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New Tocilizumab stock to arrive by next week, says Pune FDA
With officials expecting fresh stock to arrive by next week, the Indian Council of Medical Research (ICMR) on Thursday issued fresh guidelines mandating the prescription of Tocilizumab only after all criteria are met which includes patients showing no signs of improvement even after use of steroids
PUNE There has been a shortage of Tocilizumab for the past ten days with the last stock acquired on August 3 by the Pune Food and Drug Administration (FDA) lasting till September 15 after which there has been no pending stock, even as the number of Covid-19 cases in the district continue to dip and the case fatality rate (CFR) remains steady.
With officials expecting fresh stock to arrive by next week, the Indian Council of Medical Research (ICMR) on Thursday issued fresh guidelines mandating the prescription of Tocilizumab only after all criteria are met which includes patients showing no signs of improvement even after use of steroids.
FDA assistant commissioner S V Pratapwar said, “It is true that we are facing a shortage of Tocilizumab now because the demand has gone up as such. We are feeling the shortage even more since the past 15 days because the last time we got the stock was on August 3. We are expecting the fresh stock to come in by next week. As of now, Tocilizumab is still a drug controlled by the district collector. The demand has gone up as we are yet to fulfill pending demand and the last stock that came in sufficed till September 15.”
The ICMR on September 23 issued fresh guidelines stating that all criteria must be met before Tocilizumab is prescribed to any Covid-19 patient. The said criteria include presence of severe disease (preferably within 24 to 48 hours of the onset of severe disease/ICU admission), significantly raised inflammatory markers (CRP and/or IL-6), no improvement despite use of steroids, and no active bacterial/fungal/tubercular infection. The recommended single dose is 4 to 6 mg/kg (400 mg in an adult weighing 60kg) in 100 ml NS over 1 hour.
As per ICMR’s latest guidelines issued on September 23, Tocilizumab (off-label) may be considered when all of the below criteria are met:
1) Presence of severe disease (preferably within 24 to 48 hours of the onset of severe disease/ICU admission).
2) Significantly raised inflammatory markers (CRP and/or IL-6).
3) No improvement despite use of steroids.
4) No active bacterial/fungal/tubercular infection.
5) Recommended single dose: 4 to 6 mg/kg (400 mg in an adult weighing 60kg) in 100 ml NS over 1 hour.
