Biological Drugs Division shall be responsible for the evaluation, assessment, registration and licensing of Biologicals for human beings, animals and to perform other functions connected therewith including all the functions of national control authority for biologicals as required for the prequalification by World Health Organizations of locally manufactured human biological drugs.
|Application Form||Application Form for Registration of a Drug for Local Manufacture||Biological Drugs||Download|
|Application Form||Application Form for Registration of an Imported Drug||Biological Drugs||Download|
|Application Form||Application Form for Renewal of Registration of all Kinds of Drugs||Biological Drugs||Download|
|Circular||Submission Of Renewal Application Of Biological Drugs In Biological Division||Biological Drugs||Download|
|Guidelines||Guidelines for registration of rDNA therapeutic proteins||Biological Drugs||Download|
|Guidelines||Guidelines for registration of imported Enoxaparins||Biological Drugs||Download|
|SOPs||Standard Operating Procedures for approval of post-registration variations||Biological Drugs||Download|