BioSpectrum India April 2023

Years of Eppendorf India 2003 – 2023

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Vol 21; Issue 3; March 2023 4 BIO MAIL BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com Scan QR code to access BioSpectrum India Digizine Vol 21; Issue 4; April 2023 Publisher & Managing Editor: Ravindra Boratkar Editorial: Chief Editor: Dr Milind Kokje [email protected] Advisor - Content: Vijay Thombre Editor: Narayan Kulkarni [email protected] Executive Editor: Dr Manbeena Chawla [email protected] Assistant Editor: Nitesh Pillai [email protected] Assistant Editor (Digital): Sanjiv Das [email protected] Content Team: Singapore: Hithaishi C. Bhaskar [email protected] Social Media Communications: Poonam Bhosale [email protected] CFO & Special Correspondent: Manasee Kurlekar [email protected] Operations and HR: Asmita Thakar [email protected] Product & Marketing: Ankit Kankar [email protected] Production & Design: MM Activ Sci-Tech Communications Anil Walunj Circulation, Subscription and Media Enquiry: Sudam Walekar [email protected] South Region Apoorva Mahajan Key Account Executive “NITON”, Block B, First Floor, 11/3, Palace Road, Bangalore 560052 Mobile: +91-7724025888 [email protected] Mumbai Mandar More Regional Business Manager 1st Floor, CIDCO Convention Center, Sector 30A, Vashi, Navi Mumbai, Maharashtra-400703. Mobile: +91-9870009281 [email protected] MM Activ Sci-Tech Communications Nagpur Manisha Boratkar 402, Govind Apartments, Shankar Nagar Square, Nagpur - 440 010. Tel. +91-712-2555 249 ‘BioSpectrum’ monthly publication is owned by MM Activ Sci-Tech Communications Pvt. Ltd., Published and Printed by Ravindra Boratkar, Printed at Spectrum Offset, D2/4, Satyam Industrial Estate, Behind CDSS, Erandawana, Pune - 411 038. and Published at c Editor: Narayan Kulkarni. Website: www.biospectrumindia. com New Delhi Dr Manbeena Chawla Executive Editor 103-104, Rohit House 3, Tolstoy Marg, Connaught Place, New Delhi - 110 001 Mobile: +91-8861043732 [email protected] Pune Vipan Kumar Relationship Executive - Media Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Baner Road, Pune-411045 Mobile: +91-98347 45564 [email protected] INTERNATIONAL Singapore MM Activ Singapore Pte. Ltd. Saradha Mani General Manager #08-08, High Street Centre, 1 North Bridge Road, Singapore - 179094 Tel: +65-63369142 Fax:+65-63369145 [email protected] Asia Pacific and South East AsiaAnkit Kankar DY. General Manager - Digital Strategy & Programmes #08-08, High Street Centre, 1 North Bridge Road, Singapore - 179094 Mobile: +65 90150305 [email protected] North America and Europe BioSpectrum Bureau MM Activ Sci-Tech Communications Mobile: +91-9579069369 E-mail: [email protected] Acknowledgement/ Feedback Thank you for featuring my views in your article in the March edition and putting the spotlight on Femtech in India and the brilliant work that is being done to champion the cause of women’s health. - Jaya Sheryl Rebello, Mumbai Unless women begin to make women health a priority, change is difficult to come by. I am happy that the article on Femtech by BioSpectrum India symbolises the change and the strong belief in the need of Femtech. - Gitanjali Banerjee, New Delhi India marked its presence in both human and livestock vaccine domain owing to extensive research undertaken by the government institutes and private vaccine manufacturers. Truly a game changer! Thank you BioSpectrum India for the vaccine story. - Abdos Life Sciences Team The article by Qure.ai has come out very well in the March edition. Thank you! - Amrutha Joseph, Mumbai A crisp feature on the Femtech industry that will create awareness. - Praveen Kumar, Mumbai Corrigendum Read the Volume for February 2023 and March 2023 editions of BioSpectrum as 21 instead of 22 as printed. Error is regretted. – Editor

Letter from Publisher Ravindra Boratkar Publisher & Managing Editor, MD, MM Activ Sci-Tech Communications Pvt. Ltd. Dear Readers, BioSpectrum has been ranking the life sciences industry in different segments such as biopharma, bioservices, industrial biotech (enzyme), medical devices and biosuppliers for the last several years. In this issue, we will be covering a ranking of the industry. This edition reveals how Serum Institute of India Pvt Ltd (SIIPL) continues to lead the Indian Biopharmaceutical Industry at No1 position. Using the momentum gathered by national and international supply of COVID-19 vaccines, SIIPL has not only maintained its lead but its revenue has significantly increased. Hyderabad-based Bharat Biotech International Ltd, another COVID-19 vaccine maker, is in a second position registering a 480 per cent growth over last year. The Union Government has drafted a bill to replace the age-old, colonial era Drugs & Cosmetics Act, 1940 to keep pace with changing needs and times. Among the several important factors shaping the new bill, one identifies medical devices as a separate category. Hence the title of the new bill is Drugs, Medical Devices and Cosmetics Bill, 2022. The title of the bill itself shows how important the government deems the medical devices sector. With the development of new technologies, particularly in artificial intelligence, medical devices have assumed a lot of importance in diagnostics and treatment, particularly surgeries. While exploring the medical devices sector in India, our content team noticed that the sector is still a laggard when it comes to manufacturing medical devices in India. As a result, its import increased a whopping 41 per cent per annum – from Rs 44,708 crore in 2020-21 to Rs 63,200 crore in 2021-22. That also reflects our growing need for devices. India’s ambitious health infrastructure improvement plan for rural India will further propel the demand for diagnostics and medical equipment. Considering this, industry experts demand that a surgical industry hub be set up. It is hoped that with the introduction of medical devices as a category in the new bill, many issues will be resolved and simultaneously boost the medical devices industry. The impact of Rare Diseases, although prevalent, hasn’t been tackled effectively enough due to various reasons, some related to availability and affordability of drugs and also lack of innovations in this sphere. Thanks & Regards, Ravindra Boratkar Publisher & Managing Editor BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com 5 Looking for a job? See open roles at www.biospectrumjobs.com premier source of pharma healthcare & bio jobs n Find Talent n Post Jobs n Attract Candidates Find the right people no matter what your hiring needs are... TALENT SOLUTIONS

