Cooper Hospital blood bank operations suspended for 2 days over regulatory lapses

Mumbai: In a major crackdown on regulatory violations, Maharashtra’s Food and Drug Administration (FDA) has suspended the operations of the blood bank at Dr R N Cooper Hospital for two days after an inspection reportedly revealed multiple lapses in documentation, staffing and equipment maintenance.

The suspension was imposed on Thursday. However, the hospital did not challenge the decision and made alternative arrangements to ensure that its routine medical services were not disrupted.

Also Read:11 blood banks in West Bengal barred from organising camps amid probe

According to an official familiar with the developments, the hospital requires approximately 10 units of blood for its regular operations. The requirement was met through its sister facility, HBT Trauma Care Hospital in Jogeshwari.  

During an inspection, the FDA identified several violations, including the absence of an approved registered nurse and a medical social worker at the blood bank. The inspection also found that donor selection forms were incomplete, with several missing essential details, including donors' names and addresses, reports the Daily.

The inspection further revealed that the blood bank had failed to maintain updated equipment logbooks for its ELISA reader, ELISA washer and blood component separation centrifuge.

In another violation, details of a blood donation camp organised in August had not been entered in the centre's master register, as required under the prescribed regulations. The apheresis machine was also found to be non-functional during the FDA's annual routine inspection. 

“If our action inconveniences people, it is unavoidable. As per existing provisions, we have only two options for violators—suspending or cancelling their licences. There is no middle ground for provisions like adjudications, issuing notices seeking compliance, or imposing penalties. These are the only regulatory actions that we have. Besides, it is the responsibility of the blood centres to make alternative arrangements,” said an FDA official, Hindustan Times reported.

FDA Commissioner Tukaram Mundhe also justified the action, emphasising that maintaining proper records was essential for ensuring the traceability of blood stocks. He said documentation played a crucial role in identifying the source of collected blood and maintaining accountability throughout the supply chain.

“The quality of the blood is also determined by where the blood has been received, and tracing that is important,” said Mundhe.  

Apart from Cooper Hospital, the FDA has suspended two private blood banks in Ghatkopar for various regulatory violations. Both facilities have been suspended for 11 days, from October 28 to November 7.  

The latest action follows similar enforcement measures against blood banks at three prominent public hospitals in Mumbai earlier in October. St George's Hospital, BYL Nair Hospital and JJ Hospital had also faced suspension over comparable compliance-related issues.  

However, the three hospitals managed to avert the action after appealing to the state government.

The FDA's enforcement drive has extended beyond Mumbai, with several blood collection and storage facilities across Maharashtra coming under regulatory scrutiny.

Medical Dialogues had previously reported that the All India Institute of Medical Sciences (AIIMS), Nagpur, has sold more than 1,000 litres of surplus Fresh Frozen Plasma (FFP) collected from voluntary blood donors to an external facility for over Rs 16.44 lakh since 2023, according to information obtained under the Right to Information (RTI) Act.

Between April and October 2026, the department suspended the licences of 37 blood storage centres and cancelled the licences of another 13 facilities. During the same period, the FDA inspected 190 blood centres and 219 blood storage centres across Maharashtra.

Also Read:AIIMS Nagpur sold over 1,000 litres of surplus plasma for Rs 16.44 lakh, RTI reveals