NATIONAL LIST OF ESSENTIAL MEDICINES (GOVERNMENT OF INDIA)-2015
Ceiling prices of 464 formulation (amounting to nearly 7000 different stock keeping units) have been fixed by the government after the announcement of National List of Essential Medicines (NLEM), 2015 and Revised Schedule-I.
Consequent to notification of National Pharmaceuticals Pricing Policy-2012 (NPPP-2012) on 7.12.2012 and notification of Drugs (Price Control) Order, 2013 (DPCO, 2013), all the medicines as specified in the NLEM-2011 were brought under price control. Ministry of Health and Family Welfare constituted a Core-Committee to revise the NLEM. This Committee evaluated the medicines on the objective criteria for inclusion and deletion.
The criteria for deletion of medicines from National List of Essential Medicines 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 favourable safety profiles and better cost-effective 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.
Based on the scientific criteria, Core Committee recommended inclusion of 106 medicines and deletion of 70 medicines from the earlier NLEM, 2011. The Pharmaceutical Pricing Policy entails the price control of only schedule-1 medicines which are included in the NLEM. The medicines, which ceased to be part of NLEM, 2015 and Schedule-1, will only be monitored as non-scheduled medicines. Non-scheduled medicines are allowed an increase of upto 10% in the prices every year, which is monitored by the National Pharmaceutical Pricing Authority (NPPA).
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