DGDA
Background
The Directorate General of Drug Administration under the Ministry of
Health & Family Welfare, Government of the People's Republic of
Bangladesh is the Drug Regulatory Authority of the country. This
Directorate supervises and implements all prevailing Drug Regulations
in the country and regulates all activities related to import,
procurement of raw and packing materials, production and import of
finished drugs, export, sale, pricing, etc. of all kinds of medicine
including those of Ayurvedic, Unani, Herbal and Homoeopathic
systems. At present, there are 271 Allopathic, 205 Ayurvedic, 271 Unani,
32 Herbal and 79 Homeopathic drug manufacturing companies in the
country. The Directorate General of Drug Administration monitors and
regulates all the activities of these 858 companies. The chief of the
Directorate, designated as the Director General, is also empowered by
the Govt. to act as the Licensing Authority (LA) of drugs for the
purpose of issuing licenses to manufacture, store, sell, import and
export drugs and medicines. At present, there are 55 district offices of
the Directorate in the country. All officers of the
Directorate
function as "Drug Inspector" pursuant to the Drug Laws and assist the
Licensing Authority for properly discharging his responsibilities.
Besides, a number of Committees, such as Drug Control Committee
(DCC), Standing Committee for procurement and import of raw
materials and finished drugs, Pricing Committee and a number of
other relevant Committees, which comprise of experts, are there to
advise the Licensing Authority and to recommend to him matters
related to drugs and medicines.
Director General
Major General Md Mahbubur Rahman
Director General
Directorate General of Drug Administration
Ministry of Health & Family Welfare
Government of the People's Republic of Bangladesh
DGDA
Vision:
To ensure quality and safe medicines for all.
Mission:
• To safeguard the health of humans and animals by ensuring the
medicines and medical devices meet applicable standards of
safety, quality and efficacy.
• To ensure the safety and security of supply chain for medicines
and medical devices.
• To ensure availability including accessibility and affordability
and rational use of essential medicines.
• To foster a regulatory environment that supports research and
innovation and thereby ensures moving towards global
standards for quality products.
Directorate Info
Historical background
Before 1971 -An organization under the Central Govt of Pakistan under
the Controller of drugs. After the war of liberation- An attached
department of the Ministry of Health and Population Control. Since
1976 -A separate Directorate directly under the Ministry of Health and
Family Welfare, 17 January 2010 upgraded as the Directorate General
of Drug Administration.
Introduction
Directorate General of Drug Administration (DGDA) is the organization
entrusted with the responsibility of ensuring the quality, efficacy and
safety of pharmaceutical products though the implementation of
relevant legislation. The organization is trying its best to fulfill the
requirements of the pharmaceutical sector of the country and thereby
meeting the needs of the people of the country by ensuring the safety,
efficacy and quality of the medicines.
DGDA
Organogram:
1
Director General
2
Director
Manufacturing
Registration
Import
Export
Director
Administration
Director
Veterinary
Director
Quality Control
Post-marketing
Surveillance
Central Drug Testing
Laboratory
Deputy Director
Deputy Director
3
Deputy Director
Deputy Director
Deputy Director
Deputy Director
Deputy Director
4
Assistant Director
(Six AD)
Assistant Director
(one AD for Head
office)
Assistant Director
(One AD)
Assistant Director
(Three AD))
Superintendent of
Drugs (6)
Superintendent of
Drugs (6)
Dhaka Div. (one AD)
Chittagong Div. (one
AD)
Sylhet Div. (one AD)
Rajshahi Div. (one AD)
Barisal Div. (one AD)
Khulna Div. (one AD)
5
Superintendent of
Drugs (12)
Superintendent of
Drugs
Dhaka Div. (15)
Chittagong Div. (9)
Sylhet Div. (3)
Rajsahi Div. (14)
Barisal Div. (4)
Khulna Div. (14)
6
Medical Officer
(required numbers)
Drug inspector
(required numbers)
Senior Scientific officer
Responsibility
The responsibilities of this organization are as follows:
a. To ensure the quality, safety, efficacy and usefulness of all kinds of
drugs and medicines including Homeopathic, Unani, Ayurvedic and
Herbal drugs which are produced, imported and marketed in the
country and also exported to overseas.
