PH10.8 | PH10.8 | Essential Medicines and Formulary Choices — SDL Guide — Summary & Reflection

KEY TAKEAWAYS

Essential medicines are selected by WHO and India's NLEM based on three criteria: public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness. The India NLEM 2022 lists approximately 384 medicines, which are price-controlled under the DPCO — prescribing NLEM medicines directly reduces patient out-of-pocket costs. Fixed-dose combinations are rational when both components are needed simultaneously, the fixed ratio suits the majority of patients, combined use is superior to separate prescribing, and cost is not higher. Many FDCs marketed in India fail these criteria. OTC drugs are suitable for self-treatable conditions with wide therapeutic index, low abuse potential, and self-manageable interaction profiles. Choosing an essential medicine requires systematic application of P-drug criteria within the NLEM framework; non-NLEM prescribing requires explicit clinical justification.

REFLECT

Consider the essential medicines framework from both the prescriber's and the patient's perspective. A patient presents expecting a branded antibiotic 'because it is stronger' — how would you explain your choice of the generic NLEM equivalent? Now consider: is there any drug you regularly see prescribed in your clinical environment that you believe does not meet EML criteria? What evidence would you need to challenge that prescribing pattern? The essential medicines concept is ultimately about the equitable allocation of a scarce resource — effective, safe pharmacotherapy. How does it align with or challenge the commercial reality of India's pharmaceutical market?