Question : Use of Drugs under Clinical Trial for COVID-19

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:
(a) whether the Government has permitted the use of drugs under the clinical trials for treating COVID-19, rare genetic diseases and paediatric disorders without amending New Drugs and Clinical Trial Rules;
(b) if so, the details thereof and the drugs that the Government is likely to permit to use under the above exemption; and
(c) whether Government is aware of the countries using drugs under clinical trial for COVID-19; and
(d) if so, the details thereof and the drugs likely to be imported by the Government in this regard?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a): Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare grants permission to import/manufacture new drugs under the provisions of New Drugs and Clinical Trial Rules, 2019. No permission for manufacture/import of any new drug for treatment of COVID-19, rare genetic diseases and pediatric disorder, for which there is no provision in the existing New Drugs & Clinical Trial Rules, 2019, has been granted by CDSCO.

(b): Does not arise.

(c) & (d): As per information available in public domain, various drugs are under clinical trial for COVID-19 and are being used for treatment of COVID-19 patients by other countries.
However, CDSCO has approved manufacture/marketing of the following three drugs for Restricted Emergency Use in the country for treatment of COVID-19 infection:
a. Remdesivir Injectable formulations,
b. Favipiravir tablets, and
c. Itolizumab injection.