Department of Biotechnology - Achievements/Success Stories during the year 2021

The mandate of the Department of Biotechnology (DBT), Ministry of Science & Technology is to make India globally competitive in biotechnology research, innovation, translation, entrepreneurship and biotech industrial growth. The emphasis of the Department is on promotion of excellence and innovation for facilitating basic, early and late stage translational research, establishing national and international partnerships, capacity building (both human resource and infrastructure), public-private partnerships in Biotech sectors. This Department is also contributing through its various programmes/schemes to the National Missions launched by our Hon’ble Prime Minister such as   Swasth Bharat, Swachh Bharat, Start-up India, Make-in-India and Digital India. The Department has been on the fore front to address the COVID-19 pandemic with its 15 autonomous institutes, one International Center for Genetic Engineering & Biotechnology and two Public Sector Undertakings i.e. Biotechnology Industry Research Assistance Council (BIRAC) and Bharat Immunologicals and Biologicals Corporation Ltd. (BIBCOL). Major efforts are on the development of vaccines, diagnostics, therapeutics, establishment of biorepositories and genomic surveillance.

Sector-wise achievements/Success stories during the year 2021 have been summarized below:

1. Medical Biotechnology

Basic Research:

• Tuberculosis (TB) patients suffer from progressive and debilitating loss of muscle mass and function, referred to as cachexia. Though a multifactorial condition, cachexia in cancer is promoted by systemic zinc redistribution and accumulation in muscles. Clinical studies with TB patients indeed show zinc dyshomeostasis. In this context, a novel zinc metallophore from Mtb that restores zinc metabolic imbalance has been reported. These diisonitrile lipopeptides, named kupyaphores protects bacteria from host-mediated nutritional deprivation and intoxication. Kupyaphore Mtb mutant strain cannot mobilize zinc and shows reduced fitness in mice. Further,  Mtb encoded isonitrile hydratase was characterised that could mediate intracellular zinc release through covalent modification of kupyaphores. These studies could provide a molecular link between TB-induced altered zinc homeostasis and associated cachexia. (PNAS, 2021, In Press).
• Zika Virus (ZIKV) infection is associated with micro encephaly which is manifested as babies born with smaller head and under developed brain. WNT2 involved in cell fate determination was found to be downregulated in response to ZIKV protein in human fetal neuronal stem cells. This finding provides a basis to ZIKV induced neurological complications in infants born to mothers who were infected by the mosquito borne virus during their pregnancies. (Brain Research Bulletin, 176, 93-102. DOI: 10.1016/j.brainresbull.2021.08.009.Impact Factor 4.077.
• Autologous hair follicle grafting is a recent therapy to stimulate closure of such non-healing wounds. A collaboration between the academicians and clinicians demonstrated that grafting hair follicles into chronic wounds from the patient’s own scalp promotes complete repair of the injured skin. (JID Innovations, Skin Science from Molecules to Population Health; 2021. DOI :https://doi.org/10.1016/j.xjidi.2021.100041)
• Collaborative research led by clinicians and scientists analyzing whole exome sequencing provides insights into the genetic architecture of severe mental illness, such as schizophrenia and its link to immune factors, especially immune related pathways and functions related to innate immunity such as antigen binding were over presented. The findings give a hint at how selection pressures in individuals from families with a severe mental illness may diverge from the general population. (Scientific Reports: 2021, https://www.nature.com/articles/s41598-021-00123-x) Impact Factor 14.96
• A body-wide sensory organization of unique photoreceptor cells that allows movement of even headed-removed flatworm was discovered. This work illustrated how eye-independent systems can deeply influence animal physiology and behavior (Proc Natl Acad Sci U S A. 118(20):e2021426118. doi: 10.1073/pnas.2021426118) Impact Factor 11.205
• Deep neural networks have revolutionized computer vision, and their object representations across layers match coarsely with visual cortical areas in the brain. However, whether these representations exhibit qualitative patterns seen in human perception or brain representations remains unresolved. Some neural phenomena in terms of distance comparisons were found to be present in randomly initialized networks, such as the global advantage effect, sparseness, and relative size. Many others were present after object recognition training, whereas, other phenomena were absent in trained networks. These findings indicate sufficient conditions for the emergence of these phenomena in brains and deep networks, and offer clues to the properties that could be incorporated to improve deep networks. (Nature Communications, (2021)12:1872, (Impact Factor-14.92)
• Timely and tunable stoppage of RNA synthesis is vital for cellular homeostasis. Extensive and dynamic network of termination factor r interactions with RNA polymerase, nucleic acids and accessory NuS factors were found. Further factor ρ was found to mediate step-wise rearrangements of these contacts and transforms RNA polymerase complex inactivation into a moribund pre-termination intermediate state (Science: Jan 1; 371 (6524): eabd 1673; Impact Factor: 47.728)
• PRAMEF2 is a member of the PRAME multi-gene family of cancer testis antigens, which serve as prognostic marker for several cancers. PRAMEF2 regulation has been delineated under conditions of altered metabolic homeostasis. PRAMEF2 also triggers YAP nuclear accumulation, which induces the expression of proliferative and metastatic genes. These findings highlight the pivotal role of PRAMEF2 in determining YAP oncogenic signalling, which has key implications for breast cancer progression. {Proc Natl Acad Sci USA, (2021)118, e2105523118} Impact Factor 11.205

Early and late translational research:

Under Unique Methods of Management and treatment of Inherited Disorders (UMMID) initiative >1,25,000 pregnant mothers and newborns have been screened for genetic disorders. Nidan Kendra establishment at 5 centres have been strengthened. The steps have been taken for expansion of the UMMID initiative so as to cover more districts/regions across the country.

