Essential Drugs

The root causes of ill-health developing (and underdeveloped) countries like India, are malnutrition, lack of clean water and sanitation, and unemployment. With a population of more than 100 crores, India accounts for about 16 percent of the global population. India is country where 37% of the population still lives below the poverty line and where the proportion of out-of-pocket expenses out of the total expenditure on health in one of the highest in the world; with only 17% of the expenditure contributed by the government (figures from the National Health Policy 2002).

Load of Diseases in India

  • Tuberculosis 1/3 of world’s cases: 15 million cases. Largest number of multi-drug resistant cases.
  • HIV/AIDS. Second highest in the world: 3.5 million persons.
  • Acute respiratory diseases: 950,000 deaths per year.
  • Acute diarrhea: 19 crore-illness episodes per year and an estimated mortality of 1 lakh children per year.
  • Malaria especially falciparum malaria is a public health problem with an estimated 2-3 million cases per year and a mortality rate of 20,000 per year.
  • Kala-azar is a significant public health problem in certain states and causes.
  • Parasitic infections include hookworm infections, which contribute in an manner to way to iron deficiency anemia and filariasis.
  • Hypertension:20-40% in urban areas, 12-17% in rural areas.
  • Cardio-vascular diseases:31.7% of all deaths in 2000.
  • Cancer: Estimates of age standardised rate of cancer range from 99.0 to 129.6 per 100,000 in males and 104.4 to 154.3 per 100,000 in females. 7 lacs new cases per year and cause for 7.4% of all deaths in 2000.
  • Chronic respiratory diseases: 65 million cases and cause for 2.5% of all deaths in 2000.
  • Anemia: Anemia is a major public health problem in women and children with a prevalence of 74.3 in children of 6-35 months and a prevalence of 49-56% in women. (NFHS 1998/99) Anemia contributes to 1/3 of maternal mortality.

(Source: Abdul Ghaffar, K. Srinath Reddy and Monica Singhi: ‘Burden of Non-Communicable Diseases in South Asia’, BMJ, No.7443, 3 April 2004)

Why We Need Only Essential Drugs?

Increasing Drug costs to the user.

Nearly 50% of healthcare costs are contributed by expenditure on drugs. NSSO surveys reveal figures of up to 80 percent in rural areas. In a study done for the WHO on treatment costs incurred by the patients with TB, it was found that 60% of the costs were contributed by drug costs.  With the rise in health care costs the number of persons who do not seek treatment because of economic reasons has risen in both the urban and rural areas (NSS 52nd round), which is disturbing. According to a World Bank study, as a result of the costs of a single hospitalization, 35% of people fall below the poverty line.

Anatomy of a Health Disaster.

By P. Sainath

Janreddy’s family survived crop failure. But debts of 300,000 to cover health costs have nearly destroyed them. Loans taken to cover health costs have been a major contributor to the debt-suicide cycle in Andhra Pradesh.

Janreddy sat wracked with pain, a picture of ill health. “Why isn’t this man on his way to hospital.” We asked the neighbours crowding around his bed. Well”, they said nervously, “We just brought him home from one. He was there for days. This family has already lost all its money on hospitals.”

Janreddy died ours after we met him. His daughter-in-law, who became a bonded labourer to keep the family afloat, will remain one till debts of Rs.500,000 re paid off. Over Rs.300,000 of that was incurred on medical costs. His wife, who d donated one kidney to her son – both of his had collapsed – does any work she can find. The son, Narsi Reddy, confined to the house, has to drink only the purest water in a place where there is none. His medicines cost around Rs.1000 a month.

The huge medical bills of this family of six were incurred despite the son getting free operations at the Osmania Government Hospital in Hyderabad. They had first gone to private hospitals for check-ups, a biopsy and other tasks. As the costs mounted they sold off land and cattle to meet them. That Narsi Reddy had sunk four borewells didn’t help. All of them failed. Crisis on their four-acre farm in Chelliagudam village of Nalgonda district saw Janreddy’s health also cave in. “They might just have survived the crop failure, “ say the neighbours, “but their medical costs destroyed them.”

