For Quality, Essential, Generic Medicines

The root causes of ill-health in Third World countries like India, are malnutrition, lack of clean water and sanitation and unemployment.

With a population of nearly 100 crores, India accounts for 16 per cent of the global population. Sixty per cent of the people exist below the poverty line and 48 per cent of the people are illiterate. India accounts for 22 per cent of the global morbidity (illness) with only 2 per cent of the global drug production of which only 0.7 per cent are essential drugs. Yet 1.3 per cent are profit-oriented tonics which are highly priced, marginal or useless (1). The major portion of our population living in abject poverty, can barely afford a square meal a day, let alone having the means to spend on costly medicines.

Yet more and more drugs flood our markets every year. There are over 20,000 pharmaceutical units in the country producing over 1,00,000 (one lakh) formulations of drugs (2). It is paradoxical that while essential and life-saving drugs are in short supply, more and 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.

Hence there is a need to select essential drugs from the innumerable drugs, mostly unnecessary ones, available in the market.

It is with this in view, the World Health Organization (WHO) promoted the concept of essential drugs for developing countries. According to the WHO, " is clear that for optimal use of limited financial resources the available drugs must be restricted to those proven to be therapeutically effective, to have acceptable safety and to satisfy the health needs of the population" (3).

In 1977, a WHO Expert Committee compiled 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 were considered "basic, necessary and indispensable to the health needs of the population" (4). They are to be identified by their generic names.

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 the people. The key elements in the concept of essential drugs are 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 clinical tests and found to be safe and effective. Another significant factor is its affordable price and easy availability.

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. The sixth list was published in 1990. The seventh list was published in 1992 containing 221 drugs (5). Subsequent revisions have been published in 1995 and 1997. (See also Annexure 2 for a sample of country experiences.)

An essential drugs programme would:

* reduce the number of drugs to be produced.

* improve the quality of drug management, drug information, and monitoring and utilisation.

* reduce the cost to the consumer and to the country as a whole.

Advantages of an Essential Drugs List

The advantages of adopting an Essential Drugs List is mainly four-fold. They are: medical, social, economic and administrative (6).

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.