New Delhi: India’s suggestions to modify a new definition of counterfeit drugs proposed by an international task force have been accepted.
A new draft by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), a World Health Organization (WHO) initiative, was agreed upon by the 24 attending countries including the US, the UK, Canada, countries from the European Union, Brazil, Tanzania and Ghana, and WHO representatives.
Well defined: Surinder Singh, drugs controller general of India. Madhu Kapparath / Mint
A final decision will be taken in May 2009 at a world health assembly meeting. Before that, the draft will need approval at a WHO meeting in Tunisia this month and a WHO executive board meeting at Geneva in January 2009.
Indian manufacturers and officials had raised concerns on the ground that the proposed definition could deter access to legitimate off-patent or generic drugs. They had argued that a new word—history—that was inserted into the definition was ambiguous and could be used as a market barrier by some countries.
“In the conference in Bonn, we found that among the members, there were three different interpretations for ‘history’ after a deliberation of 15 minutes. This is what we highlighted. Every word in the definition has to be...well defined. India’s apprehension on this was well placed. The word has now been dropped in the final draft of the IMPACT definition,” said Surinder Singh, drugs controller general of India.
Indian officials also argued against the term “false representation,” which allowed quality defects and system errors in manufacturing to be tagged as counterfeiting.