Health spending is amongst the fastest growing components of rural family debt. For years, the state boosted the private sector in health, promoted corporate hospitals and pioneered the ‘user fees’ system in government ones.

“The Chandhrababu Naidu government dismantled the public health system,” says M. Geyanand, a leading doctor from Anantapur district. Geyanand is also state president of the Jana Vignyana Vedika (JVV), a body that aims to promote popular science and the scientific temper. “Ninety per cent of patients who go to public hospitals are poor. When that system fails them, they turn to private ones at a huge costs often count as much as 20-25% of the total expenditures of such households. And a single medial emergency can ruin them.”

A common thread running through the farmers’ suicides plaguing the states has been very medical spending. Just five households affected by such deaths had health costs totaling around Rs.400,00. All of them farming families who held between half-an-acre and three of land (some of that mortgaged). Janreddy’s family has not seen a suicide. But it fits this profile rather well.

As do countless other poor households. Even last year, we ran into a farmer who had attempted suicide in the Nallamada mandal of Ananthapur district. His friends managed to get him a hospital just in time. The rescued farmer abused his saviours. The reason: The four-day stay and treatment in hospital cost Rs.45,000. “I tried to commit suicide because I could not pay debts of Rs.150,000, he said bitterly. “Now I owe even more.”

Many of those who succeeded in taking their lives in 2004 had huge medical bills. P.Hanumantha Reddy’s family in Nizamabad district owes Rs.200,000. The survivors of A Narasimhalu in Medak have to rustle up Rs.70,000 plus interest. The tab for K. Shivarajaiah’s family in the same district is Rs.50,000. All this was money borrowed at absurd rate of interest.

“There is a link between the suicides and the crisis of health in Andhra,” says Geyanand. “The collapse of the public health system is crucial. In any poor village, you can see people dying of diseases that should not kill them. Malaria is just one example. For years now, all their support systems have been slashed. The costs are so high, they run out of money halfway through treatment. Those who fall ill are selling land, gold, cattle and other assets to pay medical bills. They also take loans they can never repay.”

In the past decade, the little access the poor had to health sharply declined. Gunala Kumar discovered when he had to fork out Rs.40,000 in medical costs to private hospitals in Medak. That remains big chunk in his total debt of over RS.200,000. A debt that caused him to take his own life in Meeradoddi village this month. Like his father who committed suicide last year.

“Maybe it is better to die,” says Yekalapu Husein of Shabuddlapur in Nalgonda. “How will we pay the fees they ask us to at these hospitals?” A toddy-tapper who suffered a fall from a tree while at work, Husein has to run up huge bills himself. Then came his malnourished wife’s illness. His ‘medical debt’ now stands at Rs.200,000. “Even if we get free care at Osmania Hospital” he laughs, “we do not have money for the bus fare to Hyderabad and back.”

In Gedavalli village in the same district, the local rural medical practitioner sold all his land to pay his own treatment costs of Rs.400,000 at a corporate hospital in Hyderabad.

In the years these dramas unfolded, public hospitals were starved of funds, medicines and drugs. Given Rs.600 crore by the World Bank for public health, the Naidu government spent this mostly on buildings. Very few doctors or nurses were recruited. The buildings now show decay for lack of maintenance. Naidu also authored a government ‘tie-up’ with corporate bodies. Under this, employees of the state went to corporate, not public hospitals. The government reimbursed their costs. This meant a windfall for those hospitals. It also meant many scams in the shape of inflated reimbursement bills. Meanwhile, health institutions in the public sphere suffered.

“The introduction of ‘user fees’ made health even less accessible to the poor.” says a Senior IAS officer. The fees have since been withdrawn by the new state government. Also dumped was an idea of handling over some super-specialty department of public hospitals to ‘private management’. That is, to corporate hospitals.

The damage, though, has been done. The medical costs of those who preferred death to debt still plague the living. We pass Janreddy’s wife at the bus stand, looking for any ‘coolie worker’ she can find. There are, after all, bills to be paid.

This article originally appeared in The Hindu, July 1, 2004.

