Aquaculture drugs and chemicals plays a pivotal role not only in fish health management but also pond construction, soil and water management, enhancement of natural aquatic productivity, feed formulation, manipulation of reproduction, growth promotion and processing. Government of Bangladesh organized an awareness program on control of AMP to create awareness among different stakeholders. Functioning of a control system for AMP is a prerequisite for quality assurance safe fishery products

1. Guidelines for the control of
Aquaculture medicinal
products(AMPs)
Presented by
Degonto Islam
Department of fisheries and marine science
Noakhali science and Technology University
Degonto Fish World

2. Content
 Introduction
 What is Aquaculture medicinal products (AMPs)?
 Objectives of AMPs
 Aqua-medicine and market share of companies
 Legal background of AMPs
 Task of DGDA & DoF
 Guidelines for the Control of Aquamedicines
 Problems in use of Aquaculture Medicinal Products
 Conclusion
 Reference

3. Introduction
Aquaculture drugs and chemicals plays a pivotal role not only
in fish health management but also pond construction, soil and
water management, enhancement of natural aquatic
productivity, feed formulation, manipulation of reproduction,
growth promotion and processing. Government of Bangladesh
organized an awareness program on control of AMP to create
awareness among different stakeholders. Functioning of a control
system for AMP is a prerequisite for quality assurance safe fishery
products

4. What is Aquaculture medicinal products
(AMPs)?
AMPs means Medicinal Products used in aquaculture or any
substance or combination of substances presented as having
properties for treating or preventing disease in aquatic animals or
combination of substances which administered to aquatic animals
with a view either to restoring, correcting or modifying
physiological functions by exerting a pharmacological,
immunological or metabolic action, or to making a medical
diagnosis.

5. Aquaculture medicinal products (AMPs)

6. Objectives of AMPs
 To control the use of aquamedicines across the production chain
of aquaculture operations.
 To ensure that the exposure of aquatic animals to aquamedicines
does not pose a risk to human health.
 To ensure maximum residue limits (MRLS) for permitted
substances.
 To prevent illegal or unauthorized use of aquamedicines
 To monitor and verify appropriate practices and effective
measures are applied at the place of manufacture, import,
distribution, retailing, and use.

7. Aqua-medicine and market share of companies
Company Name Medicine name Functioning
ACI Mega Zeo Plus Zeolite
Square Zeo-fresh
Fish tech Zeo-light gold
ACI Virex Disinfectant
Square Aquakleen
Square Gas trap
Toxic gas reducer
Novarties Ammonil
Fish tech Pond Dtox

8. Aqua-medicine and market share of companies (cont,)
Company Name Medicine name Functioning
ACI Bio-care, Bio-ox Improve Oxygen
level
Square Oxy-life
Novartis Oxyflow
Reneta Rena-C Growth promote
Square Cevit- Aqua
Fish tech Bio-premix

9. Legal background of AMPs
 This Guideline is based on the legislative framework of Bangladesh
related to drugs as well as those of international guidelines pertaining to
Aquaculture Medicinal Products and more specific regulations for
aquaculture.
 Fish and Fishery related Rules of Bangladesh
1. Fish and Fish Products (Inspection and Quality Control) Ordinance,
1983
2. Fish and Fish Products (Inspection and Quality Control) Rule 1997
(amendment 2008)

10. Legal background of AMPs (cont,)
3. Fish Hatchery Act 2010 Guidelines
4. Fish Hatchery Rules 2011
5. Fish Feed and Animal Feed Act 2010
6. Fish Feed Rules 2011

11. Task of DGDA
1. Granting Registration of AMPS
2. Controlling Pharmaceutical Manufacturers
3. Licensing and controlling of warehouses and wholesalers
4. Licensing of retailers
5. Controlling of retailers
6. Keeping a register of the licensed wholesalers and retailers
7. Implementation of the Guidelines (information and training)

12. Task of DoF
1. Controlling of retailers
2. Issue of Health Management Advisory Note for AMPS
3. Monitoring users of AMPs based on the principles of Good
Aquacultural Practices
4. Field Monitoring of AMPs
5. Implementation of the Guidelines (information and training)

13. Guideline for Obtaining Aquamedicine Registration
NO

14. Guideline for Obtaining Aquamedicine Registration (cont,)
No

15. Product labeling or leafleting
1) Name of the aquamedicine, its strength and active ingredients
2) Target species
3) Special precautions for use, including such precautions to be taken
by the person administering the medicinal product
4) Dosage and administration route
5) Withdrawal periods for the different target species
6) Date of manufacture and expiry
7) Batch number
8) Storage conditions to be followed
9) for multi-dosage containers: shelf life after first opening of the
container
10) It shall be obligatory to include a leaflet with all the required
information in the packaging of aquamedicine.

