Вы находитесь на странице: 1из 9

Country Report: Indonesia

Imron Suandy and X Suparno Quality Control for Livestock Services, Directorate of Veterinary Public Health and Post-Harvest Ministry of Agriculture, Republic of 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. In 2009, agricultural sector contributed as much as 15.3% to the National GDP and it is considered as the big two after the sectors manufacturing industry. 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 intensification and commercialization of animal food production, however it has been created several consequences for public health concern. Antimicrobial residue in food of animal origin and development of antimicrobial resistance via food of animal origin has become a big challenge to public health. Thus, the residue problems should be controlled systematically to prevent from potential risk on human health and to eliminate distortion of trade. Moreover, the growing problem of antimicrobial resistance has become a significant public health concern worldwide. The World Health Organization (WHO) has concluded that antimicrobial resistance is a serious and complex worldwide problem. To address this problem, the WHO recommended a global surveillance system in veterinary and human.

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 Animal Health and Animal Husbandry Law no.18, 2009 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 to control antimicrobial resistance and residue of veterinary drugs in livestock products

In order to control the antimicrobial resistance and 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.

1

A. Control of veterinary drugs Legal aspects

The veterinary drugs controls have been regulated in Indonesia since 1912 under The Ordinance no.432 and 435, and it 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.

The Animal Health and Animal Husbandry Law No. 18, 2009, article 22 mentioned about the restriction use of veterinary drugs (such hormones and antimicrobials intended for human medicine).

Article no.49 - 54 chapters 2 nd of Law no. 18, 2009 defined about veterinary drugs, it is described 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 can be used as feed additives 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.

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.

Institutions

The control and administration of veterinary drugs are conducted by the Sub directorate of Veterinary Drugs Control which belongs 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 province and district livestock service office to carry out the control and inspections related to veterinary drugs in their work area.

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.

2

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 microorganism, 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 harmonized with the Codex Code of Practice for Control of the Use of Veterinary Drugs (CAC/RCP 38-1993). The code of practices was also designed to cover regulations on the use of veterinary drugs in feed, and the use of veterinary drugs by an authorized company, 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 license 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 significant.

The veterinary drugs inspectors have the authority to conduct the inspection and all control aspects related to veterinary drugs in their working area.

B. Quality control of livestock products Legal aspects

Law no.18, 2009, Chapter IV, article no. 56 stated about veterinary public health authority; and article no. 58 mentioned with regard the obligation of control, monitoring, testing, standardization and registration of food of animal origin.

3

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 it’s 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.

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 (QCLLP) was established in 1994 and is designed to laboratory analysis and confirmation of residues and microbial contaminants in livestock products. This laboratory was than established as National Reference Laboratory for quality control of livestock products.

There are 8 Laboratories of Animal Diseases Investigation Center covering 8 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.

The Veterinary Public Health Inspectors are placed at provincial and district 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.

4

Veterinary Control Numbers are issued in order to improve 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.

Initiative control program for antimicrobial resistance

Although only limited research on resistant bacteria to antimicrobial has been conducted in Indonesia, unfortunately, the DGLS have not yet had a regular program for monitoring and surveillance of antimicrobial resistance. The initiative activity concerning the issue has been started by QCLLP since 2011.

In 2011, the QCLLP conducted a study to monitor the antimicrobial resistance in sentinel bacterial isolated from poultry meat from one of poultry pocket area in West Java.

In 2012, the program was continued to all Java Island (still in progress). Hopefully, based on the available data it will be proposed as a regular program in next year following the OIE guidelines on Harmonization of National Antimicrobial Resistance Surveillance and Monitoring Program.

Extent of antimicrobial use in livestock production

The key priority of the Indonesian government for the livestock sector is the expansion of the poultry industry, in particular the broiler industry. It’s revealed that the share of antimicrobials used in livestock production was dominantly in poultry farms rather than others (as shown in figure 1 below).

