Vinod Gholap | Mumbai
Maharashtra FDA Tightens Vigil on Blood Banks to Protect Patient Safety.
The Maharashtra FDA (Food and Drug Administration) has launched a major crackdown on blood centres and blood storage centres across the state, taking strict action against facilities found violating mandatory safety and quality regulations.
According to the FDA, 38 blood-related facilities faced regulatory action between April and June 2026, including licence suspensions and permanent cancellations. The move aims to ensure that patients receive safe, high-quality blood and blood components during emergencies, surgeries, childbirth, cancer treatment, thalassemia care, haemophilia treatment and other life-saving medical procedures.
413 Blood Centres and 468 Blood Storage Centres Under Surveillance
Maharashtra currently has 413 licensed Blood Centres and 468 licensed Blood Storage Centres operating under the provisions of the Drugs and Cosmetics Act, 1940.
21 Blood Centre Licences Suspended, 2 Cancelled; 13 Blood Storage Centres Suspended, 2 Cancelled.
Maharashtra currently has 413 licensed Blood Centres and 468 licensed Blood Storage Centres operating under the provisions of the Drugs and Cosmetics Act, 1940.
The FDA conducts mandatory annual inspections along with surprise inspections to verify compliance with regulations governing blood collection, testing, component separation, storage conditions, temperature monitoring, trained manpower, documentation, quality assurance and biomedical waste management.
Major Action Taken (April–June 2026)
The inspection drive resulted in:
- 21 Blood Centre licences suspended
- 2 Blood Centre licences cancelled
- 13 Blood Storage Centre licences suspended
- 2 Blood Storage Centre licences cancelled
Total Regulatory Action:
- 34 Licence Suspensions
- 4 Licence Cancellations
Why the Action Was Taken
FDA officials found several serious violations during inspections, including:
- Failure to comply with licence conditions
- Poor quality management systems
- Deficiencies in blood safety protocols
- Inaccurate or incomplete records
- Violations of the Drugs and Cosmetics Act, 1940
- Non-compliance with prescribed operational standards
Authorities stated that such violations could directly compromise the safety, purity and effectiveness of blood supplied to patients.
Licences Permanently Cancelled
The FDA permanently cancelled the licences of:
- Maya Blood Centre
- Sir J.J. Metropolitan Blood Centre, Mumbai
- Patil Hospital Blood Storage Centre, Bori Pardhi (Pune)
- Aadhar Blood Storage Centre (Trust), Bhiwandi, Thane
The decision followed detailed inspections that revealed serious violations posing potential risks to blood donors and patients.
Commissioner Tukaram Mundhe Warns: No Leniency for Institutions Endangering Public Health.
FDA Commissioner Tukaram Mundhe said blood is not an ordinary medicine but a life-saving resource, and institutions operating purely for commercial interests while violating safety norms will face strict legal action.
He emphasised that the department remains committed to ensuring the availability of safe, high-quality blood across Maharashtra through continuous monitoring and surprise inspections.
The FDA also warned that strict legal action will continue against any blood centre or blood storage centre found violating statutory provisions in future inspections.
