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New definition of fake drugs could save the day for local companies
The risk of India’s generic drugs being labelled counterfeit under the new definition proposed by WHO has receded, a government represe
ntative concerned with the issue said. This would ensure that India’s manufacturers continue to sell their drugs in foreign markets.
The WHO-funded International Medical Products Anti-Counterfeiting Taskforce (IMPACT) had proposed a new definition of counterfeit drugs as medical products with a “false representation about their identity, history or source”.
India bats for generics, seeks clarity on counterfeits
In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.
Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.
At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.
India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.
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In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.
Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.
At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.
India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.
Indian drug companies are largely producers of generic drugs or medicines that are chemically similar and are as efficacious as an innovative medicine. And India’s stance at the WHA brought cheer to the local industry, as they feared that the expanded counterfeit definition could be used as a non-tariff barrier against medicine exports from India.
WHO Counterfeit definition worries Pharmas
The domestic drug industry is concerned over ongoing World Health Organisation (WHO) negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine".
The industry feels that a proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to consider apparent "trademark violations" as "counterfeiting" cases would harm exports of generic drug makers.
If the changes do go through, they say, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets.
Today, Indian firms have several brands that sound similar to those
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The domestic drug industry is concerned over ongoing World Health Organisation (WHO) negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine".
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</script>The industry feels that a proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to consider apparent "trademark violations" as "counterfeiting" cases would harm exports of generic drug makers.
If the changes do go through, they say, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets.
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Currently, this would at the most be treated as a trademark violation. However, according to the definition proposed by IMPACT, the Indian product could be rejected as counterfeit, the sources explained.
This attempt to widen the definition of counterfeit medicine is happening at a time when a deliberate attempt is being made to label India as a major source of counterfeit medicines.
Indian companies, increasingly dependant on exports of cheap off-patented medicines to developed markets to drive business growth, will find this a major problem, the sources said.
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