INTRODUCTION:

In 1977, the World Health Organization (WHO) first proposed the idea of essential medications. The medications that meet the population's top healthcare demands are considered to be essential. They are chosen with consideration for their potential impact on public health, evidence of their efficacy and safety, and comparative cost-effectiveness. In the framework of functioning healthcare systems, essential medications should always be accessible in sufficient quantities, in the proper dosage forms, with guaranteed quality and adequate information, and at a cost that both the individual and the community can pay. The definition of what constitutes an essential drug is left up to each country, and the idea is meant to be flexible and adaptable to a wide range of circumstances. Experience has demonstrated that limiting the number of essential medicines to a small number improves the quality of care, the management of medications (including the quality of prescription medications), and the efficient use of the financial resources for healthcare.¹

India's initial list was created in 1996 and was based on the concepts of the World Health Organization's list of essential medications. Since then, it has undergone four revisions in 2003, 2011, 2015, and the present 2022. The adjustments are made while taking into account the evolving illness landscape in the nation, newly marketed treatments, drugs that are becoming dated or are no longer available due to dangers, and newer treatment regimens. It assists government organisations who do offer free drugs in prioritising which ones to distribute and it can also be utilised by organisations that reimburse the cost. The list also aids in educating aspiring physicians on the sensible use of medications. The list's primary purpose is to make these medications more accessible to the general public.²

Purpose:

Careful selection of a small number of important medications leads to better medication management (including increased quality of prescription medications) and more economical use of healthcare resources. The effect of clinical recommendations and lists of important medications on the accessibility and appropriate usage of medications within healthcare systems has been the subject of numerous research. Under these conditions, actions taken to assure a steady supply of necessary medications will lead to real health advantages and higher public confidence in the availability of healthcare services.³

Evolution of essential medicines:

The idea of "critical medicines" developed from military custom, in which soldiers were required to carry important medications (such antibiotics) into conflict zones.⁴ Governments had been concerned about the situation for years before to WHO's engagement in the essential medication idea and a few had begun to take action by supplying their citizens with the essential medicines in order to meet their therapeutic needs.⁵Cuba may have been the first nation to publish a list of essential medications in 1963.⁶Tanzania (1970)and Peru (1972) introduced national lists.⁶The first WHO Model List of Essential Medicines, which contained 212 medications, was issued in 1977.⁷

Rationale:

The idea of essential medications is connected to both supply and demand perspectives. On the demand side, public healthcare facilities only partially meet the medical demands of those from low socioeconomic strata. A medical innovation that involves discovery, production, and distribution is primarily driven by the market from the perspective of the supply.⁸ Pharmaceutical manufacturers and independent pharmacies stock these medications under the influence of return on investment in order to increase profits and focus on patients who can afford more expensive medications. Essential medications are still inaccessible in this situation since they are not affected by the supply and demand cycle.^5,9 The idea behind essential medicines is that even though there are many medicines that have been registered and are available on the market, it is important to be selective when taking into account the medical requirements of the majority of citizens as well as to ensure the safety, efficacyand affordability.

Essential medicines policies:

According to the Lancet Commission on Essential Medicines Policies(EMP), there have been three distinct periods in which EMP formulation and subsequent implementation have taken place.¹⁰The procurement, supply, prescription, and dispensing of medications as well as financial and incentive policies and the prudent use of medications, are standard components of an EMP.^{10, 11} In order to achieve Universal Health Coverage (UHC) by 2030, WHO has developed a framework to assist decision-makers in enhancing access to essential medications. This includes the four components listed below and is consistent with the Sustainable Development Goals (SGDs).¹²

· The creation of national standard treatment recommendations and national EML are related to the rational choice and use of important medications.

· Accessibility and affordability: These two aspects must be convinced through a variety of means, including the use of objective price information, allowing price competition, encouraging bulk purchases, enacting generics policies, negotiating fair pricing or the removal of duties, tariffs and taxes and encouraging local production of high-quality medications.

· Sustainable finance can be ensured via a variety of methods, such as decreasing out-of-pocket expenses, increasing public funding, expanding health insurance programmes and investigating alternative sources of funding and financing.

