The rise of the superbugs
What are the best possible strategies available for tackling this new ultimate breed of pathogens? That's the million-dollar question the physicians are faced with
By Aziz Omar
Hippocrates, the famous physician of ancient Greece, is credited to have been the pioneer in the field of medicine. He successfully identified ailments as being independent from the body and developed means of classifying them according to their symptoms. Twenty-three centuries later, the English naturalist Charles Darwin proposed the Theory of Evolution. Though still facing controversy, evolution based on natural selection and mutation has been widely applied on the emergence of all life on earth from unicellular origins. Natural phenomena have been deemed responsible for diversifying organisms over a period of roughly 4 billion years. But, since the use of synthetic drugs became widespread in the early 1900s, humans have triggered their own version of evolution in their microscopic enemies.

The drug edicts
Lack of a proper monitoring system has encouraged those dealing in spurious medicines
By Javed Aziz Khan
Could there be anything more disgraceful than the act of packaging substandard salt as life-saving drugs? The answer to this sure lies in the price the common man has to pay. But, for the government, the network formed by those dealing in spurious medicines remains an issue that hasn't been effectively dealt with, yet.

A decade and a half later, there are certain areas where we feel we fall short. For instance Pakistan is yet to establish itself as an exporter of medicines in the international market. We also import a substantial amount of raw material. And there are tough times ahead after the implementation of WTO regime. Then companies all over the world will get a chance to have their medicines patented and enjoy perfect monopolies in the international market. No one else will be able manufacture these medicines till the patents expire after 20 years. Cheap generic alternatives would not be available anymore.

The debate about the strength and weakness of the industry apart, consumers are rubbed the wrong side in more than one ways. A local NGO that has worked extensively on the safe use of drugs has alarming statistics. Around forty to fifty per cent of medicines available in Pakistan are counterfeits and Pakistan ranks thirteenth in the world on account of production and sale of counterfeit medicines.

The profit motives are merciless to say the least. The consumer pays a huge price not on account of R&D as we are made to believe but on account of the enormous marketing costs involved. Both local and multinational companies engage in malpractices to influence doctors by offering commissions, gifts, foreign trips etc.

The medicines are pacakaged in a way that, in many cases, the consumers have to buy an extra bottle or pack of medicine but they are only required to consume only ten per cent of it as per prescription.

Enough questions there for the pharmaceutical companies to answer. But are they willing to do so?

Pakistan lacks in sufficient healthcare facilities to cater to the needs of its entire population. To put it like it is, the country does not have a credible healthcare system at all. Although some health facilities are available to the public in urban centres, the situation is next to pathetic in rural areas where the common man cannot boast even the most basic facilities. According to a report, only one doctor is available for 1310-odd patients in Pakistan. This, evidently, leads to an increase in death rate.

The Economic Survey 2005-06 indicates that the government spends only 0.51 percent of the total Gross Domestic Product (GDP) on health. The federal government has allocated an amount of Rs 4.72 billion for the health sector in the annual budget 2006-2007 and most of the expenses were spent on the administrative cost to run government hospitals where there are no adequate healthcare facilities. available

It appears that the availability and affordability of essential drugs is a major challenge faced by developing countries like Pakistan. A World Health Organization (WHO) estimate shows that currently one-third of the world's population lacks access to essential drugs and that over 50 percent of the people in the developing countries in Africa and Asia do not have access to even the most basic of essential drugs.

In developing countries, 25 to 65 percent of total health expenditure is spent on pharmaceuticals, and their official health budgets are generally too low to purchase enough medicines, with the result that the poor often cannot afford them on their own. Drug pricing is often the most important factor restricting poor people's access to medicines.

The situation in Pakistan is not different from that of other developing countries. The health sector is given the least priority in the country. In recent years, health and education have seen only token increases in allocations in the annual budgets. When calculated in terms of increasing inflation rate, this rate is quite meagre. In this situation, the prices of medicines have put a heavy burden on the pockets of the average income people. Even though the government claims that it has frozen the prices of essential drugs for many years to come, the rates of medicines are only skyrocketing.

It is the Health Ministry that controls the prices of pharmaceutical products but due to widespread corruption in its departments, the government has failed to control prices, and the companies are minting money.

