The Defence Research and Development Organisation (DRDO), which developed 2-deoxy-D-glucose or 2-DG for treatment of COVID-19 patients, has invited applications for bulk production of the oral drug.
The DRDO has called for Expression of Interest (EoI) to transfer the technology to Indian pharmaceutical industries for production.
The drug, developed by DRDO’s Institute of Nuclear Medicine and Allied Sciences (INMAS) in collaboration with Dr Reddy’s Laboratories, was granted approval for the emergency by the Drugs Controller General of India last month.
According to the DRDO, industries may apply for Expression of Interest before June 17 through email.
“The EoI submitted by industries will be scrutinised by a Technical Assessment Committee (TAC). Only up to 15 industries will be given ToT on their capabilities, technical hand holding capability of DRDO and on First Come First Served Basis,” it said.
DRDO sets criteria for bidders
The pharmaceutical industries need to have a drug license to manufacture Active Pharmaceutical Ingredient (API) from Drug Licensing Authorities and WHO GMP (Good manufacturing Practices) certification among other requirements.
The bidders should have the capacity to produce the API with approximately 2000 kg per month and bring the drug in the market within a shortest possible time. They should also not be under any ban by the Centre, states or Union territories, and any other government agency.
Laboratory synthesis process for 2-DG has been developed using D-Glucose as starting material.
The synthesis process consists of conversion of D-Glucose to 2-DG through five chemical reaction steps followed by purification.
The process has been established at batch scale (100g) and pilot plant scale (500g) and necessary patents have been filed by DRDO in this regard, the Defence body said.
2-DG helps in faster recovery of hospitalised patients
According to DRDO, the oral drug “can be easily produced and made available in plenty” being a “generic molecule and analogue of glucose”.
Clinical trial results have shown that the oral drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients. In efficacy trends, patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints.