New definition of fake drugs

A decision is expected by year's end on a new global definition of counterfeit medicines, aimed at saving people from harm and even death. But activists and Indian health ministers are resisting the change, claiming it comes from vested interests and threatens the nation's vast generics industry. India should ignore the conspiracy theories and seize the opportunity both to tackle counterfeit medicines and promote its generics industry in one fell swoop.

The definition proposed by the World Health Organization's International Medical Products Anti-Counterfeiting Taskforce (IMPACT) is enthusiastically supported by countries where people suffer terribly from counterfeit drugs, such as Gambia, Ghana and Nigeria.

The World Health Organization estimates that up to 20% of drugs sold in India may be counterfeit. Although the Centre denies this, fake and sub-standard drugs from India certainly plague many other parts of the world. This year a study in six African cities showed over a third of antimalarial drugs to be sub-standard. Of the drugs from Asia (principally India and China), 32% were sub-standard.

These rip-offs provoke suffering, death and drug-resistant strands of disease and they damage the reputation of good Indian generic drugs.

Real generics are legal and high-quality copies of drugs whose patent has expired. While India has over 20,000 drug manufacturers, mostly producing generics, large and competitive generics markets also exist in Europe, the USA and elsewhere.

The new definition of counterfeit protects all drugs, generic or patented, from any part of the world: it targets all fraud, from false trademarks to pills made of chalk and sawdust or worse.

Yet the Ministry of Health and Family Welfare is seeking amendments to the new definition, citing fears of "protectionism," with concurrence from the Drugs Controller General of India (DCGI) similarly worried about "barriers to entry" for internationally-traded Indian drugs.

Both cite terms in the new definition such as "history" and "source" as being vague enough to lead to Indian generics being blocked at foreign borders. Yet the definition can only bar drugs culpable of "false representation"--and it seems reasonable that no drugs, from anywhere in the world, should be falsely represented. By backing this definition, India can raise the standards and reputation of its drugs.

Critics of the new definition also oppose the removal of the condition that a drug must have been "deliberately and fraudulently" misrepresented in order to be called a counterfeit: they argue that counterfeits should not be linked with badly made medicines.

Yet it is impossible to separate the problems of "counterfeit," "spurious," "sub-standard," or trademark-infringing drugs in this way because counterfeits are always sub-standard and because legal but sub-standard drugs do not include the correct ingredients either: neither does what it says and both will be at best useless and at worst harmful or deadly.

Furthermore, protecting brands from counterfeiting is the best way of increasing standards: people choose recognisable and dependable brands, so companies fight to create and maintain a high reputation and to close down imitations.

Only trademark laws and effective courts allow manufacturers to protect their brands. An environment that permits trademark violation creates opportunities for faking. All drugs that are falsely represented or spurious in any way must be recognised as counterfeit, whether they offer falsified trademarks, fake contents or badly-made contents.

Without this protection, there is little incentive to produce high quality drugs, as another manufacturer can simply copy your brand with a cheap imitation and undercut the price.

Similarly, strong civil and criminal law, reinforced by a vigorous independent press, allows individuals to seek redress from producers of medicines that do them harm--another deterrent to sub-standard manufacturers.

The regions of the world with the lowest levels of counterfeit and sub-standard drugs--Europe and the USA--are those with the rule of law, low corruption and good trademark laws.

But oft-cited activist Gopa Kumar from the Indian Centre for Trade and Development has stated: "Counterfeiting is an issue of trademark violation and has no bearing on public health." This is ridiculous, as countries that allow trademark violation are by definition allowing sub-standard products of all kinds, and sub-standard drugs have a terrible effect on public health. The idea that someone would fake a trademark but still produce a high quality product is laughable.

India's huge production of generic drugs could be a great benefit to its people, its economy and the world as a whole. High competition drives down prices, offering affordable drugs and improving health. But these drugs must be of high quality or they do harm instead. India must not let bad manufacturers bring down the quality of its drugs and its reputation.

With its free and critical media, India (unlike China) is already halfway there, because bad products can be denounced and customers warned.

Government and regulation cannot force every manufacturer to produce high quality drugs, nor can an edict from IMPACT protect the world from counterfeits, but the new definition will help India reinforce a business and legal environment conducive to high-quality medicines--and high-quality growth.

Julian Harris is a Research Fellow at International Policy Network, London, an international development think-tank.