The Indian Central Drugs Standard Control Organisation (CDSCO) made the comments after a report on indiatoday.in suggested that – based on research by the World Health Organisation (WHO) – as many as 20 per cent of the drugs sold in the country are fakes.
The CDSCO said that: “The issue was taken up with the WHO representative to India. The WHO has clarified their letter (no WR/D.7 dated 31 August, 2012) denying [that] such [a] study [was] conducted by WHO regarding fake drugs menace in the past several years.”
In the response letter, which was posted on the CDSCO’s website earlier today, WHO India Representative Nata Menabde said: “The figures quoted by media range from 10 per cent to 25 per cent of drugs sold in the country being spurious drugs” adding that “these are totally unsubstantiated reports.”
Menabde also said an oft quoted ‘report’ indicating 35 per cent of the world’s fake drugs come from India (examples of which can be found here and here) does not exist, explaining it “has neither confirmed its [the report’s] authenticity nor did hint the source of such figures.”
The CDSCO's most recent report on fake drugs in India - published in 2009 - indicate that 0.3 per cent of drugs circulating in the country are counterfeit.
in-Pharmatechnologist.com asked the CDSCO for its latest figures, but the organisation did not respond ahead of publication.
Definition difficulties
The publication of the WHO letter comes just a few months after a report by Indian Parliament's Standing Committee and Health and Family Welfare suggested that international pharmaceutical manufacturers are trying to make it appear that India is the source of more fakes than it actually is.
In the report the Committee cited CDSCO data and said that: "The prevalence of spurious drugs in India is less than 0.5 per cent as against the allegations by MNCs [multinational companies] of 25-30 percent.
"The MNCs are deliberately confusing the issue by clubbing and interchanging ‘spurious’ with 'counterfeit' drugs. The Indian definition of counterfeit refers to the unauthorized use of a registered brand name, even when the product is of acceptable quality. The Western definition is far wider and includes the so-called 'generic' medicines manufactured by anyone other than patent holders without innovators permission, even when there is no valid patent in India.
"If the medicines are of high quality and legally produced in India, they are still dubbed as 'counterfeits' by innovators in the West."