The story so far: On September 13, the National List of Essential Medicines (NLEM), 2022, was released, with 384 drugs in it across 27 categories. While 34 new drugs are on the list, 26 drugs from NLEM, 2015, including common gastrointestinal medicines Ranitidine and Sucralfate, have been dropped. In a tweet, Union Health Minister Mansukh Mandaviya said, “several antibiotics, vaccines, anti-cancer drugs and many other important drugs would become more affordable, and the ‘out-of-pocket’ expenditure on health care would come down.” Prices of essential medicines are regulated by the National Pharmaceutical Pricing Authority.
Four major anti-cancer drugs, hydrochloride, HCI trihydrate, lenalidomide and leuprolide acetate as well as psychotherapeutic drugs, nicotine replacement therapy and anti-parasitic drugs like ivermectin, mupirocin (topical antibiotic), and meropenem (antibiotic) are on the list. It also includes four drugs that are still under patent — bedaquiline and delamanid, used in the treatment of multiple drug-resistant tuberculosis, dolutegravir used to treat human immunodeficiency virus (HIV) infection, and daclatasavir used in treating viral infections such as Hepatitis C. Endocrine medicines and contraceptives like fludrocortisone, ormeloxifene, insulin glargine and teneligliptin (for diabetes control) have also been added to the list. Montelukast, acting on the respiratory tract, the ophthalmological drug latanoprost and cardiovascular medicines dabigatran and tenecteplase are on the list too.
Omissions include commonly used gastrointestinal drugs ranitidine, sucralfate, white petrolatum (for treating skin conditions), atenolol and methyldopa (for high blood pressure). Vivek Sehgal, director general, Organisation of Pharmaceutical Producers of India, said for the industry to be able to continue to make and supply the medicines from NLEM, the government should ensure that inflation is taken into account while fixing the ceiling price. “This will enable the pharmaceutical industry to continue on its growth trajectory. Further, this NLEM includes four patented medicines for which companies have had robust access mechanism in place for India. The Organisation of Pharmaceutical Producers of India (OPPI) is concerned with this inclusion of the four patented drugs and the implication it has on value for innovation,” he said.
For inclusion in NLEM, the drugs have to be useful in treating diseases which are a public health problem in India. They have to be licensed/approved by the Drugs Controller General (DCGI), have proven efficacy, a safety profile based on scientific evidence, comparatively cost effective, and aligned with the current treatment guidelines. They have to be recommended under the National Health Programs of India (for instance, ivermectin is part of the Accelerated Plan for Elimination of Lymphatic Filariasis, 2018). When more than one medicine is available from the same therapeutic class, a prototype that is the best suited medicine of that class is included. Besides this, the price of the total treatment is considered and not the unit price of a medicine. Fixed dose combinations are usually not included.
A medicine is deleted from the list if it is banned in India; if there are reports of concerns on the safety profile and if a medicine with better efficacy and is cheaper is available. If the disease, for which a particular medicine is recommended, is no longer a national health concern, the drug is taken off the list. Additionally, in case of antimicrobials — if the resistance pattern has rendered an antimicrobial ineffective, it is removed from the NLEM.
The primary purpose of the NLEM is to promote rational use of medicines considering three important aspects which are cost, safety and efficacy. It also helps in optimum utilisation of healthcare resources and budget, drug procurement policies, health insurance, improving prescribing habits, medical education and training and drafting pharmaceutical policies. In NLEM, the medicines are categorised based on the level of the healthcare system as primary, secondary and tertiary.
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 was revised thrice in 2003, 2011 and 2015, before 2022. The NLEM independent Standing National Committee on Medicines (SNCM) was constituted by the Union Health Ministry in 2018. After detailed consultation with experts and stakeholders, the committee revised the NLEM, 2015 and submitted its report on NLEM, 2022 to the Health Ministry. The government accepted the recommendations of the committee and adopted the list.