BIOTECH INDUSTRY LEADERS 2021-22 COVER 19 COVER DESIGN BY: DOMINIX STRATEGIC DESIGN PVT. LTD. 6 BIO CONTENT BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com “Scientifically, a nasal vaccine is much more effective than an injectable one” 22 24 Adar Poonawalla, Chief Executive Officer, Serum Institute of India Serum Institute of India Pvt. Ltd. continues to lead the Indian Biopharmaceutical industry with a revenue of Rs 25000 crore for the year 2021-22 with growth rate of 247 per cent 26 Piramal Pharma Solutions is leading the BioServices Industry with sales revenue of Rs 3960 crore in 2021-22 registering a growth of 10 per cent over last year Rossari Biotech Ltd gained No 1 position by pushing Novozymes South Asia Private Limited to No 2 position in the Indian Industrial Biotechnology (Enzymes) Industry for 2021- 22 with sales revenue of Rs 1073 crore with growth rate of 56 per cent 28 29 Transasia Bio-Medicals Ltd is leading the Indian Medical Devices and Diagnostics Industry with sales revenue of Rs 1298 crore for the year 2021-22 with growth rate of 11 per cent BioSpectrum Top 20 Survey 2022

Top Video Amol Naikawadi, Joint Managing Director, Indus Health Plus is of the view that pharmacogenomics can play a huge role in enhancing preventive healthcare ecosystem in India. Scan the QR Code » Hasmukh Rawal, Managing Director, Mylab Discovery Solutions talks about the need of investment for the diagnosis of noncommunicable diseases in India. Scan the QR Code » How has the pharma sector embraced emerging technologies and what does the future hold in 2023? A perspective by Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India. Scan the QR Code » BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com BIO CONTENT 7 Regulars BioMail .......................................................................................04 Letter from Publisher...............................................................05 BioEdit ........................................................................................08 Policy and Regulatory News...................................................10 Finance News............................................................................13 Start-Up News...........................................................................14 Company News ........................................................................16 WHO News.................................................................................18 Academia News........................................................................43 People News..............................................................................44 R&D News ..................................................................................46 Supplier News ...........................................................................48 Let’s Talk Health........................................................................50 Speaking With 41 “We’ve been working with global stakeholders to make Encephalitis a public health priority” Dr Ava Easton, CEO, The Encephalitis Society, UK Medtech 31 Who Put the Brakes on Med Devices Sector Growth? 35 How is the ‘Make in India’ MedTech transformation coming along? Debarati Sengupta, Senior Industry Analyst/ Team Lead (Medical Device and Imaging), TechVision, Frost & Sullivan Rare Diseases 37 Rare Diseases Needn’t Be Neglected Anymore 40 Addressing ‘Orphaning’ of Rare Diseases Ravi Shet, Clinical Data Management Professional

8 BIO EDIT BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com Levelling the Playing Field Two news reports published last month highlight the Indian pharma sector’s successful ride in two parallel ways. Over 9,000 ‘Jan Aushadhi Kendra’ (mass medicine centres) are operational in the country, as has been informed on January 5 (Aushadhi Divas). The Indian traditional system of medicines, mainly Ayurveda, has touched the $22 billion mark as the system is playing a vital role in healthcare and people are accepting it globally. The number of Jan Aushadhi Kendras will keep growing as per the growing need of the people. The Indian traditional medicine system’s influence too, will keep growing. But, to enhance the influence of the regular Indian medicines and drugs in other countries, three points will require more attention. They include original research to launch new medicines, moving away from generics, lesser or preferably nil rejection of medicines in other countries (as well as in India) and better regulatory vigilance, along with improved quality. In fact, if the third point is strengthened it will automatically ensure lesser rejections. Original research is already evident with the unveiling of new medicines and the government initiating various steps to encourage research. However, an important, but a controversial point has been raised yet again. Vas Narasimhan, CEO, Novartis, has stressed the need for a system for regulatory data protection (RDP) as a part of national pharma policy and further streamlining of intellectual property (IP). RDP is essential to attract basic pharma research of global majors since companies want their submitted key data to be protected. However, India does not have a system to ensure RDP. Experts feel that for biologic medicines the most important IP is RDP as it prevents competitors from exploiting clinical trials data. In whichever countries innovative biotechnology companies are concentrated, one common factor among those countries is they have clear rules for data protection. However, it is a contentious issue between the developed and developing countries. Countries with a strong pharma research base wish to incentivise industry through protection by data exclusivity. Developing countries are opposing it on the points of availability and affordability of drugs to their population. At the core of the controversy is article 39.3 of the World Trade Organisation’s (WTO) Trade-related Aspects of Intellectual Property Rights (TRIPS) agreement. Several Indian pharma companies, mostly generic producers, are opposing RDP on the same grounds of availability and affordability. Though India does not have any legal provision for data exclusivity to comply with TRIPS article 39.3, it may now have to consider it. Some experts have suggested a via media like limiting the term of data protections, termination of data exclusivity along with the expiry of patent, limiting the scope of data exclusivity to pharma products that cannot have patent. Multinational companies from developed countries will have to consider such toneddown options in the interest of affordability for the poor. While taking a firm position on the issue of data exclusivity, the government will have to strengthen the regulatory processes for ensuring quality of the products and bringing rejections of drugs to nil. This is important considering the percentage of spurious and substandard drugs. From 2020 to 2021 such incidences increased by 47 per cent. In November 2021 itself 6 per cent of the 1487 samples were sub-standard. One reason cited in a report by Authentication Solution Providers’ Association (ASPA) is ‘domestic regulations and legal structure are not as well defined as required.’ The government has already drafted a bill for a new Pharmaceutical Act in an attempt to remove the shortcomings in the decades old Act of 1940. Another issue cited by experts is that of having two authorities, one central and second for the states. To have one quality and one standard, state regulatory bodies should be merged with the Central Drugs Standard Control Organisation (CDSCO), Dr Krishna Ella of Bharat Biotech has suggested. Some of the steps need urgent attention and action to overcome the problem of substandard drugs, particularly moving from generics to original new drugs. Dr Milind Kokje Chief Editor [email protected]

