According to the WHO, fungal keratitis is a leading cause of monocular blindness i.e, blindness in one eye, in the developing world. According to a recent study published in Lancet, the highest annual incidence per 1 lakh people is reported in Southern Asia and India accounts for more than 50% of the fungal keratitis cases out of total microbial keratitis cases.

Currently,available drugs for fungal keratitis are less effective, especially in severe disease due to poor drug penetration, poor bioavailability, and antifungal efficacy. US FDA-approved Natamycin is employed as a primary line of treatment for fungal keratitis but due to poor ocular penetration, it requires prolonged and frequent dosing, causing discomfort to patients.

To develop a better antifungal strategy for fungalkeratitis,an all-women team of IIT Delhi researchers led by Prof. Archana Chugh from Kusuma School of Biological Sciences(along with her PhD students- Dr. Aastha Jain, Harsha Rohira, and Sujithra Shankar) has been working in collaboration with Dr. Sushmita G Shah, Ophthalmologist and Cornea Specialist from Dr. CM Shah Memorial Charitable Trust and Eye Life, Mumbai.

The team has successfully developed a novel peptide-based antifungal strategy for enhanced Natamycin penetration.The developed peptide-drug conjugate showed an appreciable antifungal effect in the lab.

“These peptides are known to have the ability to carry molecules with them in the cells. Therefore, when poorly permeable Natamycin was attached to the peptide, the formed complex showed better antifungal effect”, Prof Archana Chugh said.

In their research study, the scientists found that conjugate drug penetration was 5-fold higher than Natamycin in rabbits, thus enabling lowering of the dosage frequency. Further, 44% of miceshowed complete resolution of fungal infection with the novel conjugate as compared with 13% of mice that were treated with Natamycin suspension only. The study has been recently published in the International Journal of Pharmaceutics.

The animal studies were carried out in collaboration with Dr. Shikha Yadav, Head of Animal Facility at the National Institute of Biologicals, NOIDA. The research was initially funded by the Department of Biotechnology followed by Nanomission, Department of Science and Technology, Government of India.

Prof Chughfurther said, “This is a great example of “Make in India”; however, afew hurdles persist for us before this novel conjugate can enter the clinics and is useful to patients. With promising results obtained in the animal studies, we are hopeful that the Biotechnology/ Pharmaceutical industry will come forward for its clinical trials.”

Dr. Sushmita G Shah, Ophthalmologist & Cornea Specialist, Eye Life, Mumbai said, “Collaboration between Clinicians and Scientists is important to develop newer and better drugs, diagnostic devices, etc., which can improve patient care. We are very excited with the results obtained so far and look forward to initiating a clinical trial with the participation of the Industry and other relevant agencies.”

While speaking of the research study by the team led by Prof Chugh, Dr. Virender Singh Sangwan, Director Innovations, Dr. Shroff’s Charity Eye Hospital, New Delhi said, “The study clearly demonstrated enhanced penetration and effectiveness of a conjugated form of Natamycin for the treatment of fungal keratitis. In India and most of the developing countries, fungal keratitis is a significant public health problem and is responsible for almost 50% of cases of keratitis. Currentlyavailable treatment such as Natamycin has poor penetration of the drug into the cornea and hence results in delayed response to treatment.”

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Keywords: Antifungal, fungal eye infection,cornea, eyes,fungal keratitis, WHO, monocular blindness,Natamycin, ocular penetration, Dr. Shroff’s Charity Eye Hospital, Ophthalmology

This kit can be used for in vitro qualitative detection of SARS-CoV-2 antigen.The SARS-CoV-2 Ag Rapid Test is a colloidal gold enhanced double antibody sandwich immunoassay for the qualitative determination of SARS-CoV-2 antigen in human nasal swabs, throat swabs, and deep sputum samples. It is suitable for general population screening and diagnosis of COVID-19.

The invention is directed towards an in vitro diagnostic kit for the qualitative detection of SARS-CoV-2 coronavirus antigens in the nasopharyngeal swab, using the rapid immune chromatographic method.The identification is based on the monoclonal antibodies specific for the Coronavirus antigen.The results obtained are qualitative based and can be inferred visually with the naked eye.

