National List of Essential Medicines (NLEM) for Animal Use in India

National List of Essential Medicines (NLEM) for Animal Use in India

National List of Essential Medicines

The outbreaks of disease in the animals have major social and financial impacts. Animal diseases are not only danger to the Indian economy but also equally important in respect to the human health. During the recent years, majority of the infectious emerging diseases affecting the human have originated from animals. Thus, it is logical to safeguard the animal health which important for sustaining the human health. National required to be prepared based on the disease burden, priority health concem(s), affordability concerns and to be harmonized with the International Guidelines or literature for selecting use of Veterinary medicines as per the diseases prevalence and objective evidences.Therefore, there is a need for preparation of the National List of Essential Medicines (NLEM) for Veterinary use.

National Animal Disease Control Programme (NADCP) on Foot on Mouth Disease (FMD) and Brucellosis was launched by the Hon’ble Prime Minister of India from Mathura (UP) in coordination with the Ministry of Fisheries, Animal Husbandry and Dairying which  envisages to fully control the FMD by 2025 through vaccination and to eradicate it by 203(h while control of brucellosis by calf-hood vaccination with Brucella abortus S19 vaccine. In this regard. Department of Animal Husbandry and Dairying /made communication with the Ministry of Health and Family Welfare conveying that in the light of the essentiality and disease burden in the country along with and safety, etc., the FMD (Trivalent) Oil Adjuvant Vaccine and Brucella abortus vaccine to be included in the National List of Medicines (NLEM) on priority so that the s and effective veterinary vaccines can be made available to the stakeholders on reasonable to help make the national flagship programme successful within the stipulated time-frame. Accordingly, considering the need to examine the issue holistically, the Committee was constituted by the Ministry of Health and Family Welfare (MoHFW), Government of India vide File No. X-11035/385/2019-DRS, dated 15/10/2019 under the Chairmanship of Dr R.K. Singh, Director, Indian Veterinary Research Institute, Izatnagar, U.P, India to prepare List of Essential Medicines for Animal Use (Annexure 1).

What is an Essential Medicines List

As per the World Health Organisation (WHO), Essential Medicines 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 should be available in such a way that an individual or community can afford.

Drawing an essential medicines list (EML) is expected to result in better quality of medical care, better management of medicines and cost-effective use of health care resources. This is especially important for a resource limited country like India. The list of essential medicines is intended to have a positive impact on the availability and rational use of medicines

History of the Essential Medicines List

The first country in the world to compose its EML was Tanzania in 1970. Then in 1975, the World Health Assembly requested WHO to assist member states in selecting and procuring essential medicines, assuring good quality at reasonable cost.

Subsequently, the first WHO model list of essential medicines was published in the year 1977 which contained 186 medicines. It stated that essential medicines were “of utmost importance, basic, indispensable and necessary for the health and needs of the population” and criteria for selection were based on efficacy, safety, quality and total cost. The emphasis was laid on disease burden and treatment guidelines as basis for selecting medicines to the EML.

In 1985, the list of essential medicines of the WHO was recognised as important mainly for the public sector and its scope was to guide the procurement, distribution, rational use and quality assurance of medicines. The scope and ambit of WHO EML were gradually widened and the number of medicines in the WHO EML increased over the years.

National List of Essential Medicines (NLEM)

The WHO EML is a model list. The decision about which medicines are essential remains a national responsibility based on the country’s disease burden, priority health concerns, affordability concerns etc. Ministry of Health and Family Welfare, Government of India hence prepared and released the first National List of Essential Medicines of India in 1996 consisting of 279 medicines. This list was subsequently revised in 2003 and had 354 medicines. Later in 2011, the list was revised and had 348 medicines. Till June 2018, 851 medicines (including 4 medical devices i.e. Cardiac stents, drug eluting stents, condoms and intra uterine devices) are regulated under Revised Schedule – I based on National List of Essential Medicines, 2015 (NLEM, 2015). To access the complete NLEM 2015,

Purpose of the National List of Essential Medicines

The NLEM may have multiple uses. It can:

• Guide safe and effective treatment of priority disease conditions of a population
• Promote the rational use of medicines
• Optimize the available health resources of a country It can also be a guiding document for:
  • State governments to prepare their list of essential medicines
  • Procurement and supply of medicines in the public sector
  • Reimbursement of cost of medicines by organizations to its employees
  • Reimbursement by insurance companies
  • Identifying the ‘MUST KNOW’ domain for the teaching and training of health care professionals

