The Centre, on September 13, 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 latest list replaces the previous 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, among others.
“The list being published now will ensure the accessibility, affordability and safety of some of the most needed drugs in India,” 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 programmes at the primary, secondary and tertiary levels of healthcare.
These drugs 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.
As per the industry estimates, the market share of scheduled drugs in India is about 18 percent while more than 80 percent drugs are outside direct price control.
Additions and deletions
In the latest list, 34 new drugs, that were not part of NLEM, 2015 have been included and comprise medicines such as anti-tuberculosis drug bedaquiline, rotavirus vaccine and antibiotic amikacin.
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Anti-filariasis drug ivermectin and hormone insulin glargine used by diabetes patients, apart from anti-asthma drug montelukast are also part of the additions.
However, 26 drugs that were part of the previous NLEM have also been deleted from the latest list. The reasons for 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.
The new list also 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 daclatasavir used in treating viral infections such as Hepatitis C.
Out of 42 anti-cancer drugs for which the NPPA has fixed trade margins under the trade margin rationalisation approach, four are also part of the NLEM, 2022. Bendamustine hydrochloride and lenalidomide are two of these drugs.
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.
Two of the drugs repurposed for COVID-19 management, steroid dexamethasone and blood thinner anoxaparin have been listed as coronavirus drugs. These drugs were already part of the previous NLEM.
Wide consultations
The government said that the committee preparing the NLEM consulted nearly 350 experts that include subject experts, members of civil society, pharmaceutical associations, patient groups and other stakeholders.
A total of 140 meetings were held before the list was finalised.
Concerns on drug cocktails
The NLEM committee has highlighted the increasing and continued need of educating doctors against use of several fixed-dose combinations (FDCs) of antibiotics that may be completely irrational.
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Although many antibiotic FDCs with several antibiotics, analgesics, vitamins and minerals have been banned, many combinations are still in the market with doubtful rationality, it said.
“Though the committee wish to publish such negative list of such disease, it is restricting itself because the list will become only example and cannot be exhaustive,” said the panel headed by Indian Council of Medical Research director general Dr Balram Bhargava.
Industry welcomes the list
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 recognised 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.
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