The Directorate General of Drug Administration (DGDA) under the Ministry of Health & Family Welfare, Government of the People’s Republic of Bangladesh, is the Drug Regulatory Authority of the country. This DGDA supervises and implements all prevailing Drug Regulations in the country and regulates all activities related to the import, procurement of raw and packing materials, production and import of finished drugs, export, sales, pricing, etc. of all kinds of medicines including those of Ayurvedic, Unani, Herbal and Homoeopathic systems. drugs and medicines. At present, there are 47 district offices under the DGDA in the country. All the officers of the DGDA function as “Drug Inspectors” pursuant to the Drug Laws and assist the Licensing Authority in discharging its responsibilities properly. Besides, a number of Committees, such as the Drug Control Committee (DCC), the Standing Committee for Imports of raw materials and finished drugs, the Pricing Committee, and a number of other relevant Committees, which comprise experts from different fields, are there to advice Licensing Authority and recommend him about the matters related to drugs and medicines.
The Directorate General of Drug Administration’s mission is to ensure that the common people have easy access to useful, effective, safe, and good quality essential and other drugs at affordable prices.
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.
Directorate General of Drug Administration (DGDA) is the organization entrusted with the responsibility of ensuring the quality, efficacy, and safety of pharmaceutical products through the implementation of relevant legislation. The organization is trying its best to fulfill the requirements of the pharmaceutical sector of the country and thereby meet the needs of the people of the country by ensuring the safety, efficacy, and quality of the medicines.
The responsibilities of this organization are as follows :
- 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 overseas.
- To make essential drugs available and affordable to the common people of the country.
Drug Testing Laboratory
Testing of drugs is 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 in Chittagong and another in Dhaka.
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 2005
The Ordinance provides for the following legislative powers and responsibilities with respect to drugs and medicines:
- Formation of a Committee of experts, called the DCC or Drug Control Committee, for consideration of registration of medicines and/or their cancellation.
- Prohibition of manufacture and sale of drugs without the supervision of pharmacists.
- Restriction on import of certain pharmaceuticals and finished drugs.
- Review of under-licensing agreements.
- Fixation of prices of essential drugs.
- Control of advertisements and claims with respect to drugs.
- Implementation of GMP in the manufacturing units as recommended by WHO.
- Formation of Drug Courts for trying offenses related to drugs.
- Formation of a National Drug Advisory Council for advising the Govt. on matters related to essential drugs.
- Formation of an Appellate Authority.
- Recognition of Traditional and Homeopathic medicines as drugs.
- 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
- Evaluation of the proposals of new projects of all systems of medicines.
- Issue and renewal of drug manufacturing licenses.
- Issue and renewal of retail and wholesale drug licenses.
- Registration and renewal of drug products.
- Fixation of price and certification of price for drug products.
- Inspection of pharmaceutical establishments
- Approval of block list for the import of raw- and packaging materials.
- Approval of indent for import of finished drugs.
- Surveillance and pharmacovigilance activity
- Prosecution of cases in the drug courts and other courts
- Issue of export licenses, FSC (Free Sales Certificate), GMP (Good Manufacturing Practices) Certificate & CPP (Certificate for Pharmaceutical Products.)