Pharmacy Council of India (PCI), the statutory body under Ministry of Health and Family Welfare, Government of India, recently organised ‘Pharma Anveshan 2023’ to promote research and innovation, enhancing industry and academia. Dr Bharati Pravin Pawar, Minister of State for Health and Family Welfare, inaugurated Pharma Anveshan 2023 on the occasion of National Pharmacy Education Day. She also launched a ‘One Stop-Non Stop’ digital job portal of Pharmacy Council of India, which will be useful for pharma professionals as well as recruiters from the industry. This will prove to be a game changer for the students coming from small towns and villages. At the event, PCI also signed Memorandum of Understanding (MoU) with Karnataka Drugs and Pharmaceuticals Manufacturer’s Association (KDPMA), Life Sciences Sector Skill Development Council, Ministry of Skill Development and Entrepreneurship (LSSSDC), Indian Pharma Alliance (IPA) and Federation of Pharma Entrepreneurs (FOPE) to reduce the gap of industry and academia, strengthen faculty and student training and promote entrepreneurship and infrastructure development. ‘One Stop-Non-Stop’ digital job portal of Pharmacy Council of India goes live Govt announces exclusive women’s portal for research grants and funds To mark the International Women’s Day, Union Minister of State (Independent Charge) Science & Technology Dr Jitendra Singh announced an exclusive women’s portal for research grants and funds. The portal will become functional with effect from April 1. The Council of Scientific & Industrial Research (CSIR) has decided to start exclusive Research Grants for Women Scientists under CSIR-ASPIRE and an exclusive portal in this regard will be available from April 1, 2023. The Special Call inviting proposals from Women Scientists will open the same day. Only women scientists across the country will be eligible to apply for research grants to carry out R&D in major disciplines of science and engineering, namely, Life Sciences, Chemical Sciences, Physical Sciences, Engineering Sciences and inter/trans disciplinary sciences. The funds will be provided for staff (JRF/SRF/RA), contingency and minor equipment. India, Mexico sign MoU on research, technology and innovation 10 POLICY AND REGULATORY NEWS BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com India and Mexico have signed a Memorandum of Understanding (MoU) on research, technology and innovation collaborations with focus on several key technology areas like Aerospace, Electronics Instrumentation & Strategic Sectors; Civil, Infrastructure & Engineering; Ecology, Environment Earth & Ocean Sciences and Water; Mining, Minerals, Metals & Materials; Chemicals (including leather) and Petrochemicals; Energy (Conventional & NonConventional) and Energy Devices; Agri, Nutrition & Biotech and Healthcare. The multi-sectoral agreement was signed in the presence of Dr Jitendra Singh, Union Minister for Science & Technology, and Marcelo Ebrard, Foreign Minister of Mexico at the India Science Centre, New Delhi in presence of high-level delegations from both the sides. Dr Jitendra Singh pointed out that Council of Scientific & Industrial Research (CSIR) and Mexican Agencies through this MoU could contribute effectively to the global society through research and innovation partnerships for technology development, upscaling of each other’s Intellectual Property for commercialisation and research infrastructure development & sharing.

Advancing Science with Quality LIFE SCIENCES TM www.abdoslifesciences.com 011-41081897 [email protected] What Abdos Life Sciences stands for? Precision Reliability Responsiveness Innovation Sustainability Relationships Innovation at the heart of everything we do! Generation-2 Tip Box from Abdos Life Sciences is now PATENTED Ensures compatibility with major pipette brands Tip box durability extends utilisation and curbs wastage Assures better handling of liquid samples and laboratory reagents Indigenously developed design increases strength and stability

