Country Report: Sri Lanka

Transcription

1 Country Report: Sri Lanka W.K. de Silva Director-General Dpt. of Animal Production & Health Executive summary Traditionally, livestock is an integral part of the agriculture sector in Sri Lanka which plays a significant role in supplementing animal protein requirement of the human nutrition. Livestock are spread throughout all regions of Sri Lanka with concentrations of certain farming systems in particular areas due to cultural, market and agro climatic reasons. Poultry farming has been shown leading the animal production sector over dairy and pork. Under the present circumstances, livestock production sector almost totally depends on imported pharmaceuticals, vaccines and equipments except FMD, HS, NCD, Brucellosis and BQ vaccines produced at the Veterinary Research Institute of the Department. Key legal instrument which control manufacture, import, export and use of pharmaceuticals and biological products in the country is Animal Diseases Act No 59 of 1992 and its regulations. Antimicrobials have been categorised under the pharmaceuticals and hence, are covered by the provisions of the Act. Section 32 of the Act grants provisions to appoint a Veterinary Drug Control Authority (VDCA) to assist the Director General as a specialized body to regulate veterinary drugs and biologicals. VDCA composed of a Registrar and a group of experts who receive and evaluate application made for import, manufacture and sale of pharmaceutical and biological products of which DG/DAPH function as the Chairperson. Animal feeds are another possibility which certain antimicrobials may use as feed additives as growth promoters or as prophylactics. In order to regulate animal feeds in the country, a legal instrument is in operation named Animal Feed Act No 15 of 1986 and the purpose of the act is to regulate, supervise and control the manufacture, sale and distribution of animal feeds in the country. Accordingly the Department of Animal Production & Health has banned number of pharmaceutical products from using on food animals in the country and the banned products include, Nitrofurans, Dapsone, Ronidazole, Chloramphenicol, Carbadox, Olaquindox, injectable aminoglycosides, growth promoter anabolics, synthetic androgens, synthetic estrogens, synthetic steroids, therapeutic antibiotics indicated as growth promoters or prophylaxis and preparations having vitamin, mineral, amino acid mixed with therapeutic antibiotics as a measure of preventing public health hazard caused by potential residues of drugs in milk, meat and eggs. Government of Sri Lanka through its National Development Agenda has committed to achieve self reliance of food of animal origin as well as pledged to assure the food security and food safety. Under the Ministry of Livestock and Rural Community Development, the Department of Animal Production and Health has developed the plans for the coming years 1

2 to implement activities pertaining to monitoring of antimicrobial residues in food of animal origin, monitoring of antimicrobial resistance as well as to create an awareness among veterinarians and farmers on the importance of prudent use of antimicrobials. As a responsible State Organization, Department of Animal Production and Health is always receptive to the international community and hence are always agreeable with APHCA, FAO and OIE to implement appropriate proposals under the state development agenda as well. Country background Sri Lanka is a tropical agricultural island located in the Indian Ocean to the south-west of Bay of Bengal. Geographically the country is located between latitude 5 0 and 10 0 N and longitude 79 0 and 82 0 E. The country lies in close proximity to the south-eastern coast of India with which it shares a continental shelf and a narrow strip of water (Palk Strait) has, however, separated two countries. Traditionally, livestock is an integral part of the agriculture sector in Sri Lanka which plays a significant role in supplementing animal protein requirement of the human nutrition. Presently, the agricultural sector contributes around 10.4 percent of National Gross Domestic Production (GDP) in 2011 while livestock sub sector contributes around 1% of national GDP. The livestock sector contribution to the agriculture GDP was 8.65%. As far as livestock statistics are concerned, there are about 1.4 million cattle, 0.5 million buffalos, 0.4 million Goats, 15.4 million poultry and 0.08 million pigs in the country with negligible number of sheep, ducks and other species. Livestock are spread throughout all regions of Sri Lanka with concentrations of certain farming systems in particular areas due to cultural, market and agro climatic reasons. As far as the production is concerned, the country produced million liters of milk in 2011 which was in 2010 and is a 33% increase of production over the previous year. Eggs produced in the country in 2011 were Million. In 2011, country produced metric tons of chicken meat and the chicken meat availability was 5.57 kg/person/year while eggs availability was 81.78/person/year at the end of Cattle and buffalo farming are distributed throughout all regions of the country and in the up and mid-country, cattle keeps primarily for milk. In the low country wet zone and in the coconut growing area buffalo farming is an integral part of agriculture providing draft power, weed control and manure as well as being used for milk production. In the dry zone these species are regarded as a source of insurance by the small-holders as they provide a store of wealth and access to cash by means of animal sales, and milk. Ruminant production systems in the country are mostly related to the environment based on their dependency on pasture and fodder. In the hill and mid country mainly intensive management systems could be observed while intermediate zones showing semi extensive systems of management while the dry zone areas keeping cattle mostly under extensive systems. Two categories of poultry farming could be observed as commercial farming as well as backyard farming and commercial ventures are small, medium and large scale operations. The intensive poultry production systems are concentrated mainly in Western and North 2

