National List of Essential Medicines of India 2011

The National List of Essential Medicines (NLEM) 2011 is an official compilation of medicines considered essential for addressing the priority healthcare needs of the population in India. It provides a framework for ensuring the availability, affordability, and rational use of quality medicines across all levels of healthcare.
Prepared and released by the Ministry of Health and Family Welfare (MoHFW), Government of India, the NLEM 2011 replaced the previous list published in 2003. It was developed in accordance with the World Health Organization (WHO) Model List of Essential Medicines, while adapting it to India’s disease burden, healthcare priorities, and national health programmes.

Background and Context

The concept of Essential Medicines was introduced by the World Health Organization (WHO) in 1977, defining such medicines as those that satisfy the priority health care needs of the population and should be available at all times in adequate amounts and at affordable prices.
India published its first NLEM in 1996, followed by a revised list in 2003, and later, the NLEM 2011, reflecting changes in disease prevalence, therapeutic practices, and the evolution of health programmes.
The 2011 list was prepared under the guidance of the Core Committee constituted by the Directorate General of Health Services (DGHS), with experts from pharmacology, clinical medicine, and public health.

Objectives of NLEM 2011

The key objectives of the National List of Essential Medicines 2011 are:

1. To identify medicines that satisfy the priority healthcare needs of the population.
2. To promote the rational use of medicines, improving their quality, efficacy, and safety.
3. To ensure affordable access to essential drugs for all sections of society.
4. To serve as a guide for formulary preparation, procurement, and supply of medicines in public health facilities.
5. To facilitate regulatory and policy decisions, including the implementation of price control measures.

Criteria for Inclusion of Medicines

Medicines were included in NLEM 2011 based on the following criteria:

1. Public Health Relevance:
   • Medicines addressing diseases of significant public health importance in India.
2. Efficacy and Safety:
   • Proven therapeutic effectiveness and established safety profiles.
3. Cost-Effectiveness:
   • Economically viable options providing value for money in public healthcare systems.
4. Ease of Use:
   • Preference for dosage forms suitable for use at different levels of care (primary, secondary, tertiary).
5. Alignment with National Health Programmes:
   • Inclusion of medicines relevant to programmes like the National AIDS Control Programme, National Tuberculosis Control Programme, and National Malaria Eradication Programme.

Structure of the NLEM 2011

The NLEM 2011 categorised essential medicines based on the level of healthcare delivery and therapeutic class.

• Levels of Healthcare:
  1. Primary Healthcare (PHC)
  2. Secondary Healthcare
  3. Tertiary Healthcare

Each medicine was designated for one or more levels, depending on its use and complexity.

• Therapeutic Categories:The list was divided into 27 therapeutic sections, with medicines arranged under subcategories such as anti-infectives, cardiovascular drugs, gastrointestinal medicines, and so on.

Composition of the NLEM 2011

Major Therapeutic Categories in NLEM 2011

The list included medicines across a wide range of health conditions and medical needs. Key categories include:

1. Anti-Infective Agents:
   • Antibacterials (e.g., amoxicillin, ciprofloxacin, co-trimoxazole)
   • Antivirals (e.g., zidovudine, oseltamivir)
   • Antimalarials (e.g., chloroquine, artesunate, artemether-lumefantrine)
   • Antitubercular drugs (e.g., isoniazid, rifampicin)
2. Analgesics, Antipyretics, and Anti-Inflammatory Drugs:
   • Paracetamol, ibuprofen, diclofenac sodium.
3. Cardiovascular Medicines:
   • Atenolol, amlodipine, enalapril, hydrochlorothiazide, and digoxin.
4. Antidiabetic and Endocrine Drugs:
   • Insulin (various types), metformin, glibenclamide, thyroxine.
5. Gastrointestinal Medicines:
   • Omeprazole, ranitidine, oral rehydration salts (ORS).
6. Respiratory Medicines:
   • Salbutamol, beclomethasone, theophylline.
7. Central Nervous System Drugs:
   • Diazepam, phenytoin, carbamazepine, haloperidol.
8. Anticancer and Immunosuppressive Agents:
   • Cyclophosphamide, methotrexate, tamoxifen, cisplatin.
9. Vitamins and Minerals:
   • Folic acid, ferrous sulfate, multivitamins for deficiency prevention.
10. Vaccines and Biologicals:
    • BCG, DPT, hepatitis B, oral polio vaccine, rabies vaccine.
11. Emergency and Antidote Drugs:
    • Atropine, epinephrine (adrenaline), activated charcoal, calcium gluconate.
12. Disinfectants and Antiseptics:
    • Povidone-iodine, chlorine-based disinfectants.

Key Features of NLEM 2011

1. Inclusion of Rational Combinations:
   • Only scientifically justified fixed-dose combinations (FDCs) were included, excluding irrational combinations.
2. Generic Names:
   • Drugs were listed by their generic (non-proprietary) names, not brand names, to promote rational prescribing.
3. Public Health Orientation:
   • Medicines addressing India’s major disease burden—infectious diseases, maternal and child health, and chronic diseases—were prioritised.
4. Alignment with National Programmes:
   • Inclusion of drugs used in key public health programmes such as Revised National Tuberculosis Control Programme (RNTCP), National Vector Borne Disease Control Programme (NVBDCP), and National AIDS Control Programme (NACP).
5. Regulatory Linkage:
   • The NLEM served as the basis for determining which medicines would be brought under price control through the Drug Price Control Order (DPCO) issued by the National Pharmaceutical Pricing Authority (NPPA).

Comparison with Previous List (NLEM 2003)

Significance of NLEM 2011

1. Guiding Procurement Policies:
   • States and central health agencies used the NLEM as a reference for medicine procurement and supply in public health facilities.
2. Basis for Price Control:
   • The Drug Price Control Order (DPCO) 2013 used NLEM 2011 to bring 348 medicines under price regulation, ensuring affordability.
3. Promotion of Rational Drug Use:
   • Reduced irrational and excessive use of non-essential or expensive medicines.
4. Standardisation of Healthcare Delivery:
   • Helped establish uniformity in essential drug availability across primary, secondary, and tertiary care levels.

Limitations of NLEM 2011

1. Delayed Updates:
   • The 2011 list was not revised frequently enough to incorporate newer medicines or treatment protocols.
2. Limited Coverage:
   • Some life-saving drugs and newer molecules were not included.
3. Implementation Challenges:
   • Variations in adoption by state governments and procurement agencies.
4. Exclusion of Certain Disease Areas:
   • Some rare diseases and advanced therapies were outside its scope.

Subsequent Developments

• NLEM 2015: Revised version released with 376 medicines, expanding coverage for non-communicable and life-threatening diseases.
• NLEM 2022: The most recent update includes 384 medicines, reflecting modern treatment needs and changing disease profiles.