STOCK MARKET BSE NSE

Kerala Government to Curb Unethical Practices in Clinical Trials

In the wake of reports of several clinical trial centres in the state violating the principles of human research ethics, the State Government has decided to formulate a Clinical Trial Registry under the Drugs Control Department.

Published: 13th March 2014 06:00 AM  |   Last Updated: 13th March 2014 08:24 AM   |  A+A-

In the wake of reports of several clinical trial centres in the state violating the principles of human research ethics, the State Government has decided to formulate a Clinical Trial Registry under the Drugs Control Department.

The State Drugs Controller has been entrusted with the task of formulating guidelines for the Clinical Trial Registry.

When contacted, Drugs Controller P Hariprasad said that he had received the government order in this regard.

‘’The officials have been asked to prepare the guidelines on the basis of the government’s direction. We hope that the guidelines will be prepared in two months’ time,’’ he said.

Sources said that the registry would include details of the title of study, hospitals and clinicians involved, type of research and in-patient details.

 The government had decided to go for Clinical Trial Registry based on the recommendations of a committee under the chairmanship of V N Rajasekharan Pillai.

The committee was formed following media reports that illegal clinical trials were being conducted in the state.

It was found that the institutions which conduct clinical trials in the state were not following the conditions stipulated as per rules.

The committee also found that the patients on whom the studies were conducted were often selected through medical camps organised in remote villages, and mostly illiterate or people from low income groups were selected for these studies.

Health Secretary K Ellangovan said that the government had asked the Drugs Control Department to formulate the guidelines.

‘’The Drugs Control Department will be having a monitoring role.

“And entrusting this role to the Department does not mean that the doctors will be avoided.

The clinical trials will be done only by the doctors and it will be monitored by the Department,’’ he said.  

Sources said that all the centres and hospitals which conduct clinical trials should have to get registered, satisfying the conditions for trials.

The State Board of Medical Research will be entrusted with giving periodic training to investigators of clinical trials.

Stay up to date on all the latest Kerala news with The New Indian Express App. Download now

Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp