Home >Science >Health >Govt to start phase 3 trial to check efficacy of umifenovir

NEW DELHI : Government laboratories will soon start phase III trials of umifenovir, an anti-viral drug that is used in Russia and China for treating influenza, to see if it also works on covid-19 patients. Phase III trials involve testing a drug for safety and efficacy on a large number of humans, usually running into thousands.

Council of Scientific and Industrial (CSIR) constituent lab CSIR-Central Drug Research Institute (CDRI) in Lucknow has received approval from the Drugs Controller General of India (DCGI) for carrying out the tests.

The trials will be carried out at King George’s Medical University, Dr. Ram Manohar Lohia Institute of Medical Sciences and ERA’s Lucknow Medical College and Hospital, Lucknow, the department of science and technology said in a statement.

“This drug has a good safety profile and acts by preventing the entry of virus into human cells and also by priming the immune system," said the statement. To be sure, umifenovir does not have the approval of the US drug administration for treatment or prevention of influenza.

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Graphic: Mint


CSIR-CDRI has developed the process technology for umifenovir in record time and licensed it for manufacturing and marketing the drug to Goa-based Medizest Pharmaceuticals Pvt. Ltd, which has received a test licence from the DCGI.

“All the raw materials for the drug are indigenously available and if the clinical trial is successful, umifenovir can be a safe, efficacious, affordable drug against covid-19 and can be part of the national programme against covid-19," said Tapas Kundu, director CSIR-CDRI.

“This drug has the potential for prophylactic (preventive) use," he said.

The clinical trial application was processed on high priority. The next steps of the trial are being fast-tracked to enable the availability of the drug to Indian patients as soon as possible.

“This clinical trial is an integral part of the CSIR strategy of repurposing drugs for covid-19 and complimented the team of scientists of CSIR-CDRI, Nilanjana Majumdar, Ajay Kumar Srivastava, Chandra Bhushan Tripathi and Nayan Ghosh, who were coordinated by Dr. Ravishankar Ramachandran, nodal scientist," said Dr Shekhar Mande, director-general, CSIR.

Meanwhile, health minister Harsh Vardhan on Thursday launched India’s first mobile I-Lab (infectious disease diagnostic lab) for covid-19 testing. “It will be deployed in remote, interior and inaccessible parts of the country and have capability to perform 25 covid-19 RT-PCR tests/day, 300 ELISA tests/day, additional tests for TB, HIV etc. as per CGHS rates," the government said.

The I-LAB is supported by the department of biotechnology, ministry of science and technology, under the covid command strategy.

In the past 24 hours, 7,390 covid-19 patients were cured in India. A total of 194,324 patients, so far, have been cured, taking the recovery rate to 52.96%. Currently, 160,384 active cases are under medical supervision.

The number of covid-19 cases increased to 372,685 on Thursday and the death toll increased to 12,389.

“The death toll will keep climbing as the virus spreads and given India’s large population," said Dr Ramanan Laxminarayan, director of Center for Disease Dynamics, Economics and Policy. “The overall mortality rate has been low because of the relatively small proportion of the population that is over 60. Going forward, the focus should be firmly on the elderly population and those with co-morbidities to keep mortality relatively low."

In the past 24 hours, 165,412 samples were tested. The total number of samples tested thus far is around 6.2 million.

The health ministry on Thursday issued an advisory for managing healthcare staff working in covid and non-covid areas of hospitals. The government said that the healthcare personnel working in hospitals are at an increased risk of getting the disease, if there is a breach in the personal protection while managing patients. A large number of covid-19 affected health personnel are getting isolated for treatment and their close contacts undergoing quarantine affects the health/hospital service delivery, the government said.

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