A SARS-CoV-2 positive specimen produces a distinct color band in the test region, formed by the specific antibody antigen-colored conjugate complex”(Au-SARS-CoV-2-Ab)-(SARS-CoV-2-Ag)-(SARS-CoV-2-Ab)”.  The absence of this colored band in the test region suggests a negative result.A colored band always appears in the control region serving as procedural control regardless of the specimen contains SARS-CoV-2 or not.

The test is found to be suitable for early Ct values (Between 14 to 32) with a Sensitivity- 90%, Specificity- 100% and Accuracy- 98.99%, and certified by the ICMR. These are one of the best available values for any such test kit.The technology and its manufacturing are 100% indigenous, explained Dr. Harpal Singh.

MoS, Shri Sanjay Dhotre said, “I am confident that this technology will revolutionize the COVID test availability in the country. I am glad to know that the kit has been developed entirely using the internal resources at IIT Delhi.”He informed that Prime Minister Narendra Modi led government is focused on Atmanirbhar Bharat through research, development, and innovations. The focus on research in National Education Policy, National Research Foundation and initiatives like PM Research Fellowship will help further to improve the quality of research in our country. Technology plays important role in wealth creation. IITs being premier technology institutions play a major role here.

He further asked the premier institutes to make the research centres and innovation parks in their campuses more vibrant and activate industry-academia linkages. For popularising science technology among general citizens, he asked the scientists and technologists to write more on these issues in print and other media, to deliver lectures for the general public, and to venture into the field of popular science fiction and non-fiction writing. Mechanisms to be developed for regular interaction of IIT professors and students with the school students in the vicinity, and vice versa, to inspire the school students to venture in the field of science and technology, Shri Dhotre said.

Speaking on this occasion, Prof. V Ramgopal Rao, Director, IIT Delhi said, “IIT Delhi had in July 2020 launched a Rs. 399 RT PCR kit, which helped bring the RTPCR test costs to the current level. Using the technologies developed in the Institute, over 8 Million PPE kits have been supplied so far. With the launch of this Antigen based rapid test kit, we hope to make the diagnostics easy and affordable for the rural areas.”

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Keywords: IIT Delhi, Rapid Antigen Test, COVID-19, Ministry of Education, Centre for Biomedical Engineering, SARS-CoV-2, Antigen, Immunoassay,Nasal swabs, Throat swabs, Sputum samples, Diagnosis

Cryo-EM has revolutionized structural investigations of macromolecules in recent times. It is a testimonial for a revolutionary technology for structural biologists, chemical biologists, and ligand discovery, which has gained a clear edge over contemporary x-ray crystallography. In light of these advancements, cryo-electron microscopy technique was recognized with the Nobel Prize for the high-resolution structure determination of biomolecules in solution (2017). The revolution in resolution resulted in atomic-level understanding of the Zika virus surface proteins, thus aiding structure-based drug discovery, deciphering of structure of hard-to-crystallize membrane proteins and other macromolecular complexes.

The National Facilities supported by the Science & Engineering Research Board (SERB), an institution under the Department of Science & Technology (DST), would help explore Macromolecular Structures and Complexes” and create research knowledge base and skills for cryo-EM research in India to establish leadership in structural biology, enzymology, ligand/drug discovery.

The establishment of these facilities in all directions of the country–Indian Institute of Technology, Chennai; Indian Institute of Technology, Bombay; Indian Institute of Technology, Kanpur; and Bose Institute, Kolkata would help in scaling up cryo-EM based structural biology research in different corners across the country. These centers are designated as SERB National Facility for Cryo-Electron Microscopy and will work on the identified thrust areas. They will be accessible to all researchers.

Housed with 200kV machines have added advantages like lesser maintenance and can help generate human resources through training, which can also help sustain the facility for longer duration. Each Cryo-EM facility costs about Rs. 28.5 crore for a period of five years and an amount of Rs. 114 crores for research in the critically important research areas.

While IIT Chennai will focus on nano-biointerfaces (e.g. materials–microbes, materials–human tissue), IIT Bombay will execute research on ribosome translation and its implication in disease and antibiotic resistance, neurodegenerative disorders and tackle problems to address solutions to cancer, membrane structure, composition, dynamics & transport. IIT Kanpur will conduct research focused on macromolecular structures and drug discovery with a specific focus on membrane proteins, and Bose Institute, Kolkata will focus on transforming the structure-guided drug discovery and therapeutics research for communicable and non-communicable diseases, allosteric drugs, transcription, and epigenetics.

