Country Report: India
Kaithathara Vijayakumar
Joint Commissioner (LH)
Dpt. Animal Husbandry, Dairying and Fisheries
Introduction
It was the discovery of Penicillin in 1928 by Sir Alexander Fleming, a Scottish biologist which
changed the course of the history of mankind in harnessing infections. By conquering some
of the ancient scourges of the world, it turned out to be the most potent weapon to fight
infection and the most effective life saving drug. The discovery of penicillin opened up a new
saga of antibiotics to the world, spawned the huge pharmaceutical industry and also
unleashed the enigma of antimicrobial resistance.
Today, antimicrobial resistance in pathogens causing important infectious diseases is a
matter of great public health concern globally and in India. One of the main reasons for this
is the injudicious widespread use and the availability of practically all antimicrobials ‘over the
counter’ (OTC) for human as well as for animal use. Reliable Indian data on antimicrobial
resistance (AMR) for important pathogens of public health importance is an essential prerequisite for developing appropriate guidelines for the use of antimicrobials in the country.
Currently there is no accepted national database for antimicrobial resistance except in
places where there is a specific national control programme.
Though the use and misuse/ overuse of antibiotics in humans have been established as the
main reason for development of antimicrobial resistance, the use of antibiotics in food
animals has also become an important concern. The use of antibiotics in animals can be
majorly divided into four categories such as:




Therapeutic,
Prophylactic,
Metaphylactic,
Growth Promoting Use.
Growth promoters are usually administered in relatively low concentrations depending on
the drug and species treated. Scientific evidences suggest that the repeated use of these
performance enhancing antibacterial growth promoters (AGPs) may contribute to the
development of drug resistance. Therefore, it is of paramount importance that countries
develop legislations and regulations for use of AGPs.
1
Initiatives in India
In India the manufacturing of antibiotic drugs for human and veterinary purposes are
regulated by Central Drug Standard Control Organization (CDSCO) under Drugs and
Cosmetics Act of 1940 and the rules therein. However, there is as such no regulation
particularly for use of antibiotics as animal growth promoter. The Food Safety and Standards
Authority of India (FSSAI) under the Ministry of Health and Family Welfare is the main
authority for laying down science based standards for articles of food and to regulate their
manufacture, storage, distribution, sale and import, to ensure availability of safe and
wholesome food for human consumption and for matters connected therewith as per the
rules specified by Food Safety and Standard Act, 2006 (FSSA, 2006). It is the responsibility of
FSSAI to adopt Good Manufacturing Practices, Good Hygienic Practices, Hazard Analysis and
Critical Control Point and such other practices as may be specified by regulation. The various
provisions which may have direct or indirect implication for AGPs are:

As per Section 16 (2)(b) of FSSA, 2006: The Food Authority specify the limits for use of
food additives, crop contaminants, pesticide residues, residues of veterinary drugs,
heavy metals, processing aids, myco-toxins, antibiotics and pharmacological active
substances and irradiation of food.

The Section 16 (3)(b) of FSSA, 2006: The Food Authority shall also search, collect, collate,
analyse and summarise relevant scientific and technical data particularly relating to
incidence and prevalence of biological risk, residues of various contaminants,
identification of emerging risks and also includes many others also.

The Section 21(1) of FSSA, 2006 specifies “No article of food shall contain insecticides or
pesticides residues, veterinary drugs residues, antibiotic residues, solvent residues,
pharmacological active substances and micro-biological counts in excess of such
tolerance limit as may be specified by regulations.”

The Section 2.3.2 in Food Safety and Standard (Contaminants, Toxins and Residues)
Regulations, 2011 of FSSA, 2006 specifies the limits for antibiotics and other
pharmacologically active substances on the sea foods including shrimps, prawns or any
other variety of fish and fishery products. According to this clause he following limits are
prescribed as Tolerance limit for antibiotics in sea food.
Sl.No.
1.
2.
3.
4.
Name of Antibiotic
Tetracycline
Oxytetracycline
Trimethoprim
Oxolinic acid
Tolerance limit mg/kg (ppm)
0.1
0.1
0.05
0.3
This rule also prohibits the use of any of the following antibiotics and other
Pharmacologically Active Substances in any unit processing sea foods including shrimps,
prawns or any other variety of fish and fishery products namely All Nitrofurans,
Chloramphenicol, Neomycin, Nalidixic Acid, Sulphamethoxazole, Aristolochia spp. and
preparations thereof, Chloroform, Chlorpromazine, Colchicine, Dapsone, Dimetridazole,
2
Metronidazole, Ronidazole, Ipronidazole, other Nitromidazoles, Clenbuterol,
Diethylstilbesterol, Sulphonamide drugs, Fluroquinolones and Glycopeptides.

Similarly Export Inspection Council (EIC) under Ministry of Commerce and Industry has
also set up rules stipulating upper permissible limits for certain antibiotics and
anthelmintics like Albendazole and Fenbendazole in milk and milk products and MRLs
for antibiotics in egg (EIC/Milk-E.I./Feb2008 Issue 5).

As per EIC, the following antibiotics and other pharmacologically active substances are
prohibited in manufacture of feed, medication for chicken/poultry or in any stage of
production of egg powder which include Chloramphenicol, Dimetridazole,
Metronidazole, Nitofuran metabolites and anticoccidials including Nitroimidazoles (GOI
order S.O.1442 dated 19.12.03).