• GarbhINI is an Inter discisplinary Group for Advanced Research on BirtH outcomes. Under this initiative, a unique pregnancy Cohort comprising >8000 women has been established using an interdisciplinary approach comprising methodologies of clinical, epidemiological, statistical, genetic, proteomic and imaging sciences to study Pre-Term Birth (PTB). In the Cohort, the frequency of PTB has been found to be 13%, with high rates of other adverse (still birth rate 2.3%, low birth rate 27%, small for gestational age 38%) birth outcomes. The GARBH-Ini platform has also established biorepository of well characterized clinical phenotypes with around 1 million bio-specimens and ~600,000 ultrasound images.
• First clinical trial for CAR-T cell therapy being conducted at ACTREC, Tata Hospital in Mumbai;
• The first gene therapy clinical trial for a genetic disorder, Hemophilia A, in India has been approved by the Central Drugs Standard Control Organisation (CDSCO). This first in human clinical trial of gene therapy is to be conducted at the Centre for Stem Cell Research (CSCR) and the Christian Medical College, Vellore, in collaboration with the Emory University, USA. The lenti viral vector for this clinical trial has been obtained for manufacturing the final drug product with the patient’s hematopoietic stem cells at the GMP facility in CSCR.
• A novel mechanical nitinol-based clot retriever has been developed. The two braided concepts (continuous and segmented) have been prototyped which is expected to be used in the treatment of acute cerebral ischemic stroke.
• Translational efforts of the cancer research program have resulted in discovery of tumor associated antigen SPAG9 that may be ideal target for early detection and diagnosis and is being used for the targeted therapy/immunotherapy for cancer management; 
• Novel peptides against drug resistant Staphylococcus aureus, nanoparticle-based antigen (IpaC) delivery system (nanovaccine) for shigellosis and extracted chitosan (EC) coated sutures have been developed to prevent surgical site infections;
• A novel Shikimoylated Mannose Receptor Targeting (SMART) nanoparticle system has been developed for delivering mRNAs into dendritic cells for vaccine development, synthesized chemically modified mRNA;
• In a collaborative project, a technology has been developed for manufacturing of microneedles (MNs) with prototype ready in small scale. The product is expected to address the specific problems in existing intervention strategies for iron and vitamin B12 deficiency without involving skilled personnel, infrastructure or significant investment;
• The dbGENVOC, a database of genomic variations in oral cancer, has been created which is publicly-accessible. This is the first of its kind in the World. First release of dbGENVOC contains: (i) ~24 million somatic and germline variants derived from whole exome sequences of 100 Indian oral cancer patients and whole genome sequences of 5 oral cancer patients from India, (ii) somatic variation data from 220 patient samples drawn from the USA and analyzed by TCGA-HNSCC project and (iii) manually curated variation data of 118 patients from recently published peer-reviewed publications; 
• The WHO Country Office for India collaborated with the DBT to develop the list of drug resistant microbial pathogens of national relevance, in alignment with the global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics. This list shall help to facilitate prioritization of R&D of new and effective antibiotics from Indian perspective.
• SWADESH is the first large-scale multimodal neuroimaging database designed specifically for Indian population with big-data architecture and analytics for various disease categories under one platform. This is the World’s first multimodal brain imaging data and analytics developed through the integration of various modules for early diagnosis of Alzheimer’s disease. The unique brain initiative focuses on certified neuroimaging, neurochemical, neuropsychological data and analytics that are made accessible to researchers for managing brain disorders.
•  A stable clone (CHO‐HIRc‐mycGLUT4eGFP cell line) developed at NCCS was licensed to Applied Biological Materials Inc. Canada for commercialization. This cell line is a valuable tool for diabetes research. It can be used as an in-vitro assay system to screen GLUT4 translocation modulators, which are small molecules with therapeutic potential for therapeutic diabetes mitigation.
•  A sensitive reporter-based assay has been designed to determine the efficiency of genome editing in human cells. With the help of this assay, the investigators established editing of a defined locus in the cells using virus-like particles. Lgr5-specific Atoh1 or relevant gene loss using CRISPR/Cas9 was evaluated in cell-based assay at genomic locus and it was found that the locus is being targeted. This platform can improve the efficiency of genome editing in human cells and may find application in medical interventions in health and disease.
•  Membrane engineered vesicles (mEV) of non-pathogenic bacteria for targeted delivery of first-line drugs against Mycobacterium tuberculosis (Mtb) were developed. mEVs were found to be stable and provided sustained release of rifampicinwhich was effective in reducing the minimum inhibitory concentration (MIC) of pathogenic Mtb.