Malaria No More (MNM) has signed a Memorandum of Understanding (MoU) with the Department of Health & Family Welfare, Government of Odisha to eliminate malaria from the state. The tripartite partnership also included Prayatna, a grassroot organisation that is the implementing and fiduciary partner of the MNM India programme of Malaria No More. MNM has been supporting the Government of Odisha since 2018 to strengthen the state’s malaria control and elimination programme, offering technical, strategic, implementation, advocacy, and innovation support. This new MoU marks the strength of the existing partnership between MNM and Government of Odisha, with an extended partnership period of 5 years. Over the next five years, MNM seeks to build on and enhance the previous MoU by expanding operational geography to cover additional parts of Koraput and Malkangiri – two of the most malaria endemic districts of the country. The extended partnership will also focus on integration of newer tools and innovative technology, including advanced data reporting, management, and analysis tools; strengthening of inter-sectoral and interdepartmental coordination for a concerted and collaborative effort; and improving entomological capacity of the state. 12 POLICY AND REGULATORY NEWS BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com The Department of Pharmaceuticals (DoP) has released the first tranche of incentives under the Product Linked Incentive (PLI) scheme for pharmaceuticals amounting to Rs 166 crore to four selected applicants- Dr. Reddy’s Laboratories, Biocon, Strides Pharma Science, Premier Medical Corporation. The DoP has received an incentive claim of about Rs 544 crore from 15 applicants. Based on the evaluation, Rs 221 crore of claims of incentives from the selected four applicants were found to be eligible and 75 per cent of this amount i.e., Rs 165.74 crore have been released. DoP launched the PLI scheme for pharmaceuticals in 2021. The financial outlay under this PLI scheme is Rs 15,000 crore over a period of six years. So far, 55 applicants have been selected under the scheme, including 20 Micro, Small & Medium Enterprises (MSMEs). The financial year of 2022-2023 being the first year of production for the PLI Scheme, DoP has ear-marked Rs 690 crore as the budget outlay. As of January 31, 2023, sales of about Rs. 36,000 crore have been reported by the select 55 applicants. Govt releases Rs 166 Cr incentives under PLI scheme for pharma A Memorandum of Cooperation (MoC) has been signed between the Science and Engineering Research Board (SERB), and The Swedish Foundation for International Cooperation in Research and Higher Education (STINT), Stockholm, Sweden, to strengthen cooperation and promote research networking between research institutions from both countries. The MoC was signed by Dr Akhilesh Gupta, Secretary, SERB, and Dr Andreas Göthenberg, Executive Director, STINT. The MoC aims to promote mobility funding opportunities in both countries. It will facilitate academic cooperation through mobility activities as well as through seminars, workshops and conferences. Both institutions will facilitate and fund researcher mobility through their regular funding programmes. India and Sweden strengthen research cooperation Malaria No More inks MoU with Odisha to accelerate malaria elimination efforts

Sri Kauvery Medical Care (India) Limited (Kauvery Hospitals), has successfully raised equity funding of $70 million from a private equity (PE) fund managed by IIFL Asset Management Limited (IIFL AMC) for a minority stake. The company has been backed by reputed Indian and global investors, Lightrock and Dr GSK Velu’s family office, to achieve its current scale and market positioning. The hospital network offers high-quality comprehensive care across specialties with a strong focus on cardiology, oncology, neurology, renal sciences, orthopaedics, and organ transplants, amongst others. The investment holds significance in Kauvery Hospitals next phase of growth which is likely to move towards an IPO tentatively in the next three years, which comprises augmenting capacities in Chennai and Bengaluru, along with expansion in chosen clusters within Tamil Nadu and Karnataka. World Bank infuses $1B for India’s Pandemic Preparedness, Health Infrastructure Mission Goa-based medtech firm Molbio Diagnostics has acquired a 70 per cent stake in Bengaluru-based Prognosys Medical Systems, a renowned manufacturer of the Prorad range of Digital X-Ray units and C-arms and developer of a comprehensive digital health platform. Prognosys builds radiology and fluoroscopy solutions under the brand name PRORAD at its facility based out of Bengaluru that complies with national and international regulatory requirements. The recent introduction of the unique PRORAD Portable and Ultra-Portable digital x-ray units manufactured, for the first time in India, by Prognosys, can deliver high-quality chest images combined with Artificial Intelligence (AI) driven algorithms for automated interpreting and reporting at the point of care. The combination of PRORAD and Truenat systems offers a game-changing solution for screening and confirming large populations for highly contagious and devastating diseases such as tuberculosis (TB), COVID-19 and other chest anomalies. Molbio Diagnostics acquires majority stake in Prognosys Medical Systems Kauvery Hospitals eyes IPO after bagging $70 M investment from IIFL AMC BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com FINANCE NEWS 13 The Government of India and the World Bank have signed two complementary loans of $500 million each to support and enhance India’s health sector development. Through this combined financing of $1 billion, the Bank will support India’s flagship Pradhan Mantri-Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), launched in October 2021, to improve the public healthcare infrastructure across the country. In addition to the national level interventions, one of the loans will prioritise health service delivery in seven states including Andhra Pradesh, Kerala, Meghalaya, Odisha, Punjab, Tamil Nadu, and Uttar Pradesh. The $500 million Public Health Systems for Pandemic Preparedness Programme (PHSPP) will support the government’s efforts to prepare India’s surveillance system to be ready to detect and report epidemics of potential international concern, ensure rapid response, and prevent emergence of pathogens; to enhance India’s capacity to detect pathogens, including zoonotic diseases, to inform India’s biosecurity response and commercialisation of new technologies to prevent, detect or treat infectious diseases.

14 STARUPS NEWS BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com Mylab launches range of rapid tests for STDs Pristyn Care forays into holistic weight-loss and metabolic health management IISc-incubated ShanMukha Innovations develops India’s first diagnostic kit for Sickle-Cell Anaemia ShanMukha Innovations, a health-tech startup incubated by the Society for Innovation and Development (SID) at the Indian Institute of Science (IISc) in Bengaluru, has developed SickleCert, India’s first indigenous diagnostic kit for Sickle-Cell Anaemia. A screening test kit called SickleFind has also been developed. The technology called High Performance Optical Spectroscopy (HPOS) consisting of test kits (SickleCert), and portable analyser (HaemoCube) was developed by researchers at IISc. The technology has been licensed to a spin-off from IISc, ShanMukha Innovations for commercialisation. A companion smartphone application enables digital data recording, analysis and integration with various registries, Ayushman Bharat Health Account (ABHA) and other cloud-based patient health record systems. The Government of India has announced an ambitious National Sickle Cell Elimination Mission to eradicate the disease from the country by 2047 in the recent Budget. The Mission plans to screen 7 crore people over the next three years as a first step. Pune-based startup Mylab Discovery Solutions has expanded its portfolio of rapid tests for sexually transmitted diseases (STDs), namely HIV, HCV and Syphilis. Among these tests, HIV 1/2 Ab and HCV Ab are rapid tests for the detection of antibodies specific to HIV-1 and HIV-2 and HCV respectively, while Syphilis Antibody test detects antibodies (IgG, IgA, IgM) to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis. The PathoCatch HIV 1/2 Ab test measures the presence of antibodies in response to the presence of HIV, providing accurate and reliable results in less than 20 minutes, while the PathoCatch HCV Ab test detects antibodies generated as a response to hepatitis C virus (HCV) infection. These tests are easy to use, capable of being stored at room temperature and can be deployed at point of care in resource-limited settings. Additionally, these tests can be used at blood banks for effective detection of transfusiontransmissible infections (TTIs) among blood donors and reducing their transmission. Gurugram-based startup Pristyn Care has entered into a strategic partnership with US-based Allurion Technologies, in order to offer a holistic weightloss and obesity care platform. Allurion has developed the world’s first and only procedureless swallowable gastric balloon. In a 15-minute OPD visit, the patient swallows a vegan capsule that contains the gastric balloon. Once in the stomach, a catheter is used to inflate the balloon with 550 ml of liquid – no surgery, endoscopy or anaesthesia is required. A simple X-ray is used to ensure the balloon is in the right position. After placement, the balloon – roughly the size of a grapefruit – takes up space in the patient’s stomach, creating a feeling of fullness and reducing food intake. The balloon reduces feelings of hunger, and in approximately 16 weeks, it automatically deflates and passes out of the body naturally. With this partnership, Pristyn Care will go live with this treatment in 6 metro cities - Delhi, Bengaluru, Mumbai, Hyderabad, Chennai and Pune, which have close to 100 clinics and over 400 hospital tie-ups.