The first national cryo-EM facility was established at National Centre for Biological Sciences (NCBS) in 2017 and then subsequently in IISc, Bangaluru, and RCB Faridabad. However, it was felt that the existing cryo-EM research facilities in the country are not adequate to leave a mark at the global stage. Historically, Indian scientists have contributed significantly in the area of Prof. GN Ramachandran and Dr. G. Kartha made a remarkable contribution to structural biology, biological, chemical, physical, computational, and theoretical crystallography and materials crystallography. Given significant advances in cryo-EM of large structures, SERB has taken the responsibility that concerted funding should be provided to establish leadership in this area to enable and empower Indian researchers to lead from the front.

The hand sanitizer has been developed by WeinnovateBiosolutions. The slow-release silver nanoparticles prolong antimicrobial activity thus obviating the need for repeated applications. It has cleared Central Drugs Standards Control Organisation (CDSCO) approved clinical trial for the hand sanitizer and demonstrated high efficiency in killing viruses.

WeinnovateBiosolutions was supported by CAWACH (Centre forAugmenting War with COVID-19 Health Crisis) 2020grant fromthe National Science and Technology Entrepreneurship Development Board (NSTEDB) under the Department of Science and Technology (DST) and the project was incubated at Entrepreneurship Development Centre, Pune.

Co-founder and COO of WeinnovateBiosolutions Dr. Anupama Engineer says- “We are very confident of the study outcomes and waiting to get the license for our hand sanitizer formulation from CDSCO, India. We are sure that such innovation will push India towards its ‘Atmanirbhar Bharat’ mission and make India a self-sustained nation to face such pandemics in future.”

“A study to evaluate the efficacy of hand sanitizer on different types of viruses is also currently underway,” she added.

Recurrent drying up of hands due to repeated application of hand sanitizers is a challenge that people have faced during the COVID 19 pandemic. The startup has developed a colloidal silver solution-based hand sanitizer. The technology operates on the ability of the silver nanoparticles to prevent the synthesis of viral negative-strand RNA and viral budding.

Silver nanoparticles are effective antiviral that acts against many deadly viruses like HIV, Hepatitis B, Herpes simplex virus, Influenza virus, and so on. Recent reports have suggested the role of Glutathione capped-Ag2S NCs that is silver nano clusters, in inhibiting the proliferation of coronavirus by preventing the synthesis of viral negative-strand RNA and viral budding. The colloidal silver, on which the technology of the sanitizers is based, can help arrest COVID -19 spread by blocking the RNA replication and surface glycoproteins.

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Keywords: Science, Innovation, Startup, Pune, India, Sanitizer, Chemicals, Research, Nanoclusters, Nanoparticles, Glutathione, Covid-19, Corona Virus, Alcohol, Pandemic.

Studies have shown that the anti-COVID oral drug 2- DG has resulted in quick recovery and reduction in oxygen dependence among moderately and severely affected patients. This drug in the form of powder formulation was earlier launched by Dr. Reddy’s Laboratories in India.

Under the terms of the license agreement, Anthem Biosciences Pvt. Ltd. gets a non-exclusive license for the process know-how for the synthesis of 2-DG (2-Deoxy-D-Glucose).

“The agreement is in line with CSIR’s efforts to help people access various therapeutic options to combat COVID-19. CSIR labs have undertaken clinical trials of various repurposed drugs for the treatment of COVID-19”, said Dr Chandrasekhar, Director CSIR-IICT.

Anthem Biosciences Pvt. Ltd. is in the process of applying to the DCGI, New Delhi, for approval, and will subsequently manufacture and commercialize 2-DG from their facilities located at Bommasandra, Bangalore &Harohalli, Kanakapura, Karnataka.

Speaking on the occasion Ajay Bhardwaj, CEO & founder of Anthem Biosciences said “Anthem Biosciences is in the forefront of working on a niche and complex biopharmaceuticals. We have hands-on experience in the development and manufacturing of the prodrug of 2-DG API for a discovery research biopharmaceutical company from the USA. Because of our prior experience on 2-DG Prodrug, post DCGI approval, we are geared up to supply multi-ton API to meet the immediate demand that might arise due to ongoing COVID-19 pandemic”.

“We have also developed domestic vendors for key raw materials for uninterrupted supplies to manufacture 2-DG API. Alternatively, we have developed an in-house process for key raw materials as we foresee the short supplies of these materials in coming months”, Bhardwaj added.