The drug manufacturers, particularly the multinational pharmaceutical manufacturers, have been pressing on the government to adjust the prices of medicines in line with the prevailing rate of inflation, which is above 7 per cent. Since 2004, the government has been following the policy of uniform pricing on the basis of molecule to both the local and multinational companies, through an eleven-member Prices Recommendatory Committee that recommends the prices for fixation to the government.

Pakistan's pharmaceutical manufacturing industry can be broadly classified into two major groups -- multinational and local. According to the government statistics, there are about 316 pharmaceutical manufacturing companies in Pakistan that include 30 multinationals. Although the local companies are in large numbers, the market share of multinational companies is about 47 per cent.

The local Pakistani pharmaceutical companies started growing in the 1960s. But, for the last decade with substantial investments on the production facilities and latest technologies they have made big progress and introduced many new products of high quality that previously were either unavailable or available only on a limited scale at very expensive prices.

"Pakistani pharmaceutical companies by providing quality medicines at economical rates have contributed substantially towards public health," claims Dr Qaiser Waheed Shaikh, Chairman Pakistan Pharmaceutical Manufacturers Association (PPMA), talking exclusively to TNS.

He adds that the key to success for our pharmaceutical companies is based on a simple formula which is to produce high quality product at modern CGMP compliant facilities and offer them at most economical rates.

"Nearly all the leading pharmaceutical companies of Pakistan have maintained high standards to ensure that all operations of production and quality control comply with the CGMP guidelines and are now successfully exporting their products to various international territories," he says.

The local pharmaceutical industry has now started exporting its products to Central Asian, Middle Eastern and African countries like UAE, Saudia Arabia, Yemen, Uzbekistan, Kazakhstan, Azerbaijan, Morocco, Sudan, Ghana, Nigeria, Ethiopia, Senegal etc. The Pakistani manufactures of medicines are keeping an eye on the American and European markets.

Both MNCs and local companies meet about 80 per cent of Pakistan's domestic demand of medicines and about 20 per cent drugs are imported. Some special products like immunologicals, anti-cancer drugs, certain anti-diabetics, antidotes and products manufactured from biotechnology are imported in the finished form. Various dosage forms including tablet, capsule, syrup, suspension, drops, cream, gel, ointment, ophthalmic/optic drops, infusions, insulin, suppositories, vaccines, liquid and powder injections, inhalers, vitamin sachets, disposable enemas, modified release dosage forms are being manufactured in Pakistan.

Total local production/consumption of pharmaceuticals is estimated at $2 billion. The market for pharmaceuticals in Pakistan is expanding at a rate of around 10 to 15 per cent since last few years. The number of local manufacturers is increasing as against the multinationals, whose number is shrinking.

Almost 95 per cent of the basic raw materials used for manufacturing of medicines are imported from China, India, Japan, United Kingdom, Germany, Netherlands and other countries.

PPMA claims that currently the Pakistani pharmaceutical products enjoy a clear edge over the other products from the South East Asian region since the API's (Active Pharmaceutical Ingredient) of nearly all the products manufactured in Pakistan is imported from quality manufacturers of the world.

"Due to this, the potency and efficacy of the medicines manufactured in Pakistan is far more superior than the products manufactured in the neighbouring countries," said PPMA chief.

The API is manufactured in Pakistan at a very limited level and currently there are only few companies which are manufacturing quality API's in the country. The government of Pakistan is encouraging the API manufacturing in the country and has often supported the quality API manufacturers by granting various tariff concessions.

The pharmaceutical manufacture and trade in Pakistan is regulated through the Drug Act 1976, and the rules framed according to it. Pakistan is considered to be the first country amongst the developing nations of the world to have introduced good manufacturing practices as a mandatory requirement. Registrations are granted by the Central Licensing and Registration Boards.

The federal government has set up nine Drugs Courts under Section 31 of the Drugs Act 1976 at Lahore, Quetta, Faisalabad, Bahawalpur, Peshawar, Lahore, Karachi, Multan and Rawalpindi.

Moreover, the Supreme Court had directed the federal drug controllers in 2006 to ensure voluntary destruction of expired medicines by pharmaceutical manufacturers and not allow the sale of life-saving drugs without the doctors' prescription. It further directed healthcare authorities to draft a comprehensive policy to stop the ongoing flow of spurious drugs in the country. However, despite all these serious steps, the government has failed to control the situation.