DGDA
b. To make essential drugs available and affordable to the common
people of the country.
Drug Testing Laboratory
Testing of drugs are required for evaluating pre-registration and
post-marketed drugs and medicines quality. At present, there are
two Govt. Drug Testing Laboratories in the country, one unit in
Chittagong and another in Dhaka.
Legislation
All the activities of DGDA are governed & guided by
* The Drug Act 1940
* The Drug Rules 1945 and their amendments
* The Drug Rules 1946 and their amendments
* The Drug (Control) Ordinance 1982 and its amendments
* The Drug (Control) Ordinance Amendment Act 2006
* National Drug Policy 2016
The Ordinance (* The Drug (Control) Ordinance 1982) provides for the
following legislative powers and responsibilities with respect to
drugs and medicines:
1. Formation of a Committee of experts, called the DCC or Drug
Control Committee, for consideration of registration of medicines
and/or their cancellation.
2. Prohibition of manufacture and sale of drugs without the
supervision of pharmacists.
3. Restriction on import of certain pharmaceuticals and finished
drugs.
4. Review of under-licensing agreements.
5. Fixation of prices of essential drugs.
6. Control of advertisements and claims in respect of drugs.
7. Implementation of GMP in the manufacturing units as
recommended by WHO.
8. Formation of Drug Courts for trying offenses related to drugs.
DGDA
9. Formation of a National Drug Advisory Council for advising the
Govt. on matters related to essential drugs.
10. Formation of an Appellate Authority.
11. Recognition of Traditional and Homeopathic medicines as
drugs.
12. Imposition of penalty for:
- manufacture and sale of adulterated, spurious and
restricted drugs.
- manufacture and sale of substandard drugs.
- unauthorized import of drugs and raw materials.
- sale of medicines at prices higher than the Maximum Retail
Price (MRP) by the Licensing Authority.
- theft of Drugs from Govt. hospitals and stores.
- illegal advertisement of drugs and claims about their
qualities and uses.
Major Function of DGDA
1. Evaluation of the proposals of new projects of all systems of
medicines.
2. Issue and renewal of drug manufacturing licenses.
3. Issue and renewal of retail and whole sale drug licenses.
4. Registration and renewal of drug products.
5. Fixation of price and certification of price for drug products.
6. Inspection of pharmaceutical establishments
7. Approval of block list for the import of raw- and packaging
materials.
8. Approval of indent for import of finished drugs.
9. Surveillance and pharmacovigilance activity
10. Prosecution of cases in the drug courts and other courts
11. Issue of export licenses, FSC (Free Sales Certificate), GMP (Good
Manufacturing Practices) Certificate & CPP (Certificate for
Pharmaceutical Products.)
DGDA
Committees
• Standing Committee for Import of Pharmaceuticals
• Adverse Drug Reaction Advisory Committee (ADRAC)
• Drug Control Committee (DCC)
• Technical Sub-Committee (of Human Medicine) for DCC
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Medical Device Technical Sub-Committee for DCC
Herbal Medicine Advisor Committee (TSC) For DCC
Price Fixation Committee
Price Fixation Technical Sub-committee
National Unani and Ayurvedic Formulary Committee
DGDA offers two types of Manufacturing Licenses
1. Biological
2. Non-Biological
What is a biologic drug (biologics)?
• A biologic drug (biologics) is a product that is produced from
living organisms or contain components of living organisms.
• Biologic drugs include a wide variety of products derived from
human, animal, or microorganisms by using biotechnology.
Types of biologic drugs include•
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vaccines,
blood components,
cells (cells that produce substances that suppress or activate
components of the immune system)
allergens,
genes,
tissues,
recombinant proteins
Hormones
Antibodies
Antibiotics