(P. Sainath is Rural Affair Editor of the Hindu. He received the A.H. Boerma Award, in 2001, for his contribution to the development debate in the Indian media. This article first appeared in The Hindu)

Increasing Drug resistance.

A problem, which has complicated the control and treatment of infectious and communicable diseases in India, is the increasing problem of drug resistance in common infectious and diseases of public health importance. Drug resistance have become increasing frequent: chloroquine resistant falciparam malaria, multi-drug resistant tuberculosis TB (new strains resistant to both INH and Rifampicin), in Typhoid new strains resistant to not only to chloramphenicol but increasingly resistant to even quinolones is being seen, resulting in a dramatic escalation of cost, and requiring the use of 3 generation cephalosporins.

Earlier acute respiratory infectious were responsive to the effect of co-trimoxazole, which is an inexpensive drug. Now increasingly resistance to co-trimoxazole is being reported necessitating the use of other drugs for acute bacterial infections in children.

Urinary tract infections are one of the common causes of fever in women. E coli, which causes the majority of these infections, has also shown disturbing levels of resistance, first to co-trimoxazole, and now to quinolones and even cephalosporins.

The problem of drug resistance in common infectious diseases have to be factored in any pharma related policy in India. Repeated and improper uses of antibiotics are primary causes of the increase in drug resistant bacteria. Misuse of antibiotics endangers the usefulness of essential drugs. Decreasing inappropriate antibiotic use is the best way to control resistance. And more importantly making non-scientific combinations of antibiotics, itself the result of a lack of essentials-only policy, increases the possibility of drug resistance.

Poverty amidst Plenty.

The situation of medicine availability in India is therefore one of poverty and ill-health amidst adequacy if not plenty. We have a doctor to population ratio as good as the US; we have one of the developing world’s most flourishing pharmaceutical industries but yet most common and useful drugs are not easily available, or if available they are not affordable. Our public sector facilities are very inadequately stocked with essential medicines.

How many drug units are there and how many formulations are made in India? As against the frequently quoted figure of about 20,000 manufacturing units, the actual number of drug manufacturing licenses issued was-bulk (1333), formulations (4534), large volume parenterals (134), and vaccines (56). The total number of manufacturing units engaged in production of bulk drug and formulations is not more than 5877. Besides there are 199 medical devices units, 638 surgical dressings and 272 disinfectant units, 4645 loan licences and 318 repacking units, 1806 blood banks, 2228 cosmetics units and 287 other units not covered in the above categories. According to the Director, National Pharmaceutical Pricing Authority of the Government of India (NPPA), the number of APIs (Active Pharmaceutical Ingredients) used in 550, APIs manufactured is 400, formulations marketed are 20,000 under 8000 brand names. The NPPA monitors 20,000 formulations and according to its figures, 56 percent of these formulations available are based on a single ingredient bulk drug, 20 percent on 2 bulk drugs, 8 percent on 3 bulk drugs 4 percent on 4 bulk drugs, 2.5 percent on 5 bulk drugs, and 9.5 percent on 5 or more bulk drugs.

If we examine the list of Top-selling 300 brands (as per ORG-Neilson Oct 2003), we find that only 115 b are of drugs that are mentioned in the National Medicines List (NEML) 2003, i.e. only 38% of brands of the Top-selling selling ones are of drugs mentioned in the NEML, he other 62% are of drugs which do not find mention in the NEML. Among these, 62% brands comprise drugs that are highest priced alternatives without a clear therapeutic advantage, and many drugs that are necessary, irrational and even hazardous.

The number of drugs represented by these 115 brands is only 68. That means the majority of the Top-selling brands are of drugs which are outside the National Essential Medicines List, which means that the majority of the drugs which are the most cost effective for the treatment of priority health needs of the people are not the ones which are selling the most.

A dramatic illustration of the lack of public health relevance of these Top-selling preparations is the case of preparations for iron deficiency anemia, which is one of India’s most prevalent public health problems.

There is not a single preparation in the top 300, which has been the ingredients for an anemia preparation as mentioned in the National essential Medicines List.

