Joint FAO/WHO Technical Workshop on Residues of Veterinary Drugs without ADI/MRL Working papers

Indonesian Regulatory Framework For The Control Of

Residues Of Veterinary Drugs
Fadjar Sumping Tjatur Rasa, Indonesia

Introduction
Indonesia is one of the countries where the agriculture sector can be considered to be a main
national income resource. The agriculture development has been a main focus of the national
development programs. To support agriculture development the government has established some
policies and recently some programs have been set up to accelerate growth of agriculture production
and the transformation of the agriculture system from traditional small holder farming to modern
business agriculture industries.
As a result of the growing public knowledge on the quality of food products particularly on food
safety and as part of the requirement in international trade, the residue of veterinary drugs have
become an important issue both in the country and at international level. The residue problems
should be controlled systematically to prevent from potential risk on human health and to eliminate
distortion of trade.
The Ministry of Agriculture (MOA) through the Directorate General of Livestock Services (DGLS)
is responsible for controlling livestock production including animal health and quality of livestock
products. The regulations based on Law no.6, 1967 which stipulated the authority to control animal
health and livestock production, including veterinary public health.
In connection with the use of veterinary drugs in aquaculture the law is effective and being referred,
however the authority is under the Ministry of fisheries.
Regulatory Framework
On controlling of the residue of veterinary drugs in livestock products the initiatives were focused
on 2 main aspects: Strengthening of veterinary drugs control and Improving the quality of livestock
products.
A. The control of veterinary drugs
Legal Aspects
• The veterinary drugs control have been regulated in Indonesia since 1912 under The
Ordinance no.432 and 435, and its were reviewed in 1937 under the Ordinance no. 541. In
1949, under the ordinance no. 419 the veterinary drugs control has been specifically pointed
out and the drugs were classified to strong drugs and free drugs.
• Article no.23 paragraph 1. of Law no. 6, 1962 defined that the control of manufacturing,
storage, distribution and used of veterinary drugs are under the government authority.
• The Government Regulation no. 15, 1977 chapter IV article 7 defined the competency of the
Ministry of Agriculture to control the veterinary drugs.
• The Government Regulation no. 78, 1992 defined the control of veterinary drugs such as
biologics, pharmaceuticals and premixes products including raw materials for veterinary
drugs preparation.
• The Veterinary Drugs Inspector and the operation procedure for controlling of veterinary
drugs were established with the decree of Minister of Agriculture no. 15, 1994.
• The veterinary drugs classifications, list of drugs and the prohibition to use
Chloramphenicol and Hormone Growth Promoters in food producing animals were
stipulated in the decree of Minister of Agriculture no. 806, 1994.

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• The regulations on the veterinary drugs used in aquaculture were cited in the decree of the
Minister of Oceanic and Fisheries no. 26, 2002 and no. 4158, 2003.
The Institutions

• The control and administration of veterinary drugs are conducted by the Sub directorate of
Veterinary Drugs Control which belong to Directorate of Animal Health of the Directorate
General of Livestock Services.
• The Veterinary Drugs Commission was established to give advice on the policy related to
veterinary drugs, and the Veterinary Drugs Assessment Committee to conduct technical
assessment on administration of veterinary drugs.
• The quality control and assay of veterinary drugs are carried out at the Veterinary Drugs
Assay Laboratory. The laboratory is designed to conduct the test and to issue the quality
certificate for the products to prove that they meet the requirements.
• The Veterinary Drugs Inspectors are placed at district and province livestock service office
to carry out the control and inspections related to veterinary drugs in their work area.
The control systems
The control of veterinary drugs covers the administration and registration system, assay system,
Good Manufacturing Practice, monitoring and surveillance system, monitoring of drug side
effect and the prudent use of veterinary drugs.
• The registration of veterinary drugs requires an approval based on a document explaining
the nature and characteristics of a drug. The safety, efficacy and quality of the drug being
proposed should be assessed clearly by the Veterinary Drugs Assessment Committee and/or
Veterinary Drugs Commission.
• The veterinary drugs assay system has been established since the veterinary drug assay
laboratory began to operate in 1985 (decree of MOA no.328, 1985) under a cooperation with
the government of Japan. The assays are conducted for the drugs being registered and for
monitoring of distributed drugs.
• Good Manufacturing Practice (GMP) was introduced in 1999 by establishing the guideline
for implementation of GMP (decree of MOA no. 466, 1999) and the guideline of operational
procedures for GMP (decree of DGLS no. 247, 1999). The rules of GMP will come into
effect in the year 2005, and all manufacturers will be subject to audit and inspections. By
implementing GMP, the quality of veterinary drugs is controlled during the production
process involving raw materials, facilities, process, quality controls and other relevant
factors required by Good Manufacturing Practice (GMP).
• The monitoring and surveillance programs are conducted to confirm the quality of
veterinary drugs in distribution, in storages, in the markets, and at the farms. Samples are
collected and sent to assay laboratory by the veterinary drugs inspectors of the district or
province livestock offices, or are conducted directly by the assay laboratory.
• The potential side effects of veterinary drugs are monitored particularly for drugs which
have been used for long time or for drugs which are reported to induce abnormal symptoms
in animals including effects on micro organism, environment and human health.
• The prudent use of veterinary drugs was outlined in the code of practice for using veterinary
drugs. To promote the prudent use of veterinary drugs, code of practices were prepared to be
harmonised with the Codex Code of Practice for Control of the Use of Veterinary Drugs
(CAC/RCP 38-1993). The code of practices were also designed to cover regulations on the
use of veterinary drugs in feed, and the use of veterinary drugs by an authorised company,