3 Western part of the country as a commercial venture due to their easy access to market facilities and input availability with improved infrastructure facilities. The extensive production systems are scattered throughout the island as a backyard system. Pig farming is concentrated in the Western coastal pig belt as intensive systems with fatteners and as extensive systems. Under the extensive pig farming, small farmers keep 1to 2 pigs as a scavenging system. Under the present circumstances, livestock production sector almost totally depends on imported pharmaceuticals, vaccines and equipments except FMD, HS, NCD, Brucellosis and BQ vaccines produced at the Veterinary Research Institute of the Department. The pharmaceutical and equipment supply industry is totally run by the private sector and as there is no price control system for animal drugs in the country, the prices are fluctuated with world market prices and the foreign exchange rates. Feed production is also in the hands of the private sector and depends mainly on imported raw materials. Legal framework Key legal instrument which control manufacture, import, export and use of pharmaceuticals and biological products in the country is Animal Diseases Act No 59 of 1992 and its regulations. Antimicrobials have been categorised under the pharmaceuticals and hence, are covered under the provisions of the Act. Director General of the Department of Animal Production and Health is the legally empowered officer for the general administration of this Act and should be essentially a registered veterinarian of the country. According to the section 17 of the Act, no person shall manufacture any veterinary drug veterinary biological product in Sri Lanka except under of veterinary authority or a license issued in that behalf. The license issued so is valid only for a period of one year unless it is cancelled or suspended prior to completion of the period. This will maintain the authority of the Department to oversee manufacturing of drugs and is therefore able to prevent the possibility of releasing undesirable products to the market to be used on livestock. The section 21 of the Act prohibits import of any veterinary drug without a proper approval of the Director General. Further strengthening the provisions of the Section 21, Section 31 has further provide the implementing authority to not to recommend the issue of a permit to any person for the import of any veterinary drug or veterinary biological product unless such person produces a certificate from the Chief Veterinary Surgeon or a veterinary surgeon authorized by him in the country of origin of the product, certifying the safety of such drug or veterinary biological product. This section prevents unauthorized or discontinued products for sales in the country of origin to dump in Sri Lanka in the form of imported veterinary products. Therefore this section provides the opportunity to prevent entry of recently banned antimicrobials for the purpose of prevention and using as growth promoters. Section 32 of the Act has granted opportunity to appoint a Veterinary Drug Control Authority to assist the Director General as a specialized body in reviewing the requests make for manufacture or import of pharmaceutical products. Accordingly Director General 3

