The Maharashtra Food and Drug Administration has issued a comprehensive compliance order for all licensed Blood Centres and Blood Storage Centres across the state, introducing a uniform framework aimed at strengthening blood safety, quality standards and the protection of patients and donors.
The order issued on August 6, seeks to ensure strict compliance with the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
According to the order, human blood and its components are classified as a “drug” under the Drugs and Cosmetics Act, 1940. Therefore, no blood centre or institution can collect, process, store or distribute blood without a valid licence. Blood centres are also required to comply with the statutory conditions prescribed under Schedule F, Part XII-B of the Drugs and Cosmetics Rules, 1945.
The FDA’s order lays down detailed guidelines covering infrastructure, appointment of qualified and trained personnel, blood donor selection and collection procedures. It also specifies requirements for mandatory testing of blood and blood components, preparation and storage of components, and labelling of blood units.
The framework further covers record maintenance, quality control systems, biomedical waste management, organisation of blood donation camps, safe transportation of blood and daily updating of information on the e-RaktKosh portal.
The FDA said inspections of certain blood centres had revealed instances of non-compliance with statutory requirements under Schedule F, Part XII-B of the Drugs and Cosmetics Rules, 1945. The comprehensive order has therefore been issued to ensure effective and uniform implementation of these provisions across Maharashtra.
ALSO READ: Licence Cancelled: Tukaram Mundhe-Led FDA Cracks Down on Pune’s Inducare Pharma
Key Provisions Of The Compliance Order
- Ensure infrastructure as prescribed under Schedule F, Part XII-B, including counselling rooms, quality control units and facilities for blood component processing.
- Appoint qualified medical officers, technical supervisors, blood bank technicians, nurses and counsellors as required under the regulations.
- Strictly implement the revised 2020 Donor Selection Criteria, including temporary and permanent donor deferral norms.
- Screen every blood unit for HIV, Hepatitis B, Hepatitis C, Syphilis and Malaria.
- Store blood and blood components at prescribed temperatures, maintain the cold chain and provide separate quarantine facilities for suspected blood units.
- Ensure proper labelling of blood bags, preserve records for the prescribed period and follow approved procedures for preparing blood components.
- Conduct regular self-audits to ensure compliance with prescribed operating procedures.
- Ensure adequate manpower, equipment, emergency facilities and transportation arrangements for blood donation camps, along with post-camp reporting.
- Update blood stock and related information on the e-RaktKosh portal every day.
The FDA has directed all blood centres across Maharashtra to immediately review their existing procedures and undertake necessary corrective measures. Blood centres found violating the order will face strict action under the applicable legal provisions.
FDA Commissioner Tukaram Mundhe said safe and reliable healthcare is a fundamental right of every citizen and that blood is an essential requirement for patients. “Every blood donor and every patient in need of blood has the right to receive safe, quality-assured and reliable blood and blood components,” Mundhe said in an official statement.
“Through this comprehensive order, we aim to ensure uniform standards, transparency, quality control and legal compliance across all blood centres in Maharashtra. All licensed blood centres must implement this order,” he added.
ALSO READ: Tukaram Mundhe-Led FDA Shuts Two IIT Bombay Canteens, Warns Another
Essential Business Intelligence,
Sharp Market Insights,
Practical Personal Finance Advice, Daily Fuel, Gold and Silver Prices and Latest Stories — On NDTV Profit.
