Despite having put through the first progressive drugs legislation in Southasia back in 1982, Bangladesh has fallen behind on the promise of its pharmaceutical policy.
Bangladesh’s endeavour to establish a comprehensive drug policy dates back to 1972, when a committee of experts, lead by the renowned physician Dr Nurul Islam, first proposed the banning of hazardous and useless drugs. However, the committee lacked support from key sectors of the government and was soon dismantled. This was not surprising, given that in the 1970s through the early 1980s, the pharmaceutical market in Bangladesh was dominated by just a few multinational companies, including Squibb, Wyeth Laboratories, SmithKline, Pfizer and Eli Lilly. Together, the foreign companies controlled more than 75 percent of the market, and supplied most of the essential drugs to the government, at very high prices. Additional ramifications of this industry composition included the flooding of the market with dangerous and unnecessary drugs, including vitamins, tonics, enzymes, gripe waters, cough mixtures, restoratives and digestants. A market survey in 1978 reported that harmful and pointless drugs accounted for a full third of the total drug consumption in the country.
After a decade of disquiet over this toxic situation, pushed by academics, regulatory experts and health activists, Bangladesh implemented the National Drug Policy (NDP) in 1982. It aimed to ensure quality and, importantly, to expand the domestic drugs industry. Yet the new policy received an immediate and hostile response from domestic and multinational pharmaceutical companies alike, as well as associations of local health professionals and certain foreign governments, including the US, Britain, West Germany and the Netherlands. These parties argued that the new policy would discourage foreign investors, would result in more harm than good for public health, and would not achieve the goal of increased availability of medicines. For their part, the multinationals further warned that the policy could result in a decision to halt all pharmaceutical production by foreign companies, with devastating impact. Within two months, although the Dhaka government persisted with the main thrust of its drug policy, some changes were introduced in response to this pressure. These included permitting some banned products back on the market, extending the time period for implementation of regulation, introducing an appeals process, and altering the list of permitted products.
Despite the mild watering-down, the NDP policy did articulate a vision of self-reliance, giving priority to the country’s basic drugs needs, coupled with a proud defiance of the multinationals. The policy was essentially people-oriented, which may be why the government was able to sustain its tough stance against the huge pressure from powerful opponents. At the same time, it is important to note that the new policy came up within a very particular political context, at the time when the military government led by General Hussain Muhammad Ershad had just come to power. By immediately choosing to focus on an issue as sensitive as the drugs industry, the government was able to give itself the option of achieving both domestic political goals and international recognition. The domestic goals included objectives that were populist and political (providing drugs at lower prices for the poor) and politico-economic (winning support from part of the local pharmaceutical industry through protectionism). In order to achieve these, the government had to risk antagonising the multinationals and foreign governments.
Second, in order to achieve international recognition, the government engaged respected and internationally known figures with close relations with influential international agencies such as the World Health Organisation (WHO), Oxfam, the Danish government’s development programme (DANIDA) and others. The choice of a national essential-drugs policy gave the military government high visibility at the WHO, where the topic was much discussed, and a dynamic leader to implement the policy was being sought in developing countries. Indeed, Bangladesh soon emerged a regional leader on the drugs issue, while its neighbours lagged behind.
The new legislation saw immediate effect. After the implementation of the NDP in 1982, nearly 1700 drug formulations were deemed hazardous or of no therapeutic value, and were gradually banned. Owing to the new restrictions, many foreign drugs manufacturers (Squibb, ICI, SmithKline and French) did discontinue their businesses in the country; notably, foreign companies were no longer allowed to manufacture ‘simple’ products, such as antacids and oral vitamin preparations. Moreover, they were not permitted to import or manufacture a number of drugs locally if similar products were already being made in the country.
