The Core-Committee (Committee) constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India, reviewed and revised the National List of Essential Medicines(NLEM),2011 and formulated the criteria for inclusion and deletion of medicines in National List of Essential Medicines based upon the directions to look into the matter of coronary stents directed by Hon'ble High Court of Delhi in the Writ Petition No 1772 of 2015 wherein petitioner filed PIL seeking a direction to the respondents to include coronary stents in the National List of Essential Medicines (NLEM) thereby controlling the sale price of the same.
Findings of the Committee
Upon the detailed examination, the Committee came to know that all the medicines are not listed in the National List of Essential Medicines (NLEM), 2011. The Committee opined that all medicines are essential and is taken only when it is needed by the patient and all these medicines, including life saving drugs, should be available in the market at affordable price. To keep this in view, the Committee recommended that the scope of price control needs to be enlarged to make all the drugs available, especially life saving drugs. Expressing concern over large sum of money spent on importing pharmaceutical products, the panel also called for incentivising domestic bulk drug industry and discourages Indian firms from buying from overseas. The report of the Committee addressed the topics pertaining to concept of essential medicines, criteria's considered for framing the NLEM and the necessity of revising the NLEM on a regular basis due to changing disease burden profile, emergence of antimicrobial resistance, development of newer and better medicines to preserve NLEM's relevance. NLEM has been revised twice the last being in 2011 and Committee recommended the revision of it at every three years.
Salient Feat ures of NLEM 2015
There were 348 medicines listed in NLEM, 2011. A total of 106 medicines have been added, and 70 medicines have been deleted to prepare NLEM, 2015 which now contains a total of 376 medicines. Medicines in NLEM, 2015 are listed with reference to the levels of healthcare, namely, Primary (P), Secondary (S) and Tertiary (T) because the treatment facilities, training, experience and availability of health care personnel differ at these levels. There are 209 medicine formulations listed for all levels of health care (P, S, T),115 medicine formulations for secondary and tertiary levels (S, T) and 79 medicine formulations for the tertiary level (T). It is to be noted that formulations of certain medicines are listed at different levels but as item, they are counted as one. The total number of medicines remains 376. The essentiality of a medicine has been considered in terms of its dosage form and strength also. In general, medicines have been mentioned with respect to their active moieties, without mentioning the salts. The NLEM, 2015 has been prepared adhering to the basic principles of Efficacy, Safety, Cost- Effectiveness and considering of diseases as public health problems in India.
What is an Essential Medicine
As per the World Health Organization, Essential Medicines1 are those that satisfy the priority health care needs of the population. The list is made with consideration to disease prevalence, efficacy, safety and comparative cost-effectiveness of the medicines. Such medicines are intended to be available in adequate amounts, in appropriate dosage forms and strengths with assured quality. They are available in the market such a way that an individual or community can afford. The concept of essential medicines revolves around addressing "priority health care needs" specific to a country. It is therefore important to take into consideration the 'burden' of diseases in that population. The burden of a disease may vary from country to country, so do the priority health care needs. For example, tuberculosis, malaria and diarrheal diseases are priority health care concerns in lowand middle- income countries, but it may not be so for high- income countries. On the same lines, trypanosomiasis may be a priority health care concern in the African region where it is endemic but not so in India.
Criteria Considered For Inclusion of A Medicine Into NLEM, 2015
For inclusion of a medicine into NLEM, 2015, certain criteria were considered such as medicine to be licensed and approved in the country by Drugs Controller General (India); medicine to be useful in disease which is a public health problem in India; medicine have proven efficacy and safety profile based on valid scientific evidence; medicine to be comparatively cost effective; medicine aligned with the current treatment guidelines for the disease; medicine to be stable under the storage conditions in India2. In addition to these criterias, other criteria were also considered such as, when more than one medicine are available from the same therapeutic class, preferably one prototype, medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost-effectiveness; price of total treatment is considered and not the unit price of a medicine; Fixed Dose Combinations are not included unless the combination has unequivocally proven advantage over single compounds administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance; the medicine in NLEM, 2015 are based at primary/ secondary/tertiary level of health care according to treatment facilities and training, experience and availability of health care personnel at these levels.
Criteria Considered For Deletion of A Medicine Into NLEM, 2015
Deletion of any medicine from the NLEM is based on certain conditions like the medicine has been banned in India; existence of reports of concerns on the safety profile of a medicine; if medicine with better efficacy or favourable safety profile and better cost-effectiveness is available; the disease burden for which a medicine is indicated is no longer a national health concern; and in case of antimicrobials, if the resistance pattern has rendered a medicine ineffective etc.3
Specific Issues Deliberated During The Revision Process
The specific dimensions were considered during the deliberation by the Core- Committee for revising the NLEM, 2015 such as, dosage forms/ formulations; strengths of medicines; salts of active moieties of medicines; isomers/ analogues/ derivatives etc. of medicines; medicines in national health programmes; pack size of formulations; incremental innovation; formulations of modified release/ sustained release/ extended release etc., and improved or novel drug delivery systems.
Enforceability of NLEM
NLEM is a list of medicines prepared by the Ministry of Health and Family Welfare based on essentiality and made part of the Drugs Price Control Orders (DPCO), 2013 (DPCO 2013) in the form of first Schedule of the DPCO 2013. DPCO 2013 is an order issued by the Central Government having power under section 3 of the Essential Commodity Act, 1955 which enables it to fix the prices of essential bulk drugs and their formulations mentioned under the NLEM. The formulations which are included in NLEM i.e. first Schedule of the DPCO 2013 whether referred by generic name or brand are known as Scheduled Formulations. Any person acting in contravention of the DPCO 2013 is punishable under section 7 of the Essential Commodities Act, 1955, punishable with imprisonment for a term of not less than three months and may extend upto seven years. Where the person is convicted again the court may in addition to the penalty, direct the person to abstain from doing any business in essential commodities for a period not less than six months. Any company which is found acting in contravention of the DPCO 2013, the person responsible for the conduct of the business of such company shall be liable along with the company, for such contravention of the order.
Revision of NLEM in 2015 was based on the complex process in the light of fast changing concepts in medicines, treatment regimens, introduction of new technologies and incremental innovations in drug delivery systems and formulations, wide differences in medical practice pattern in the country, regional variations in health care system etc. NLEM has been made part of the DPCO 2013 which gives right to the Central Government to fix/regulate the prices of formulations listed therein.
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