[Ip-health] NGOs Urge Govt. to boycott WHO's IMPACT meeting

[Sangeeta]

NGOs urge govt to boycott WHO meeting on definition of counterfeit drugs

Monday, November 17, 2008 08:00 IST
Ramesh Shankar, Mumbai

The NGOs working in the health sector have urged the government to boycott
the meeting called by International Medical Products Anti-Counterfeiting
Taskforce (IMPACT) of the WHO to discuss the issue of giving a new
definition to counterfeit drugs. The NGOs alleged that this is an attempt by
the big multinational companies to prevent the Indian generic drugs from
going to different parts of the world.

DCGI Dr Surinder Singh and joint secretary in the Union health ministry
Debashish Panda are to attend the meeting to be held in Germany on November
24 and 25.

Questioning the legitimacy of the IMPACT in changing the definition of
counterfeit drugs, the NGOs said that counterfeit is not an IPR issue and
this is basically a quality issue which should be discussed in the World
Health Assembly.

The NGOs also raised this issue at a government-industry meeting convened by
the Union health ministry on November 14 to discuss WHO's proposal to give a
new definition to counterfeit drugs which the ministry had earlier turned
down due to the resistance of the Indian drug industry. All the major
industry associations like IDMA, IPA, FOPE, SPIC, CIPI, etc participated in
the meeting.

The industry pleaded with the government that the new definition will act
against the Indian drug industry, especially the generic drug manufacturers
as the new definition considers apparent 'trademark violations' as
'counterfeiting' cases. The Indian drug manufacturers, especially the small
scale sector, are concerned over the WHO proposal as they fear the efforts
would be another attempt by the big multinational companies to kill the
Indian generic drug makers.

As per the proposal by the IMPACT, apparent 'trademark violations' will be
considered as 'counterfeiting' cases which the Indian drug makers said would
harm exports of generic drug makers.

The current definition of WHO says counterfeit drugs are 'medicines which
are deliberately and fraudulently mislabeled with respect to identity or
source. Counterfeiting occurs both with branded and generic products and
counterfeit medicines include products with the correct ingredients but fake
packaging, with the wrong ingredients, without active ingredients or with
insufficient active ingredients'.

The definition proposed by IMPACT removes the clause 'deliberately and
fraudulently' and replaces it with 'a medical product is counterfeit when
there is a false representation in relation to its identity, history, or
source'. It also says that 'this applies to the product, its container,
packaging or other labeling information'.

IMPACT also wants to see that WHO definition on counterfeiting 'can apply to
both branded and generic products and include products with correct
ingredients/components, with wrong ingredients/components, without active
ingredients, with incorrect amounts of active ingredients, or with fake
packaging'.

 http://www.pharmabiz.com/article/detnews.asp?articleid=46996&sectionid=&z=y
<http://www.pharmabiz.com/article/detnews.asp?articleid=46996&amp;sectionid=
&amp;z=y>