· Reliable health care and a steady supply of high-quality goods are critical to maintaining access to essential medications. Development of the health sector, an effective public-private-NGO mix, regulatory supervision, an efficient procurement system the use of complementary and alternative medicines are all factors that support an efficient health and supply system.³⁴

WHO provides advice to nations on a variety of drug pricing options that are available to governments and healthcare systems.¹³"Internal and external reference pricing, "¹⁴ "Reimbursement limits and fair co-payments, "¹⁵" Controlling increases to factory-gate prices," "Establishing distribution chain price controls" and "Governing professional and other fees" are some of the topics covered.¹⁶ While many policy options are applicable to nations where the public sector provides the majority of healthcare, other options are only made available when nations adopt a purchaser supplier split.¹⁷

· Procurement interventions

§ Pooled procurement employing little competition (tender)

§ Pooled procurement (or the use of monopsony power), with price negotiations based on volumes purchased or inclusion on a list of items eligible for reimbursement

· Pro-generic policies (note that these policies also rely on an effective medicines regulatory authority, which can assure the quality of all products on the local market)

§ International non-proprietary name prescribing

§ Mandatory offer of generic substitution or enablement of generic substitution by pharmacists and other dispensers

· Pricing interventions

§ Reduction or removal of import taxes or sales taxes

§ Internal reference pricing (note that this type of pricing is also a pro-generic policy, as it depends on the ability to set a reimbursement limit by reference to the price of a selected generic option)

§ External reference pricing

§ Regulation of distribution chain mark-ups

§ Regulation of professional fees

§ Regulation of annual factory-gate price increases

§ Patent-related interventions such as encouragement of voluntary licensing and patent pools

Fundamental rights of human:

· Every human being has the inherent right to the best possible level of health, regardless of ethnicity, religion, political beliefs, economic status or social standing.¹⁸

· Everyone has the right to a standard of living that is sufficient for his or her family's health as well as their own, including access to food, clothing, housing, medical treatment and essential social services.¹⁹

· Governments and the international community have a duty to guarantee that the right to health is gradually realised. This duty includes the requirement to prevent, treat, and control disease as well as to establish the prerequisites for ensuring access to medical facilities, suppliesand services.²⁰

· Of course, having access to products and services includes having access to the vital medications required for the treatment and prevention of common ailments.

Any health system attempting to achieve UHC faces a major hurdle in the pricing of necessary medications.²¹A crucial element of UHC is a suitable benefit package that includes carefully chosen critical medications.²² The capacity "to acquire a necessary quantity of a product or level of service without experiencing excessive financial hardship" is referred to as affordability.²³Comparing the cost of a treatment course payment to the household's available resources is a popular technique to gauge affordability at the individual or household level.^{23, 24}

Despite being readily available from numerous sources, many settings cannot afford commonly used necessary drugs. This is especially valid for people who are paying cash. Patients are compelled to use their own money to pay for medications when they are not available in the public sector.²⁵ Between 2007 and 2014, generic medications were accessible in an average of 58% of public health facilities in Lower income class(LIC) and lower-Middle income class(MIC) (availability ranged from 17% to 100%).²⁶

When medications must be used continuously, as is the case for the treatment of chronic communicable or noncommunicable diseases, affordability becomes a serious issue. Treatments for hypertension are frequently more expensive than necessary medications for diabetes and cancer. However, a review of the costs of four widely used cardiovascular drugs at private pharmacies across 18 nations revealed that they may be out of reach for at least some patients in each nation. It also observed a major lack of data to fully track progress. It stated that access to necessary medicines at affordable costs remains highly problematic, with many households being priced out of the market due to high pricing and limited supply. It is necessary to analyse and comprehend price data in order to develop solutions that would increase affordability. However, there are significant gaps in the availability and quality of data on the cost and accessibility of medicines that have been carefully gathered and examined on a global scale.²⁷

National list of Essential Medicines (NLEM):

The NLEM is a dynamic document that is regularly updated to reflect evolving public health goals and new findings in the field of pharmaceuticals. The NLEM was initially developed in 1996 and has since undergone three revisions, in 2003, 2011, and 2015. 2018 saw the establishment of the independent Standing National Committee on Medicines (SNCM) by the Union Health Ministry. The Committee amended the NLEM, 2015 after extensive consultation with experts and stakeholders. It then presented its report on the NLEM, 2022 to the Ministry of Health and Family Welfare.

The idea is founded on the idea that a small number of well-chosen drugs can enhance healthcare quality, offer affordable healthcare and facilitate better administration of medications. The main goal of NLEM is to encourage the sensible use of medications while taking into account its three key components, namely cost, safety and efficacy. Additionally, it aids in developing pharmaceutical policies, drug procurement policies, health insurance, bettering prescribing practises, medical education and training for UG/PG students and the most effective use of healthcare resources and budget.

According to the level of the healthcare system, medications are classed in NLEM as follows:

· P- Primary

· S- Secondary

· T- Tertiary

The choice to include a medicine in the NLEM is influenced by a number of variables. A shifting illness burden also has an influence on the decision-making process in the context of NLEM, where a treatment may be necessary when taking the entire population into account. Efficacy, safety and cost-effectiveness are further considerations. If another medication performs better in terms of these aforementioned parameters, the drug in question is withdrawn from the NLEM. 34 new medications have been added to the list of 384, while 26 pharmaceuticals from the previous list have been removed. 27 therapeutic categories have been used to group the medications.²⁸

Criteria for inclusion of a medicine in NLEM:

Essentiality: Depending on the exact illness conditions it is prescribed for, each medication may be required or even crucial. However, in the context of NLEM, a medication may be necessary taking into account the general population should adhere to the previously given criteria.

