|
New
Bill to regulate scientific research on humans
A
new Bill titled as - The Biomedical Research on Human Subjects
(Promotion & Regulation) Bill, has been proposed by the Government
to regulate and enforce ethical practices in scientific research
on humans. It is likely to be introduced in the next session of
Parliament.
The
need for the Bill arose as currently only the commercial aspects
of research on humans through clinical trials was being regulated
under the Drugs and Cosmetics Act,1945, more specifically Schedule
Y. Further, concerns were being raised as to the unethical practices
in the industry. The current bill which relies heavily on the
ethical guidelines for biomedical research on human subjects
issued by the Indian Council of Medical Research (ICMR), aims
to plug the holes and encompass all kinds of research on humans.
This would include clinical trials - both commercial and academic,
as well as the entire range of research, including genomics, gene
mapping, foetal tissue transplant, and stem cell research.
The
Bill is driven by ethical considerations in research and its
schedules contain the principles and processes , such as:
- ethical
considerations
- ethical
review procedures
- clinical
trials
- clinical
evaluation of devices
- diagnostics
- vaccines
- epidemiological
studies
- stem cell
research (including human genetics research)
- transplant
research
- assisted
reproductive technologies
It
also covers stem cell research,a very controversial area of research
which has been opposed in many countries. A further need to regulate
this kind of research in India was felt as there are many cases
of forced uniformed consents and clinical research on the illiterate
and poor, which could lead to unregulated abortions, and the general
flouting of medical ethics and scientific principles by doctors.
Currently
the only regulator on human research in India is the Drug Controller-General
of India who regulates commercially conducted clinical trials.
The Bill proposes that the ethics committee of ICMR be designated
as the national ethics committee, which will also be the technical
adviser to the biomedical regulator. It also prescribes fines
up to Rs 1 lakh and imprisonment of up to a year for norm violations.
Though,
the Bill has been seen by some as a right move in the direction
of bringing in more regulation into a much needed space, others
feel that it would be causing a multiplicity of regulation, as
there is the Drugs and Cosmetics Act already regulating clinical
trials. Hence, it is felt that such a move would actually hinder
the burgeoning market for clinical trials in India.
|
|
|
You
can direct your queries or comments to the authors
|
Source:
Business
Standard (December 15, 2005)
|
