A growing number of pharmaceutical products are available on the world market and there has been an increase, both in the consumption of drugs, and in expenditure on them. But in spite of this, many people throughout the world cannot obtain the drugs they need. There are also many people who do have access to drugs but who do not get the right drug, in the right dosage, when they need it. The essential drugs concept was developed in response to these problems and continues to be central to policies and strategies that aim to address them. The essential drugs concept is central to the development of national drug policy.
The World Health Organisation (WHO) defines essential drugs as -
Essential drugs are those that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms.
The first WHO model list of essential drugs was published in 1975.Since 1977, WHO has promoted the use of limited Essential Drug Lists (EDL) as part of Essential Drug Concept. Initially drugs were selected on the basis of experience. Recently WHO has begun to advocate a change towards an “evidence-based” approach. The Indian government published its first National Essential Drugs list (EDL) in 1996, and some state governments have also adopted an EDL. It is believed that only about 250 drugs are essential to treat the majority of diseases in a country. Selecting some drugs as part of the EDL does not lower the importance of other drugs - a list of essential drugs is a positive list, mainly intended to define priority drugs for public procurement and reimbursement, and for training of health personnel
Selection of Drugs in EDL
Correct selection and purchase of pharmaceuticals aims to improve the affordability and quality of health care to the population. Implementation of the ED concept starts with selection of drugs to be on the national EDLs. Selection is a complex issue and the committee considers multiple factors such as the available human and financial resources, disease prevalence, health indicators and demographic situation. The primary criteria for inclusion are accurate clinical data on safety and efficacy of the drug, its availability, cost and cost-effectiveness. Ideally the selection process should be consultative and transparent; the criteria should be explicit and linked to evidence-based clinical guidelines.
- Pattern of prevalent diseases
- Drugs required for national programs given priority
- Generics are cheaper
- Newer is not always better
- Good manufacturing processes
- To measure effects of information/regulation on drug usage pattern
- To study absolute/relative efficacy and safety
- To indicate overuse/under use or misuse of drug/drug classes
Generally fixed-dose combinations are not encouraged in the EDL except where clear benefits are known (E.g. Co-Trimoxazole, Oral Contraceptives). The selection of drugs in the EDL is a continuing process and review and revisions must be made as and when new advances take place in pharmacological and pharmaceutical knowledge.
National Drug Policy of India
With a population of nearly 100 crores, India accounts for 16 per cent of the global population. Sizeable population lives below the poverty line and 48 per cent of the people are illiterate. India was among the first few countries to attempt at a National drug policy. This has resulted in the establishment of a pharmaceutical industry, the development of technological capabilities in pharmaceuticals and price control of selected essential drugs.
In the initial 3 decades after independence, public sector production units were set up to produce drugs such as antibiotics etc. which the private sector/ foreign owned companies were reluctant to produce. Indian Patents Act, 1970 disallowed pharmaceutical product patents and limited duration of process patents to 5-7 years - helping in growth of domestic manufacturers. The Drug Control General India (DCGI) was created on similar lines to the Food and Drug Administrations (FDAs).
In the early 1990's liberalization policies led to a two to threefold rise in prices of many important drugs. A National Pharmaceutical Pricing Authority (NPPA) was formed in 1996 to ensure price stability and availability of commonly used medicine. To ensure international standards Schedule M of the Drugs and Cosmetic Acts, 1945 was amended in 2001. In 2003 the Essential Drugs List was amended/ reviewed for the first time after it was created in 1996. In 2004, India became a signatory to the GATT - Uruguay round of International Trade Agreement - hence patents are back for 20 year durations and cost of many drugs are bound to rise.
There are a total of 354 drugs in the National List of Essential Medicines (NLEM), which are adequate to take care of the majority of the health needs of the population. But when we analyze the sales of top 300 brands only 38% of brands are of the drugs mentioned in the NLEM. The other 62% brands comprise drugs that are higher priced alternatives without a clear therapeutic advantage and many are unnecessary, irrational and even hazardous.This indicates that contrary to what is advocated by WHO & as adopted in our national health policy, the drugs which are most useful & cost effective for the treatment are not being prescribed & the non costlier & irrational drugs are sold more often.
Rational drug use has not been integrated into government policy, and non-essential drugs and irrational drug combinations continue to be approved for marketing. Ethical promotion of drug advertising, funding for drug information centres, drug utilisation research, patient education in medication use should also be a part of any national drug policy; which are sadly, missing in the National Drug Policy of India.