HOW BIG IS THE 'FAKE DRUGS' PROBLEM?

There are frequent stories in both local as well as international media about ‘fake’ medicines being a huge menace in India. However, the International Dispensary Association (IDA), one of the largest non-profit procurers of medicines, which procures 70% of medicines that they distribute in 130 countries insists that Indian companies produce medicines that meet the highest quality standards. Does that mean that no fake drugs are produced in India?

It might not be that simple. 
What it indicates is that IDA with its stringent quality checks and procurement mechanism identifies companies that produce high quality medicines, mostly generics, and procure from them. What it indicates is that that there are enough drug manufacturers in India capable of producing medicines that meet international standards of production processes and quality. This only goes to show that if there are producers of fake or sub-standard drugs who manage to get their products into the market in India, it is a because of the failure of the regulatory system in India to identify such companies that make them and shut them down.


The Central Drug Standards Control Organisation (CDSCO), the drug regulatory authority of India conducted a nation-wide survey in 2009 to put to rest these allegations of huge proportion of fake drugs being made in India. During the survey, over 24,000 samples were collected from all over India and tested. It was found that only 11 samples or 0.046% were spurious. An earlier survey funded by the World Health Organisation (WHO) and undertaken by the International Pharmaceutical Federation, a global federation representing three million pharmacists and pharmaceutical scientists worldwide, lifted and tested of 10,000 samples. In that survey 3.1% of drugs were found to be counterfeit. But counterfeit could just mean that they were copies of branded drugs. It does not mean that the ingredients in the drug were substandard or fake.

These very low figures are a far cry from the ?gures quoted by media which range from 10% to 25% of drugs in the country being spurious drugs. “These are totally unsubstantiated reports.  For example, on the basis of an alleged WHO report, the media frequently reports that 35% of fake drugs produced in the world come from India. However, when enquired, WHO has neither con?rmed its authenticity nor did it hint the source of such ?gures. WHO Representative in India has clari?ed that there is no actual study by WHO concluding that 35% of the World spurious drugs are produced in India. He has also regretted that occasionally some individuals in the media and the organizations use WHO references incorrectly and even irresponsibly,” stated the CDSCO report. Despite such clarifications from the WHO, the media continue to repeat this figure.

“If 20- 25% of the medicines were fake, then every fifth, if not fourth medicine medicine sold would be fake. In that case, we should be seeing a lot more deaths,” points out Dr C M Gulhati, editor of the Monthly Index of Medical Specialities (MIMS) who rubbishes these high estimates as figures which are not backed by any reliable data. In fact, for an excellent article about the whole issue of fake drugs in India written by Dr Gulhati, you can google “Fake Drugs in India: Points to ponder”. It lays bare the entire issue in simple language.

Clearly, the problem is not as bad as it is made out to be. However, the problem does exist and its severity differs from state to state. Indian pharmaceutical industry comprises 250 large units and about 8000 small scale units. Regulating such a large number of units is not easy. “Being a clandestine activity, it is difficult to assess the actual quantum of spurious drugs,” admits the CDSCO office but adds that a study of samples tested all over the country during the last 10 years reveals that about 0.2%- 0.4% fall within the category of spurious drugs.

While most manufacturers might be above-board and well intentioned, a small section seems to be engaging in rogue practices and getting away with it. A national-level scientifically structured large sample collection and testing is urgently required, says Dr Gulhati.

Organisations like the Tamil Nadu Medical Services Corporation Ltd, which procures essential drugs and medicines for the state's government health facilities, tests the quality of drugs it procures and regularly blacklists companies whose products do not meet standards. But there seems to be no punitive action against such companies beyond blacklisting like suspending or permanent revoking of their licence. It is a pity that the actions of a small section of the industry is being allowed to sully the reputation of an industry that is catering to the medical needs of the country and also helping to make India the pharmacy of the developing world.