New list of essential medicines: 39 new drugs added, 16 dropped

APIs are the raw materials that give drugs the intended therapeutic effect.

The government released the revised list of National List of Essential Medicines (NLEM), in which it has added 39 drugs, removed 16 drugs.

Most of the new drugs added to the list were anti-cancer like Azacitidine and Fludarabine antiretroviral such as Dolutegravir, Darunavir+Ritonavir, new generation TB medications such as Bedaquiline and Delamanid, anti-allergy Montelukast, anti diabetes drugs like Teneligliptin and Insulin Glargine, and tobacco cessation and addiction treatment drugs like nicotine replacement therapy (NRT), Buprenorphine ( opioid antagonists), Buprenorphine+Naloxone.

The 39 new drugs included Amikacin (antibiotic), Azacitidine (anti-cancer), Bedaquiline (anti-TB), Bendamustine Hydrochloride (anti-cancer), Buprenorphine ( opioid antagonists), Buprenorphine+Naloxone (opioid antagonists), Cefuroxime (antibiotic), Dabigatran (anticoagulant), Daclatasvir (antiviral), Darunavir+Ritonavir (antiretroviral), Delamanid (anti-TB), Dolutegravir (antiretroviral), Fludarabine (anti-cancer), Fludrocortisone (corticosteroid), Fulvestrant (anti-cancer), Insulin Glargine (anti-diabetes), Irinotecan HCL Trihydrate (anti-cancer), Itraconazole (antifungal), Ivermectin (anti-parasitic), Lamivudine (antiretroviral), Latanoprost (treat ocular hypertension), Lenalidomide (anti-cancer), Montelukast (anti-allergy), Mupirocin (topical antibiotic), Nicotine replacement therapy, Nitazoxanide (antibiotic), Ormeloxifene (oral contraceptive), Phenoxymethyl penicillin (antibiotic), Procaine Benzylpenicillin (antibiotic), Rotavirus vaccine, Secnidazole (anti-microbial), Teneligliptin (anti-diabetes), Tenofovir+Lamivudine+Dolutegravir (antiretroviral), Tenofovir+Alafenamide Fumarate (TAF) (antiretroviral), Terbinafine (antifungal), and Valganiclovir (antiviral).

The deleted drugs are Alteplase (clot buster), Atenolol (anti-hypertension), Bleaching Powder, Cetrimide (antiseptic), Erythromycin (antibiotic), Ethinylestradiol+Norethisterone (birth control), Ganciclovir (antiviral), Lamivudine+Nevirapine+Stavudine (antiretroviral), Leflunomide (antirheumatic), Nicotinamide (Vitamin-B), Pegylated interferon alfa 2a, Pegylated interferon alfa 2b (antiviral), Pentamidine (antifungal), Prilocaine+Lignocaine (anesthetic), Rifabutin (antibiotic),Stavudine+Lamivudine (antiretroviral), and Sucralfate (anti-ulcer)

NLEM list is revised and the ceiling prices are fixed every five years. NLEM 2015, which was implemented from 2016 has ended in March 2021

The Health Ministry prepares a list of drugs eligible for price regulation, following which the Department of Pharmaceuticals, which comes under the Ministry of Chemicals and Fertilizers, incorporates them into Schedule 1 of DPCO. The Standing Committee on Affordable Medicines and Health Products (SCAMHP) will advise the drug price regulator the National Pharmaceutical Pricing Authority (NPPA) on vetting the list. The NPPA then fixes the prices of drugs in this Schedule.

At present, around 374 medicines are part of NLEM which are subject to price controls. About 18 percent of the drugs sold in India are under price controls.