There are two types of “so called” medicines which are seriously endangering medical treatment. One is the spurious medicine and the other is counterfeit medicine. Spurious medicines are those in which there is no active ingredient and the sample will fail when tested in the laboratory, thus it will cause injury to the patient, whereas counterfeit medicines present a different problem in that they contain the medicine that has been mentioned on label and the given sample will pass the laboratory test. Thus spurious and counterfeit medicines are not synonymous with each other but often tend to be used for all medicines that are not up to the standard or just labelled as fake drugs.
The problem of spurious and substandard drugs in the country is quite rampant, as is evident from periodic reports in the media on seizures and confiscation of fake drugs from large consignments or godowns. These, however, would constitute only a small fraction of the real extent of the illegal activity, which perhaps is no different from the extent of counterfeit trade in other commercial products.
According to Frost & Sullivan analysts, the business of selling fake drugs is a burgeoning global industry, estimated to grow 13% a year to reach $75 billion by next year, a 92% increase from 2005. World Health Organisation (WHO) estimates that as much as 10% of the world’s drug trade–25% in poor countries–consists of fake medicines. In India it is estimated that fake allopathic as well as homeopathic medicines are estimated to occupy between 15 to 20% of the `40,000 crore Indian pharmaceutical market. The extent of fake drug market in India has been hugely controversial as will be mentioned below.

Recommendations by government
Several reports have been submitted and recommendations have been made on this issue, as Indian drugs are even exported to several countries including USA and few European countries as well. One among them is the Mashelkar Committee, in the year 2003, which studied the various aspects of the growing threat from spurious drugs, submits an interim report recommending stringent punishment for offenders. In addition more controversies spring from this report as well. According to Mashelkar report, the figures quoted in the media and by different sources on the extent of spurious drugs have varied from 0.5 per cent to 35 per cent. Obviously, on the basis of the wide variation, the data are unreliable. The lower limit is based on the samples tested by the State authorities for the period 1995-2003. The upper limit is from a report in the medical journal Lancet in 2001 by an Indian journalist, ostensibly based on WHO figures, which had claimed that 35 per cent of world’s counterfeit drugs came from India, the fake drug market of which itself was over `4,000 crores (about 20 per cent of the total turnover).
WHO, however, wrote to the committee on August 11 - just a day before the report was released - clarifying that there was no study conducted by WHO that had said that 35 per cent of world’s spurious drugs are produced in India. Interestingly, the WHO letter went on to add: “The Indian pharmaceutical market, with annual sales ranging between $7 billion to $8 billion, ranks third in the world, and the majority of the Indian pharmaceuticals are produced by large manufacturers according to WHO, follow Good Manufacturing Practices (GMP)!” It could be noted that these figures differ from the government’s own figures.
Even before the Mashelkar report there was Lentin Commission Report in 1986, which examined the case of 14 patients having died of acute renal failure at the J. J. Hospital in Mumbai after being administered glycerol adulterated with diethylene glycol.
It was found that the adulterated glycerol which is meant for industrial use was supplied by Alpana Pharma, whose tender to supply had been accepted by the Tender Committee, in gross violation of several rules of acceptance of tenders. In addition, Chem Med Lab had given a quality control report stating the drug to be of standard quality without even conducting the requisite tests. And most horrendous of all, even after the killer drug was more or less identified, it continued to be administered due to negligence of those concerned.
Prior to the publication of the Lentin Commission Report, the state Health Minister, resigned saying the Commission had drawn unpermissible conclusions. In an unprecedented show of solidarity, MLAs from the opposition and the ruling party joined hands in criticising the Lentin Commission’s findings regarding the role of the politicians in the glycerol scandal. Indeed one opposition MLA even raised a notice of breach of privilege against Justice Lentin. However the Lentin Commission has at last made public what was always suspected - the rot which has set in the public health care system and the drugs administration, and the corruption of high-level officials, ministers and the drug industry. This particular incident highlights the nexus between our politicians and the spurious drugs manufacturing companies and explains as to how the problem of spurious medicines is ingrained within the Indian politics.
In spite of these reports nothing much has changed, as far as regulations of spurious drugs, except few cosmetic changes here and there.
But spurious drugs are not just in the realm of national politics as there are also international players in it, as explained below.

