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Eased the norms for Clinical Trials

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There has been greatly lower clinical advancement in terms of research in India. This is being the main reason due to the fact of banning the clinical trials without the prior permission of Drug Controller General of India (DCGI). Due to the delay in getting the permission from DCGI, they are not able to perform research at the desired pace. Public Health experts commenting over the same says that this particular move is a kind of set back for those who is working for a safer and more transparent clinical trials.

DESIGN OF TRIAL TITRATION (INCREASING DOSE) DESIGNS CROSS-OVER DESIGN: Each person acts as their own control (Reduces number of people) PARALLEL GROUP. (Image Courtesy: Google)
DESIGN OF TRIAL TITRATION (INCREASING DOSE) DESIGNS CROSS-OVER DESIGN: Each person acts as their own control (Reduces number of people) PARALLEL GROUP. (Image Courtesy: Google)

Initiation of the Restriction over Clinical Trials

The quite booming of the clinical trials in India came under the scrutiny during the year of 2013. It took place after the deaths of about 370 which took place due to the Serious Adverse Events (SEAs) during the trials. In September 2013, the apex court ruled out that no further clinical trials should be permitted until the regulatory body is being informed.

The latest amendments to the D & C act is following the recommendations being given by Professor Ranjit Roy Choudhury Committee, which suggested that the academic research should be approved by the Institutional Ethics Committees. They in-particular doesn’t want to promote the innovation and research in a manner which catches it in a red tape. The testing by many of the students and even their detailed study is being delayed because of the permissions being required from the DCGI.

DRUG DEVELOPMENT PROCESS. (Image Courtesy: Google)
DRUG DEVELOPMENT PROCESS. (Image Courtesy: Google)

Chances of Misuse

Their Institutional Ethics committee are quite being authorized for allowing them to nurture an environment of research in the country, says G. N. Singh, DCGI, Central Drugs Standard Control Organization. C. M. Gulhati, Editor of the Monthly Index of Medical Specialties commenting over the same says that, there are also greater chances of the misuse if anyone is being given such an authority.

The main criteria for the defence of this decision is it is being taken for the academic and not commercial. Thus these research will be carried out for the academic purposes. They can’t experiment with the newer molecules. There are quite greater chances for the risk factor but the ethics committee needs to be independent. It is quite dependent over the institutions of how to use the same which is quite leaving a loophole behind.

Ban over the Trials

During 2013, Supreme court has banned the trials after the filing of public interest litigation petition which has brought to light that the trials are being conducted in the various parts of the country and the patients’ rights of being informed consent is not being taken. The patients which are being subjected to the clinical trials includes newborns, children, pregnant women and also the mentally challenged persons.

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