Compared to the pharmaceutical industry in neighbouring India, the size of Pakistani companies is very small and hence noncompetitive. The Indian pharmaceutical industry has grown tremendously and it has become a net exporter. They are now putting up USA-approved plants and exporting to advanced countries such as USA and Europe.

In some pharmaceutical raw materials, the Indian companies are the only suppliers worldwide. The country ranks 4th worldwide accounting for 8 per cent of the world's production by volume and 1.5 percent by value. India is also among the top twenty pharmaceutical exporters and among the top five manufacturers of bulk drugs in the world.

According to State Bank of Pakistan, during FY03 and FY04, Pakistan imported 4.3 per cent and 6.8 per cent of its total imports of chemicals and pharmaceutical products respectively from India. Out of the total imports of $2.9 billion (1105 items) in FY04, India supplied 353 items worth $196.8 million. Out of the total imported chemicals and pharmaceutical products from India, 166 items had a lower unit value of imports compared to the unit value of the same items imported from elsewhere. These items have the potential to enhance imports from India.

Pakistan's pharmaceutical industry is facing a number of problems. According to PPMA, the major problems include unavailability of Bio-equivalence and Bio-availability Centres of international standard, a lack of financial support to carry out WHO/FDA/MCA/EU/TGA accreditations, import duty on pharmaceutical manufacturing machinery and equipment, influx of imported pharmaceutical products already manufactured by substantial number of Pakistani manufacturers and patent and intellectual property (IP) issues etc.

Despite the fact that the pharmaceutical industry is facing a number of challenges in Pakistan, it has made a robust progress in meeting the local demands.

Counter feats

Although there are strict regulatory laws in Pakistan, the counterfeit drugs still prevail in the local market. According to an estimate by the Network for Consumer Protection, an Islamabad based NGO, the counterfeit drugs constitute 40 to 50 per cent of all medicines available in Pakistan.

Pakistanis spend about 77 per cent of their household health budgets on the purchase of medicines, half of which may be fake or unfit for human consumption.

The NGO report says that Pakistan has been ranked 13th in the world on account of production and sale of counterfeit medicines. Reports from the pharmaceutical industry and governments clearly indicate that the methods and channels used by counterfeiters are becoming more sophisticated, making detection more difficult. This alarming situation needs immediate steps to control the situation.

According to the WHO, about 25 per cent of the drugs consumed in the developing countries are fake. The Organisation defines a counterfeit medicine as a drug which is deliberately and fraudulently mis-labeled with respect to its identity and/or source. Counterfeit drugs may contain wrong active ingredients, wrong quantities of the ingredients, or no active ingredients at all. These drugs result in death or disability; or, at best, lead to therapeutic failure and disease resistance.

Although the government has taken some serious measures to control counterfeit drugs, the sale of these drugs goes on.

-- S. Qureshi

Healthcare education has a significant impact on the health of the community and on improving services for the patient. It also instills fundamental values and directs specific attitudes in the healthcare professionals. In most of the world, pharmacy education enables the pharmacists to deal with the safe and effective use of drugs, primary healthcare, preventive medicine and health promotion. It also emphasises on the research and development of pharmaceuticals and the production of new drugs.

The pharmacist's role in the healthcare system is rising with the development of new drugs, emergence of new resistant microbes, and the changes in healthcare delivery systems. With increasing healthcare costs, pharmacists' role in providing cost effective medicines is becoming vital. Pharmacists are the third largest healthcare professional group in the world.

Pakistan now boasts 21 institutes that teach pharmacy and is expected to expand this number. The World Health Organization's (WHO's) Eastern Mediterranean Regional Office (EMRO) website shows the expanding number of pharmacy schools, ranging from remote areas in the north such as Malakand to the university colleges in Lahore and Islamabad According to an estimate 6000 pharmacists pass out of these institutes each year.

In 2004, the Higher Education Commission (HEC) of Pakistan revised the pharmacy syllabus and changed the 4-year Bachelor of Pharmacy (B.Pharm) degree to a 5-year Doctor of Pharmacy (Pharm. D.).

Salman Shahid is a third-year student at a local university in Lahore. "The syllabus was revised but it still shows insufficiencies and shortcomings and does not meet international standards."

