INDIA – Four key anti-cancer drugs and four patented antivirals used in the treatment of tuberculosis, HIV, and hepatitis C are set to get cheaper with their inclusion in the latest published edition of National List of Essential Medicines (NLEM), 2022.

The list features 384 medicines as against 376 in NLEM, 2015. It adds 34 medicines and deletes 26 from the previous list.

The deletion has been done based on the parameters of cost-effectiveness and availability of better drugs.

The 34 new medicines in NLEM, 2022, feature four anti-cancer drugs so far in the non-scheduled drug category and hence are expensive.

These include injections and tablets used in the treatment of cancers of white blood cells, pancreas, prostate, and bone marrow.

With these additions NLEM, 2022 has 63 anti-cancer medicines which are now under price control and affordable.

For the first time, NLEM, 2022, has also included four patented drugs which will get cheaper in the coming days once the National Pharmaceutical Pricing Authority fixes a ceiling price for all 384 essential medicines.

NLEM drugs cannot be sold above National Pharmaceutical Pricing Authority’s (NPPA) ceiling prices. All other drugs are allowed a maximum yearly price increase of 10 percent.

The patented antivirals in NLEM, 2022 are anti-TB drugs Bedaquiline and Delamanid, and anti-HIV Dolutegravir and anti-hepatitis C Daclatasvir.

The new drugs under NLEM also include anti-diabetic insulin Glargine injection, de-addiction formulations Buprenorphine tablet and nicotine replacement therapy; cardiovascular drugs tablet Dabigatran and injection Tenecteplase and indigenous Rotavirus vaccine.

No Covid-19 drug in the list

YK Gupta who headed the standing committee on essential medicines that formulated NLEM, 2022 said no covid-19 drug had yet been included in the list as all these drugs had emergency use approval and more data are required to grant them regular approvals.

We have kept the pandemic proportions of antimicrobial resistance in mind while formulating NLEM, 2022, which included drugs that can treat 80 percent of India’s current diseases. The list has a whole range of effective antibiotics,” Gupta said.

NLEM can feature only those medicines that are approved and licensed in India by the drug regulator and not drugs that may be approved abroad but not in India.

Also, any medicine to enter NLEM must have public health value to India, proven efficacy and safety, and cost-effectiveness.

The 384 NLEM 2022 medicines have been categorized into 27 therapeutic categories. Of the 34 new drugs the list features 18 in the anti-infective segment; four in anti-cancer; two in cardio; one in immunological (Rotavirus vaccine); one in eye segment; three in drug de-addiction category and one in the respiratory tract segment.

The first NLEM was published in 1996 and had 279 medicines. NLEM is revised every three years. The latest list was delayed due to covid. The last came in 2015.

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