2. Agriculture Biotechnology, Livestock, Aquaculture and Marine Biotechnology

Basic Research:

• Prion-like proteins (PrLPs) have been widely demonstrated to be present in plants, but their role in plant stress and memory remains unexplored. The rice prionome was found to be significantly enriched in transposons /retrotransposons (Ts/RTRs) and over 60 rice PrLPs that were differentially regulated in stress and developmental responses were identified. By integrating the available rice interactome, transcriptome, and regulome data sets, links between stress and memory pathways could be explored. (Front Plant Sci. 2021.12:707286, Impact Factor- 5.44);
• Tomato leaf curl New Delhi virus (ToLCNDV) infection causes severe losses in tomato yield worldwide. Lack of information on resistance (R) genes against ToLCNDV has considerably retarded the pace of crop improvement against this rapidly spreading pathogen. An effective defense strategy deployed by a resistant tomato cultivar against ToLCNDV was reported. It employs Sw5a (R gene) that recognizes AC4 protein (viral effector) of ToLCNDV to restrict virus spread. These findings could be translated into development of resistance in susceptible cultivars of tomato through modern breeding or molecular approaches. (PNAS August 17, 2021 118 (33) e2101833118; https://doi.org/10.1073/pnas.2101833118) Impact Factor 11.205;
• Angiosperm leaves show extensive shape diversity and are broadly divided into two forms; simple leaves with intact lamina and compound leaves with lamina dissected into leaflets. The mechanistic basis of margin dissection and leaflet initiation has been inferred primarily by analysing compound-leaf architecture, and thus whether the intact lamina of simple leaves has the potential to initiate leaflets upon endogenous gene inactivation remains unclear. A conserved developmental mechanism that promotes simple leaf architecture in which CIN-TCP–KNOX-II forms a strong differentiation module that suppresses the KNO7TEDI like proliferating cell factors network and leaflet initiation. (Nature Communications, (2021) 12:1872, (Impact Factor-14.92);
• Rice pan-genome genotyping array (RPGA), a 90K SNP genotyping array based on 3K rice pan-genome had been developed for genomics-assisted breeding and accelerated crop improvement. Contrary to conventional SNP genotyping arrays that relies on single reference genome RPGA assays variants from entire 3K rice pan-genome. This enables RPGA to tag haplotype variation present in entire pan-genome, which include both core (genes shared by all accessions) as well as dispensable (subpopulation/cultivar specific genes) genome. The usefulness of RPGA for large-scale pan-genome based genotyping applications was demonstrated by their high-throughput genotyping in the natural germplasm accessions and RIL mapping population of rice;
• Genotypic and phenotypic characterization of available germplasm resources in the country along with exotic lines from diverse agro climatic regions & elite lines of International Institutes is being undertaken for minor oilseeds (Sesame, Linseed, Safflower, Niger), Cereals (Rice and Wheat)and Pulses (Chickpea).

Early and late translational research:

•  Varieties released and developed:

• Country’s first ever non-GM (genetically modified) herbicide tolerant basmati rice varieties Pusa Basmati 1979 and Pusa Basmati 1985  for direct seeded conditions which can significantly save water and labour compared to conventional transplanting; 
• A drought tolerant rice line CBMAS14110 possessing two drought-tolerant QTLs (qDTY1.1 and qDTY3.1) of Apo was developed and nominated for evaluation under AICRIP and State MLT; 
• Salinity tolerant version of a popular variety “Improved White Ponni” rice variety namely IWP-Saltolwas developed, evaluated and registered with NBPGR;
• CG Barani Dhan– 2 (R-RF-105) rice variety carrying multiple QTLs for drought tolerance (qDTY 1-1 and qDTY 12-1) and QTL for root traits has been released and notified for Chhattisgarh in 2021;
• CR Dhan 803 (Pooja-Sub1) rice variety has been released for Odisha Sate. It has high yield under submergence conditions, high hulling, milling, no grain chalkiness and intermediate amylose content. It is also resistant to stem borer (dead heart), moderately resistant to white ear head, leaf folder, plant hopper &case worm, neck blast and tungro virus.
• A promising short duration rice variety, ADT 55 through marker assisted selection resistance to bacterial blightwas released for cultivation in Tamil Nadu during 2020-21.
• Three wheat lines (HUWL2036, HUWL2037& HUWL2038) developed to incorporate rust-resistant genes along with yield and quality traits showed resistance to Leaf & Stripe Rust both and among these lines, one line (HUWL2036) has been sent in AICRP NIVT 5.
• Four Brassica lines with improved rust resistance developed through Marker-Assisted selection are under AICRP trials.
• A drought tolerant chickpea variety IPCL4 -14 has been released for timely sown, rainfed conditions in north-west plain zone.
• A drought tolerant chickpea variety BG 4005 has been released for timely sown, rainfed conditions in north-west plain zone. This variety was developed through department’s support through introgression breeding in desi chickpea variety Pusa 362.
• A chickpea variety IPCMB 19-3 with wilt resistance has been has been released for timely sown, irrigated conditions in central zone.

