Report

Introduction
As per World Health Organization (WHO), Essential Medicines are those that
satisfy the priority health care needs of any population. These medicines should
have established safety, efficacy, and comparative cost effectiveness. The aim
behind formulating essential medicine list (EML) is to ensure that these
medicines are available in adequate amounts, in appropriate dosage forms and
strengths with assured quality. EML is expected to aid in improving quality and
accessibility of health care while ensuring cost effective use of resources. This
has obvious importance for resource limited country like India. Further, EML is
intended to promote rational use of medicines.

Evolution of Essential Medicines List

Tanzania was the first country to compose its own country specific EML in
1970. In 1975, the World Health Assembly requested WHO to assist member
states in identifying essential medicines specific to them and assuring their
availability, assuring good quality at reasonable cost. WHO published first
model list of essential medicines in 1977 which contained 186 medicines. It was
intended to be used as a template by member countries. It stated that essential
medicines
the health and needs of the p
efficacy, safety, quality, and total cost. The emphasis was laid on disease burden
and treatment guidelines as basis for selecting essential medicines.

In 1985, the list of essential medicines of the WHO was recognized as

important, mainly for the public sector and its scope was to guide the
procurement, distribution, rational use, and quality assurance of medicines. As
the disease diversity and burden grew, the number of medicines in the WHO
EML increased over the years, a trend that has also been seen with National List
of Essential Medicines (NLEM) of India.
Requirement for Country Specific EML
The essential medicines list prepared by WHO is a prototype list that can be
used as a template by individual countries. Since priority health care needs of
countries differ, it is logical that each country shall have its own country
specific EML. Socio-demographic factors and economy are other factors that
are likely to influence composition of EML for any country.

Disease burden may vary in different countries

The central concept of Essential medicines is to address the

lation. For example, HIV, tuberculosis,

malaria and diarrheal diseases are priority health care concerns in low- and
middle- income countries including India, but it may not be so for evolved
economies. On the same line, trypanosomiasis and yellow fever may be a
priority health care concern in some countries but not in our country.

Variations in Priority Health Care Concerns within a country

For our country, which has a large geographical area with huge diversity in
climate, food habits, culture etc., there are differences in health care priorities
within the states, across different regions. For example, kala-azar is more
prevalent in Bihar whereas Japanese encephalitis is more prevalent in Bihar and
Assam. Therefore, medicines for priority health care conditions for different
regions of the country have been considered for inclusion in NLEM 2022.
Indian healthcare needs are also peculiar as they involve not only problems of
low-income countries but that of high-income countries also, such as
hypertension, diabetes mellitus and other lifestyle diseases.
What makes Indian NLEM different
Disease Prevalence Patterns in India
With the improvement in public health care and the socioeconomic status, India
faces the twin epidemic of continuing/ emerging infectious diseases as well as
non-communicable, lifestyle diseases. The temporal landscape of India s health
care priorities makes an intriguing study.

The current disease prevalence scenario is unique with an increase in the

burden of non- communicable diseases and resurgence of certain communicable
diseases either due to emergence of drug resistance, like in tuberculosis and
malaria, or occurrence of certain co-infections like HIV and TB, and HIV and
sexually transmitted diseases, or due to evolution of the pathogens as in case of
dengue, influenza like H1N1, etc.

The essential medicines selection for various therapeutic areas have been
considered taking into view the larger perspective of current demographic
profile of disease burden as well as likely future trends.

Meeting the healthcare needs of a common man in India

In fiscal year 2018-19, the value of public health expenditure by states and
union territories together amounted to around 1.58 trillion Indian rupees. This
Urgent need has
now been felt to enhance the budgetary allocation in health sector. Huge
funding support has been provided by government to meet the healthcare needs.

Rupees that same year1. The past decade has also seen a rise in the public

1
*Reference - India - estimated public health expenditure 2017-2020 | Statista [Internet]. Statista. 2021 [cited 9
July 2021]. Available from: https://www.statista.com/statistics/684924/india-public-health-expenditure/
adoption of insurance schemes. Nevertheless, the health insurance schemes are
often underutilized in India. Very-small subset of the Indian population is
covered through health insurance, most of it being government employees and
organized sectors. The most vulnerable groups like workers of unorganized
sectors, migrant workers and agriculture dependent population are left out of the
insurance coverage and are dependent on the out of the pocket or public
spending for purchase of medicines. Various programmes like the Ayushman
Bharat,
Jan Aushadhi Yojana, AMRIT Pharmacies and the National Health Mission
have been implemented to provide affordable healthcare to the common man of
India.

The National Health Policy 2017 emphasized on the vision of health for
all and universal health coverage. To fulfill this objective, the Government of
India conceived Ayushman Bharat, an
Minister. It aims to provide financial protection (Swasthya Suraksha) to 10
crore poor and deprived rural families and identified categories of urban
s largest healthcare programme and insurance
scheme that aims to provide free healthcare access to low income population of
the country.

Out-of-pocket expenditure constitutes over 60% of total health

expenditure, with a substantial 40% being incurred on medicines. With this
background, it is of paramount importance that accessibility and affordability of
medicines be enhanced in order to reduce the financial burden on the
households. Access to safe, effective, quality, and affordable essential
medicines can be achieved with the use of NLEM. It provides the framework
for judicious use of medicines as all the drugs listed are based on criteria of
efficacy, safety, cost-effectiveness data. The drugs listed in NLEM are
considered scheduled drugs under Drugs Price Control Order (DPCO) and their
prices are regulated by National Pharmaceutical Pricing Authority (NPPA) to
ensure affordability. India is a resource limited country, and the allocated
budget has to be used judiciously so that maximum number of beneficiaries can
be covered. NLEM is an important tool to achieve this goal, not only by
rationalizing the therapeutics but also by economizing the resources. The
NLEM will also help in optimization of S

Balance of affordability and essentiality in NLEM

There may be situations where certain medicines or formulations may have
some advantage over others in similar class, but the high cost differential may
not merit their inclusion in NLEM. For example the injectable iron
preparations used for iron deficiency anemia include iron dextran, iron sucrose,
and ferric carboxymaltose. Iron dextran is the cheapest of the three but has
substantial safety concerns due to risk for anaphylaxis. Iron sucrose is though
relatively bit expensive but is safer. Ferric carboxymaltose has the least safety
concern and can deliver the maximum amount of iron. Ferric carboxymaltose is
however, very expensive and hence it does not justify inclusion. Considering
comparative efficacy, safety and cost, out of the three, iron sucrose has been
included in the NLEM.

As a corollary, there may also be a situation where a medicine/

formulation are included in NLEM despite it being more expensive as it has
significant advantage of safety and/or efficacy. However, considering the
socioeconomic conditions, the less expensive, other formulation may also find a
place in the list. For example three formulations of amphotericin B
(conventional, relatively expensive lipid formulations as well as the much
expensive liposomal) have been included.
Issues related to Price Control of Medicines and NLEM 2022
To make medicines affordable, the government promulgated the National
Pharmaceutical Pricing Policy, 2012, to bring 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.

The issue related to price control sometimes became the main focus of

regarding the inclusion of medicines in NLEM was taken considering the main
themes of safety, efficacy, and disease burden in the country, their affordability
and accessibility.

NLEM a dynamic process that needs a standing committee

As the health and science are dynamic, the usefulness of medicines is also
dynamic. The list of essential medicines cannot be static but must be ever
dynamic. It needs to be updated/ revised periodically. The approval of newer
and better medicines may lead to change in treatment practices/ guidelines for
various disease conditions. For example, ergot alkaloids (dihydroergotamine)
were commonly used for the treatment of acute attack of migraine. However,
with the introduction of safer alternatives of 5-HT1b/d agonists like medicines of
this class are now preferred over the existing ones. Among various 5-HT1b/d
agonists, sumatriptan has been considered as essential in place of
dihydroergotamine. Similarly, availability of rituximab for NHL has changed
the treatment regimen for this disease.

Further, some medicines may become obsolete whereas some may

become the drug of choice. Thus, monitoring and evaluation of benefit-risk,
availability, affordability needs to be continuous over time. This philosophy
formed the basis for constitution of a Standing Committee. This will preserve
the relevance of NLEM for the Indian population.

During the process of revision of NLEM, there were several practical

questions were which need to be answered through simple observational
studies. The data generated through such studies will support evidence-based
decisions. Some examples of such questions are listed as a separate chapter. The
academic institutions can take up these studies

Various purposes that can be served by National List of Essential Medicines

The NLEM may serve multiple purposes as under:

Promote the rational use of medicines

Guide safe and effective treatment of priority disease conditions of a

population and optimize the available health resources of the country.

It can also serve as a guiding document for:

State governments to prepare their list of essential medicines

Developing Standard Treatment Guidelines

Help in preparing hospital formularies

Procurement and supply of medicines in the public sector as well as

private sector hospitals

Reimbursement of cost of pharmaceutical products by employers

Reimbursement by insurance companies

Identifying the MUST KNOW omain for the teaching and training of
health care professionals (medical, dental, pharmacy and nursing).
Salient features of NLEM 2022
The current National List of Essential Medicines (NLEM 2022) contains 386
medicines. The NLEM 2015 contained 376 medicines. In 2015, 70 medicines
were deleted, and 106 medicines were added. In NLEM 2022, 34 medicines
have been added and 26 medicines have been deleted. Thus, the current list
contains a total of 384 medicines. Out of these 384 medicines, 342 appear in
single therapeutic category, 41 drugs appear in two therapeutic categories, 11
appear in three therapeutic categories and 4 drugs appear in four therapeutic
categories. Hence, the total list is 440 items long. There are relatively lesser
number of deletions and additions in the current list.

Table: Addition, deletion and total number of medicines in successive NLEMs

Year 2011 2015 2022

Number of medicines
47 106 34
added

Number of medicines
43 70 26
deleted

Total number of
348 376 384
medicines
 Figure: Number of medicines in successive NLEMs

Therapeutic Categories of medicines

In NLEM 2015, the medicines were listed in 30 therapeutic categories in. In
NLEM 2022, it was decided to merge four categories (Antiepileptic medicines,
Antiparkinsonism medicines, Antimigraine and Medicines used in Dementia)
into a single therapeutic category
D
was merged into one category and named as
aesthes Further, a new section of Medicines for
COVID-19 Management has been added. Thus, NLEM 2022 contains 27
therapeutic categories as opposed to 30 in NLEM 2015.

Each deletion/ addition of medicines/ formulations was carried out after

extensive deliberation among the experts, considering published evidence
(papers, meta-analysis, national and international guidelines, safety data from
published reports, and reports from Pharmacovigilance Programmed of India),
seeking inputs from stakeholders and also assessing the availability in the
market. This nationwide rigorous consultative process has led to a consensus
decision in all modifications.

The medicines in various National Health Programmes have been

considered for inclusion in NLEM. Any medicine/ vaccine, as and when
recommended under any National Health Programmes will be deemed
included in NLEM.

More than 130 suggestions/ inputs, from Pharmaceutical Industries,

Associations/ Bodies, non-governmental organizations (NGOs), Ministries
were received. After deliberations on each, wherever considered
appropriate, the viewpoints have been included.

The major deletions and additions in NLEM 2015 list were in the therapeutic
category of anti-infective medicines (deletion 16 and additions 33) as compared
to 09 deletions and 18 additions in NLEM 2022.

Maximum numbers of additions in anti-infective therapeutic category of

medicines. In this category 18 medicines have been added and 09 have been
deleted. The second maximum numbers of medicine 63 (including duplication)
are in anti-cancer agents including Immunosuppressive and Medicines used in
Palliative care therapeutic category.
Details of changes made in NLEM from 2011 till 2022 are given in the table
below:

Total Total
No. of
in in
Section Therapeutic Category Deleted Added Deleted Added Medici
NLEM NLEM
nes*
2011 2015

Medicines used in
1. 23 4 2 21 1 0 20(6)
Anaesthesia
Analgesics,
antipyretics, non-
steroidal anti-
inflammatory
2. medicines, medicines 14 0 1 15 1 0 14(8)
used to treat gout and
disease modifying
agents used in
rheumatoid disorders

Antiallergics and
3. medicines used in 9 2 0 7 1 0 6(3)
anaphylaxis

Antidotes and Other

Substances used in
4. Management of 14 1 1 14 1 0 13(4)
Poisonings/Envenomati
on
Medicines used in
5 14 2 5 17 0 0/3 20(8)
neurological disorders

Anti-Infective
6. 69 16 33 86 09 18/32 109
Medicines
(34)
7. Anti-cancer agents 40 6 25 59 1 4/5 63
 Total Total
No. of
in in
Section Therapeutic Category Deleted Added Deleted Added Medici
NLEM NLEM
nes*
2011 2015

including (16)
Immunosuppressives
and Medicines used in
Palliative Care
Medicines affecting
8. 10 3 6 13 0 0 13 (3)
blood
Blood products and
9. 10 4 2 8 0 0 8(0)
Plasma substitutes
Cardiovascular
10. 29 5 5 30 2 2/5 30(8)
medicines

Dermatological
11. 16 6 5 15 3/2 0 12 (2)
medicines (Topical)

12. Diagnostic agents 11 6 2 7 1/1 0/1 7(2)

Dialysis components
13. (Hemodialysis and 1 0 1 2 0 0 2(0)
Peritoneal Dialysis)
Antiseptics and
14. 12 3 0 9 2 0 7(1)
Disinfectants

15. Diuretics 4 0 0 4 0 0 4(2)

Ear, nose, throat
16. 0 0 4 4 0 0 4(3)
medicines
Gastrointestinal
17. 16 3 3 16 2 0 14(4)
medicines
Hormones, other
18. endocrine medicines 24 4 3 23 2 4/5 25(5)
and contraceptives

19. Immunological 13 0 4 17 0 1/1 18(1)

 Total Total
No. of
in in
Section Therapeutic Category Deleted Added Deleted Added Medici
NLEM NLEM
nes*
2011 2015

Medicines for Neonatal

20. 0 0 3 3 0 0 3(0)
Care
Ophthalmological
21. 17 5 6 17 2/1 1/1 16(8)
Medicines

Oxytocics and
22. 7 1 1 7 0 0 7(0)
Antioxytocics
Medicines in treatment
23. 11 5 7 13 0 3/4 17(6)
of Psychiatric Disorders

Medicines acting on the

24. 6 3 3 6 0 1/1 7(2)
Respiratory tract

Solutions correcting
Water, Electrolyte
25. 10 0 0 8 0 0 8(2)
disturbances and Acid-
base disturbances*

26. Vitamins and Mineral 10 2 1 9 1 0 8(1)

Medicines in
27. management of - - - - - 0/5 5(5)
COVID-19

376/ 384**
Total Number of 348/390
Medicines 430 460#
(56)
* Total in NLEM 2022 (No of medicines appearing more than once)
** Actual Number of medicines, i.e. Medicines appearing at more than one category is
counted once only
# Total Number of medicines i.e. the medicines repeating in more than one category have
been counted for each category. For example Hydroxyurea appearing at two places is
counted as two. Morphine appearing at 3 places is counted as three.
The process of revision of NLEM
Ministry of Health & Family Welfare (MoHFW), Government of India,
constituted Standing National Committee on Medicines (SNCM) under the
chairmanship of Prof. Balram Bhargava, Secretary, Department of Health
Research (DHR) and Director General, Indian Council of Medical Research
(ICMR), and Prof. Y.K. Gupta, Formerly Head, Department of Pharmacology
and Dean, All India Institute of Medical Sciences (AIIMS), New Delhi as its
Vice Chairman.

The notification provided the list of experts of different disciplines from

across the country with a provision that the chairman may consult other experts
as and where required.

The committee deliberated on the criteria of inclusion and exclusion for

the current revision of NLEM and decided that the criteria adopted in NLEM
2015 will largely be followed since the principle of essentiality remains
unchanged. The committee paid special attention to antimicrobial resistance
while deliberating on the essentiality of antibiotics. It also noted the availability
issues of certain formulations listed in NLEM 2015 and considered this aspect
while listing them in the current NLEM. Enlisting of medicines in NLEM was
stratified according to the level of health care, i.e. Primary (P), Secondary (S)
and Tertiary (T) because the requirements, treatment facilities, training,
experience and availability of health care personnel differ at these levels.
Criteria for inclusion and deletion
The criteria for inclusion of a medicine are listed below:

The medicine should be approved/ licensed in India.

The efficacy and safety profile of the medicine should be based on robust
scientific evidence.
The medicine should be useful in disease which is a public health problem
in India.
All medicines enlisted in National Health Programmes/ National Disease
Control Programmes are as such essential and hence included in the
NLEM 2022.
The medicine should be affordable to the community in the Indian context.
The medicine should be readily accessible at P, S, T healthcare levels
When more than one medicine are available from the same therapeutic
class, preferably one prototype/ best suited medicine of that class to be
included after due deliberation and careful evaluation of their relative
safety, efficacy, availability and affordability.
Overall cost of therapy was considered and not just the unit cost of the
medicine.
A Fixed Dose Combination (FDC) was generally not included unless the
combination had unequivocally proven advantage over individual
ingredients administered separately, in terms of increasing efficacy,
reducing adverse effects and/or improving compliance.
The criteria for deletion of a medicine from the existing NLEM are listed
below:

The medicine has been banned in India by the regulatory authority.

There are reports of serious concerns on the safety profile of a medicine.
Another medicine with better efficacy or favourable safety profile or better
accessibility and affordability is now available.
The disease burden, for which a medicine is indicated, is no longer a
national health concern for India.
In case of antimicrobials, if the resistance pattern has rendered an
antimicrobial ineffective in the Indian context.

Reference documents to guide the revision process

The NLEM 2015 was treated as the base document for drafting NLEM 2022.
Any suggestions regarding addition to the list were discussed within the
cornerstones of essentiality. Other documents such as WHO EML 2019, Indian
Pharmacopoeia, National Formulary of India 2016, Drug compendia including
online drug information sources and formularies of other countries (like British
National Formulary) were also perused before taking a decision regarding
suggested inclusion. Guidelines drawn from major National Health
Programmes/ Disease Control Programmes were also referred to. Any additions
of medicines in these were also included in NLEM 2022.

To consider the safety issue of the drugs, the available literature, the
safety reports from WHO and other countries as well as information from
Pharmacovigilance Programme of India (PvPI) were considered. If there was
any emerging safety issue which tilted adversely the risk benefit assessment, the
medicine was considered for deletion.
Involvement of Experts and stakeholders
The NLEM revision process involved nation-wide, transparent consultation
process. For this, the subject experts were drawn from different medical
institutions, including those situated in peri-urban and rural areas. A country
wide representation (including North-East and Jammu Kashmir regions) was
ensured. The experts were of different subject domain. Representatives of
different national health Programme such as National TB Elimination Program
(NTEP), National AIDS Control Programme (NACP), and National Vector
Borne Disease Control Programme (NVBDCP); were invited.

To get the inputs and opinions of pharmaceutical industry and NGOs, an

advertisement was placed in national newspapers and on the ICMR website.
Representatives from pharmaceutical industry and NGOs presented their
viewpoints in stakeholder meetings. Inputs from the experts were also received
through emails. The committee deliberated on online and offline submissions
from stakeholders.

Transparent approach in NLEM meetings and deliberations

The meetings with experts were earlier planned as National consultative meetings
in various parts of the country i.e. Delhi, Kolkata, Mumbai, Chennai and
Guwahati. The initial few meetings were held face-to-face in DHR/ ICMR.
However, due to the onset of Covid-19 pandemic, from April 2020 the
subsequent meetings were conducted through online video conferencing. The
meetings were conducted according to the therapeutic categories and the subject
experts were invited accordingly. To reiterate the concept and principles of
NLEM, a briefing session was organized before the start of each consultation
meeting, highlighting the need for NLEM, its philosophy, principles and
practices to be kept in mind while deliberating the matter. Key considerations for
framing NLEM 2022 were explained to the experts with the help of real-world
examples.

Four consultative meetings were held with pharmaceutical industry,

NGOs, pharmaceutical associations along with subject experts to get their
inputs. The dates and venue of these consultation meetings are given below:

25.07.2019 at Department of Health Research, MoHFW, Delhi

04.11.2019 at Department of Health Research, MoHFW, Delhi

17.08.2020 at Indian Council of Medical Research, Delhi

19.02.2022 at Indian Council of Medical Research, Delhi

The committee received more than 60 representations from institutions, industry

associations, pharmaceutical companies, NGOs, as well as individual experts.
All these representations were carefully considered and deliberated upon.

Proceedings of all the meetings were audio recorded after obtaining

verbal consent. The recordings have been archived. More than 130 meetings
were held subject wise and therapeutic category wise in which 120 meetings
were expert group meetings, 4 national consultation meetings, 8
SNCM meetings and 18 drafting group meetings.

Evidence Based Additions and Deletions

The experts were requested to support their recommendations with suitable
evidence. If their opinion was based on their clinical judgment and experience,
it was recorded as such. A summary sheet providing evidence-based
justification for each addition and deletion of medicines listed in the NLEM was
documented.
 The process of revision of NLEM 2022
Constitution of the Standing National Committee on Medicines by Ministry of Health
and Family Welfare to review and revise NLEM 2015

Chairman: Prof. Balram Bhargava, Secretary, DHR & DG, ICMR

Vice Chairman: Prof. Y.K. Gupta, Formerly HOD, Pharmacology, AIIMS, Delhi

Outline of NLEM revision process

Review of criteria for inclusion/ deletion of medicines
Identification of subject experts from across the country
Reorganization of therapeutic categories

Consulting various source documents of medicines

Source documents of medicines with dosage forms and strengths referred to:
NLEM 2011 and 2015
WHO EML 2019 and EMLc 2019
National Formulary of India 2016
National Health Programmes
Standard Treatment Workflows, Treatment guidelines of associations and
professional bodies
Newsletters of Pharmacovigilance Programme of India

Stakeholde
Ministry of Health and Family Welfare, Ministry of AYUSH, Department of
Consumer Affairs, Department of Pharmaceuticals, NPPA, CDSCO , IPC, NGOs,
pharmaceutical industry, associations and patient groups

Stakeholders were informed through print media and website of ICMR, IPC and
CDSCO. Total four stakeholders meetings were held.