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Keywords: Partnership, Manufacturing, Anti-COVID Drug, 2-DG, CSIR, Indian Institute of Chemical Technology, IICT,  Council of Scientific and Industrial Research,Anthem Biosciences Pvt Ltd, Biopharma

Marc Laboratories is an Uttar Pradesh-based young progressive enterprise withoperating base in 13 otherstates. This agreement between CSIR-CDRI and Marc Laboratories could pave the way for developing a synthetic compound S-007-867 as modulator of blood coagulation cascade, in particular as inhibitor of collagen-induced platelet aggregation. This could be helpful in treating coronary and cerebral artery diseases, CSIR-CDRI statement said.

Arterial thrombosis is an acute complication that develops on the chronic lesions of atherosclerosis leading to heart attack and stroke. Therefore, inhibition of platelet-collagen interaction is anticipated to be a promising therapeutic strategy to treat intravascular thrombosis. The compound,S-007-867,significantly inhibits collagen-mediated platelet activation and subsequently reduces release of ATP from dense granules and thromboxane A2 via COX1 activation. Thus it effectively maintains blood flow velocity and delays vascular occlusion (blockage of the blood vessel, usually with a clot) and inhibits thrombogenesis (formation of blood clot) without compromising hemostasis.

This drug has less bleeding risk as compare to presently existing therapies for coronary and cerebral artery diseases. In animal experiments, the compound elicited better antithrombotic protection than the standard of care with minimal bleeding tendency.The Institute has recently obtained permission to initiate Phase I clinical trials for the drug.

Besides, in COVID-19 disease, critical patients with Acute respiratory distress syndrome (ARDS) have high D-dimer and reduced prothrombin time (PT), suggesting pro-thrombotic state. In addition, these patients have high number of circulating neutrophils, inflammatory mediators/cytokine, CRP and lymphocytopenia. Therefore, drugs reducing platelet reactivity and neutrophil activation could be beneficial, and based on these criteria the prophylactic use of this compound could be an option due to its high safety and less effect on bleeding time.

On this occasion, Prof. Tapas K. Kundu, Director (CDRI) said, “This is a great moment for CSIR-CDRI, the premiere drug development and research institute of the country to license out an in-house developed compound for further investigations as part of our commitment of affordable healthcare for all.” He was optimistic that this compound would reach the market soon to benefit the humanity.

Likewise, Mr. Prem Kishore, Chairman Marc Laboratories said, “Marc’s association with CSIR-CDRI will be beneficial to both parties and they will be working hard to take the compound forward so that it sees light of the day soon.”

“This Industry-Institute partnership will surely be very beneficial for development of Pharma cluster in Uttar Pradesh and will open up new avenues for it by their collective efforts as broadly visualized by honourable Union Minister for Health & Family Welfare, Dr Harsh Vardhan; Director General, CSIR, Dr Shekhar C. Mande and honourable Chief Minister, U.P., Yogi Adityanath,” Prof.Kundu added. —————————————————————————————————————————————————–

Keywords: CSIR-CDRI, CSIR, Coronarydiseases, Cerebral arterydiseases, Council of Scientific and Industrial Research, CSIR, Central Drug Research Institute,Marc Laboratories, Heart Attack, Stroke, Drug Compound,  S-007-867, MoHFW, DST, DSIR

Dr Shekhar C Mande, Director General, CSIR expressed his happiness over the SEC recommendations to conduct this Phase II clinical trial using Niclosamide, which is generic, affordable drug and easily available in India and therefore can be made available to our population. Dr Ram Vishwakarma, Advisor to DG-CSIR pointed out that

a) in a screen to identify drugs that can inhibit syncytia formation, Niclosamide was identified as a promising repurposed drug by research group from King’s College, London, who collaborated in this project. The syncytia or fused cells observed in the lungs of patients with COVID-19 probably results from the fusogenic activity of the SARS-CoV-2 spike protein and Niclosamide can inhibit syncytia formation.

b) Independently, collaborative research between CSIR-IIIM, Jammu and NCBS, Bangalore has recently demonstrated that Niclosamide is also a potential SARS-CoV2 entry inhibitor blocking the viral entry through pH dependent endocytic pathway. Given these two independent experimental studies, Niclosamide has now emerged as a promising drug candidate for clinical trial in Covid-19 patients.

