COVID-19 Updates : Status of Remdesivir

June 14, 2020
Doctor drawing ecg heartbeat chart with marker on whiteboard concept for healthcare and medicine

India

healthysoch

New Delhi, June 14, 2020 :

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.

Stay informed with the latest news from HealthySoch. Sign up today for exclusive insights and updates!

We promise we never spam!

Leave a Reply

Your email address will not be published.

Health Tips

Dr. T S Kler Padma Bhushan Awardee
MD, DM, MRCP, FRCP(U.K), FACC, D.Sc
Chairman – Fortis Heart Institute Gurugram

Precautions to avoid Corona Virus:

  1. Stay home as far as possible.
  2. Wash hands with soap and water frequently.
  3. Keep distance from people even your home members.
  4. Keep atleast 1-2 metres away from anybody coughing.
  5. Don’t touch your face, nose and mouth.

 

Dr. K.K Says

Archives

MonTueWedThuFriSatSun
    123
45678910
18192021222324
25262728293031
       
   1234
567891011
12131415161718
26272829   
       
891011121314
293031    
       
    123
45678910
11121314151617
25262728293031
       
  12345
6789101112
13141516171819
27282930   
       
      1
2345678
9101112131415
16171819202122
3031     
     12
17181920212223
24252627282930
31      
   1234
567891011
12131415161718
2627282930  
       
1234567
891011121314
22232425262728
293031    
       
     12
3456789
17181920212223
24252627282930
       
  12345
6789101112
       
  12345
13141516171819
2728     
       
      1
9101112131415
3031     
   1234
567891011
       
282930    
       
    123
45678910
       
  12345
27282930   
       
      1
3031     
    123
11121314151617
       
28      
       
2930     
       
    123
       
       
       
      1
9101112131415
3031     
     12
3456789
10111213141516
17181920212223
242526272829 
       
  12345
13141516171819
2728293031  
       
      1
23242526272829
3031     
    123
       
    123
25262728   
       
78910111213
28293031   
       
293031    
       
14151617181920
28293031   
       
   1234
567891011
       
   1234
567891011
262728    
       
891011121314
293031    
       
    123
18192021222324
25262728293031
       
  12345
27282930   
       
      1
2345678
16171819202122
3031     
    123
45678910
18192021222324
       
28293031   
       
     12
31      
   1234
       
  12345
6789101112
       
HealthySoch

Don't Miss

HANTA VIRUS DEATH IN Wuhan China

India healthysoch Dr K K Aggarwal, President CMAAO, HCFI and

WHO strongly recommends Dolutegravir as preferred HIV treatment option

healthysoch Mexico City , July 23, 2019 : Based on