Written informed consent of each patient is required before the use of remdesivir and results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events have to be submitted.
India’s Drug Regulator on Saturday gave permission to Hetero and Cipla to manufacture and market antiviral drug remdesivir for “restricted emergency use” on hospitalised COVID-19 patients, official sources said. This comes a day after the Drug Controller General of India (DCGI), considering the emergency and unmet need for medicines in light of the coronavirus outbreak, granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market favipiravir for “restricted emergency use” in mild to moderate cases.
“The approval to Hetero and Cipla was given on Saturday,” a source said. Written informed consent of each patient is required before the use of remdesivir and results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events have to be submitted.
The Union health ministry, in its ‘Clinical Management Protocols for COVID-19’, recommended the use of the remdesivir on patients in moderate stage of the disease that is, those on oxygen. The drug has been included as an “investigational therapy” only for restricted emergency use purposes.”
It is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, the document on ‘Clinical Management Protocols for COVID-19’ stated.
The drug, administered in the form of injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for five days. Cipla and Hetero Labs have already entered into non-exclusive licensing agreements with US pharma giant Gilead Sciences, which is the patent holder of the drug remdesivir.
Gilead Sciences had applied to the Indian Drug Regulatory Agency, CDSCO, for import and marketing of Remdesivir on May 29. After due deliberations, permission under emergency use authorization was granted by DCGI on June?1 in the interest of patient safety and obtaining further data.
Besides Hetero and Cipla, three other firms BDR, Jubilant, Mylan and DR Reddy’s Labs have also applied to CDSCO for permission to manufacture and market the drug in India and are still awaiting permission.
These applications are being processed by the CDSCO in accordance with the laid down procedures. The companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol etc, the health ministry had earlier said.
Being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility become very critical for patient safety and this data need to be provided by the companies, the ministry had said.