The Defence Research and Development Organisation (DRDO), which developed 2-Deoxy-D-Glucose (2-DG), a drug used for treatment of Covid-19 patients, has called for Expression of Interest (EoI) to transfer the technology to Indian pharmaceutical industries for production.
2-DG was developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO, in collaboration with Dr Reddy's Laboratories.
Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients.
According to the EoI document, applications should be submitted 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.
The bidders should have a Drug licence to manufacture Active Pharmaceutical Ingredient (API) from Drug Licensing Authorities and WHO GMP (Good manufacturing Practices) certification among others.
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.
CSIR-IICT, pharma firm sign agreement for production of 2-DG
Hyderabad-based Lee Pharma has entered into an agreement with the Indian Institute of Chemical Technology (IICT), a constituent laboratory of CSIR, to manufacture and commercialise 2-Deoxy-D-Glucose (2-DG) used to treat Covid patients, a statement said on Wednesday. An integrated pharmaceutical company, Lee Pharma entered into the non-exclusive licensing agreement for the synthesis of 2-DG, recently developed by DRDO and Dr Reddy's Laboratories.
The drug has received approval for use in Covid-19 patients. It has been found to help speed up recovery and reduce oxygen dependence, and Dr. Reddy’s Laboratories has launched the drug in the form of sachets.
Lee Pharma said they would file the application for getting the approval from the drug regulator. It will manufacture and commercialise the 2-DG sachets from their formulation facility located at SEZ, Duvvada, Visakhapatnam, Andhra, which has the accreditation by global regulatory agencies, the Council for Scientific and Industrial Research (CSIR) said.
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New Delhi: Hyderabad-based vaccine manufacturer Bharat Biotech, carrying out its phase 3 trial will publish the data in July following the company will be applying for the full licensure of Covaxin. “It is critical to understand, and further emphasise the Phase 3 data will first be submitted to Central Drugs Standard Control Organisation, followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier COVAXIN(r) phase 3 results full trial data will be made public during July. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN(r),” Bharat Biotech said.
About the efficacy of the vaccine, it said, “Vaccine efficacy refers to the ability of a vaccine to bring about the intended beneficial effects on vaccinated individuals in a defined population under ideal conditions of use. When it comes to efficacy and safety, the efficacy data of Covaxin have been reported at overall efficacy is 78% and efficacy against hospitalisations is 100%.”
Monoclonal antibody can change Covid scenario: Hospital
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Rockwell ties up with Dr Reddy’s lab for Sputnik V freezer
Hyderabad: Hyderabad-based Rockwell Industries has joined hands with Dr. Reddy's Laboratories to provide its WHO PQS (World Health Organisation - Performance, Quality and Safety) certified Covid vaccine freezers to enable storage of Sputnik V vaccine across India. A Rockwell statement said, the Covid-19 vaccines are temperature sensitive, hence require precise temperature to maintain its potency. The vaccine freezer plays a very critical role in the safety of vaccines and its potency. Sputnik V vaccine made available in India through Dr. Reddy's requires a temp range of -18°C, to keep the vaccine stable and potent. "Rockwell took lead in developing the vaccine freezers as per the WHO PQS Standard and after 3 years of efforts, R&D Team of Rockwell achieved stringent design protocol and finally the product was tested at WHO authorised test lab, Denmark and got 2 different sizes of vaccine freezers certified.