Dozee, Qure AI win recognition by Marico Innovation Foundation India Health Fund supports faster & accurate diagnosis of mosquito-borne diseases India Health Fund (IHF), a Tata Trusts initiative focused on improving health outcomes in infectious diseases, has announced funding for two pioneering platform tools that can be used for diagnosis of multiple diseases. Developed by Ameliorate Biotech (a startup by alumni of the Indian Institute of Technology- Kharagpur and incubated at the Atal Incubation Centre, NITTE University, Karnataka) and Thane-based startup Medprime Technologies respectively, the innovations, a fever panel to detect dengue, chikungunya, and malaria; and a microscopeagnostic artificial intelligence (AI)-enabled diagnosis software that is applicable across diseases. Ameliorate Biotech has developed an accurate, multiplexed rapid diagnostic test (RDT) for dengue, chikungunya and malaria (with malaria falciparum and vivax differentiation). The simple 15-min test uses a single test kit and a single blood sample and can be easily used by minimally trained workforce at primary level. India’s first medical weight-loss company Elevate Now secures pre-seed funding W Health Ventures has led a pre-seed funding round in New Delhibased startup Elevate Now, India’s first medical weight-loss company. The funding will help Elevate Now to expand its operations and deliver innovative weight loss solutions to more individuals across India. The company offers tailored and doctor-led medication-based weight loss programmes, personalised health coaching, and habit coaching that aligns with clinical protocols designed for the Indian population. Focussed on an omnichannel distribution strategy from the get-go, the company has already launched its first co-branded obesity clinic in Aurangabad, with the next set of clinics planned in Bengaluru and Delhi. With this financing, Elevate Now plans to establish more offline partnerships to accelerate its nationwide expansion, aiming to set up over 10 clinics throughout India in 2023. By leveraging its innovative doctor-led approach to weight loss, Elevate Now is transforming the industry and empowering millions of individuals to achieve a healthier lifestyle. BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com STARUPS NEWS 15 Marico Innovation Foundation (MIF) recently announced 7 winners in its 9th edition. Innovations were recognised across two broad categories - Business & Social. Amongst other verticals, two health tech startups- Dozee (India’s first contactless remote patient monitoring and early warning system) and Qure AI (artificial intelligence driven healthcare startup with automated interpretation of radiology exams) won in the business category. The business category saw applications from 20+ sectors, including Healthcare/ Med-Tech, Agritech, Waste Management, Robotics, Manufacturing, and others. On the other hand, applications in the social category presented solutions for 15+ social challenges across education and training, women’s development, health and well-being, sustainability, and others. The applications also saw women innovators apply in significant numbers this year, with considerable organisations featuring women -only and at least one woman founder. The 9th edition winners were shortlisted and selected from applications across the country post an extensive outreach phase.

US-based medtech firm Stryker has announced the launch of the SmartMedic platform at the 29th Annual Conference of the Indian Society of Critical Care Medicine in Indore. SmartMedic is a patient care platform which enhances existing intensive care unit (ICU) bed capabilities at hospitals. This solution is intended to manage changes in patient weight, monitor patient turns from nurse stations and help medical staff to perform X-rays on patients within the ICU, without having to move them. SmartMedic is aimed at reducing a patient’s discomfort and providing enhanced care to them while hospitalised at all levels of acuity. The first-ofits-kind platform can wirelessly link to nurse call systems, helping increase productivity and efficiency of the nursing staff to deliver care, thereby reducing possibly high hospital expenses. SmartMedic is an effective solution for any hospital because it can be installed and is compatible with any ICU bed. Stryker launches India’s first ICU bed upgrade platform IIT-K and Reliance Life Sciences to revolutionise gene therapy for hereditary eye diseases Sanofi to bring drugs for Pompe and Niemann-Pick disease to India Sanofi Speciality Care has reaffirmed its commitment to rare diseases in India on the occasion of Rare Disease Day- 28th February, stating that it will continue with its efforts in empowering the lives of patients with rare diseases by offering transformative healthcare options. With the largest portfolio of rare disease therapies, the company has also received a recommendation from the Subject Expert Committee to import and market two new products in India - Nexviazyme (Avalglucosidase alfa powder) and Xenpozyme (Olipudase alfa powder) for Pompe disease and NiemannPick disease (ASMD) respectively. Both these products have been granted orphan drug status and approval in several countries including the US, Australia, EU, UK and Japan, to name a few. Both these products have been granted orphan drug status and approval in several countries including the US, Australia, EU, UK and Japan, to name a few. The Indian Institute of Technology, Kanpur (IIT-K) has licensed a pioneering technology to Reliance Life Sciences that has the potential to revolutionise the field of gene therapy, especially for many genetic eye diseases. This marks the first time that a gene therapy related technology has been developed and transferred from an academic institution to a company in India. The gene therapy technology from IIT-K will be further developed as an indigenous product by Reliance Life Sciences. Developed by Prof. Jayandharan Giridhara Rao and Shubham Maurya from the Department of Biological Sciences and Bioengineering (BSBE), IIT-K, the patented technology modifies the gene of an organism to treat a hereditary disorder. The technology modifies this location to optimise its ability to deliver genes to the affected cells and improve its effectiveness. The technology has the ability to improve gene therapy for many hereditary diseases, especially inherited eye diseases. It has shown significant promise in correcting the vision impairment in animal models of blindness. Reliance Life Sciences is developing several gene therapies to address unmet clinical needs. In addition to gene therapies, Reliance Life Sciences is developing a range of human and animal health vaccines and mRNA products. 16 COMPANY NEWS BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com

