National List of Essential Medicines of India 2011
The National List of Essential Medicines of India 2011 (NLEM 2011) is a list of medicines, prepared by the Ministry of Health and Family Welfare, which are considered essential in India. The first such list was released in 1996. That list was subsequently revised in 2003. The latest list prepared and released in 2011 addresses the issues of changing disease prevalence in the country and the associated treatment modalities, besides taking into consideration the new medicines which are now available.
World Health Organisation defines ‘essential medicines’ as those that satisfy the priority health care needs of the population. The medicines are selected with regard to the prevalence of disease, efficacy, safety and comparative cost-effectiveness. These medicines are intended to be available within the health systems in adequate amounts, in appropriate dosages, with assured quality.
In 2010-11, the National List of Essential Medicines 2003 (NLEM 2003) was reviewed by an expert core committee in the context of contemporary knowledge of therapeutic products being available. The committee was of the view that the list of essential medicines prepared by World Health Organisation could not be adopted by India as such, but needed to be modified to suit country-specific needs. The purpose of NLEM 2011 is to promote the rational usage of medicines considering their cost, safety and efficacy. NLEM 2011 consists of 348 medicines, spanning across 27 therapeutic segments. From NLEM 2003, 47 medicines were deleted and 43 added to arrive at NLEM 2011. NLEM 2011 presents the category of essential medicines, the route of their administration and their dosage strengths.
A definition of “National List of Essential Medicines” has now appeared in the Drug Price Control Order 2013. According to it, NLEM means National List of Essential Medicines, 2011 published by the Ministry of Health and Family Welfare as updated or revised from time to time and included in the first schedule of the Drug Price Control Order by the Government through a notification in the Official Gazette;
Purpose of NLEM
The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e. cost, safety and efficacy. NLEM is one of the key instruments in balanced healthcare delivery systems of the country which includes accessible, affordable quality medicines at all the primary, secondary and tertiary levels of healthcare.
The concept of essential medicines, first introduced by WHO in 1977, has now been adopted by many countries, non-governmental organizations and international non-profit supply agencies though not to the same extent. The list is considered to include the most cost-effective medicines for a particular indication. It is developed in concordance with the standard treatment guidelines keeping in mind the healthcare needs of the majority of the population.
Careful selection of a limited range of essential medicines results in a higher quality of care, better management of medicines and more cost-effective use of health resources. The list of essential medicines guides the hospital drug policies, procurement and supply of medicines in public sector, medicine cost reimbursement and medicine donations. It helps in monitoring the pricing of medicines. The list serves as a reference document for correct dosage form and strength for prescribing. Preference is given to single drug formulations as opposed to fixed dose combinations where appropriate. Hence use of NLEM is expected to improve prescribing practices as well as the health outcomes. The appropriate use of medicines selected in the NLEM promotes rational use of medicines. Such rational use of medicines, especially antimicrobial drugs, reduces development of drug resistance. The list also serves as a reference for assessing the healthcare access of the populace. Lastly, NEML serves as a tool for public education and training of healthcare providers.
WHO list of Essential Medicines
The WHO Model List of Essential Medicines which serves as a guide for the development of national and institutional essential medicine lists is updated and revised every two years by the WHO Expert Committee on Selection and Use of Medicines. The 19th WHO Model List of Essential Medicines and 6th WHO Model List of Essential Medicines for Children were endorsed by the 20th WHO Expert Committee on Selection and Use which met in April 2015.
The Model List is a guide for the development of national and institutional essential medicine lists. It was not designed as a global standard. However, for the past 30 years the Model List has led to a global acceptance of the concept of essential medicines as a powerful means to promote health equity. Most countries have national lists and some have provincial or state lists as well. National lists of essential medicines usually relate closely to national guidelines for clinical health care practice which are used for the training and supervision of health workers.
- National List of Essential Medicines of India 2011 (NLEM 2011)
- WHO Guidelines on Essential Medicines
- WHO list of Essential Medicines