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 production of anti-viral drug remdesivir which would have efficacy, stability, safety for “restricted emergency use” on COVID-19 patients. Two pharma giants–Cipla and Hetero were ahead among the other applications. Some of the companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol etc.”
Speaking on the approval from DCGI, Dharmesh Shah, CMD, BDR Pharmaceuticals told Usha Sharma from Express Pharma, “I am very happy that regulators fast-tracked clearance. This will help many patients in need of medicines. In the last few days, we received several calls from doctors for patients suffering from COVID-19 and also NRIs whose parents or relatives are in critical condition and in need of remdesivir. We did whatever we could to help on compassionate grounds. Now, we can help freely to benefit needy patients, thanks to regulators. We are completely geared up to ensure that patients don’t need to struggle for medicines.”
Cipla has a contract manufacturing agreement with BDR Pharmaceuticals for remdesivir.