Online/offline submissions from stakeholders were received.

Therapeutic category wise meetings of experts

Video conferencing/face to face meetings
Total meetings more than 130
Audio-visual recording and minutes have been archived.

Meetings of SNCM Core Committee to review the recommendations of all subject

experts meetings, deliberations on the submissions of NGOs, pharmaceutical
associations, patient groups and other stakeholders.

Drafting the report of NLEM 2022

Submission to the Ministry of Health and Family Welfare
General Considerations for preparing the NLEM 2022
Essentiality
Any medicine may be necessary or even critical for specific disease conditions
for which it is indicated. However, in the context of national list of essential
medicines, a medicine should be essential considering the population at large
and should fit into the definition of essentiality of a medicine. 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 not necessarily means that if a particular drug is not
included in the list of essential medicines, it is not necessary in therapeutics.
Non-inclusion of such drugs in the list of essential medicines does not
undermine their importance in therapeutics.

Some examples are:

Plerixafor is the medicine which is used for stem cell mobilization prior to
stem cell transplant. Since the drug serves a very small group of population, it
may not find a place in the national list of essential medicines.

For the prevention of vertical transmission of Toxoplasma gondii infection,

spiramycin is the only treatment available. However, toxoplasmosis is
relatively less prevalent and hence, spiramycin is not an essential medicine in
the Indian context.

For the treatment for diabetes insipidus, desmopressin is required but

considering the rarity of the condition it may not find a place in the essential
medicines list.

For effective healthcare delivery, the NLEM can serve as a reference document
for medicines of national priority so that administrative, scientific,
pharmaceutical and logistic efforts are appropriately directed towards optimum
utilization of the available resources.
Efficacy and Safety
The most important parameters for considering essentiality of a medicine are
efficacy and safety. For a medicine to be considered essential, it should have an
unequivocal evidence of efficacy and wider acceptance in medical science. It
should also 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.

Considerations of comparative costs of treatment

This issue is important when selecting from more than one medicine from the
same therapeutic category which do not differ significantly in their efficacy and
safety. Sometimes per unit price of a medicine may be more but it may be
prescribed at a lesser frequency. Other costs involved in drug administration
such as cost of injection, hospitalization if required, etc., may differ between
two equi-effective medicines of the same category. Thus, the total price of the
treatment schedule including direct and indirect costs should be taken into
consideration and not only the unit price of a medicine.

Feasibility in the context of advantage in storage

An essential medicine should be available in a form in which adequate quality
can be assured throughout its shelf-life under recommended storage conditions.
However, it may not always be feasible to ensure the recommended storage
conditions for a particular medicine. In such conditions, alternate forms of the
medicine suited to the available storage conditions should be considered. For
example, liquid formulation of antisnake venom is cheaper and equi-efficacious
as compared to the lyophilized preparation albeit requiring cold chain, which is
sometimes difficult to maintain in its distribution channel. On the other hand,
lyophilized polyvalent offers the advantage of longer shelf-life and less
stringent storage requirements. Therefore, both lyophilized and liquid
formulations have been included in the list.

Consideration of inclusion of Fixed Dose Combinations (FDCs)

In essential medicines list as a principle, single medicines are preferred. An
FDC is included only if the combination is rational and has a proven advantage
in terms of improved therapeutic efficacy, safety and compliance or in
decreasing the emergence of drug resistance. For example, FDCs for the
treatment of diseases such as malaria and Human Immunodeficiency Virus
(HIV) infection/ Acquired Immunodeficiency Syndrome (AIDS) offer dual
advantage of improving therapeutic outcomes and limiting the emergence of
antimicrobial resistance. In these therapeutic categories, certain FDCs have
been considered as essential and are included in the list. In certain other cases,
FDCs are required to achieve optimal therapeutic efficacy, and are thus
considered essential. For example, FDCs of levodopa and carbidopa, and
amoxicillin and clavulanic acid.

FDCs which do not have strong published evidence of their merit in

therapeutics have not been included.

High Sales of a medicine does not necessarily indicate essentiality

The high sales of a drug with reference to Moving Annual Total (MAT) volume
and MAT value do not necessarily mean essentiality. The sale of a medicine is
likely to be impacted by factors such as market forces, physici s preferences,
and influence 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. Sometimes, such FDCs may
not even be rational and need attention of regulator to assess their continued
marketing. Such formulations do not meet the essentiality criteria and therefore
have not been included.

Hierarchical Healthcare Structure in India

In India, the health care system is categorized as 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, medicines for critical care settings, for specialized treatments like
organ transplantation and for inpatient setup.

At the primary care center, the health care facilities do not carry out
certain sophisticated therapeutic interventions (such as dialysis, neonatal
intensive care, palliative care, treatment of malignant diseases) and therefore do
not have such special facilities and personnel. Therefore, such medicines are not
essential for primary care however; they may essentially be required at
secondary and tertiary healthcare level. Similarly, use of high-end
antimicrobials, medicines for conditions like systemic fungal infections,
resistant tuberculosis, resistant malaria, kala-azar, etc., will be required more in
secondary and tertiary care. Thus, the essentiality of medicines also depends
upon the hierarchy of the health care system, and hence there is need to stratify
the recommendation for inclusion of medicines at:

(P) = Primary care facility

(S) = Secondary care facility and

(T) = Tertiary care facility

Specific issues addressed in NLEM 2022
Dosage form of the medicines
Formulation of medicines may be available in different dosage forms as under:

Oral solid dosage forms which include tablet, capsule, sachet, granules,
powder, etc.

- Tablets which include conventional, enteric coated, film coated, sugar

coated tablet, etc.

- Capsules include hard gelatin and soft gelatin capsules. (Unless specified,
capsules mentioned in the NLEM are considered as hard gelatin
capsules).

Oral liquid dosage forms include syrup, suspension, elixir, etc.

Injectable dosage forms include conventional liquid injection or powder for

injection, as well as delivery system like depot, liposomal/ lipid complex,
etc.

Topical dosage forms include ointment, cream, lotion, drops etc.

When the solid oral dosage form of a medicine is available both as tablet and
capsule, the more commonly available dosage form (between tablet and
capsule), is listed in NLEM. If both the formulations i.e. tablet and capsule are
available in almost equal proportions, the formulation as included in Indian
Pharmacopoeia, has been listed in NLEM. For example, ibuprofen which is
included in IP as tablet, is listed in NLEM as tablet though it is also available as
capsule. Similarly, tramadol is mentioned in IP as capsule, but is also available
as tablet. In NLEM, it has been listed as capsule only. If more than one solid
oral dosage form is mentioned in IP, the more commonly used form is listed in
NLEM.
 Oral liquid formulations (syrups, suspensions, solutions, etc.) are listed in
the NLEM as oral liquid unless the specific formulations which require
identification such as doxycycline, amoxicillin (A) + clavulanic acid (B) have
been included as dry syrups. Similarly, many medicines intended for topical use
are available as cream, ointment, lotion, etc. If the formulation is included in the
IP, the same dosage form as mentioned in IP is listed in NLEM. For example,
fusidic acid and silver sulfadiazine are available as cream and ointment, but
only cream is mentioned in IP. Hence, in NLEM they are listed as cream.
Where, more than one dosage form is mentioned in IP, the more commonly
used form is listed in NLEM. However, in case the medicine is not included in
IP, the commonly available form is mentioned in NLEM.

For pricing and policy decisions, only the similar dosage forms of a
medicine should be grouped together. However, if different technology is
involved, which confers significant difference in pharmacokinetics/
pharmacodynamics/ efficacy/ safety over the dosage form mentioned in the list,
such technologically different dosage forms should not be grouped together.
They should be considered separately for purposes of pricing, procurement, etc.

Any dosage form of a medicine other than that included in NLEM but in
same strength and route of administration, which does not demonstrate
significant difference in terms of pharmacokinetics/ pharmacodynamics/
efficacy /safety over the dosage form mentioned in the list, should be
considered as included. To elaborate, if tablet is included, other oral solid
dosage form such as capsule is considered as included. However, such different
dosage forms should be considered differently for purposes of procurement
policy, pricing etc. This principle also applies to all other dosage forms e.g. oral
liquid dosage forms, injectables, topical dosage forms etc.
Strengths of a Medicine
Formulations of a medicine are usually available in many strengths. The
committee deliberated that where more than one strength(s) is/ are available, the
strength(s) which is/ are appropriate and meet the need of most, are to be
considered for inclusion in the NLEM. Some strengths of a particular
formulation, presently available in the market, do not appear to be appropriate
or not commonly required, have not been considered for inclusion in NLEM.

Where multiple salts of medicines are available

The committee decided that in general, medicines should be mentioned in the
NLEM in terms of their active moieties, without mentioning the salts. In case, a
medicine is available in more than one salt without any significant difference in
potency/ pharmacokinetics/ pharmacodynamics/ efficacy-safety profile aspects,
it indicates that these salts are therapeutically similar. Therefore, all salts of
such medicines with specified dosage form and strength are considered included
in NLEM 2022. For example, diclofenac is available as diclofenac sodium or
diclofenac potassium and there is no significant difference in the above-
mentioned aspects, between the two salts. Hence, mention of only diclofenac
implies that both its sodium and potassium salts are included and it suffices for
the purpose of procurement and other policy decisions.

However, in case, where the different salts of a medicine have significant

difference in potency/ pharmacokinetics/ pharmacodynamics/ efficacy-safety
profile, the medicine has been mentioned in the list with respect to its specific
salt. In case of topical betamethasone, its valerate salt has been specifically
mentioned, because it has lower potency and has fewer systemic adverse effects
as compared to its dipropionate salt.
Isomeric forms wherever applicable
Different isomers of a molecule may differ with respect to potency/
pharmacodynamics/ safety-efficacy profile. For example, S-amlodipine is an
optical isomer of amlodipine. These two forms have been considered as separate
entities and approved as two different medicines. Therefore, inclusion of
amlodipine in NLEM does not imply that S-amlodipine is also included in
NLEM.

Prodrugs/ Analogues / Derivatives of medicines wherever applicable

Prodrugs/ analogues/ derivatives of one active moiety are available as different
medicines. They may differ with respect to potency/ pharmacokinetics/
pharmacodynamics/ safety-efficacy profile. For example, valganciclovir which
is a prodrug of ganciclovir should be considered differently from ganciclovir for
the purpose of pricing, policy, etc. Similarly, oxcarbazepine is a derivative of
carbamazepine and both oxcarbazepine and carbamazepine have been
considered and licensed as different medicines. Inclusion of carbamazepine in
NLEM does not imply that oxcarbazepine is also included. Thus, wherever,
such different forms exist, which have been considered as different entities and
licensed as different medicines, inclusion of one form of such medicines in
NLEM will not automatically imply inclusion of other forms.

Biological Products
Vaccines, sera and immunoglobulins are complex biological products, which
may be manufactured from various sources, by using different processes and
technologies. In such cases, irrespective of variation in source, composition, or
strengths, all the products of the same vaccine/ sera/ immunoglobulin, as
approved by licensing authority are considered as included in NLEM. However,
considering the source, process, technology and other relevant aspects, different
products of a biologic should be considered differently by the user.
Medicines under patent protection
Most of the medicines that are listed in the NLEM are off-patent. The generic
version of the drugs which after patent expiration become cheaper because of
market competition. In addition, market availability of such medicines is
improved given the multitude of manufacturers.
Whether a drug which is under patent protection can be included in NLEM,
the issue was deliberated at length in the stakeholder meeting where the
representatives of industry, academia, Department of Pharmaceuticals (DoP),
NPPA, ICMR, Directorate General of Health Services (DGHS) were present. It
was appreciated that new drug development is a complex, lengthy, expensive
and risky process and the innovator company invests significant amount of
capital, time and expert human resource for the development of a new molecule.
The committee deliberated the issue whether a new patented drug to be
considered essential or not. This needs to be determined in individual cases with
consideration of several aspects like essentiality criteria for inclusion /exclusion,
need of such drug in Indian scenario, urgency, special situations like public
health emergencies, etc. The committee was of the opinion that, even when a
drug is patented, if it meets the requirements of essentiality from public health
perspective, t
issue has been considered in the past on the same lines and sofosbuvir which is
a patented drug was listed in NLEM in 2015, considering that the drug met all
the criteria of essentiality in view of its favourable safety, efficacy profile and
unmet therapeutic needs for hepatitis C patients in the country. This principle is
in line with WHO principles2. Based on this principle, the patented medicines
like bedaquiline, delamanid, dolutegravir, etc. have been considered essential
and included in the NLEM 2022.

2
https://www.who.int/healthsystems/topics/health-law/chapter15.pdf
NLEM and the need to encourage innovations
Considering the huge disease burden in India, research and development is of
paramount importance for bringing new medicines for the patients. Discovery
and development of new drug molecules is a complex, knowledge intensive
activity requiring involvement of expertise from various fields, considerable
time and resources. However, Indian pharmaceutical industry being strong in
manufacture of generic medicines and Novel Drug Delivery Systems (NDDS)
should be encouraged for innovations including incremental innovations in
therapeutics and medicine.

The committee deliberated in detail about the issue of inclusion of

improved formulations of a medicine developed through radical/ incremental
innovation involving technology. The committee considered that such
formulations including novel drug delivery systems like lipid/ liposomal
formulations, modified release formulations of a medicine, which are developed
to overcome certain disadvantages associated with the use of conventional
formulations, will be considered included only if specified in the list against the
medicine.

An innovation could be an incremental innovation leading to some ease

of administration improving compliance or better packaging for stability; or it
could provide a significant therapeutic advantage in drug delivery system,
significant reduction in the cost of therapy, significant reduction in adverse
effects. Whereas minor incremental innovation may not merit separate class of
drug in NLEM, but the significant advantage should entitle them to be
considered as a separate class. The differential pricing policy will promote
innovation and help the pharmaceutical sector of India to remain contemporary
Market availability of the formulations across the country
The availability of medicines listed in National List of Essential Medicines at all
times and all places needs to be ensured. From the different feedbacks of NLEM
2015, it was noted that some strengths/ formulations of medicines have very
little availability in the market. This information was also received from NPPA.
An intense exercise was conducted to further confirm the availability of these
medicines and their formulations across the country. The information regarding
availability was also gathered from doctors of primary, secondary and tertiary
care hospitals across the country. The medicines which were poorly available or
unavailable were deliberated by experts for their essentiality.

Based on deliberation, many formulations which were present in 2015

and are now not available in the market or have very poor availability, and their
alternative dosage form and strength are available have been deleted. For
example sodium thiosulphate injection 100 mg/mL, morphine tablet 20 mg
etc.

National List of Essential Medicines 2022 and Anti-microbial Resistance

Management of infectious diseases is heading from a pre-antibiotic era to a
post-antimicrobial era due to the threat of antimicrobial resistance. Tuberculosis
has gone from drug sensitive to isoniazid resistant to multidrug resistant
(MDR) to extensively resistant (XDR). Other bacterial infections have
progressed from being penicillin sensitive to penicillin resistant to even
carbapenem resistant.

Most of the old antimicrobials have increasingly become ineffective e.g.

tetracycline and nalidixic acid are effective in only 57% and 50% cases of
Shigella respectively. Similarly, Pseudomonas has become resistant to amikacin
and ciprofloxacin in 20% cases (4)3,4. Even relatively newer drugs like
piperacillin tazobactam, cefepime and meropenem are not effective in 28.6%,
21.8% and 8.5% cases, respectively (5)3,5. It is also considered that the anti-
microbial resistance is becoming a silent pandemic which if not addressed
effectively today, will be catastrophic tomorrow.

Several antimicrobial agents such as tetracycline, chloramphenicol,

streptomycin, penicillin was first line of treatment at one point of time. These
once very useful antimicrobial agents gradually became resistant and almost
ineffective in most of the conditions in which they were once drugs of choice.
Development of antibiotic resistance is dynamic and at times a swift process.
For example, tetracycline resistance to Vibrio cholera increased from 1-76%
between 2004 to 2007 before decreasing to 50% in 2009 6. Even after
widespread development of resistance, some microorganisms may still remain
susceptible and hence, this antibiotic may retain its effectiveness in certain
conditions. For example, tetracycline is still effective in rickettsial infections, as
is chloramphenicol in conjunctival infections. However, their clinical utility is
limited and therefore, these antimicrobials were deleted from NLEM 2011
(tetracycline, clarithromycin, ketoconazole, mebendazole, norfloxacin) and
NLEM 2015 (sulphadiazine, ofloxacin, nelfinavir).

An expert group from different disciplines i.e. medicine, pediatrics,

neonatology, pulmonology, critical care, microbiology, community health
physicians from different parts of the country and health programme officials
met on several occasions and deliberated the issue of growing anti-microbial
3
Kakkar M, Walia K, Vong S, Chatterjee P, Sharma A. Antibiotic resistance and its containment in India BMJ
2017; 358 :j2687 doi:10.1136/bmj.j2687.
4
Bhattacharya, K., Kanungo, S., Sur, D., Lal Sarkar, B., Manna, B., Lopez, A. L., Bhattacharya, M., Nandy, S.,
& Kumar Niyogi, S. (2011). Tetracycline-resistant Vibrio cholerae O1, Kolkata, India. Emerging infectious
diseases, 17(3), 568 569. https://doi.org/10.3201/eid1703.101176.
5
Vazquez-Guillamet MC, Vazquez R, Micek ST, Kollef MH. Predicting Resistance to Piperacillin-Tazobactam,
Cefepime and Meropenem in Septic Patients With Bloodstream Infection Due to Gram-Negative Bacteria. Clin
Infect Dis. 2017 Oct 30;65(10):1607-1614. doi: 10.1093/cid/cix612. PMID: 29020294.
6
Antiobiotics. (2021). Retrieved 6 May 2021, from https://www.nhsinform.scot/tests-and-treatments/medicines-
and-medical-aids/types-of-medicine/antibiotics
resistance in India. The inputs from other stakeholders were also considered.
The issue was discussed in the context of the AWaRe (Access, Watch and
Reserve) classification of antimicrobial agents in WHO EML 2021.

A. ACCESS
commonly encountered susceptible pathogens which also showing lower
resistance potential than antibiotics in the other groups. Selected access
group antibiotics are recommended as essential first or second choice
empiric treatment options for infectious syndromes as reviewed by the
Expert Committee of EML of WHO and are listed as individual medicines
on the Model Lists to improve access and promote appropriate use. They are
essential antibiotics that should be widely available, affordable and quality

From the 20 antibiotics listed in the Access Category of WHO EML

2021, the following 16 antimicrobial agents are present in the NLEM 2021:

Amikacin Cloxacillin

Amoxicillin Doxycycline

Amoxicillin + clavulanic acid Gentamicin

Ampicillin Metronidazole

Benzathine benzylpenicillin Nitrofurantoin

Benzylpenicillin Phenoxymethylpenicillin

Cefazolin Procaine benzylpenicillin

Clindamycin Sulfamethoxazole + trimethoprim

B. WATCH a
includes most of the highest priority agents among the Critically Important
Antimicrobials for Human Medicine and/or antibiotics that are at relatively
high risk of selection of bacterial resistance. These medicines should be
prioritized as key targets of stewardship programmes and monitoring.
Selected Watch group antibiotics are recommended as essential first or
second choice empiric treatment options for a limited number of specific
infectious syndromes and are listed as individual medicines on the Model
of WHO.