It is paradoxical that while essential and life saving drugs are in short supply, more drugs which are therapeutically ineffective, irrational, and may be even dangerous, are being produced with absolute disregard to the country’s health needs. The problem becomes more acute in developing countries where resources for the purchase of drugs are scarce.

Why an Essential Medicines List? 

The proliferation of drugs (medicines) and brands creates further confusion even as it is necessary to ensure policies that conserve society’s resources for only useful drugs. Hence there is a need to select essential drugs from the innumerable drugs, mostly unnecessary ones, available in the market.

It is with this view, the World Health Organisation (WHO) promoted the concept of essential drugs. According to the WHO:”Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems art all times in adequate amounts, in the appropriate dosage forms, with assumed quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.”

In 1977, a WHO Expert Committee complied a list of essential drugs. The WHO list is a model which developing countries can use to make their own selection of essential drugs which are considered “basic, necessary and indispensable to the health needs of the population”. They are to be identified by their generic names. The first Model List of Essential drugs of 1977 identified 208 individual drugs that together could provide safe, effective treatment for the majority of communicable and non-communicable diseases. The 14th Model List of Essential Medicines of March 2005 contains 306 individual medicines in 405 formulations.

Basically, an essential drugs policy means the availability of a minimum number of rational drugs that will satisfy the health care needs of the majority of people. The key elements in the concept of essential drugs that they be rational, scientifically proven, therapeutically effective, safe for use, economical and readily available in the country.

The criteria for the selection of the essential drugs depends on such factors as: prevalent disease patterns, available treatment facilities, training of existing health personnel, financial resources, and the genetic, demographic and environmental factors that influence the state of health and illness in a particular country. They should have gone through adequate price and easy availability.

Selection Criteria

Which treatment is recommended and which medicines are selected depend on many factors, such as pattern of prevalent disease, treatment facilities, the training and experience of available personnel, financial resources, and genetic, demographic and environmental factors. The following criteria are used by the WHO Expert Committee on the selection and use of Essential Medicines:-

  • Only medicines for which sound and adequate evidence of efficacy and safety is available should be selected.
  • Relative cost-effectiveness is a major consideration for choosing medicines within the same therapeutic category.
  • In comparisons between medicines, the total cost of the treatment not only the unit cost of the medicine must be considered and be compared with its efficacy.
  • In some cases, the choice may also be influenced by other factors such as properties or by local considerations such as the availability of facilities for manufacture or storage.
  • Each medicine selected must be available in a form in which adequate quality, including bioavailability, can be ensured; its stability under the anticipated conditions of storage and use must be determined.
  • Most essential medicines should be formulated as single compounds.
  • Fixed dose combination products are selected only when the combination has a proven advantage in therapeutic effect, safety, adherence or in decreasing the emergence of drug resistance in malaria, tuberculosis and HIV/AIDS. (Source: WHO EDM Library)

An essential drugs list may vary from country to country depending on the above factors. The selection of essential drugs is a continuous process of evaluating the current health needs of the country. The WHO list serves as a model list for adoption in national health policy. It is revised and updated periodically. (See also Annexure 3 for a sample of country experiences.)

A successful essential drugs programme would:

    • Reduce the number of drugs to be produced and available in the market.
    • Improve the quality of drug management, drug information, and monitoring and utilization.
    • Reduce the cost to the consumer and to the country as a whole.

Advantage of an Essential Drugs List

The advantages of adopting an Essential Medicines List is mainly four-fold. They are: medical, social, economic and administrative.

Medical Advantages.

·        It is medically, therapeutically and scientifically sound, and it ensures rational use of drugs.

·        It limits the use of irrational and hazardous drugs and decreases the risks of iatrogenesis (drug and doctor induced disease).

·        It improves the possibility of monitoring adverse drug reactions in patients.

Economic Advantages.

·        It is economically beneficial to the nation because it prevents wastage of scarce resources on non-essentials.

·        The economies of scale achieved in the larger production of priority drugs brings down their prices.

·        It curtails the aggressive marketing of non-essential formulations.

·        It is economically beneficial to the patient because it prevents wastage on irrational and non-essentials.

Social Advantage.

·        It responds to the real health needs of people.

