Last Updated on December 1, 2020 by The Health Master
Mumbai: Government has notified new rules for blood banks under the Drugs and Cosmetics (D&C) (Second Amendment) Rules, 2020 for effective compliance based on Drug Technical Advisory Board (DTAB) recommendation.
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As per a gazette notification, the Central government hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945 which will be called as the Drugs and Cosmetics (Second Amendment) Rules, 2020. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), in Part X B, in the heading, for the words ?Blood Banks, the words ? Blood Centres shall be substituted.
In the said rules, in rule 122EA, in sub-rule (1),?(i) For clause (d) following shall be substituted, namely (d) Blood Centre is an authorized premises in an organization or institution as the case may be, for carrying out all or any of the operations including collection, apheresis, processing, storage and distribution of blood drawn from donors or received from another licensed Blood Centre and for preparation, storage and distribution of blood components.
Also read: FAQs – on Blood Bank (Series-1)
In clause (g), after the word accepting, the words against donated unit shall be inserted (iii) after clause (m), the following clause shall be inserted, namely,?(n) Erythrocytapheresis means selective collection of one or two units of red cells from a donor or patient using a cell separator and re-transfusing the remaining blood into the donor or patient.
In the said rules, in rule 122EA, rule 122F, rule 122G, rule 122I and rule 122P, for the words ? Blood Bank, the words ? Blood Centre wherever they occur shall be substituted.
In the said rules, in rule 122G, in sub-rule (1), for condition (i) the following shall be substituted-
(i) The operation of Blood Centre or processing or both 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 a Degree in Medicine having experience of working in Blood Centre, not less than 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 or preparation of its components or both.
Eligibility criteria also covers Degree in Medicine with Diploma in Clinical Pathology or Diploma in Pathology and Bacteriology with six months experience in a licensed Blood Centre or Degree in Medicine with Diploma in Transfusion Medicine or Diploma in Immunohematology or Blood Transfusion with three months experience in a licensed Blood Centre or Doctor of Medicine Pathology or Diplomate of National Board Pathology with three months experience in a licensed Blood Centre or Postgraduate degree in Transfusion Medicine -Doctor of Medicine Transfusion Medicine or Diplomate of National Board Transfusion Medicine, Doctor of Medicine Immunohematology and Blood Transfusion, the degree or diploma being from a University recognized by the Central Government or State Government.
For the purposes of this condition, the experience in Blood Centre shall not apply in the case of persons who are approved by the Licensing Authority or Central Licence Approving Authority or both prior to the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1999.
In the said rules, in rule 122G, for sub-rule (2) and explanation thereto, the following shall be substituted – applications for grant or renewal of license for operation of Blood Centre or processing of Human blood components shall be made by the Blood Centre run by the Government, Indian Red Cross Society, Hospital, Charitable Trust or Voluntary organization and Blood Centre run by Charitable Trust or Voluntary organization need to be approved by a State or Union territory Blood Transfusion Council as per procedure laid down in this regard by the National Blood Transfusion Council.
For the purpose of this sub-rule, renewal shall include renewal of any license issued after the commencement of the Drugs and Cosmetics (Sixth Amendment) Rules, 2005.