The Indian Union Health Ministry recently launched an updated National List of Essential Medicines (NLEM), incorporating 384 drugs, including 34 new additions and excluding 26 from the preceding list. This concept of Essential Medicines, introduced by the World Health Organisation (WHO), comprises the medicines that cater to the primary healthcare requirements of a population.
Understanding the National List of Essential Medicines (NLEM)
The NLEM is a document released by India’s Ministry of Health and Family Welfare that lists medicines sold at prices capped by the National Pharmaceuticals Pricing Authority (NPPA). This list, crafted along the lines of the Essential Medicines List (EML) from WHO, had its first iteration in India in 1996 with 279 medicines.
The list has been updated several times since, in 2003, 2011, 2015, and 2022. The purpose of making such a list is to guide safe and effective treatment for prevalent diseases, promote rational use of medicines and optimize health resources. It also serves as a reference for state governments to prepare their own lists and manage medicine procurement and supply in the public sector.
Criteria for Inclusion in the NLEM
There are several factors taken into consideration before a drug is included in the NLEM:
1. Essentiality: The drug should be essential to a significant portion of the population and meet the definition stated above.
2. Changing disease burden: The disease burden fluctuates over time, which is accounted for when preparing the list.
3. Efficacy and Safety: The medical product must have indisputable efficacy evidence and a broad safety acceptance.
4. Cost-Effectiveness: The overall cost of the treatment should be considered.
5. Fixed Dose Combinations (FDCs): These are considered only if they give a proven therapeutic advantage.
6. Turnover: High sales alone do not justify inclusion in the NLEM; other factors should also be considered.
Conditions for Deletion from the NLEM
A drug may be deleted from the NLEM if it is banned in India, if concerns about its safety arise, or if a better drug in terms of efficacy, safety, and cost-effectiveness is available.
About Essential Medicine List (EML)
The EML considers disease prevalence, drug efficacy, safety, and comparative cost-effectiveness. The WHO updates the EML every two years through the Expert Committee on Selection and Use of Essential Medicines. The first country to formulate its own EML was Tanzania in 1970. In 1975, the World Health Assembly (WHA) requested WHO’s assistance in selecting and procuring essential medicines, maintaining quality, and managing costs. As a result, the initial WHO model list of essential medicines was published in 1977 and included 186 drugs.
Question from Previous Year (2013) UPSC Civil Services Examination
Q. What do you understand by Fixed Dose Drug Combinations (FDCs)? Discuss their merits and demerits.