Under this protectionism, the Bangladeshi pharmaceutical market began to flourish. In 1981, the year before the NDP went into effect, the value of locally produced drugs was about USD 58 million; by 1985, that figure had nearly doubled. Before the drug policy was implemented, the national companies’ share in local production had been about 30 percent; by 1985, this had reached 54 percent, and increased to 67 percent by 1988. By 1991, the top three firms in pharmaceutical sales were all Bangladeshi owned.
According to the national Directorate of Drug Administration (DDA), there are today a total of 807 drug companies involved in the production of various modern and alternative – Ayurvedic, Unani (or Greco-Arabic) and homeopathic – medicines in Bangladesh. Out of the 231 registered allopathic manufacturers, only 170 are currently in operation; these are producing around 450 generic drugs for 5300 registered brands, at thousands of dosages and strengths. About 80 percent of the drugs marketed in Bangladesh are generics, while the rest are patented drugs. (In most cases, generic products become available once the patent protections afforded to the original developer have expired, generally after seven to 12 years. The principal reason for the relatively low price of generic medicines is that competition increases among producers when drugs are no longer protected by patents.)
At present, the domestic manufacturers own 82 percent of the total market share, followed by 13 percent by the locally based multinational corporations. Only the remaining five percent is imported, thus demonstrating notable national self-sufficiency in pharmaceutical manufacture. Overall, the current market size of the Bangladesh drug industry stands at some USD 500 million – compared with approximately USD 1.2 billion, USD 140 million and USD 116 million respectively for India, Pakistan and Nepal. (Pakistan today has about 400 local pharmaceutical-manufacturing units; Nepal has about 265, of which 40 are considered in good shape.)
Against these potentially optimistic figures, however, is one that remains notably daunting: Bangladesh continues to import approximately 80 percent of the raw material required to feed its drug industry, mostly from India and China. As such, the country is forced to spend more than USD 130 million a year on imports of pharmaceutical raw materials. Although promoting local production of basic raw materials was a major objective of the NDP, this aspect has seen failure. The easy availability of pharmaceutical raw materials at competitive prices, coupled with lack of government support and lack of relevant technologies, have discouraged national manufacturers from producing these.
Testing the NDP
Indeed, beyond the significant growth in the domestic pharmaceutical sector sparked by the 1982 legislation, many of the key objectives of the National Drug Policy have not been attained over the subsequent two and a half decades. One of the NDP’s primary objectives was to ensure medicine of standard quality for the country’s large poor population. A 2005 government report did confirm that the quality of drugs has improved and that the proportion of substandard drugs has fallen to just two percent, compared to 36 percent during the pre-NDP era. At the same time, however, in its annual round of drug evaluation in 2004, the national drug-testing authority identified counterfeit medicine making up some six percent of the supply. Significantly, these include many popular antibiotics and lifesaving drugs. The rate signifies a high incidence of substandard drugs in the county, considering the large number of available drugs in the market, and that substandard drugs are harmful at any dose. These have a particularly adverse impact on the poor, given that antibiotics are commonly used to treat sanitation-related diseases such as diarrhoea.
In fact, however, it is very difficult to generalise regarding substandard drugs in Bangladesh, due to the small sample sizes of the previous studies. Based on sporadic drug-evaluation reports, a far-larger problem seems to exist than the figures quoted above would seem to suggest. For instance, with regards solely to non-prescription drugs – antacids, paracetamol, vitamins and minerals – anywhere between 27 and 69 percent have been identified as substandard. On the other hand, for lifesaving prescription drugs including antibiotics, as much as 50 to 80 percent have been identified as substandard on various occasions.
