[india-drug] Response to Legalizing off -label use of drugs

[Rama Murthy <NVRAMAMURTHY@express2.indexp.co.in>]

Response to Legalizing off -label use of drugs
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The Indian Medical Association has recently submitted guidelines to the

Union Health Ministry on the usage of off-label medicines in India. 
The Indian  drug manufacturers, prolific in introducing new products in
the Indian  markets till now, will not be able to do so from next year
once the product  patent regime comes into effect.  The timing of the
proposal may seem to be  a coincidence,but it appears that the IMA is
taking up the cudgels for the drug industry.

There is no denying the fact that off-label dispensing of drugs is 
resorted to by qualified and competent medical practitioners in
developed countries.  
But there is a difference.  The onus and responsibility squarely rests 
on the doctors who do so and more importantly, the doctors there are 
transparent and reveal the facts to the patients.  And even while 
carefully monitoring the dosage and responses, if anything goes wrong,
the doctor takes full responsibility.  No such thing happens in India
and the media which may not understand the finer nuances in such
situations, could be justified in raising concerns that generally are
not addressed in the first place.

Like it is in most walks of Indian life, people stand up vehemently for

their rights while relegating their responsibilities to the farthest 
orbit.  The medical profession is no exception.  For off-label usage,
evidence based scientific rationale is a pre-requisite.  But, a
research bent exists only in a small percentage of clinical
practitioners, the majority of them depend on peer's experience and
reports in scientific journals.  Nothing wrong in  that
with well established medicines, but every practitioner cannot have  
such liberties with new and unknown drugs. It could be dangerous.

The point is, unlabelled usage is a clinical experimentation.  Keeping 
notes and records is a must in research without which the evidence
hardly exists.  The question IMA must ask is what percentage of its
practitioners  keep records. 

Meticulous records have to be maintained by practitioners, the 
recordings and observations conveyed to the Medical Council which
should ideally be involved in approval and monitoring of new drugs
coming into off-label usage.

Doctors may be right in saying that they do not require Drug 
Controller's permission for off-label usage, but there must be some one
monitoring such first-time usage if frivolous and unethical promotions
by pharma companies has to be kept in check.  Indian drug manufacturers
have consistently avoided conducting clinical trials even in reasonable
number of patients to take advantage of cheap pricing.  As long as
evidence based scientific data in large numbers was obtainable from
"public domain" for patentable molecules it was all right. 

But if blanket permission is available to all practitioners to 
prescribe off-label usage without sound scientific evidence & medical
opinion, then most lay practitioner will continue to prescribe
antihistamine like preparations for appetite stimulation even if they
are banned elsewhere or without understanding the long term
consequences of such dispensation.

There is bound to be a push for off-label use of existing drugs by 
Indian pharma companies and the medical community would do well to be
extra cautious and demand authentic scientific evidence for safety &
efficacy of use and not repose faith in small time studies or paper
approvals.  These are the potential dangers for doctors and patients
alike. Better to be warned.

N V Ramamurthy
Editor
Express Pharma Pulse
Express Healthcare Management
Express Towers, First Floor
Nariman Point,
Mumbai 400 021
Tel : 5630 1020 Extn 223
e-mail : <nvramamurthy@express2.indexp.co.in>


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