Union Health Ministry releases NLEM 2022, 34 drugs added, 26 removed

With the new list of essential medicines (also called scheduled drugs) out, several essential medicines are set to get cheaper in India. These include medicines like anti diabetes drug insulin glargine, anti TB drug delamanid, ivermectin and antiparasite.

"National List of Essential Medicines (NLEM) plays an important role in ensuring accessibility of affordable quality medicines at all levels of healthcare which will give boost to cost-effective, quality medicines and contribute towards reduction in Out of Pocket Expenditure on healthcare for the citizens," Union Health Minister Mansukh Mandaviya said.

Revised every 3 years, NLEM was last updated in 2015 and a revision was delayed due to the Covid-19 pandemic. Finally, NLEM 2022 has been prepared after consultation with 350 experts. A total of 140 meetings took place before the list was finalized.

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 were followed for inclusion in NLEM:

* be useful in diseases which is a public health problem in India

* be licensed/ approved Drugs Controller General (India) (DCGI)

* have proven efficacy and safety profile based on scientific evidence

* be comparatively cost effective

* be aligned with the current treatment guidelines

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

* when more than one medicine are available from the same therapeutic class, one prototype/ medically best suited medicine of that class to be included.

* price of total treatment is considered and not the unit price of a medicine

* fixed dose combinations are usually not included

* vaccines as and when are included in Universal Immunization Program (e.g. Rotavirus vaccine).

What is new in the list?

34 new medicines have been added to the list, while 26 drugs have been removed. Popular antacid salt Ranitidine sold under the brand names Aciloc, Zinetac, and Rantac, among others such as Sucralfate has been deleted from the list.

List of Medicines Removed from NLEM 2022

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

Ranitidine was pulled out of the essential stock after detailed discussion with the Drug Controller General of India and All India Institute of Medical Sciences (AIIMS) citing concerns over cancer-causing impurity N-nitrosodimethylamine (NDMA).

The cause of the deletion of certain medicines range from medicines being banned, safety concerns, alternatives with better efficacy and safety and changes in the disease burden which makes a medicine non-essential and resistance pattern in case of antibiotics.

Meanwhile, the 34 new medicines have been added to the list that includes 4 drugs that are still under patent namely Bedaquiline, Delamind, Doulutegravir and Daclatasavir.

List of 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

Commenting on NLEM 2022, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance said, " The pharmaceutical industry in India is a strategic sector that is recognised around the world for providing affordable and high-quality medicines. The NLEM 2022 is the result of extensive consultation with all stakeholders in healthcare, including experts in the field. This list strives to strike a balance between patient centricity, public health concerns, future policy direction and thrust, going forward. Antimicrobial resistance is a critical issue, and the NLEM 2022 has attempted to address it."

Speaking on the occasion, Union Health Minister stated that the primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e., cost, safety and efficacy. It also helps in optimum utilization of healthcare resources and budget; drug procurement policies, health insurance; improving prescribing habits; medical education and training for UG/PG; and drafting pharmaceutical policies. In NLEM, the medicines are categorized based on level of healthcare system as- P- Primary; S- Secondary and T- Tertiary.

He elaborated that the concept is based on the premise that a limited list of carefully selected medicines will improve quality of health care, provide cost-effective health care and better management of medicines. He added that the NLEM is a dynamic document and is revised on a regular basis considering the changing public health priorities as well as advancement in pharmaceutical knowledge. The National List of Essential Medicines was first formulated in 1996 and it was revised thrice earlier in 2003, 2011, and 2015.

"The independent Standing National Committee on Medicines (SNCM) was constituted by 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", he stated. He also noted that the process of creation of NLEM depends on the feedback backed by scientific sources from stakeholders and inclusion/exclusion principle followed.

While congratulating the stakeholders for the revised NLEM which takes the country forward in the direction of provisioning of affordable healthcare to its citizens, Dr Bharati Pravin Pawar, Union Minister of State stressed on enhancing awareness regarding Antimicrobial Resistance (AMR) which "is emerging as a big challenge for our scientists and community and we need to create awareness in the society about AMR".

NLEM 2022 can be accessed here: