Lok Sabha Question No. 1363 (UNSTARRED), answered on 2026-02-06
Subject: India as a Global Epicenter of AMR
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Smt. Sajda Ahmed

## GOVERNMENTOFINDIA MINISTRYOF HEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE

## LOK SABHA UNSTARRED QUESTION NO. 1363 TO BE ANSWERED ON 06.02.2026

## INDIAASAGLOBALEPICENTEROFAMR

## 1363. SMT. SAJDA AHMED:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:-

(a) whether the Government is aware that India is becoming a global epicentre of Antimicorbial Resistance (AMR) due to antibiotic misuse and weak enforcement and if so, the details thereof;

(b) the data on AMR infections and related deaths during the last five years and the current status of the National AMR Surveillance Network, State-wise;

(c) the number of inspections, prosecutions and penalties for violations of Schedule H/H1 during the last five years; and

(d) whether the Government has a time-bound plan to tighten regulation, mandate prescription audits and expand district-level surveillance in the country and if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH & FAMILY WELFARE (SHRI PRATAPRAO JADHAV)

(a): The Government is aware of the growing challenge of Antimicrobial Resistance (AMR) in the country. To address this public health concern, the Government has taken a number of strategic and coordinated measures across sectors. The details of the steps taken are at Annexure-I.

(b): No, such data is centrally maintained. However, under the National Programme on AMR Containment, National AMR Surveillance Network (NARSNET) has been established under which identified medical colleges in the country have been strengthened to generate quality AMR data of 9 priority pathogens causing clinical infections.

(c): The sale and distribution of drugs including Schedule H drugs are regulated by State Licensing Authorities under Drugs Rules 1945. Further, sale of Schedule H drugs without prescription of a registered medical practitioner is a punishable offence and the State Licensing Authorities (SLA) are empowered to take action for the same.

Further, the State Drugs Controllers/other stake holders have been sensitized about concerns regarding sale of prescription drugs by retail without prescription of Registered Medical Practitioners. Various Notices/Advisories/Letters have been issued to State Drugs

Controllers and other stake holders for strict compliance of the requirements of Drugs and Cosmetics Act and Rules.

At the national level, the Government, through the Central Drugs Standard Control Organization (CDSCO), has undertaken several key regulatory measures. The details of these measures are at Annexure-II.

(d): Under the National Action Plan on Antimicrobial Resistance 2.0 (2025-29), the Government has prioritized enhancement and expansion of AMR surveillance capacity and laboratory networks across human health, animal health, food and environmental sectors in line with One Health approach. This includes strengthening laboratory infrastructure, data reporting and integration from a broader range of diagnostic facilities to improve representativeness and timeliness of AMR data, consistent with WHO's Global Antimicrobial Resistance Surveillance System objectives.

## Details of steps taken by Government to contain AMR as mentioned in part (a) of the reply are as under;

1. 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 domain on the NCDC website.
2. Guidelines on Infection Prevention and Control (IPC) have been issued to prevent and control healthcare-associated infections and reduce unnecessary use of antibiotics in healthcare settings.
3. To promote judicious use of antibiotics and create awareness about AMR, the National Centre for Disease Control (NCDC) has developed IEC materials including audio-visual content, social media messages and outdoor media campaigns. These materials are available in the public domain and have been shared with States/UTs for wider dissemination.
4. The Indian Council of Medical Research (ICMR) has established an AMR 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 is also supporting multiple research projects covering basic, clinical and applied AMR research.
5. ICMR released guidelines on Infection control in hospitals in 2016 to facilitate hospitals to develop infection control program which are available at: https://www.icmr.nic.in/sites/default/files/guidelines/Hospital\_Infection\_control\_guidelines.p

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## Details of key regulatory measures taken by the Central Drugs Standard Control Organization (CDSCO) as mentioned in part (c) of the reply are as under:

1. The Central Drugs Standard Control Organization (CDSCO) regulates the safety, 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 by retail only on the prescription of a Registered Medical Practitioner.

2. States/UTs have been advised to promote prescription of generic medicines and conduct regular prescription audits in public health facilities. Prescription audit is also one of the requirements under National Quality Assurance Standards (NQAS) certification.

3. CDSCO have issued various notices, advisories and communications to State Drug Regulators and stakeholders for strict compliance with regulatory provisions and to raise awareness regarding misuse of antibiotics.

4. Amendment of Drugs & Cosmetics Rules, 1945 (effective 01.03.2014) introducing Schedule H1, covering specified antibiotics, anti-TB and habit-forming drugs, with stricter labelling, prescription and record-keeping requirements.

5. Mandatory maintenance of separate sale registers for Schedule H1 drugs, including prescriber and patient details, to be preserved for three years for inspection.

6. Amendment of Rule 97 requiring medicines meant for treatment of food-producing animals to display the withdrawal period on labels.

7. Advisories issued by the Department of Animal Husbandry and DCG(I) to States/UTs for judicious use of antibiotics in animals and discontinuation of antibiotics and hormones in animal feed.

8. Prohibition of Colistin and its formulations for manufacture, sale and distribution for food-producing animals, poultry, aquaculture and animal feed supplements (effective 19.07.2019).

9. Prohibition of Chloramphenicol and Nitrofurans and their formulations for import, manufacture, sale and distribution for use in any food-producing animal rearing system (effective 12.03.2025).

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