The new list, released on September 13, includes more cancer drugs, new diabetes drugs and even four patent medicines.
What is the National Essential Medicines List?
Curated by experts in consultation with stakeholders, the list includes medicines needed to meet the priority health needs of the majority of the population. The drugs included are those that are best for the treatment of a particular condition and at the same time are cost effective. This is why the list almost always sees the inclusion of generics (non-branded drugs, such as paracetamol instead of crocin).
The list typically includes drugs that are part of government health programs, such as bedaquiline, included in 2022, which is used in the country’s tuberculosis elimination program.
Framed on the principles of the World Health Organization’s Essential Medicines List, India’s first list was developed in 1996. Since then, it has been amended four times – in 2003, 2011, 2015 and now in 2022.
Revisions are made keeping in mind the changing disease profile in the country, new drugs entering the market, obsolete or banned drugs for certain risks, and new treatment protocols.
The list creates a framework for the supply of medicines in public health facilities – essential medicines should ideally be available in all health centers depending on the level of care (the NLEM marks all medicines as P, S or T depending on whether they should be available in primary, secondary or tertiary health care facilities). It also helps hospitals create their drug policies, such as which drugs to use – NLEM-2022 replaced several antibiotics based on the resistance pattern, including a strong broad-spectrum antibiotic Meropenem in the list.
It helps government facilities that provide free drugs to prioritize which ones; and can also be used by fee-reimbursing agencies. In addition, the list helps to train young doctors in the rational use of drugs.
But the most important use on the list is to make these drugs affordable for the general population.
How does the NLEM make medicines affordable?
The government has the power to control the prices of certain medicines, those necessary for the public interest, through the Medicines Price Control Ordinance. The national list of essential drugs is the main basis for considering a drug as essential and controlling its prices. In addition, the prices of drugs other than those included in the NLEM can also be controlled through the DPCO.
Once a medicine is included in the NLEM, its prices are controlled by the central government and cannot be changed by the companies themselves.
“Based on this list, the NPPA will decide on the ceiling prices. The prices of drugs falling under the NLEM cannot be increased by the companies themselves, but each year the prices increase or decrease according to the wholesale price index, which means that the prices of these drugs cannot be increased unreasonably,” Union Health Minister Dr Mansukh Mandaviya said. during the event to launch the list.
What are the significant additions to NLEM-2022?
The new list added 34 drugs that were not in the NLEM-2015, the most significant being that it added four cancer drugs – Bendamustine Hydrochloride – used to treat certain types of blood and lymph node cancers, Irinotecan HCI Trihydrate used for the treatment of colorectal and pancreatic cancers, lenalidomide for the treatment of various types of cancers and leuprolide acetate for the treatment of prostate cancer. Cancer therapies are usually very expensive, but also have higher markups.
The list also includes a new class of drugs that are now commonly used by doctors for the management of diabetes – the drug Teneligliptin and the insulin Glargine. The rotavirus vaccine, now part of the government’s universal immunization programme, was also included.
Importantly, the list also includes at least four drugs that are still under patent – such as bedaquiline and delaminide for tuberculosis, dolutegravir for HIV and daclatasvir for the treatment of hepatitis C – which are all part of the government’s national health programs. This is the first time that patent medicines have been included in the list because these medicines generally cost more.
“The question arises time and time again whether patented medicines should be included in the NLEM. Thus, the committee, together with the stakeholders and the ministry, took the decision that patented medicines can also be part of the NLEM if they meet the criteria (of need, safety, efficacy and cost-effectiveness). And these drugs are very important and should be part of it,” said Dr YK Gupta, who leads the Standing National Drugs Committee which was created in 2018 to amend the list.
The list made another notable addition – it included nicotine and opioid replacement therapy, with no therapy in the category available in previous lists.
What drugs have been removed from NLEM-2022?
There were 26 drugs that were deleted from the previous list, bringing the total number of drugs in the NLEM-2022 to 384. The most significant deletions were three anti-tuberculosis drugs, including kanamycin injection which was used in patients with drug-resistant tuberculosis. Apart from the fact that the government is now introducing an all-oral regimen for these patients, the drug was also associated with serious side effects such as kidney problems and hearing loss.
While adding antibiotics like the antiparasitic meropenem and ivermectin (which is also part of the government’s lymphatic filariasis programme), the list has removed antimicrobials like capreomycin, ganciclovir (which is known to be carcinogenic and cause birth defects embryos) and an ineffective anti-hepatitis drug.
Vaseline and bleaching powder have also been removed from the list.