A report prepared by the London-based International Policy Network (INP) could be greatly responsible for shaping the anti-Indian generics policy mindset that many of the African countries have either adopted in recent past or are in the process of adopting. This report, ?Keeping it real: combating the spread of fake drugs in poor countries?, is learnt to be in wide circulation among the African countries and is being referred to. The governments of these countries conclude that India and China seem to be the largest producer of fake medicine.
It infers so on the basis of estimates derived from various secondary sources such as European Commission, The Associated Chambers of Commerce and media reports.
A 2004 survey of medicines on sale at a large bazaar in New Delhi found that only 7.5% were genuine. A report in a newspaper said that fakes are freely sold to exporters who sell them to unsuspecting health administrators in Sub-Saharan Africa, who receive some of the millions in aid money. The bazaar being reported about is Bhagirath Palace market, Chandni Chowk and the survey referred to was reportedly conducted by Delhi Medical Association with a size of 53 samples. Industry players are also questioning the definition of the word being used ?genuine?, which could be different from spurious, fake or counterfeit. When contacted, the president of DMA Naresh Chawla told FE, ?Although we have been running a crusade against medicine quackery for a decade now, we do not test samples and pronounce verdicts. This is the jurisdiction of Drug Controller General of India and if at all this data has been tested, it couldn?t have been by DMA.? On the definition of ?genuine?, Chawla said that there are three parameters which are taken into consideration by DMA while deciding on the factor of genuineness -firstly on quantity and purity terms, if a drug promises 500 mg of a specific constituent and gives 450 mg, it would be termed non-genuine, secondly on constituent terms, for instance whether a specific salt in the drug has been substituted by simple glucose powder and thirdly misbranding, for instance claiming to be a Cipla drug when it is actually not manufactured by Cipla. Allying fears of the industry that DMA could have mixed patent issues in its definition of ?genuine?, Chawla categorically said, ?Patent and counterfeit are exclusive and separate matters and have no links.?
The IPN report also quotes European Commission to show that 75 % of counterfeit drugs are being imported from India, home to around 22,000 small drug producers, many of which are informal. The Associated Chambers of Commerce and Industry of India estimate this market is growing by 20-25 % per annum, it further says. However the report released in May 2009, makes no mention of the periodic health ministry estimates, which put spurious drugs estimates at less than 0.5%.
The IPN study has been co sponsored by Centre for Ethics and Technological Development, Nigeria Free Market Foundation, South Africa IMANI Center for Policy & Education, Ghana Initiative for Public Policy Analysis, Nigeria Institute for Free Enterprise, Germany Institute of Public Affairs, Australia Institute of Public Policy Analysis, Zambia among others.
Amidst Indian pharma industry?s allegations that the entire Africa issue could be part of a the larger ploy of big pharma companies to grab an important market-Africa from the Indian generic players, some industry members have floated the idea that the Indian government should investigate the funding pattern of the sponsors (mainly NGOS) of the study to either allay their fears or confirm such doubts. The Department of Pharma has taken note of the report already and has discussed the matter with industry stakeholders in a meeting on Wednesday.
The report also criticises India for blocking anti-counterfeit measures at world forums such as WHO?s anti counterfeit task force IMPACT in the report while Indian players have maintained all along that they have been protesting against linking patent infringement with the definition of ?Counterfeit? at the forum. A draft policy on anti-counterfeiting, anti-piracy, and intellectual property rights (IPR) violations is in the process of being adopted in many African nations like Tanzania, Rwanda, Burundi, Libya. This draft policy is on the lines of recently- passed anti-counterfeit bills in Kenya and Uganda, which link the definition of low-cost versions of branded drugs with that of counterfeit drugs. According to Pharmaceutical Export Promotion Council estimates,Africa accounts for 15% of the total Indian pharma exports pie, valued at $1.12 billion approximately.
