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Application for grant or Renewal of Licence for Blood Bank

DOCUMENTS TO BE SUBMITTED TO THE LICENSING AUTHORITY ,DRUGS CONTROL ADMINISTRATION BY THE APPLICANT FOR GRANT/ RENEWAL OF LICENCES FOR BLOOD BANK

  1. Application in Form — 27-C.
  2. Constitution of the Blood Bank with names and addresses of the Proprietor/Partner/Directors not require in case of Government Hospital.
  3. List of machinery and equipment with supporting invoices.
  4. List of technical personnel appointed, with their qualifications, experience, consent and appointment letters.
  5. Copy of ownership/ tenancy agreement for the premises (not required in case of Govt. Hospital).
  6. Receipt for the fees paid (Challan for Rs.7500/- for grant of licence) (Challan for 7.500/- for renewal of licence.
  7. Head of accounts:  0210: Medical and Public Health
                                   04 : Public Health
       
                              104 : Fees, Fines etc.
  8. Draft specimen labels and records proposed to be maintained including donor card.
  9. List of products.
  10. An undertaking from the Blood Bank that it will not draw blood from professional donors.
  11. Details of Partners/ Directors / Proprietor with their residential addresses. (Not required in the case of Government Hospital).
  12. List of records, maintained along with the requisite columns and information as per Drugs and Cosmetics Rules.
  13. Affidavit regarding responsibility attested by Notary.
  14. Copy of list of the donors.
  15. Application in Form-27-C, duly Filled in along with above said enclosures, may he sent to the Drugs Controller General (India), New Delhi, with copies endorsed to the concerned State Drugs Controller and the Zonal Officer as below:
  16. Disposal of Bio Medical waste.
  17. SBIC approval from A.P.S.A.C.S.
  18. SOP manual.