On 13 September 2022, India’s Health Ministry released the National List of Essential Medicines (NLEM), 2022 comprising 384 drugs and over 1,000 formulations across 27 therapeutic categories. The list includes some of the most commonly used medicines in the country. The list replaces one published seven years ago and includes medicines used to treat common conditions such as fever, infections, heart diseases, hypertension, kidney dysfunction, tuberculosis, diabetes, skin diseases, and blood disorders.
“The list being published now will ensure the accessibility, affordability, and safety of some of the most needed drugs in India. Several antibiotics, vaccines, anti-cancer drugs, and many other important drugs will become more affordable and reduce patients’ out-of-pocket expenses,” said Union health minister Mansukh Mandaviya while releasing the list.
The medicines on the list, also called scheduled drugs, are mostly made available free of cost to patients through government hospitals as part of various health programs at the primary, secondary and tertiary levels of healthcare. The drugs on the essential list are regulated under the Drugs Price Control Order, 2013 which means that the National Pharmaceutical Pricing Authority (NPPA) fixes a ceiling price for their cost to customers every year. It is estimated that the listed drugs under price control comprise 18% of the organized pharmaceutical market in India while 80% are not price-controlled. 34 new drugs listed
In the list released yesterday, 34 drugs have been added, that were not previously listed in 2015. These include the antibiotic amikacin, rotavirus vaccine, and anti-tuberculosis drug bedaquiline. The hormone insulin glargine used by diabetes patients, the anti-filariasis drug ivermectin, and the anti-asthma drug montelukast have also been added.
No specific drugs for the treatment of Covid-19 have been added to the new list although it includes four drugs that are still under patent. These include bedaquiline and delamind used in the treatment of multiple drug-resistant tuberculosis, doulutegravir used to treat human immunodeficiency virus (HIV) infection, and daclatasvir used in treating viral infections such as Hepatitis C. Apparently India has 1.3 million tuberculosis patients.
Out of 42 anti-cancer drugs for which the NPPA has fixed trade margins under the trade margin rationalization approach, four drugs are also part of the new list with two of these being Bendamustine hydrochloride and lenalidomide. No drugs used specifically for the treatment of Covid-19 however have been made part of the list as the committee preparing the list was of the view that the clinical trials to check the efficacy of the drugs are not yet conclusive. However, two drugs that were already listed in the 2015 NLEM remain in the list and are shown as repurposed for Covid-19 management – the steroid dexamethasone and blood thinner anoxaparin.
The new list deletes 26 drugs that were part of the NLEM 2015 for reasons such as safety concerns that have arisen, drugs that have been banned, and where they have been replaced with more efficacious alternatives and changes in the pattern of the most serious illnesses and in the case of certain antibiotics where the resistance patterns have increased. None of the delisted drugs are required for disease control programs in the country according to public health experts.
Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance, a network of research-oriented drugmakers, said that the pharmaceutical industry in India is a strategic sector that is recognized around the world for providing affordable and high-quality medicines. “This list strives to strike a balance between patient centricity, public health concerns, future policy direction, and thrust, going forward,” he said, adding that antimicrobial resistance is a critical issue and the NLEM 2022 has attempted to address it.