16. Guidelines for Manufacture of Aquamedicine
 Pharmaceutical Manufacturers producing aquamedicine shall
follow the principles of GMP as outlined in "The Drugs
(Control) Ordinance, 1982.
 The Directorate General of Drug Administration (DGDA) is
responsible for control of the manufacturers to comply with
these regulations.

17. Guidelines for Distribution, Warehousing,
Wholesaling and Retailing of Aquamedicine
 Distribution: The initiator shall ensure that the standards of
Good Distribution Practice are followed. Among these are:
 Record keeping about product identity
 product name
 batch number
 Distribution information
 quantity - receiver
 date of delivery
 Temperature or other physical requirements

18. Guidelines for Distribution, Warehousing, Wholesaling
and Retailing of Aquamedicine (cont,)
 Warehousing, Wholesaling, Retailing: Licenses are required
for stock keeping (warehousing), wholesaling and retailing,
including the exhibit for sale of aquamedicine. Such license
shall be granted by DGDA. Aquamedicine shall be stored at
wholesalers and retailers in areas exclusively used for these
products. DGDA shall include wholesalers and retailers in the
inspection program and keep a register of the licensed
wholesalers and retailers.

19. Guidelines for Import and Possession of
Aquamedicine
 No product must be imported into Bangladesh if its label or
anything accompanying the drug bears any statement, or device
which makes any false claim for the drug (as per The Drug Act
1940 Chapter III 9 (f)).
 All the imported products shall comply with the registration
granted by DGDA before releasing to market.
 ion.

20. Guidelines for Import and Possession of
Aquamedicine (cont,)
 Market release shall be done by Pharmaceutical manufacturers
or importing Companies.
 If non-registered products are found during routine inspection
by the DoF, this shall be reported to DGDA for appropriate
actions including seizure and destruct

21. Guidelines for Issue of Advisory
Note/Prescription of Aquamedicines
• Aquamedicines shall only be advised by Fisheries
Professionals or by Qualified Personnel, who have education
and knowledge in health and disease management of aquatic
animals (fishes, molluscs and crustaceans).
• 1. Immediate solution
Fisheries
professionals
issue the health
management
advisory note
Users receive
advisory note and
buy AMPs
Retailers sell
AMPs to users as
per the advisory
note

22. Guidelines for Issue of Advisory Note/Prescription
of Aquamedicines (cont,)
2. Medium-term solution - Condensed diploma course offered for
fisheries professionals on pharmacology Condensed course offered
through pharmacology experts. Command area officers will
complete the above course first and get qualified; rest of the
interested/existing fisheries professionals take the course and get
qualified.
3. Long-term solution - Integration of "Pharmacology" and related
subjects in the curriculum of scientific education of fishery science
and formation of Fisheries Council.

23. Problems in use of Aquaculture Medicinal
Products
The present study identified some problems associated with the
use of Aquaculture Medicinal Products which included:
I. Lack of knowledge about use of chemicals
II. Lack of knowledge of application of drugs and chemicals
III. Indiscriminate use of chemicals
IV. Pressure on farmers from pharmaceutical companies and
pesticide sellers

24. Problems in use of Aquaculture Medicinal
Products (cont,)
V. Lack of awareness about the safety issues in using
hazardous chemicals
VI. Lack of information on the label of chemical about possible
hazard
VII. Lack of knowledge about residual effect and expiry date.

25. Conclusion
Aquaculture has rapidly growing to a major industry, providing not only
economic income and high-quality food products but also provides
employment to hundreds of thousands of skilled and unskilled workers.
Moreover, considering the rapid growth and importance of the
aquaculture industry in many regions of the world, the widespread use of
antibacterial agents is getting increased and intensified, and often
unregulated (without professional consultation or supervision) for aquatic
animal production, which has created many health issue problems, not
only for fish but also for humans. Therefore, both the government and
nongovernment organizations should take initiative for better
understanding of chemical uses in aquaculture management .

26. Reference
1. BFRI(1999) ,“Fish diseases: prevention and
control”, Bangladesh Fisheries Research institute,
Circular leaflet no 6. 2nd edition. P.7.3. Brown D
and Brooks A (2002), “A survey of dise
2. Faruk MAR, SultanaN and Kabir M B(2005),“Use of
chemicals in aquaculture activities in Mymensingh
area, Bangladesh”, Bangladesh J. Fish., Vol. 29,
No. 1-2, pp. 1-10.
3. Subasinghe RP, Barg U and Tacon A(1996),
“Chemicals in Asian aquaculture: need , usage,
issues and challenges.” Southeast Asian Fisheries
Development Center, Aquaculture Department
Tigbauan, Iloilo, Philippines, pp. 1-6.Plumb J A
(1992), “Disease control in aquaculture.”