In the US, in the early 1960s, the pharmacy practice changed its focus from industrial and compounding pharmacy towards patient-oriented and hospital-based practice. Gradually, practice-based programmes were renamed as Pharm. D. (Doctorate of Pharmacy). This clinical and community based pharmacy model was largely welcomed in all parts of the world

Zohaib Aslam is another student who thinks there is a problem with the syllabus. He says, "The purpose of practice based or Pharm. D. models in these countries was to focus on patient care and to include a societal perspective to pharmacy. But Pharm. D. in Pakistan is only slightly related to these models. The content and the subjects in the final year (fifth year) are just an extension of the first four years."

A teacher who has been teaching for many years had this to say, "We don't emphasise drug policy, rational drug usage and medicine promotion and as a result our graduates have a poor knowledge of rational prescribing and pharmaceutical promotion. In almost all the world after gaining a degree in pharmacy, students have to undergo a one-year compulsory apprenticeship either in hospital, industrial or drug regulatory areas. But, in Pakistan, this is not compulsory and a pharmacist can be registered with the pharmacy council as soon as he passes the exam. This practice needs to be changed, as new graduates are not trained to meet the challenges in the healthcare system."

The weakness in pharmacy education has marginalised the pharmacy profession and hindered pharmacists from consolidating their role. As a result, pharmacy practice has been affected and subsequently posing adverse effects on the country's healthcare sector. One of the consequences is that the pharmacist's role is not protected. For example, a pharmacy assistant can also open a pharmacy and can dispense the drugs. As a result of this practice, the public is subject to untrained drug traders and quacks. Most of the clinical and administrative pharmacy services such as Total Parental Nutrition (TPN), Therapeutic Drug Monitoring (TDM), and Ward Pharmacy Services are non-existent at the majority of the public hospitals.

There are no independent drug information services at public hospitals and this provides opportunities for drug detailers and medical representatives to disseminate biased drug information to doctors. Medication errors and adverse drug reactions go unreported because of the lack of pharmacy support services. The pharmacist's role in public hospitals is that of a mere storekeeper and he is hardly involved in decision-making processes.

The last one and a half decade has seen Pakistan's pharmaceutical industry prosper at a fast pace. This has been mainly due to the government's policy of de-regulating the prices of medicines -- something that encouraged the national companies to produce and market medicines at prices equal or close to those offered by the multinational companies. The number of local pharmaceutical companies registered during this phase was the highest in the history of the country.

However, these companies are not feeling comfortable with the WTO regime. There is an ever-increasing concern among different stakeholders that the Pakistani pharmaceutical industry will not be able to compete with its foreign counterparts who enjoy economies of scale and are technologically miles ahead. It is feared that even competitors like India and China will give tough time to the Pakistani pharmaceutical industry by flooding the country with their patented medicines.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) under the WTO regime gives a provision to the pharmaceutical companies all over the world to get their medicines patented and acquire exclusive rights to manufacture and market them for a period of 20 years. Big pharmaceutical companies argue that strong patent protection in developing countries will increase R&D on 'neglected' diseases that afflict the poor. They also try to justify TRIPS by arguing that strengthened patent protection is needed to reward R&D. Though this provision is meant for all and sundry, in practice the patents will go mainly to the huge multinational companies who have put billions of dollars into research and development going on at their leisure.

Currently, the national pharmaceutical companies are manufacturing mainly off-patented medicines or generic equivalents of patented medicines. The production volumes are low, machines obsolete and quality standards no way comparable with those of the multinationals. So far, they survive by manufacturing cheaper generic alternatives of branded/patented medicines. But, once the transition phase is over, this would no longer be possible until the expiry of the 20-year period. During this period, however, the companies who own the patents will have all the liberty to charge whatever they want for their products.

Another matter of concern for the Pakistani pharmaceutical industry is the multinationals likely to stop the transfer of technology and bring investment into Pakistan. This will also translate into a loss of jobs in case the multinationals wrap up their operations and set up their units elsewhere. The TRIPS Agreement requires patents to be granted regardless of whether the products are imported or produced locally. This means that patent holders can merely import their product, without having to work the patent in the country granting the right.

This would mean that a multinational company can supply its medicines in global markets under the patent monopoly, exporting the finished product instead of transferring technology or making foreign direct investment. This rubbishes TRIPS supporters' argument that strict patent regimes will increase the flow of technology and investment into developing countries.

The concept of intellectual property rights has been there for ages. But it was during the 1980s that developed countries felt threatened from Asian countries in the field of manufacturing and technology. It was then that the industrial lobbies convinced the governments of the developed countries about the need to link trade with intellectual property rights, in order to prevent imitation and to increase returns on research and development.

