilities for carrying out such trials exist, and the investigators carrying out the trial are competent and have experience in the successful conduct of such trials. The Committee also recommended that the decision regarding the number of clinical trials a Principal Investigators can undertake should be taken by the Principal Investigators and the Institute Ethics Committee.
Quintiles, a leading provider of product development and integrated healthcare services, has also appreciated the move. Naz Haji, SVP & India CRO Head, Quintiles said, “We are very pleased to see the positive decisions announced by the DCGI. These developments are indicative of the regulators’ responsiveness to concerns of stakeholders and will give sponsors the choice of the best and most appropriate sites and investigators for a study. More importantly, they are also reflective of the regulators’ commitment to creating a more rational and scientific framework for ensuring patient safety and efficacy in clinical trials, while still enabling sponsors to drive innovation.
“The DCGI’s announcements will allow us to work with sites and investigators who are driven by the same commitment and patient-centric approach. I would also like to add that as we move forward on the path of regulatory reform in India, all stakeholders of clinical research in the country have an important role to play in rebuilding trust in doing clinical research here given the high burden of disease we have and the need to ensure better and more effective treatment options for patients,” he added.
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