The ‘Biomedical Research Human Subjects Promotion and Regulation Bill’, which has literally been lying in cold storage for more than eight years due to official apathy, is all set to see the light of the day as the Indian Council of Medical Research (ICMR), which was given the responsibility of drafting the bill, is working overtime to introduce the Bill in the winter session of Parliament.
The ICMR will soon send the draft Bill once again to the union law ministry for its final nod before introducing it in the winter session of Parliament.
“The scientific part of the Bill is complete and the final draft Bill will once again be sent to the law ministry next month for its nod,” ICMR director general Dr Vishwa Mohan Katoch said and added that the Bill will be introduced in Parliament in the winter session of Parliament which is expected to be held in November this year.
Dr Katoch, who has shown keen interest in bringing the Bill, said that the ICMR has finalised the Bill by incorporating several new features in the final draft, which is aimed at protecting the safety and rights of humans used in scientific research, to make it an updated document as per the international standard. Apart from several other features, more punishment has been provided in the Bill as a deterrent at par with the international laws in this regard, Dr Katoch, who is also the secretary of department of health research, said.
Earlier, the review committee formed to give final shape to the Bill met several times to fine-tune the Bill in line with the international changes witnessed during the last eight years when the Bill was first drafted. Major changes in the Bill have been made in the area of punishment as the Bill in its previous form was weak as far as punishment is concerned. Since the Bill has been pending for many years, several features of the Bill have become irrelevant and have to be reviewed and changes have to be made accordingly.
Once the bill gets the final clearance from the law ministry, it will be placed before Union Cabinet for its nod to introduce the same in Parliament.
Once the bill gets the Parliament nod, it will become mandatory for all medical institutions conducting human research to get registered by a central agency. The ethics committees in individual institutions will also have to get registered with the agency. The Bill seeks to protect the human subjects used in any form of scientific research – behavioural or intrusive—done by an academic institution or pharmaceutical company.
The need for uniform ethical guidelines for research on human subjects, which is universally recognised, acquired a new sense of urgency as the critical issues in the areas of biogenetic research involving human subjects have become sensitive. Apart from the mandatory clinical trials on new drugs, a number of diagnostic procedures, therapeutic interventions and preventive measures including the use of vaccines are being introduced involving human subjects.
The advent of new medical devices and radio-active materials, and therapeutic benefits of recombinant DNA products have added a new dimension to the ethical issues that need to be considered before evaluating these for their efficacy, utility and safety.
Source:Pharmabiz
The ICMR will soon send the draft Bill once again to the union law ministry for its final nod before introducing it in the winter session of Parliament.
“The scientific part of the Bill is complete and the final draft Bill will once again be sent to the law ministry next month for its nod,” ICMR director general Dr Vishwa Mohan Katoch said and added that the Bill will be introduced in Parliament in the winter session of Parliament which is expected to be held in November this year.
Dr Katoch, who has shown keen interest in bringing the Bill, said that the ICMR has finalised the Bill by incorporating several new features in the final draft, which is aimed at protecting the safety and rights of humans used in scientific research, to make it an updated document as per the international standard. Apart from several other features, more punishment has been provided in the Bill as a deterrent at par with the international laws in this regard, Dr Katoch, who is also the secretary of department of health research, said.
Earlier, the review committee formed to give final shape to the Bill met several times to fine-tune the Bill in line with the international changes witnessed during the last eight years when the Bill was first drafted. Major changes in the Bill have been made in the area of punishment as the Bill in its previous form was weak as far as punishment is concerned. Since the Bill has been pending for many years, several features of the Bill have become irrelevant and have to be reviewed and changes have to be made accordingly.
Once the bill gets the final clearance from the law ministry, it will be placed before Union Cabinet for its nod to introduce the same in Parliament.
Once the bill gets the Parliament nod, it will become mandatory for all medical institutions conducting human research to get registered by a central agency. The ethics committees in individual institutions will also have to get registered with the agency. The Bill seeks to protect the human subjects used in any form of scientific research – behavioural or intrusive—done by an academic institution or pharmaceutical company.
The need for uniform ethical guidelines for research on human subjects, which is universally recognised, acquired a new sense of urgency as the critical issues in the areas of biogenetic research involving human subjects have become sensitive. Apart from the mandatory clinical trials on new drugs, a number of diagnostic procedures, therapeutic interventions and preventive measures including the use of vaccines are being introduced involving human subjects.
The advent of new medical devices and radio-active materials, and therapeutic benefits of recombinant DNA products have added a new dimension to the ethical issues that need to be considered before evaluating these for their efficacy, utility and safety.
Source:Pharmabiz
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