Muhammad Zaka-ur-Rehman, Chief Executive Officer, The Schazoo Laboratories (Pvt.) Ltd, and former chairman Pakistan Pharmaceutical Manufacturers Association (PPMA) told TNS that in the current scenario, "the winners will be the large, northern-based companies where innovation is concentrated and which account for 90 per cent of pharmaceutical patents. The strengthened protection provided by the (TRIPS) Agreement allows them to sell their new medicines at higher prices for longer periods in more countries. The losers are the millions of people in poor countries who will be further excluded from access to these vital medicines, and their cash-strapped government health services."

Zaka stressed on the need to understand that the implementation of IPR law in pharmaceuticals, i.e. patent law, should be linked with the ability to buy medicines.

"The WTO has ignored this factor. That is why we are facing problems in implementation," he added.

Zaka was of the opinion that the government of Pakistan must consult the pharmaceutical industry before signing any agreement. The agreement signed earlier was kept secret from the public and the industry, he revealed.

He further said that the WTO had the power to amend rules; so the government of Pakistan must not relax, and continue to struggle to turn them in favour of the general public.

Where TRIPS rings warning bells for Pakistan's local pharmaceutical industry, it gives some unique options to the government to take certain measures in public interest. For example, it can allow parallel import or resort to compulsory licensing. According to the TRIPS regulations, if a company fails to supply the medicines consistently or adopts anti-competitive practices, then the government can grant compulsory license to any third party without the consent of a patent holder.

Similarly, parallel importing is a means by which developing countries could lower drug prices. Where there is price difference for the same product in different markets, it is possible to import the product from the cheaper market for resale. For example, if company 'A' is selling medicine 'B' at Rs 15 per tablet in India and Rs 5 per tablet in Sri Lanka, Pakistan can import it from Sri Lanka to save on costs. But, in order to make such decisions, sufficient expertise is required which, according to the industry experts, is still lacking among the government functionaries.

An interesting point here is that three different federal ministries are controlling the pharmaceutical industry in Pakistan. It is regulated by the Ministry of Health, while the IPR law is looked after by the Ministry of Industries and the WTO agreements taken care of by the Ministry of Commerce. This often leads to confusion over major important issues confronting the industry.

One of the suggestions to the government and the pharmaceutical industry at this critical juncture is to look for 'contract manufacturing'. It's a concept wherein a multinational company can get its medicines produced at some local factory and save a lot on the count of overheads and the costs associated with fixed assets.

Secondly, the government should ensure production of drugs whose patents have run out to lower the prices of drugs. Besides, the government must facilitate the local pharmaceutical industry by allowing duty-free import of machinery and other equipment and encourage R&D so that more and more Pakistani companies can get their patents registered.

Hippocrates, the famous physician of ancient Greece, is credited to have been the pioneer in the field of medicine. He successfully identified ailments as being independent from the body and developed means of classifying them according to their symptoms. Twenty-three centuries later, the English naturalist Charles Darwin proposed the Theory of Evolution. Though still facing controversy, evolution based on natural selection and mutation has been widely applied on the emergence of all life on earth from unicellular origins. Natural phenomena have been deemed responsible for diversifying organisms over a period of roughly 4 billion years. But, since the use of synthetic drugs became widespread in the early 1900s, humans have triggered their own version of evolution in their microscopic enemies.

All antimicrobials (pathogen fighting drugs) potentially can bring about genetic variations in their target agents such as parasites, viruses, fungi, cancer cells and bacteria. Yet it is in treatment of the last category of biological entities, and that too with synthetic forms of antibiotics, that has yielded the most powerful and drug-resistant bugs. Now more popularly referred to as superbugs, their rise has been traced to the period in which the first true antibiotic, penicillin was discovered and synthesised from its natural mouldy form. After successful administration of penicillin in its natural form to the injured soldiers of the World War II, synthetic variations such as ampicillin and methicillin were manufactured on a mass scale in the 1950s.

Ironically, it was the very bacterium Staphylococcus aureus which was involved in the discovery of penicillin that yielded the first super-strain with antibiotic resistance. And so individually responsible was the synthetic-penicillin drug of methicillin, that the granddaddy of superbugs has come to be identified as Methicillin-resistant Staphylococcus aureusor MRSA. Called Staph for short, it is found to naturally exist in the noses and skin of most healthy individuals and can cause ailments from pimples and boils to meningitis and pneumonia.