From the 11 antibiotics listed in the Watch Category of WHO EML

2021, the following 11antimicrobial agents are present in the NLEM 2022:

Azithromycin
Cefixime
Cefotaxime
Ceftriaxone
Cefuroxime
Ciprofloxacin
Clarithromycin
Meropenem
Piperacillin + Tazobactam
Vancomycin
Ceftazidime

C. RESERVE a
confirmed or suspected infections due to multi-drug-resistant organisms.

Reserve group antibiotics are listed as individual medicines on the Model

 Lists when they have a favourable risk-benefit profile and proven activity

WHO Priority Pathogens List, notably carbapenem resistant

Enterobacteriaceae. These antibiotics should be accessible, but their use
should be tailored to highly specific patients and settings, when all
alternatives have failed or are not suitable. These medicines could be
protected and prioritized as key targets of national and international
stewardship programmes involving monitoring and utilization reporting, to

From the 7 antibiotics listed in the Reserve Category of WHO EML 2021 the
following 1antimicrobial agents are listed in the NLEM 2022:
Linezolid

The antimicrobial agents which are useful in majority of the situations/

conditions to combat the common infections have been listed in NLEM. The
antimicrobial agents which, in recent years, are showing development of
resistance but may still be useful in many situations have been retained in
NLEM.
It was argued in the meetings that, many antimicrobial agents have shown
pattern of high resistance. Some antimicrobial agents have shown resistance,
albeit in limited studies, which may not be truly representative of the country
due to huge variability in the demography, and also may not represent the
difference / variability in resistance pattern in rural, semi urban and urban
populations. There may also be differences in the level of healthcare delivery in
the primary, secondary and tertiary setups.
The committee also noted that certain microorganisms have been reported
to rapidly develop resistance against specific antimicrobials e.g. Pseudomonas
resistance in 42% of cases against piperacillin tazobactam and in 50% of cases
against meropenem7. This observation is based on a few studies and the data
may be skewed towards the urban tertiary care setups. The committee decided
that despite increasing incidence of resistance, some of these drugs are still life-
saving and thus essential in the treatment of serious bacterial infections, for
example, penicillin G and V in sexually transmitted infections8.
It was argued by some experts that antimicrobials for which some studies
show high resistance should be deleted from the NLEM. This will reduce the
access to these antibiotics thus reducing their overuse and might help in
preserving their effectiveness and perhaps reversing their resistance pattern.
However, majority of the experts opined that making such antimicrobial agents
less available by removing them from the NLEM may in fact deprive the
patients having serious bacterial infections of the beneficial effects of these
drugs. Therefore, the committee opined that a strong antimicrobial stewardship
programme and continuous education to the prescribers /doctors would be a
better and effective strategy rather than restricting their availability. With this
background, the drugs like piperacillin tazobactam have been retained in
NLEM 2022.
In the Indian context, although antimicrobials are not classified as
Access, Watch and Reserve in NLEM 2022, but the philosophy similar to WHO
AWaRe antimicrobial classification was kept in mind. The antimicrobial agents
which have less possibility for development of resistance and are commonly
needed should also be judiciously prescribed. These drugs can be considered
akin to ACCESS category in WHO EML 2021.
The other group of drugs which have high potential for development of
resistance should also be prescribed cautiously. Continuous education regarding
appropriate antibiotic prescribing and use in a correct manner (dose, frequency,

7
Kakkar M, Walia K, Vong S, Chatterjee P, Sharma A. Antibiotic resistance and its containment in India BMJ
2017; 358 :j2687 doi:10.1136/bmj.j2687.
8
Antibiotics. (2021). Retrieved 6 May 2021, from https://www.nhsinform.scot/tests-and-treatments/medicines-
and-medical-aids/types-of-medicine/antibiotics
duration) must be emphasized in undergraduate and post graduate curriculum,
as well as in routine clinical practice. The resistance pattern of these
antimicrobial agents should be carefully monitored and their use should be
appropriately tailored. These drugs can be considered akin to WATCH category
in WHO EML 2021.
Special emphasis is being made on the philosophy of classification of
WHO reserving antibiotics like linezolid in specific conditions where their use
is strongly justified and should be given only by the concerned specialist. Their
prescription should also be governed through appropriate, strong oversight
programme of hospitals. Their availability should also be strongly regulated.
These can be considered akin to the RESERVE class of drugs in WHO
category.
The antimicrobial resistance is a dynamic process and depends on several
factors namely, genetic mutation in bacteria, overuse/ misuse (dose, frequency,
duration, etc), inadequate evidence for use in prophylaxis, use in viral
conditions like, common cold, flu and most upper respiratory tract infections 9,10.
In current times of COVID-19, misuse and overuse of antimicrobial
agents is being witnessed, with little/no evidence of benefit. Making
antimicrobial agents unavailable in the market, perhaps, is not an appropriate
strategy. Rather, continuous sensitization of prescribers, strict prescription audit
and antimicrobial stewardship programmes will go a long way in discouraging
irrational antimicrobial prescribing and prevent antimicrobial resistance.
Thus, to preserve the therapeutic effectiveness of existing antimicrobial
agents, a multi-pronged approach comprising of education, audits, surveillance
and regulatory oversight is essential.

9
Shiley, K. T., Lautenbach, E., & Lee, I. (2010). The use of antimicrobial agents after diagnosis of viral
respiratory tract infections in hospitalized adults: antibiotics or anxiolytics?. Infection control and hospital
epidemiology, 31(11), 1177 1183. https://doi.org/10.1086/656596.
10
Antibiotics. (2021). Retrieved 6 May 2021, from https://www.nhsinform.scot/tests-and-treatments/medicines-
and-medical-aids/types-of-medicine/antibiotics
Fixed Dose Combination (FDC) of Antibiotics
The committee also specifically wanted to highlight the increasing and
continued need of educating the healthcare professionals/ doctors against the
use of FDCs of antibiotics, unless there is convincing evidence of therapeutic
superiority over individual drugs. Although, many antibiotic FDCs with
multiple antibiotics, analgesics, vitamins, minerals, etc have been banned by
regulator in India, still many combinations with unestablished rationality are
available in the market and physicians/doctors tend to prescribe many of these.
Though, the committee wishes to publish a list of such irrational FDCs, it is
restricting itself because preparation of such a list will require, separate
extensive exercise.

Essentiality of 42 anticancer drugs which were subjected to Trade

Margin Rationalization (TMR) by NPPA
Background of the notification by NPPA, DoP, Govt. of India
Considering the representations and several other issues, the NPPA issued the
notification on 27 February, 2019 to put a cap on trade margins of 42 anti-
cancer medicines.

The relevant para 9 of the notification is reproduced below:

High trade margin in sale of drugs leading to

high out of pocket expenses on healthcare, the Government hereby, seeks to
Trade Margin Rationalisation
-
sched
of Concept by capping prices of select Anti-Cancer drugs, identified by the
MoHFW

To further quote relevant para 12, para 13, para 14 and para 15-
the category of Anti-neoplastic/immunosuppressive, Hormones & Antihormones
and medicines used for palliative care. Pricing of these medicines are
controlled through Drug Pricing Control Order (DPCO) 2013 as amended from

(MoHFW) after examining in detail, deliberating and considering all available

information/data/viewpoints and all relevant options for ensuring affordability
of essential drugs to the patients, in case of Anti-cancer Medicines, had
recommended 42 Anti-Cancer medicines for price control on pilot basis

And accordingly, NPPA had put a cap on trade margin of 30% and directed
vide notification, manufacturers to fix their retail price based on price at first
point of sale of product (hereinafter referred as Price to Stockist), as formulated
in Table A, of the non-scheduled formulations containing any of the 42 drugs
vide notification on 27th Feb 2019. The list of the 42 drugs is as below:

Table: List of anticancer drugs under TMR by NPPA

Sl. No. Name of the Drug Sl. No Name of the

Drug
1. Azacitidine 22. Nilotinib

2. Bendamustine 23. Plerixafor

Hydrochloride
3. Bortezomib 24. Carfilzomib

4. Crizotinib 25. Cladribine

5. Cytarabine 26. Triptorelin

6. Dasatinib 27. Pomalidomide

7 Decitabine 28. Osimertinib

8. Doxorubicin HCI 29. Pegasperagase

Pegylated Liposomal
Injection
9. Enzalutamide 30. Regorafenib

10. Epirubicin 31. Ribociclib

11. Eribulin mesylate 32. Clofarabine

12. Erlotinib HC 33. Sunitinib

13. Estramustine 34. Olaparib

phosphate
14. Everolimus 35. Paclitaxel (Protein-
bound particles)
15. Exemestane 36. Olaratumab

16. Fulvestrant 37. Cabazitaxel

17. Irinotecan HCI Trihydrate 38. Bevacizumab

18. Lapatanib 39. Lenalidomide

19. Leuprolide acetate depot 40. Pegfilgrastim

for inj
20. Lomustine 41. Mitomycin

21. Mitoxantrone 42. Pemetrexed

SNCM examined all the 42 drugs under Trade Margin Rationalization (TMR) to
assess if they meet the criteria of essentiality. In a series of meetings, with
oncology and related experts from across the country and stakeholders, SNCM
deliberated on the abovementioned list of anticancer drugs. The committee
agreed on the following criteria to be considered while discussing inclusion of
these anticancer drugs in NLEM

Unequivocal proof of benefit versus previous comparator.

Higher priority to drugs that have the potential to cure a fraction of patients
versus those that have been proven to only prolong lives in metastatic
settings.
Marginal advantage in limited number of patients.

Further, committee also considered that medicines which are established to have
cure rate of >90% for certain cancer even though the incidence of such cancer is
low, should be included in the NLEM.

After consultations and detailed deliberations, the following anticancer

drugs were recommended for inclusion in NLEM 2022.

Bendamustine hydrochloride
Irinotecan HCl Trihydrate
Lenalidomide

Assessment of availability and essentiality of specific formulations in

NLEM 2015

The last NLEM was published in 2015 which had 376 medicines and their
formulations. The medicines listed in NLEM are referred to as scheduled drugs
under Drug Price Control Order (DPCO), 2013 and their prices are fixed by the
National Pharmaceutical Pricing Authority (NPPA) using a defined
methodology. The NPPA could not fix the price for some formulations of
NLEM 2015 as their market data could not be found. This list was shared by
NPPA with SNCM for assessment of their essentiality and availability. The
SNCM decided to review each of these formulations considering the following:

Availability
In the market
Through hospital supplies
Through National Health Programmes (GOI)
Essentiality as per eligibility criteria of the NLEM

The following methodology was adopted:

The list was shared with subject experts from different specialities, public health
professionals and medical professionals across different parts of the country. A
group of experts and officials examined the inputs received and deliberated on
the formulations based on the available evidence. In case, a particular dosage
form or strength of a drug had limited /no availability, its essentiality was
deliberated in detail and decision was taken to retain/replace/delete the drug
from the NLEM.
The group consisted of the following:

Prof. Y.K. Gupta, Vice- Chairman, SNCM

Prof. Santanu Tripathi, Professor & Head, Department of Clinical &
Experimental Pharmacology, School of Tropical Medicine, Kolkata
Prof. Lalit Gupta, Professor, Dept. of Pharmacology, LHMC, Delhi
Col. (Dr.) Prafull Mohan, Professor, Dept. of Pharmacology, AFMC,
Pune
Dr. Biswa Mohan Padhy, Associate Professor, Dept. of Pharmacology,
AIIMS, Bhubaneswar
Dr. Pooja Gupta, Associate Professor, Department of Pharmacology,
AIIMS, Delhi
Dr. Ashish Kakkar, Assistant Professor, Dept. of Pharmacology,
PGIMER, Chandigarh

SNCM Secretariat
Dr. Monika Pahuja, Scientist D, Division of BMS, ICMR, Delhi
Amal Verma, Govind Singh Technical Assistant

National Pharmaceutical Pricing Authority (NPPA)

Mr. N.I. Choudhary, Advisor
Mr. Prasenjeet Das, Deputy Director

CDSCO
Mr. A.K. Pradhan, Joint Drug Controller (I)

IPC, Ghaziabad
Dr. Jai Prakash, Senior Principal Scientific Officer
Programme officers of National Public Health Programmes

Availability of the formulations was enquired from the following sources:

National disease control programmes

Jan Aushadhi stores and pharmacies of various hospitals
Rate contract, AIIMS, Bhubaneshwar
DGAFMS rate contract
Online drug information sources
Speciality experts from different institutions

The group decided to deliberate and recommend the formulations for

retention/deletion based on the following criteria:

a. Specific formulations to be retained in NLEM 2022 on the basis of

essentiality.

b. Specific formulations to be deleted because of non-availability/limited

availability and non-essentiality in the present context.

c. Specific formulations to be retained because they are listed in various

national health programmes and their procurement is done through the

programme although these may not be available in the open market.

d. Special formulations like blood products and other biologicals to be

retained as these are supplied through designated supply chain and may not

be available in the open market.

 It was noted that in some situations there was change in the prescription
practices. Such changes may be because of non-availability of certain
formulations and/or availability of alternate formulations with claimed ease of
administration, better patient compliance and may be influence of sales
promotion.

In addition, the group also noted that sometimes, to circumvent the

NLEM and subsequent price capping, there may be possibility that alternate
formulations may be manufactured and marketed which over a period of time
may change the prescribing habit of the practitioners. It was felt that, in order to
discourage such practices that dilute the importance and applicability of NLEM
in letter and spirit, continuous sensitization of prescribers and treating
physicians is required. The Group after due deliberation and consideration of
above-mentioned criteria made recommendations as detailed in the table below,
for retention/deletion/replacement of the formulations.

It is envisaged that these recommendations will give a message to the

stakeholders including the manufacturers as well as the prescribing physicians
and policy makers, regulators to make the best use of NLEM. The Group was
also of the opinion that such exercise should be undertaken periodically to
assess the trend in prescription practices, marketing strategy vis-à-vis the
availability of the formulations.
 Assessment of specific formulations listed in NLEM 2015 referred by
NPPA for availability and essentiality

S. No Details Total No. Annexure

no.

Specific formulations to be retained in NLEM

a. 18 2.1
2022 on the basis of essentiality.

Specific formulations to be retained because they are

listed in various national health programs and their
b. 12 2.2
procurement is done through the program although
these may not be available in the open market.

Special formulations like blood products and other

biologicals to be retained as these are supplied through
c. 9 2.3
designated supply chain and may not be available in
the open market

Specific formulations to be deleted because of non-

d. availability/limited availability and non-essentiality in 46 2.4
the present context.

Total 85
Issue of essentiality of Desferrioxamine referred by NPPA
The NPPA also referred the case of desferrioxamine powder for injection 500
mg. This is listed in NLEM 2015 under the heading of chelating agent. NPPA
informed that it is imported and marketed by only one company and as per the
information there is negligible sale in last two years. The committee deliberated
on its essentiality and noted the following:

Desferrioxamine is mainly indicated as iron chelator in thalassemia.

The numbers of cases of thalassemia in India are 1 lakh and it is an
important disease.
Desferrioxamine is an affordable and time-tested injectable drug. In
contrast, the newer oral preparations (Deferiprone and Deferasirox) are
relatively expensive.
There are some patients who show less response to oral chelator and thus,
injectable chelator is required.
Drugs listed in the Prevention and Control of Hemoglobinopathies in India
Thalassemias, Sickle Cell Disease and Other Variant Haemoglobins 2016 ,
are Injectable Desferrioxamine and oral preparations of Deferiprone and
Deferasirox. In WHO EML 2019 list, deferoxamine injection 500 mg which is
same as desferrioxamine powder for injection 500mg is the only preparation
that is included for this indication.
The committee noted that injectable desferrioxamine is also indicated in
iron overload because of sickle cell anaemia and iron toxicity by iron overload.
After considering the above aspects, the committee opined that for
thalassemia programme all 3 drugs are important but for NLEM purpose, only
injectable desferrioxamine merits inclusion.
Important changes in NLEM 2022
Addition of new sections/sub sections
In consultation with the programme in-charge of National AIDS Control
Programme (NACP) the following two sub sections have been added.

Medicines for treating opportunistic infections in People Living with HIV

(PLHIV)
HIV infection leads to AIDS and opportunistic infections are the major cause of
morbidity and mortality in such patients, which considerably affect the health
and quality of life of such infected people. The common opportunistic infections
are tuberculosis, oral candidiasis and diarrhoea etc. The total number of PLHIV
in India is estimated around 21.40 lakhs in 2017. Children (<15 years) account
for 0.61 lakh while females (15+ years) accounts for 8.79 lakh PLHIV in
India11. Considering this, a separate sub section 6.7.5 has been added in the
NLEM 2022 for opportunistic infections in PLHIV.

Additional medicines for syndromic management of sexually transmitted

infections
Sexually transmitted infections are commonly associated with HIV infection.
After the consultation with the programme officers, a subsection 6.7.6 of
additional medicines for syndromic management of sexually transmitted
infections has been added.

Addition of new section for management of Covid-19 pandemic

January 2020 witnessed the starting of COVID 19 pandemic in India. The
symptomatology of the illness caused by this new virus was evolving, the
etiopathogenesis was poorly understood and since no available antiviral drug

11
Chapter - 24 National AIDS Control Organization (NACO) [Internet]. Main.mohfw.gov.in. [cited 9 August
2022]. Available from: https://main.mohfw.gov.in/sites/default/files/24%20Chapter%20496AN2018-19.pdf
was able to successfully contain the virus, no specific guidelines were available.
Being a novel pathogen, vaccine was also not available. Soon COVID 19
pandemic turned into a serious public health emergency globally. Initial
response was focused on containing the spread by community interventions.
Meanwhile, scientific community initiated a massive effort to find out an
effective answer for this catastrophic problem.

The research for developing drugs for combating the COVID-19 pandemic
could be categorized into following broad areas:

1. Repurposing of drugs: Use of established drugs or drugs under

development for other indications for the prevention/treatment of COVID-
19 infection. This category contained some established drugs albeit for
different indications such as hydroxychloroquine (HCQS), ivermectin,
azithromycin, doxycycline to name a few. These drugs were tried both for
prevention as well as for treatment of COVID 19. Some other drugs
approved for other indications (such as baricitinib) were also tried in
COVID 19. Extensive multicentric clinical trials (such as SOLIDARITY
(remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon) were
undertaken. Some trials are still continuing, and data continues to emerge.
Of these, HCQS was recommended in India as a prophylactic agent (subject
to certain conditions). Baricitinib (Janus kinase inhibitor, approved for RA),
itolizumab (anti CD 6 Mab, approved for acute psoriasis) Pegylated
Interferon alfa-2b Injection (anti-cancer drug) were given approval in India
for restricted use under emergency situation in COVID 19. Examples of
some other drugs for which several clinical trials have been conducted and
are still going on alone or in combination are nitazoxanide, colchicine, etc.
Some drugs have also been tried as off label.
2. Development of new chemical entity (NCE) for COVID 19 treatment
based on the etiopathology: several new chemical entities were also
investigated and for some, clinical trials are still ongoing. Favipiravir,
remdesivir, 2-Deoxy-D-Glucose, casirivimab and imdevimab Injection
(combination therapy) and bamlanivimab and etesevimab injection
(combination therapy), have received approval for restricted use under
emergency situation in India.

The conditional approval/emergency use approval with respect to above drugs

and some other drugs (not mentioned in para 1 and 2 above) were guided on the
basis of potential benefit exceeding the potential risk (risk benefit ratio) on the
basis of the available in vitro, non-clinical and clinical trial data. The data of all
these medicines is still not conclusive and complete in the regulatory
perspective. Thus, specific precautions and emphasis on post marketing
surveillance (PMS) studies have been advised.
The Pharmacovigilance Program of India has developed a specific
Adverse Drug Reaction (ADR) reporting form for COVID-19 drugs. The
Ministry of Health and Family Welfare has also constituted a national
pharmacovigilance committee under the chairmanship of Prof. Y.K. Gupta for
monitoring of ADRs of drugs used in COVID-19. The collection, collation, and
causality assessment of the ADRs collected from different centers is ongoing.
The safety and efficacy data regarding these interventions are still emerging and
their exact status in treating COVID-19 will become clear with completion of
trials, analysis of data and meta-analysis.

Therefore, the committee was of the opinion that in absence of

unequivocal evidence of efficacy and safety, the medicines mentioned above do
ended for inclusion
in the NLEM 2022.
3. Management of pathophysiological phenomenon associated with
COVID-19 infection (such as cytokine storm, coagulopathy,
inflammatory response etc.). In this category some drugs such as steroids,
Low Molecular Weight Heparin (LMWH) and tocilizumab are being
extensively used. Among them there is strong evidence regarding the use of
steroids and LMWHs in improving clinical outcomes. Along with medical
oxygen and antipyretics, these therapeutic interventions have a clear role in
COVID-19 management. These four medicines are already included in
NLEM 2022 in other therapeutic categories. Considering the above aspects,
the committee recommended that these interventions meet the criteria of
essentiality of COVID-19 management and accordingly such medicines
have been included in a separate section of COVID-19 category in the list.
Other drugs from para 1 and 2 shall be added to this category once more
convincing data is available. Extensive research and development activities
are ongoing all over the world for finding reliable/evidence-based medicines
for COVID 19. As and when such convincing data for specific medicines is
available, they will be considered for inclusion based on the criteria of
essentiality.

4. Use of some drugs without unequivocal evidence Some medicines have

been used in COVID-19 patients with the expectation/ inconclusive
evidence to offer some advantage such as, antiviral, anti-inflammatory and
immune boosting. These medicines are already in use for other indications;
examples are zinc, vitamin cholecalciferol, etc. The committee did not find
evidence for them to be included in NLEM.

5. Development of COVID-19 vaccine It has been another massive global

effort to develop COVID-19 vaccines to fight the COVID-19 pandemic. As
on date five COVID-19 vaccines have been approved in India for restricted
 use under emergency situation (COVAXIN, Covishield, Sputnik V,
MODERNA and Johnson & Johnson). All available COVID-19 vaccines
have established their protective effect and also, favorable risk-benefit ratio.
However, factors such as duration of protection, protection against various
mutants, requirement of boosters, use in special population and longterm
sequelae of vaccination are yet to be established with these vaccines.
Considering these aspects, the committee was of the opinion that with
availability of further long-term efficacy and safety data, these vaccines may
be considered for inclusion in future.

Some medicines have however been considered essential for supportive

management of COVID and accordingly, a separate section containing the list
of such medicines has been added in the NLEM 2022.

On the basis of definitive evidence for benefits the following drugs have
been listed in the COVID-19 category in NLEM 2022: Paracetamol,
Methylprednisolone, Dexamethasone, Enoxaparin and Oxygen. All these drugs
are also listed in other indications.