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institution or personnel. The enforcement of compliance to withdrawal times were put as

priority.
• Veterinary drugs business and trade:
The regulations have been issued in order to control and promote business and trade of
veterinary drugs. Any company involved in business and trade of veterinary drugs should
be authorized, and a licence will be granted to the company which has to meet the
requirements according to the regulations.
The Contribution of the Veterinary Drugs Association on controlling and promoting
business and trade of veterinary drug in Indonesia are significantly.
• The veterinary drugs inspectors have an authority to conduct the inspection and all control
aspects related to veterinary drugs in their working area.

B. The Quality control of livestock products

Legal aspects
• Law no.6, 1967, Chapter III, article no. 21 paragraph 1c stated the control and testing for
meat, milk and eggs; and at the paragraph 1e the control and testing of processed food of
animal origin.
• Food Law no. 7, 1996, article no.20 and 21 stated the food quality assurance and laboratory
testing for food. According to the law, for all parties producing and distributing food for
sale and trading purpose, it is obligatory to manage a quality assurance system. Before its
distributed the food products are subject to laboratory examinations at the designed
laboratory.
• Consumer Protection Law no. 8, 1999. article no.19 lined out the responsibilities of the
producers to protect consumers from deviations of their products.
• Government regulation no.22, 1983 covers the Veterinary Public Health aspects
• The establishment and operations of the Quality Control Laboratory for Livestock Products
were stated in decree of MOA no. 426, 1994.
The Institutions
• The quality control of food products is managed under the authority of the Ministry of
Agriculture for livestock products, the Ministry of Oceanic and Fisheries for marine and
fish products and the Food and Drugs Control Agency for most processed foods. Some other
institutions such as Ministry of Health and Ministry of Trade are also involved.
• Under the Ministry of Agriculture, there is Sub-Directorate of Residues which belongs to
the Directorate of Veterinary Public Health of the Directorate-General of Livestock Services.
The Sub-Directorate of Residues conducts the control of residue of veterinary drugs in
livestock products.
• The Quality Control Laboratory for Livestock Products was established in 1994 and is
designed to analyse and confirm residues and microbial contaminants in livestock products.
This laboratory was than established as National Reference Laboratory for quality control of
livestock products.
• There are 7 Laboratories of Animal Diseases Investigation Center covering 7 regions of the
national area; they have been promoted as Veterinary Assay Laboratories with additional
competency on analysis of residues and microbial contaminants.
• The Veterinary Public Health Laboratory located in districts and provincial areas are
operated to carry out simple tests of livestock product.
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• The Veterinary Public Health Inspectors are placed at district and provincial livestock
service offices to carry out the control and inspection related to the quality of livestock
products.
• The Livestock Products Sampling Officers are trained and appointed to carry out the
sampling operations of livestock products for laboratory examinations.
• The National Veterinary Research Laboratory conducts research and development of
methods of analysis for residue of veterinary drugs.
Residue control system
• To improve the quality of livestock products the government launched the quality assurance
program called “ASUH” meaning Aman (safe), Sehat (healthy), Utuh (wholesomeness) and
Halal (edible under religious rules).
• The animals should be slaughtered at the slaughter houses or other places designed
specifically to meet the criteria for slaughter house under the inspection of the authorized
officers.
• The animals are subjected to examination of the drug administration and health conditions
under the control of veterinarians before their slaughtered.
• Veterinary Control Numbers are issued in order to improved the quality assurance of food
safety by implementing the minimum requirements for sanitation and hygiene. The
numbers are issued to the institutions such as slaughtered house, processing plant, and
private such as importer, cold storage and processing plant.
• HACCP principles were introduced and socialized since 1998, however the implementation
of the principles is still under preparation. Following demand for export purposes some
company have implemented the principles already.
• Monitoring and surveillance of residue and microbial contaminants, the programs called
“PMSR” have been established since 1998. The samples are collected and tested by the
institutions and laboratories involved in the control of livestock products. The results of
monitoring are evaluated at the annual meeting of PMSR, and the data are used for strategic
planning of the programs. The programs were prepared to improve the national monitoring
and surveillance system.
• Laboratory accreditation programs based on ISO-17025 was one of the efforts which has
been implemented to provide testing laboratories with a recognized Good Laboratory
Practice status and valid test results.
• SNI-BMR is a national standard for maximum residue limit (MRL) of veterinary drugs
which adopted from Codex MRL, so that the risk analysis procedure were provided and
approved at the international level.

Conclusions
The system for the control of residues of veterinary drugs in Indonesia has been designed and
established, however, the are still many problems to be faced which need to be phased out,
relating to facilities, human resources, and laws enforcement.
The development of technology involved is growing very fast such as ultra sensitive analytical
methods which require sophisticated instruments and high budget demand. These conditions
should be considered to assure the continuity of agriculture developments in country and to
prevent distortions on international trade.

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