The all-resistant mutant version, however, appeared in 1961 in British hospitals, and had its causes entrenched in either the course not being completed or the synthetic drugs not possessing complete effectiveness. Hence, this kind of hospital 'Staph' took over the wards and rendered them as the 'hot beds' for the spawning of the superbugs. Consequently, the naturally stronger bacteria were able to develop a hyper-resistive gene known as mecA, in the aftermath of the extermination of the weaker microbes. Other members of the superbug club to have reared their ugly heads in the 1960s are penicillin-resistant strains of gnorrhea and pneumonia. Horrifically, by now there are reports of some of the current batch of variants having developed resistance to virtually all conventional drugs such as levofloxacin and ofloxacin.

What is shocking is that many doctors often prescribe antibiotics for viral infections, which obviously are not in the least adversely affected by them. Apart from triggering mutation in inactive hostile bacteria residing in our body, it often destroys the 'friendly' microbes and beneficial flora that serve the role of sentinels and are found usually in the stomach. This misuse of drugs also interferes with our body's immune system and hinders the development disease fighting cells. Furthermore, more than half of the antibiotics manufactured are delivered to animals such as poultry and dairy ones. Intended to prevent various infections, the drugs often end up advancing the evolutionary development of lethal bacteria such as Salmonella and E. coli. The deadly mutants, along with the troublesome drugs are passed onto us humans during consumption.

An analogous alarming scenario is also being detected in our own country. The deadly infectious disease of tuberculosis is caused by the bacterium Mycobacterium tuberculosis. By infecting the lungs, central nervous system and the lymphatic system that is crucial to our immune defenses, this microbe causes more deaths among adults than any other transmittable illness. It is already present in one third of the world's population and poses a high risk of a major epidemic, especially in the developing countries.

In Pakistan, in the last two decades or so, studies have been carried out in cities such as Lahore and Karachi, especially with regards to antibiotic-resistance.

One of the first of such studies was conducted in 1989 by the Institute of Tuberculosis and Chest Diseases at King Edward Medical College in Lahore. At this time, of the sample population of TB patients that were involved in the study, one-third showed resistance to mainstream drugs such as streptomycin and isoniazid. Four years later, another similar study was performed by the Department of Medicine at Agha Khan University at Karachi. The analysis was conducted on the basis of ascertaining primary and secondary resistance -- the former relating to patients with no history of medication and the latter to those having received treatment of TB specimens to anti-tuberculosis drugs. The primary resistance was found to be lower (around 17 per cent) as compared to a doubling (of 36 per cent) for secondary resistance cases.

Nevertheless, as recent as 2006, The Department of Pathology and Microbiology at the same medical institution published its findings of a study conducted on samples collected in 2004. What is a horrific revelation is that the Mycobacterium tuberculosis strains had now developed multi-drug resistance (MDR), pushing the numbers as high as 47 per cent.The primary resistance of the mutants had jumped up to 39 per cent where as the microbes in previously treated patients had evolved to present an astonishing 79 per cent resistance in the face of isoniazid and rifampicin.

Therefore, obviously, the multi-billion dollar question arises as to what are the best possible strategies available for tackling this new ultimate breed of pathogens. Antibitotics typically act by targeting certain mechanisms of the intended bacterium. Either a portion of their physical structure, such as the cell wall is directly damaged or the antibiotic dismantles the growth and development processes within the microbe.

During the 1970s and early 80s, there was a mad rush by notable pharmaceutical companies such as Pfizer, GlaxoSmithKline and Merck to churn out a whole barrage of antibiotics. Resistance occurred when the bacteria prevented the drugs in question from binding to their structure. Hence a vicious cycle ensued, with the drug companies developing only chemical variants of their products instead of novel ones, and the microbes becoming more and more advanced in their genetic makeup.

Physicians, especially those working in hospitals in affected areas, are now realising that it is a back-to-basics approach that will work best: that of prevention, proper hygiene and careful administrations of existing drugs. There is a trend in many countries now of employing herbal and natural remedies whose active agents will either adapt to the mutated microbes or facilitate in the body immune system. The $600 billion worth pharmaceutical industry spends around $40-$50 billion dollars on research & development. However, developing more expensive and insufficiently available medicines might just open the Pandora's Box of pathogenic super freaks.

