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Centre releases NLEM 2022 of 384 medicines with 34 new medicines & 25 deletions

Our Bureau, New Delhi
Tuesday, September 13, 2022, 17:15 Hrs  [IST]

Union minister for health and family welfare Dr Mansukh Mandaviya has released the National List of Essential Medicines (NLEM) 2022, with a total of 384 medicines of which 34 are new medicines added to the list while 26 from the previous list were deleted due to various reasons. The medicines have been categorised into 27 therapeutic categories.
 
Speaking on the occasion, the Union Health Minister stated that the “essential medicines” are those that satisfy the priority health care needs, based on efficacy, safety, quality and total cost of the treatment. The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e., cost, safety and efficacy.”
 
It also helps in optimum utilization of healthcare resources and budget; drug procurement policies, health insurance; improving prescribing habits; medical education and training for UG/PG; and drafting pharmaceutical policies. In NLEM, the medicines are categorized based on the level of the healthcare system as- P- Primary; S- Secondary and T- Tertiary, said the Minister.
 
He elaborated that the concept is based on the premise that a limited list of carefully selected medicines will improve quality of health care, provide cost-effective health care and better management of medicines. The NLEM is a dynamic document and is revised on a regular basis considering the changing public health priorities as well as advancement in pharmaceutical knowledge. The National List of Essential Medicines was first formulated in 1996 and it was revised thrice earlier in 2003, 2011, and 2015.
 
“The independent Standing National Committee on Medicines (SNCM) was constituted by the Union Health Ministry in 2018. The Committee after detailed consultation with experts and stakeholders has revised the NLEM, 2015 and submitted its report on NLEM, 2022 to the Ministry of Health & Family Welfare. The Government of India has accepted the recommendations of the Committee and adopted the list”, he stated.
 
He also noted that the process of creation of NLEM depends on the feedback backed by scientific sources from stakeholders and the inclusion/exclusion principle followed.
 
Interestingly, the Minister, in September, 2021, announced in his twitter account that he has released the NLEM 2021 version during a visit to the Indian Council of Medical Research (ICMR), where he reviewed the ongoing research work. The copy of the List was not available in the public domain, while select pages of the revised list available showed that it had an addition of 39 drugs including anti-cancer, anti-diabetes and antiretroviral drugs while 16 drugs from the NLEM 2015, including erythromycin and a combination of lamivudine, were deleted.
 
While releasing the NLEM 2022 on September 13, 2022, Dr Bharati Pravin Pawar, Union Minister of State stressed on enhancing awareness regarding antimicrobial resistance (AMR) which “is emerging as a big challenge for our scientists and community and we need to create awareness in the society about AMR”.
 
There were 348 medicines in the NLEM 2011, of which 47 medicines were added and 43 were deleted. There were a total of 376 medicines in the NLEM 2015, of which 106 were newly added while around 70 were deleted, which were present in the previous NLEM. However, the Covid-19 management medicines were not included in the list considering the data of such medicines are still not conclusive and complete from the regulatory perspective.
 
There has been much advancement in the anti cancer drugs category and affordability is an issue. NPPA has fixed the price of 42 non-NLEM drugs by Trade Margin Rationalisation and out of this, the Committee has decided that four of them can be included in NLEM, said Dr Y K Gupta, vice chairman of the SNCM.
 
The Committee also specifically wanted to highlight the increasing and continued need of educating the health professionals and doctors against the use of several Fixed Dose Combinations of antibiotics. Although many antibiotic FDCs with multiple antibiotics, analgesics, vitamins, minerals etc have been banned, still many combinations are in the market with doubtful rationality. Though the committee wishes to publish such a negative list of such diseases, it is restricting itself because the list will become only an example and cannot be exhaustive. The Committee also put great emphasis on rational use of antimicrobial agents by all stakeholders including manufacturers, doctors, patients and veterinary experts.
 
The NLEM 2022 also has drugs including bedaquiline, delamanid, doulutegravir and daclatasavir, which are still under patent.
 
While in the NLEM 2015, various modified release solid oral dosage forms were listed as sustained release, controlled release, delayed release, extended release, prolonged release etc., considering many of these are often introduced with incremental innovation and drug delivery systems are evolving rapidly, the NLEM 2022, uses the term Modified release has been used to represent these delivery forms to broadly reflect all such modified release dosage forms.
 
The NLEM 2022 has been prepared after consulting various documents of medicines including the NLEM 2011 and 2015, World Health Organisation’s Essential Medicines List 2021, National Formulary of India, National Health Programmes, Standard Treatment Workflow of ICMR, Treatment guidelines of associations and professional bodies and newsletters of pharmacovigilance programme of India. It has also conducted various meetings with the stakeholders including the Ministries, Department of Pharmaceuticals, National Pharmaceutical Pricing Authority, CDSCO, Indian Pharmacopeia Commission, various non-government organisations, and pharmaceutical industry associations.
 
Over 350 experts from various fields across the country were consulted in a total of 140 consultative meetings following which the drafting committee meetings were held before preparing the List. Every meeting has audio visual recordings and minutes to prove who said what in the meeting.

 

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