NEW DELHI: After permitting restricted emergency use of antivirals Remdesivir and Favipiravir in COVID-19 patients, the government on Wednesday issued guidance on the manner of supply of drugs to ensure their proper use.
The apex drug regulator said Remdesivir injectable formulations allowed for use in severe COVID-19 patients can’t be sold off chemist counters and will only be supplied for use directly to hospitals and institutions.
Favipiravir tablets, approved by Drug Controller General of India (DCGI) for use in mild to moderate COVID-19 cases, will, however, be available at chemist shops.
“Both drugs will be sold only on medical prescription by the treating doctor and in both cases, informed consent of the patient or his representative in a prescribed form are mandatory before initiating treatment,” DCGI VG Somani said in an order today.
Informed consent form requires patients to sign up for: “I have been informed of the possible benefits and well as risks (including side effects) from the usage of the drug by my physician after which I have made an informed choice to take it.”
In a major development, the government has restricted the stability period for Favipiravir tablets to four months from June to September which means its use will be reviewed after four months.
“The idea is to collect efficacy data on the drug which has been approved for COVID use for the first time in India. The current shelf life of FabiFlu which Glenmark will market is only four months. If the efficacy data is satisfactory the expiry date can be extended. If not, drug use can be modified,” a source said.
While Remdesivir injectable formulations are expected to be available within 48 hours in hospitals, Favipiravir has already been stocked by chemists.
DCGI has allowed Cipla and Hetero Drugs to manufacture and market the generic version of Remdesivir, originally developed by the US-based Gilead Sciences; while Glenmark Pharmaceuticals have been permitted to make Favipiravir, the first oral therapy for COVID-19. Favipiravir has shown rapid reductions in viral load in limited trials.