Essential Medicines
Essential Medicines are those drugs that satisfy the priority healthcare needs of the population. They are selected based on their efficacy, safety, quality, and cost-effectiveness, and are intended to be available at all times within a functioning healthcare system, in adequate amounts, appropriate dosage forms, assured quality, and at affordable prices.
The concept of Essential Medicines is a cornerstone of public health policy, ensuring equitable access to life-saving and disease-preventing treatments, especially in low- and middle-income countries like India.
Background and Evolution
The concept of Essential Medicines was introduced by the World Health Organization (WHO) in 1977, when it published the first Model List of Essential Medicines (EML) containing 208 drugs. The list provided a framework for governments to select and prioritise medicines that meet the most important healthcare needs of their populations.
WHO updates its Model List every two years based on new evidence, changing disease patterns, and technological advances. The Essential Medicines concept has since been adopted by over 150 countries, including India, to guide national medicine policies, procurement, and rational use.
Objectives of Essential Medicines Policy
The key objectives behind establishing an Essential Medicines framework are:
- To ensure universal access to safe, effective, and affordable medicines.
- To promote rational use of medicines and avoid overuse or misuse.
- To guide public procurement and supply chain management.
- To support health system strengthening by ensuring consistent availability of critical drugs.
- To provide a reference for reimbursement and pricing under public health insurance schemes.
- To assist in capacity building for healthcare workers and pharmacists in the selection and use of medicines.
WHO Model List of Essential Medicines
The WHO Model List serves as a global reference document and classifies medicines into two categories:
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Core List:
- Includes the most essential medicines that address priority healthcare needs and should be available at all primary health facilities.
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Complementary List:
- Includes medicines for specific diseases requiring specialised facilities, equipment, or training.
Medicines are included based on criteria such as:
- Evidence of clinical effectiveness and safety.
- Comparative cost-effectiveness.
- Public health relevance and disease burden.
- Feasibility of use in various healthcare settings.
Examples of medicines typically on the WHO Model List include antibiotics (amoxicillin), antimalarials (artemisinin-based combinations), pain relievers (paracetamol), insulin, vaccines, and oral rehydration salts (ORS).
National List of Essential Medicines (NLEM) – India
India has developed its own National List of Essential Medicines (NLEM), first introduced in 1996 and subsequently revised in 2003, 2011, 2015, and 2022. The NLEM is prepared and periodically updated by an expert committee constituted by the Ministry of Health and Family Welfare, guided by WHO’s principles but tailored to national health priorities.
Objectives of the NLEM
- To guide procurement, supply, and distribution of medicines in the public health system.
- To rationalise medicine use and promote generic prescriptions.
- To serve as a reference for price control under the Drugs (Prices Control) Order (DPCO).
- To promote equitable access to quality medicines in all parts of the country.
Criteria for Inclusion in NLEM
A medicine is included in the NLEM if it meets the following conditions:
- Addresses a public health problem of national importance.
- Has proven efficacy, safety, and cost-effectiveness.
- Is suitable for prevalent disease patterns in India.
- Is licensed and approved for marketing in the country.
- Can be stored, transported, and administered with ease under Indian conditions.
Major Features of NLEM 2022
The latest revision, NLEM 2022, includes 384 essential medicines, an increase from 376 in the 2015 list. Key highlights include:
- Inclusion of anti-diabetic, anti-cancer, and anti-viral drugs, such as Insulin Glargine, Teneligliptin, and Favipiravir.
- Addition of antimicrobials like Meropenem, Cefuroxime, and Ivermectin.
- Addition of vaccines, contraceptives, and diagnostics-related medicines.
- Removal of outdated or less effective drugs.
- Emphasis on the availability of generic formulations to reduce treatment costs.
Significance of Essential Medicines
Essential Medicines play a crucial role in strengthening health systems and achieving universal health coverage. Their significance can be viewed across multiple dimensions:
1. Public Health Impact
- Ensures that vital medicines are always available for the most common diseases.
- Reduces morbidity and mortality by prioritising life-saving treatments.
2. Economic Efficiency
- Helps governments optimise expenditure on medicines through bulk procurement.
- Promotes cost-effective healthcare delivery and rational pricing.
3. Equity and Accessibility
- Supports equitable distribution of medicines, especially to marginalised and rural populations.
- Reduces dependence on expensive branded formulations.
4. Quality and Rational Use
- Ensures only scientifically proven and standardised medicines are used.
- Encourages rational prescribing and reduces irrational drug combinations.
Linkage with Price Control and Public Procurement
In India, medicines included in the NLEM are automatically subject to price regulation under the Drugs (Prices Control) Order (DPCO) administered by the National Pharmaceutical Pricing Authority (NPPA). This ensures that essential medicines remain affordable for the public.
Additionally, the NLEM serves as a guiding document for public procurement, particularly in schemes like:
- Jan Aushadhi Yojana, providing affordable generic drugs.
- National Health Mission (NHM) procurement programmes.
- Central Government Health Scheme (CGHS) and ESIC dispensaries.
Challenges in Ensuring Access to Essential Medicines
Despite policy frameworks, several challenges persist:
- Supply Chain Inefficiency: Delays in procurement and distribution disrupt availability in rural health centres.
- Quality Assurance Issues: Variations in manufacturing standards affect drug safety and efficacy.
- Irrational Drug Use: Overprescription and self-medication undermine the principles of rational medicine use.
- Awareness Gaps: Lack of knowledge among patients and healthcare providers about essential medicine policies.
- Dependence on Imports: For raw materials (Active Pharmaceutical Ingredients), affecting affordability and supply security.
Measures to Strengthen Essential Medicine Availability
The government has taken multiple steps to improve access and reliability:
- Strengthening Supply Chains: Introduction of e-platforms such as the Government e-Marketplace (GeM) for procurement.
- Promotion of Generic Drugs: Expansion of Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) outlets across India.
- Public Awareness Campaigns: Encouraging rational drug use through educational programmes.
- Periodic Revision of NLEM: Regular updates to include new and more effective medicines.
- Pharmacovigilance Systems: Strengthened monitoring of drug quality and safety.
Role in Achieving Sustainable Development Goals (SDGs)
Access to essential medicines directly contributes to the achievement of SDG 3 – Good Health and Well-being, which emphasises universal access to affordable, quality healthcare. By ensuring the availability of necessary medicines for all, nations can reduce preventable deaths, control epidemics, and promote public health equity.