After three long years, the National List of Essential Medicines (NLEM) is being revised and the process of consultations is now over. The Core Committee is expected to submit its final recommendations by the end of March, following which the government would announce the revised list. The Indian healthcare sector keeps its fingers crossed. As per the indications given by members of the Committee, the revised list would be ‘healthier’ (number of medicines going up) and ‘India-centric’ (medicine appropriate for wide prevalence of diseases in the country).
The NLEM caters to the primary healthcare needs of the country. Safety, efficacy and cost-effectiveness are its core concerns. It ensures availability of medicines in adequate amount and appropriate dosage forms with assured quality at an affordable price. The list of essential medicine is revised and updated from time to time in the context of contemporary knowledge of therapeutic products and their uses. The first NLEM was prepared and released in 1996. It was subsequently revised in 2003. The NLEM 2011 has 348 medicines from 27 therapeutic categories such as cardiovascular, anti-cancer, antineoplastic, immunological, anti-infective, ophthalmological preparations, diuretics, anti-allergic, etc. Medicines have also been categorised on the basis of essentiality at different levels of healthcare.
There are 181 medicines for primary (P), secondary (S) and tertiary (T) healthcare. 106 are for secondary(S) and tertiary (T) healthcare, while 61 are for tertiary (T) healthcare only.
To revise NLEM 2011, a core committee, headed by VM Katoch, secretary, department of health research, was formed in May 2014. Prof YK Gupta, Head of Pharmacology Department, AIIMS is the Vice-Chairman of the committee that has completed five rounds of consultations with expert groups in five metros. During the meetings, experts have rightly suggested that we need India-centric list as prevalence of diseases is not similar in the USA or Europe. The core committee should take all aspects under consideration to identify more drugs for the NLEM. It should ensure that all life-saving and essential drugs of mass consumption are included in the revised NLEM for safeguarding public interest.
The core committee has carried out a comprehensive analysis of the top 300 molecules “in terms of moving annual total (MAT) volume and MAT value” and other studies. The issues such as strengths and dosage forms are taken care of.
The committee has given due emphasis on preparing a separate list of lifesaving drugs on the basis of existing list of government agencies like the CGHS. It also revisited the region-specific needs as reflected in states’ essential drugs lists.
Is Largest Selling Medicine Essential?
Neither every medicine nor the largest selling drugs can or should be categorised as essential. We have witnessed that price mechanism is sometimes guided by market forces and some essential drugs mentioned in the NLEM disappear from the market. So, apart from essential drugs list, we need to inculcate rational prescription practice among doctors. The new NLEM should also ensure that it does not kill innovation and manufacturing in India. We have a tendency to import cheaper drugs from China if they are found expensive to manufacture in the country. The Committee is following a transparent mechanism and the reasons for addition and deletion would be made public at the draft stage.
In this context, Prof Gupta pointed out that it would be difficult to create an ideal list. However, he expects to have a ‘best fit list’, which should not be perceived only as a tool of price control.
Need for an Effective Delivery System
The objective of the NLEM is to include drugs that are adequate to meet the contemporary health needs of the common people. It is one of the key instruments for balanced healthcare delivery system of a country. For the health administrators, it is a general obligation to ensure adequate availability of these drugs. Amendments in the Drugs and Cosmetics Rules, 1945 are needed and strengthening of rules pertaining to quality control of drugs, cosmetics and medical devices is also a prerequisite. Introduction of provisions related to phytopharmaceutical drugs (ingredients having origin in plants) under the system of modern medicine is also essential for a strong delivery system. Reforms should include simplification and rationalisation of various formats of applications and licences under the Drugs and Cosmetics Rules, 1945.
We hope that the NLEM 2015 addresses issues related to pricing of drugs and their availability. It would be prudent if the government makes public the rationality behind inclusion of new drugs.
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