Antibiotics and cancer drugs are now said to be more affordable as the government has added 34 new drugs to the National Essential Medicines List 2022.
Several cancer drugs, antibiotics and vaccines will now become more affordable as they are among 34 new additions to the national list of essential medicines, with the government saying this will reduce “out-of-pocket expenses for patients”.
Anti-infectives like ivermectin, mupirocin and meropenem were added to the list, bringing the total number of drugs to 384.
Four main anticancer drugs – bendamustine hydrochloride, irinotecan HCI trihydrate, lenalidomide and leuprolide acetate which are effective in various types of cancers – and psychotherapeutic drugs – nicotine replacement therapy and buprenorphine – have been added to the list.
However, 26 drugs such as ranitidine, sucralfate, white petrolatum, atenolol and methyldopa were removed from the previous list of 376 drugs in total.
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The deletion was made based on the parameters of cost-effectiveness and availability of better drugs.
Criteria for removal from NLEM include — banned in India, reports of concerns regarding the safety profile, the disease burden for which a drug is indicated is no longer a national health concern and, in the case of antimicrobials, whether the resistance profile has rendered an antimicrobial ineffective.
After launching the list on Tuesday, Union Health Minister Mansukh Mandaviya tweeted: “National Essential Medicines List 2022 released. It includes 384 medicines in 27 categories. Many antibiotics, vaccines, cancer drugs and many other important drugs will become more affordable. & reduce out-of-pocket expenses for patients.”
NLEM drugs are included in the planned category and their price is regulated by the National Pharmaceutical Pricing Authority. Speaking on the occasion, Mandaviya said his ministry is taking various steps as part of Prime Minister Narendra Modi’s vision towards “Sabko Dawai, Sasti Dawai”.
“In this direction, the National List of Essential Medicines (NLEM) plays an important role in ensuring the accessibility of affordable quality medicines at all levels of health care. This will give a boost to cost-effective and quality medicines and will contribute to the reduction of out-of-pocket expenses on health care for citizens,” he said.
The main objective of NLEM is to promote the rational use of medicines by considering the three important aspects – cost, safety and effectiveness, Mandaviya said.
He said the NLEM is a living document and is revised regularly in light of changing public health priorities as well as advances in pharmaceutical knowledge. The NLEM was formulated in 1996 and it was revised three times earlier in 2003, 2011 and 2015.
The revision of NLEM 2022 was carried out after constant consultation with stakeholders from academia, industry and public policy experts, etc. been added.
Montelukast, which acts on the airways, and the eye medication Latanoprost are also on the list. In addition, the cardiovascular drugs Dabigatran and Tenecteplase also find their place in the list alongside drugs used in palliative care.
“Anti-infectives such as ivermectin, meropenem, cefuroxime, amikacin, bedaquiline, delamanid, itraconazole ABC Dolutegravir have been added to the NLM,” said Dr. YK Gupta, vice- Chairman of the National Standing Committee on Medicines. The rotavirus vaccine has also been added to the list.
NLEM drugs are included in the planned category and their price is regulated by the National Pharmaceutical Pricing Authority, Dr Gupta said.
He said Covid drugs and vaccines have not been added to the list because they have obtained emergency use authorizations and the data is still inconclusive and regulatory complete.
The committee considered the essentiality of drugs for COVID-19. Conditional approval/emergency use approval has been granted to some new drugs for COVID-19, keeping in mind the risk of spreading the pandemic versus the potential benefit (risk-benefit ratio) on the basis of available in vitro, non-clinical and clinical data, Dr. Gupta said.
“The committee also emphasized the rational use of antimicrobial agents by all stakeholders, including manufacturers, physicians, patients and veterinary experts,” he said.
A revised list of 399 formulations was submitted by an expert committee of the Indian Council of Medical Research (ICMR) last year. After a detailed analysis of Indian needs, major changes were sought by Mandaviya.
The criteria for the inclusion of drugs in the NLEM are that they are useful in diseases that are a public health problem in India, licensed/approved by the Drug Controller General of India (DCGI), have a profile of efficacy and safety proven based on scientific evidence.
These are relatively cost effective and should be aligned with the current and recommended treatment guidelines under India’s national health programs. (for example, ivermectin is part of the 2018 Accelerated Lymphatic Filariasis Elimination Plan).