• An energy efficient, innovative and cheap device has been developed which can address the problem of postharvest losses in India. A Start-up Fruvetech Pvt Ltd has been registered (CIN: U72900DL2021PTC376517) for commercialization of this technology and NIPGR will be executing technology transfer in due course.
• A Genomic selection and Speed Breeding Facility has been established at IRRI, Varanasi. This is first of its kind facility in India to facilitate faster genetic gains through speed breeding for generation advancement to undertake haplotype-based backcross breeding to transfer the superior haplotypes from landraces into elite backgrounds.
• The National Genomics and Genotyping Facility has been established and would be providing service to the scientific community very soon. A first ever pan-genome based SNP genotyping array has been developed in crop plants, rice and chickpea, which would enormously help the rice and chickpea mission programs on germplasm characterization for trait discovery.
• An advanced 650 terraflops supercomputing facility was established in NABI for the analysis of BIG DATA accruing from the large-scale genomics, functional genomics, structural genomics and population studies being carried out at various Institutes and universities of national and international repute. The facility has come up under the National Supercomputing Mission (NSM) in collaboration with C-DAC, Pune;
• IndiGau chip India’s first Single Nucleotide Polymorphism (SNP) based chip for the conservation of pure varieties of indigenous cattle breeds like, Gir, Kankrej, Sahiwal, Ongole, etc. was developed. IndiGau is the largest cattle chip of the world with 11,496 markers (SNPs) more than that placed on 777K Illumina chip of US & UK breeds;
• First One Health mega project launched with 27 organizations led by DBT-National Institute of Animal Biotechnology, Hyderabad. This programme envisages carrying out surveillance of important bacterial, viral and parasitic infections of zoonotic as well as transboundary pathogens in India, including the North-eastern part of the country;
• A point of care aptamer based lateral flow detection system was developed for detection of oxytetracycline in milk. Field trials for detection of oxytetracycline in milk of cow are ongoing.
• Towards developing improved diagnostic assays for brucellosis, an indirect ELISA using the purified BM5 protein of Brucella was developed for detection of brucellosis with DIVA capability. This kit will have the ability to differentiate between the immunity generated by vaccine and the one generated by natural infection. This kit is in the process of field validation.
• A nanoparticle based field applicable kit for detection of subclinical mastitis in farm animals was developed. It is based on the aggregation of nanoparticles in the milk infected with pathogen responsible for mastitis. It will help in screening of animals for mastitis to start timely treatment of animals.
• Live feeds in fish and shellfish culture:  Based on the nutritional segregation of the selected microalgal species in terms of carbohydrates, protein and lipids, amino acids, fatty acids and minerals and the feeding trials with the copepod Oithona rigida, new isolates of marine microalgal species such as Nannochloropsis oceanica MACC 24 and MACC 26, Nannochloropsis sp. MACC 22 and Nannochloropsis sp. MACC 27 were identified as potential candidates as live feeds in aquaculture;
• Three generations of improved catla were produced by selective breeding from the base population created by bringing catla from different geographical regions. The improved catla showed 30% higher growth rate in comparison to the normal catla.
• A first ever reference grade genome of an extraordinarily salt-tolerant species called Avicenniamarina, consisting of 31,477 protein coding genes was reported by DBT-ILS and Annamalai University (Communications Biology 2021: https://doi.org/10.1038/s42003-021-02384-8) Impact Factor 5.489)
• A Marine Bioresource and Biotechnology network has been implemented with strong linkages with the Deep Ocean Mission of the Ministry of Earth Sciences. Prospecting, conservation and exploration of deep-sea biodiversity is essential component of this initiative. Seven network projects under this consortium have been implemented.
• A Memorandum of Understanding has been signed with the Ministry of Earth Sciences for mutual collaboration to explore the possibility of cooperation, convergence and synergy to bring out the expertise and services of both the organizations under one roof and work hand-in-hand for addressing relevant questions in the field of polar biology.
• MoU signed with the Ministry of Earth Sciences for the Setting up of DBT MOES Polar Research Centre to explore the possibility of cooperation, convergence and synergy to bring out the expertise and services of both the organizations under one roof and work hand-in-hand for addressing relevant questions in the field of polar biology. Initially these efforts would be taken up through collaborative proposal by the researchers at MOES institutes making use of the presently available set ups of MOES at Polar Regions.
• The ICGEB's Dengue Botanical drug has entered into clinical trials in July, 2021 after receiving all necessary regulatory approvals. It will be the first botanical drug against Dengue. ICGEB has been collaborating with Sun Pharmaceutical limited for this project.

3. Computational Biology including Artificial Intelligence:

• Biotech-PRIDE (Promotion of Research and Innovation through Data Exchange) Guidelines: The Biotech-PRIDE Guidelines have been developed through extensive Expert Consultation and Inter-ministerial consultation to facilitate and enable sharing and exchange of high-throughput, high-volume biological data, knowledge and information generated within the country for promotion of research and innovation.
• Indian Biological Data Centre (IBDC) Phase-I project initiated for deposition, storage, annotation and sharing of biological data generated in the country through extensive funding from various Government Organizations. The Biotech-PRIDE Guidelines will be implemented through the Indian Biological Data Centre.  The IBDC will enable life science researchers to deposit biological data in a central repository and thus safeguard data generated using public resources from loss. It will perform quality control, curation, and annotation of data.

