CDSCO grants import approval to MGC Pharma CimetrA for Covid19
New Delhi: In a significant development, the Central Drugs Standard Control Organisation (CDSCO) has granted a license to a European biopharmaceutical company, MGC Pharma, to import CimetrA into India in order to complete final product testing for its application for Emergency Use Authorisation (EUA) to treat patients with Covid-19.
This import license will aid in the completion of the application for an Emergency Use Authorization for CimetrA to treat Covid-19 patients. The Emergency Use Authorisation would enable MGC Pharma to market and sell CimetrA as an approved medicine for the treatment of COVID‐19 in India, and potentially in other territories under international Mutual Recognition protocols for medicines.
The application for Emergency Use Authorisation by CDSCO has been coordinated by P.T.K. Consulting Ltd (PTK), an Israeli consulting company operating in the fields of Medicine, Medical Technology, and Pharmaceuticals, as per a recent release by MGC Pharma.
Medopharm, one of the manufacturers and exporters of pharmaceutical products in India, is managing the Emergency Use Authorisation process for CimetrA in India on MGC Pharma's behalf. Medopharm has been appointed as the importer of CimetrA in India once the Emergency Use Authorisation has been granted.
The Emergency Use Authorisation allows local regulators to help strengthen the nation's public health protection against chemical, biological, and other threats, including infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies.
"Medopharm has over 50 years of experience in inhouse development and licensing of medicinal products and will use this experience to manage the Marketing Authorisation approval process for CimetrA in India, on behalf of MGC Pharma," the release added.
MGC Pharma has secured this import license from CDSCO for CimetrA to enable it to submit final samples of CimetrA for testing and analysis. If the tests are successful, the temporary import approval will be converted to a permanent approval once CimetrA has been registered as a medicine in India under the Emergency Use Authorisation Protocols. The process is expected to take 90 days from the import of the CimetrA samples into India.
To meet the potential significant increase in demand for CimetrA as a result of the Emergency Use Authorisation in India, MGC has secured agreements with two additional EU GMP certified production facilities which can be used to manufacture large commercial quantities of CimetrATM until the Company's Malta production facility completes its commissioning and is fully operational in 2022.
CimetrA is a nanoparticle micellar formulation based on a pharmaceutical synergetic composition consisting of Curcumin and Boswellia. CimetrA has antiinflammatory and immunomodulating effects, and can be designed for multiple therapeutic applications utilising selfnanoemulsifying drug delivery systems.
Preclinical and clinical results to date have demonstrated CimetrA's mechanism of action as an anti‐inflammatory and immunomodulatory agent effective in the prevention of severe inflammation by control of the increased cytokine production found in different variants and mutations of COVID19, the forerunner of cytokine storm, believed to be the main reason for mortality in severe COVID19 patients.
CimetrA is currently undergoing a Phase III clinical trial in Israel as an Investigational Medicinal Product for the treatment of COVID19 following successful Phase II trials in 2020. The first patient was enrolled in the trial in July 2021.
Roby Zomer, Cofounder and Managing Director of MGC Pharma, commented, "We are pleased to have secured a license to import CimetrA as an Emergency Use Drug in India, and hope that we can secure approval swiftly to expand its availability to a much wider patient base. India has been acutely affected by the COVID‐19 pandemic and we believe that CimetrA can make an important difference in treating the symptoms of COVID‐19 and alleviate patient suffering. It is important that we have secured Medopharm, as the importer and the marketing authorisation holder of CimetrA given their vast experience of taking medicinal products through the process to full approval for sale."