Bengaluru-based MedGenome Labs has announced the launch of a ground-breaking first-ever Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1) test in India. MedGenome Labs is the first commercial lab to offer this new genetic test that will help individuals with FSHD1 to get an early and accurate diagnosis, leading to improved disease management options. The FSHD1 Optical Genome Mapping Test (OGM) is a highly advanced diagnostic tool that uses cutting-edge technology to provide a comprehensive and accurate assessment of genetic changes in patients with FSHD1. The test can detect large-scale insertions and duplications, as well as more subtle changes in DNA that can cause FSHD1. Facioscapulohumeral Muscular Dystrophy (FSHD) is a common form of muscular dystrophy with an extremely complex genotype. It is progressive myopathy which accounts for 2 to 3% of the muscular dystrophy cases in India. FSHD1 is a rare genetic disorder that affects the muscles of the face, shoulder blades, and upper arms. The disease is caused by the deletion of genetic material from the D4Z4 repeat region on chromosome 4, leading to the loss of muscle tissue and weakness in affected areas. MedGenome Labs unveils FSHD1 genetic screening test for rare disease diagnosis Vara, a German medical technology company focused on breast cancer screening and detection, has announced its expansion to India. With a mission to improve the lives of women and their families through early detection of breast cancer, Vara will roll out its data-driven breast cancer screening solution with first screening centres in Mumbai through its partnership with Suburban Diagnostics and NM Medical. Through these partnerships, Vara will offer screenings at affordable prices and raise awareness about the importance of breast cancer prevention and early detection. Vara’s technology combines Artificial Intelligence (AI) with digital mammography to detect breast cancer at its earliest stages. Vara’s technology combines Artificial Intelligence (AI) with digital mammography to detect breast cancer at its earliest stages. By using machine learning algorithms to analyse images and identify earliest signs of potential abnormalities, Vara’s technology can improve the accuracy of breast cancer screening while reducing the number of unnecessary biopsies. German medtech firm Vara brings breast cancer screening solution Neuberg Centre for Genomic Medicine (NCGM) has launched the most cutting edge and fastest prenatal diagnostic test called the Prenatal Aneuploidy NCG test (PAN Test) and an upgraded version of Chromosomal Microarray Analysis test with launch of Cyto-ONE test for the first time in India. Neuberg’s PAN test and Cyto-ONE test are innovative prenatal diagnostic tests that are designed to provide better coverage of disorders in the foetus without compromising on turnaround time or cost. These tests are developed by Neuberg Centre for Genomic Medicine, and they represent significant upgrades to existing technologies for diagnosing foetal abnormalities. The PAN test is capable of detecting abnormalities on all chromosomes and sub-chromosomal regions, providing comprehensive answers for doctors and expecting mothers who wish to get the most robust and exhaustive diagnostic results in the shortest time without the need for getting multiple tests done. Neuberg Centre for Genomic Medicine revolutionises prenatal diagnosis outcomes BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com COMPANY NEWS 17

New WHO guide for NGOs advocates lifesaving emergency care New collaboration targets better bone health and ageing The World Health Organisation (WHO) has released a new primary ear and hearing care training manual to assist countries in building the capacity of their health workforce to provide ear and hearing care at the community level. The manual is a practical guide on the prevention, identification and management of hearing loss and common ear diseases and can be used to train health workers and doctors who work at community level primary healthcare facilities. It contains modules on the mechanism of hearing, conducting ear examination and hearing assessment, guidance on prevention, management, and referral of common ear diseases, as well as rehabilitation of hearing loss. It includes hands-on practical activities for skill development. In most places, services for ear and hearing problems remain mainly limited to the tertiary or secondary levels of care, and are provided by highly skilled professionals such as ear, nose and throat (ENT) specialists and audiologists. Globally, there is shortage of highly trained ear and hearing care professionals which is a big challenge towards providing ear and hearing care for all. The majority of low- and middle-income countries have less than one ENT specialist and one audiologist per million population. WHO promotes access to ear and hearing care in communities 18 WHO NEWS BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com The World Health Organisation (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) have signed an agreement to develop a strategic roadmap on bone health and ageing and advocate for a public health strategy to prevent fractures among older people. The agreement includes the development of a public health strategy and action plan to prevent fractures among older people as well as to improve the coverage of health services for fractures which are critical for achieving the triple billion targets of WHO’s Thirteen General Programme of Work (GPW13). The fiveyear agreement was signed at the WHO Headquarters in Geneva, Switzerland by Dr Anshu Banerjee, WHO Assistant Director-General ad interim, Universal Health Coverage/Life Course and Dr Jean-Yves Reginster, President of ESCEO. A new practical guide released by the World Health Organisation (WHO) supports non-governmental organisations to more effectively advocate for lifesaving emergency care. Developed collaboratively by WHO, including the WHO Global Alliance for Care of the Injured, and the Global Alliance of NGOs for Road Safety, Advocating for emergency care: a guide for non-governmental organisations is especially targeted towards non-governmental organisations that operate with limited resources. It proposes a step-by-step advocacy framework that encourages its users to assess the terrain, prepare to act, take action and review progress. A series of case studies from around the world and links to useful resources are also included. Around the world, acutely ill and injured people seek care every day for medical, surgical and obstetric emergencies, including injuries resulting from road traffic crashes.