Considerations for Framing the NLEM 2015

• Essentiality – Every medicine may be necessary or even critical for specific disease conditions for which it is indicated. But in the context of NLEM, a medicine may be essential considering the population at large and should fit into the definition mentioned earlier. Hence, a medicine which is critical for a specific condition may not be listed in the list of essential medicines if the disease condition for which it is indicated has low prevalence or is rare. This does not mean that if a particular medicine is not included in the list of essential medicines, it is not necessary. In no way, exclusion of such medicines from the list undermines their importance in therapeutics and need of their availability at an affordable cost.
• Changing Disease Burden – Disease burden is an important consideration for identifying the essential medicines. Medicines needed to manage diseases that are highly prevalent or are emerging diseases in the population will qualify for inclusion in the NLEM. For example, MDR tuberculosis is increasing in incidence and is a public health issue. Similar is the case with increasing prevalence of resistant malaria. These necessitate the inclusion of medicines in NLEM to address the above issues.
• Efficacy and Safety – Safety and efficacy are the most important criteria for considering essentiality of a medicine. For a medicine to be considered essential, it should have an unequivocal evidence of efficacy and wider acceptance in medical science. The medicine should have a safety profile which is acceptable in terms of risk benefit assessment. The safety profile of a medicine may change over time as new adverse effects may be discovered after wider use of the drug. This may change the risk benefit assessment and a drug once preferred may no longer remain so. For example, pioglitazone is an effective and cheap antidiabetic drug but it recently came under the scanner because of the safety concern of bladder cancer. Though the drug finds its use in specific diabetic conditions, the same is with various safety restrictions. Therefore, pioglitazone has not been considered essential in spite of being effective for a specific diabetic condition.
• Comparative Cost-effectiveness – This is especially important when selecting more than one medicine from the same therapeutic category and when they do not differ significantly in their efficacy & safety. Sometimes per unit price of the medicine may be more but it may be required to be given at a lesser frequency. Thus the total price of the treatment schedule should be taken into consideration and not the unit price alone.
• Feasibility in context of advantage and cost-effectiveness – An essential medicine should be available in a form in which adequate quality throughout its shelf-life under recommended storage conditions is ensured. For example, liquid formulation of antisnake venom is cheaper and equi-efficacious as compared to the lyophilised preparation. However, lyophilisation involves use of technology and cost. Whereas, liquid formulation requires cold chain, which is sometimes difficult to maintain in its distribution channel. Considering the advantage of one and the costeffectiveness of the other, both lyophilized and liquid formulations have been included in the List. They have been listed as separate items and should be considered differently by the user of NLEM.
• Fixed Dose Combinations (FDCs) – As a principle, single medicines are to be preferred. FDCs are included only if the combination is rational and has a proven advantage with respect to therapeutic effect, safety and compliance or in decreasing the emergence of drug resistance. Some examples are, diseases such as malaria, Human Immunodeficiency Virus (HIV) infection/ Acquired Immunodeficiency Syndrome (AIDS), where the emergence of antimicrobial resistance is an important issue, which may be partly caused by poor compliance. In these therapeutic categories, certain FDCs have been considered as essential.  In certain other cases where FDCs are critical for their optimal efficacy, such FDCs are also considered as essential. For example, FDC of levodopa and carbidopa, and FDC of amoxicillin and clavulanic acid.
• Sales Turnover – The sales of a medicine in terms of moving annual total (MAT) volume and MAT value may not be criteria for essentiality. A medicine with high volume of sales may or may not qualify as essential since the sales of a medicine is likely to be impacted by factors such as market forces, physician’s preferences, and influences of Key Opinion Leaders etc especially for countries like India where there is lack of universally acceptable treatment guidelines for many disease conditions. For example, several multivitamin preparations such as Vitamin B complex, Vitamin C with minerals like zinc etc are widely consumed and figure very high on the MAT list. But considering the criteria for inclusion in NLEM, these preparations do not qualify for their inclusion. Some FDC which figure very high may not be even rational and need attention of regulator to assess their continued marketing. Such formulations obviously, will not meet the essentiality criteria.
• Hierarchy of Health Care Structure – The health care system in India is essentially a three-tier system with primary, secondary and tertiary levels having different health care concerns and medicine requirements. While a primary health care level setup may require medicines prescribed in an outpatient setup like basic antibiotics, analgesics and anti-inflammatory drugs; a tertiary level setup might need more parenteral medicines and medicines used in an inpatient setup. The health care facility at the primary care center may not be adequate for use of medicines which require special facilities and techniques for their  administration. Therefore, infrastructure at the PHC might preclude use of such medicines. The use of high-end antimicrobials, and medicines for conditions like resistant tuberculosis, malaria, kala-azar; oncology medicines etc will be required more in tertiary care. Thus, the essentiality of the medicine will also depend upon the hierarchy of the health care system, and hence the need to bucket the essentiality as:
  • (P) = Primary care facility
  • (S) = Secondary care facility and
  • (T) = Tertiary care facility

Criteria for inclusion of a medicine in NLEM 2015

The criteria are as follows

• The medicine should be approved/licensed in India.
• The medicine should be useful in disease which is a public health problem in India.
• The medicine should have proven efficacy and safety profile based on valid scientific evidence.
• The medicine should be cost effective.
• The medicine should be aligned with the current treatment guidelines for the disease.
• The medicine should be stable under the storage conditions in India.
• 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 to be considered and not the unit price of a medicine.
• Fixed Dose Combinations (FDCs) are generally not included unless the combination has unequivocally proven advantage over individual ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance.
• The listing of medicine in NLEM is based according to the level of health care, i.e. Primary (P), Secondary (S) and Tertiary (T) because the treatment facilities, training, experience and availability of health care personnel differ at these levels.

