The government has included 34 drugs and dropped 26 from the National List of Essential Medicines (NLEM). The updated list was released by Union ministers Dr Bharti Panwar and Mansukh Mandaviya. The list now contains 384 medicines approved by the central authorities. Several antibiotics, vaccines and anti-cancer drugs will become more affordable by their addition to the list. However, 26 drugs such as Ranitidine, Sucralfate, white petrolatum, Atenolol and Methyldopa have been deleted from the revised list. The deletion has been done based on the parameters of cost effectiveness and availability of better drugs.
The drugs in NLEM are included in scheduled category and their price is regulated by the National Pharmaceutical Pricing Authority.
What is an essential medicine list?
According to World Health Organisation (WHO), essential medicines are those that satisfy the priority healthcare needs of a population. The global health body said on its website that these medicines are intended to be available in functioning health systems at all times, in appropriate dosage forms, of assured quality and at prices individuals and health systems can afford.
The first WHO model list of medicines was published in 1977, which contained 186 medicines.
In 1985, this list was recognised as important for the public sector and a guide for the procurement, distribution, rational use and quality assurance of medicines.
What are the criteria for inclusion of a medicine in NLEM?
Many things are discussed by regulatory authorities before taking a decision to include a medicine in NLEM. These are:
Essentiality: A website developed by Ministry of Electronics and Information Technology said that every medicine may be necessary or even critical for specific disease conditions for which it is indicated. But in the context of NLEM, a medicine may be essential considering the population at large and should fit into the definition mentioned earlier.
Changing Disease Burden: Disease burden is an important consideration for identifying the essential medicines. Medicines needed to manage diseases that are highly prevalent or are emerging diseases in the population, according to the regulations set by the central government in 2015.
Efficacy and Safety: For a medicine to be considered essential, it should have an unequivocal evidence of efficacy and wider acceptance in medical science. The medicine should have a safety profile which is acceptable in terms of risk benefit assessment.
Comparative Cost-effectiveness: Sometimes per unit price of the medicine may be more but it may be required to be given at a lesser frequency. So, according to the website, the total price of the treatment schedule should be taken into consideration and not the unit price alone.
The other criteria used for the purpose are: Feasibility in context of advantage and cost-effectiveness, fixed dose combinations and sales turnover.
When is a medicine deleted from NLEM?
For this, the government takes into consideration some important aspects such as:
- The medicine has been banned in India
- There are reports of concerns on the safety profile of a medicine
- A medicine with better efficacy or favourable safety profiles and better cost-effectiveness is now available
- The disease burden for which a medicine is indicated is no longer a national health concern in India
The WHO said that selection of a limited number of medicines as essential can lead to improved access through streamlined procurement and distribution of quality-assured medicines, support more rational or appropriate prescribing and use and lower costs for both health care systems and for patients.