·        It facilitates the dissemination of correct information about the drugs to health personnel, medical practitioners and consumers in general.

·        It makes it imperative to draw up priorities to meet the most urgent needs of the people for essential health care.

Administrative Advantage.

·        It is organizationally sound because it makes quality control of drugs, because of the limited number of drugs to be monitored.

·        It facilitates the streamlining of production, storage, and distribution of drugs, because of the smaller number of drugs involved.

·        It helps in the clear identification of drugs.

·        It facilitates the fixing from prices as well as revision/ withdrawal of duties, sales tax etc.

An essential drugs programme is to be implemented as part of the rational drug policy. Its implementation depends on the political will of all the governments without which drug marketing will continue uncontrolled with aggressive promotion of useless, irrational, dangerous or expensive drugs. And low cost, essential drugs will continue to be short supply and information on drugs will remain dangerously inadequate.

Essential Lists in Countries.

The WHO’s Action Programme on essential drugs recommended about 306 drugs in its March 2005 list to meet most of the health care needs of any developing country. As of 2002, 156 countries have a national list of essential drugs, of which 81 have been updated in the previous 5 years.

In 1972, the Sri Lankan government selected 600 essential drugs. In 1977, Afghanistan reduced the number of drugs from over 2000 to 400 in private as well as public sector and allowed the sale of only by their generic names. Nepal in 1986 chose 260 drugs for the national level with approved list of essential drugs for various levels, Mozambique chose 343 drugs in 1980, Iran selected 600 in 1980, Kenya a maximum of 200 drugs. Bangladesh issued a drug ordinance in 1982 allowing only 150 drugs (See Annexure 1 for Criteria used in Bangladesh to weed out drugs). Norway and the Nordic countries also implemented the essential drugs list. Other countries which have taken the lead include: Belarus, 1995 (250 essential drugs); Georgia, 1995; Maldives, 1995 (532 drugs by generic name); Turke, 1995 (382 drugs) and South Africa which had an essential drugs list in 24 therapeutic groups for primary health care (1996) with standard treatment  guidelines. The Hathi Committee which was appointed in 1977 by the government of India to study the drug industry in India recommended that greater emphasis be laid on the production of 117 identified essential drugs and recommended abolishing the use of brand names in a phased manner. However this recommendation has been ignored by the Government of India.

The government of India’s Ministry of Health and Family Welfare had come with an essential drug list in 1996 and again in 2003. The latter called National Essential Medicines List (NEML 2003) consists of about 350 drugs. The NEML has to be seen in the context of the National Health Policy and the Pharmaceutical Policy 2002. Both these lists seem to be hanging out in the air without any directions to the public health facilities in India as to how to use the same. In the meanwhile many state governments notable Tamil Nadu and Delhi State and Rajasthan have implemented the lists actively by using them in their bulk procurement exercises for all the Government health facilities in their states. Considerable savings have been reported (see later in the chapter) by the adoption of such lists.

The report of the government of India “Task Force to Explore Options other than  Price control for Achieving the objective of Making Available Life–saving Drugs at Reasonable Prices” (sep 2005) has recommended that all drugs in the National Essential Medicines (NLEM) 2003 would form the basis of drugs for control / monitoring.

Despite the WHO recommendations for the use of essential drugs list and implementation of the programmme and the Hathi Committee report calling for urgent measures to improve the Indian drug situation, the drug formulation market in India remains skewed. This is because as already mentioned many non-essential drugs, or drug combinations that do not find mention in any standard pharmacology textbook are licensed for manufacture in India and therefore also find their way in the Indian market.

Essential drug lists have however not been successfully implemented in most countries due to pressure from transnational countries and other vested interests. WHO’s own double standards are another major reason the essential drugs concept has not got the push that it deserves. Nevertheless WHO’s Essential Medicines Division claims that more than 150 countries have essential drug lists even as the concept itself had its silver jubilee in 2002.

One response to “Essential Drugs

  1. efforts at all levels are required to put into minds of all concerned that essential generic medicines when used will help us to cut undue exp.&mobilisation of such generated funds for the needy of our country-let it become part of general science/ social sciences text books in modified versions at high school level

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s