20 Sep National List of Essential Medicines (NLEM): ensuring accessibility and affordability of medicines in India
National List of Essential Medicines (NLEM)
Prelims: National List of Essential Medicines (NLEM), National Pharmaceuticals Pricing Authority (NPPA)
Mains: GS Paper II – Health, Government Policies, and Interventions,
Context
The new revised National List of Essential Medicines has been released by the Union Health Ministry after 7 years. NLEM, 2022, has 34 new drugs which include 4 patented drugs.
National List of Essential Medicines (NLEM)
What is the National List of Essential Medicines (NLEM)?
- These are medicines to address the priority health care needs of the majority of the population and thereby treat diseases that are a public health concern. For a medicine to be included in NLEM, it must satisfy conditions of affordability, safety, and efficacy and must be approved by the Drugs Controller General (DCGI).
- It usually contains those medicines which are recommended under the National Health Programs of India. (ex. Bedaquiline used in TB Elimination Program)
- It is published by the Ministry of Health and Family Welfare and is revised from time to time depending on the changing public health priorities as well as advancement in pharmaceutical knowledge.
- NLEM falls under the First Schedule of The Drugs (Price Control) Order, 2013.
- So far, it has been revised four times since its inception in 1996,- 2003,2011,2015, and now in 2022.
Pricing of drugs under the National List of Essential Medicin
- Under the powers conferred under the Essential Commodities Act, of 1955, the Government issues Drug Price Control Orders (DPCO) which allow it to set a ceiling price for lifesaving medicines. This ensures that the general public can access these medicines at an affordable price.
- NLEM contains medicine that falls under Schedule I of DPCO and is hence subject to price control
- Pricing is fixed by National Pharmaceutical Pricing Authority (NPPA)
- Once a drug falls into NLEM, its price cannot be changed by the drug manufacturing company.
- The prices are increased or decreased every year based on the Wholesale Price Index (WPI)
Need for Revisions
- While some medicines may become redundant and obsolete, or are found to be hazardous for health with significant side effects and hence removed from the list-for example, the anti-TB drug kanamycin was removed from the revised list due to its side effects on kidney and hearing impairment.
- It may also be removed from the list if the disease it aims to treat is no longer a public health concern.
- On the other hand, new treatment protocols may emerge or new drugs may be made which are more efficacious and affordable due to scientific advancement in the pharmaceutical sector.
- Hence the NELM must match the concerns and relevancy of the public health system.
- The most significant feature of the 2022 list is the addition of some patented drugs. Generally, NELM consists of generic drugs only, but this time, these patented drugs are added due to their effectiveness in treating serious health diseases like Bedaquiline and Delaminid for TB, Dolutegravir for HIV, and Daclatasvir for the treatment of Hepatitis C.
Significance of NLEM
- The NLEM ensures accessibility and availability of medicines at affordable prices. It thus reduces the out-of-pocket expenditure of the common man and promotes rational usage of medicines.
Sources
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