5

Figure 1. Distribution of antimicrobial use by animal species Source: ASOHI 2011 Remarkably, the veterinary

Figure 1. Distribution of antimicrobial use by animal species

Source: ASOHI 2011

Remarkably, the veterinary drugs were used as feed additive have a highest market share in Indonesia, although the trend was a bit decreasing in 2011 (see table 1).

Table 1. Market share of veterinary drugs in year 2010 2011

 

2010

2011

Value

%

Value

%

(billion Rp.)

(billion Rp.)

Biological agents

617.6

30.8

693.8

32.1

Pharmaceuticals

461.5

23.1

489.7

22.6

Feed additives

921.2

46.1

980.0

45.3

Total

2,000.3

2,163.5

Source: ASOHI, 2011

Based on the data from the DGLS, number of exported of veterinary drugs tent to be increasing in each years. The same trend was also shown for number of export. Although the data up to August 2011 was shown decreasing, but the ASOHI have been predicted it will rise.

Table 2. Balance of export and import of veterinary drugs year 2009 -2010 (US$)

 

2009

2010

2011*

Export

4,704,648

5,346,775

12,025,932

Import

41,731,023

46,465,313

30,611,856

* Data were updated up to August 2011; Source: Directorate General of Livestock Services

Findings

of

monitoring

program

for

antimicrobial

residues

and

resistance

Monitoring of antimicrobial residues in food of animal origin The National monitoring program was conducted and prioritized in livestock pocket production area in country. Further action must be taken will be recommended to local authority as responded of result finding. The data below were resulted from QCLLP monitoring program, as national laboratory reference on veterinary public health services.

6

Figure 2. Number and type of samples taken for antimicrobial residue testing 2010 and 2011

Figure 2. Number and type of samples taken for antimicrobial residue testing 2010 and 2011

The data of monitoring program resulted from QCLLP mentioned that the antibiotic residue was prevalent in each year. The results were showed a varieties trend of residue on group of antimicrobials in each year. In year 2012, the residues of macrolides and aminoglycoside group tend to be increasing (as shown in figure below).

group tend to be increasing (as shown in figure below). Figure 3. Proportion of samples positive

Figure 3. Proportion of samples positive for antimicrobial residues 2010-2012

Monitoring of antimicrobial resistance A study was conducted to monitor the antimicrobial resistance of sentinel bacteria (E. coli) isolated from broiler meat in one area of main poultry pocket production in West Java by QCLLP in 2011. In general, resistance patterns reflected the commonness of use of antimicrobials in the farms. Although chloramphenicol is a prohibited antimicrobial for use in food animals resistance could be detected (see figure below).

7

Figure 4. Results of antimicrobial resistance testing The study also showed that the prevalence of

Figure 4. Results of antimicrobial resistance testing

The study also showed that the prevalence of multidrug resistance was highest in four drugs combination of antimicrobial. The combination of tetracycline, erythromycin, and ampicillin was the pattern most frequently observed.

and ampicillin was the pattern most frequently observed. Figure 5. Prevalence of multidrug resistance Fund to

Figure 5. Prevalence of multidrug resistance

Fund to support AMR control program Main source of fund is supplied by central government budget via APBN (Anggaran Pendapatan dan Belanja Negara) or National Budget that can be divided into two kinds. First, budget from APBN straight come to DGLS, and the budget from APBN via other government institutions. Sometimes there is an external budget from international organization, but not significant in terms of amount and frequency. Unfortunately, there are a limited budget have been prioritized to support AMR control program in particular.

8

Conclusions

The system for the control of residues of veterinary drugs in Indonesia has been designed and established, however, there are still many problems to be faced which need to be phased out, relating to facilities, human resources, and laws enforcement. The intervention strategies for controlling antimicrobials used on farms should be reconsidered. It is required to set up a routine monitoring and surveillance program, and improve farming practices in order to reduce the development of antimicrobial resistance and minimize the likelihood of transfers of antimicrobial resistance genes to other microbes in the food chain.

These conditions should be considered to assure the continuity of agriculture developments in country, to prevent distortions on international trade and ultimately to secure the safety of consumers.

9