Changing Disease Burden: The load of the disease must be taken into account while choosing the crucial medications. According to the rules established by the federal government in 2015, medications are required to treat diseases that are either very prevalent or emerging diseases in the community.

Efficacy and Safety: A medication has to have clear proof of effectiveness and widespread acceptance in the medical community in order to be deemed necessary. The drug should have a safety profile that passes muster in terms of weighing risk vs benefit.

Comparative Cost-effectiveness: Sometimes a medicine's per-unit cost may be higher yet it may only need to be administered seldom. According to the website, the treatment schedule's overall cost should be considered rather than just the unit price²⁹

· Be beneficial in illnesses which is a public health concern in India.

· Be licensed/ authorised Drugs Controller General (India) (DCGI) (DCGI).

· Have demonstrated efficacy and safety profile based on scientific data.

· Be reasonably cost-effective.

· Be aligned with the current therapy standards.

· Suggested under India's National Health Programs. (e.g. Ivermectin part of Accelerated Plan for Elimination of Lymphatic Filariasis 2018).

· One prototype or the medically best-suited pharmaceutical from that class should be provided when more than one medication is available from the same therapeutic class.

· Price of whole therapy is evaluated and not the unit price of a drug.

· Typically, fixed dosage combinations are excluded.

· Vaccines that are added to the universal immunisation programme as needed (such as the rotavirus vaccine)³⁰

When is a medicine deleted from NLEM:

The government considers a number of crucial factors in this, including:

· The drug is no longer available in India

· There are reports of worries regarding the safety profile of a drug

· There is now a medication with improved efficacy or favourable safety profiles and improved cost-effectiveness.

· In India, the prevalence of the ailment for which a medication is suggested is no longer a public health concern²⁹

The significant additions to the NLEM-2022:

The revised list has added 34 drugs that were not in the NLEM-2015, most crucially it has added four cancer treatments

· Bendamustine hydrochloride, which is used to treat specific kinds of lymph node and blood malignancies

· Irinotecan HCI Trihydrate, a medication used to treat pancreatic and colorectal tumours

· Lenalidomide for the treatment of several types of cancer³⁶

· Leuprolide acetate for prostate cancer treatment^{39, 40}

The medication Teneligliptin and the insulin Glargine, both members of a more recent family of medications that doctors now often use to control diabetes, have also been added to the list.^35,42

Additionally, the government's universal immunisation programme now includes the rotavirus vaccination.³⁷

Four medications on the list are still covered by patents, and they are as follows:

· Bedaquiline and Delaminid for TB⁴¹

· Dolutegravir for HIV³⁸

· Daclatasvir for the treatment of Hepatitis C

They all fall within the government's national health programmes. Considering that patented medications often cost more, this is the first time they have been listed.

Meropenem and the anti-parasitic antibiotic ivermectin were also added.³¹

Calculation of ceiling price of a scheduled formulation:

The ceiling price of a scheduled formulation of defined strengths and doses as stipulated under the first schedule should be computed as under:

Step1. First, the planned formulation's average price to retailers, i.e. P(s) will be determined as follows:

Average Price to Retailer, P(s) = (Sum of prices to retailer of all the brands and generic versions of the medicine having market share more than or equal to one percent of the total market turnover on the basis of moving annual turnover of that medicine) / (Total number of such brands and generic versions of the medicine having market share more than or equal to one percent of total market turnover on the basis of moving annual turnover for that medicine.)

Step 2. Thereafter, the ceiling price of the scheduled

formulation i.e. P(c) shall be calculated as below:

P(c) = P(s). (1+M/100), where

P(s) = Average Price to Retailer for the same strength and dosage of the medicine as calculated in step1 above.

M = % Margin to retailer and its value =16

(2) The ceiling price calculated as per sub-paragraph (1) and notified by the Government shall be applicable to scheduled imported formulations also.^{32, 33}

CONCLUSION:

According to this study, non-essential medications are less common in healthcare settings than essential medications. The implementation of the essential medicines list has caused essential medicines to be prioritised, especially in low- and lower-middle income countries. The essential drugs concept, first proposed in 1975, is now widely acknowledged as a highly pragmatic strategy for providing the best of contemporary, evidence-based, and cost-effective healthcare. The difficulty is in keeping treatment choices current in light of new therapeutic possibilities, evolving therapeutic requirements, the need to assure drug quality and ongoing development of newer medications, medications for developing disorders, and medications to address shifting resistance patterns. Additionally, there is a need to close any gaps in the accessibility, price, and availability of medications for the poor.

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Received on 15.12.2022 Modified on 23.08.2023

Asian J. Res. Pharm. Sci. 2024; 14(1):87-91.

DOI: 10.52711/2231-5659.2024.00014