At least 53 blood banks across Maharashtra, attached to noted government and private hospitals are functioning without a valid licence, revealed an RTI query. Experts, blaming lethargy on the part of Food and Drugs Administration (FDA) and of Drugs Controller General of India (DGCI), said officials have been sitting on files for years forcing the blood banks to function with an expired licence.
The query, filed by activist Chetan Kothari revealed six regions — Greater Mumbai, Konkan, Aurangabad, Nagpur, Nashik and Pune — which have 53 blood banks, functioning with an expired license. Eight blood banks from Mumbai include JJ Mahanagar Raktapedhi and St George Hospital blood banks that are awaiting license renewal from more than three to four years now.
Kothari said while the licences are valid for five years, it is important as the joint inspections carried out by FDA and Central Drug Standard Control Organisation (CDSCO) help eliminate errors. “The issue might be technical, but it’s illegal to run a blood bank with expired licences. Moreover, since the penalising and licence renewing authority is the same, no action is ever taken in this regard,” said Kothari.
RPY Rao, a Dadar-based health activist said this inaction is akin to playing with patients’ safety. “The period is kept as five years because the joint inspections rule out the errors on the part of the blood banks such as shortage of doctors, unavailability of kits to test antibodies or other equipment related issues. In the absence of inspections, the blood banks will continue to function with loopholes,” said Bhide.
The data revealed that 95% of blood banks have completed the process from their side. Moreover, the delay is causing the individual head of departments to apply over and over again even after timely completion. “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,” said a senior doctor from one of the blood banks awaiting renewal.
A senior FDA official said the problem occurs due to short staffed inspecting bodies and confusion between FDA, CDSCO and DCGI. “Some time back, DCGI had authorised their state counterparts to issue and renew licenses. After a while, they retained the right and asked the state bodies to send the files again for approvals. That caused a lot of confusion and thus delayed the entire process,” said the official.
BR Masal, Joint Director FDA (Drugs) accepted the delay and said the process will now be streamlined. “We have cleared a lot of files in recent times. Now since joint inspections are happening rapidly, soon we will clear the backlog,” said Masal.