Subject Expert Comiite asks for Drug Controller General of India approval over phase 3 trails Thymosin injection

The Subject Expert Committee at the Central Drugs Standard Control Organisation has suggested that the top drug regulator of the country to grant permission for phase 3 of clinical trial using the  Thymosin @-1 injection 1.6 mg on moderate to severe coronavirus infected  patients, informed senior health ministry official. The senior government official stated that , “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 com

Until now, Thymosin @-1 injection 1.6 mg have 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 notice that in the absence of a potential drug or vaccine against Covid-19 infection, around the world scientists and pharma experts are conducting the clinical trials to evaluate the efficacy of a medicine to combat the novel pandemic.


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