Criteria for deletion of a medicine from NLEM 2015

• The medicine has been banned in India.
• There are reports of concerns on the safety profile of a medicine.
• A medicine with better efficacy or favorable safety profiles and better cost-effectiveness is now available.
• The disease burden for which a medicine is indicated is no longer a national health concern in India.
• In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective in Indian context.

NLEM and Related Price Control Issue

In order to make medicines affordable, Government of India promulgated the National Pharmaceutical Pricing Policy, 2012 bringing all medicines with specified dosage and strength included in NLEM under price control. Accordingly, Drug Price Control Order, 2013 was issued by Department of Pharmaceuticals under Ministry of Chemicals and Fertilizers for fixing the ceiling price of medicines included in NLEM, 2011.

Revision of NLEM is based on the two important national reference documents i.e., Indian Pharmacopeia  and National Formulary of India. Indian Pharmacopoeia (IP) is an official authoritative document prescribing the standards of identity, purity and strength of medicines meant for overall quality control and assurance of pharmaceutical products marketed in India so as to ensure their safety, efficacy and affordability. National Formulary of India represents a broad consensus of medical opinion in respect of drugs and their formulations and provides the healthcare professionals with the information on rational use of medicines, forming the basis of national drug therapy.

Why essential medicines are identified?
The NLEM-2011 has clarified the grounds for creating a selected list of essential medicines. A 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 reimbursements 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 prescriptions. Preference is given to single drug formulations as opposed to fixed dose combinations, where appropriate. Hence, use of a list of essential medicine 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, it serves as a tool for public education and training of healthcare providers.

India is among the countries with the highest Out Of Pocket (OOP) expenses on health care. Expenditure on drugs constitutes over 67% of out of pocket expenditure on health care (NSSO 68th Round 2011-12). High Level Expert Group Report (HLEG) on Universal Health Coverage (UHC) for India recommended that an increase in the public procurement of medicines from around 0.1% to 0.5% of GDP would ensure universal access to essential drugs, greatly reduce the burden of out-of-pocket expenditures and increase the financial protection for households. As per WHO study estimates, about 65% of the Indian population lacks regular access to essential medicines. This is a paradox given that India is one of the largest manufacturers and suppliers of generic drugs to the world.

Price control of Essential Medicines

Essential medicines are subject to price controls in India. Supreme Court of India has authorised the use of price controls in Essential medicines. Government notified National Pharmaceutical Pricing Policy (NPPP), 2012, on 07.12.2012 to bring the prices of essential medicines, as listed under National List of Essential Medicines-2011, under price control. This is enforced through the Drug Price Control Orders (DPCO) issued from time to time (the latest being DPCO -2013). The NPPP, 2012 envisages regulation of the prices of formulations only (actual medicines used by the consumers and not the intermediate or bulk drugs from which it is made), identified on the basis of essentiality of drugs.

The objective of National Pharmaceutical Pricing Policy-2012 is to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines – “essential medicines” – at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of industry, thereby meeting the goals of employment and shared economic well-being for all.

All the manufacturers/importers manufacturing/importing the medicines as specified under NLEM-2011 are under the purview of price control. Such medicines shall have a maximum retail price (MRP) equal to or lower than the ceiling price (plus local taxes as applicable) as notified by the Government for respective medicines.

As per the provisions of DPCO-2013, ceiling prices are now being fixed at the average retail price of the medicine, produced by all those companies engaged in its production with a market share of ≥ 1% of the total market turnover, and adding 16% margin to retailer thereto. For details see here. All the previous DPCOs, 1970, 1979, 1987 and 1995 were based on cost to manufacturers with allowance for post manufacturing expenses.

