Section 122G in The Drugs and Cosmetics Rules, 1945
122G. Form of license for the operation of a Blood Bank/processing of whole human blood for components and manufacture of blood products and the conditions for the grant or renewal of such license.
- [(1)] [Renumbered as sub-Rule (1) thereof by G.S.R. 733(E), dated 21.12.2005 (w.e.f. 21.12.2005).] A license for the operation of a blood bank or for processing whole human blood for components and manufacture of blood products shall be issued in [Form 28-C or Form 28-E or Form 26-G or Form 26-I, as the case may be] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).]. Before a license in [Form 28-C or Form 28-E or Form 26-G or Form 26-I, as the case may be,] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).] is granted or renewed the following conditions shall be complied with by the applicant:-(i)[ The operation of blood bank and/or processing of whole human blood for components shall be conducted under the active direction and personal supervision of competent technical staff consisting of at least one person who is whole-time employee and who is Medical Officer, and possessing- [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).](a)Post-graduate degree in Medicine-M.D. (Pathology/Transfusion Medicines); or(b)Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion Medicines having adequate knowledge in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components; or(c)Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year during regular service and also has adequate knowledge and experience in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components, the degree or diploma being from a University recognized by the Central Government.Explanation. - For the purposes of this condition, the experience in Blood Bank for one year shall not apply in the case of persons who are approved by the licensing authority and/or Central License Approving Authority prior to the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1999.](ii)The applicant shall provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. The space, plant and equipment required for various operations is given in Schedule F, Part XII-B and/or XII-C.(iii)The applicant shall provide and maintain adequate technical staff as specified in Schedule F, Part XII-B and/or XII-C.(iv)The applicant shall provide adequate arrangements for storage of whole human blood, human blood components and blood products.(v)The applicant shall furnish to the licensing authority, if required to do so, data on the stability of whole human blood, its components or blood products which are likely to deteriorate, for fixing the date of expiry which shall be printed on the labels of such products on the basis of the data so furnished.(2)[ Application for grant or renewal of a license for operation of blood bank or processing of human blood components shall be made by the blood bank run by the Government, Indian Red Cross Society, hospital, charitable trust or voluntary organisation approved by a State/Union Territory Blood Transfusion Council only.Explanation. - For the purpose of this sub-rule, "renewal" shall include renewal of any license issued prior to the commencement of the Drugs and Cosmetics (Amendment) Rules, 2005.] [Inserted by G.S.R. 733(E), dated 21.12.2005 (w.e.f. 21.12.2005).]