These efforts will help to establish benchmarks for the quality of data deposited and thus improve the quality of experimental research conducted in the country. It will also facilitate distribution of biological data to researchers for further analysis and the discovery of  emergent properties in biological systems. IBDC is also mandated to conduct training programs on data storage and analytics to help increase the number of manpower skilled in Data Science in the country. The revamped Bioinformatics centers and other major data sets (Spokes) will be linked to IBDC (Hub).

• The Department is supporting projects for application of ‘Artificial Intelligence (AI)’ in accordance with the NITI Aayog’s Policies of #AIforAll. Artificial Intelligence is an important area which is bringing a paradigm shift to the healthcare sector and considering the immense importance of AI applications, department has supported projects on AI applications for Affordable and Accessible Healthcare programme in the area of cancer, tuberculosis and pulmonary diseases, diabetic & cardiovascular diseases, ophthalmological diseases, neurological disorders and drug development;
• An ‘Imaging BioBank for Cancer’ has been supported jointly at Medical Schools, Research Institutes, and IIT with the intent to develop AI tools and database for advance research in cancer and also aiming cancer diagnosis/ prognosis and cancer care. The team is mainly working towards development of a database of two types of cancer i.e. Head Neck Cancer and Lung Cancer radiology and pathology images linked to their clinical information and to drive the AI based algorithm/application development using the BioBank infrastructure and data along with infrastructure.
• The Department has launched “MANAV: Human Atlas Initiative” for construction of world’s most comprehensive human atlas by assimilating all the known macro-level and micro-level information from scientific literature and public databases. The proposed human map refers to a computational representation, which will provide knowledge in holistic fashion from inter-organ dependencies to intra-organ, tissue level, cell and sub-cellular level biological reactions. This project helps to deliver an open source annotation platform, organ (skin) model development, up-skilled manpower and community. Some of the key progress made so far are highlighted below:

1. Manav annotation platform development: Manav 1.0 platform has been developed to perform proof-of-concepts (PoCs) on annotation guidelines, data capture, data validation and platform validation by engaging ~100 students. About 97% of these students from various background provide a feedback that the platform was intuitive.
2. Organ (skin) model development: Publicly available scientific articles on human skin to develop skin model were identified.
3. Scientific upskilling and Manav community building: Multiple outreach and network building activities are being organized to create awareness on Manav project. A pan-country initiative was organized to reach out to student community through various approaches viz. science festivals, institutional visits, beta testing workshops, social media and mass communication. More than 1700 students, 64 faculties and 61 reviewers have been enrolled across 58 cities in 20 States of India.

4. Bioenergy and Environmental Biotechnology

• The Scientists have developed cellulose enzyme technology using engineered fungal strain and scaled up the technology to about 15,000 L scale. This study will provide an in-house fungal platform to produce cellulase enzymes at a commercial scale for use in a 2G-ethanol plant.
• A 0.5- 1 ton per day (TPD) CO2 capture pilot plant (IOT based, fully computer-controlled). for Industrial CO₂ Capture has been developed. Another process intensified CO₂ capture absorber based on rotating packed bed operation of capacity 0.5-1 TPD CO2 has also been developed.
• Bacterial production of a biosurfactant of plant origin, Cauloside C – a plant-based saponin was discovered for the first time.This biosurfactant exhibited great stability under diverse environmental conditions and has been demonstrated to have huge potential for solubilization of polyaromatic hydrocarbons and in enhancing the recovery of residual oil from oil reservoirs.

5. Societal Programmes:

• Jammu and Kashmir imports milk from neighbouring states as the prevalence of cattle diseases like mastitis, severely mar their milk production capacity. DBT selected SC/ST population of 4 villages and trained over 370 farmers for profitable dairy farming using scientific interventions. Now they are earning 2 to 5 times more than their previous income;
• Biotech-KISAN, a scientist-farmer partnership scheme, launched by DBT in 2017 for agriculture innovation with an objective to connect science laboratories with the farmers to find out innovative solutions and technologies. The programme covers all 15 agro-climatic zones of the country. Significant achievements include:

No. of Ongoing Biotech-KISAN Hubs supported	36
Satellite Centers	169
No. of Aspirational Districts covered	112
No. of Demonstrations carried out	8000
No. of Interventions carried out	55
No. of Farmer beneficiaries covered under training prog. & workshops	3,00,000
entrepreneurships developed in the rural areas	200

 

Salient achievements of HRD Programmes include:

