[Ip-health] Indian SMEs concerned with WHO's definition on counterfeit

[Sangeeta]

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SPIC urges govt to safeguard export business of SME units while reframing
counterfeit definition

Friday, November 21, 2008 08:00 IST
Joseph Alexander, New Delhi

Joining the issue of redefining the counterfeit drugs which has already
drawn more flak than support from across the industry and public interest
groups, the small and medium scale pharma sector has expressed apprehensions
of facing major setbacks to their exports if India buckled under the WHO
pressure to accept the new definition.

The SME Pharma Industries Confederation (SPIC), in a letter to the health
department officials, called for safeguarding the export interests of the
SME sector by excluding the trademark violations issue from the ambit of the
definition. The move under the pressure from the WHO was described as an
attempt to put up barriers for the generic drugs and the SME units surviving
on exports to developing and underdeveloped countries would be hit harder,
SPIC vice chairman Lalit Kumar Jain said.

SPIC has urged the government to drop the words 'correct ingredients
(components)' and exclude drugs already approved by the regulatory
authorities in the country of origin from the original definition. "A
medicine/a medical product (medicine, vaccine, diagnostic or medical device)
is counterfeit when it is deliberately and fraudulently mislabeled with
respect to its identity and/ or source. Counterfeit can apply to both
branded and generic products. Counterfeit includes [components], with wrong
ingredients, without active ingredients, with incorrect amounts of active
ingredients, with fake packaging, or not approved by the regulatory
authority in the country of origin," it said.

"A counterfeit can be defined as an imitation designed to deceive or
defraud. With the deletion of words with correct ingredients, separates the
quality issue and trade issue of copyright. Issues of compulsory licensing
as per Doha round can not be overlooked and the government rights of
compulsory licensing would be intact since with this definition it does not
include the matters relating to Trade mark. It means the medicine resembling
with other medicine in design, colour and shape but containing same active
ingredient and used for the same purpose shall not be covered in the
definition of counterfeit," SPIC letter said.

The definition should not involve transit problems through developed/third
countries. WHO is concerned only with the question of quality and since the
quality apprehensions of IMPACT have been address to, WHO should not exceed
its jurisdiction of WTO, which is a body concerned with the trade issues.
When the quality issue has been addressed in the amended definition, the
trade issue if any can be taken up in WTO, the association suggested.

The addition of 'words or medicine not approved b y the regulatory authority
of the country of origin' would stop supply of all products by
multinationals to developing nations which are not approved in their own
country. This will boost Indian exports to developing countries, SPIC said.
http://www.pharmabiz.com/article/detnews.asp?articleid=47069&sectionid=&z=y
<http://www.pharmabiz.com/article/detnews.asp?articleid=47069&amp;sectionid=
&amp;z=y>



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