An initiative to test at least 1% of blood units arriving from other states; pilot tube and infection test report mandatory with every consignment
Serious issues found in inspection of 208 blood centres; licences of 55 centres were suspended
Stricter norms on blood quality, safe storage and donor-to-patient traceability
TTI report, donor form and temperature record mandatory with every bulk transfer consignment
Blood bank operations barred in the absence of technical staff; warning of licence cancellation for violations
Directions to preserve information on every unit from donor to patient and to retain samples for seven days
Lucknow, October 2026 : Serious diseases such as Hepatitis-B, Hepatitis-C and HIV can spread through blood. It is therefore extremely important to ensure the purity and quality of blood given to patients. The prescribed standards must be followed at every stage, from collecting blood from the donor, testing it and storing it safely, to giving it to the patient. With this objective, the Uttar Pradesh Food Safety and Drug Administration (UPFSDA) has taken an initiative to strengthen the quality testing system for blood and its components brought in large quantities from other states. On behalf of Commissioner, FSDA, Dr. Roshan Jacob, a proposal has been sent to the National Blood Transfusion Council (NBTC) to get blood units arriving through bulk transfer tested at the recipient centre as well. Under the proposal, it has been recommended that at least one percent of units of each consignment, or a minimum of one unit per consignment, whichever is higher, be tested. It is proposed that this testing be carried out at a government blood centre in the presence of drug inspector. The aim is to confirm the quality of blood arriving from other states and to reduce the risk of infected blood, or blood that does not meet the prescribed standards, reaching patients.
On the orders of the Commissioner, Food Safety and Drug Administration, Uttar Pradesh, 208 blood centres run by charitable trusts were inspected in March 2026. Of these, licences of 55 centres were suspended. The inspection revealed serious irregularities in infection testing, maintenance of records of temperature-controlled storage, technical staff, hygiene and records. In particular, shortcomings related to necessary documents and quality verification were found while large consignments of Packed Red Blood Cells (PRBC) were being procured from other states. This important step has been taken following that.
Bulk transfers were taking place without adequate documents
During the inspection, some blood centres were found without a written justification for procuring blood in large quantities, Transfusion-Transmissible Infection (TTI) test reports, donor forms and records of maintaining the prescribed temperature during transport. It was also found challenging to confirm the licences of supplier centres in other states and whether the prescribed rules for blood collection and testing were being followed there. The absence of clear identification information on the packaging of bulk transfers also makes the situation unclear. Often the recipient centre does not have the blood's test reports and proof of temperature-controlled transport. In such a situation, it becomes difficult to verify whether the sending centre collected and tested the blood according to the prescribed procedure.
Because prior intimation of bulk transfers is not received, drug inspectors are unable to check in time the recipient centre's actual requirement, storage capacity and temperature control arrangements. Given the risk of serious diseases spreading through blood, it is necessary to remove these deficiencies so that the quality and safe supply of blood can be ensured.
Under the NBTC guidelines of 28 October 2015, the responsibilities of supplier and recipient centres are defined. Generally, the supplier centre is responsible for infection testing of the blood, while the recipient centre performs cross-matching before giving blood to the patient. To strengthen this arrangement, UPFSDA has proposed that quality testing of units arriving through bulk transfer also be done at the recipient centre.
Pilot tube and TTI report necessary with every unit
UPFSDA issued directions to all blood centres in the state through a letter dated 21 August 2026. According to these, while taking bulk supply of PRBC from other states, it is mandatory to obtain, with each unit, a pilot tube of the original blood at least 30 centimetres long, i.e. three segments. Of the units received, testing of at least one percent at a government blood centre in the presence of the local drug inspector, and preservation of its report, has been directed. A copy of the TTI test report and donor form will also be mandatory with every unit. The form must record consent for the unit to be used outside the original centre after donation. Records of the prescribed temperature during transport, blood storage cabinets of adequate capacity, and information about thermographs that record their temperature must also be kept available. This will make it possible to monitor the safe transfer and storage of blood.
NBTC recommended on labelling, prior intimation and SOP
To strengthen the system at the national level, UPFSDA has made three main proposals. First, at least two pilot tube segments, totalling about 20 centimetres in length, should be provided with each unit. Second, along with marking "Bulk Transferred Unit" on the unit, the name, address and licence number of the supplier and recipient centres should be recorded, so that the identity of the blood and the source of its supply can be traced. Third, it should be made mandatory for the recipient centre to inform the local drug inspector before a bulk transfer. Along with this, it has been recommended that a Standard Operating Procedure (SOP) and checklist be prepared for each consignment. This will include the condition of the blood bag and pilot tube, TTI report, details of both centres, time limit of the transfer and the temperature record during transport.
Strictness from infection testing to record-keeping
In blood centres of the state, except in emergency situations, infection testing of all blood samples by 100 percent ELISA or chemiluminescence technique has been made mandatory. The donor's Aadhaar card and Aadhaar-linked mobile number must be recorded in the donor register, and the patient's or attendant's Aadhaar card and linked mobile number in the issue register. Pilot tubes and patient blood samples must be preserved for at least seven days. Separate storage of blood and its various components at prescribed temperatures, thermograph records, hygiene, and calibration of all necessary equipment at least once a year are also mandatory. The fee list prescribed by the State Blood Transfusion Council (SBTC) must be displayed prominently. The donor register, master register, issue register, blood bag and stock register must be kept updated. By preserving the complete record of receipt, testing and issue of blood to the patient, information on every unit from donor to patient must be kept available. This will allow information about its source and testing to be gathered in case of a complaint or doubt about any unit. Operation of a blood centre in the absence of technical staff is prohibited. Action to cancel the licence may be taken in case of serious irregularities or deficiency in mandatory records.
Stringent standards for licences of charitable trusts too
For new licences and renewal of blood centres, it has been made necessary that the trust has been functioning for at least two years, has adequate resources, and is not controlled by a single person or family. The objectives of the trust must clearly mention health and blood transfusion services. Along with the application, a PAN card, registration certificate under the Income Tax Act, names, addresses and identity documents of members, details of charitable activities of the past two years, and an audit report must be submitted. The names, addresses, licence numbers, validity, and details of any suspension or cancellation of all blood centres run by the trust must also be provided. If any member is associated with another trust operating blood centres, its details must be submitted. If the technician or technical supervisor of the blood centre holds DMLT qualification/registration, approval of the certificate by the UP State Medical Faculty Board is also necessary.
Goal is to provide safe blood to patients
The aim of this UPFSDA initiative is to ensure the availability, quality and safe supply of blood. Monitoring of bulk transfers, infection test reports, temperature-controlled transport and checking of records of safe storage will help ascertain whether blood has been received and stored according to the prescribed standards. Testing of samples at the recipient centre, prior intimation to the drug inspector, and the system of preserving records from donor to patient will increase the accountability of blood centres. It will also help ensure strict compliance with NBTC guidelines and reduce the risk of infections spreading through blood.
