With the Central Drugs Standard Control Organization (CDSCO)'s draft Clinical Trials Rules, 2018 under review, clinical trial experts have hailed the positive trend of approval of 99 global clinical trials (GCTs) conducted in India in 2017 as compared to 38 in 2016.  

Out of the 107 clinical studies reviewed and approved in the country, 43 were GCTs till the period ending August 2015. This was much below as compared to the year 2014 when 150 clinical studies were reviewed and approved out of which 87 were GCTs.

In the year 2013, just 17 GCTs were approved to be conducted in India due to hard-hitting revisions in compensation guidelines in January, 2013 which negatively impacted the growth of clinical research in India.

A clinical study involves research using human volunteers also called participants that is intended to add to medical knowledge. There are two main types of clinical studies called interventional studies and observational studies.
 
As per latest data, out of 2,68,620 clinical studies done globally, 3,315 studies are being done in India, South Asia at 4,050 studies, Afghanistan at 17, Bangladesh at 286, 2 in Bhutan, 86 in Nepal, 411 in Pakistan and 57 in Sri Lanka.  

India has been lagging behind smaller countries like Korea, Taiwan and Japan due to regulations framed following a public interest litigation (PIL) in the Supreme Court four years ago. The regulations were enforced based on the recommendations of the professor Ranjit Roy Choudhury expert committee appointed by the ministry of health and family welfare.

According to experts, there is an increasing need to do more clinical research in India to meet emerging health concerns such as antibiotic resistant pathogens, H1N1, dengue, entrenched diseases such as HIV, malaria, tuberculosis especially drug resistant TB and equally, rare diseases such as Gaucher disease, Pompe disease, etc.

India accounts for 20 per cent of the world's disease burden and 17 per cent of the world's population, yet less than 1.4 per cent of global clinical trials are done in India.

In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention.