Presentation on theme: "BACKGROUND: The Directorate General of Drug Administration under the Ministry of Health & Family Welfare, Government of the People's Republic of Bangladesh,"— Presentation transcript:
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 265 Allopathic, 201 Ayurvedic, 268 Unani, 25 Herbal and 79 Homeopathic drug manufacturing companies in the country. The Directorate General of Drug Administration monitors and regulates all the activities of these 838 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 licences to manufacture, store, sell, import and export drugs and medicines. medicines.
At present, there are 33 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
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 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. b. To make essential drugs available and affordable to the common people of the country.
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 amendemnts * 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: 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. 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. - unauthorised 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 pharmacovigillance 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.)