Health Ministry approves emergency use of Remdesivir for 'moderate' COVID-19 patients

The Ministry of Health on Sunday, June 14, approved the restricted emergency use of Remdesivir as per the newly updated Clinical Management Protocol for COVID-19. Listed as an investigational therapy along with Convalescent plasma and Tocilizumab, Remdesivir should be used only in a defined subgroup of patients. The protocol also mentions that the use of these therapies is based on limited available evidence. Moreover, Remdesivir has still not received market authorization from the US Food and Drug Administration (USFDA). The aforesaid drug can be considered in patients with moderate disease (those with oxygen) not having the following contraindications:-

• AST/ALT > 5 times Upper limit of normal (ULN)
• Severe renal impairment (i.e., eGFR < 30ml/min/m2 or need for hemodialysis)
• Pregnancy or lactating females
• Children (< 12 years of age)

The dose has been prescribed as follows: 200 mg IV on day 1 followed by 100 mg IV daily for 5 days

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Written informed consent of the patient required

The Health Ministry added that the emergency use of a drug requires the written informed consent of the patient. The process also involves results of additional clinical trials, active surveillance data of all treated patients, risk management plan along with active post-marketing surveillance, and reporting of serious adverse events to be submitted. Furthermore, the first 3 batches of imported consignments will be tested and the concerned reports shall be submitted to the Central Drug Standard Control Organisation.

The CDSCO granted permission to M/s Gilead for the import and marketing of Remdesivir on June 1 in the interest of patient safety and obtaining further data. Additionally, 6 Indian companies- M/s Hetero, M/s Cipla, M/s BDR, M/s Jubilant, M/s Mylan and Dr. Reddy's Labs have applied to CDSCO for permission to manufacture and market the drug in India. 5 of the aforesaid companies have also entered into an agreement with M/s Gilead. 

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COVID-19 crisis in India

Currently, there are 3,20,922 confirmed novel coronavirus cases in India out of which 1,62,378 patients have been discharged while 9195 casualties have been reported. The country's recovery rate surged to 50.60% after 8049 patients recovered in the last 24 hours. As of now, 1,49,348 cases are under active medical supervision. The number of government and private labs for COVID-19 testing has increased to 646 and 247 respectively. 

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