Hyderabad: BDR Pharma, a leading pharmaceutical company, has received approval and signed a license agreement with the Hyderabad-based Defence Research and Development Establishment (DRDE) and the Institute of Nuclear Medicine and Allied Sciences (INMAS) of the Defence Research and Development Organisation (DRDO) for the manufacturing, distribution, and marketing of an oral medicine to treat COVID-19 patents.
Last month, the Drugs Controller General of India (DCGI) approved the 2- Deoxy-D-Glucose (2-DG) medication for emergency usage as adjuvant therapy in mild to severe COVID-19 patients in India.
The DRDE, which is based in Gwalior, had produced the 2-DG. Clinical trials were undertaken in collaboration with Dr. Reddy’s Laboratories and Institute of Nuclear Medicine and Allied Sciences (INMAS), a DRDO lab, said a press release.
After receiving positive responses in Phase-II and Phase-IIb trials, the DCGI permitted 2DG phase-III trials in November 2020. The Phase-II trial, which lasted from December 2020 to March 2021, enrolled 220 patients. The medicine was discovered to speed up the recovery of COVID-19 patients in hospitals and to lessen the need for supplementary oxygen in COVID-19 patients, it added.
Dharmesh Shah, CMD, BDR Pharmaceuticals, said, “We are pleased to secure a license from the DRDO and add 2-Deoxy-D-Glucose to our Covid product offering. This arrangement aims to ensure that this drug reaches as many eligible Indian patients as possible who are suffering from the devastating pandemic.”
The collaboration to manufacture 2-DG will improve local treatment options. Clinical trial data supplied by the government based on the emergency approval demonstrated that the chemical aids in the speedier recovery of COVID-19 patients and minimizes their reliance on supplementary oxygen.
The product will be priced competitively and will be available in powder form in a sachet that can be consumed orally after being dissolved in water. BDR has applied to the Drug Controller General of India (DCGI) for restricted emergency use authorization to manufacture Drug 2-DG to treat COVID-19 patients in India. For the development of 2-DG drugs, the DRDO has recently signed agreements with four major Indian generic medicine producers.