The committee also recommended that to encounter public health

emergencies in future for such pandemic, government research bodies (such as
ICMR) articulate suitable, flexible recommendations on the basis of emerging
data. This way, medical response to emergencies is likely to be more responsive
and quicker.
Consideration of immunotherapeutic agents for cancer
Immune checkpoint inhibitors represent an important development in cancer
immunotherapy. Anti-CTLA-4 monoclonal anti-body ipilimumab has been
found to be useful in advanced melanoma. Anti-PD1 monoclonal antibodies,
nivolumab and pembrolizumab, are other immune checkpoint inhibitors that
have demonstrated higher efficacy than conventional anti-cancer drugs in
clinical trials for a variety of advanced solid tumors including melanoma, non-
small cell lung carcinoma and renal carcinoma. These studies have indicated
that the enhancement of anti-cancer immunity by controlling the immune
suppressive environment within the cancer tissues is important for the
development of cancer immunotherapy.

The committee deliberated in detail the immunotherapeutic agents for the

treatment of various malignancies. It was noted that immunotherapy is useful as
a therapeutic tool mainly in renal cell cancer, head and neck cancer, bladder
cancer and lung cancer. The immunotherapeutic agents are used only in very
limited cases where the other anti-cancer agents have failed. However, the cost
of immunotherapy is exorbitant and overall therapeutic response is less
predictable. Several clinical trials are still ongoing to demonstrate their efficacy
in different stages of cancer patients.

Targeted oncology therapies are suitable for a specified and small

subgroup of cancer patients. In these patients, presence of specific genetic
markers is often required for predicting their response to the treatment. This was
considered an additional challenge in the use of certain targeted oncology
therapy in India.

Considering the above aspects, the experts including oncologists were

unanimously of the opinion that, as on date immunotherapeutic agents for
cancer do not meet the criteria of their usefulness for majority of cases of cancer
patients, risk benefit ratio, cost- effectiveness, established therapeutic efficacy,
availability in India and hence such immunotherapeutic agents are not included
in NLEM at present.

Graphical representation of addition and deletion of medicines in each

therapeutic category
Changes in writing the names of the medicines
Some changes in writing the names of the medicines have been done to bring
better clarity. Such changes will now better reflect specific salts, isomers,
formulation and specific property of the pharmaceutical/biological products.
Such changes made in NLEM 2022 are listed below:

Table: Changes in writing the names of the medicines

S.No In NLEM 2015 In NLEM 2022

1 Penicillamine D Penicillamine

2 Amphotericin B Amphotericin B

a) Amphotericin B (conventional) a) Amphotericin B (conventional)

b) Lipid/ Liposomal Amphotericin B b) Lipid Amphotericin B

c) Liposomal Amphotericin B

3 Protamine Protamine Sulphate

4 Platelet rich plasma Platelet rich plasma / Platelet

concentrates

5 Red blood cells Red blood cells / Packed RBCs

6 Betamethasone Betamethasone valerate

7 Gadobenate Gadobenate dimeglumine

8 Intraperitoneal dialysis solution Peritoneal dialysis solution

9 5-aminosalicylic acid 5-aminosalicylic acid (Mesalazine/

Mesalamine)

10 Clomiphene Clomiphene citrate

Modified release dosage forms are drug delivery systems (DDS) that, by virtue
of their formulation and product design, provide drug release in a modified form
which is different from that of the conventional/ immediate release dosage
forms. The oral modified release (MR) dosage forms are developed by altering
the rate/kinetics and site of drug release and absorption to confer advantages
like improved patient compliance, optimized efficacy and/or reduced adverse
events. This may be achieved through specialized formulation design or
innovative manufacturing methods. The various types of delivery technologies
could be as extended, delayed, controlled, prolonged, multiphasic release
system, etc.

The modified release dosage forms may sometimes offer following advantages
over conventional formulations e.g. improved patient compliance- by reducing
the frequency of drug administration, the reduction in the total cost of therapy as
lesser number of pills may be required. The MR forms may also offer better
bioavailability. Another advantage that modified release dosage forms may
offer is to minimize the fluctuations in drug plasma concentrations and
facilitating continuous levels above minimum effective concentrations. This
may also avoid certain adverse drug reactions.

In NLEM 2015, various modified release solid oral dosage forms were listed as
sustained release, controlled release, delayed release, extended release,
prolonged release, etc. However, the drug delivery systems are evolving rapidly,
and the pharmaceutical industry is increasingly focusing on novel drug delivery
systems. Many of these are often introduced with incremental innovation. To
broadly reflect all such modified release dosage forms, in NLEM 2022, the term
Modified Release has been used to represent controlled release, sustained
release, prolonged release, extended release etc. with respect to tablets and
capsules as the case may be.
 Medicines where modified release formulations have been mentioned are
Carbamazepine, Levetiracetam, Phenytoin, Sodium Valproate, Levodopa +
Carbidopa, Morphine, Diltiazem, Isosorbide 5 Mononitrate, Metoprolol,
Metformin, etc.

Modifications in Names of Therapeutic Categories (Sections and Sub-

sections)
In NLEM 2022, names of some therapeutic categories (Sections and Sub-
sections) have been modified. This has been done to bring better clarity
regarding the medicines listed therein. The changes in names of therapeutic
categories are listed below:

Table: Changes in names of Therapeutic categories

Therapeutic Categories Therapeutic Categories

in NLEM 2015 in NLEM 2022

Section 1 Section 1
Anaesthetic Agents Medicines used in Anaesthesia

Section 2
Section 2
Analgesics, Antipyretics, Non-Steroidal
Analgesics, antipyretics, non-steroidal anti-
Anti-Inflammatory Drugs (NSAIDs),
inflammatory medicines, medicines used to
Medicines used to treat Gout and Disease
treat gout and disease modifying agents
Modifying Agents used in Rheumatoid
used in rheumatoid disorders
Disorders

Section 4 Section 4
Antidotes and other substances used in Antidotes and Other Substances used in
poisoning Management of Poisonings/ Envenomation

Section 7
Section 7
Anti-cancer agents including
Antineoplastic/ immunosuppressives and Immunosuppressives and Medicines used in
medicines used in palliative care Palliative Care
Section 6.5.1 Section 6.9.1

Antiamoebic and antigiardiasis medicines Medicines used for amoebiasis and other
parasitic infections

Section 12.5 Section 10.5

Antithrombotic medicine (Cardiovascular/ Antiplatelet and antithrombotic medicines

Cerebrovascular)

Section 14.2 Section 11.2

Anti-infective medicines Antibacterial medicines

Section 14.4 Section 11.4

Medicines affecting skin differentiation and Keratolytic agents

proliferation

Section 16 Section 13

Dialysis solutions Dialysis components (haemodialysis and

peritoneal dialysis)

Section 17 Section 14

Disinfectants and antiseptics Antiseptics and disinfectants

Section 27 Section 23

Psychotherapeutic medicines Medicines used in treatment of psychiatric

disorders
Merging of Therapeutic Categories (Sections and sub-sections)
In NLEM 2022, some therapeutic categories which were listed as individual
sections have been merged. The medicines belonging to one disease have been
listed as sub section. For example In NLEM 2015, there were different sections
for antiepileptic drugs, Antimigraine drugs, Antiparkinsonism drugs and drugs
for Dementia. In NLEM 2022, these four sections have been merged as Section 5
i.e. Medicines used in neurological disorders.

Table: Merging of Therapeutic Categories (Sections and sub-sections)

In NLEM 2015 In NLEM 2022

Section 5
Section 5,7,9,13
Medicines in used neurological disorders
Section 5 Section 5.1
Anticonvulsants / Antiepileptics Anticonvulsants / Antiepileptics
Section 7 Section 5.2
Antimigraine Medicines Antimigraine Medicines
Section 9 Section 5.3
Antiparkinsonism Medicines Antiparkinsonism Medicines
Section 13 Section 5.4
Medicines used in Dementia Medicines used in Dementia
Section 1
Medicines used in Anaesthesia
Section 1.1
General anaesthetics and oxygen
Section 23 Section 1.2
Muscle Relaxants and cholinesterase Local anaesthetics
inhibitors Section 1.3
Perioperative medications
Section 1.4
Muscle relaxants and cholinesterase
inhibitors
Section 25.6 Section 21.6
Ophthalmic surgical aids Miscellaneous
Splitting of Therapeutic Categories (Sections and sub-sections)
In NLEM 2015, the section 6 describes anti-infective medicines. The two
important therapeutic category drugs i.e. antileprosy and anti-tubercular drugs
were mentioned as two sub sections, (6.2.3 and 6.2.4) respectively of a sub
section i.e. antibacterial (Section 6.2).

In NLEM 2022, the rationalization of therapeutic categories has been done and
antileprosy has been made a sub section as 6.2 and anti-tubercular has been
made sub section 6.3. Similarly, antiretroviral drugs are now listed as separate
sub-section (6.7) which was earlier placed as 6.4.3 in NLEM 2015.

Table: Splitting of Therapeutic Categories (Sections and sub-sections)

In NLEM 2015 In NLEM 2022

Section 6 Section 6
Anti- Infective medicines Anti- Infective medicines

6.1 Anthelminthics 6.1-Anthelminthics

6.2 Antibacterials 6.2-Antibacterials
6.2.1 Beta-lactam medicines 6.3-Antileprosy medicines
6.2.2 Other antibacterials 6.4-Antituberculosis medicines
6.2.3 Antileprosy medicines 6.5-Antifungal medicines
6.2.4 Antituberculosis medicines 6.6-Antiviral medicines
6.3 Antifungal medicines 6.7-Medicines used in the
6.4 Antiviral medicines management of HIV
6.5 Antiprotozoal Medicines 6.8- Medicines used in Hepatitis B
and Hepatitis C
6.9-Antiprotozoal Medicines
6.10-Antimalarial medicines
Change in therapeutic categories of medicines
In NLEM 2015, certain drugs were listed in therapeutic categories which did
not accurately reflect their indication/ therapeutic use. In NLEM 2022, these
medicines have now been placed under therapeutic categories which are better
indicative of their use.

These changes in therapeutic categories are listed below:

Table: Change in therapeutic categories of medicines

Drug In NLEM 2015 In NLEM 2022

Mesna Section 8.1 Section 8.4

Antineoplastic Medicines Palliative Care

Human Chorionic Section 21.1.2 Section 18.5.2

Gonadotropin
Adrenal Hormones and Ovulation Inducers
Substitutes

Levonorgestrel Section 21.3.2 Section 18.2.2

Estrogens Hormonal Contraceptives

Clopidogrel Section 12.1.2 Section 10.5.2

Medicines used in angina Antiplatelet and Antithrombotic

Medicines
Changes in Level of Healthcare for drugs

In NLEM, the medicines have been categorized as P Primary, S Secondary,

T Tertiary. Over the years, some drugs which were only used in tertiary care
setups are now being commonly used in secondary care setups also.

The list of such changes in level of healthcare for drugs is given in Annexure
3.1.

Changes in Dosage form(s) of Medicines

Over the years, new dosage forms have been introduced into the market which
have shown advantage in terms of safety, efficacy, bioavailability and ease of
administration, etc. Where such dosage forms found merit, have been added.
The list of such changes in dosage form(s) of medicines is given in Annexure 3.2.

Changes in Strength(s) of Medicines

For some medicines, it was noted that some strengths listed in NLEM 2015
have limited availability. Their availability was checked from multiple drug
information sources and obtained feedback from physicians,
pharmacists/chemist shops across the country. Such strengths with limited
availability were deleted from the list considering that alternate essential
strengths are included.
The list of such changes in strength(s) of Medicines is given in Annexure 3.3.
Medicines listed in more than one therapeutic category
There are 56 drugs which are listed in more than one therapeutic category
because they are indicated in more than one conditions. In these indications,
dosage form and strength may be same or different. Some representative
examples are given below:

Aspirin is used as analgesic in 325 mg strength whereas 75 mg is used as

anti-platelet.

Lignocaine 2% injection is used as antiarrhythmic agent and 1% injection as

topical anaesthetic agent.

Diazepam is used as 2 mg tablet in palliative care and as 5 mg/mL injection

is used as anticonvulsant.

Out of 386 medicines in NLEM 2022, 342 appear in single therapeutic category,
41 drugs appear in two therapeutic categories (Annexure 4.1), 11 appear in three
therapeutic categories (Annexure 4.2) and 4 drugs appear in four therapeutic
categories (Annexure 4.3).

SNCM s vision for revision of NLEM: The way forward

Therapeutics and pharmaceutical landscape have changed rapidly with the
advent of newer technologies and incremental innovations, globally as well as
in India. Rapid advances in point of care diagnostics, molecular biology
platforms, monoclonal antibodies, biosimilars, nanomedicine, radioprotective
agents, special drug delivery systems, wearable devices, etc have driven the
therapeutics arena significantly. While drug therapy has become safer,
predictable and more personalized, there has been a sustained increase in cost
and in affordability/accessibility, as a consequence. Furthermore, real world
data about their effectiveness and long-term safety continues to emerge, which
shall determine their exact place in therapeutics some years down the line.

Till that happens, continuous and critical analysis of such technologies is

warranted in the form of standardized and validated HTA protocols for ensuring
their accessibility in Indian context so as to harness their prowess for larger
public good. There is a need t
on and fast track their development. It is equally important to identify and weed
Either way,
continuous HTA remains important and it is recommended that this be taken up
on priority as part of SNCM activity. Indian healthcare ecosystem is cost
sensitive due to minimal insurance coverage and lesser public spending on
healthcare. Though the cost of medicines in India are much cheaper than the
western world, still the expenditure incurred by an average individual is
unbearable as he has to shell out about 80% of the medicine cost as out of
pocket expenses.

One of the cornerstones of SNCM is to identify drugs/medicines of public

importance so as to improve their accessibility through suitable executive
interventions. Such identification, needless to say is a dynamic process, based
on regular accrual of country specific data and is subject to continuous
refinement. Such refinement cannot take place in silo and has to factor in
simultaneous advancements in other related fields. Analysis of associated
factors that affect cost (such as cost of therapy taken in-toto, cost of ADRs, cost
of diagnostic tests, loss of wages, hospital admission costs, cost of travel etc)
have to be taken in cognizance and incorporated into pharmacoeconomic
decision making process. The NLEM is essentially linked to rational use of
medicines which is influenced by multiple factors. Therefore, the committee
deliberated on the following related issues:
NLEM for rational therapeutics
The NLEM should not remain the only dear/fear for pharmaceutical industry
but should become an important tool for improving rational therapeutics in
Indian healthcare system so that the limited resources of the health care sector
can be optimized and majority of the population gets benefited.

Need for Capacity Building for Pharmacoeconomics as a discipline in India

The committee recommends that the discipline of pharmacoeconomics must be
formally encouraged/practiced/included in the UG and PG curriculum of
medical, dental and nursing courses for optimum financial and therapeutic
benefits. The important purpose of NLEM is to ensure adequate and regular
access to the essential medicines.

The concept of essential medicines is one of the pharmacoeconomic tools

to economize/ optimize the purchase/ procurement of medicines. The
pharmacoeconomics particularly focuses on cost and benefits of drug therapy.
Medicines account for a significant proportion of total healthcare cost and
prescription can be considered as important therapeutic intervention in practice
of medicine. It is therefore important that each prescribing doctor is empowered
with right knowledge to practice effectively the principles of
pharmacoeconomics which will help promote rational prescribing.

The committee, therefore, recommends that the basic training in

pharmacoeconomic principles should be mandatory in MBBS and post graduate
curriculum. Advanced pharmacoeconomic courses should be made available
for those involved in committees like hospital formulary committee, drug and
therapeutic committee, making of essential medicines list and preparing
standard treatment guidelines, medical superintendents, directors, etc. This will
also curtail irrational use of medicines. By applying the pharmacoeconomic
principles, the substantial government exchequer can also be saved.
Strengthening translational value of Pharmacovigilance Programme of
India (PvPI) and NLEM

Periodic dissemination of signals and alerts generated by IPC through PvPI to

the practicing clinicians will significantly improve the therapeutic outcomes.
Any new treatment which is adopted in country needs to be specially monitored.
The committee, therefore, recommends that Pharmacovigilance
Programme of India needs to be strengthened by inculcating the practice of
Adverse Drug Reaction (ADR) reporting during early clinical exposure of
medical, dental, nursing and paraclinical students.

NLEM India to become global guidance document for developing world

NLEM 2022 has been drafted after detailed countrywide deliberations and is
based on robust scientific evidence, accessibility considerations and healthcare
needs of the country. This approach can be adopted by other countries. This is
especially pertinent to geographically proximate nations as they share similar
health issues. Therefore, the committee recommends that necessary measures
should be taken to disseminate the NLEM 2022to other countries especially to
the geographically proximate nations.

Discouraging irrational formulations of medicines

In order to appear different, many pharmaceutical houses make formulations of
different strengths, dosage forms, and fixed dose combinations of medicines
claiming some advantage. However, many of such formulations are without
robust scientific evidences. Incidentally, such medicines are also prescribed.
These often create confusion, unnecessary economic burden and sometimes
more adverse reactions because of multiple drugs in FDC. The committee
recommends that such formulations of medicines should be discouraged by the
physicians, regulators, pharmaceutical industry and policy makers.
 Similarly, many formulations which are almost similar in active principle
but have combinations of not relevant medicines. There are several me too
drugs with marginally or sometimes significantly higher costs. There are several
strengths of a medicine/formulation, however, for these medicines, only few
strengths may serve the purpose of majority. Innumerable fixed dose
combinations of medicines particularly of vitamins and minerals are available in
the market. Addition of probiotics to other drugs is necessity only in limited
cases whereas these are used in many formulations without any scientific
justifications. Similar is the case with several antioxidants which are available
in different combinations with different medications. The education of concept
of essential medicines to post graduate medical students, nursing students,
pharmacy students would discourage such formulations. Sometimes their use
can be confusing and do not offer any advantage to the patients. The experts
engaged with the regulators while approving such formulations can also act as
gatekeeper of not flooding me too formulations in the market.

Need for impact assessment of NLEM

NLEM is in existence in India since 1996. After 2015, its visibility and
popularity increased primarily because of its implication on pricing of essential
medicines in India. Though the basic philosophy of NLEM is to ensure
accessibility, availability of quality medicines even in resource limited settings,
sometimes, its influence on pricing becomes more prominent feature. It is
important that there should be mechanism to carry out impact assessment of
NLEM on rational use of medicines, improvement in their accessibility and
affordability to the society as well as impact on optimization of healthcare
budget of the country.
Issue of FDC of multiple drugs iron, vitamin and calcium preparations
In some cases, FDC of two drugs, particularly in cases of iron, calcium were
included in NLEM 2015. For example-

a) Oral Liquid Ferrous Salt (20 mg elemental iron) + Folic Acid (100 mcg)

b) Tablet Ferrous Salt (45 mg elemental iron) + Folic Acid (400 mcg).

However, NPPA could not fix the ceiling price in some of these formulations as
these formulations are not available in the market. These formulations are listed
in national programme National Iron + Initiative and supplied by the
programme.

The reason for non-availability of these formulations in the market may

be due to shifting of the market to other FDCs containing iron and folic acid
along with other multiminerals and multivitamins. Several similar examples are
with vitamin, minerals and calcium. These are examples where essentiality of
the drugs is taken over by the marketing strategies and become the pen of
physicians.

The concerned department/organization should ensure that the

formulations which have little scientific rationale should be discouraged during
licensing by the regulator and practice by the physicians.

NLEM and self-reliant India ( ) for Active Pharmaceutical

Ingredients (APIs)/ Key Starting Materials (KSMs)

India today has emerged as pharmacy of the world with its pharmaceutical
industry ranking third largest in terms of medicines produced by volume and
accounts for 20% of global generic medicines. However, the Indian
pharmaceutical industry has over the years become significantly dependent on
import of basic raw materials that are used to produce the finished dosage
formulations. The import dependence of APIs, KSMs and intermediates for
many medicines which are in NLEM create a vulnerable situation for Indian
healthcare system. This could be on account of multiple factors: a)
Unpredictable fluctuations of import cost affecting the affordability; b)
Uncertainty about the import in the time of conflicts/emergencies; c) Extra
expenditure to ascertain and verify the quality of imported material; d) High
dependency on the limited number of importers. The challenges for ensuring
availability and affordability of API for several pharmaceutical products which
are listed in NLEM were realized during recent COVID-19 times.

Several deliberations were held in Ministry of Commerce, Ministry of

Health and Family Welfare, Indian Council of Medical Research and CDSCO to
address the issue of availability and affordability of APIs/KSMs for medicines
listed in the NLEM, particularly those which are critical. Pharmaceutical
manufacturing associations, NPPA and Department of Pharmaceuticals jointly
identified specific APIs / KSMs for which the import dependency was very high
(even up to 100%). Out of these, the SNCM further identified some APIs as
critical and essential. It is important that the manufacturing of these APIs in
India be taken up on top priority so as to become self-reliant ( )
for formulations of essential medicines. Other strategies for competitive import
from multiple sources be explored and kept in readiness. The Department of
Pharmaceuticals has launched a scheme named as Production Linked Incentive
scheme for APIs/KSMs to promote production of APIs in India. This will go a
long way to ensure the availability of key medicines in the country at all times.
Conclusion
While the extended mandate of the Standing National Committee on Medicines
(SNCM) to revise NLEM 2015. i.e. including medical devices, medical
disposables, medical consumables and other products used for Health and
Hygiene used for general public in NLEM, is being deliberated, the SNCM has
finalized the recommendations of essential medicines and NLEM 2022 has been
prepared and placed in this report.