Piramal Pharma Solutions is leading the BioServices Industry with sales revenue of Rs 3960 crore in 2021-22 registering a growth of 10 per cent over last year Transasia Bio-Medicals Ltd is leading the Indian Medical Devices and Diagnostics Industry with sales revenue of Rs 1298 crore for the year 2021-22 with growth rate of 11 per cent Rossari Biotech Ltd gained No 1 position by pushing Novozymes South Asia Private Limited to No 2 position in the Indian Industrial Biotechnology (Enzymes) Industry for 2021-22 with sales revenue of Rs 1073 crore with growth rate of 56 per cent Serum Institute of India Pvt. Ltd. continues to lead the Indian Biopharmaceutical industry with a revenue of Rs 25000 crore for the year 2021-22 with growth rate of 247 per cent * We have not covered some of the leading Biotech Companies as they are unable to participate in the BioSpectrum Biotech Industry Survey 2022 BioSpectrum Top 20 Biotech Companies for 2021-22* Sr. No Company Segment Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth over last year (%) Category Location State Region 1 Serum Institute of India Pvt. Ltd. BioPharma 25000 7201 247 India Pune Maharashtra West 2 Bharat Biotech International Ltd. BioPharma 8352 1439 480 India Hyderabad Telangana South 3 Biocon Ltd. BioPharma 5805 5163 12 India Bangalore Karnataka South 4 Piramal Pharma Solutions BioServices 3960 3616 10 India Mumbai Maharashtra West 5 Jubilant Pharmova Ltd. BioServices 3673 3709 -1 India Noida Uttar Pradesh North 6 Syngene International Ltd. BioServices 2604 2184 19 India Bangalore Karnataka South 7 Biological E Ltd. BioPharma 2,588 1418 82 India Hyderabad Telangana South 8 IQVIA RDS (India) Pvt. Ltd. BioServices 2451 1803 36 MNC Bangalore Karnataka South 9 Reliance Life Science Pvt. Ltd. BioPharma 1969 1404 40 India Mumbai Maharashtra West 10 Novo Nordisk India Pvt. Ltd. BioPharma 1950 1467 33 MNC Bangalore Karnataka South 11 Intas Pharmaceuticals Ltd. BioPharma 1340 1071 25 India Ahmedabad Gujarat West 12 Suven Pharmaceuticals Ltd. BioServices 1320 1010 31 India Hyderabad Telangana South 13 Transasia Bio-Medicals Ltd. Diagnostics 1298 1166 11 India Mumbai Maharastra West 14 Bharat Serums & Vaccines Ltd. BioPharma 1240 942 32 India Mumbai Maharashtra West 15 Aragen Life Sciences Pvt. Ltd. BioServices 1236 950 30 India Hyderabad Telangana South 16 Anthem Biosciences Pvt. Ltd. BioServices 1231 1103 12 India Bangalore Karnataka South 17 Rossari Biotech Ltd. Enzyme 1073 688 56 India Mumbai Maharashtra West 18 Trivitron Healthcare Pvt. Ltd. Diagnostics 900 469 92 India Chennai Tamil Nadu South 19 Novozymes South Asia Pvt. Ltd. Enzyme 815 731 11 MNC Bangalore Karnataka South 20 Molbio Diagnostics Pvt. Ltd. Diagnostics 800 1272 -37 India Verna Goa West BIOTECH INDUSTRY LEADERS 2021-22 BioSpectrum Top 20 Survey 2022 BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com COVER 19

