New Delhi: In a significant development, the Drug Controller General of India (DCGI) has given approval to the Council of Scientific and Industrial Research (CSIR) for a clinical trial to evaluate drug efficacy to reduce mortality in critically ill COVID-19 patients.
"The CSIR India is initiating a randomised clinical trial to evaluate the efficacy of a drug for reducing mortality in critically ill Covid patients suffering from Gram-negative sepsis...DCGI has approved the trials and trials will start soon at multiple hospitals," said Lav Aggrawal, joint secretary in the Health Ministry on Tuesday.
CSIR is launching a randomised, blinded, two arms, active comparator-controlled clinical trial and given the similarities between the clinical characteristics of a patient suffering from COVID-19 and Gram-negative sepsis, DCGI has given the approval.
On the other hand, the Directorate General of Health Service (DGHS), Central Drugs Standard Control Organisation has also given permission to conduct a clinical trial of Convalescent Plasma as a therapy for COVID-19 to HCG Bangalore Institute of Oncology Speciality Centre. It may be mentioned here that a COVID-19 patient who underwent Convalescent Plasma treatment at Max hospital in New Delhi recently has responded well to the treatment.
Addressing a daily briefing over COVID-19, Agarwal said that in last 24 hours 1336 new COVID-19 cases have been reported from across India taking the toll to 18601. "So far, 3252 people (17.48 %) have recovered including 705 people who recovered yesterday. This takes our recovery percentage to 17.48 percent," said Aggrawal.
He informed that 61 additional districts from 23 states and UTs have not reported any fresh cash in the last 14 days. "Additional 4 new districts have been included in the list of districts where no Covid positive cases have been reported in the last 28 days. These districts are - Latur, Osmanabad, Hingoli and Washim in Maharashtra," he said. He said that the Health Ministry has asked all States and UTs that while we focus on COVID-19, other patients who need dialysis, or treatment for cancer, must get it.
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Referring to asymptomatic cases, Aggrawal said that by using community surveillance and contact tracing, "we are taking preemptive action to test asymptomatic persons with high-risk contact so that we are able to identify COVID-19 patients in early-stage with them and reduced mortality." Among total COVID-19 tests conducted so far, 69 percent were asymptomatic cases and 31 percent were symptomatic cases.
Meanwhile, India's apex medical research institute (ICMR) has asked States not to use rapid testing kits for two days after they were reported faulty. These kits were supplied by Chinese companies. "A lot of variations, kits will be tested and validated by on-ground teams and we will give advisory in the next two day. If there is some fault in the batch, we will ask the company to replace the kits," said Dr Ratan R Gangakhedkar from ICMR.
He said that the decision was taken following complaints from different states over RTPCR kits and their variations. "However, considering the variation, in the next two days, we have decided to send our 8 institutes to the field, collect lots and do validation of test results. Since the infection is new, we recognise that we have to refine our approach as we proceed. However, we have decided that these issue regarding variation in the detection of positive Covid cases in RTPCR samples cannot be ignored," said Dr Gangakhedkar. He said that there is significant variation in detection of RTPCR positive cases, varying from 6 percent to 71 percent.
Talking about the involvement and activities of science over COVID-19, Dr Gangakhedkar said that never before did science make such progress in just 3 months. On the other hand, Health Minister Dr Harsh Vardhan held a meeting with Indian Red Cross Society chairman and members to intensify fight against COVID-19. He also interacted Rotarians across the country with an aim to involve them to assist in involving more and more concerned people in the fight against Covid.
Health Ministry, meanwhile, has written to all health departments of states and UTs to ensure adequate availability of blood in blood banks. In particular, for people needing regular blood transfusion with blood disorders. The ministry in another order said that importation of the human remains of confirmed and suspected COVID-19 case into India is not recommended. "The ash remains after cremation poses no risk to the relatives who handle such moral remains and will be cleared," the ministry said.
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The Health Ministry has also stopped the export of anti-TB drugs. Expressing concern over the shortage of anti-TB drugs, Health Secretary Preeti Sudan has written a letter to Parameswaran Iyer, secretary, department of drinking water and sanitation and the chair of the Empowers Group for Facilitating Supply Chain and Logistic Management said that the production capacity of the leading anti-TB drug manufacturers of India has been affected as the country is fighting against COVID-19 pandemic.
"The empowered group may issue necessary direction for prohibiting export of anti-TB medicines while considering mandatorily the need of the country as overriding priority to ensure smooth supply of anti-TB drugs so that the NTEP does not face any problem in receiving this anti-TB drugs," said Sudan in her letter. Meanwhile, the central government has also set up a Covid warrior database of more than one crore Covid warriors.
"Online training had been launched. There are 20 categories and 49 subcategories in the database who can contribute to COVID-19 management efforts," the government official said.
