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New Delhi: The ministry of health and family welfare has sought amendments in the new definition of counterfeit drugs as proposed by International Medical Products Anti-Counterfeiting Taskforce, a World Health Organization, or WHO, initiative, over concerns that it may create barriers to the access to legitimate off-patent or generic drugs.

A decision on the definition is likely to be taken next month.

The task force defines a counterfeit drug “when there is a false representation in relation to its identity, history or source. This applies to the product, its container, packaging or other labelling information". Counterfeit copies, which it says covers both branded and generic products, “may include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging".

Such a wide-ranging definition was not acceptable to India, a senior health ministry official said. “As on date, we do not accept the proposed definition and India will be pressing for modifications in it at the WHO meeting at Bonn in November," said this official with knowledge of the development, who asked not to be identified since India has not yet presented its view before the WHO body. Brazil and South Africa endorse India’s stand and last month, New Delhi received support on the issue from the countries in the South-East Asia region.

India’s drugs quality regulator, the Drugs Controller General of India, or DCGI, in a note prepared for a meeting with health ministers of Brazil and South Africa in July, argued that the new definition put forward by the task force was vague. “...besides clubbing ‘substandard’ (drugs) with counterfeit (drugs), (the definition) adds a new dimension to the existing definition by inserting the word ‘history’ without being specific," the note said. This has raised concerns among public health activists and generic drug makers that such a definition might be used as a market barrier by some countries.

India is suggesting changes in definition, a second official at the ministry added. Besides India, Thailand, Brazil, Argentina, Venezuela, Chile, Sri Lanka, the Maldives, Cuba and Bangladesh have spoken against the task force’s definition. The health ministry has not only sought amendments in the definition, but also urged developing countries to unite and take initiative for proper definition of counterfeit medical products. “(Else), the developed countries will succeed in creating new barriers to access by clubbing legitimate generics with counterfeits," the DCGI note said.

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