The Central Government vide notification dated11th November, 2022 has issued the Drugs (Prices Control) Amendment Order, 2022. The amendment has revised the National List of Essential Medicines (NLEM) 2022. Any dosage form of a medicine not included in the revised list, but in same strength and route of administration, which does not demonstrate significant difference in terms of pharmacokinetics/pharmacodynamics/ efficacy / safety over the dosage form mentioned in the list, should be considered as included.
To elaborate, if a tablet is included in the list, other oral solid dosage form such as capsule is considered as included. However, such different dosage forms should be considered differently for purposes of procurement policy, pricing etc. This principle also applies to all other dosage forms e.g. oral liquid dosage forms, injectables, topical dosage forms etc.
