Parliament Question: Antimicrobial resistance

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARRED QUESTION NO. 1211 TO BE ANSWERED ON10.02.2026 ANTIMICROBIALRESISTANCE 1211.SHRIPRAMOD TIWARI: Willthe MINISTEROFHEALTH AND FAMILYWELFAREbe pleased tostate : - (a)whether antimicrobial resistance hasnow become a majorpublic health andeconomicthreat; (b) if so, the detailsthereof; and (c) the steps proposed to be taken by Government for safe disposal of expired or unused antibiotics alongside inspections of manufacturing units to ensure compliance with bio-medical waste managementrules? ANSWER THE MINISTER OFSTATE INTHE MINISTRYOFHEALTH & FAMILYWELFARE (SHRIPRATAPRAO JADHAV) (a) & (b) : The Government is aware of the growing challenge of Antimicrobial Resistance (AMR) inthe country. Toaddress thispublic health concern,the Government hastakena number of strategic and coordinated measures across sectors. The details of the steps taken are at Annexure-I. (c): The Government has taken measures for safe disposal of expired or unused antibiotics and for ensuring compliance of manufacturing units with bio-medical waste management requirements. The steps taken include the following: I. The Central Drugs Standard Control Organization (CDSCO) has issued a Guidance Document on Disposal of Expired/Unused Drugs providing a framework for environmentallysafe and compliantdisposal practices. II. Under the amended Schedule M of the Drugs Rules, 1945 (notified vide GSR 922(E) dated 28.12.2023), specific provisions relating to bio-medical waste management and safe handlinganddisposal practices are mandatedfor licenseddrug manufacturingunits. III. Regulationof manufacture andsale of drugs undertheDrugs andCosmetics Act, 1940 and Rules made thereunder is carried out through a system of licensing and periodic inspections by State Licensing Authorities appointed by the respective State Governments. IV. Manufacturingpremisesarerequiredtocomplywithlicenceconditions,includingGood Manufacturing Practices (GMP) and prescribed waste management standards. State LicensingAuthoritiesare empowered totake regulatoryactionincase of non-compliance. *****ANNEXURE Details of stepstakenbyGovernment to containAntimicrobial Resistance (AMR) I. The Ministry of Health and Family Welfare has issued Standard Treatment Guidelines (STGs) for rational use of medicines, including antibiotics. These guidelines are available in the public domainonthe NCDC website. II. Guidelines on Infection Prevention and Control (IPC) have been issued to prevent and control healthcare-associated infections and to reduce unnecessary use of antibiotics in healthcaresettings. III. To promote judicious use of antibiotics and generateawareness on AMR, the National Centre for Disease Control (NCDC) has developed IEC materials includingaudio-visual content, social media messages and outdoor media campaigns. These materials are available inthe public domainandhave beenshared with States/UTsfor wider dissemination. IV. The IndianCouncil of Medical Research (ICMR) hasestablished anAMR surveillance and research network comprising 21 tertiary care hospitals. Antimicrobial Stewardship (AMS) programmes have been implemented in these hospitals, and each hospital has developed its own antibiotic policy. ICMR also supports multiple research projects covering basic, clinical and appliedAMR research. V. ICMR has issued Guidelines on Infection Control in Hospitals (2016) to facilitate hospitals indevelopinginfection control programmes. VI. TheCentralDrugsStandardControlOrganization(CDSCO)regulatesthesafety,efficacy and quality of drugs under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. Antibiotics are included under Schedule H and Schedule H1 and are required to be sold only on the prescription of a Registered Medical Practitioner. VII. Amendment of the Drugs & Cosmetics Rules, 1945(effective 01.03.2014) introduced Schedule H1 covering specified antibiotics, anti-TB and habit-forming drugs, with stricter labelling,prescription andrecord-keepingrequirements. VIII. MaintenanceofseparatesaleregistersforScheduleH1drugshasbeenmademandatory, includingprescriber andpatient details, tobe preserved for three yearsfor inspection. IX. CDSCO has issued various notices, advisories and communications to State Drug Regulators and other stakeholders for strict compliance with regulatory provisions and for curbingmisuse of antibiotics. X. States/UTs have been advised to promote prescription of generic medicines and to conduct regular prescription audits inpublic health facilities. Prescription auditis also one of the requirementsunderNational QualityAssurance Standards(NQAS) certification. *****