Could there be anything more disgraceful than the act of packaging substandard salt as life-saving drugs? The answer to this sure lies in the price the common man has to pay. But, for the government, the network formed by those dealing in spurious medicines remains an issue that hasn't been effectively dealt with, yet.

Today, pharmaceuticals is possibly one of the few businesses that guarantees mega-bucks. No wonder the industry is growing by the year, at an average rate of 10 to 15 per cent, while the number of pharmaceutical units has crossed 550. What's more, the margin of profit on various items is generally huge because these items go unchecked - in many cases, due to the lack of a proper monitoring system, with the result that most culprits escape the clutches of the law.

A wholesale pharmaceutical dealer, requesting anonymity, told TNS that the government had failed to catch hold of the culprits.

"A large number of people selling spurious drugs are doing so without acquiring security from the distributor. That is why, if a drug is proven fake, neither the wholesaler nor the distributor is ready to take responsibility for that."

He also identified the business of stolen medicines, adding that these were marketed locally via tribal areas.

Huge profit margins afforded to the retailers is another related issue that needs serious consideration on the part of the government. The retail price of every pack of a drug that was got at, say, Rs 10 to 20 in the wholesale, would be something between Rs 200 to 450, which means one man's fortune at the expense of millions of consumers. For instance, 'Progard' (tablets), manufactured by a local company, is available in the market at Rs 190 per pack whereas it is being sold at only Rs 30 in the wholesale. Similarly, 'Femme' (tablets) carries the price tag of Rs 110 a strip but the retailer gets it for only Rs 9. The list goes on.

In Pakistan, the maximum penalty for the sale of spurious drugs is life imprisonment. Though, in nine out of ten cases, the culprit gets away with just a nominal fine.

According to Inayatullah, NWFP Minister for Health, "We registered 1105 cases between 2003 and 2006 in which the Drug Court disposed off 808 cases."

Responding to the complaint of Dr Shams uz Zaman received by its human rights cell on April 10, 2007 the Supreme Court of Pakistan asked the chairman of Quality Control Board, the federal secretary, and Director General Health to submit details of the drug cases registered in Pakistan so far. A three-member bench comprising Chief Justice of Pakistan Justice Iftikhar Mohammad Chaudhry, Justice Mian Shakirullah Jan and Justice M Javed Buttar heard the complaint. The apex court, through a notice, asked Chairman Quality Control Ahmed Jan to produce complete details of the cases registered in 2005 under the Drug Act 1976, and the number of persons challaned for counterfeiting.

At present, Provincial Drug Inspector Syed Wilayat Shah says, there are around 570 local and multinational pharmaceutical manufacturers functioning in the country. They are producing 45,000 medicines with different brand names. In NWFP alone, 70 FIRs were registered against 101 persons for selling fake medicines in the past four years.

"We have collected Rs 6.04 million from those accused," he declares, "Besides, a person was sentenced to three years' rigorous imprisonment together with a fine of Rs 50,000. He moved the Peshawar High Court and then the Supreme Court against the penalty but both the apex courts dismissed his petitions."

Syed Wilayat Shah further said that a case had been registered against one Inamullah in Swabi who also moved the apex court but the latter maintained the verdict given by the Drug Court.

Apparently, there is no monitoring system in the entire tribal belt which is spread over seven agencies and six frontier regions and boasts a population of over 4 million. The Provincial Drug Inspector registered a case against one person in Bajaur Agency, recovering a stack of fake medicines. The accused was also handed over to the political authorities but later his counsel argued before the apex court that the Drug Courts were not meant for the federally administered areas (FATA). So, there was no way that they could convict a person from a tribal agency.

"We are yet to have a system that can effectively check the business of spurious medicines in tribal areas," Director Health FATA, Dr Mohammad Zubair admitted to TNS, adding that efforts were being made to develop a proper mechanism.

He also said that the Agency surgeons - who were looking after the health department in their respective areas - had been called to help for the purpose.

If the provincial drug controlling authorities are to believe, the situation is improving already.

"We had in our records 60 cases of spurious medicines in the local market, in 2003. This figure came down to 36 in 2004, and 15 in 2005, while last year we recovered only 6 from the entire province," claims Syed Wilayat Shah.

However, he adds that the figure quoted was about allopathic medicines only, and did not include herbal or home products.