• PG Teaching Programmes (M.Sc./ M.Tech./ M.V.Sc): 1217;  DBT sanctioned seats distributed in 63 PG courses at 56 participating Universities/Institutes;
• DBT Star College Scheme: Supported science Departments in >300 colleges all over the country;
• Science Setu Programme: 15 Autonomous Institutes engaged with 225 colleges to organize 125 seminars benefitting  >7500 students;
• Star College Mentorship Programme: So far, 240 UG colleges, 55 colleges from rural areas and 8 colleges from Aspirational Districts  have been supported. 17 new colleges were supported this year.
• Skill Vigyan Programme (Skill Development Programme) in Biotechnology being implemented in 9 States. The Expert Committee recommended the proposals of 6 States. Efforts are being made to partner with all States/UTs S&T Councils/Departments.
• Under DBT JRF 795 ongoing students have been supported and 125 new fellows have joined so far under the DBT-JRF Programme. A total of 170 research articles and reviews in journals of national and international repute have been published by DBT-JRF fellows and 52 fellows have reported getting job placement. A total of 29 DBT-JRF fellows submitted their PhD theses in 2021-22 and 29 were awarded doctoral degree of respective institutions.
• Under DBT Research Associateship, 148 ongoing fellows have been supported under this programme; 7 fellows reported placement in jobs
• Ramalingaswami Re-entry Fellowship - 276 ongoing fellows being supported;
• MK Bhan - Young Researchers Fellowship Programme First batch of 50 M.K,Bhan - Young Researcher Fellows selected;
• Under Biotechnology Career Advancement and Re-orientation (BioCARe) Programme 2 women scientists have been supported for their new projects;
• PhD Fellowship Programme under Indo-Australia Collaboration, 43 PhD students are being supported at various departments of IITB - Monash Research Academy;
• No. of Research publications during 2021-22: 245;
• EMBO Lab Leadership Course: 4 Cohorts of the course were successfully conducted. 64 Senior Researchers from institutions across the country have been trained in Research Leadership.

6. Promoting Biotechnology in North Eastern Region

• Under twinning R&D programme for NER, currently >150 projects are being supported;
• Centre for Bioresources and Sustainable Development at Kimin, Papum, Arunachal Pradesh has been established;
• North East Centre for Agriculture Biotechnology (NECAB), AAU, Jorhat has been established to strengthen the R&D activities and extend the agriculture technologies to North-Eastern States. Major emphasis is on stress tolerance in rice, gene-based improvement of chickpea, bioprospecting of soil microbes, novel biofertilisers and  biopesticides and extension activities. GM chickpea lines have also been developed using Bt Cry genes and these have entered into regulatory pipeline.

7. International Partnerships:

• DBT has active bilateral partnerships with Australia, Brazil, Canada, Denmark, European Union, Finland, Germany, Japan, Russia, Spain, Sweden, Switzerland, South Africa, UK, USA and The Netherlands for mutually agreed areas;
• Multilateral Partnerships with BRICS, TaSE, and Globalstars (EUREKA) and contribution partnerships with HFSPO, EMBO have provided state of the art platform for scientific interactions;
• Partnerships with Bill & Melinda Gates Foundation (BMGF); Wellcome Trust (WT)-UK); Cancer Research UK (CRUK) Philanthropic Organizations and global Universities (Cambridge University UK; Monash University Australia; and Heidelberg University Germany as well as NGOs; Nobel Media; Prakash labs are providing scope for leapfrog jump in translational research, capacity building, outreach and frugal science areas in India;

• DBT started a new partnership with Academy of Medical Sciences (AMS), UK jointly launched AMS-DBT Newton International Fellowship. This unique opportunity offers a 3-year jointly supported post-doctoral fellowship for Indian scholars. 3 selected scholars from the very first Cohort are working towards better understanding of non-functioning pituitary tumours; developing novel Antimicrobial Agents; and designing nanocarrier systems for improved treatment of glioblastoma multiforme;
• DBT also partnered with UK to support joint research for understanding differential response to COVID-19 infection among South-Asian populations based in India and the UK. Projects supported under this partnership seek to understand innate immune activation and cardiovascular disease risk; prospective investigation of the determinants for COVID-19 outcomes; the role of the oral microbiome & mucosal immunity; and explaining the differential severity of COVID-19 infections;

• Recognizing the importance and benefits of collaborative efforts of India and France in the field of Biotechnology, both the parties (DBT, India and CNRS, France) agreed to sign the MOU for a period of 5 years to further foster the Indo-French bilateral relations on exchange of research personnel, joint research in structural, systems and synthetic biology, bioengineering, marine biology;
• To accelerate the commercialization of integrated biorefineries and achieve the goal of replacing an additional 10% of fossil carbon equivalent by sustainable bio-carbon in fuels, chemicals, and materials derived from residues and wastes by 2030, the GoI and the Netherlands-led Mission Integrated Biorefineries was launched amongst the global clean energy community at a side event of COP26.

8. DBT’s efforts in combating COVID-19 pandemic

The concerted efforts of the Department of Biotechnology (DBT) with its, Autonomous Institutions (AIs) and PSUs BIRAC and BIBCOL have resulted into development of several effective bio-medical interventions in combating the pandemic.

Highlights during 2021, across various thematic activities have been summarized below:

