Clinical trials are an indispensable
part of medical R&D to test the safety and efficacy of a new drug,
treatment or a diagnostic technique in humans. While these are essential
in the fight for better health, India has been shockingly lax in
enforcing strict guidelines, and indeed even in evolving a stringent
protocol for the same. Serious questions were raised about rules and
regulations related to clinical trials when four girls died in Andhra
Pradesh last year, after being administered a vaccine for human papiloma
virus to prevent cervical cancer. While a committee has concluded that
the deaths were most likely unrelated to the vaccine, it nonetheless put
into sharp focus the existing protocol and safeguards for volunteers.
The Drug Controller General of India (DCGI) has
finally come out with new draft guidelines that make it mandatory for
all companies conducting critical trials to take the written consent of
the volunteer. This provision has been arbitrary until now, leading to
allegations that “informed consent” is a fallacy since volunteers are
seldom given a full picture of the trial or of the risks involved. The
socio-economic status of the volunteer too has to be mentioned: this
could set the alarm bells ringing if there’s any widespread exploitation
of any particular section of society. Equally importantly, the
guidelines require the companies to report to the DCGI any serious
adverse effect during the conduct of the trial, the reasons for that and
details of compensation given.
