Parliament Question: National List of Essential Medicines

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 2252 TOBE ANSWERED ON 31ST JULY,2026 NATIONALLISTOFESSENTIALMEDICINES

2252.SHRIKODIKUNNILSURESH:

Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:

(a) whether the Government has initiated the process for revision of the National List of Essential Medicines (NLEMs), if so, the present status thereof along with the timeline fixed for publicationof the revised list;

(b) the scientific criteria and guidelines adopted by the Standing National Committee on Medicines(SNCMs) for inclusion andexclusion of medicines inthe revised NLEM;

(c) whether representations have been receivedfrom State Governments, medicalexperts and otherstakeholdersinthisregard,if so,the detailsthereof;

(d) the details of medicines, fixed-dose combinations and pharmaceutical products presently banned, prohibited or withdrawn from manufacture, sale or distribution in the country, indicatingtheirgeneric names, therapeuticuse andreasons for the ban;

(e) whether the Government maintains a list of the brand names and manufacturers of such banned medicines, if so, the details thereof along with the action taken by the Government against manufacturers, importers anddistributors for violationof prohibitionorders; and

(f) the steps takenor proposed tobe takenbythe Government toensure timelyrevision of the NLEM and to prevent the manufacture, distribution and sale of banned medicines in the country? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL)

(a)to(c): The National List of Essential Medicines (NLEM) is prepared and revised takingintoconsiderationthe country'sdisease burden,public healthpriorities,safety, efficacy, cost-effectiveness, contemporary knowledge of use of therapeutic products in health & hygiene of general public, various documents of medicines, availability of medicines including World Health Organization (WHO) Model List through an established expert consultative mechanism.Revision of the NLEM, including addition, deletion or modification of medicines, is undertaken from time to time based on the recommendations of the Standing National Committee onMedicines (SNCM), a Government-appointedexpert committee.

During such revision, medicines across all therapeutic categories, are considered based on the prescribed criteria and available scientific evidence. These include drug approval status, banned drugs status in the country, safety & efficacy profile of drug and Fixed Dose Combination (FDCs), resistance patterns against antimicrobials, disease burden, medicinesenlisted in National healthprograms, affordability,accessibility, cost-effectiveness, better alternatives, therapeutic advances, safety concerns and representations received from variousstakeholders which are discussed inrespective expertgroup meetings.

(d) to(f): There are provisions under the Drugs and Cosmetics Act, 1940, under which Central Government may regulate, restrict or prohibit manufacture, of any drug including FDCs in public interest if, the use of drugs is likely to involve any risk to human beings or animals or there is no therapeutic justification for the ingredients contained in FDCs. List of banneddrugs includingFDCsare available onthe website of CDSCO i.e.www.cdsco.gov.in Manufacture, sale and distribution of prohibited/banned drugs is a punishable offence under Section 18 of the Drugs and Cosmetics Act, 1940 and the State Licensing Authorities are empowered to take action in this regard. As and when any such complaints/issues is received, the matter is taken up with the concerned State Licensing Authority for necessary actionincludingthe cancellationof the manufacturinglicenses.

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