[india-drug] Legalizing off label use of drugs

[Sunitha srinivas <s.srinivas@ru.ac.za>]

(Source:
http://www.phronline.net/article/detnews.asp?articleid=14653&sectionid=1...Thanks...SS

Idrug participants are requested to ensure an interesting discussion
leading to a logical conclusion regarding the following topic.

In India we have too many pharmaceutical industries and too many
formulations. We still do not know how many of these companies practice
ethical promotion. In this situation, if off label uses are legalised,
what is the guarantee that we are able to safeguard the interests of
the patients by prescribing medicnes for which approval has not been
given in developed countries for "approved uses"?

It is a request to the clinicians and clinical pharmacologists in Idrug
to please puts things into perspective as to why the Drug regulatory
authorities in developed countries make this clear distinction between
"approved use" and "off label use" for the drugs when they register in
their countries. WHY are we allowing the pharmaceutical companies to
follow the double standards ....they register drugs with clear
demarkation of "labelled" and "off label uses" in their home countries
but can ruthlessly push drugs in developing countries without these
restrictions. It will be followed suit by other companies in due course
in India. We still do not have a pharmacovigilance system to sustain
our public health needs and are not able to ban drugs that are not
approved in developed countries...but we want to relax the restrictions
on our Drug laws that are already not being followed, off paper.

A big request to clinicians and clinical pharmacologists to please
voice their opinions regarding this and suggest as to how we are to
deal with this issue.Thanks.....looking forward to interesting results
that will follow this discussion....SS ) 

Centre to examine possibility of legalizing off label use of drugs
------------------------------------------------------------------

Joe C Mathew, New Delhi

The Central government is exploring the pros and cons of legalizing
"off label" use of medicines in India. The official move in this regard
has come after the recurring reports of use of drugs for unapproved
indications in recent months. The pharmaceutical industry and the
Indian Medical Association have been lobbying hard for such a change. 

The recently held Drugs Technical Advisory Board (DTAB) meeting of the
Central Drugs Standard Control Organisation (CDSCO) is known to have
discussed the possibilities of allowing a registered medical
practitioner to prescribe any drug that has been approved for sale in
the country. 

The DTAB had observed that the practice of restricting the use of
certain drugs to certain specialists is not a common practice among
drug regulatory authorities. The discussions were based on a
representation made by IMA with regard to the off label use of drugs.
The IMA is of the opinion that once DCGI releases a particular drug for
use, the medical profession should be given the privilege to use it. 

"A particular drug may be used by a doctor for different diseases.
Moreover, the practice of medicine is regulated by Medical Council of
India. It would not be correct to classify drugs to be used by a
particular specialist only", they had noted. These restrictions were
imposed to avoid possible indiscriminate use / prescription of these
drugs except by medical specialists who possess adequate qualification
and experience in respect of use of such drugs. 

As a fall out of the discussions, IMA was asked to submit a detailed
report on the various aspects relating to off label use of drugs. It is
known that IMA had recommended for a change in the drug laws, which can
lawfully allow a registered medical practitioner to use an approved
drug for an unlabelled indication when such use is based upon sound
scientific evidence and sound medical opinion. 

Accepting the committee's recommendation, CDSCO has decided to put
forth its suggestions in the forthcoming Drugs Consultative Committee
meeting. The authorities have observed that off label use of drugs by
medical practitioners may be out of scope of direct intervention by
drug authorities in the context of available provisions under Drugs and
Cosmetics Act. It has decided to examine the issue in the forthcoming
DCC meeting.


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