Currently, the Indian regulator has restricted the number of studies/trials to be undertaken by an investigator to only three with another clause stating the size of the hospital to be a 50-bed hospital, as per the current law.
Clinical research experts have, however, urged the Union health ministry to empower the institutional ethics committee (IEC) based in hospitals to take the onus of deciding the number of studies/trials an investigator can undertake.
This, according to the recommendation of the Indian Society of Clinical Research (ISCR) should be based on the competency/capability of the investigator, requirement of the trial/study and infrastructure of the hospital. According to experts, studies conducted for 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.
According to a senior health ministry official associated with the development, the Central Drugs Standard Control Organisation (CDSCO) will soon issue executive orders on the same based on the response from the Union health ministry and the country will see a more favourable environment for innovations in drug discovery through streamlining of a robust India specific clinical trial mechanism.
In order to enhance investigator led clinical research for diseases that immensely impact Indian population, there is an urgent need, according to clinical research experts, to amend contentious clauses like putting a cap on trials per investigator and that clinical research is mandated only to be performed in a 50-bed hospital.
Experts also argue that in order to ensure that better clinical research prevails in the country as per the ethical guidelines as laid down in Good Clinical Practices (GCP), investigators who are well versed in clinical practice should also acquire skills of documentation, presentation, management and forecasting of the study to usher in clinical research to address unmet medical needs of the Indian population.
Clinical research is essential not just for developing medicines for emerging health concerns like antibiotic resistant pathogens, H1N1 and dengue but also to find safer medicines for endemic diseases such as malaria, tuberculosis and lifestyle diseases such as diabetes and cardiac disorders.
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 before more rational guidelines in 2015 restored some balance in the regulatory environment.
Pharm.D @ SRIPMS-CBE-TN