4 function as the Chairman of the Committee and a Veterinary Surgeon employed under the Department of Animal Production and Health appointed by the Minister concern of the discipline function as the Registrar as well as the Secretary of the Committee. In addition six specialized personnel in the disciplines of clinical practice in State and Private sectors, microbiology and immunology, parasitology, pharmacology, nutrition, reproductive physiology and endocrinology also would be appointed by the Minister concern to function in the Committee. Additionally there is an opportunity to appoint another veterinarian to represent the local pharmaceutical industry as well. According to the Act the period valid for such an appointed member except Director General is limited to three years unless leave or removed prior to completion of the period. The same section of the Act very clearly indicates the powers of the Veterinary Drug Control Authority and they are as follows. a. Exercise control over the manufacture, import, export, sale and use of veterinary drugs and veterinary biological products; b. Ensure the efficient and safe use of veterinary drugs and veterinary biological products on animals c. Determine whether licenses shall be granted for the manufacture or importation of veterinary drugs and veterinary biological products; d. Advise the Minister on any matter he may refer to the Authority for advice or any other matter which it considers necessary to bring to the notice of the Minister; e. Promote research which the Authority considers necessary to test or improve veterinary drugs and veterinary biological products; f. Disseminate information relating to the safe and efficient use of veterinary drugs and veterinary biological products ; and g. Carry out or cause to be carried out, tests on veterinary drugs and veterinary biological products already licensed or pending issue of a license whenever necessary in the opinion of the Authority. Export of veterinary pharmaceuticals and biological are governed by the provisions of the section and accordingly no person shall export any animal, animal product, veterinary drug, veterinary biological product, semen or embryo except under the authority of a permit issued by the Controller of Imports and Exports on the recommendation of the Director General of Animal Production and Health. For the purpose of implementing the Act effectively the Minster concern make regulations in respect of all matters which are required by this Act to be prescribed or in respect of which regulations are authorized to be made and in particular in respect of all or any of the maters namely the mode and manner in which an application for a license may be made and to decide the fees payable for the issue and renewal of a license. Animal feeds are another possibility which certain antimicrobials may use as feed additives as growth promoters or as prophylaxis. In order to regulate animal feeds in the country a legal instrument is in operation named Animal Feed Act No 15 of 1986 and the purpose of the act is to regulate, supervise and control the manufacture, sale and distribution of animal feeds in the country. In order to implement the functions of the Act, an Animal Feed 4

5 Advisory Committee has been established under the Department of which a Veterinary Officer attached to the Department function as the Registrar while Director General functions as the Chairman. Licensing of raw materials intended to be imported, registration of feeds, registration of feed mills, monitoring the industry and identification of issues pertaining to the industry are the main functions of the committee. Institutional arrangements Department of Animal Production and Health is the primary organization which is responsible for regulating matters pertaining to antimicrobial manufacture, import sale and use in the country. Under the Department, a technical division entitled Division of Veterinary Regulatory Affairs has been established and presently Veterinary Drug Control Authority functions under this division. Main functions implement by the Veterinary Drug Control Authority at present are limited to evaluation of applications receive for manufacture and import, registration of products, notification of registered products and clearing of invoices for routine imports. On receiving applications, they are submitted by the Registrar to the Veterinary Drug Control Committee and evaluated at the committee meetings held at least six times a year. Approved products are informed to the Controller of Imports and Exports as well as to the applicant for consequent action. Import applications are mainly for two purposes namely for purpose of sales that is called free sales license and for using on the animals exclusively owned by the importer called user permits. Free sales license are valid for a period of three years from the date of issue and user permits are valid for the particular consignment only. All the licensing process are fee involved and free sales permit will be issued on payment of approximately US$50 while user permits are issued on payment of approximately US$ 10 provided that the applications meet the country requirement. Based on global and local requirements, Veterinary Drug Control Authority time to time considers elimination of products especially antimicrobial products for the best interest of public health. Accordingly the Department of Animal Production & Health of Sri Lanka has banned a number of pharmaceutical products from using on food animals in the country and the banned products include, Nitrofurans, Dapsone, Ronidazole, Chloramphenicol, Carbadox, Olaquindox, injectable aminoglycosides, growth promoter anabolics, synthetic androgens, synthetic estrogens, synthetic steroids, therapeutic antibiotics indicated for growth promotion or prevention of infections and preparations having vitamin, mineral, amino acid mixed with therapeutic antibiotics as a measure of preventing public health hazard caused by potential residues of drugs in milk, meat and eggs. However, it has to mention here that there is no proper system for market vigilance, adverse reaction reporting and residue monitoring so far but the Department is in the process of developing systems through bringing in modifications to the regulations of the Animal Diseases Act. Therefore, in order to bridging the gap, Department conducts educational programs targeting farmers, potential users and pharmaceutical industry regularly on 5

