ICMR Director General Balram Bhargava told the media on Tuesday that Tocilizumab and Itolizumab, which have received permission from the Drugs Controller General of India for use in moderate to severe COVID-19 patients, have not shown any reduction in mortality during the trials. The ICMR DG was responding to a question on norms for off-label use of drugs during a press briefing on Tuesday.
Officer on Special Duty (OSD) to the Health Ministry Rajesh Bhushan said that the drugs have been given emergency authorisation by the DCGI. This is a process available globally to all regulators, which means that based on restricted evidence submitted by drug makers to the regulator, an emergency authorisation is given, which is distinct from a market authorisation.
"Market authorisation, whenever it is given by a regulator, means that the manufacturer of that drug can freely market it. Emergency authorisation means that it can be procured only in emergency circumstances, the treating clinician has to certify this and informed consent needs to be obtained. In case a patient is not in a condition to provide this consent, the caregivers or family members can give the same," Dr Bhargava said.
He added that in severe patients of COVID-19, there is a problem of a cytokine storm. Cytokines are released by the immune system and can affect other cells, and they are responsible for a storm that ultimately leads to serious conditions.
These two drugs produced by Bengaluru-based biotech major Biocon – Tocilizumab and Itolizumab – are believed to be preventing the cytokine storm. They have received permission from the Drugs Controller General of India for use in moderate to severe COVID-19 patients. Biocon’s Itolizumab will hit the market as ALZUMAb.
"Having said that, they have not yet demonstrated mortality reduction by any trial and therefore, trials are happening in different parts of the world to look at whether there is mortality reduction with these two drugs,” Dr Bhargava said.
He also said that human clinical trials for a vaccine have been initiated in the country with approximately 1,000 volunteers participating in the exercise for each of the two indigenously developed vaccine candidates.
Earlier, Biocon faced a lot of criticism over the small scale of trials based on which it received approvals. Biocon tested the drug in a small clinical trial involving only 30 people. On Twitter, Biocon chairperson Kiran Mazumdar Shaw stated that the company will carry out more clinical trials and currently, only emergency authorisation has been given to the drug.
“His (ICMR DG's) statement is right, as he is saying to establish this (mortality reduction) you need larger data sets to corroborate these findings and we will do it through India PH-4 n US clinical trials. Emergency use in COVID-19 is only because of promising findings to save lives,” Shaw said in a tweet, responding to questions by journalists.
Shaw had earlier stated that Itolizumab will come in the form of an injection containing 25mg/5mL solution for emergency use in India for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ADRS) patients caused by the COVID-19. Shaw said the therapy costing Rs 32,000 is given to the patient in four vials with each vial priced at Rs 8,000.
With PTI inputs