• COVID Vaccine development:
  • World’s first COVID-19 DNA Vaccine, ZyCoV-D, developed by Zydus Cadila, supported under Mission COVID Suraksha, received Emergency Use Authorization (EUA) from the National Regulatory Authority (NRA) on 20^th August, 2021;
  • The indigenously developed protein subunit vaccine (CORBEVAX^TM) developed by Biological E is the 2^nd vaccine candidate under Mission COVID Suraksha, to have received EUA on 28^th December, 2021;
  • Nation’s first mRNA-based vaccine developed by Gennova Biopharmaceuticals Ltd. is currently in Phase II/III clinical stage of development;
  • India’s first Intranasal Vaccine developed by Bharat Biotech International Ltd. (BBIL), supported by DBT-BIRAC under Mission COVID Suraksha, is in Phase II clinical stage of development;
  • Indian Immunolgicals Limited (IIL), supported under Mission COVID Suraksha, for augmentation of manufacturing capacity for COVAXIN®, has achieved production capacity of 20 lakh doses/month equivalent Drug Substance (DS) in September, 2021. A total of 56 lakh doses equivalent DS was transferred to BBIL as on date;
  • Validation of the facility at Bharat Biotech International Limited (BBIL), supported under Mission COVID Suraksha, for augmentation of manufacturing capacity for COVAXIN®, at Malur, Bengaluru, is complete. Approximately 2 Crore doses equivalent of Drug Substance (DS) of COVAXIN® have been filled in so far;
  • The CEPI Centralized network lab at DBT-THSTI Faridabad, was inaugurated by the Hon’ble Minister of Science & Technology on January 5, 2021. This NABL accredited Bioassay Laboratory validated COVID-19 kits and performed immunogenicity testing of vaccine candidates for various industries and academic institutions;
  • With support from PM-CARES Funds, two DBT Autonomous Institutes- National Institute of Animal Biotechnology (NIAB), Hyderabad and National Centre for Cell Science (NCCS), Pune, have been upgraded as Central Drug Laboratories (CDLs), for testing and batch release of vaccines. The facility at NCCS, Pune, was notified as CDL, on June 28, 2021; the facility at NIAB, Hyderabad was notified on 17th August, 2021 by Ministry of Health and Family Welfare;
  • Under the Partnerships for Advancing Clinical Trials (PACT) programme, a science diplomacy initiative of the Department, two series of training programmes for strengthening clinical trial capacities in neighboring countries, were held between Sep-Dec 2020 and Feb- Apr 2021, for more than 2400 candidates across 14 neighboring and friendly countries;
  • The tableau of DBT for the Republic Day Parade 2021, titled ‘India Fights COVID-19’ adjudged the best among Ministries / Departments of India;
• COVID Diagnostic and Testing Efforts:

• DBT has identified 30 City /Regional clusters to scale up COVID testing as a part of the Hub and Spoke model. 9 DBT AIs (THSTI, ICGEB, RGCB, CDFD, inStem, NCCS, IBSD, NII and ILS) are approved as Hubs for COVID-19 testing.  As on December 17, 2021, DBT supported COVID Testing centres have tested 70.24 Lakh samples; 29,990 samples have been tested in the mobile I-lab attached to DBT-Translational Health Science and Technology Institute, Faridabad.
• DBT supported ‘AMTZ COMManD (COVID-19 Medtech Manufacturing Development) Consortium’, an indigenous manufacturing facility set up at the Andhra Med Tech Zone (AMTZ) has achieved a production capacity of ~10 Lakh RT-PCR COVID-19 diagnostic tests/day and ~1 Lakh VTM/day. AMTZ has been able to achieve production of 9.00 Cr. units of Tru-NAT RT-PCR kits; 1.5 Cr. Covid-IgG ELISA / LFA kits; 08 lakh Viral Transport Media (VTM) kits, 3000 IR thermometers, 2000 Pulse oximeters along with 11000 ventilators and other critical medical devices.

• COVID-19 Genomics

• Indian SARS-CoV-2 Genomics Consortium (INSACOG) is a consortium of 38 Regional Genome Sequencing Laboratories (RGSLs) established by DBT and MoHFW for molecular surveillance of SARS-CoV-2 variants. The INSACOG has sequenced 1,14,972 SARS -CoV-2 genomes  (as on 20.12.2021 ) of which 1,14,265 have been analyzed and assigned Pangolin lineage and results of 87,932 samples have been updated in IHIP/ submitted to NCDC.

• COVID-19 therapeutics

• DBT-BIRAC supported anti-viral drug – Virafin (pegylated interferon alpha-2b) – developed by Zydus Cadila, has recently been accorded restricted emergency use approval, for treatment of moderate COVID-19. Virafin is available in 214 hospitals across the country; included in 3 state protocols, supplied to 4 states; 6 states actively considering including in protocol.

9. Other COVID Achievements:

• THSTI contributed immensely in the clinical trials/development of vaccines for COVID-19 including Dr. Reddy’s (Sputnik), Zydus Cadilla (DNA vaccine), and Biological E and entered into an international collaboration with Nanogen Pharmaceutical Biotechnology JSC, a Vietnamese pharmaceutical company which is developing a new vaccine for COVID-19;
• "COVID-Anosmia checker", a tool for Covid-19/olfactory dysfunction screening, developed by RGCB has been transferred to Instigator e-Supporting Services Private Ltd, Thiruvananthapuram.

10.   Science Outreach Progarmmes:

• Global Bio India 2021

The DBT along with its PSU, Biotechnology Industry Research Assistance Council (BIRAC) organized the 2^nd edition of Global Bio-India 2021 from 1^st-3^rd March, 2021 on a digital platform. The event showcased India’s potential in the biotech sector both within the country and to the international community. The theme of this year was ‘Transforming Lives’ with the tag line ‘Biosciences to Bio-economy’. The event witnessed the participation from >8400 delegates; 40+ countries; >50 international speakers; >1000 Entrepreneurs & startups; facilitated 23 Awards; 140+ investor-startup meetings; 150+ exhibitors; 350+ Bio-partnering meetings.