Dr Srivari Chandrashekhar, Director CSIR-IICT Hyderabad, highlighted that the Active Pharmaceutical Ingredient (API) is being made by Laxai Life Sciences based on improved technology developed at IICT and the lab is a partner in this important clinical trial which could provide cost effective therapeutic options for patients if trial is successful.

Dr Ram Upadhayaya, CEO, Laxai informed, that realizing the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials. Having received approval from drug regulator, the clinical trial has been initiated this week at different sites and is expected that the trial will be completed within 8-12 weeks. Based on successful clinical evidence generated during clinical trials in Indian studies, emergency use authorization may be sought so that more treatment options are available to COVID-19 patients.

The experimentation with these animals needs people with multiple expertise and specialised animal biosafety level 3 laboratories (ABSL3). Realising the importance of these requirements for developing antiviral and vaccine candidates for SARC-COV-2, scientists at the Institute of Life Sciences, Bhubaneswar (an autonomous research institute of Department of Biotechnology, Govt. of India) have established these animal models and a ABSL3 laboratory. This platform at ILS has been established with the support from Biotechnology Industry Research Assistance Council (BIRAC) under Mission COVID Suraksha.

The COVID-19 research team of this institute has recently established and characterised hamster models of SARS-CoV-2 infection by using a local virus isolate cultured and characterised at ILS. The proteomic studies carried out at ILS shows the similarities between SARS-CoV-2 infection in humans and hamsters.This along with analysis of clinical parameters it has been observed that tissue samples show the pathophysiological manifestation of SARS‐CoV‐2 infection similarto that reported earlier in COVID‐19 patients. This provided strong molecular evidence that supports the clinical relevance of this model in COVID-19 research. The findings of this study have recently been published in a prestigious journal, FASEB (Federation of American Societies for Experimental Biology) Journal. ‘The current and perspective users of the ILS platform include NIRRH, Mumbai, IIT Indore, NCBS-InStem, Bangalore; NCL, Pune, CIAB, Mohali etc”

The manufacturing complexity is a major reason for the therapy cost. In order to promote and support development of CAR-T cell technology against cancer and other diseases, BIRAC and DBT have taken initiatives and launched specialized calls to invite proposals in the last 2 years.

The 4th June, 2021 was a historic day for TMH, IIT Bombay team and cancer care in India as the first CAR-T cell therapy (a type of gene therapy) was done at the Bone Marrow Transplant unit at ACTREC, Tata Memorial Center in Mumbai. The CAR-T cells were designed and manufactured at Bioscience and Bioengineering (BSBE) department of IIT Bombay.

This work is partly supported by BIRAC-PACE scheme. The TMC-IIT Bombay team are further supported to extend this project for conducting Phase I/II trial of their CAR-T product by DBT/BIRAC, through National Biopharma Mission.

This is a “first in India” gene therapy in early phase pilot clinical trial and the dedicated efforts and excellent collaboration between IIT Bombay and Tata Memorial Hospital, Mumbai.The central government’s National Biopharma Mission-BIRAC has approved 19.15 Cr crore to the team for conducting a first-in-human phase-1/2 clinical trial of the CAR-T cells. The clinical trials are being done by Dr (Surg Cdr) Gaurav Narula, Professor of Paediatric Oncology and Health Sciences, and his team from TMC, Mumbai, and the novel CAR-T cells that will act as drugs that were manufactured by Prof Rahul Purwar, Bioscience and Bioengineering (BSBE) department and his team at IIT Bombay. The design, development, and extensive pre-clinical testing was carried out by IIT-B as a collaborative project with Tata Memorial Center, Mumbai by the two Investigators.

IIT-B director Subhasis Chaudhuri said this was a significant feat for the institute as well as the country. “We at IIT-B are delighted that our scientists along with Tata Memorial Hospital have come out with the most sophisticated therapy in cancer treatment. If the trials are successful, it may save millions of lives by making the treatment available in India at an affordable cost. It is a research of IIT-B that is expected to touch the lives of all,” said Chaudhuri.

National Biopharma Mission is also supporting the development of Lentiviral vector manufacturing facility for packaging plasmids used to transfer the modified T cell inside the body, cGMP facility for T-cell transduction and expansion for CAR T-cell manufacturing to two other organizations. The development of CAR-T cell technology for diseases including acute lymphocytic leukemia, multiple myeloma, glioblastoma, hepatocellular carcinoma and type-2 diabetes is supported through DBT.