• The Ministry of Health and Family Welfare prepared and released the first National List of Essential Medicines of India in 1996, encompassing 279 drugs, and this list was subsequently revised in 2003, 2011, 2015, and now in 2022.

• Dr Mansukh Mandaviya, Union Minister for the Ministry of Health and Family Welfare, launched The National Lists of Essential Medicines (NLEM) 2022 on 13th September 2022 under the vision of Hon. Prime Minister Shri Narendra Modi Ji towards Sabko Dawai, Sasti Dawai.

• In this trend, NLEM plays a significant role in ensuring the accessibility of affordable quality medicines at all levels of healthcare (primary, secondary, and tertiary). The medicines in the NLEM list should be sold under a price ceiling fixed by the National Pharmaceutical Pricing Authority (NPPA). So, NLEM provides a lift to cost-effective, quality medicines and contributes towards a reduction in Out-of-Pocket Expenditure on healthcare for the citizens.

• Almost 384 drugs have been included in this list with the addition of 34 drugs, while 26 from the previous list have been dropped. The medicines have been categorized into 27 therapeutic categories.

• In NLEM, the medicines are categorized based on the level of the healthcare system as P- Primary, S- Secondary and T- Tertiary. The independent Standing National Committee on Medicines (SNCM) was constituted by the Union Health Ministry in 2018. The Committee, after detailed consultation with experts and stakeholders, has revised the NLEM, 2015 and submitted its report on NLEM 2022 to the Ministry of Health & Family Welfare.

• The Government of India has accepted the recommendations of the Committee and adopted the list. Revision of NLEM 2022 has been done after constant consultation with stakeholders spanning from academia, industrialists and public policy experts etc., and crucial documents like WHO EML 2021.

The following criteria are followed for inclusion in NLEM

1. Be useful in diseases which is a public health problem in India

2. Be licensed/ approved Drugs Controller General (India) (DCGI)

3. have proven efficacy and safety profiles based on scientific evidence

4. Be comparatively cost-effective

5. Be aligned with the current treatment guidelines

6. Recommended under the National Health Programs of India. (e.g. Ivermectin part of Accelerated Plan for Elimination of Lymphatic Filariasis 2018)

7. When more than one medicines are available from the same therapeutic class, one prototype/ medically best-suited medicine of that class to be included

8. Price of total treatment is considered and not the unit price of a medicine

9. Fixed dose combinations are usually not included

10. Vaccines as and when are included in the Universal Immunization Program (e.g. Rotavirus vaccine)

Reasons for exclusion from NLEM

1. Changes in the disease burden, which makes a drug non-essential

2. Gets banned in India

3. Concerns about drug safety

4. Availability of alternative drugs with better efficacy and safety profile

5. Change in resistance pattern regarding antimicrobials

Medicines added to NLEM 2022

1. Amikacin

2. Bedaquiline

3. Bendamustine Hydrochloride

4. Buprenorphine

5. Buprenorphine (A) + Naloxone (B)

6. Cefuroxime

7. Dabigatran

8. Daclatasvir

9. Darunavir (A) + Ritonavir (B)

10. Delamanid

11. Dolutegravir

12. Fludrocortisone

13. Insulin Glargine

14. Irinotecan HCI Trihydrate

15. Itraconazole

16. Ivermectin

17. Lamivudine

18. Latanoprost

19. Lenalidomide

20. Leuprolide acetate

21. Meropenem

22. Montelukast

23. Mupirocin

24. Nicotine replacement therapy (NRT)

25. Ormeloxifene (Centchroman)

26. Phenoxymethyl penicillin

27. Procaine Benzyl penicillin

28. Rotavirus vaccine

29. Tenecteplase

30. Teneligliptin

31. Tenofovir (A) + Lamivudine (B) + Dolutegravir (C)

32. Tenofovir Alafenamide Fumarate (TAF)

33. Terbinafine

34. Valganciclovir

Medicines Deleted from NLEM 2015

1. Alteplase

2. Atenolol

3. Bleaching Powder

4. Capreomycin

5. Cetrimide

6. Chlorpheniramine

7. Diloxanide furoate

8. Dimercaprol

9. Erythromycin

10. Ethinylestradiol

11. Ethinylestradiol(A) Norethisterone (B)

12. Ganciclovir

13. Kanamycin

14. Lamivudine (A) + Nevirapine (B) + Stavudine (C)

15. Leflunomide

16. Methyldopa

17. Nicotinamide

18. Pegylated interferon alfa 2a, Pegylated interferon alfa 2b

19. Pentamidine

20. Prilocaine (A) + Lignocaine (B)

21. Procarbazine

22. Ranitidine

23. Rifabutin

24.  Stavudine (A) + Lamivudine (B)

25. Sucralfate

26. White Petrolatum