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. Major steps of a Drug Registration

1. DGDA
Mohammad Akhter Hussain
Ref: Website of DGDA

2. Major steps of a Drug Registration
• Recipe application & approval (Prescribed form)
• Packaging Material/label information application & approval
• Annexure approval (recipe part), DAR NO. (Drug Administration
Registration Number)
• Price approval

3. • 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 (DGDA).
Historical background of DGDA

4. DGDA
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.
At present, there are
• 271 Allopathic,
• 205 Ayurvedic
• 271 Unani,
• 32 Herbal and
• 79 Homeopathic
drug manufacturing companies in the country.

5. DGDA
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.

7. Responsibility
The responsibilities of DGDA 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.
Drug Testing Laboratory (DTL)
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.

8. 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 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.

9. 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.
- 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.

10. 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.)

11. Vision :
We shall strive 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 standrads for quality products.

15. 1. Albendazole Chewable Tablet 2. Antacid Chewable Tablet/ Suspension
3. Ascorbic Acid Chewable Tablet/ Syrup 4. Benzyl Benzoate Lotion
5. Calcium Tablet 6. Chloramphenicol Eye/Ear Ointment/Drops
7. Chlorhexidine Lotion/ Cream 8. Chloroxylenol Lotion/ Cream
9. Chlorpheniramine Maleate Tablet/ Syrup 10. Condoms 11. Diclofenac
Gel 12. Dextromethorphen Syrup 13. Ferrous (Sulphate,
Gluconate&Fumarate) Tablet/ Capsule/ Syrup 14. Gentian Violet
15. Glycerin Suppository 16. Low Dose Contraceptive Pills
17. Mebendazole Tablet 18. Metronidazole Tablet/ Suspension
19. Methyl Salicylate Gel 20. Milk of Magnesia Suspension
LIST OF OTC DRUGS-2016 DRUG POLICY

16. 21. Mouthwash Preparations 22. MultivitaminTablet/ Capsule/ Drops
23. Neomycin/ Gentamycin/ Bacitracin or combination Ointment/
Cream/ Dusting Powder 24. Omeprazole capsule 25. Oral Rehydration
Salt (ORS) (with or without glucose or flavours) Sachets 26.
Paracetamol/Acetaminophen Tablet/ Syrup/ Suspension/Suppository
27. Permethrin Ointment/ Cream
28. Potassium Permenganate Granules for Gargle 29. Povidone Iodine
30. Promethazine Theoclate Tablet 31. Ranitidin Tablet
32. Riboflavine tablet 33. Salbutamol Tablet 34. Salicylic Acid + Benzoic
Acid Ointment 35. Silver Sulphadiazine Ointment
36. Sunscreen Preparations 37. Vitamin A Capsule 38. Vitamin B
Complex (individual or combinations) Tablet/ Syrup/ Drops
39. Xylometazoline 0.1% Nasal
LIST OF OTC DRUGS-2016 DRUG POLICY

17. 1. Who is the Licensing Authority of Drugs?
Ans: Director General Of Drug Administration.
2. Under Which Ministry Directorate General of Drug Administration
belongs to?
Ans: Ministry Of Health and Family Welfare.
3. How many system of medicine available in Bangladesh?
Ans: Allopathic, Unani, Homeopathic, Biochemic, Ayurvedic and Herbal.
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4. What is the legal basis of control of drugs in Bangladesh?
Ans: The Drug Acts 1940 and its amendment. The Drug (Control) Ordinance
1982 and its amendment.
5. How many manufacturing unit of drugs in the country?
Ans: Allopathic-258
Unani-268
Homeopathic-79
Ayurvedic –201
Herbal-17

18. 6. How many drug shop (pharmacy) in the country?
Ans: 1,01,917 (One lac one thousand nine hundred and seventeen).
7. What is the market size of Drugs in the country?
Ans: 10000 croretaka(approx.).
8. How many generics of Allopathic medicine available in the country?
Ans: 1268 (One thousand two hundred sixty eight)
9. How many brands of allopathic medicine available in the country?
Ans: 23,568 (Twenty three thousand five hundred and sixty eight)
10. What are the different fees for different purpose?
Ans: Click “Information Center=>Forms=>Different Fee” button and then check the desired ones.
11. What are the necessary documents/papers required for different activities of DGDA?
Ans: Click “Information Center=>Forms=>Required Document for Different Activities” button.
12. What are the prescribed forms for application of different activities?
Ans: Click “Information Center=>Forms=>Application Forms” button.
13. In how many countries drugs are being exported from Bangladesh?
Ans: 87 countries.

19. 4. How many valid sources for importing raw material of Drugs?
Ans: 2550. For details please click “Information Center=>List of Foreign Drugs” button.
15. How many FSC(Free Sales Certificate) required for importation of Pharmaceutical Finished Product?
Ans: a) For Human Products –FSC from country of Origin and one FSC out of any of the following countries. (UK,
USA, GERMANY, AUSTRALIA, FRANCE, SWITZERTLAND, JAPAN)
b) For Veterinary Products- FSC from country of Origin and one FSC out of any of the 24 following countries.
c) For Medical Devices—FSC from country of origin.
16. Where to submit complain related to drugs?
Ans: In Dhaka – DGDA Head Office
In District- Office of the super intendent of Drugs.
17. How much time needed to get retail Drug License and Manufacturing License of Drugs?
Ans: 2-3 months needed to get the Retail Drug License and 3-4 months needed to get a Manufacturing License of
Drugs.
18. Is it needed to take prior approval to import any Drug?
Ans: Yes. Prior approval needed from DGDA to import any Drugs.
19. Does the government Control the price of the manufactured drugs?
Ans: Government controls the price of 117 generic drug in specified dosage form. All imported medicines and all
APIs produced in the country.