Concerted action by all stakeholders on counterfeit medicines is the need of the hour.

The concern of some section of the stakeholders that IPR is being extended to the definition of counterfeit medicines, in my view, is misplaced. As even in India, ‘misbranding’ though an integral part of IPR, is considered as a public health issue and is an offence under Section 17 of the Drugs and Cosmetics Acts, 1940.Currently, the magnitude of this problem is anybody’s guess. Earlier a study sponsored by the World Health Organization (WHO) and conducted by SEARPharm reported that only 0.3% drugs were spurious and 3% of drugs were counterfeits. To scientifically assess the magnitude of this problem the Drugs Controller General of India (DCGI) India, for the first time ever, has initiated a study with 61 popular brands from nine therapeutic categories for testing 24000 samples. The study is expected to cost Rs.50 million and is expected to be published, soon.However, on the above study, Pharmabiz dated August 26, 2009 has reported the following:

“The Union Health Ministry’s ambitious nationwide survey to get an authentic estimate of spurious drugs in the country found no significant amount of spurious drugs in the pharmaceutical market. Among the 24,000 samples collected by the government for the survey, only around 10 were found to be spurious, it is reliably learnt.”

India being a part of ‘International Medical Products Anti-Counterfeiting Taskforce’ (IMPACT), established under WHO in 2006, decided to work together to combat the growing menace of counterfeit medicines. The Drugs Controller General of India (DCGI) was reported to have several discussions with the convenor of the IMPACT to effectively address the issue.

A study done by IMPACT in 2006 indicates that in countries like, the USA, EU, Japan, Australia, Canada and New Zealand the problem is less than 1%. On the other hand, in the developing nations like parts of Asia, Latin America and Africa more than 30% of the medicines are counterfeits. In South East Asia, estimated prevalence of counterfeit Artesunate for malaria is 33-53%.

It appears that in all those countries where access to modern medicines is poor, incidences of counterfeit medicines, ranging from anti-malarial, anti-hypertensive, anti-tubercular, anti-retroviral to cardiovascular and other life saving and life style drugs, are higher.

Apprehensions from some section of the generic pharmaceutical industry that attempts are being made by the interested groups to bring generic drugs under the purview of counterfeit medicines, is unfounded. Why should there be any such threat at all, when the world is witnessing the global pharmaceutical companies scaling up their generic business operations?

Incidence like recent detention in transit of DRL shipment of the generic version of Losartan in the Netherlands or a consignment of Amoxicillin at the Frankfurt airport on the ground of patent infringement cannot be considered as attempts of MNCs to brand Indian generic pharmaceuticals as counterfeit medicines. These drugs violated valid patents held in those countries prompting the local authorities to enforce the law of the land by detaining those consignments. India also has been detaining similar consignments for Nepal whenever those transit consignments violated the intellectual property laws of India. It will, therefore, be not fair to expect Netherlands or Germany to follow a different set of rules for goods in transit, when Indian law itself defines ‘imports’ covering goods in ‘transit’. Thus Government of India should take up this issue on a bilateral platform with the European Union (EU) for a desirable resolution to the problem. Meanwhile, to ensure that pharmaceuticals exports from India do not get adversely affected, Indian pharmaceutical exporters should ensure, till such issues are bilaterally resolved, that their export consignments for third countries transit through non EU routes.

Further, the incidence of fake drugs seized recently with made in India label and originating from China is indeed a fraudulent and criminal action of some irresponsible people who bring disgrace to humanity. Such incidences must be strongly condemned and be taken up by the Government India with the Chinese authorities effectively, to stop recurrence of such criminal activities in future.

The sales of counterfeit medicines across the world as estimated by the ‘Centre for Medicine in Public Interest’ will reach US$75 billion by end of 2010. This is an increase of over 90% as compared to 2005. A report from the WHO’s Executive Board in its 124th session indicated that the detection of counterfeit medicines in 2007 had increased to more than 1,500. This reflects an increase of around 20% over 2006 and ten times more compared to year 2000.

WHO indicated that in 2005-06 the volume of counterfeit drug seizures included 2.7 million articles and the main countries where these articles originated from India: 31%, UAE: 31% and China: 20%.

Enough data are available to establish that counterfeit drugs are posing a growing menace to the humanity. All stakeholders should join hands to address this public health issue, leaving aside petty commercial interests, be it generic pharmaceutical companies or research based pharmaceutical companies, across the world and India is no exception. Otherwise, thugs and criminals who are involved in this illicit trade of manufacturing and distributing counterfeit medicines at the cost of the innocent patients, will keep remaing almost scot free, forever.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion

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