An important dimension deliberated by SNCM is anti-infective agents in

the light of antimicrobial resistance and the classification of antimicrobial agents
as AWaRe (Access, Watch and Reserve) in WHO EML 2022. It is
recommended that continuous sensitization of prescribers, strict prescription
audit, anti-microbial stewardship programmes and adherence to NLEM 2022
will go a long way in promoting rational antimicrobial prescribing and prevent
antimicrobial resistance.

The COVID-19 pandemic has been a challenge globally as well as for

India. The SNCM deliberated on essentiality of medicines for COVID-19 and
opined that the data of new medications are still not conclusive and complete in
regulatory perspective. Therefore, in absence of unequivocal evidence of
efficacy and safety, the new COVID-19 medicines have not been included as of
now. However, the supportive management has been added in a separate section.

The medicines and their formulations (dosage form and strength) which
had limited availability and not commonly used by the physicians have been
deleted after considering their essentiality. Innovation for improving
therapeutics and vaccines for Indian patients must be encouraged. The
ecosystem needs to be developed so that inclusion of innovative products in
NLEM gives a boost rather than the apprehension of commercial sustainability.
 Innovations, changes in disease burden, revision in treatment guidelines,
changing pharmacoeconomics and pharmacovigilance dimensions make the
NLEM revision process dynamic. Continuous feedback and suggestions from all
stakeholders to the Standing National Committee on Medicines is crucial in
keeping the NLEM up-to-date.

It is reiterated that addressing all the issues is difficult but the basic
principles of essentiality, i.e. efficacy, safety, cost of treatment, need to address
public health problems and common diseases prevalent in India were adhered to.
Thus, the NLEM remains a Best Fit list. More application of important tools like
Health Technology Assessment, pharmacovigilance, pharmacoeconomics and
disease epidemiology will be useful for addressing the several challenges faced
during the process of revision of NLEM.
Annexures
Annexure 1 Order of Ministry of Health and Family Welfare for
constitution of SNCM for revision of NLEM
Annexure 2 Assessment of specific formulations listed in NLEM 2015
referred by NPPA for availability and essentiality

Annexure 2.1
A. Specific formulations to be retained in NLEM 2022 on the basis of
essentiality

S.No. Drug Name Strength Recommendations of Experts

1. Acetylsalicylic acid The committee noted that commonly marketed

preparations are Disprin and Disprin Plus available
Effervescent/
as 325 mg and 500 mg. Therefore, expert
Dispersible/ Enteric
committee recommended that Effervescent/
coated
Dispersible/ Enteric coated Tablet 300 mg to 500
Tablet 300 mg to 500 mg be retained in NLEM 2022.

mg

2. Acetylsalicylic acid Different formulations of acetylsalicylic acid are

Tablet 300 mg to 500 available as effervescent / plain/ effervescent/
mg (351 mg to 500mg) dispersible/ enteric coated. Therefore, expert
committee recommended that Tablet 300 mg to
500 mg to be retained in NLEM 2022.

3. Activated charcoal The committee noted that it is less commonly sold

Powder (as licensed) in market. But the drug is essential as a universal
antidote for poisoning cases. Therefore, expert
committee recommended that Activated charcoal
Powder (As licensed) to be retained in NLEM
2022.

4. Calcium carbonate The committee noted that calcium carbonate is

available in the market and is commonly used by
 Tablet 250 mg clinicians. Therefore, expert committee
recommended that Calcium carbonate Tablet 250
mg to be retained in NLEM 2022.

5. Calcium folinate The committee noted that calcium folinate is

Injection 3 mg/ml available in the market and is commonly used by
clinicians. Therefore, expert committee
recommended that calcium folinate injection
3mg/mL be retained in NLEM 2022.

6. Cloxacillin The committee noted that Cloxacillin Oral liquid is

available in the market and is commonly used by
Oral Liquid 125 mg/5
clinicians. Therefore, expert committee
ml
recommended that Oral Liquid 125 mg/5 ml be
retained in NLEM 2022.

7. Doxycycline The committee noted that

Dry syrup 50 mg/5 ml Doxycycline is in National Malaria

Elimination Programme.

Earlier there was concern for toxicity, but

recent reports show no toxicity.

Therefore, expert committee recommended that

Dry syrup 50 mg/5mL be retained in NLEM 2022.

8. Hydroxocobalamin Vitamin B12 (cobalamin) is used in cases of

Injection 1 mg/ml deficiency which is at times supported by low
blood levels also. The deficiency could be due to
factors like pernicious anaemia, megaloblastic
anaemia, inflammatory bowel disease, short bowel
syndrome, inherited disorders like methylmalonic
aciduria, strict vegetarian diet especially in elderly,
and worm infestation. It is common in India and
hence warrants inclusion of vitamin B12,
particularly parenteral preparation in the NLEM.
Parenteral preparation is needed when the
deficiency is severe and blood levels are very low,
leading to either anaemia or its specific secondary
effects such as peripheral or central neurological
symptoms.

Vitamin B12 supplementation is available in 3

different forms: hydroxo-; cyano- and methyl-
cobalamin. Hydroxo- is parenteral only and cyano-
and methyl- are both oral and parenteral. Hydroxo-
and cyano- are storage forms in the blood and
methyl- is the intracellular active form as cyano- is
converted to hydroxo- which is then converted to
methyl-
(https://en.wikipedia.org/wiki/Hydroxocobalamin).
Hydroxo-cobalamin, in addition is useful for
treatment of cyanide poisoning as well
(https://www.ncbi.nlm.nih.gov/books/NBK557632)

All three forms are available and used, based on

regional preferences, market forces and personal
choices. Hydroxocobalamin is more commonly used
in Europe and cyanocobalamin is more commonly
used in USA
(https://www.ncbi.nlm.nih.gov/books/NBK557632).

As per British National Formulary, for maintenance

therapy, hydroxocobalamin requires once in three
months dosing as compared to once a month for
cyano-
(https://www.bmj.com/content/349/bmj.g5389). It
directs that when vitamin B12 injection is prescribed
 or demanded hydroxocobalamin injection shall be
dispensed or supplied (https://bnf
cyanocobalamin). Hydroxocobalamin is included in
the WHO EML also.

Thus, the above information supports the inclusion

of hydroxocobalamin 1 mg/ml injection in the
NLEM. Therefore, expert committee
recommended that Injection 1mg/mL to be retained
in NLEM 2022.

9. Iohexol The information from AIIMS Bhubaneshwar

procured through rate contract (GE Healthcare).
Injection 140 to 350
Other hospitals also may be procuring through rate
mg iodine/ml
contract. The availability of this product was
checked and it was found that the whole spectrum
from 140 350 mg iodine/ml is available.

Therefore, expert committee recommended that

Injection 140 mg to 350 mg iodine /mL be retained
in NLEM 2022.

10. Medroxyprogesterone Subject experts opined that Tablet

acetate medroxyprogesterone acetate 10 mg is commonly
used, but some patients are started on 5 mg and the
Tablet 5 mg
dose is increased depending on the tolerability and
clinical response. Therefore, expert committee
recommended that both 5 mg and 10 mg be
retained in NLEM 2022.

11. Methylthioninium The committee noted that Injection 10 mg/ml is an

chloride (Methylene essential drug for management of cases leading to
blue) Injection 10 drug induced methemoglobinemia. Therefore, the
 mg/ml committee recommended that it should continue as
essential in NLEM 2022.

12. Nystatin Nystatin was approved by the FDA in 1971 and is

currently widely used in the treatment of
Pessary 100,000 IU
superficial candida infections of the skin, mucous
membranes and gastrointestinal tract, including
oropharyngeal candidiasis.

https://www.ncbi.nlm.nih.gov/books/NBK548581/

Nystatin is available in multiple forms such as

tablets, troches, powder for suspension, creams and
ointments and varying concentrations which are
usually measured in units.

The committee deliberated regarding different

formulations of nystatin. The following were
noted:

The nystatin formulation has limited

availability.

Purportedly more efficacious with better safety

profile antifungals are commonly used now a
days. For example

Fluconazole for GI candidiasis.

Clotrimazole for vulvovaginal candidiasis

Both agents are listed in NLEM 2022

The committee appreciated that the chances of

resistance with nystatin is low. It is also the most
economical antifungal agent as compared to newer
 antifungal agents. This drug is locally effective and
not absorbed systemically. The formulations are
also listed in WHO EML 2019. The committee
therefore recommends that Pessary 100000 IU and
Oral Liquid 100000 IU/mL should be retained and
Tablet 500000 IU be deleted in NLEM 2022, even
though there are other anti-fungal agents in the list.

The committee recommended that there should be

a reassessment after one year for efficacy, safety
and resistance. The use pattern, resistance, efficacy
should be kept in watch.

13. Nystatin Nystatin was approved by the FDA in 1971 and is

currently widely used in the treatment of
Oral Liquid 100, 000
superficial candida infections of the skin, mucous
IU/ml
membranes and gastrointestinal tract, including
oropharyngeal candidiasis

https://www.ncbi.nlm.nih.gov/books/NBK548581/

Nystatin is available in multiple forms such as

tablets, troches, powder for suspension, creams and
ointments and varying concentrations which are
usually measured in units.

The committee deliberated regarding different

formulations of nystatin. The following were
noted:

The availability of nystatin formulation has

limited availability.

More efficacious with better safety profile

antifungals are commonly used now a days.
 Commonly used examples are

Fluconazole for GI candidiasis

Clotrimazole for vulvovaginal candidiasis

Both of these agents are listed in NLEM 2022

The committee appreciated that the chances of

resistance with nystatin is low. It is also the most
economical antifungal agent as compared to newer
antifungal agents. This drug is locally effective and
not absorbed systemically. The formulations are
also listed in WHO EML 2019. The committee
therefore recommends that Pessary 100000 IU and
Oral Liquid 100000 IU/mL should be retained and
Tablet 500000 IU be deleted in NLEM 2022. Even
though there are other anti-fungal agents in the list.

The committee recommended that there should be

a reassessment after one year for efficacy, safety
and resistance. The use pattern, resistance, efficacy
should be kept in watch.

14. Podophyllin resin The committee deliberated and noted that

Podophyllum resin (Podophyllin) is commonly
Solution 10% to 25%
used for warts. Though different strengths from 10
to 25% are available, commonly used and available
strength in India is 20%. Therefore, the committee
recommended Podophyllin resin 20% should be
retained.

15. Povidone iodine The committee noted that it is available as 5%

drops and has limited availability. In clinical
Drops 5%
practice, Povidone-iodine (PVI) solutions have
 been widely used for several decades with
adequate tolerability and safety. It is a universally
accepted antiseptic agent used in ophthalmic
surgery with strong evidence for its efficacy.

https://www.nature.com/articles/s41433-021-
01447-8

Therefore, the committee recommended that it

should continue as essential in NLEM 2022.

16. Pyridoxine Several formulations are available and commonly

used. Thus, the committee recommended to retain
Tablet 50 mg
it in NLEM 2022.

17. Sodium chloride Both 3% and 5% hypertonic saline (HS) are

currently FDA-approved for use in hyponatremia
Injection 3%
and increased intracranial pressure (ICP).

https://www.sort.nhs.uk/Media/Guidelines/Hyperto
nicsaline3sodiumchlorideguideline.pdf

The committee deliberated and noted the

following:

1. 3% hypertonic saline is commonly used in

management of hyponatremia, raised ICP,
cerebral oedema.

2. It is also available in the market, few of the

manufacturers are listed above.

3. USFDA also recommends use of 3%

hypertonic saline (HS) in hyponatremia and
increased intracranial pressure (ICP).

Therefore, the committee recommended retention of

 3% sodium chloride.

18. Vitamin A The capsules of 50000 IU can meet dose titration

needs for most of the indications. The expert
Oral liquid 100000 committee thus recommended deletion of Capsule 1
IU/ml Lac IU and retention of oral liquid 100000 IU/mL.
Annexure 2.2
B. Specific formulations recommended to be retained
The formulations which were referred by NPPA for limited/non-availability in
the market were assessed by the expert group. The nationwide feedback was
also collected on the availability. It was noted that these formulations are poorly
available or not available in the market. However, these formulations are
directly procured and provided by the respective programmes. Thus, after
deliberation the committee, on the basis of essentiality, recommended retention
of these formulations in NLEM 2022.

The formulations of medicines and name of the National Health Programme is

given in the following table:

Name of the National Health Programme

S.No. Drug Name and Strength
in which the drug is mentioned

1. Abacavir
National AIDS Control Programme
Tablet 60 mg

2. Cycloserine
National TB Elimination Programme
Capsule 125 mg

3. Dapsone
National Leprosy Elimination Programme
Tablet 50 mg

4. Ethionamide
National TB Elimination Programme
Tablet 125 mg
5. Ferrous salt (A) + Folic acid (B) National Iron + Initiative
Oral liquid 20 mg elemental iron The committee also noted that several
(A) + 100 mcg preparations of Oral liquid 20 mg elemental
iron (A) + 100 mcg (B) as FDC are
available in the market with additional
constituents such as zinc, vitamin B12.
These FDCs are commonly sold. Therefore,
the experts recommended retention of this
formulation in NLEM 2022.

6. Ferrous salts
Tablet equivalent to 60 mg of National Iron + Initiative
elemental iron

7. Lamivudine (A) + Zidovudine

(B) National AIDS Control Programme
Tablet 30 mg (A) + 60 mg (B)

8. Miltefosine National Vector Borne Disease Control

Capsule 50 mg Programme (NVBDCP)

9. Nevirapine
National AIDS Control Programme
Dispersible Tablet 50 mg

10. Paromomycin National programme for Kala Azar

Injection 375 mg/ml (NVBDCP)

11. Zidovudine
National AIDS Control Programme
Oral liquid 50 mg/5 ml

12. Zidovudine (A) + Lamivudine

(B) + Nevirapine (C)
National AIDS Control Programme
Tablet 60 mg (A) + 30 mg (B) +
50 mg (C)
Annexure 2.3

C. Special formulations like blood products and other biologicals to be

retained as these are supplied through designated supply chain and may
not be available in open market

S.No. Drug Name Recommendations of experts

1. Condom NPPA informed that ceiling price has been

fixed based on NLEM 2011. Presently this
As per the standards prescribed in
is under litigation as informed by regulator.
Schedule R of Drugs and
Cosmetics Rules, 1945 The data for Condom is available on the
online source.

2. Cryoprecipitate There are certain biological products which

are special in nature in terms of their
As licensed
availability and use and thus are not
expected to be available in the general/open
market.

3. Fresh frozen plasma There are certain biological products which

are special in nature in terms of their
As licensed
availability and use. These are not expected
to be available in the general/open market.

4. Inactivated polio Vaccine Inactivated Polio Vaccine is not yet

included in Universal Immunization
As licensed
Programme of India and thus it is not
enlisted in NLEM.
5. Intraperitoneal dialysis solution There are certain biological products which
As licensed are special in nature in terms of their
availability and use. These are not expected
to be available in the general/open market.
6. Platelet rich plasma There are certain biological products which
are special in nature in terms of their
As licensed
availability and use. These are not expected
to be available in the general/open market.

7. Red blood cell There are certain biological products which

are special in nature in terms of their
As licensed
availability and use. These are not expected
to be available in the general/open market.

8. Tuberculin, Purified Protein There are certain biological products which

derivative are special in nature in terms of their
availability and use. These are not expected
As licensed
to be available in the general/open market.
This Tuberculin, Purified Protein Derivative
might be procured by the laboratories.

There are certain biological products which

Whole blood
are special in nature in terms of their
9.
availability and use. These are not expected
As licensed
to be available in the general/open market.
Annexure 2.4

D. Specific formulations deleted because of non-availability/limited

availability and / or non-essentiality in the present context

S.No. Drug Name and Recommendations of Experts

Strength

1. Atropine Injection 0.6 mg/ml is commonly used. Experts from

different parts of the country could not confirm the
Injection 1 mg/ml
availability of Injection 1 mg/ml in their hospitals.

Therefore, expert committee recommended that the

strength of 1mg/ml strength is being deleted in NLEM
2022.

The high dose of atropine will be required in

Organophosphorus poisoning cases where Injection
0.6mg/ml (although high volume) can also serve the
purpose.
Barium Sulphate Oral Liquid 250 % w/v and 100%
2. Barium sulphate
w/v are very less used. Although different strengths

Oral liquid 100% w/v are available. Thus, availability in the market is not
there.
Most commonly used strength is oral liquid 95 % w/v
as confirmed by most of the radiologists who
responded. This strength (95%w/v) meets requirement
of majority of the cases.
Hence, the strengths of 100% w/v and 250% w/v are
deleted from NLEM 2022 and are replaced with one
strength i.e. oral liquid 95% w/v.
3. Barium sulphate Barium Sulphate Oral Liquid 250 % w/v and 100%
w/v are very less used. Although different strengths
Oral liquid 250% w/v
are available. Thus, availability in the market is not
there

Most commonly used strength is oral liquid 95 % w/v

as confirmed by most of the radiologists who
responded. This strength (95%w/v) meets requirement
of majority of the cases.

Hence, the strengths of 100% w/v and 250% w/v are

deleted from NLEM and are replaced with one
strength i.e. oral liquid 95% w/v.

4. Bleaching powder The experts noted that as it is not used by clinicians

Containing not less than and the fact that this can better fit into category of
30% w/w of available hygiene and healthcare products. This is
recommended for deletion in NLEM 2022.

5. Carbamazepine Experts from different parts of the country could not

confirm availability of 200mg/5ml. Oral Liquid
Oral Liquid 200 mg/5ml
100mg/5ml is freely available and is commonly used.

The subject expert group recommended that

200mg/5ml to be deleted from NLEM 2015.

Therefore, the committee recommended deletion of

200mg/5ml as the purpose will be solved with
100mg/5ml.

6. Chlorpheniramine The committee noted the following regarding the oral

liquid 2mg/5mL formulation of chlorpheniramine:
Oral liquid 2 mg/5 ml
1. Not in WHO EML 2019

2. Not available in market

 3. Alternative oral liquid antihistaminic is
Cetirizine Oral Liquid 5mg/5mL is present in
NLEM.

4. The literature review also suggests the

superiority of cetirizine over other second generation.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7043
022/

In view of the above, expert committee recommended

chlorpheniramine oral liquid 2mg/5mL for deletion.

7. Coal tar Solution 5% Coal Tar solution has limited availability in the
market as a single agent. Coal Tar is rather used
commonly in the form of an FDC with Salicylic Acid
Coal Tar Solution 1% coal tar + 3% Salicylic Acid
is commonly used formulation.

The expert recommended that coal tar solution is

replaced by Coal tar (A) + Salicylic Acid (B) solution
Solution 1% (A) + 3% (B) in NLEM, 2022.

8. Cyclophosphamide Feedback from subject experts concluded that tablet

Tablet 200 mg 200 mg is not used where high dose is used, it is given
as injectable for which 500 mg ampoule is already
present in NLEM.

Therefore, the expert committee were of the opinion

that higher doses are used only for injection and not as
oral dose/tablet. And also, WHO EML 2019 enlisted
Tablet 25 mg and 50 mg only. Thus, it is
recommended to delete Tablet 200 mg in NLEM
2022.
9. Cyclosporine Experts from different parts of the country could not
confirm the availability of Cyclosporine Capsule 10
Capsule10 mg
mg. This strength (capsule 10 mg) is not commonly
used. The starting dose is 10 mg but, the liquid
preparation can serve the purpose which is also in
NLEM, therefore, capsule 10 mg is recommended to
be deleted.

10. Dapsone The anti Leprosy drug Dapsone tablet 25 mg is not

listed in the National Leprosy Eradication Programme
Tablet 25 mg
(NLEP). The committee noted that in the National
Leprosy Eradication Programme (NLEP) 50 mg and
100 mg dose is recommended for children and adults
respectively. Once a day tablet of 50 and 100 mg
(daily dose). In any situation where 25 mg is to be
given of tablet 50 mg can serve the purpose.

The experts from different parts of the country

informed that 25 mg is not commonly available.
Therefore, the committee recommended its deletion in
NLEM 2022.

11. Efavirenz The anti-HIV drug Efavirenz tablet 50 mg is not listed

in the National AIDS Control Programme (NACP).
Tablet 50 mg
Other formulations Tablet 200 mg for children and
Tablet 600 mg for adults are listed in the (NACP).
Therefore, the expert committee recommended
deletion of Tablet 50 mg in NLEM 2022.
The expert group confirmed the non-availability of
12. Erythromycin
this formulation. They further noted that erythromycin

Ointment 0.5% is not superior to existing ophthalmic antibiotics.

Therefore, the committee recommended for its
 deletion in NLEM, 2022.

13. Ethinylestradiol (A) + Experts informed that FDC of Ethinylestradiol (A) +

Norethisterone Norethisterone (B) is not commonly prescribed. The
NLEM 2015 already has alternative combination of
Tablet 0.035 mg (A) + 1
hormonal contraceptives which is commonly used.
mg (B)
The FDC is:

Ethinylestradiol (A) + Levonorgestrel (B)

Tablet 0.03 mg (A) + 0.15 mg (B)

The expert committee thus recommended its deletion

from NLEM 2022.

14. Etoposide Capsule 100 mg is less commonly used, wherever 100

mg dose is required, two Capsules of 50 mg can serve
Capsule 100 mg
the purpose. Thus, the expert committee
recommended that 100 mg be deleted from NLEM,
2022. For higher dose, Injection 200mg/ml is
available.

