The Central Drug Standard Control Organization (CDSCO), the Apex drug regulatory authority of the country, plans to publish the revised National List of Essential Medicines (NLEM 2015). This is part of the policy initiative planned for the year 2015. The revision of NLEM is long overdue as it was prepared in 2011 and being criticized for several lapses. The revision is very much necessary as the list is linked to regulating the price of medicines.
The essential medicines are defined by the World Health Organization (WHO) as those medicines that satisfy the priority healthcare need of the population. These medicines are of utmost importance and are basic necessity for providing quality care. The health facilities must have uninterrupted availability of these limited number of medicines in appropriate dose with assured quality and adequate information and at an affordable price. The World Health Organization adopted the concept of essential medicines in 1977 as a part of ‘Health for All by 2000’. Though 'Health for All' could not be achieved, the concept of essential medicines remains valid and useful. The WHO first developed a model list of essential drugs in 1977 and since then the essential drugs list is revised every two years. The WHO has been advocating the national governments to develop their own essential medicines list for use within their territory. The WHO model list can be used as reference.
The terminology ‘drugs’ is being replaced by ‘medicines’. Concept of essential medicines has global acceptance applicable for both private and public sector and at different level of healthcare facilities. The essential medicine list, a compilation of limited number of safe and cost effective medicines, provides a higher quality of care, better management of medicines including utilization, and more cost effective use of health resources. The handling of limited number of medicines is easy too and their supply can be more easily maintained than handling large number of medicines. Though concept of essential drugs was initially designed for resource constraint situations/facilities, the concept is no longer restricted to poor and developing countries. The credit of using this innovative idea of using carefully identified limited number of medicines in the health system goes to Sri Lanka dated back to 1959 much earlier than the WHO’s adoption.
The WHO revises the model list of essential medicines periodically. The model list is for guidance to develop National or facility based list. The model is not for global acceptance. The choice of medicines for the list is made after careful consideration of factors like disease burden, sound and adequate data on safety, efficacy and comparative effectiveness of treatment. In cost comparisons between medicines, the cost of total treatment is considered and not just the unit cost. Cost and cost effectiveness are considered among the alternate treatment within the same therapeutic category. The revision of model list is done in a transparent way using predefined procedure where experts and other stake holders have opportunities to provide feedback.
The first National List of Essential Medicines called National Essential Drugs List was prepared in 1996 which was then revised in 2003 as National List of Essential Medicines (NLEM). Nearly eight years after the preparation of previous list and with Supreme Court of India’s direction, the Health Ministry developed the third list in 2011. Though the list was developed after wide consultation for almost two years, it was not done in a transparent manner. It was not kept in public domain inviting suggestions from all stake holders. The list had many omissions and errors. It was alleged that the revision failed to incorporate many essential medicines which belong to anti-diarrhoeal, anti-TB, anti-diabetics, etc. All these therapeutic categories are of significant health influence for our country. The lacuna of NLEM 2011 varied from improper selection to non-inclusion of vital medicines to many syntax errors. The Government of India too was not serious as evident from not using National List of Essential Medicines for healthcare. At last the National List of Essential Medicines found some use when the Supreme Court directed the Government of India to bring price control mechanisms to make the medicines more affordable. The Price Control Order 2013 brought the prices of all medicines in National List of Essential Medicines under price capping. It brought down the prices of from just few medicines (Drugs Price Control Order 1995) to 348 medicines (Drugs Price Control Order 2013). As many of vital medicines are not included in the list these medicines remain outside the domain of price control order.
The WHO advises the countries to develop the essential medicines list for national level as well as for healthcare facility levels. The list which is imposed from the above may not have much acceptance by the healthcare providers. The locally developing list provides opportunity to the local healthcare providers to participate in the development and the latter would have ownership feeling too. The selection process should be consultative and transparent and must be linked to evidence based clinical guidelines. The Government of India has no clinical guidelines except of National Programmes like TB, HIV, Malaria etc. and old standard treatment guidelines for selected conditions developed by Armed Force Medical College in association with WHO country office.
Essential medicines list is a continually changing tool which needs periodic revision based on change in disease epidemiology, new findings of old medicines and introduction of new medicines. Though our National List of Essential Medicines could not be revised periodically as advocated by the World Health Organization, when the Government proposes to revise the 2011 List, it needs to be done in a transparent manner so that all stakeholders can provide their input. This would not only help in avoiding the avoidable mistakes or errors but also improves the credibility. The list needs to be more than just ornamental. The Government should think of utilising the list for procurement of medicines for healthcare facilities and price control of medicines for open market.
(Author is with Division of Pharmacy Practice, Department of Pharmacy, Annamalai University, Annamalai Nagar PO, Tamil Nadu)