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A Guideline of Drug Registration in Bangladesh

Registration of medicines is focal point of any regulatory framework. The registration section is responsible for reviewing application dossiers submitted for the registration of medicines, related substances and medical devices. In addition it also reviews all post registration amendments made to any registered medicines, related substances and medical devices.

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 Bangladesh. This DGDA 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, sales, pricing, etc. of all kinds of medicines including those of Ayurvedic, Unani, Herbal and Homoeopathic systems drugs and medicines. All the officers of the DGDA function as "Drug Inspector" in pursuant to the Drug Laws and assist the Licensing Authority to discharging his responsibilities properly.

The registration activities are summarized below:

  • Medicine application dossiers from pendingApps are received, screened for completeness and that application fees have been included
  • Data on the dossiers is entered into the registration data base; an application number is allocated and information communicated to the applicant.
  • Dossier is scheduled for evaluation by staff of the registration section. A detailed evaluation report is generated. Deficiencies, missing information etc communicated to applicant and deadline to respond to queries outlined.
  • Completed dossier reports and recommendation are forwarded to The Pharmaceutical and Analytical Committee of the NMRC.
  • Recommendations from this committee to Council may define whether a product is to be registered or not.
  • Products approved by NMRC based on the recommendations of the Pharmaceutical and Analytical Committee are allocated a registration number and gazetted. The product is then entered into the Medicines Register

Other activities done by the registration section include, but not limited to:

  • Processing of import / export permits for Narcotic and Psychotropic Substances controlled in terms of the International Narcotics Control Board (INCB).
  • Submission of quarterly and annual consumption reports of Narcotic and Psychotropic products to the International Narcotic Control Board.
  • Staff members of this section are also responsible for evaluating application for importation of unregistered medicines that are allowed for compassionate reasons. Such importation and sale is authorized in terms of Section 27 of the medicines and Related substances control Act, Act 13 of 2003.

The process of drug registration in Bangladesh is under control of DGDA under the MHFW.

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