APPROVAL FOR BLOOD STORAGE CENTRE

 

The Drugs Control Department ensures that Blood Storage Centres maintain the prescribed standards for safe storage and availability of blood and blood components. Approval is granted to eligible centres after verification of the required infrastructure, equipment, qualified personnel and safety requirements, in accordance with the applicable provisions of the Drugs & Cosmetics Act and Rules.

 

CHECKLIST FOR BLOOD STORAGE CENTRE FRESH APPROVAL /RENEWAL

 

 

  1. Covering letter (Court stamp Rs. 5/- to be affixed)
  2. Questionnaire (Click Here)
  3. Photo ID card of the applicant.
  4. e- Challan for Rs. 5000/- head of account (0210-04-104-99) drug licence fee payable to Drugs Controller, Thiruvananthapuram (NOT APPLICABLE TO GOVT. HOSPITALS)
  5. Copy of the MBBS/MD qualification certificate of Medical Officer
  6. Copy of Medical Council Registration of Medical Officer
  7. Copy of certificate showing the experience if, any gained by the Medical Officer in the field of transfusion medicine and or training certificate issued by KSACS.
  8. Declaration of Medical Officer with passport size photo.
  9. Copy of BSc MLT/DMLT/ any other equivalent qualifying certificate of Technician.
  10. Copy of Para Medical Council Registration of Technician
  11. Copy of certificate showing the experience , if any gained by the Technician in Blood Banking/Grouping Serology and or training certificate issued by KSACS.
  12. Declaration of the Technician with passport sixe photo.
  13. Copy of the partnership deed/memorandum and articles of association of the applicant (if applicable)
  14. Certificate of incorporation of the applicant (if applicable)
  15. List of Directors of the applicant (if applicable)
  16. Copy resolution of Partners/Board of Directors (if applicable)
  17. Affidavit on stamp paper, Value Rs. 50/- executed before Notary Public by the applicant.
  18. Consent letter form the Mother Blood Bank
  19. List of equipments including facilities available for safe transportation of Blood and Components.
  20. List of registers and forms.
  21. Standard Operating Procedure.
  22. Agreement regarding Bio Medical Waste disposal.
  23. Location plan and layout. The applicant should provide a separate air conditioned roomwith minimum area of 10m2. The room should be well lit, ventilated and the walls asfloor should be covered with washable material, free form cracks and crevices.

 

Fee Structure – Blood Storage Centre Approval

 

 

Service Fee
New Approval / Renewal ₹5,000
Late Fee for Renewal ₹2,000 per month
Change of Name ₹1,500
Change of Technical Person ₹2,500/Person
Validity of Approval 2 Years

 

The application shall be sent to : 

 

Drugs Controller, Red Cross Road, Vanchiyoor (P.O), Thiruvananthapuram -695 035
Ph: 0471 2471896,  E-mail : dckerala@gmail.com  ORIGINAL ONLY