Low-quality drugs clearly remain a significant problem in Bangladesh today. Year after year, massive seizures of fake medicines have taken place in markets across the country. The most common of these are formulated either by providing smaller amounts of active drug ingredients than required, or simply by using inactive substances such as flour, arrowroot powder or lactose in the place of the main ingredients. Although it is of course very difficult to pinpoint, the general belief is that only the top 20 or 25 drug companies in Bangladesh produce drugs of standard quality, nearly all of which are domestic manufacturers. The effects of this are there for all to see. In 1992, for instance, 233 children died after consuming paracetamol syrup that was adulterated with an antifreeze agent. And although in 2001 the government did cancel the licences of 44 small-scale companies for producing counterfeit drugs, in general little official action is taken. Interestingly, the country also exports around one percent of its drugs to over 70 countries; these are of standard quality, having to meet the requirements of the importing countries. Meanwhile, around USD 150 million in spurious drugs annually threaten local public health.
Leaving aside for the moment the issue of quality, government documents today suggest that demand for essential drugs in Bangladesh is at least largely being met. On the ground, however, the situation seems different, with significant evidence of a scarcity of essential drugs in public health facilities. This shortage is not because Bangladesh exports drugs to other countries, as the country continues to produce more than 95 percent of the medicine that it requires. Rather, the reasons behind the drug shortage include budgetary constraints, improper distribution and storage of medicines, mismanagement and other related factors. Coupled with these, theft and pilferage of essential medicine from government hospitals have become very common, to the extent that it is today something of an open secret. While these shortages seem to be particularly acute in rural areas, public health facilities in urban areas are not entirely free from such shortfalls.
The failure of regulation of NDP policies is even more significant. The government has long set a maximum retail price for 117 essential drugs, which experts consider sufficient for the treatment of the majority of common diseases in Bangladesh. Beyond these, however, the Directorate of Drug Administration merely endorses prices as proposed by drug manufacturers, with no further negotiation. In practice, the regulatory authorities have no control over drug prices in Bangladesh, leading to what is today a wilderness of price differences in the drug market. Price variations of three to five times or more among various brands for the same generic drug are quite common. For example, the cost of 500 mg tablets of the common antibiotic ciprofloxacin ranges from less than BDT 2.5 to almost BDT 14. Likewise, diclofenac (a painkiller) eye drops can be found for as little as BDT 40 or as much as BDT 200 per unit.
Promoting so-called rational use of medicines was another key element of the NDP in 1982, aiming to improve the quality of health and medical care. Generally, ‘rational use’ means prescribing the correct drug in adequate doses for a sufficient duration – and, importantly, appropriate to the clinical needs of the patient at the lowest cost. Factors that can affect rational drug use, meanwhile, include lack of drug information or outright misinformation, inadequate training for health professionals, poor communication between patients and doctors, lax drug regulation and defective drug supply, advertising and promotion by the drug companies, and so on.
While there is general uproar regarding the quality of drugs in Bangladesh today, almost nobody talks much about rational use. Yet such a discussion is critical, given that even high-quality drugs can cause life-threatening complications if not used properly. Particularly worrisome is the fact that there remains no apparent distinction between prescription and non-prescription drugs in Bangladesh. Supposedly prescription-only drugs are in fact freely available in pharmacies throughout the country, without a doctor’s prescription. Moreover, as little as 13 percent of drugs are sold according to a doctor’s prescription, in addition to the fact that most physicians today prescribe unessential drugs.
The practice of inappropriate self-medication among the general population is commonplace, with 30 to 40 percent of the population stating that they do so regularly. More often, drugstore salespersons engage in the illegal recommendation and over-the-counter sale of prescription medicine. This is quite a problem, given that the drug-distribution system in Bangladesh is mostly composed of small, independent pharmacies; yet out of the roughly 200,000 such pharmacies, only 76,000 have been listed as registered. Most of these are run by unqualified people, including those without formal training. According to recent surveys by Consumers International, more than half of the medicine in Bangladesh (including lifesaving drugs and antibiotics) are today inappropriately prescribed.
