National List of Essential Meidicne 2022 by DrugsInfo

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

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 W hile 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: When more than one medicine are available from the same therapeutic class, one prototype/medically best suited medicine of t hat class to be included The price of total treatments shall be considered and not the unit price of a medicine The fixed dose combinations are usually not included 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 The medicine shall be useful in diseases that is a public health problem in India The medicine shall be licensed/approved by the Drugs Controller General of India (DCGI) It shall have proven efficacy and safety profile based on scientific evidence It should be comparatively cost effective and aligned with the current treatment guidelines The medicine shall be recommended under National Health Programs of India

6. The criteria for deletion from NLEM is based on: The medicine has been banned in India If there are reports of concerns on the safety profile If medicine with better efficacy or favourable safety profile and better cost-effectiveness is now available The disease burden for which medicine is indicated is no longer a national health concern In case of antimicrobials, if the resistance pattern has rendered an antimicrobial ineffective

7. Medicines in NLEM 2011, 2015, and 2022 A- Added D-Deleted

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 T rade Margin R ationalisation (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 sti ll 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 B edaquiline D elamanid D olutegravir D aclatasvir

14. List of medicines removed from NLEM 2022 (total 26) Alteplase Atenolol Bleaching Powder Capreomycin Cetrimide Chlorpheniramine Diloxanide furoate Dimercaprol Erythromycin Ethinylestradiol Ethinylestradiol (A) Norethisterone (B) Ganciclovir Kanamycin Lamivudine (A) + Nevirapine (B) + Stavudine (C) Leflunomide

15. List of medicines removed from NLEM 2022 (total 26) Methyldopa Nicotinamide Pegylated interferon alfa 2a, Pegylated interferon alfa 2b Pentamidine Prilocaine (A) + Lignocaine (B) Procarbazine Ranitidine Rifabutin Stavudine (A) + Lamivudine (B) Sucralfate White Petrolatum

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

19. List of medicines added to NLEM 2022 (total 34) Amikacin Bedaquiline Bendamustine Hydrochloride Buprenorphine Buprenorphine (A) + Naloxone (B) Cefuroxime Dabigatran Daclatasvir Darunavir (A) + Ritonavir (B) Delamanid Dolutegravir Fludrocortisone Insulin Glargine Irinotecan HCI Trihydrate Itraconazole Ivermectin Lamivudine Latanoprost Lenalidomide Leuprolide acetate

20. List of medicines added to from NLEM 2022 (total 34) Meropenem Montelukast Mupirocin Nicotine replacement therapy (NRT) Ormeloxifene ( Centchroman ) Phenoxymethyl penicillin Procaine Benzyl penicillin Rotavirus vaccine Tenecteplase Teneligliptin Tenofovir (A) + Lamivudine (B) + Dolutegravir (C) Tenofovir Alafenamide Fumarate (TAF) Terbinafine Valganciclovir

21. List of medicines added to from NLEM 2022 (total 34) Meropenem Montelukast Mupirocin Nicotine replacement therapy (NRT) Ormeloxifene ( Centchroman ) Phenoxymethyl penicillin Procaine Benzyl penicillin Rotavirus vaccine Tenecteplase Teneligliptin Tenofovir (A) + Lamivudine (B) + Dolutegravir (C) Tenofovir Alafenamide Fumarate (TAF) Terbinafine Valganciclovir

22. 34 new drugs added in NLEM 2022, 26 drugs were removed Therapeutic category Additions Deletions Analgesics NIL Leflunomide Antibiotic Meropenem Kanamycin Cefuroxime Rifabutin Amikacin Capreomycin Anti-HIV Dolutegravir Hepatitis C Daclatasvir Anti TB Bedaquiline Delamanid Under Patent drug

23. 34 new drugs added in NLEM 2022, 26 drugs were removed Therapeutic category Additions Deletions Cardiovascular drugs Dabigatran Atenolol Tenecteplase Alteplase Vaccine Rotavirus Vitamins and minerals NIL Nicotinamide Anti-diabetes Teneligliptin Insulin glargine

24. National List of Essential Medicine (NLEM) 2022 Part-4 List of all 384 drugs included in NLEM Prepared by: Akash Agnihotri

25. L ist of 384 medicines included in the NLEM 2022

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33. L ist of 384 medicines included in the NLEM 2022 Link is available in description/caption for downloading the list