6 responsible use and sales of antimicrobial products in view of minimizing residues in food commodities and preventing it from developing resistant strains. Extent of antimicrobial use in livestock production Poultry subsector in Sri Lanka approximately up to 80% operates under intensive management system and use variety of antimicrobials, anthelmintics and anti-coccidial drugs depending on the requirement. Drugs in the poultry sector are administered through oral route and products are available either in liquid form or powder form. Along the western coast of the island pig farming is considered as a popular livestock species depending on socio-cultural and religious status and can be seen reared in intensive and extensive systems. Next to the poultry subsector, pig farming also utilizes a considerable amount of antimicrobials and anthelmintics. The main route of administering antimicrobials in pig sector is parenteral. Comparatively dairy industry uses less amounts of antimicrobials except in cases of difficult parturition process. Based on their physiological complexicity, antimicrobials are used through parenteral route but to a limited extent. The main way of using antimicrobials are as treatment for clinical mastitis and the details of antibiotic sensitivity profile is given under Section 7 of the paper. Table 1 below shows the quantities of antimicrobials imported into the country in Table 1. Imports of antimicrobials into Sri Lanka in 2011 Nr. Active ingredient Quantity (kg) 1 Enrofloxacin 2,696 2 Amoxycillin 6,130 3 Tylosine 3,026 4 Sulphadiazine 5,264 5 Trimethoprim 1,300 6 Oxytetracycline 1,032 7 Chlortetracycline Neomycin Bactrim Doxycycline Flumequine Penicilin Ceftiofor 8 Total 23,168 Current and planned arrangements Department of Animal Production and Health as the implementing organization of the laws and regulations pertaining to veterinary pharmaceutical usage in the country has well recognized the importance of the issues of antimicrobial resistance and residues in food of 6

7 animal origin. Currently the Department is in the process of updating the regulations governing the subject. It has been planned to regularize the monitoring process related to pharmaceuticals (which include antimicrobials as well) from the point of registration to usage in the farm by adopting various measures. Registration of pharmaceutical importers, stockers, retail vendors has been included into the newly drafted regulations. In addition the registration process itself also has further strengthened by introducing a renewal process every three years after registration. Pharmaceutical manufacturing and re-packing also are under scrutiny so as to prevent adulteration and assure the quality of the product which reach the user. The department has enhanced the attention towards strengthening its programs in the field of food safety as well. In order to bring the program to the track, animal identification and farm registration activities are kept in place and fast track programs are underway with the assistance of Provincial Departments. The department has already launched the activities in the discipline of Veterinary Public Health and antimicrobial residue monitoring at the field level has been recognized as a program which would be implemented at the Veterinary Research Institute in the coming year. Patterns and extent of AMR animal pathogens At present, studies on antimicrobial resistance and sensitivity are largely limited to testing of milk samples obtained in the field prior to initiate treatment for mastitis through veterinary investigation centres. In addition veterinary investigation centres perform ABST for field samples receive from Divisional Veterinary Surgeons in the course of antimicrobial treatment for OPD as well as out bound cases. In 2012, veterinary investigation centres have performed 1,609 ABST, which 790 were milk samples and 819 other laboratory samples. The organisms commonly identified are mainly Staphylococus, E. coli and coliforms. Irrespective of the organism, ABST results of 576 milk samples tested for mastitis at ten veterinary investigation centres were evaluated to generate basic understanding of the antimicrobials resistance. The primary picture is as depicted in Table 2 and the further details are as Annex 1. 7

8 Table 2. Number of samples detected as resistant to antimicrobials in ABST, 2012 Antimicrobial Agent Total % Amoxycillin Enrofloxacin Gentamycin Oxytetracycline Cephalexin Cloxacillin Penicillin Sulpha+Trimethoprim Neomycin Doxycycline Ampicillin Streptomycin Sulphamethoxazole Chloramphenicol Tetracycline Erythromycin Total 576 According to the results, it has been indicated that resistant has been developed against the antibiotics of penicillin group including Amoxycillin, Cephalexin, Cloxacillin, Penicillin and Ampicillin. In addition it indicates the resistance against Enrofloxacin as well. According to the present regulations, macrolide group of antimicrobials are not permitted to be used in food producing animals through parenteral route and in the results less resistance against macrolides could be observed as well. Considering the alarming situation in relation to resistance this could be recognized as an area which needs further research as well as intensive attention in view of averting the risk of developing generalized resistance of large number of disease causing bacteria which could be introduced to human through the food chain. At present Faculty of Veterinary Medicine and Animal Science is engaged in routinely performing studies in relation to antimicrobial resistance and residues while providing a service to the livestock production sector as well as to the aquaculture sector and those details have not been included in this paper. 8