The National Blood Transfusion Council (NBTC), operating under the Ministry of Health & Family Welfare, has officially finalized and approved revised norms for licensed blood centers concerning the handling and distribution of Transfusion-Transmissible Infection (TTI) sero-reactive blood bags. These new guidelines, approved during the 33rd Meeting of the NBTC Governing Body on November 19, 2024, supersede the previous norms notified on March 5, 2021.
The comprehensive revisions aim to streamline the process for utilizing TTI reactive blood bags for essential purposes such as scientific research, preparation of seroconversion and Quality Control (QC) panels, and the manufacture of indigenous diagnostic/screening kits, all while maintaining stringent safety and ethical standards.
Key General Norms for Blood Centers
Permitted Recipients
Licensed blood centers are now permitted to send TTI sero-reactive blood bags to identified Reference Laboratories, Indigenous diagnostic kit manufacturers, and Proficiency Testing (PT) providers across the public, private (indigenous), and charitable sectors.
Approval Process
A No Objection Certificate (NOC) for such transfers will be issued by the respective State Blood Transfusion Councils (SBTCs) upon receiving an application from the concerned organization.
Blood bags will be issued free of cost to public sector reference laboratories and government-approved External Quality Assessment Scheme (EQAS) providers. However, indigenous manufacturers may be charged processing fees for whole blood, as per government-approved rates.
Disposal Responsibility
Receiving organizations must provide a written undertaking to ensure proper transport and disposal of any remaining infective material in strict accordance with Biomedical Waste Management (BMW) rules, absolving the issuing blood center of this responsibility.
Record Keeping
All transactions must be meticulously recorded by licensed blood centers as per formats prescribed by NBTC/SBTC.
Research Protocols
For any research purposes, proposals must be submitted to the Indian Council of Medical Research (ICMR) through proper channels, ensuring appropriate ethics clearance.
Informed Consent
All licensed blood centers are required to obtain informed consent from blood donors at the time of donation, explicitly stating that their blood or blood components/products may be used for panel preparation, scientific research, and indigenous manufacturing, addressing all ethical concerns.
Specific Norms for Indigenous Kit & Medical Device Manufacturers
Eligibility
TTI sero-reactive blood bags can be issued to indigenous manufacturers of kits and medical devices holding valid manufacturing licenses from both State Licensing Authorities and the Central License Approving Authority, as well as to indigenous manufacturers of diagnostic raw materials like antigens and antibodies.
Audits & Undertakings
During the manufacturing license application process, auditors from the Central Drugs Standard Control Organization (CDSCO) will verify risk management protocols and records related to the usage, handling, and disposal of infectious materials to ensure employee health, safety, and environmental protection. Firms must also submit an affidavit to the blood center (with copies to relevant authorities) ensuring that the collected TTI sero-reactive blood is used solely as raw material for In vitro diagnostic (IVD) reagents.
Biomedical Waste Management
Manufacturers are required to provide an undertaking to the concerned blood center, committing to adhere to the Biomedical Waste Management Rules, 2016, for biohazardous materials during collection, transport, storage, use, and disposal.
Cost Recovery for Blood Centers
Blood centers are permitted to invoice manufacturers for unused sero-reactive units to compensate for expenses incurred during testing and processing.
Traceability and Records
Both blood centers and manufacturers must maintain detailed records for traceability from the collection point through to the manufacturing of kits. Manufacturers are required to provide a receipt upon collection of blood bags, detailing unit numbers, date, addresses, and signatures from both parties.
Approval Process and MoUs
Manufacturers must approach their respective SBTCs to obtain approval for collecting reactive blood bags from blood centers within that State/UT. Once approved, a Memorandum of Understanding (MoU) must be signed between the approved manufacturer and the blood center, with the SBTC being informed.
Data Confidentiality
Maintaining data confidentiality is paramount when supplying seropositive blood bags.
These revised norms are issued with the approval of the competent authority and aim to enhance the safety, efficiency, and ethical framework surrounding the use of TTI reactive blood bags in India’s medical and diagnostic sectors.