Such an unregulated situation gives a significant advantage to drug representatives keen on increasing sales. An aggressive approach is used on doctors and pharmacies to promote spurious or inappropriate drugs. Currently, hundreds of locally produced ‘me-too’ drugs (drugs having close structural similarities with already-known drugs, but which possess minor differences) have flooded the drug market in Bangladesh. To survive in this therapeutic jungle, drug manufacturers frequently engage in aggressive promotional activities. In general, a quarter of a company’s sales are invested in promotion. In return for prescribing medicines from multiple pharmaceutical companies, most physicians and pharmacy owners enjoy a wide range of perks, ranging from direct cash benefits, household appliances, cars, foreign trips and even residential flats. This is certainly not the limit of the unethical marketing of drugs however, which also includes the promotion off-label (unapproved) indications; the dissemination of misleading, unproven or forged information or exaggeration of efficacy; as well as the evasion of contradictions and underplaying of adverse effects.
The major objectives of Bangladesh’s drug policy when it was unveiled in 1982 were multiple, but essentially revolved around increased regulation of cost and quality, in addition to promoting local production of both finished drugs and raw materials. In 2005, the NDP was amended in order to expand this latter objective, by allowing foreign drug manufacturers to operate alone or in joint venture with local companies. But a number of experts have subsequently warned that the post-2005 drugs policy is no longer pro-people. The revised policy, they say, is an exploitation only of drug-export potential, rather than providing drugs access to the common people. In essence, Bangladesh’s quarter-century experiment with a progressive drugs policy had suddenly switched its priority to privilege the pharmaceutical industry (in particular MNCs), rather than the public-health sector.
Whether or not the 2005 amendment should be seen as a loosening of policy, it has certainly not led to a strengthening of regulation. The situation today is largely a result of the absence of a coordinated effort by health experts and the drug-regulating authority. While the Directorate of Drug Administration (DDA) is tasked with monitoring and regulating the activities of all drug companies, it does so with the assistance of less than 50 drug inspectors. Beyond the scarce human resources, technical support is even more wanting; currently there are no more than two drug-testing laboratories in all of Bangladesh, and both of these, too, are severely under-resourced.
The resources crunch is so severe that the testing laboratories is only able to test around a fifth of available drugs. Inevitably this assures that thousands upon thousands of entirely untested drugs make it onto Bangladeshi streets, and into Bangladeshi bodies, every year. In addition to the resources-poor settings, poor governance, corruption, lack of accountability and low morale are all contributing to the deterioration of Bangladesh’s drug-control mechanisms. All the while, even as numerous new drug molecules are being introduced into the country’s drug market on a regular basis, the importance of post-marketing surveillance for adverse drug reactions has never gained any understanding.
Looking back over the 27 years of the NDP, there have clearly been some notable advances in the production of quality drugs in Bangladesh. In addition, successes have been seen in the elimination of harmful and unnecessary drugs, provision of essential drugs, and in terms of some control over drug prices. At the same time, other critical issues have remained unaddressed – such as preventing the spread of counterfeit drugs, controlling unethical drug marketing, promoting rational drug use, increasing the local production of raw materials for pharmaceuticals, improving the standards of drug dispensing, and controlling the standards of alternative medicines. It is largely due to the rapid advancement of the country’s drug sector that the infrastructure needed to prevent the spread of spurious drugs has not been allowed to build up in Bangladesh. The local pharmaceutical-industry lobby has grown very strong, and the absence of various other local or international drugs-monitoring and patient-rights groups has left drugs-promotion activities largely uncontrolled. Although unethical drug promotion makes it to the headlines from time to time, the consumer associations of Bangladesh rarely take up the matter. To date, no substantive issue regarding the prevailing drug-promotion activities has been raised in Bangladesh, by either a public or private organisation.
Yet until the people and their representatives are able to take responsibility for the oversight of pharmaceuticals away from the drugs companies themselves, Bangladesh’s progressive drugs policy may continue to evolve as more harmful than helpful to the public’s health. The irony is that the NDP of 1982 strengthened the local industry, which has now begun to act like the much-reviled multinationals – expanding its base at the cost of the masses.
~ Mohammad Saidul Islam is a doctoral student at the University of Sydney.