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A World Health Organisation
committee
has initiated steps to take India on board while proposing a change
in the definition of counterfeiting at the next World Health
Assembly.
In the recently concluded
inter-country
consultations on combating counterfeit medicines, members of the
International Medical Products Anti-Counterfeiting Taskforce (IMPACT)
have stressed the need for a consensus in finalising the matter.
The new definition says any
"false
representation in relation to identity, history or source" would be
considered a case of counterfeiting.
The significance of the
move stems from
fears that the new definition could lead to India's authorised
exports of genuine drugs being termed counterfeit, if, by no fault of
the exporters, the medicine is smuggled into a different foreign
destination. Under the new definition, if medicines originally
intended for one country end up in another country where they are not
registered, they would be declared counterfeit.
The IMPACT proposal to
enlarge the
scope of "counterfeit definition" by including such "trade mark
violations" was not considered by the WHA during its last meeting
in May due to Indian objection.
India has opposed the new
definition
saying it goes beyond the issue of "quality, safety and efficacy",
and could be used as a tool to project India as a centre of
substandard and counterfeit drug production. India also called for
further discussions among the WHO member countries to harmonise the
definition of "counterfeit" to avoid genuine medicines being
tagged as counterfeit - a term normally associated with illegally
produced or supplied medicines that may or may not conform to quality
specifications.
India had also stated that
a generic or
branded medicine not registered in a particular country, but
available in that country is not counterfeit but simply an
unregistered product.
The domestic drug industry
had also
expressed apprehensions over the WHO negotiations meant to bring
non-health issues that have no direct implications on the safety of a
drug within the ambit of the definition of "counterfeit medicine".
The industry had also said
the IMPACT
definition, if read with the EC Regulation, Article 2.1(c) of the EU,
could mean a serious threat to India's exports of pharmaceutical
products. The EC Regulation allows seizure of "counterfeit"
products even during transit. (Source: Business Standard)
August 12, 2008
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