Even as the Union health ministry is currently reviewing to amend the clause under the clinical trial rules to remove cap on the number of clinical trials an investigator can undertake at a time, clinical research experts have raised concern that this is impeding clinical research in the country as this has led to the under-utilisation of the healthcare infrastructure developed over the last one decade on one hand coupled with high attrition rates in the industry.
This, according to the recommendation of the Indian Society of Clinical Research (ISCR) to the Union health ministry, should be based on the competency/capability of the investigator, requirement of the trial/study and infrastructure of the hospital.
According to a senior health ministry official associated with the development, the Central Drugs Standard Control Organisation (CDSCO) is currently reviewing the recommendation on the same based on the stakeholders submissions. DCGI has also reiterated his commitment towards patient safety, ethics and quality and to work together to address growing disease burden effectively and efficiently through clinical trials.
Over the last few years, clinical research in India went through a very turbulent period. Hard-hitting revisions in compensation guidelines in January, 2013 negatively impacted the growth of clinical research in India.
At present, a principal investigator cannot undertake more than three clinical trials at a time as per the Drugs and Cosmetics Rules, 1945. Regulating clinical trials and the necessary rules, procedures and guidelines to be followed have been framed under the Drugs and Cosmetics Rules, 1945. Rules for conducting clinical trials in India are prescribed under Rule-122DA, 122DAA, 122DAB, 122DAC, 122DD, 122E and Schedule Y of the Drug and Cosmetics Rules, 1945.
As per the current rules, the Indian regulator has restricted the number of studies/trials to be undertaken by an investigator to only three. As per its provisions, another clause stipulates the size of the hospital to be a 50-bed hospital.
Clinical research experts have for long been advocating empowerment of institutional ethics committee (IEC) based in hospitals to take the onus of deciding the number of studies/trials an investigator can undertake.
Vaccines may require 10,000 trial subjects whereas studies on cancer may require 60 to 70 trial subjects. Therefore, restricting the number of studies for an investigator is not justified in the interest of clinical research to address the unmet medical needs of the country.
According to ISCR report, India is lagging behind smaller countries like Korea, Taiwan and Japan in clinical trials due to such regulations. According to official data, of 1,80,649 clinical trials in 178 countries, just 2,563 studies or 1.4 per cent are being done in India.
Clinical research is essential to address emerging health concerns like antibiotic resistant pathogens, H1N1 and dengue but also to develop medicines for malaria, tuberculosis and lifestyle diseases such as diabetes and cardiac disorders.