Nod for leukapheresis eludes PMCH due to infra gaps

The team from the Central Drugs Standard Control Organisation (CDSCO), Kolkata, which inspected the blood centre on November 7, sought justification for licence of leukapheresis using an automatic cell separator machine when the hospital did not have BMT facility

Infrastructure deficiencies have prevented the Bihar State Blood Centre of the Patna Medical College Hospital (PMCH), the oldest and largest medical college hospital in the state, from getting the Centre’s nod for commencing leukapheresis, a medical procedure to separate white blood cells (WBC) from whole blood, used in bone marrow transplant (BMT) for treatment of blood related disorders like blood cancer, thalassemia, aplastic anaemia, etc., said people familiar with the development.

The Patna Medical College and Hospital. (HT Photo)

The team from the Central Drugs Standard Control Organisation (CDSCO), Kolkata, which inspected the blood centre on November 7, sought justification for licence of leukapheresis using an automatic cell separator machine when the hospital did not have BMT facility. It asked the blood centre to either withdraw its request for leukapheresis, or cite valid justifications for it, which the latter could not, said an official privy to the inspection.

In defence, the state health officials said the same licence was given last year to the Model Blood Centre at Patna’s Jaiprabha hospital, Kankerbagh, without the hospital having BMT facility. The argument, however, failed to cut ice with the inspectors.

The central team then asked the PMCH blood centre to fill afresh form 27C for grant of licence for processing of whole blood and preparation of blood components, leaving out its request for leukapheresis.

“Any insistence on licence for leukopheresis may have drawn adverse comments from the inspectors and even cast a shadow on the licence for platelet pheresis and plasma pheresis, which is more essential given an uptick in dengue cases in the state,” said a state health officer looking after blood transfusion safety.

The Centre’s inspection report is yet to reach the state.

“Leukapheresis is highly specialised, and requires well-trained personnel to handle its complications like fever, rigour, hypotension, tingling, numbness, etc.,” said Dr Avinash Kumar Singh, a senior consultant haematologist at Patna’s Paras HMRI hospital, which does the procedure.

The Central team comprised Prakash Kumar Parida, drugs inspector, CDSCO, east zone, Kolkata, and “subject expert” Dr Upendra Prasad Sinha, a former chief medical officer of the PMCH blood centre for over 15 years. Both refused to talk, saying they were not authorised to speak to the media.