Dr Mansukh Mandaviya launches National Lists of Essential Medicines (NLEM) 2022
384 Drugs included in NLEM 2022; 34 new drugs added
“Under Hon. PM’s vision of Sabko Dawai, Sasti Dawai NLEM another step towards affordable healthcare with reduced Out-of-Pocket-Expenditure (OOPE)”
It will further ensure efficacy, safety, quality, affordability and accessibility of medicines: Dr Mansukh Mandaviya
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National List of Essential Meidicne 2022 by DrugsInfo
1. National List of Essential
Medicine (NLEM) 2022
Part-1
Criteria for adding
and deletion of
medicine in NLEM
Prepared by: Akash Agnihotri
2. NLEM-2022: Highlights
• 384 drugs have been included in this list with
addition of 34 drugs
• While 26 from the previous list have been dropped
• The medicines have been categorized into 27
therapeutic categories
3. NLEM
• National List of Essential Medicines (NLEM) are
those that satisfy the priority healthcare needs,
based on: efficacy, safety, quality and the total
cost of treatment.
• The purpose of the list is to ensure safety, quality,
affordability and accessible of medicines for the
population.
• In India, the essential medicines list is categorized
based on medicines at primary, secondary, and
tertiary healthcare levels.
4. A significant criteria for
inclusion in NLEM is based on:
6. When more than one medicine are available from
the same therapeutic class, one
prototype/medically best suited medicine of that
class to be included
7. The price of total treatments shall be considered
and not the unit price of a medicine
8. The fixed dose combinations are usually not
included
9. In case of vaccines, It is as and when it is
included in Universal Immunization Programme
5. A significant criteria for
inclusion in NLEM is based on
1. The medicine shall be useful in diseases that is a
public health problem in India
2. The medicine shall be licensed/approved by the
Drugs Controller General of India (DCGI)
3. It shall have proven efficacy and safety profile
based on scientific evidence
4. It should be comparatively cost effective and
aligned with the current treatment guidelines
5. The medicine shall be recommended under
National Health Programs of India
6. The criteria for deletion from
NLEM is based on:
1. The medicine has been banned in India
2. If there are reports of concerns on the safety
profile
3. If medicine with better efficacy or favourable
safety profile and better cost-effectiveness is now
available
4. The disease burden for which medicine is
indicated is no longer a national health concern
5. In case of antimicrobials, if the resistance pattern
has rendered an antimicrobial ineffective
8. NLEM Info
• The National List of Essential Medicines was first
formulated in 1996 and it was revised thrice earlier in
2003, 2011, and 2015
• “Under Hon. PM’s vision of Sabko Dawai, Sasti
Dawai NLEM another step towards affordable
healthcare with reduced Out-of-Pocket-Expenditure
(OOPE)”
9. National List of Essential
Medicine (NLEM) 2022
Part-2
List of drugs
deleted
Prepared by: Akash Agnihotri
10. NLEM For Antimicrobials drugs
• For the antimicrobial drugs, the World Health
Organization (WHO) has classified anti-microbials
as Access, Watch and Reserve group.
• In Indian context, though the committee did not
specify as Access, Watch and Reserve in NLEM
2022, but a similar philosophy of WHO
antimicrobial classification was kept in mind for
the list.
11. NLEM For Anticancer drugs
For the anticancer drugs, with advancement in
treatment and affordability being an issue, out of 42
non-NLEM Trade Margin Rationalisation (TMR)
drugs, there are now four in NLEM.
"Four Anti-cancer drugs have been added to the list like
Bendamustine Hydrochloride, Irinotecan HCI Trihydrate,
Lenalidomide and Leuprolide acetate, these medicines are
effective in various types of cancers and these are
affordable also,"
12. NLEM For Fixed dose
combinations
• For the fixed drug combinations, although, many
antibiotic FDCs with multiple antibiotics,
analgesics, vitamins, minerals, etc have been
banned, there are still many combinations in the
market with doubtful rationality.
• Though, the committee wish to publish a negative
list of such disease, it is restricting itself as the list
will become only example and cannot be
exhaustive.
13. NLEM: Still under patent drugs
• NLEM 2022 also mentions four drugs which are
still under patent, namely
• Bedaquiline
• Delamanid
• Dolutegravir
• Daclatasvir
16. List of medicines removed from
NLEM 2022
Ranitidine was pulled out of the essential list after
detailed discussion with the Drug Controller General
of India (DCGI) and All India Institute of Medical
Sciences (AIIMS) citing concerns over cancer
causing N-nitrosodimethylamine (NDMA)
17. List of medicines removed from
NLEM 2022
Ranitidine, Sucralfate, White Petrolatum, Atenolol and
Methyldopa, etc have been deleted from the revised list.
The deletion has been done based on the parameters of
cost-effectiveness and availability of better drugs.
Important drugs:
18. National List of Essential
Medicine (NLEM) 2022
Part-3
List of drugs added
Prepared by: Akash Agnihotri