Licence issued to Lokmanya Tilak Municipal General Hospital at Sion, Nair Hospital near Mumbai Central and Rajawadi Hospital in Ghatkopar, expired a few years ago; renewal has been delayed by the FDA
In the same week that mid-day reported that Mumbai's blood banks are running on just 57 per cent of their staff, here comes another shocker. Three of the city’s eight blood banks have been functioning without the licenses.
These are Lokmanya Tilak Municipal General Hospital at Sion, Nair Hospital near Mumbai Central and Rajawadi Hospital in Ghatkopar, with a yearly blood collection capacity of around 41,000 units (14,350 litres) collectively. While the three hospitals have applied for a renewal, the same has been delayed by the Food and Drug Authority (which renews the license) on grounds of much pending work.
An RTI application response received in June 2015 to a query on the status of blood banks in the city, has shown Nair Hospital’s licence expired in December 2012. However, dates of the expiry date at Sion and Rajawadi were not available. The RTI was filed by an independent doctor with the Municipal Corporation of Greater Mumbai.
Meanwhile, the blood banks continue to function without a licence. “While the issue is technical, in layman’s terms, it is close to driving a vehicle with an expired license. While if caught you can be penalised in this case since the licence renewing and penalising authority is the same, which happens to be FDA, there is complete negligence on this important part,” said the RTI applicant.
Talking to SUNDAY mid-day, a senior pathology expert who also happens to be a medical director of one of the civic blood banks said that the blood banks cannot function with an expired license but at the same time, they cannot be held responsible because their application is in process. However, he added that three years is a long time for the renewal and generally the process takes about six months or a year.
“After an application is received, FDA conducts a combined inspection of the blood bank with civic officials and prepares the report. The compliance committee looks at issues like shortfall of staff or equipment, and then recommendations are sent via Central Drugs Standard Control Organisation (CDSCO) officials to FDA state headquarters. Then the application, with all necessary recommendations, goes to Delhi, which revokes or extends the term. While the process is lengthy, it takes about six months to a year,” said the expert on the condition of anonymity. He added that several times, the delay takes place on the part of blood bank officials or FDA authorities that don’t pay much attention to the renewal of licenses.
BR Masal, Joint Commissioner (Drugs) FDA, said the applications may have come in the term of his preceding officer and they are in process. “The issue is that a lot of pending files are with the state FDA office which have to go to Delhi for approval. The process of renewal goes on continuously and I will have to check if the applications of these blood banks have already been sent to Delhi,” said Masal.
Gururaj Puranik, HOD Pathology, Nair Hospital said, “The due process of the license has been completed from our end.” However, another senior doctor, on condition of anonymity, said that the short staffed FDA delays the license issuing for so long that the hospital is left with merely a year to apply again. “The licenses are issued for five years, while our license expired in 2012, there is a possibility that it will be renewed later this year. Then, again in 2017 we will have to apply for renewal.”
On the other hand, Alka Kalgutkar, HOD, Pathology Sion hospital, said that there is no problem that they face due to the issue. “It’s a continuous practice and doesn’t affect the blood bank’s work. I’ll have to check if the license of our blood bank is renewed yet,” she added.
Dr Mahendra Wadiwal, Chief Superintendent for secondary care BMC hospital that looks after Rajawadi Hospital was busy and said he won’t be able to comment on the issue.