In India, the licensing and regulation of blood banks are governed by the Drugs and Cosmetics Act, 1940 and the corresponding Drugs and Cosmetics Rules, 1945. Human blood and its components are legally classified as “drugs” under the Act, which mandates that any organization or institution engaged in the collection, storage, processing, or distribution of blood must obtain a valid license before commencing operations. The licensing system aims to ensure that blood and blood products made available for transfusion meet the required standards of quality, safety, and efficacy, thereby protecting recipients from avoidable health risks.

In this article, CA Manish Mishra talks about Blood Bank License under Drugs and Cosmetics Act.

Classification and Regulatory Authority

All blood banks—whether operated by government hospitals, private hospitals, charitable trusts, Red Cross organizations, or standalone institutions—must be licensed under the Drugs and Cosmetics Rules. The regulation is enforced through a dual licensing mechanism. While the State Drug Control Department is responsible for issuing and renewing blood bank licenses at the state level, approval from the Central Licensing Authority is also mandatory, particularly for blood banks involved in processing and manufacturing components like plasma, platelets, or cryoprecipitate. The standard validity of a license is five years, after which it must be renewed in a timely manner to continue lawful operations.

Applicable Rules and Provisions

The operational, infrastructural, and procedural aspects of blood banks are detailed under Part X-B of Schedule F of the Drugs and Cosmetics Rules, 1945. These rules outline comprehensive norms for premises, equipment, personnel, quality control, documentation, and hygiene. A blood bank must be established in a clean and well-ventilated facility with designated areas for donor examination, blood collection, storage, and processing. It should be equipped with calibrated centrifuges, temperature-controlled refrigerators, deep freezers, sterile laminar flow hoods, and emergency medical equipment. Furthermore, only qualified medical personnel with relevant experience are permitted to supervise blood collection and testing procedures.

Licensing Procedure and Documentation

To obtain a blood bank license, the applicant must submit an application in the prescribed form to the State Drug Control Authority along with the necessary documents and prescribed fees. The application must include site plans of the facility, details of the equipment installed, the list of technical staff along with their qualifications, standard operating procedures (SOPs), waste management protocols, and quality assurance manuals. Once the application is reviewed, an inspection is conducted by drug inspectors to verify compliance with the required standards. If the facility meets all the prescribed norms, the license is granted subject to periodic inspections and compliance monitoring.

Testing and Quality Standards

A licensed blood bank must follow mandatory protocols for screening every unit of collected blood for infectious diseases such as HIV, hepatitis B, hepatitis C, syphilis, and malaria. Testing must be carried out using approved kits and methods. Blood should only be collected from healthy voluntary donors after a thorough medical examination. Professional or paid donors are strictly prohibited, and any violation may result in cancellation of the license and legal proceedings. Quality assurance systems must be implemented to maintain consistency, including routine internal audits, equipment calibration, documentation of batch testing, and validation of all procedures.

Storage, Labelling, and Distribution

Proper storage and labelling of blood units are essential for traceability and safety. Blood must be stored under controlled temperatures as per the type of component—whole blood, platelets, or plasma. Labels must contain all necessary details including blood group, Rh factor, collection and expiry date, and a unique identification number. The release of blood units must be accompanied by proper documentation, and records should be maintained for a minimum period as prescribed under the law. Blood banks are also required to maintain donor records, transfusion reaction reports, and audit logs for inspections.

Penalties and Suspension

Operating a blood bank without a valid license is a punishable offence under the Drugs and Cosmetics Act. In case of non-compliance with licensing conditions or breach of safety standards, the State Drug Control Authority has the power to suspend or cancel the license. Violations such as use of untested blood, non-compliance with donor screening protocols, improper waste disposal, or storage violations are treated seriously and may lead to criminal prosecution, monetary penalties, or both. The regulatory authority may also seize blood stocks and issue closure orders in the public interest.

Recent Updates and Technological Advancements

Recent regulatory developments have emphasized digitization, quality improvement, and traceability. The introduction of national digital portals for blood bank licensing and reporting has improved efficiency in application tracking and inspections. There is a renewed focus on voluntary blood donation drives, improved haemovigilance systems, and establishment of regional blood testing laboratories to support smaller facilities. Updated guidelines also stress on continuous training of staff, adherence to Good Manufacturing Practices (GMP), and implementation of barcode-based inventory systems to enhance the traceability and safety of blood units.

Conclusion

Licensing of blood banks under the Drugs and Cosmetics Act plays a crucial role in maintaining the safety and availability of quality blood for transfusion. The stringent standards prescribed under Schedule F ensure that only institutions with proper infrastructure, qualified personnel, and robust safety protocols are allowed to operate. With increasing demand for safe blood and component therapy, compliance with licensing norms is not only a legal requirement but also a public health necessity. Facilities operating or planning to operate as a blood bank must keep themselves updated with regulatory changes, invest in quality infrastructure, and adopt best practices to ensure continued legal operation and patient safety.