15. Ferrous salt (A) + Folic The formulation of Ferrous Salt and Folic acid are
acid (B) available with various combinations of vitamins. The
reason may be, due to promotion and shifting of
Tablet 45mg elemental
market to other FDCs containing iron and folic acid
iron (A) + 400 mcg (B)
along with multimineral and multivitamins.

The preparations available have additional

constituents like zinc, Vitamin B12.

The committee recommended addition of

a. Iron dextran 50 mg/ml in 2 ml ampoules

b. Iron sorbitol citrate complex 50 mg/ml in 2 ml

 ampoules

This will also align with the Iron + Initiatives it is

indicated for the treatment of anaemia.

Therefore it is recommended for S,T levels of

healthcare.

16. Ferrous salts The experts noted that this formulation is

Oral liquid equivalent to 1. Is listed in Iron + initiative

25 mg of elemental
2. Is formulation is not available in market
iron/ml

3. It is not listed in WHO EML 2019

However, the committee noted that this formulation is

available in FDC with folic acid, Vit B12, as
Tonoferon and recommended its deletion in NLEM
2022.
17. Fluorescein The expert committee noted the following:
Eye drop 1% 1. Cost of the strip per patient compared to drops is
higher. However, the drops have limitation that it
has to be used in multiple patients once the vial is
opened. So, the drops are useful in hospitals with
high patient load.
2. There is issue of drug wastage in drops as once the
vial is opened, it is to be used for multiple patients
in one sitting.
3. Drops have Economic advantage over strips
4. There is ease of use in case of strips.
5. Cost of the strips is higher than the drops which is
the only limitation of strips.
6. Most of the clinicians shifted from drops to strips
and market availability could not be confirmed.
Therefore, the expert committee recommended
 deletion of eye drops 1% and addition of strips in
NLEM 2022.

18. Framycetin The expert group noted that Framycetin Cream 0.5%
is not used and is not available. Instead, Framycetin
Cream 0.5%
Cream 1% is available and commonly used.
Therefore, the experts recommended to delete 0.5%
and replace it with Framycetin Cream 0.5% with 1%
in NLEM, 2022.

19. Isoniazid The committee perused NTEP and noted that 50 mg

tablet is not mentioned whereas oral liquid 50mg/5ml
Tablet 50 mg
is mentioned. Therefore, the committee recommended
the deletion of tablet 50 mg. (Oral Liquid 50mg/5ml
has been added).

20. Isoniazid The committee noted the following:

1. Other formulations of 100mg/5ml are in
Oral Liquid 100mg/5ml
combination with other ingredients.
2. The more commonly available formulation is 50
mg/5ml.
3. 50 mg/5ml is also commonly used as per subject

4. 50mg/5ml is also listed in WHO EML 2019.

5. 50mg/5ml is also listed in Guidelines for
programmatic management of drug resistant TB in
India 2022.
(https://tbcindia.gov.in/showfile.php?lid=3590)

Therefore, the committee recommended the deletion

of 100mg/5ml and inclusion of 50mg/5ml strength.

21. Lignocaine The subject experts informed that at present

Lignocaine 4% drops are not available and are not
Eye drop 4%
being used in current practice. They have been
 replaced by Proparacaine 0.5% eye drops which are
easily available. One bottle of Proparacaine costs
approx. Rs 50 and is manufactured by a large number
of companies in India. As lignocaine drops 4% is no
more essential, it can be dropped from the list.

Considering the above, the expert committee

recommended to delete Lignocaine eye drops 4 % and
addition of Proparacaine eye drops 0.5% in NLEM
2022.

22. Lopinavir (A) + As per the inputs received from NACP, the
Ritonavir (B) formulation Lopinavir + Ritonavir Oral liquid 400
mg (A) + 100 mg (B)/ 5mL is not part of the
Oral liquid 400 mg (A) +
programme. Therefore, the expert committee
100 mg (B)/ 5ml
recommended deletion of this formulation in NLEM,
2022.

23. Mefenamic acid The committee noted that there is more frequent
availability of tablet formulation. Therefore, expert
Capsule 250 mg
committee recommended replacement of Ccapsule
250 mg by Tablet 250 mg.

24. Mefenamic acid The committee noted that usually the daily dose is
500mg to start with followed by maintenance dose of
Capsule 500 mg
250mg oral. The commonly available and used form
is tablet but capsules are also available. Therefore,
expert committee recommended deletion of Capsule
500 mg in NLEM 2022.

25. Methyl prednisolone The committee noted the following:

Tablet 32 mg 1. 32 mg methylprednisolone has limited availability

2. Cost difference

3. Not commonly used

 4. Equivalent efficacy can be achieved with
equipotent doses of prednisolone which is much
cheaper. (http://rc.rcjournal.com/content/63/6/655)

5. This deletion of all oral formulations of

methylprednisolone also aligns with WHO EML
2019.

Therefore, the expert committee recommended

deletion of Tablet 32 mg in NLEM 2022.

26. Midazolam The expert committee noted that the oral liquid 2
mg/mL formulation of midazolam is not used while
Oral liquid 2 mg/ml
nasal spray is used. Midazolam nasal spray is
acceptable and is a good alternative to oral midazolam
as premedication in the pediatric population.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6545
947/

Therefore, the committee recommended addition of

midazolam nasal sprays 0.5 mg and 1.25 mg and
deletion of oral liquid 2mg/mL.

27. Midazolam The committee noted that 15 mg tablet is rarely used

instead nasal spray is preferred. The cost effectiveness
Tablet 15 mg
of nasal spray to be assessed after 1 year for the
purpose of inclusion in NLEM.

Though this is less commonly available, committee

recommended the deletion of tablet 15 mg in NLEM
2022.

28. Miltefosine The currently recommended dose for miltefosine as

monotherapy for either CL or VL is 2.5 mg/kg/day for
Capsule 10 mg
a total of 28 days. However, due to regular
unavailability of the 10 mg capsule in clinical
 practice, other dosages are being administered.
National programme for elimination of Elimination of
Leishmania recommends 100 mg/day miltefosine for
patients with a body wei
1.7 4 mg/kg/day) and 50 mg/day for body weights
<25 kg (corresponding to 2 5.5 mg/kg/day).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3393
397/

The miltefosine dose is 2.5 mg/kg. For better titration,

10 mg/kg is useful. However, 10 mg capsules are not
available. Therefore, the national programme
recommends that patient with less than 25 kg be given
one capsule of 50 mg and patient with more than 25
kg be given a capsule of 100 mg.

The above-mentioned reference also indicates similar

dosing strategy i.e. less than 45 kg 50mg twice daily
50 mg thrice daily.

Considering the above, the committee recommended

deletion of 10 mg capsule.

29. Morphine The committee noted that the availability of 20 mg is

not reliable and also not commonly used. Most of the
Tablet 20 mg
needs are fulfilled by 10 mg and SR 30 mg.
Therefore, the committee recommended deletion of
morphine tablet 20 mg from the NLEM, 2022.

30. Moxifloxacin Although the dose 200 mg is listed in Programmatic

management of Drug Resistant Tuberculosis in India
Tablet 200 mg
2022. Considering the non-availability of 200 mg
tablet and the fact that half tablet of 400 mg serves the
purpose, the 200mg tablet is recommended for
 deletion.

The committee recommended that all 400 mg tablet

should be manufactured as scored tablet to align with
programmatic recommendations.

31. Nicotinamide Nicotinamide 50 mg had been included in the NLEM

for the management of nutritional deficiency of
Tablet 50 mg
Vitamin B3 pellagra.

Until the late 1950s, pellagra was considered as an

endemic disease in India. Research reports revealed
that people who consumed millet jowar (sorghum) as
their staple diet were more prone to pellagra. The high
leucine content in millet decreases the absorption of
nicotinic acid. But scientists did not resort to nicotinic
acid supplementation. Instead, they advised these
populations not to rely solely on jowar but to vary
their diets by including other cereals and millets.
Meanwhile, when the Green Revolution arrived in the
late 1960s, the price of rice and wheat supplied
through ration shops fell to low and readily affordable
levels. People switched to eating rice, and soon
thereafter pellagra perished. Over the past two
decades, only a few pellagra cases have been reported.
By the year 2011, Pellagra had almost disappeared
due to public distribution system.

(https://www.cdriadvlkn.org/article.asp?issn=2542-
551X;year=2019;volume=3;issue=2;spage=126;epage
=129;aulast=Brahmaiah)
(https://www.ijmr.org.in/article.asp?issn=0971-
5916;year=2013;volume=138;issue=3;spage=392;epa
ge=397;aulast=Gopalan)
 It is pertinent to note that in 2007, the WHO EMLc
(children) Subcommittee noted that most of the listed
indications for nicotinamide, including nicotinamide
deficiency, are now rare in children and therefore
decided not to include nicotinamide in the EMLc.

The online survey of available formulations in the

Indian market also revealed limited availability of this
dosage strength. Therefore, in view of its limited
utility, it was opined by the expert group that the
formulation no longer meets the criteria for inclusion
in the NLEM and it was decided to delete it from the
revised list.

The committee noted the following:

1. The tablet of 50 mg nicotinamide is not available.

However, nicotinamide in varying amount is
available in different multivitamin formulations.

2. Nicotinamide is drug of choice as replacement

therapy in pellagra. Pellagra is no more a public
health concern in India.

Considering the above, the committee recommended

deletion of nicotinamide 50 mg in NLEM 2022.

32. Nystatin Nystatin was approved by the FDA in 1971 and is

currently widely used in the treatment of superficial
Tablet 500,000 IU
candida infections of the skin, mucous membranes
and gastrointestinal tract, including oropharyngeal
candidiasis.

Nystatin is available in multiple forms such as tablets,

troches, powder for suspension, creams and ointments
and varying concentrations which are usually
measured in units.

The committee deliberated regarding different

formulations of nystatin. The following were noted:

1. The availability of nystatin formulation has

limited availability.

2. More efficacious with better safety profile

antifungals are commonly used now a days.
Commonly used examples are

Fluconazole for GI candidiasis

Clotrimazole for vulvovaginal candidiasis

Both of these agents are listed in NLEM 2022

The committee appreciated that the chances of

resistance with nystatin is low. It is also the most
economical antifungal agent as compared to newer
antifungal agents. This drug is locally effective and
not absorbed systemically. The formulations are also
listed in WHO EML 2019.

The committee therefore recommended Pessary

100000 IU and Oral Liquid 100000 IU/mL should be
retained and Tablet 500000 IU be deleted in NLEM
2022. Even though there are other anti-fungal agents
in the list.

The committee also recommended that there should

be reassessment after 1 year for efficacy, safety and
resistance. The use pattern, resistance, efficacy should
 be kept in watch.

33. Oxaliplatin The experts noted the following:

Injection 5 mg/ml 1. This drug is useful and commonly used in

advanced colorectal cancer as Folfox regimen.

2. 5mg/mL concentrate for solution for infusion

10 mL and 20 mL vials are commonly used.

3. These formulations are manufactured by many

reputed pharmaceutical companies.

Considering the above, the expert committee

recommended oxaliplatin to be retained in NLEM
2022 as follows:

Injection 50 mg/10 mL in 10- mL vial

Injection 100 mg/20 mL in 20- mL vial

34. Para-aminosalicylic acid The committee noted that Para-aminosalicylic acid

Tablet 500 mg (PAS) is listed in Guidelines for Programmatic
management of Drug resistant TB in India 2022
(pg-239) and mentioned as 4g sachet granules and
PAS sodium salt (equivalent to 4 g PAS acid) sachet
and 60% w/w (9.2 g; equivalent to 4 g PAS acid)
sachet are mentioned.

Immediate release PAS tablets produce substantial GI

intolerance.
(https://pubmed.ncbi.nlm.nih.gov/8159600/ )

The committee therefore recommended that Tablet

500 mg be deleted and only granules be kept.

35. Paracetamol Paracetamol Oral liquid formulations are available in

different dosage forms such as suspension/syrup/
 solution, and in different strengths.
Suspension 156.25 mg/5
ml The committee noted that multiple dosage forms such
as suspension/solution/syrup in multiple strengths of
paracetamol are available in the market/. The
commonly used strengths are following:

Oral liquid 120mg/5mL

Oral Liquid 125 mg/5mL

Oral Liquid 250 mg/5mL

The 120 mg/5mL and 125 mg/5mL are also listed in

WHO EML 2019. The committee therefore
recommended that above mentioned three
formulations for inclusion in NLEM 2022.

36. Pentamidine Pentamidine Powder for Injection 200 mg is no

longer used for Kala-azar under NVBDCP. Therefore,
Powder for Injection 200
the committee recommended its deletion in NLEM
mg
2022.

37. Povidone iodine The experts noted that Povidone iodine 0.6% w/v (6%
w/w) has limited availability and not commonly used.
Drops 0.6 %
Whereas more commonly used strength is 0.5% w/v
(5% w/w). The committee therefore recommended
Povidone iodine 0.6% w/v for deletion in NLEM
2022.

38. Povidone iodine The experts noted that Povidone iodine 0.6% w/v (6%
w/w) has limited availability and not commonly used.
Drops 0.6 %
Whereas more commonly used strength is 0.5% w/v
(5% w/w). The committee therefore recommended
Povidone iodine 0.6% w/v for deletion in NLEM
2022.
39. Prednisolone Experts from different parts of the country could not
confirm the availability of prednisolone drops and the
Drops 0.1%
expert committee deliberated and got the feedback
from subject experts also that prednisolone drops are
used but in 1 % strength. Drops of 0.1% are not used.
Therefore, the committee recommended deletion of
drops 0.1% in NLEM, 2022.

40. Riboflavin Riboflavin supplements come in 25 mg, 50 mg, and

100 mg tablets. According to the National Institute of
Tablet 5 mg
Health, the recommended daily nutrient intake of
riboflavin is 1.3 mg for men, 1.1 mg for women, 1.3
mg for male adolescents (age 14 to 18), and 1.0 mg
for female adolescents (age 14 to 18).
Recommendations are that pregnant women take 1.4
mg, and breastfeeding women take 1.6 mg. Its dose
for infants of age 0 to 6 months old is 0.3 mg, 7 to 12
months is 0.4 mg, 1 to 3 years old is 0.5 mg, 4 to 8
years old is 0.6 mg, and 9 to 13 years is 0.9 mg.

https://www.ncbi.nlm.nih.gov/books/NBK470460/

A few Indian studies show biochemical evidence of

riboflavin deficiency in >70% of children from low-
income groups,6 largely attributed to the inadequacy
of riboflavin in the diet

Bamji MS, Lakshmi AV. Less recognised

micronutrient deficiencies in India. NFI Bull 1998;
19: 5 8.

The committee noted that riboflavin is required to be

retained in NLEM, as riboflavin deficiency continues
to be a problem in India (Swaminathan, S., Edward,
 B. & Kurpad, A. Micronutrient deficiency and
cognitive and physical performance in Indian
children. Eur J Clin Nutr 67, 467 474 (2013).
https://doi.org/10.1038/ejcn.2013.14). However, the
availability of 5 mg is limited and this strength is also
less commonly used while 10 mg is widely available
and commonly prescribed. National Health Mission
also listed riboflavin tablet 10 mg in its guideline
Guideline for District Hospitals (Revised 2012).

Therefore, the committee recommended deletion of

Tablet 5 mg and addition of Tablet 10 mg.

41. Sodium chloride The committee noted the following:

Injection 0.45% 1. 0.45% sodium chloride (half normal saline) has

limited utility in cases of hypernatremia.

2. This strength is not commonly available in the

market and if required, it is locally made by
diluting 0.9% solution.

3. 0.45 % is not listed in WHO EML 2019.

The committee therefore recommended deletion of

0.45% strength in NLEM 2022.

42. Sodium thiosulphate The expert committee noted the following:

Injection 100 mg/ml
1. Injection 100mg/ml is not commonly used and
has limited availability. The strength of
250mg/ml is commonly used.

2. This has indication in cyanide poisoning and

cisplatin extravasation and nephrotoxicity.

According to some experts, the drug is very less used,

 its usefulness needs to be studied. The status to be
reviewed after 1 year. And also, the discussion with
WHO to be done.

Therefore, the committee recommended deletion of

100 mg/mL and addition of 250 mg/mL.

43. Stavudine (A) + Stavudine has been reported to be hepatotoxic

Lamivudine (B) therefore all formulations containing stavudine are
Dispersible Tablet 6 mg recommended for deletion in NLEM, 2022.
(A) + 30 mg (B)

44. Sumatriptan Triptans are often considered the best choice for first-
line therapy. The most rapidly effective treatment in
Injection 6 mg/ 0.5 ml
the class is 6 mg subcutaneous (SC) sumatriptan,
which reaches peak plasma concentration (tmax) in 12
min, has an onset of action of 10 min, and relieves
migraine pain in 82% of patients at 2 h post dose.
Despite its excellent efficacy profile, fewer than 10%
of migraineurs who might benefit from SC
sumatriptan use it to treat their condition [18]. This
may be because most (59%) SC sumatriptan-treated
patients have injection site reactions, and many (42%)
experience triptan sensations (e.g., tingling, warm/hot,
tightness/pressure) that appear to be dose-related [19].
Concerns about drug-related adverse events have
caused two thirds of migraine patients to delay or
avoid treating an attack

https://thejournalofheadacheandpain.biomedcentral.co
m/articles/10.1186/s10194-018-0881-z

The expert committee consulted subject experts who

informed that injectable sumatriptan is rarely used.
Therefore, the committee recommended the deletion
 of injection 6 mg/ 0.5 ml in NLEM 2022.

45. Vitamin A The committee noted that capsules of 50000 IU can

meet dose titration needs for most of the indications.
Capsule 100000 IU
Therefore, the expert recommended deletion of
Capsule 1 Lac IU.

46. Vitamin A The committee noted that capsules of 50000 IU can

meet dose titration needs for most of the indications.
Capsule 5000 IU
Therefore, the expert recommended deletion of
Capsule 5000 IU.
Annexure 3 Changes in NLEM 2022 from NLEM 2015
Annexure 3.1: Changes in Level of Healthcare for drugs

Medicine In NLEM 2015 In NLEM 2022

Level
Level of
Dosage form(s) and of Dosage form(s) and
Health
strength(s) Health strength(s)
care
care

Section 1.1- General Anaesthetics and Oxygen

Sevoflurane T Inhalation S,T Liquid for inhalation

Section 2.4-Disease Modifying Agents used in Rheumatoid Disorders

Hydroxychloroq Tablet 200 mg Tablet 200 mg

S,T P,S,T
uine Tablet 400 mg Tablet 400 mg

Methotrexate S,T Tablet 5 mg P,S,T Tablet 2.5 mg

Tablet 7.5 mg Tablet 5 mg

Tablet 10 mg Tablet 10 mg

Injection 25 mg/ mL
Section 5.1-Anticonvulsants/ Antiepileptics

P,S,T Tablet 200 mg Tablet 200 mg

Tablet 300 mg
Tablet 300 mg
Tablet 500 mg
CR Tablet 300 mg
Modified Release
P,S,T
Tablet 500 mg
Sodium Tablet 300 mg
Valproate CR Tablet 500 mg Tablet 500 mg

Oral liquid 200 Oral liquid 200 mg/5mL

mg/5ml (p)

T Injection 100 mg/mL S,T Injection 100 mg/mL

Section 6.2.1 Beta-lactam medicines

Capsule 125 mg
Powder for Injection Capsule 250 mg
250 mg Powder for Injection 250
Powder for Injection mg
Vancomycin T S,T
500 mg Powder for Injection 500
Powder for Injection mg
1000 mg Powder for Injection 1000
mg

Section 6.4-Antituberculosis medicines

Capsule 125 mg Capsule 125 mg

Cycloserine P,S,T S,T
Capsule 250 mg Capsule 250 mg
 Tablet 125 mg Tablet 125 mg
Ethionamide P,S,T S,T
Tablet 250 mg Tablet 250 mg

Powder for Injection Powder for Injection 500

500 mg mg
Powder for Injection Powder for Injection 750
Kanamycin P,S,T S,T
750 mg mg
Powder for Injection Powder for Injection 1000
1000 mg mg

Para-
Tablet 500 mg
aminosalicylic P,S,T S,T Granules (As licensed)
Granules (As licensed)
acid

Section 6.5-Antifungal medicines

Pessary 1 Lac IU
Tablet 500,000 IU
Oral Liquid 1 Lac IU/mL
Nystatin P,S,T S,T
Pessary 100,000 IU (p)
Oral Liquid 1 Lac
IU/mL

Section 6.7.2 Non-nucleoside reverse transcriptase inhibitors

Nevirapine S,T Tablet 200 mg P,S,T Tablet 200 mg

Dispersible Tablet 50 Dispersible Tablet 50 mg
mg (p)
Oral liquid 50 mg/5 Oral liquid 50 mg/5 mL (p)
mL
Section 7.1 Antineoplastic medicines

Tablet 2.5 mg Tablet 2.5 mg

Tablet 5 mg Tablet 5 mg
Methotrexate T S,T
Tablet 10 mg Tablet 10 mg
Injection 50 mg/mL Injection 50 mg/mL

Allopurinol T Tablet 100 mg S,T Tablet 100 mg

Tablet 10 mg Tablet 10 mg
Amitriptyline T S,T
Tablet 25 mg Tablet 25 mg

Tablet 0.5 mg Tablet 0.5 mg

Dexamethasone T Injection 4 mg/mL S,T Tablet 4 mg

Injection 4 mg/mL

Tablet 2 mg Tablet 2 mg
Diazepam T Tablet 5 mg S,T Tablet 5 mg
Injection 5 mg/mL Injection 5 mg/mL

