Subject Expert Committee seeks DCGI nod to use hepatitis injection in phase 3 trial of COVID-19 vaccine
The Subject Expert Committee (SEC) at the Central Drugs Standard Control Organisation (CDSCO) has recommended that the country's top drug regulator grant permission for phase 3 clinical trial using Thymosin @-1 injection 1.6 mg on moderate to severe COVID-19 patients, said a senior health ministry official on Wednesday.
The senior government official said: "Domestic pharma giant Gufic Bioscience has submitted its application to DCGI for its permission to use Thymosin @-1 injection 1.6 mg on coronavirus patients. Our subject experts committee reviewed it thoroughly and further recommended to the Drugs Controller General of India (DCGI) for its consideration."
So far, Thymosin @-1 injection 1.6 mg has been used in the treatment of chronic hepatitis B.
The study title presented to the drug regulator says that an open label, multi-center two arm (standard control) randomised, phase 3 clinical study is needed to evaluate the effectiveness and safety of Thymosin @-1 injection 1.6 mg as on add on treatment to existing standard care treatment in moderate to severe COVID-19 patients.
It is important to note that in the absence of an potential drug or vaccine against coronavirus infection, scientists and pharma experts around the world are conducting clinical trials to evaluate efficacy of a medicine to combat the coronavirus pandemic.