The far cry against the WHO's attempt to give a new definition to counterfeit drugs is mounting day by day. Close on the heels of the Indian industry expressing concern over the WHO proposal, an international humanitarian medical aid organization Medecins Sans Frontieres (MSF) has urged the Indian government to keep away from the developed countries' deliberate attempt to confuse the two totally different issues of substandard drugs and counterfeit drugs which is designed to trap the legally manufactured generic drugs from developing countries under the definition of counterfeiting.
"By confusing the issues of counterfeit medicines and substandard medicines, WHO and governments are attacking the wrong problem, which does nothing to improve the quality of medicines, which is a far greater public health concern. Counterfeit is a trademark and IPR issue that should not be confused with quality issues," MSF's project manager for India Leena Menghaney said.
In a letter to Union health minister Dr Anbumani Ramadoss, the MSF urged the Indian government to project a true picture in this regard at the forthcoming international meeting called by IMPACT of the WHO on giving new definition to counterfeit drugs. India's role at these negotiations will strengthen negotiations by developing countries to prevent such trade barriers from being created.
DCGI Dr Surinder Singh and joint secretary in the Union health ministry Debashish Panda are scheduled to attend the meeting to be held in Germany on November 24 and 25.
The MSF is seriously concerned that legally manufactured generics could fall under the definition of counterfeiting being proposed under international resolutions, agreements or treaties. Indeed the 'Anti Counterfeiting Trade Agreement (ACTA)' negotiations are being conducted with little participation from developing countries.
In addition, the anti-counterfeit issue also needs to be seen in the context of moves by the European Union and other developed countries to strengthen intellectual property enforcement. One such mode of enforcement is to amend regulations that govern practices by customs authorities towards counterfeit goods across the globe. In conjunction, this could lead to customs authorities, seizing or delaying the transit of legitimate generic medicines, on suspicion of being 'counterfeit'.
As a consequence, there is a risk that life-saving essential medicines imported from India may be banned or held up, such as those used by Médecins Sans Frontières in African countries to treat people living with HIV/AIDS. The consequences on access to life-saving medicines and on the sustainability of AIDS and other treatment programmes that rely on generic production or importation would be devastating, MSF warned the Indian government.
MSF currently treats 1.4 lakh people living with HIV/AIDS in 27 countries including India. Most of the patients in MSF's treatment programmes are receiving affordable generic medicines manufactured in India that allow the MSF to treat the largest possible number of people. Access to affordable medicines is therefore key in making life-extending treatment available to more people who need it.