Government of India has framed some new rules for blood centers and the blood component sunder Drug and Cosmetics rules, 2020 for better compliance as per the Drug Technical Advisory Board (DTAB) recommendations.
According to the gazette notification, the government has made the rules to amend the Drugs and Cosmetic rules, 1945 which is to be known as Drugs and Cosmetics rules 2020. As per the Drugs and Cosmetics Rules, 1945, in part XB and part XII B, in the heading in place of blood banks the word blood centers shall be used.
In the said rules it has been stated that:
“The blood centre is one of the authorized premises present in an organization or an institution whatever may be the case, for operating all or part of the operations that includes collection, processing, strong and distribution of the blood that is drawn from any donor or obtained from a licensed blood centre for the sake of preparation, storing and circulation of the blood components.”
In the stated rules 122G, The blood centre operation or its processing or even both of the human blood for all components shall be done under dynamic direction as well as personal supervision of any competent technical person comprising any person who is a full-time employee and someone who is a medical officer, having a degree in Medicine with working experience in blood group serology, blood group procedures and medical principles indulged in blood procurement and preparation of its components or even both.
The eligibility condition also involves degree in medicine with diploma in clinical pathology or diploma in pathology and bacteriology with experience of six months in any of the licensed blood centre.
The other eligibility condition involves Degree in Medicine with Diploma in Transfusion Medicine or Diploma in Immunohematology or Blood transfusion with experience of three months in any licensed blood centre or Doctor of medicine pathology or Diplomats of National Board Pathology with three months experience in an authorized blood centre.
The experience in the blood centre shall not apply for persons who have approval by the licensing authority or the central license approving authority or even both before the start of Drugs and Cosmetics rules, 1999. As per the rule 122G, for the rule 2 and further explanation, the applications for granting license renewal for blood centre operation or processing of the blood components shall be done by the blood centre that is under the Government like Indian Red Crosssociety, hospitals or any voluntary organization.
The blood centre that is run by the charitable trust or the voluntary organization should have approval from any state or union territory Blood transfusion council as per the rule laid down on this by the National Blood Transfusion Council.