Fluoxetine T Capsule 20 mg S,T Capsule 20 mg

Tablet 1.5 mg Tablet 1.5 mg

Haloperidol T Tablet 5 mg S,T Tablet 5 mg
Injection 5 mg/mL Injection 5 mg/mL

Lactulose T Oral liquid 10 g/15 mL S,T Oral liquid 10 g/15 mL

Loperamide T Tablet 2 mg S,T Tablet 2 mg

 Tablet 10 mg
Tablet 10 mg
Oral liquid 5 mg/5 mL
Metoclopramide T S,T Oral liquid 5 mg/5 mL (p)
(p)
Injection 5 mg/mL
Injection 5 mg/mL

Midazolam T Injection 1 mg/mL S,T Injection 1 mg/mL

Tablet 10 mg Tablet 10 mg

Morphine T S,T
Tablet 20 mg Modified Release
SR Tablet 30 mg Tablet 30 mg

Section 8.1-Antianaemia medicines

Hydroxyurea P,S,T Capsule 500 mg S,T Capsule 500 mg

Section 8.2-Medicines affecting coagulation

Injection 40 mg/0.4
mL Injection 40 mg/0.4 mL
Enoxaparin T S,T
Injection 60 mg/0.6 Injection 60 mg/0.6 mL
mL

Section 10.1-Medicines used in angina

Tablet 30 mg
Tablet 30 mg
Tablet 60 mg
P,S,T Tablet 60 mg P,S,T
Modified Release
Diltiazem SR Tablet 90 mg
Tablet 180 mg

T Injection 5 mg/mL S, T Injection 5 mg/mL

 Tablet 25 mg
Tablet 25 mg Tablet 50 mg

P,S,T Tablet 50 mg P,S,T Tablet 100 mg

Metoprolol Modified Release
SR Tablet 25 mg
Tablet 100 mg
SR Tablet 50 mg
S, T Injection 1 mg/mL

Section 10.3-Antihypertensive medicines

Tablet 50 mg
P,S,T
Tablet 100 mg
Labetalol
P,S,T Injection 5 mg/ml
S,T Injection 5 mg/mL

Sodium
T Injection 10 mg/mL S, T Injection 10 mg/mL
nitroprusside

Section 18.5-Ovulation Inducers

Human Injection 2000 IU

Injection 1000 IU
chorionic T S,T Injection 5000 IU
Injection 5000 IU
gonadotropin Injection 10000 IU

Section 22.1-Oxytocics and abortifacient

Mifepristone T Tablet 200 mg P,S,T Tablet 200 mg

Misoprostol T Tablet 100 mcg P,S,T Tablet 100 mcg

Tablet 200 mcg Tablet 200 mcg
Oxytocin S,T Injection 5 IU/mL P,S,T Injection 5 IU/mL
Injection 10 IU/mL Injection 10 IU/mL

Section 23.1-Medicines used in psychotic disorders

Fluphenazine S,T Depot Injection 25 P,S,T Injection 25 mg/mL

mg/mL

Section 25-Solutions correcting Water, Electrolyte disturbances and Acid-base

disturbances

Potassium P,S,T Oral liquid 500 mg/5 P,S,T Oral liquid 500 mg/5 mL
chloride mL
S,T Injection 150 mg/mL
Injection 150 mg/mL
Annexure 3.2: Modification(s) in Dosage form(s) of Medicines in NLEM
2022

In NLEM 2015 In NLEM 2022

Level
Medicine Level of
of
Health Dosage form(s) Dosage form(s)
Health
care
care

Section 1.1- General Anaesthetics and Oxygen

Halothane S,T Inhalation S,T Liquid for inhalation

Isoflurane S,T Inhalation S,T Liquid for inhalation

As licensed for medical

Nitrous oxide P,S,T Inhalation P,S,T
purpose

Inhalation As licensed for medical

Oxygen P,S,T P,S,T
(Medicinal gas) purpose

Sevoflurane T Inhalation S, T Liquid for inhalation

2.1-Non-opioid analgesics, antipyretics and nonsteroidal anti-inflammatory medicines

Capsule 250 mg
Tablet 250 mg
Capsule 500 mg
Mefenamic acid P,S,T P,S,T Oral liquid 100 mg/5 mL
Oral liquid 100 (p)
mg/5 ml
Section 2.4-Disease modifying agents used in rheumatoid disorders

Section 4.2 Specific

Capsule 150 mg (p)

D Penicillamine P,S,T Capsule 250 mg P,S,T
Capsule 250 mg

Snake venom
antiserum
a) Injection a) Soluble/ liquid
a) Soluble/ polyvalent Injection
b) Powder for
liquid P,S,T P,S,T
Injection
polyvalent b) Lyophilized polyvalent
Powder for Injection
b) Lyophilize
d polyvalent

Section 5.1-Anticonvulsants/ Antiepileptics

Tablet 100 mg

Tablet 200 mg Tablet 100 mg

Tablet 200 mg
CR Tablet 200 mg
Tablet 400 mg
Tablet 400 mg
Modified Release
Carbamazepine P,S,T P,S,T
CR Tablet 400 mg
Tablet 200 mg
Oral liquid 100 Tablet 400 mg
mg/5 ml Oral liquid 100 mg/5 mL
(p)
Oral liquid 200
mg/5 ml
 Tablet 250 mg Tablet 250 mg
Tablet 500 mg
Tablet 500 mg
Tablet 750 mg
Tablet 750 mg
Modified Release
Levetiracetam S,T S,T
ER Tablet 750 mg Tablet 750 mg

Oral liquid 100

mg/ml Injection 100 Oral liquid 100 mg/mL (p)
mg/ml Injection 100 mg/mL

Tablet 50 mg
Tablet 50 mg
Tablet 100 mg
Tablet 100 mg

Tablet 300 mg Tablet 300 mg

ER Tablet 300 mg Modified Release

Tablet 300 mg
Phenytoin P,S,T Oral liquid 30 mg/5 P,S,T Oral liquid 30 mg/5 mL
ml (p)
Oral liquid 125 mg/5 mL
Oral liquid 125
(p)
mg/5 ml Injection
Injection 25 mg/mL
25 mg/ml
Injection 50 mg/mL
Injection 50 mg/ml
 Tablet 200 mg Tablet 200 mg
Tablet 300 mg
Tablet 300 mg
Tablet 500 mg
CR Tablet 300 mg
Modified Release

Tablet 500 mg
P,S,T Tablet 300 mg
P,S,T CR Tablet 500 mg Tablet 500 mg
Sodium Valproate

Oral liquid 200

mg/5ml
Oral liquid 200 mg/5mL
(p)

T Injection 100 S,T Injection 100 mg/mL

mg/mL

Section 5.3- Antiparkinsonism medicines

Tablet 100 mg (A)

Tablet 100 mg (A) + 10
+ 10 mg (B)
mg (B) Tablet 100 mg (A)
Tablet 100 mg (A) + 25 mg (B)
+ 25 mg (B) CR Tablet 250 mg (A) + 25
P,S,T Tablet 100 mg (A) mg (B)
Levodopa (A) +
+ 25 mg (B) P,S,T
Carbidopa (B) Modified Release
CR Tablet 200 mg
Tablet 100 mg (A) + 25
(A) + 50 (B) mg
mg (B)
Tablet 250 mg (A) Tablet 200 mg (A) + 50
+ 25 mg (B) mg (B)

Section 6.1.1 - Intestinal anthelminthics

 Tablet 400 mg
Tablet 400 mg
Chewable Tablet 400 mg
Albendazole P,S,T Oral liquid 200 P,S,T
Oral liquid 200 mg/5 mL
mg/5 mL
(p)

Section 6.5-Antifungal medicines

a) Amphotericin B
Amphotericin B (conventional) -
Injection 50 mg/vial
a)Amphotericin B
(conventional) Powder for b) Lipid Amphotericin B -
S,T S,T
Injection 50 mg Injection 50 mg/vial
b) Lipid/Liposomal
Amphotericin B
c) Liposomal
Amphotericin B -
Injection 50 mg/vial

Section 6.10 - Antileishmaniasis medicines

a) Amphotericin B
Amphotericin B (conventional) -
a) Amphotericin B Powder for b) Lipid Amphotericin
(conventional) S,T Injection 50 mg S,T B - Injection 50 mg
b) Lipid/Liposomal c) Liposomal
Amphotericin B Amphotericin B -
Injection 50 mg
 Injection 100 mg/
mL
Injection 100 mg/Vial
Cytosine Powder for
T T
arabinoside Injection 500 mg Injection 500 mg/Vial
Injection 1000 mg/vial
Powder for
Injection 1000 mg

Section 7.3-Immunosuppressive medicines

7.4-Medicines used in palliative care

Tablet 10 mg Tablet 10 mg
Morphine T Tablet 20 mg S,T Modified Release
SR Tablet 30 mg Tablet 30 mg

Section 10.1-Medicines used in angina

Tablet 30 mg
Tablet 30 mg
Tablet 60 mg
P,S,T Tablet 60 mg P,S,T
Modified Release
Diltiazem SR Tablet 90 mg
Tablet 180 mg

T Injection 5 mg/mL S, T Injection 5 mg/mL

Tablet 10 mg
Tablet 10 mg

Isosorbide-5- Tablet 20 mg Tablet 20 mg

P,S,T P,S,T
mononitrate SR Tablet 30 mg Modified Release
Tablet 60 mg
SR Tablet 60 mg
 Tablet 25 mg
Tablet 25 mg Tablet 50 mg

P,S,T Tablet 50 mg P,S,T Tablet 100 mg

Metoprolol Modified Release
SR Tablet 25 mg
Tablet 100 mg
SR Tablet 50 mg
S, T Injection 1 mg/mL

Section 10.3-Antihypertensive medicines

Section 10.5- Antiplatelet and Antithrombotic Medicines

Tablet 75 mg

Effervescent/
Dispersible/ Enteric Conventional/Effervescent
coated Tablet 75 mg / Dispersible/ Enteric
coated Tablets 150 mg
Tablet 100 mg
Conventional/Effervescent
Effervescent/
/ Dispersible/ Enteric
Acetylsalicylic acid P,S,T Dispersible/ Enteric P,S,T coated Tablets 325 mg
coated Tablet 100
mg Enteric coated Tablet 75
mg
Tablet 150 mg
Enteric coated Tablet 100
Effervescent/
mg
Dispersible/ Enteric
coated Tablet 150
mg
Section 11.6-Miscellaneous

Glycerin (as
P,S,T Oral Liquid P,S,T As Licensed
mentioned in IP)

Section 12.1-Ophthalmic Medicines

Fluorescein S,T Eye drop 1 % S,T Ophthalmic strips

Section 14.2 Disinfectants

Glutaraldehyde S,T Solution 2 % S,T As Licensed

Section 18.1 - Adrenal Hormones and synthetic substitutes

Tablet 5 mg
Tablet 5 mg
Tablet 10 mg
Tablet 10 mg
Hydrocortisone P,S,T P,S,T Tablet 20 mg
Injection 100
Powder for Injection 100
mg/mL
mg

Section 18.2.3 - Barrier methods

As per the standards

prescribed in As Licensed as per the
Condom P,S,T Schedule R of Drugs P,S,T standards of Drugs Rules,
and Cosmetics 1945
rules,1945
Section 18.4.1 - Insulins and other antidiabetic agents

Tablet 500mg
Tablet 500mg
Tablet 750mg
Tablet 1000 mg
Metformin P,S,T Tablet 1000 mg P,S,T
Modified release
(Immediate and
Tablet 1000 mg
controlled release)

Section 19.1-Diagnostic agents

Tuberculin,
Purified Protein P,S,T P,S,T As Licensed
derivative

Section 19.2-Sera and immunoglobulins (Liquid/ Lyophilized)

Anti-rabies
P,S,T P,S,T As Licensed
immunoglobulin

Anti-tetanus
P,S,T P,S,T As Licensed
immunoglobulin

Anti-D
S,T S,T As Licensed
immunoglobulin

Diphtheria antitoxin P,S,T P,S,T As Licensed

Hepatitis B
S,T S,T As Licensed
immunoglobulin
Human normal
T T As Licensed
immunoglobulin

Snake Venom
Antiserum a) Soluble/ liquid
polyvalent - As Licensed
a) Soluble/ liquid
P,S,T P,S,T
polyvalent b) Lyophilized polyvalent
- As Licensed
b) Lyophilized
polyvalent

Section 19.3.1 - For universal immunization

BCG vaccine P,S,T P,S,T As licensed

DPT+ Hib+ Hep B

P,S,T P,S,T As licensed
vaccine

DPT vaccine P,S,T P,S,T As licensed

Hepatitis B vaccine P,S,T P,S,T As licensed

Japanese
P,S/,T P,S/,T As licensed
encephalitis vaccine

Measles vaccine P,S,T P,S,T As licensed

Oral poliomyelitis
P,S,T P,S,T As licensed
vaccine

Tetanus toxoid P,S,T P,S,T As licensed

Section 23.1-Medicines used in psychotic disorders

Depot Injection 25
Fluphenazine S,T P,S,T Injection 25 mg/mL
mg/mL

Section 23.2.1 - Medicines used in Bipolar disorders

Sodium valproate P,S,T Tablet 200 mg P,S,T Tablet 200 mg

Tablet 500 mg Tablet 300 mg

Tablet 500 mg

Modified Release

Tablet 300 mg
Tablet 500 mg

Section 24.1 - Antiasthmatic Medicines

Powder for Injection 100

Injection 100 mg mg
Hydrocortisone P,S,T P,S,T
Injection 200 mg Powder for Injection 200
mg

Section 26-Vitamins and Minerals

Solid oral dosage form

Tablet 1000 IU
1000 IU
Tablet 60000 IU
Cholecalciferol P,S,T P,S,T Solid oral dosage form
Oral liquid 400
60000 IU
IU/mL
Oral liquid 400 IU/mL
 Capsule 5000 IU

Capsule 50000 IU Capsule/Tablet 50000 IU

(including Chewable
Vitamin A P,S,T Capsule 100000 IU P,S,T tablet)
Oral liquid 100000 IU/mL
Oral liquid 100000
Injection 50000 IU/mL
IU/ml Injection
50000 IU/ml
Annexure 3.3: Modification(s) in strength(s) of Medicines in NLEM 2022

In NLEM 2015 In NLEM 2022

Medicine Level of Level of

Health Strength(s) Health Strength(s)
care care

2.1-Non-opioid analgesics, antipyretics and nonsteroidal anti-inflammatory

medicines

Capsule 250 mg
Tablet 250 mg
Capsule 500 mg
Mefenamic acid P,S,T P,S,T Oral liquid 100 mg/5 mL
Oral liquid 100 mg/5
(p)
ml

Tablet 500 mg Tablet 500 mg

Tablet 650 mg Tablet 650 mg
All licensed oral Oral liquid 120 mg/5mL
liquid dosage forms Oral Liquid 125mg/5ml (p)
Paracetamol P,S,T P,S,T
and strengths Oral Liquid 250 mg/5mL
Injection 150 mg/ml Injection 150 mg/mL
Suppository 80 mg Suppository 80 mg
Suppository 170 mg Suppository 170 mg

Section 2.4-Disease Modifying Agents used in Rheumatoid Disorders

Tablet 25 mg (p)
Azathioprine S, T Tablet 50 mg S,T
Tablet 50 mg

Tablet 5 mg Tablet 2.5 mg

Tablet 7.5 mg Tablet 5 mg
Methotrexate S,T P,S,T
Tablet 10 mg Tablet 10 mg
Injection 25 mg/mL
 Tablet 4 mg
Chlorpheniramine P,S,T Tablet 4 mg
Oral liquid 2 mg/5 mL P,S,T

Tablet 0.5 mg
Tablet 2 mg
Tablet 0.5 mg Tablet 4 mg
Dexamethasone P,S,T P,S,T
Injection 4 mg/mL Oral liquid 0.5 mg/5 mL
(p)
Injection 4 mg/mL

Tablet 5 mg
Tablet 10 mg
Powder for Injection Powder for Injection 100
Hydrocortisone P,S,T P,S,T
100 mg mg
Powder for Injection 200
mg

Section 4.2 Specific

Atropine P,S,T Injection 1 mg/mL P,S,T Injection 0.6 mg/mL

Capsule 150 mg (p)

D Penicillamine P,S,T Capsule 250 mg P,S,T
Capsule 250 mg

Sodium
S,T Injection 100 mg/mL S,T Injection 250 mg/mL
thiosulphate

Section 5.1-Anticonvulsants/ Antiepileptics

 Tablet 100 mg
Tablet 100 mg
Tablet 200 mg
Tablet 200 mg
CR Tablet 200 mg
Tablet 400 mg
Tablet 400 mg
Modified Release
Carbamazepine P,S,T CR Tablet 400 mg P,S,T
Tablet 200 mg
Oral liquid 100 mg/5
Tablet 400 mg
ml
Oral liquid 100 mg/5 mL
Oral liquid 200 mg/5
(p)
ml

Tablet 1 mg Tablet 1 mg
Tablet 2 mg Tablet 2 mg
Lorazepam P,S,T P,S,T
Injection 2 mg/mL Injection 2 mg/mL
Injection 4 mg/mL

Section 5.2- Antimigraine medicines

Tablet 500 mg
Tablet 650 mg
Oral liquid 120mg/5mL
Tablet 500 mg (p)
Paracetamol P,S,T P,S,T
Tablet 650 mg Oral Liquid 125 mg/5mL
(p)
Oral Liquid 250 mg/5mL
(p)

Tablet 25 mg Tablet
Tablet 25 mg
Sumatriptan P,S,T 50 mg Injection 6 mg/ P,S,T
Tablet 50 mg
0.5 ml

Tablet 10 mg Tablet 10 mg
Propranolol P,S,T Tablet 40 mg P,S,T Tablet 20 mg
Tablet 80 mg Tablet 40 mg

Section 5.3- Antiparkinsonism medicines

Section 6.1.1 - Intestinal anthelminthics

Tablet 400 mg
Tablet 400 mg
Chewable Tablet 400 mg
Albendazole P,S,T Oral liquid 200 mg/5 P,S,T
Oral liquid 200 mg/5 mL
mL
(p)

Section 6.2.1 Beta-lactam antibacterials

Capsule 250 mg
Capsule 500 mg
Oral liquid 125 mg/5 mL
(p)
Capsule 250 mg Oral liquid 250 mg/5 mL
Capsule 500 mg (p)
Amoxicillin P,S,T P,S,T
Oral liquid 250 mg/5 Powder for Injection
mL 250mg
Powder for Injection 500
mg
Powder for injection 1000
mg

Powder for injection 6 lac

Powder for injection 6 units
Benzathine lac units Powder for injection 12 lac
P,S,T P,S,T
Benzylpenicillin Powder for injection units
12 lac units Powder for injection 24 lac
units

Powder for injection 5 lac

Powder for injection
units
Benzyl penicillin P,S,T 10 lac units P,S,T
Powder for injection 10 lac
units

Section 6.2.2 Other antibacterials

 Capsule 100 mg
Capsule 100 mg Dry Syrup 50mg/5 mL (p)
Doxycycline P,S,T P,S,T
Dry Syrup 50mg/5 mL Power for Injection 100
mg

Capsule 125 mg
Powder for Injection Capsule 250 mg
250 mg Powder for Injection 250
Powder for Injection mg
Vancomycin T S,T
500 mg Powder for Injection 500
Powder for Injection mg
1000 mg Powder for Injection 1000
mg

Section 6.3-Antileprosy medicines

Tablet 25 mg
Tablet 50 mg
Dapsone P,S,T Tablet 50 mg P,S,T
Tablet 100 mg
Tablet 100 mg

Section 6.4 - Antituberculosis medicines

Powder for Injection 500

mg
Powder for Injection 750
Capreomycin P,S,T Powder for Injection P,S,T
mg
1000 mg
Powder for Injection 1000
mg

Tablet 50 mg
Tablet 100 mg
Tablet 100 mg
Tablet 300 mg
Isoniazid P,S,T Tablet 300 mg P,S,T
Oral Liquid 50 mg/5 mL
Oral liquid 100 mg/5
(p)
mL

Tablet 200 mg
Moxifloxacin P,S,T P,S,T Tablet 400 mg
Tablet 400 mg
Section 6.5-Antifungal medicines
Tablet 100 mg Tablet 50 mg
Tablet 150 mg Tablet 100 mg
Tablet 200 mg Tablet 150 mg
P,S,T Tablet 400 mg P,S,T Tablet 200 mg
Fluconazole Oral liquid 50 mg/5 Tablet 400 mg
mL Oral liquid 50 mg/5 mL (p)
Injection 200 mg/100
S,T S,T Injection 200 mg /100 mL
mL

Tablet 5,00,000 Lac

IU Pessary 1 Lac IU
Nystatin P,S,T Pessary 1,00,000 IU S,T Oral Liquid 1 Lac IU/mL
Oral Liquid 1,00,000 (p)
IU/mL

Section 6.6.1 Antiherpes medicines

Tablet 200 mg
Tablet 200 mg
Tablet 400 mg
Tablet 400 mg
Tablet 800 mg
Powder for Injection
Powder for Injection 250
Acyclovir P,S,T 250 mg P,S,T
mg
Powder for Injection
Powder for Injection 500
500 mg Oral liquid
mg Oral liquid 400 mg/5
400 mg/5 mL
mL (p)