An insertion to Rule 97 to the Drug and Cosmetics Rules, 1945 which came in to force in
17.01.2012 specifies that the container of a medicine for treatment for food producing
animals shall be labeled with the withdrawal period of the drug for the species on which
it is intended to be used. Provided that if the specific withdrawal period shall not be less
than seven days for eggs or milk, twenty eight days for meat from poultry and mammals
including fat and offal, five hundred degree days for fish meat.
Antimicrobial resistance monitoring
Antimicrobial resistance in pathogens causing important communicable diseases has
become a matter of great public health concern globally including our country. Resistance
has emerged even to newer, more potent antimicrobial agents like carbapenems. The
factors responsible for this are widespread use and availability of practically all the
antimicrobials across the counter meant for human, animal and industrial consumption.
There are definite policies and guidelines for appropriate use of antimicrobials at national
level in specific national health programmes being run in the country. In order to monitor
antimicrobial resistance it is necessary to have regulations for use and misuse of antibiotics
in the country, creation of national surveillance system for antibiotic resistance, mechanism
of monitoring prescription audits, regulatory provision for monitoring use of antibiotics in
human, veterinary & industrial sectors and identification of specific intervention measures
for rational use of antibiotics.
In this regard a task force has been constituted with the following terms of reference:
1.
2.
3.
4.
To review the current situation regarding manufacture, use and misuse of antibiotics in
the country.
To recommend the design for creation of a national Surveillance System for Antibiotic
Resistance.
To initiate studies documenting prescriptions patterns & establish a Monitoring system
for the same.
To enforce and enhance regulatory provisions for use of antibiotics in human &
veterinary and industrial use.
3
5.
6.
To recommend specific intervention measures such as rational use of antibiotics and
antibiotic policies in hospitals.
Diagnostic Methods pertaining to Antimicrobial Resistance Monitoring.

For monitoring use and misuse of antibiotics: Schedule H of the drug and cosmetics
act contains a list of 536 drugs which are required to be dispensed on the
prescriptions of a registered medical practitioner. In order to have separate
regulation to check unauthorized sale of antibiotics, a separate schedule as Schedule
H1 may be introduced under the Drugs and Cosmetics Rules to regulate the sale of
antibiotics exclusively. Corresponding provisions under the Rules could be framed for
their implementation. A system of colour coding of third generation antibiotics and
all newer molecules may be put in place restricting their access to only tertiary
hospitals. Appropriate steps should be taken to curtail the availability of fixed dose
combination of antibiotics in the market.
 For strengthen diagnostics for AMR monitoring: The current methods as well as
newly developed ones will be utilized for AMR surveillance with a robust quality
assurance system put in place through a neutral central institute.
Aims of the national policy for containment of antimicrobial resistance
a) Understanding emergence and spread of antimicrobial resistance and the factors
influencing it.
b) Establish a nationwide well coordinated antimicrobial programme with well defined
and interlinked responsibilities and functions of different arms of the programme.
c) Rationalizing the usage of available antimicrobials.
d) Reducing antibiotic selection pressures by appropriate control measures.
e) Promotion of discovery of newer and effective antimicrobials based on current
knowledge of resistance mechanisms.
f) Rapid and accurate diagnosis of infections and infectious diseases.
Points of action
1. Establish government commitment and support for nation-wide antimicrobial
program and within it the policy and set up national focal point for collaborations and
compilation.
2. Establish a National Alliance for prevention and control of antimicrobial resistance.
3. Institute a surveillance system that captures the emerging resistance, seeks and
envisions trends in its spread and correlates with utilization of antimicrobial agents in
community as health care set ups.
4. Promote rational usage of antimicrobial agents.
5. Strengthen infection prevention and control measures-healthcare associated and
community based
6. Support research in developing newer antimicrobial agents and improving usage of
available ones, based on pharmacological properties.
7. Educate, train and motivate all stake holders in rational and appropriate usage of
antimicrobials and its regulation.
4
8. Establish a Quality System and a National registry for Antimicrobial resistance for
bacteria, fungi and viruses at national focal point.
9. Co-development of antimicrobial agents with pharmaceuticals and leaving the
distribution, sales and promotion with the government.
To conclude
In livestock production, antibiotics are dispensed to animals for a number of different
reasons viz. therapeutic treatment, disease prophylaxis and growth promotion. The
administration of antibiotics against bacterial populations is a significant driving force for
selection of resistant forms of bacteria, which can spread from one organism to another.
There is, therefore, an important question of whether the use of antibiotics in animal food
production poses a threat to human health. In particular, the worry is that resistant forms of
bacteria may spread from animals and/or the environment (ground water/ surface water/
soil) to humans.
It is pertinent to note that there is lack of quality database on use of antibiotics and the
problem of AMR has little recognition. The indiscriminate and inappropriate use of
antimicrobials has resulted in rapid increase of AMR. To add to this there is no regulation in
India to monitor use of antibiotics in food animals intended for human consumption. To
redress the situation the National policy for containment of AMR in India has suggested for
the institution of an ‘Inter-Sectoral Co-ordination Committee’ to give specific
recommendations which is in progress. The consultations made by the committee are in line
with the strategy of WHO to ensure prudent use of antimicrobials to combat development of
AMR. They include:
1. Develop and promote guidelines to minimize and contain AMR arising from use of
antimicrobials in food producing animals
2. Develop a list of critically important antimicrobials (CIA) for human health as well as
for treatment of food producing animals in order to guide risk management
strategies.
3. Provide technical support and capacity building in monitoring AMR through research
projects, training activities and reference services of the WHO Global Food borne
Infections Network (GFN).
4. Establish and perform pilot studies to address lack of data for risk assessment.
5. Measures for improving animal health to reduce/restrict antibiotic use and to create
awareness through IEC campaigns.
6. Develop regulations and advisories considering the Indian scenario on the use of
antimicrobials with continuous supervision, audit and feedback.
7. Ban in a phased manner the non-therapeutic / growth promoter use of antimicrobials
to prevent the development of AMR.
5