Clinical trials in India

Clinical Trials In India

India has been in focus as a hub of clinical trials. Many Indian cities and villages have centres which do clinical trials. There are two questions :

1) Do India need to allow the clinical trial

2)ethical issues

3) Is there heavy exploitation in name of clinical trial.

The clinical trials are done by mostly big pharma companies. It is difficult for these companies to get permission in their respective nations for the trials. The pharma companies have a great opportunity to have their trials in India due to high population/ lesser activism against trails/ more persons willing to take trials (lack of alternative)

                                      The heavy exploitation where the middle men in India

 ( agencies/doctors/outsourced companies) bag the money while the person who takes the trial getting a pittance is another sad side. There are complaints that people are brought into the trial through half-truths about the interventions they are to undergo.

source: padisysmobileclinicaltrials.wordpress.com

Why india is a favoured destination?

India has diversity in population and also all diseases. The poor people and easy access to people due to lack of proper health care. All diseases – communicable and non communicable are present in large numbers in india. India has lot of patients who cannot afford medical care. They are lured into the drug trials since they have no other option for treatment.

How is clinical trial conducted in India?

The company has to get the clearance from DGCI and the clinical trial is conducted under scheduleY of drug and cosmetic rules. The pharmaceutical companies deploys CROs(contract research organisations) for conducting researches. The permission of local ethics committee has be acquired before conducting clinical trial.

Is the present system sufficient?

The DGCI's monitoring system is flawed. There is not enough staff or enough expertise to check the plan design or the impact of clinical trial.

Time and over again NGO's/ journalists/ social media have questioned the ease with which many companies got permission for the trials. The incidence where 5 persons undergoing trials at Khamman Andhrapradesh died turned focus on the safeguards of the trials. The SC had also come heavily against the unethical trials. (click here).

The Ranjit Roy report has recommendations for betterment of the system.

Download Ranjit Roy Report (only the recommendations part needed). Read the action taken by government regarding the report.

The links to the recent updates can be found here (click here)

The Action taken report (Click here)