G/LIC/Q/BGD/4  
 
30 September 2013  
(13-5236)  Page: 1/2  
Committee on Import Licensing  Original: English  
 
NOTIFICATION UNDER ARTICLES 1.4(A) AND 8.2(B) OF THE AGREEMENT ON IMPORT 
LICENSING PROCEDURES FROM BANGLADESH1 
REPLIES FROM BANGLADESH TO QUESTIONS FROM THE UNITED STATES2 
The following communication, dated 25 September 2013, is being circulated at the request of the 
delegation of Bangladesh.  
_______________ 
  (i)
  In accordance with Article 7.3 of the Import  Licensing Procedures Agreements, Bangladesh 
made notification in 2007 regarding the abolition of the Import Licensing system. However, 
Bangladesh is taking steps to fulfill its notification obligation in this regard.  
(ii)  Bangladesh would like to place the following facts as regards to the observations and 
questions made in the para. 3 and 4:  
(a)
   What is the status of this 1998 directiv e of the Prime Minister? Is it still being 
implemented?  
  
-  There is a committee named Standing Committee for Import of Pharmaceuticals constituted by 
the Ministry of Health & Family Welfare, The Government of the People's Republic of Bangladesh. 
This committee accord approval for importation of drugs & medicines assessing their requirements.  Yes, 1998 directive of the Prime Minister is still being implemented. We encourage 
technology transfer of recently innovated life savings drugs from the research based 
pharmaceuticals.   
(b)
   Please describe the purpose of “Indent” re quests submitted to the Director General 
of Drug Administration (DGDA), the basis fo r approving indent requests; and, what the 
procedures and requirements are for obtaining an indent.  
  
-  The purpose of “Indent” requests submitted to the Director General of Drug Administration is for 
getting prior approval to import registered products on the basis of country demand.   
-
  The importer submit indent of the registered pr oducts as per prescribed From of Directorate 
General of Drug Administration. It is then placed before the Standing Committee meeting for Import of Pharmaceuticals who evaluates the need & importance of the products to be imported 
and if satisfied accords indent approval. After getti ng approval of an indent, the importer opens a 
Letter of Credit with the bank. When the consignm ent of drugs arrives in the country they need 
clearance from the DGDA to release the drugs from the Custom Authority.   
(c)
  We understand that importers are required to obtain an indent in order to import 
medicines. Are local producers requ ired to obtain such approval?  
  
-  Yes, Local producers also need to get such approval to import Drug Substances. 
  
                                               
1G/LIC/N/1/BGD/1. 
2G/LIC/Q/BGD/1. G/LIC/Q/BGD/4 
 
- 2 - 
 
  (d)  What is a certificate of registration from  the Directorate of Drug Administration? 
Who is required to obtain such registrati on? Is such registration required before 
Bangladesh will allow imports of pharmaceuticals into the market?  
  
-  Certificate of registration of a product means permission from the DGDA to manufacture for sale 
or import of medicine. According to Section 5(1) of Drug Control Ordinance 1982, Registration is mandatory for manufacture for sale or import of medicines. The section 5(1) of Drug Control 
Ordinance is –“No Medicine of any kind shall be manufactured for sale or be imported, distributed 
or sold unless it is registered with the Licensing Authority.”   (e)
    How long does the process take to receiv e a certificate of registration and an 
indent?  
  
-    For introduced it takes six month and for unintroduced molecule it takes none month to one 
year to receive a certificate of registration. In case of indent it usually takes one month for 
approval.  
 
__________