FDA revokes licenses of 4 blood banks, suspends another 25

The four blood banks, that were asked to shut down are located in Pune, Satara, Solapur and Kolhapur districts, according to officials

SLUG: Show-cause notices to 31 facilities

During scrutiny rounds, the blood banks were found breaching norms such as not maintaining a blood cold chain or functioning without blood transfusion officers (BTO) amongst other things. (REPRESENTATIVE PIC)

PUNE

The Food and Drugs Administration (FDA) has revoked the licenses of four blood banks and suspended licenses of 25 similar facilities for violating various provisions of the Drugs and Cosmetics Act, 1940.

Also, show-cause notices have been issued to over 25 blood banks, the officials said.

The decision follows thorough inspections of 103 blood banks in the Pune division from April 2022 to March 2023, according to FDA authorities.

The four blood banks, that were asked to shut down are located in Pune, Satara, Solapur and Kolhapur districts, according to officials.

During scrutiny rounds, the blood banks were found breaching norms such as not maintaining a blood cold chain or functioning without blood transfusion officers (BTO) amongst other things. They further claimed that certain blood banks were operating without competent technical staff and that blood bank storage was unsanitary.

S V Pratapwar, joint commissioner of FDA, Pune Division, noted that licences were revoked in cases where blood banks were not adhering to the guidelines.

As per the FDA officials, a blood bank functioning sans BTOs is similar to a hospital without doctors. Significant activities such as the collection, and transfusion of blood and its components, such as plasma, and white blood cells among others have to be done in the presence of a BTO. This can lead to fatal errors and can be prevented only if qualified staff is present.

Another FDA official, speaking on the condition of anonymity, stated that noncompliance in terms of personnel strength and instrumentation is a violation of Schedule F of the Drugs and Cosmetics Act of 1940, for which certain blood banks’ licences have been suspended.

“When it comes to blood banks, hygiene and storage are critical. Licences were revoked in circumstances where blood was stored or transferred without maintaining a cold chain for an extended period of time. When blood is transfused, it loses its ability to transport oxygen or carbon dioxide to and from tissues if the temperature is not maintained,” he explained.

Pratapwar went on to say that certain blood banks failed to keep necessary records or testing results on blood donors.

“The blood banks that were found violating these norms have been issued notices. The violators come up with an excuse that during the blood donation camps, it is impossible to keep track record of a mob. But it is not acceptable, as it leads to chaos later,” he said.