The Federal Government is pushing to bring in a
new law to regulate drug trials in the country on humans by the end of
this year. The new legislation would oversee all forms of drug trials
and contain stringent provisions for violators, including imprisonment
for a period of five to 10 years and a penalty of Rs700,000.
The
move comes In the backdrop of the recent public outrage over the
botched clinical trials in Madhya Pradesh on children with learning
disabilities. “We are working on the bill on biomedical research on
human subjects. The draft will be sent to the Law Ministry for vetting
before being sent to the cabinet for approval. We are hopeful that the
law will be in place by the end of this year,” Director General of
Indian Council of Medical Research (ICMR) Dr V.M. Katoch said speaking
on the sidelines of the ongoing 99th Indian Science Congress here.
Dr
Katoch said the Health Ministry had been receiving several complaints
regarding illegal drug trials on humans. At present, the guidelines
governing the clinical trials are weak and ineffective. Low costs, weak
laws and inadequate enforcement and penalties are blamed for the present
state of affairs. The inadequacy of the present regulatory regime came
to the fore following the recent action against 12 doctors in Bhopal for
conducting drug trials on children in violation of norms.
Under
the new legislation, all clinical research activity on human beings
would be covered. At present, the Drugs and Cosmetics Act of 1945
provides the regulatory framework for conducting human clinical trials
of drugs and vaccines. A clinical trial for a new drug can be started
only after permission from the Drugs Controller General of India after
approval from the ethics panel.
For
all the trials, investigators have to obtain written and informed
consent from all study participants in an approved format. However,
there is no provision for punishment for those who violate the
guidelines.
