Cipla, Hetero get DCGI nod to manufacture remdesivir
With this move, domestic production of remdesivir for “restricted emergency use” can begin
The Central Drugs Standard Control Organisation (CDSCO) has granted licenses to Cipla and Hetero to manufacture and market remdesivir for the treatment of COVID-19 with moderate disease (those on oxygen).
However, the approval has been granted to license holders with conditions. They are:
- The labelling of the drug shall conform to the requirements specified in the Drugs and Cosmetics Rule 1945
- The label of the immediate container of the drug as well as packing in which the container is enclosed should contain warning i.e. to be sold by retail on the prescription of specialised for use in hospital/institutional set up only and warning should be in the box with red background
- As post-marketing surveillance, the applicant needs to submit periodic safety update reports
- All reported serious unexpected adverse reactions related to the drug needs to be intimated to the central licensing authority, and regulatory action resulting from their review shall be complied with
- No claims except those mentioned above shall be made for the drugs without prior approval from the central licensing authority
- Specimen of the carton, labels, package inserted that will be adopted for the marketing the drug in the country needs to be approved from the central licensing authority before the drug is marketed
- Updated stability study needs to be submitted at periodic intervals. If long term stability data submitted do not propose the shelf life of the product then the stability study needs to be continued to firmly establish the shelf-life and the complete stability data needs to be submitted
The drug regulating authority has also specified the conditions for shelf line storage of the drug. As per instructions, for the first three months, remdesivir injection 100mg/20ml needs to be refrigerated at a temperature of 2o Celsius to 8o Celsius until it is required for use.
Reportedly, these pharma companies have also been asked to get written informed consent from every patient, submit results of additional clinical trials and active surveillance data of all patients treated with the drug, provide a risk management plan, active post-marketing surveillance and reports of serious adverse events.
A senior official, speaking to ANI, informed, “With this development, India is soon to begin the domestic productio