Report of the Core-Committee for Revision of National List of Essential Medicines (NLEM). November 2015 - India
(2015; 38 pages)

Resumen

The Core-Committee in its initial meetings deliberated and decided on the criteria for inclusion and deletion of medicines in National List of Essential Medicines (NLEM).

The criteria for inclusion of a medicine in NLEM are as follows:

  • The medicine should be approved/licensed in India.
  • The medicine should be useful in disease which is a public health problem in India.
  • The medicine should have proven efficacy and safety profile based on valid scientific evidence.
  • The medicine should be cost effective.
  • The medicine should be aligned with the current treatment guidelines for the disease.
  • The medicine should be stable under the storage conditions in India.
  • When more than one medicine are available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost-effectiveness.
  • Price of total treatment to be considered and not the unit price of a medicine.
  • Fixed Dose Combinations (FDCs) are generally not included unless the combination has unequivocally proven advantage over individual ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance.
  • The listing of medicine in NLEM is based according to the level of health care, i.e. Primary (P), Secondary (S) and Tertiary (T) because the treatment facilities, training, experience and availability of health care personnel differ at these levels.

The criteria for deletion of a medicine from NLEM is as follows:

  • 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 favorable 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.
  • In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective in Indian context.

The Core-Committee through a series of meetings and consultations across the country, deliberated and revised the National List of Essential Medicines (NLEM) 2011.

 
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