Essential Medicines Vs Medicines under Drug Price Control Order

The latest Drug Price Control Order (DPCO-2013) was issued by the Government on 15.05.2013 on the basis of National Pharmaceutical Pricing Policy, 2012 (NPPP). As per DPCOs price controls are applicable to what is generally known as “Scheduled drugs” or “Scheduled formulations”- that is, those medicines which are listed out in the Schedule I of Drug Price Control Order (DPCO). Since 2013, scheduled formulations consist of the “Essential Medicines” declared so by the Government through its National List of Essential Medicines (NLEM)^[3]. Thus, NLEM forms the basis of deciding which medicines should come under price control via DPCO, since DPCO 2013. In fact, Schedule 1 of DPCO, 2013 is the NLEM list. Any formulation based on combination of any one of these drugs appearing under NLEM can be subject to price fixation. (Scheduled drugs in terms of price regulation do not mean the drugs appearing in the various schedules to Drugs & Cosmetic Act and Rules, 1945; For instance, Schedule H drugs under Drugs and Cosmetic Act and Rules mean those medicines which cannot be purchased without the prescription of a doctor. In common parlance, the drugs and formulations mentioned in Schedule 1 of DPCO are also called as “scheduled drugs” in India).

Since 2013, all essential medicines (as defined under NLEM) are treated as scheduled formulations (under DPCO-2013). However, it does not mean that all drugs brought under price control are essential medicines. Certain non-scheduled drugs which may be considered as essential or life saving have also been brought under price cap by the Government. Under the DPCO, 2013, the Govt, in extra ordinary circumstances and in public interest, also has the option to fix the price of any drugs/ formulations which are outside the NLEM. Thus, even though the NLEM-2011 list contains only 348 drugs with various dosages/ strength, any formulations based on combination of any one of these drugs can be subject to price fixation.

Under the latest DPCO 2013, the prices of 348 drugs specified in the National List of Essential Medicine 2011 (NLEM) covering around 628 formulations have been brought under the purview of price control. Out of this 628, the National Pharmaceutical Pricing Authority (NPPA) which enforces DPCO has fixed the ceiling price of 530 formulations as on 22 July 2015. NPPA has not fixed the ceiling price of remaining 98 formulations due to lack of retail market data on these formulations^[4].

The Drug Price Control Orders (the latest being that of 2013) are issued by Ministry of Chemicals and Fertilisers which is the main nodal administrative ministry for pharmaceutical companies, whereas essentiality is determined through NLEM by Ministry of Health and Family welfare. NPPP is the policy governing price control and DPCO, backed up the Essential Commodities Act, 1955, is the order by which price control is enforced.

Supply and Distribution of essential medicines

Public health being a state subject, primary responsibility of free distribution of essential drugs at public health facilities is that of State/Union Territory (UT) Governments. However, under National Health Mission (NHM), financial and technical support is being extended to States/UTs for free distribution of essential drugs to all those who access public health facilities based on the proposals submitted by the States/UTs. The states are incentivized to roll out free/subsidized provision of drugs. Roughly around Rs. 3000 -3300 Crores per annum are being spent by the Central Government (during 2013-15) for encouraging the supply of essential medicines by the States and UTs as per a press release dated 11 August 2015. In addition, in 2008, Government launched the Jan Aushadi Scheme to make available generic drugs at affordable prices to citizens and to encourage the prescription of generic medicines rather than the branded ones.  Union Government has also released operational guidelines/ standard operating procedures for facilitating states in the free provision of drugs, diagnostics services and mobile medical units.

NB- The term “Drug” Includes – (i) all medicines for internal or external use of human beings or animals and all substances intended to be used for, or in the diagnosis treatment, mitigation, or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) such substances, intended to affect the structure or any function of the human or animal body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Government by notification in the official Gazette; and (iii) bulk drugs and formulations.

Bulk drug or Active pharmaceutical ingredients (API) means any pharmaceutical, chemical, biological or plant product including its salts, esters, isomers, analogues and derivatives, conforming to standards specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and which is used as such or as an ingredient in any formulation.

On the other hand, “formulation” means a medicine processed out of or containing one or more drugs with or without use of any pharmaceutical aids, for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease and, but shall not include any AYUSH medicine.
Generic medicines are unbranded medicines which are equally safe and having the same efficacy as that of branded medicines in terms of their therapeutic value. The prices of generic medicines are much cheaper than their branded equivalent.

A branded generic is a drug that is bioequivalent to the original product, but is now marketed under another company’s brand name. IMS Health, which began tracking and reporting on branded generics in 2002, defines the category as including prescription “products that are either novel dosage forms of off-patent products produced by a manufacturer that is not the originator of the molecule, or a molecule copy of an off-patent product with a trade name.” This definition is used by both the FDA in US and the United Kingdom’s National Health Service (NHS).

Report of Committee for preparation of National List of Essential Medicines (NLEM) for Animal Use in India can be downloaded from here:

https://main.mohfw.gov.in/sites/default/files/Report%20of%20the%20committee%20constituted%20for%20preparation%20of.pdf

https://www.nhp.gov.in/NHPfiles/NLEM%2C%202015.pdf

1. Source: Operational Guidelines on Free drug service Initiative
2. Source: Press release of NPPA dated 22 July 2015

https://www.pashudhanpraharee.com/veterinary-drug-index-pdf/

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