How govt’s essential medicines list ensures supply, keeps prices in check

What is the National List of Essential Medicines?

Curated by experts in consultation with stakeholders, the list includes medicines that are needed to address the priority healthcare needs of the majority of the population. The drugs included are those that are best for the treatment of a particular condition and are cost-effective at the same time. This is the reason the list almost always sees the inclusion of generics (unbranded medicines, like paracetamol instead of crocin).

The list usually includes medicines that are a part of government’s health programmes, such as bedaquiline, included in the 2022, that is used in the country’s TB elimination programme.

Framed on the principles of the World Health Organisation’s essential medicine list, India’s first list was developed in 1996. It has since been modified four time – in 2003, 2011, 2015, and now in 2022.

The revisions are done keeping in mind the changing profile of diseases in the country, newer drugs becoming available in the market, drugs becoming obsolete or being banned for certain risks, and newer treatment protocols.

The list creates a framework for procurement of medicines at government healthcare facilities – the essential medicines should ideally be available at all healthcare centres depending on the level of care (NLEM marks all drugs as P, S, or T depending on whether they ought to be available at primary, secondary or tertiary healthcare facilities). It also helps hospitals create their drug policies such as which medicines to be used – the NLEM-2022 switched up several antibiotics depending on the resistance pattern, including a strong, broad-spectrum antibiotic Meropenem in the list.

It helps government facilities that do provide free medicines to prioritise which ones; and can also be used by agencies reimbursing the cost. In addition, the list helps in training young doctors on rational use of medicines.

But, the most important use of the list is to make these medicines affordable to the general population.

How does the NLEM make the medicines affordable?

The government has the power to control the prices of certain medicines, those needed in public interest, through the Drug Prices Control Order. The National List of Essential Medicines forms the primary basis for considering a drug as essential and controlling its prices. Additionally, the prices of drugs other than those included in the NLEM may also be controlled through the DPCO.

Once a drug is included in the NLEM, its prices are controlled by the central government and cannot be changed by companies themselves.

“Based on this list, the NPPA will decide the ceiling prices. The prices of medicines under the NLEM cannot be increased by the companies themselves, but every year the prices are increased or decreased as per the Wholesale Price Index, meaning the prices of these medicines cannot be increased unreasonably,” Union Health Minister Dr Mansukh Mandaviya said during the event to launch the list.

What are the significant additions to the NLEM-2022?

The new list has added 34 medicines that were not in the NLEM-2015, most significantly it has added four cancer medicines — Bendamustine Hydrochloride — that used for treating certain types of blood and lymph node cancers, Irinotecan HCI Trihydrate used for treating colorectal and pancreatic cancers, Lenalidomide for treating various type of cancers, and Leuprolide acetate for treating prostate cancer. Cancer therapies are usually very costly, but also have higher trade margins.

The list has also included newer class of drugs that are now routinely used for diabetes management by doctors – the medicine Teneligliptin and the insulin Glargine. The rotavirus vaccine which is now a part of the government’s universal immunisation programme has also been included.

Importantly, the list has also included at least four drugs that are still under patent — such as Bedaquiline and Delaminid for TB, Dolutegravir for HIV, and Daclatasvir for the treatment of Hepatitis C – all of which are part of government’s national health programmes. This is the first time that patented drugs have been included in the list as these drugs usually cost more.

“A question is raised time and again whether patented drugs should be included in the NLEM. So, the committee, as well as the stakeholders and the ministry, took the decision that patented drugs can also be a part of NLEM if they fulfil the criteria (of need, safety, efficacy, and cost effectiveness). And, these medicines are very important and should be a part,” said Dr YK Gupta, who heads the Standing National Committee on Medicines that was set up in 2018 to modify the list.

The list has made another notable addition – it has included nicotine and opioid replacement therapy, with no therapy in the category available in the previous lists.

Which drugs were removed from the 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-tuberculor drugs, including Kanamycin injection that was used in patients with drug resistant TB. Besides with the government now introducing an all-oral regimen for such patients, the drug was also associated with severe side effects such as kidney problems and hearing loss.

While adding antibiotics like meropenem and anti-parasitic ivermectin (which is also a part of the government’s lymphatic filariasis programme), the list has deleted antimicrobials like capreomycin, ganciclovir (that is known to be a carcinogen and lead to embryo malformation), and a hepatitis medicine with poor efficacy.

Petroleum jelly and bleaching powder have also been removed from the list.