From Our Bureau

14TH JUNE 2020

A total of 3,20,922 confirmed cases of COVID-19 have been reported in the country so far and the death toll rose to 9,195 on Sunday.

With 8,049 COVID-19 patients cured in the last 24 hours, the recovery rate has increased to more than 50 percent. A total of 1,62,379 patients, so far, have been cured of COVID-19. Currently, the recovery rate is 50.60 percent. This indicates that of all the cases of COVID-19, half of them have recovered from the disease. Timely case identification and proper clinical management has been the road to recovery. Currently, 1,49,348 active cases are under medical supervision.

ICMR‘s testing capacity for detecting the novel Corona virus in infected persons is continuously being ramped up. The number of government labs has been increased to 646 and private labs has been increased to 247 (a total of 893). In the last 24 hours, 1,51,432 samples were tested. The total number of samples tested thus far is 56,58,614.

Today, the Union Health Minister along with the Union Home Minister held a meeting with the Lieutenant Governor of Delhi and Chief Minister of Delhi to review the COVID-19 situation in the NCT of Delhi. Strengthening of containment measures, ramping up testing and adequate health infrastructure preparedness were discussed in the meeting.

Union Home Minister Amit Shah said that the Central Government is committed to check the COVID-19 spread in Delhi and keep the national capital safe. In a meeting with the Chief Minister Arvind Kejriwal besides senior officers, several important decisions were taken to ensure safety of the citizens of Delhi against the infection.

Shah said that in view of the scarcity of beds for Corona patients in Delhi hospitals, the Central Government has decided to immediately provide 500 converted rail coaches to the Delhi Government. With this, 8,000 more beds will be available in Delhi and these will be equipped with all facilities in the treatment of COVID-19 patients.

The Union Home Minister said house-to-house health surveys will be conducted in Containment Zones in the capital to improve Contact Mapping, and the survey report will be available within a week. For effective monitoring, all residents will be asked to download Aarogya Setu app on their mobile phones.

The Home Minister said COVID-19 testing will be doubled within the next two days and trebled after six days in order to check the Corona virus spread in Delhi. Besides, in the Containment Zones, testing facility will be made available in each Polling Station.

For effective transmission of guidelines and information regarding Corona virus to clinics and minor hospitals in Delhi, the Central Government has decided to constitute a Committee of senior doctors in AIIMS so that the Best Practices in the fight against Corona are communicated to the lowest level. A Helpline Number on telephonic guidance will be set up and released tomorrow.

Shah said a Committee has been constituted under the chairmanship of Dr. VKPaul, Member NITI Aayog, to ensure the availability of 60 percent of their Corona beds by private hospitals at lower rates and to fix the rate of Corona testing and treatment. The Committee will submit its report by tomorrow.

The Home Minister underlined the country’s resolve in tackling the Corona pandemic with vigour and strength and shared the pain of the families who have lost their dear ones. He said the Government has decided to issue fresh guidelines regarding the last rites of the deceased, which will reduce the waiting time.

Amit Shah said the nation is fighting this global outbreak with alertness and cooperation of all under the leadership of Prime Minister Narendra Modi. The country is also sincerely indebted to several NGOs for their exemplary devotion during this crisis. In this effort, the Government has decided to enroll the services of Scouts & Guides, NCC, NSS and other voluntary organizations as volunteers, with Health Services. The Central Government has decided to depute five more senior officers to the Delhi Government in order to effectively fight the Corona virus.

Several other decisions were also taken during today’s meeting. A joint team of doctors of the Health Departments of Government of India and Delhi Government, AIIMS and all three Municipal Corporations of Delhi will visit all Corona Hospitals in Delhi and submit a report after inspecting the Health Infrastructure and preparedness for treatment of COVID-19 patients.

Shah issued directions to ensure that the various decisions taken today are implemented at the ground level by the Health and other Departments of Central and Delhi Governments and experts.

The Central Government assured the Delhi Government that it would provide all necessary resources including Oxygen cylinders, Ventilators and Pulse Oximeters.

Meanwhile, there are reports in a section of the media regarding the use of Remdesivir as part of the Clinical Management Protocol for COVID-19, and its availability in the country. 

An updated Clinical Management Protocol for COVID-19 has been released by the Ministry of Health and Family Welfare on 13th June, 2020 in which the drug Remdesivir has been included as an “investigational therapy” only for restricted emergency use purposes along with off label use of Tocilizumab and Convalescent Plasma. The said protocol also clearly mentions that the use of these therapies is based on limited available evidence and limited availability at present. Use of Remdesivir under emergency use may be considered in patients with moderate disease (those on oxygen) but with no specified contraindications.

This drug has still not been approved (market authorization) by the US Food and Drug Administration (USFDA), where like India it continues only under an Emergency Use Authorization.

Restricted Emergency Use of drugs in the country for treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalised with severe disease is subject to the following conditions- Written informed consent of each patient required, results of additional clinical trials to be submitted, active surveillance data of all treated patients to be submitted, risk management plan along with active post marketing surveillance and reporting of serious adverse events also to be submitted. Additionally, first three batches of imported consignments are to be tested and reports submitted to Central Drug Standard Control Organisation (CDSCO).

M/s Gilead had applied to the Indian Drug Regulatory Agency, namely CDSCO, for import and marketing of Remdesivir on 29th May, 2020. After due deliberations, permission under Emergency Use Authorization was granted on 1st June, 2020 in the interest of patient safety and obtaining further data.

Six Indian companies, namely M/s Hetero, M/s Cipla, M/s BDR, M/s Jubilant, M/s Mylan and Dr. Reddy’s Labs have also applied to CDSCO for permission to manufacture and market the drug in India. Five of these have also entered into an agreement with M/s Gilead. These applications are being processed by the CDSCO on priority and in accordance with the laid down procedures. The companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol etc.

Being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility become very critical for patient safety and this data need to be provided by the companies. CDSCO is awaiting the data and is providing complete support to these companies. It has already waived off the requirement of local clinical trials for these companies by invoking emergency provisions. The regulatory processes are being facilitated and expedited by CDSCO. (eom)

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