Section 6.7.2 Non -nucleoside reverse transcriptase inhibitors

Tablet 50 mg
Tablet 200 mg (p)
Efavirenz S,T Tablet 200 mg S,T
Tablet 600 mg
Tablet 600 mg
Section 6.7.4 - Protease inhibitors

Tablet 100 mg (A) + 25

mg (B)
Tablet 200 mg (A) + 50
Tablet 100 mg (A) + 25
mg (B)
mg (B) Tablet 200 mg
Lopinavir (A) + Oral Liquid 80 mg (A) +
S,T (A) + 50 mg (B) Oral S,T
Ritonavir (B) 20 mg (B) /mL (p)
liquid 400 mg (A) + 100
Capsule/ Sachet
mg (B)/ 5ml
(containing
Pellets/Granules) 40 mg
(A) +10 mg (B) (p)

Section 6.8 -Medicines for Hepatitis B and Hepatitis C

Tablet 0.5 mg
Entecavir S,T Tablet 0.5 mg S,T Tablet 1 mg
Tablet 1 mg Syrup 0.05 mg/mL (p)

Section 6.10 - Antileishmaniasis medicines

Capsule 10 mg
Miltefosine P,S,T P,S,T Capsule 50 mg
Capsule 50 mg

Section 6.10 - Antimalarial medicines

Tablet 20 mg (A) +
Tablet 20 mg (A) + 120
120 mg (B) Tablet 40
mg (B)
mg (A) + 240 mg (B)
Artemether (A) + Tablet 40 mg (A) + 240
P,S,T Tablet 80 mg (A) + P,S,T
Lumefantrine (B) mg (B)
480 mg (B)
Tablet 80 mg (A) + 480
Oral liquid 80 mg (A)
mg (B)
+ 480 mg (B)/5 mL

Section 7.1-Antineoplastic medicines

Tablet 50 mg
Tablet 50 mg
Tablet 200 mg
Cyclophosphamide T T Powder for Injection 500
Powder for Injection
mg
500 mg
 Capsule 50 mg
Capsule 50 mg
Etoposide T Capsule 100 mg T
Injection 20 mg/mL
Injection 20 mg/mL

Capsule10 mg
Capsule 25 mg Capsule 25 mg
Capsule 50 mg Capsule 50 mg
Cyclosporine T Capsule 100 mg T Capsule 100 mg
Oral liquid 100 Oral liquid 100 mg/mL (p)
mg/mL Injection 50 mg/mL
Injection 50 mg/mL

Injection 5mg/mL in 10
Oxaliplatin T Injection 5 mg/mL T
mL and 20 mL vial

Section 7.3-Immunosuppressive medicines

Capsule 10 mg
Capsule 25 mg Capsule 25 mg
Capsule 50 mg Capsule 50 mg
Cyclosporine T Capsule 100 mg T Capsule 100 mg
Oral liquid 100 Oral liquid 100 mg/mL (p)
mg/mL Injection 50 mg/mL
Injection 50 mg/mL

7.4-Medicines used in Palliative Care

Tablet 0.5 mg
Tablet 0.5 mg
Dexamethasone T S,T Tablet 4 mg
Injection 4 mg/mL
Injection 4 mg/mL

Tablet 10 mg Tablet 10 mg
Morphine T Tablet 20 mg S,T Modified Release
SR Tablet 30 mg Tablet 30 mg
Section 8.1-Antianaemia medicines
Tablet equivalent to
Ferrous salts Tablet equivalent to 60 mg
60mg of elemental
of elemental iron
iron
(a) Iron Dextran P,S,T P,S,T
Oral liquid equivalent
(b) Iron sorbitol Injection 50 mg/mL
to 25mg of elemental
citrate complex Injection 50 mg/mL
iron/mL
Tablet 1 mg
Folic Acid P,S,T Tablet 5 mg P,S,T
Tablet 5 mg
Section 10.1-Medicines used in angina

Tablet 30 mg
Tablet 30 mg
Tablet 60 mg
Tablet 60 mg P,S,T
Diltiazem P,S,T Modified Release
SR Tablet 90 mg
Tablet 180 mg

T Injection 5 mg/mL S, T Injection 5 mg/mL

Tablet 10 mg Tablet 10 mg
Isosorbide-5- Tablet 20 mg Tablet 20 mg
P,S,T P,S,T
mononitrate SR Tablet 30 mg Modified Release
SR Tablet 60 mg Tablet 60 mg

Tablet 25 mg
Tablet 50 mg
Tablet 25 mg
P,S,T Tablet 100 mg
P,S,T Tablet 50 mg
Metoprolol Modified Release
SR Tablet 25 mg
Tablet 100 mg
SR Tablet 50 mg
S, T Injection 1 mg/mL

Section 10.2-Antiarrhythmic medicines

Injection 2%
Lignocaine S,T (Preservative free for S,T Injection 2%
IV use)

Section 10.3-Antihypertensive medicines

Tablet 50 mg
P,S,T
Tablet 100 mg
Labetalol P,S,T Injection 5 mg/mL
S,T Injection 5 mg/mL
Section 10.5- Antiplatelet and Antithrombotic Medicines

Tablet 75 mg
Effervescent/ Conventional/Effervescent/
Dispersible/ Enteric Dispersible/ Enteric coated
coated Tablet 75 mg Tablets 150 mg
Tablet 100 mg Conventional/Effervescent/
Effervescent/ Dispersible/ Enteric coated
Acetylsalicylic acid P,S,T P,S,T
Dispersible/ Enteric Tablets 325 mg
coated Tablet 100 mg Enteric coated Tablet 75
Tablet 150 mg mg
Effervescent/ Enteric coated Tablet 100
Dispersible/ Enteric mg
coated Tablet 150 mg

Tablet 75 mg
Clopidogrel P,S,T Tablet 75 mg P,S,T
Tablet 150 mg

Section 10.6-Hypolipidemic medicines

Tablet 10 mg
Tablet 10 mg
Tablet 20 mg
Atorvastatin P,S,T Tablet 20 mg P,S,T
Tablet 40 mg
Tablet 40 mg
Tablet 80 mg

Section 11.1 - Antifungal medicines

Cream 1%
Clotrimazole P,S,T Cream 1% P,S,T
Lotion 1%

Section 11.2 - Antibacterial medicines

Framycetin P,S,T Cream 0.5% P,S,T Cream 1%

Section 11.4-Keratolytic agents

Benzoyl peroxide P,S,T Gel 2.5% P,S,T Gel 2.5% - 5%

Coal tar (A) +
P,S,T Solution 5% (A) P,S,T Solution 1% (A) + 3% (B)
Salicylic Acid (B)

Solution 10 % to 25 %
Podophyllin resin S,T S,T Solution 20%
Solution 20%

Section 11.6-Miscellaneous

Glycerin (as
P,S,T Oral Liquid P,S,T As Licensed
mentioned in IP)

Section 12.2-Radiocontrast media

Oral liquid 100 % w/v

Barium sulphate S,T S,T Oral Liquid 95% w/v
Oral liquid 250 % w/v

Section 17.2 Antiemetics

Tablet 10 mg
Metoclopramide P,S,T Injection 5 mg/mL P,S,T
Injection 5 mg/mL

Section 18.1 - Adrenal Hormones and synthetic substitutes

Tablet 5 mg
Tablet 5 mg Tablet 10 mg
Hydrocortisone P,S,T Tablet 10 mg P,S,T Tablet 20 mg
Injection 100 mg/mL Powder for Injection 100
mg

Tablet 8 mg
Tablet 16 mg
Methylprednisolone S,T S,T Injection 40 mg/mL
Tablet 32 mg
Injection 40 mg/mL
 Tablet 5 mg
Tablet 5 mg Tablet 10 mg
Prednisolone P,S,T Tablet 10 mg P,S,T Tablet 20 mg
Tablet 20 mg Oral liquid 5 mg/5 mL (p)
Oral liquid 15 mg/5 mL

Section 18.4.1 - Insulins and other antidiabetic agents

Tablet 500 mg
Tablet 500 mg
Tablet 750 mg
Tablet 1000 mg
Metformin P,S,T Tablet 1000 mg P,S,T
Modified release
(Immediate and
Tablet 1000 mg
controlled release)

Section 18.5-Ovulation Inducers

Injection 2000 IU
Human chorionic Injection 1000 IU
T S,T Injection 5000 IU
gonadotropin Injection 5000 IU
Injection 10000 IU

Section 18.6 - Progestogens

Tablet 5 mg
Medroxyprogestero Tablet 5 mg
P,S,T P,S,T Tablet 10 mg
ne acetate Tablet 10 mg
Injection 150 mg/ mL

Section 18.7-Thyroid and antithyroid medicines

Tablet 5 mg
Tablet 5 mg
Carbimazole P,S,T P,S,T Tablet 10 mg
Tablet 10 mg
Tablet 20 mg
Section 21.1 - Anti-infective medicines

Drops 0.6%
Povidone iodine P,S,T P,S,T Drops 5%
Drops 5%

Section 21.2 - Anti-inflammatory medicine

Drops 0.1%
Prednisolone P,S,T P,S,T Drops 1%
Drops 1%

Section 23.1-Medicines used in psychotic disorders

Tablet 2 mg
Tablet 5 mg Tablet 5 mg
Tablet 10 mg Tablet 10 mg
Haloperidol S,T S,T
Tablet 20 mg Tablet 20 mg
Oral liquid 2 mg/5 mL Oral liquid 2 mg/5 mL
Injection 5 mg/mL

Tablet 1 mg
Tablet 2 mg
Tablet 1 mg Tablet 4 mg
Tablet 2 mg Oral liquid 1 mg/mL
Risperidone P,S,T P,S,T
Tablet 4 mg Injection (Long acting) 25
Oral liquid 1 mg/mL mg
Injection (Long acting)
37.5 mg
Section 23.2.1 - Medicines used in Bipolar disorders

Tablet 200 mg
Tablet 300 mg
Tablet 200 mg Tablet 500 mg
Sodium valproate P,S,T P,S,T
Tablet 500 mg Modified Release
Tablet 300 mg
Tablet 500 mg

Section 25 - Solutions correcting Water, Electrolyte disturbances and Acid-base

disturbances

P,S,T Injection 0.9% P,S,T Injection 0.9%

Sodium chloride
Injection 0.45%
S,T S,T Injection 3%
Injection 3%

Section 26-Vitamins and minerals

Tablet 1250 mg
Tablet 250 mg
Calcium carbonate P,S,T P,S,T (equivalent to elemental
Tablet 500 mg
calcium 500 mg)

Riboflavin P,S,T Tablet 5 mg P,S,T Tablet 10 mg

Capsule 5000 IU
Capsule/Tablet 50000 IU
Capsule 50000 IU
(including Chewable
Capsule 100000 IU
Vitamin A P,S,T P,S,T tablet)
Oral liquid 100000
Oral liquid 100000 IU/mL
IU/ml Injection 50000
Injection 50000 IU/mL
IU/ml
Annexure 4 Drugs figuring in more than one therapeutic category

Annexure 4.1: Drugs figuring in two therapeutic categories

Drugs Figuring in Two Therapeutic Categories

S.No. Drug Therapeutic Category

1. Albendazole Sub Section 6.1.2 Antifilarial

Sub Section 6.1.1- Intestinal Anthelminthics

2. Allopurinol Sub Section 2.3 - Medicines used to treat gout

Sub Section 7.4 - Medicines used in palliative care

3. Amphotericin B Sub Section 6.5.1- Antifungal medicines

Sub Section 6.9.3- Antileishmaniasis medicines

4. Azathioprine Sub Section 2.4 - Disease Modifying Agents used in

Rheumatoid Disorders

Sub Section 7.3- Immunosuppressive medicines

5. Azithromycin Sub Section 6.2.14- Other antibacterials

Sub Section 6.7.26- Additional Medicines for Syndromic

Management of Sexually Transmitted Infections

6. Budesonide Sub Section 16- Ear, Nose and Throat Medicines

Sub Section 24.1 -Antiasthmatic Medicines

7. Calcium Gluconate Sub Section 4.2.2 - Antidotes and Other Substances used in
Management of Poisonings/Envenomation- Specific

Sub Section 26.3 - Vitamins and Minerals

8. Carbamazepine Sub Section 5.1.1 Anticonvulsants/antiepileptics

Sub Section 23.2.6-Medicines used in Bipolar disorders

9. Cefotaxime Sub Section 6.2.9 Beta Lactam medicines

Sub Section 6.7.21- Medicines for treating Opportunistic

Infections in People living with HIV

10. Clarithromycin Sub Section 6.2.17-Other antibacterials

Sub Section 6.4.4 Anti-tuberculosis medicines

11.
Clofazimine Sub Section 6.3.1- Antileprosy medicines

Sub Section 6.4.5 Anti-tuberculosis medicines

12. Co-trimoxazole Sub Section 6.2.19- Other antibacterials

[Sulphamethoxazole
(A) + Trimethoprim
(B) Sub Section 6.9.7-Antipneumocystosis and
antitoxoplasmosis medicines
13. Diazepam Sub Section 5.1.3- Anticonvulsants/ Antiepileptics

Sub Section 7.4.4 - Medicines used in palliative care

14. Digoxin Sub Section 10.2.3- Antiarrhythmic medicines

Sub Section 10.4.1- Medicines used in Shock and Heart

Failure

15. Doxycycline Sub Section 6.2.20- Other antibacterials

Sub Section 6.10.8 For prophylaxis

16. Glucose Sub Section 18.4.8- Medicines used to treat hypoglycemia

Sub Section 25.1-Solutions correcting Water, Electrolyte

disturbances and Acid-base disturbances

17. Haloperidol Sub Section 7.4.7 - Medicines used in Palliative Care

Sub Section 23.1.3 - Medicines used in psychotic disorders

18. Heparin Sub Section 8.2.2 - Medicines affecting coagulation

Sub Section 10.5.3 -Antithrombotic medicine

(Cardiovascular/Cerebrovascular)
19. Hydrochlorothiazide Sub Section 10.3.3 - Antihypertensive medicines

Sub Section 15.2 - Diuretics

20. Hydroxyurea Sub Section 7.1.6 Antineoplastic medicines

Sub Section 8.1.6 - Antianaemia medicines

21. Ibuprofen Sub Section 2.1.3- Non-opioid Analgesics, Antipyretics

and Non-steroidal Anti-inflammatory Drugs

Sub Section 5.3.2 Medicines used in Neurological

disorders- Antimigraine medicines

22. Lactulose Sub Section 7.4.8 Medicines used in Palliative Care

Sub Section 17.5.3 Gastrointestinal medicines -

Laxatives

23. Lignocaine Sub Section 1.2.2- Local Anaesthetics

Sub Section 10.2.5 Antiarrhythmic medicines

24. Methotrexate Sub Section 2.4.3- Disease Modifying Agents used in

Rheumatoid Disorders

Sub Section 7.1.33 -Antineoplastic medicines

25. Methylprednisolone Sub Section 18.1- Adrenal Hormones and Synthetic

 substitutes

Section 27 - Medicines for COVID 19 management

26. Metoclopramide Sub Section 7.4.10 Medicines used in Palliative Care

Sub Section 17.2.2 Antiemetics

27. Metronidazole Sub Section 6.2.22 Other antibacterials

Sub Section 6.9.2 Medicines used for amoebiasis and

other parasitic infections

28. Neostigmine Sub Section 6.9.2 Medicines used for amoebiasis and
other parasitic infections

Sub Section 4.2.10 Antidotes and Other Substances used

in Management of Poisonings/Envenomation- Specific

29. Ondansetron Sub Section 7.4.15- Medicines used in Palliative Care

Sub Section 17.2.3 Anti-ulcer medicines

30. Oral Rehydration Salts Sub Section 17.6.1 Medicines used in diarrhoea

Sub Section 25.3 Solutions correcting Water, Electrolyte

disturbances and Acid-base disturbances

31. Oxygen Sub Section 1.1.5 - General Anaesthetics and Oxygen

 Sub Section 27.5- Medicines for COVID 19 management

32. Povidone iodine Section 14.1.5 Antiseptics and Disinfectants- Antiseptics

Sub Section 21.1.5 - Anti-infective medicine

33. Proparacaine Sub Section 12.1.2 - Diagnostic agents - Ophthalmic

Medicines

Sub Section 21.3.1 - Local anaesthetic

34. Rifampicin Sub Section 6.3.3- Antileprosy medicines

Sub Section 6.4.17 Anti-tubercular medicines

35. Snake Venom Sub Section 4.2.12 Antidotes and Other Substances used
Antiserum in Management of Poisonings/Envenomation- Specific

Sub Section 19.2.7 Sera and immunoglobulins (Liquid/

Lyophilized)

36. Sodium Valproate Sub Section 5.1.9 Anticonvulsants /antiepileptics

Sub Section 23.2.5- Medicines used in mood disorders

37. Spironolactone Sub Section 10.4.5 - Medicines used in shock and heart
failure

Sub Section 15.4 - Diuretics

38. Tenofovir Disproxil Sub Section 6.7.4 Nucleoside reverse transcriptase

Fumarate (TDF) inhibitors
 Sub Section 6.8 Medicines for Hepatitis B and Hepatitis C

39. Tramadol Sub Section 2.2.- Opioid Analgesics

Sub Section 7.4.- Medicines used in Palliative Care

40. Tropicamide Sub Section 12.1.- Ophthalmic Medicines

Sub Section 21.5. - Mydriatics

41. Valganciclovir Sub Section 6.6.2- Anti Cytomegalovirus (CMV)

Medicines

Sub Section 6.7.5- Medicines for treating Opportunistic

Infections in People living with HIV
Annexure 4.2: Drugs Figuring in Three Therapeutic Categories

Drugs Figuring in Three Therapeutic Categories

S.No. Drug Therapeutic Category

1. Acetylsalicylic acid Sub Section 2.1. - Non-opioid Analgesics, Antipyretics

and Non-steroidal Anti-inflammatory Drugs

Section 5.2- Antimigraine Medicines

Sub Section 10.5- Antiplatelet and Antithrombotic

Medicines

2. Acyclovir Sub Section 6.6.1 - Anti-herpes medicines

Sub Section 6.7.5- Medicines for treating Opportunistic

Infections in People living with HIV

Sub Section 21.1- Anti-infective medicine

3. Amitriptyline Sub Section 5.2.1 - For Prophylaxis

Sub Section 7.4 - Medicines used in Palliative Care

Sub Section 23.2.1 - Medicines used in Depressive

Disorder
4. Atropine Sub Section 1.3- Preoperative Medication and Sedation
for Short Term Procedures

Sub Section 4.2.1- Antidotes and Other Substances used

in Management of Poisonings/Envenomation- Specific

Sub Section 21.5.1 - Ophthalmological Medicines-

Mydriatics

5. Ciprofloxacin Sub Section 6.2.2 - Anti-infective medicines-

Antibacterials -Other Antibacterials

Sub Section 16.2 - Ear, Nose and Throat Medicines

Sub Section 21.1-Anti-infective Medicines

6. Enoxaparin Sub Section 10.5.4 - Antiplatelet and Antithrombotic

Medicines

Sub Section 8.2.1- Medicines affecting coagulation

Section 27 - Medicines for COVID 19 management

7. Fluoxetine Sub Section 7.4 -Medicines used in Palliative Care

Sub Section 23.2.1 - Medicines used in Depressive

Disorders

Sub Section 23.4 - Medicines used in Obsessive

Compulsive Disorders and Panic attacks

8. Hydrocortisone Sub Section 3.5- Antiallergics and Medicines used in

 Anaphylaxis

Sub Section 18.1.3- Adrenal hormones and synthetic

substitutes

Sub Section 24.1 -Antiasthmatic Medicines

9. Midazolam Sub Section 1.3- Preoperative Medication and Sedation

for Short Term Procedures

Sub Section 5.1- Anticonvulsants/ Antiepileptics

Sub Section 7.4- Medicines used in Palliative Care

10. Morphine Sub Section- 1.3- Preoperative Medication and Sedation

for Short Term Procedures

Sub Section 2.2- Opioid Analgesics

Sub Section - 7.4-Medicines used in Palliative Care

11. Paracetamol Sub Section 2.1 - Non-opioid Analgesics, Antipyretics

and Non-steroidal Anti-inflammatory Drugs

Sub Section 5.2- Antimigraine Medicines

Section 27- Medicines for COVID 19 management

Annexure 4.3: Drugs Figuring in Four Therapeutic Categories

Drugs Figuring in Four Therapeutic Categories

S.No. Drug Therapeutic Category

1. Clindamycin Sub Section 6.2.- Other antibacterials

Sub Section 6.7.5- Medicines for treating Opportunistic

Infections in People living with HIV

Sub Section 6.9.3- Antipneumocystosis and

antitoxoplasmosis medicines

Sub Section 6.10.1 - For curative treatment

2. Clotrimazole Sub Section 6.5- Antifungal medicines

Sub Section 6.7.5- Medicines for treating Opportunistic

Infections in People living with HIV

Sub Section 11.1. - Antifungal medicines

Section 16- Ear, nose and throat medicines

3. Dexamethasone Section 3 - Antiallergics and Medicines used in

 Anaphylaxis

Sub Section 7.4 - Medicines used in Palliative Care

Sub Section 18.1- Adrenal Hormones and Synthetic

substitutes

Section 27 - Medicines for COVID 19 management

4 Prednisolone Sub Section 3.- Antiallergics and medicines used in

anaphylaxis

Sub Section 7.2.- Hormones and anti-hormones used in

cancer therapy

Sub Section 18.1- Adrenal hormones and synthetic

substitutes

Sub Section 21.1- Anti-inflammatory medicine