WHO and counterfeit medicines
IMPACT is an acronym for International Medical Products Anti-Counterfeiting Taskforce, created by WHO in the year 2006, to counter the global menace and danger of counterfeit medical products. Counterfeit medicines play havoc on people’s health, including causing harmful effects and in worst scenario even death. Everything looked fine and good but the intentions behind IMPACT do not appear to be simple and seem to be more than what they appear.
During March last year, the Netherland government seized medicines that were being distributed to Nigeria from India. What made the authorities seize the drugs? The Dutch authorities claim that these products are patent protected in the Netherlands and thus were labelled as “counterfeits”. These were life saving medicines and their deprivation would have jeopardized the lives of many HIV/AIDS patients in Nigeria. Again the seizure of medicines by Dutch authorities was not an isolated incident. The seizure was the latest episode in a series of abuses of European Union regulations, which enable customs authorities to seize medicines in-transit suspected of infringing certain intellectual property rights. In February this year again, Dutch authorities seized a shipment of a cardiovascular medicine (Losartan) destined for Brazil and last year there have been at least 14 other documented cases. These seizures are particularly threatening the health care systems of developing countries that rely on generic medicines to legally provide affordable health care to poor people.
During the World Health Assembly, at Geneva during May 2009, the issue was raised by developing countries over the definition of “counterfeit”, as designated by IMPACT. The highlight of the World Health Assembly discussion was that IMPACT and its definition of counterfeit was being misused and abused by the drug industries in the rich countries (brand companies) to prevent medicines being transported and shipped by drug industries in developing countries (generic industries). Most brand drug companies claimed that the medicines seized by the Dutch authorities, were indeed “counterfeit”, because these medicines were patented in the country that it was transiting through, i.e. the Netherlands in this situation. But the claim by the generic drug manufacturers that these medicines were meant for use in another country that is Nigeria in this situation and not meant for use in the country that it was transiting through. So also states international trade law. This statement by generic companies has received support from global civil society members and from country heads of India, Brazil, Kenya, Bangladesh, South Africa and several other developing countries, during the World Health assembly.
The reason behind the discussion at WHO can be traced to the fact that Indian generic drug industries has made an impact globally as the supplier of affordable and life saving medicines to around 200 developing countries. Rightly Indian generics have been called “Pharmacy of the developing countries”. And this particular success of the Indian generic drug companies has neither been liked by the brand drug companies (most of them situated in USA or Europe) nor by the developed countries alike. And consequently the brand drug companies along with the developed countries continue to support the work of IMPACT and thus push hurdles to access to life saving medicines in developing countries. This attempt by the developed countries and the brand drug companies to create hurdles for accessing medicines to the developing countries is not new and has been done on several occasions.
The current crises of IMPACT and WHO has been resolved as a resolution has been passed that emphasised that WHO should restrict itself to public health issues only and that intellectual property or trade issues will not form part of its concern. But this is only a temporary truce.

What needs to be done?
It is obvious that the problem of spurious drugs can only be addressed if there is a political will to uproot the problem with stringent measures that is demanded by the people. It’s only when people demand a new visionary and committed political system and support, in which the needs of the last person in the society are taken care of, will we be free from the heinous and monstrous problem of spurious medicines.

The writer is a medical post graduate. He is currently the President of Drug Action Forum - Karnataka (DAF-K), Co-convener of All India Drug Action Network (AIDAN), founder member and current office bearer of grass root organisation JAGRUTI. He is also honorary member of Healthy Skepticism, Australia and Health Action International - Europe (HAI Europe).

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