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. {source}

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

 

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.

 

14.  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.

 

 

 

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