• 7^th India International Science Festival (IISF)

The Department of Biotechnology proactively participated and coordinated the 7^th IISF, 2021 at Goa for: a) New Age Technology, b) Eco-Fest and c) Expo with its all Autonomous institutes and PSUs. Being the Chief Coordinator, the Department has coordinated ‘New Age Technology’ and Eco-FEST. In the “New Age Technology” the event had dedicated themes, viz. Artificial Intelligence (AI), Machine Learning (ML), Data Analytics; Internet of Things; AR/VR/MR/XR and AI-ML; Innovation showcase in New Age technologies in Life Sciences. DBT organized the dedicated session on ‘New Age Technology in Life Sciences’ showcasing the novel technologies in life sciences and the way they are shaping human health science endeavours. In the Expo of IISF, all the AIs of DBT and PSU (BIRAC) participated actively.

11. Policy and Guidelines Reforms:

• The “SOPs for exchange of infectious biosamples/biospecimen from Biorepsitory, 2021” were notified to ensure biosafety during collection, processing, storage and transaction of biosamples/biospecimens which require BSL-2 or above containment facility for undertaking R&D activities; and is applicable for both public and private organisations engaged in R&D activities and handling of GE organisms and non-GE HMOs.
• The List of Infective microorganisms corresponding to different “Risk Groups” was revised and updated and notified on 9^th December, 2021. It supersedes the Annexure-I of "Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017"

Certification of BSL-3 facilities:

With the notification of Guidelines for the establishment of containment facilities i.e. BSL-2 and BSL-3 and Certification of BSL-3 facility, DBT has initiated the certification of the nationwide BSL-3 facilities and has certified 10 facilities.

Biosafety Regulation:

• The DBT is committed towards promoting the advancement of research and teaching activities by ensuring that all experiments involving Hazardous Microorganisms/Genetically Engineered Organisms are conducted in compliance with (Rules, 1989) under the Environment (Protection) Act, 1986 (EPA 1986). The Rules, 1989 delegated the Department to administer the functioning of: i) Institutional Biosafety Committees (IBSCs) which operate directly from the premises of institutions and ensures on-site assessment and monitoring of adherence to the biosafety guidelines with overall oversight of the regulatory process, at the institutional level and ii) Review Committee on Genetic Manipulation (RCGM) which monitors & reviews all ongoing research projects involving high risk category and confined field experiments and ensure the compliance of biosafety rules & regulations. Framing and implementation of safety measures & guidelines while conducting research on high risk group microorganisms and GE organisms have been entrusted upon RCGM;
• During 2021, the RCGM evaluated 651 applications from public/private/autonomous  organizations including Universities in 19 meetings in the areas of agriculture, healthcare and industrial products specifically for authorization to import, export & exchange of high risk group microorganisms and recombinant DNA research related materials including seeds, gene constructs, plasmids, vectors and genetically engineered/living modifiedorganisms; to conduct pre-clinical toxicity studies; for  evaluation of pre-clinical study reports; to conduct confined field trials on GE crops viz. cotton, corn, rice etc. for generation of biosafety data; and to conduct rDNA research in pharmaceutical & agriculture sectors. This included 270 COVID related applications for the research and product development of vaccines, diagnostics, prophylactics and therapeutics and import/export/exchange;
• During the year, 16 rDNA products were permitted by RCGM for conducting pre-clinical toxicity studies by 12 private/public institutions/companies. Based on the evaluation of pre-clinical study reports, 12 rDNA were recommended to DCGI for appropriate phase of human clinical trials;
• As a measure to observe strict compliance of biosafety guidelines for rDNA activities by various colleges, universities, institutions, laboratories, and industry through their Institutional Biosafety Committees (IBSCs), more than 180 new IBSCs have been constituted, while more than 20 old IBSCs were renewed;
• Total 19 Interactive Sessions in 2021 for Biosafety Awareness for Researchers have been conducted in 2021, with participation from academia and industry both in public and private sectors to create awareness on existing regulations for biosafety in research and well versed with the existing Rules and Regulations to ensure sustainable and effective implementation of the Biosafety regulation in India.

12. Impact of the Public Sector Undertakings of DBT during the year 2021:

• Bharat Immunologicals and Biologicals Corporation Ltd. (BIBCOL), Bulandshahar, UP:

The BIBCOL has produced and supplied 1731.44 lakhs doses of Oral Polio Vaccine. This PSU has also produced 4704.10 litres of Hand Sanitizer to fight against COVD pandemic.

• Biotechnology Industry Research Assistance Council (BIRAC)’s  activities:

The PPP schemes operated by BIRAC, a PSU of DBT have been instrumental in facilitating the development of several affordable products and technologies. Many of them are in the market and have beginning to make an impact. During the year, >1000 Startups have been funded; support has been provided to 60 Bioincubators; 298 Patents have been filed; >150 Products & Technologies developed under various schemes/programmes; support has been provided to 333 Academic Institutes; >1,40,000 people enhanced skills and accessed networks established; 1344 beneficiaries have been supported; and provided support to 781 companies.

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