Boycotting WHO definition on counterfeits

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Vijay

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E-DRUG: NGOs urge govt to boycott WHO meeting on definition of

counterfeit drugs

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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'.

Source:Chronicle Pharmabiz, Monday, November 17, 2008, Mumbai

Regards,

Habeeb

India

habeebibrahim_ar@...