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State approvals / Bihar / Health Department

Grant of Drug Manufacturing License

DepartmentHealth Department
TypeNew
StagePre-Establishment
Time limit30 days
FeeNo fee
AppliedApply on NSWS
Apply on National Single Window System

Documents to submit

#DocumentConditionRequired
1 Application in Statutory form. 2. License Fee/Challan. 3. Declaration (Notarised affidavit) for new drug sale license in prescribed format by applicant (proprietor/Partners/Director/Authorised Signatory/Power of attorney). 4. Residential certificate, Voter ID, Aadhar card for proof of residential address (permanent). 5. Proof of educational qualification of applicant. 6. Proof of date of birth of applicant. 7. Government document with photo for identification. 8. Four (4) passport size colored photo of applicant. 9. Partnership deed in case of partnership firm/ Article of association, Memorandum of association, List of Directors resolution of Board of directors/Power of attorney (In case of a company). 10. Affidavit in prescribed format regarding character by applicant/character certificate of applicant issued by competent authority. 11. Affidavit in prescribed format regarding consent and appointment of Registered Pharmacist. 12. Registration certificate and up to date renewal of registration of registered pharmacist issued by Bihar State Council, Patna. 13. If the proposed premise is on rental basis, rent agreement on India Non Judicial Stamp with updated property tax pay receipt. 14. Purchase receipt of refrigerator with make and capacity. i. If competent person is registered pharmacist following documents are required: a) Affidavit in prescribed format regarding consent and appointment of registered pharmacist. b) Registration certificate and up to date renewal of registration of Registered Pharmacist issued by Bihar State Pharmacy Council, Patna. c) Four (4) passport size colored photo of registered pharmacist. ii. If competent person is experienced person, following documents are required: a) Affidavit in prescribed format regarding consent and appointment of competent person. a) Educational qualification certificate from a recognized university. b) Experience certificate of four (4) years in dealing with sale of drugs after passing the matriculation examination or its equivalent examination/Experience certificate of one year after passing degree examination from licensed wholesale drug premises. iii. Photocopy of license certificate and updated renewal certificate of experience certificate issuing whole sale drug premises — Required
  • Note: i. Photocopy of all documents should be self-attested by applicant. ii. Documents relating to competent person/registered pharmacist should be self-attested by C.P./R. Pharmacist and by applicant also

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