**Executive Summary:**
This advisory, issued by the Central Drugs Standard Control Organization (CDSCO) on 23/01/2024, addresses the critical issue of antimicrobial resistance (AMR) and promotes the rational use of antibiotics. It references the National Action Plan on AMR (NAPAMR) released on 19.04.2017, and outlines regulatory steps taken to control the indiscriminate use of antibiotics. It also specifies actions required by State Drugs Controllers, chemists and druggists, and the pharma industry.
**Key Points / Main Content:**
* **Regulatory Measures:**
* Antibiotics are included in Schedule H and H1 of the Drugs and Cosmetics Rules, 1945, requiring sale by prescription only.
* Schedule H1 introduced in 2013 (G.S.R 588 E dated 30.08.2013) imposes stricter controls on the sale of specific drugs, including antibiotics and anti-TB drugs.
* Amendment G.S.R. 28 E dated 17.01.2012 mandates mentioning withdrawal periods on veterinary drug labels for food-producing animals.
* Colistin and its formulations are prohibited since 19.07.2019 for use in food-producing animals, poultry, aqua farming, and animal feed.
* The Ministry of Agriculture has requested judicious use of antibiotics and hormones in food-producing animals.
* **Required Actions by Stakeholders:**
* State/UT Drugs Controllers must ensure antibiotics are sold only with a prescription.
* All India Organization of Chemists and Druggists should educate members to adhere to license conditions and prevent unauthorized sales.
* The Pharma Industry should discourage pharmacists from selling antibiotics without prescriptions.
**Impact Analysis:**
**State/UT Drugs Controllers**
* *Impact:* Responsible for enforcing regulations related to the sale of antibiotics.
* *Action Required:* Sensitize enforcement officials to monitor and prevent the sale of antibiotics without a valid prescription.
**All India Organization of Chemists and Druggists**
* *Impact:* Represents pharmacies and drug retailers.
* *Action Required:* Educate members to strictly follow license conditions for drug sales and cooperate with regulatory authorities to prevent unauthorized sales of antibiotics.
**Pharma Industry**
* *Impact:* Manufacturers and marketers of pharmaceutical products, including antibiotics.
* *Action Required:* Use their marketing networks to discourage pharmacists from selling antibiotics without a prescription.
Key Entities Referenced
Antimicrobial Resistance: A serious threat to public health due to the spread of multidrug-resistant bacteria and the lack of new antibiotics.
National Action Plan on AMR: A plan developed by the Ministry of Health and Family Welfare in consultation with stakeholders to address antimicrobial resistance across various sectors.
Ministry of Health and Family Welfare: The Indian governmental body responsible for public health initiatives, including the development of the National Action Plan on AMR.
Central Drugs Standard Control Organization: An Indian regulatory body responsible for ensuring the safety of public health and limiting development of antimicrobial resistance.
Drugs and Cosmetics Rules, 1945: Indian regulations governing the sale and distribution of drugs, including antibiotics.
Schedule H1: A schedule under the Drugs and Cosmetics Rules, 1945 that lists antibiotics, Anti-TB drugs and certain habit-forming drugs requiring stricter control over their sale.
Colistin: An antibiotic that has been prohibited for manufacture, sale, and distribution for use in food-producing animals, poultry, aqua farming, and animal feed supplements.
All India Organization of Chemists and Druggists: An organization that should educate their members to follow the conditions of Licence for sale of drugs strictly and cooperate with regulatory authorities to prevent such sale of drugs.
F. No. AMR/Misc/02/NCDC-NAP-AMR/18
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, Kotla Road,
New Delhi — 110 002, India
Dated: 23 |)>1>e 4
Advisory
RATIONAL USE OF ANTIBIOTICS FOR LIMITING ANTIMICROBIAL RESISTANCE
Antimicrobial Resistance (AMR) is an increasingly serious threat to public health.
The spread of multi-drug resistant bacteria and the lack of new antibiotics to treat
infections caused by these organisms pose a rapidly increasing threat to human health
which urgently needs to be tackled.
Ministry of Health and Family Welfare in consultation with various stakeholders
developed National Action Plan on AMR (NAP-AMR), which was officially released on
19.04.2017. The NAP-AMR outlines the priorities and interventions planned which
consider harmonized approach across various sectors to address the use of and
resistance to antimicrobial agents in human health, agriculture, food products and the
environment.
As a part of overall responsibility for ensuring the safety of public health and
limiting development of antimicrobial resistance in the country, the CDSCO and Ministry
of Health and Family Welfare have been continuously taking regulatory steps to curb
and control indiscriminate use of antibiotics.
Details of regulatory steps taken in this regards are as under:
1. Antibiotics are included in Schedule H and H1 of the Drugs and Cosmetics
Rules, 1945 and are required to be sold by retail only under the prescription
of a Registered Medical Practitioner. A separate Schedule H1 under the
Drugs and Cosmetics Rules, 1945 was introduced vide G.S.R 588 (E) dated
30.08.2013 containing antibiotics, Anti-TB drugs and certain habit forming
drugs. The drugs falling under Schedule H1 are required to be sold in the
country for stricter control over these drugs.
2. The Drugs and Cosmetics Rules, 1945 were amended vide G.S.R. 28 (E)
dated 17.01.2012 for making it mandatory to mention withdrawal period on
1F. No. AMR/Misc/02/NCDC-NAP-AMR/18
the label of veterinary drugs used in food producing animals to ensure that
the food stuffs produced from the animals do not exceed the residual limit
specified for them.
3. Colistin and its formulations have been prohibited on 19.07.2019 for
manufacture, sell and distribution for food producing animals, poultry, aqua
farming and animal feed supplements.
4. The Ministry of Agriculture also issued a circular to Directors/Commissioners
of Animal Husbandry of all States and UT’s requesting the State Govt. and
Union Territories to advice State veterinarians, feed manufacturers and also
the persons involved in the treatment of animals for judicious use of
antibiotics and hormones for the treatment of ailing food producing animals.
5. Various Notices/Advisories/Letters have been issued to the State Drugs
Regulators, and other stake holders for strict compliance of the requirements
of Drugs and Cosmetics Act and Rules made thereunder and raising
awareness in the public regarding adverse effects of misuse of antibiotics.
Steps required to be taken by stakeholders
1. All State & UT Drugs Controllers should sensitize their enforcement
officials to keep strong vigil to ensure that such drugs are not sold by retail
without prescription of Registered Medical Practitioners in accordance with
Drugs and Cosmetics Act, 1940 and rules made thereunder.
2. All India Organization of Chemists and Druggists should play an active
role to educate their members to follow the conditions of Licence for sale of
drugs strictly and co-operate with regulatory authorities to prevent such sale
of drugs.
3. The Pharma Industry should use their well-developed marketing network to
discourage the pharmacists in selling of such drugs without prescription.
All the stakeholders are advised to join hands in rational use of antibiotics to
adhere to the mission of use of medicines appropriately to safe guard right, safety and
well- being of the patients.
V[eyor
(Dr. V. G. Somani)
Drugs Controller General (India)