BioSpectrum Top 21-61 Biotech Companies for 2021-22* Sr. No Company Segment Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth over last year (%) Category Location State Region 21 Indian Immunologicals Ltd. BioPharma 798 747 7 India Hyderabad Telangana South 22 Concord Biotech Ltd. BioPharma 713 617 16 India Ahmedabad Gujarat West 23 Advanced Enzyme Technologies Ltd. Enzyme 536 511 5 India Thane Maharashtra West 24 Labcorp Drug Development India Pvt. Ltd. BioServices 461 330 40 MNC Mumbai Maharashtra West 25 Agappe Diagnostics Ltd. Diagnostics 441 275 60 India Ernakulam Kerala South 26 Meril Diagnostics Pvt. Ltd. Diagnostics 391 203 93 India Vapi Gujarat West 27 Aurigene Pharmaceutical Services Ltd. BioServices 361 191 89 India Bangalore Karnataka South 28 Gennova Biopharmaceuticals Ltd. BioPharma 343 260 214 India Pune Maharashtra West 29 Hetero Biopharma Ltd. BioPharma 335 131 124 India Hyderabad Telangana South 30 PPD Pharmaceutical Development India Pvt. Ltd. BioServices 322 214 50 MNC Mumbai Maharashtra West 31 Labcorp Scientific Services & Solutions Pvt. Ltd. BioServices 304 207 46 MNC Mumbai Maharashtra West 32 Mylab Discovery Solutions Pvt. Ltd. Diagnostics 300 840 -64 India Pune Maharastra West 33 Aurigene Oncology Ltd. (formerly, Aurigene Discovery Technologies Ltd.) BioServices 290 306 -5 India Bangalore Karnataka South 34 Neuland Laboratories Ltd. BioServices 286 269 6 India Hyderabad Telangana South 35 Vimta Labs Ltd. BioServices 277 210 32 India Hyderabad Telangana South 36 Nureca Ltd. Diagnostics 263 216 22 India Mumbai Maharastra West 37 Lambda Therapeutic Research Ltd. BioServices 253 472 -46 India Ahmedabad Gujarat West 38 Panacea Biotec Ltd. BioPharma 235 228 3 India New Delhi New Delhi North 39 Veeda Clinical Research Ltd. BioServices 224 196 14 India Ahmedabad Gujarat West 40 Beacon Diagnostics Pvt. Ltd. Diagnostics 196 113 74 India Navsari Gujarat West 41 J. Mitra & Co. Pvt. Ltd. Diagnostics 182 99 84 India New Delhi New Delhi North 41 Oscar Medicare Pvt. Ltd. Diagnostics 182 74 146 India New Delhi New Delhi North 42 Haffkine Bio-Pharmaceutical Corporation Ltd. BioPharma 172 102 69 India Mumbai Maharashtra West 43 Aizant Drug Research Solutions Pvt. Ltd. BioServices 169 132 28 India Hyderabad Telangana South 44 Hester Biosciences Ltd, BioPharma 162 154 5 India Ahmedabad Gujarat West 45 Titan Biotech Ltd. Enzyme 154 143 8 India Delhi Delhi North 46 Medsource Ozone BioMedicals Pvt. Ltd. Diagnostics 150 113 33 India Faridabad Haryana North 47 Peerless Biotech Pvt. Ltd. Diagnostics 145 83 74 India Chennai Tamil Nadu South 48 Advy Chemical Pvt. Ltd. Diagnostics 137 96 43 India Thane Maharastra West 49 Kemwell Biopharma Pvt. Ltd. BioServices 107 55 94 India Bangalore Karnataka South 50 Eurofins Advinus Biopharma Services India Pvt. Ltd. BioServices 106 8 1267 India Bangalore Karnataka South 51 Ecron Acunova Ltd. BioServices 97 91 6 India Bangalore Karnataka South 52 BioSystems Diagnostics Pvt. Ltd. Diagnostics 94 63 51 India Kancheepuram Tamil Nadu South 52 Diasys Diagnostics India Pvt. Ltd. Diagnostics 94 49 90 MNC Mumbai Maharastra West 53 Indovax Pvt. Ltd. BioPharma 92 80 16 India Gurugram Haryana North 54 Paramount Surgimed Ltd. Diagnostics 82 60 36 India New Delhi New Delhi North 55 Athenese-Dx Pvt. Ltd. Diagnostics 80 52 55 India Chennai Tamil Nadu South 56 Bharat Immunologicals And Biologicals Corporation Ltd. BioPharma 79 87 -9 India Bulandshahr Uttar Pradesh North 57 QPS Bioserve India Pvt. Ltd. BioServices 78 48 60 MNC Hyderabad Telangana South 58 Shilpa Medicare Ltd. BioServices 77 107 -28 India Raichur Karnataka South 59 VINS BIO Products Ltd. BioPharma 76 76 India Hyderabad Telangana South 60 Immunoshop India Pvt. Ltd. Diagnostics 73 48 53 India Mumbai Maharastra West 61 Siro Clinpharm Pvt. Ltd. BioServices 69 56 24 India Navi Mumbai Maharashtra West 20 COVER BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com

* We have not covered some of the leading Biotech Companies as they are unable to participate in the BioSpectrum Biotech Industry Survey 2022 62 Tex Biosciences (P) Ltd. Enzyme 61 42 47 India Chennai Tamil Nadu South 62 Biosense Technologies Pvt. Ltd. Diagnostics 61 100 -39 India Thane Maharastra West 62 AGD Biomedicals Pvt. Ltd. Diagnostics 61 39 56 India Mumbai Maharastra West 63 Synapse Labs Pvt. Ltd. BioServices 59 43 36 India Pune Maharashtra West 64 Pathkits Healthcare Pvt. Ltd. Diagnostics 57 10 473 India Gurugram Haryana North 65 Brilliant Bio Pharma Pvt. Ltd. BioPharma 53 67 -20 India Hyderabad Telangana South 65 Accurex Biomedical Pvt. Ltd. Diagnostics 53 36 47 India Mumbai Maharastra West 66 Vivo Bio Tech Ltd. BioServices 51 52 -1 India Hyderabad Telangana South 67 Bhat Biotech India (P) Ltd. Diagnostics 50 93 -46 India Bangalore Karnataka South 68 Genuine Biosystem Pvt. Ltd. Diagnostics 49 27 80 India Chennai Tamil Nadu South 69 Lumis Biotech Pvt. Ltd. Enzyme 45 50 -10 India Mumbai Maharashtra West 70 Norwich Clinical Services Pvt. Ltd. BioServices 43 38 14 India Bangalore Karnataka South 71 Novotech Clinical Research India Pvt. Ltd. BioServices 36 25 43 MNC Bangalore Karnataka South 72 Pharmaffiliates Analytics and Synthetics Pvt. Ltd. BioServices 34 25 38 India Panchkula Haryana North 72 Aspen Laboratories Pvt. Ltd. Diagnostics 34 21 64 India Delhi New Delhi North 73 Reckon Diagnostics Pvt. Ltd. Diagnostics 31 20 54 India Vadodara Gujarat West 74 Aumgene Biosciences Pvt. Ltd. Enzyme 28 24 15 India Surat Gujarat West 75 Enzyme Bioscience Pvt. Ltd. Enzyme 27 19 39 India Surat Gujarat West 76 Fruzyme Biotech India Pvt. Ltd. Enzyme 26 22 22 India Tirupur Tamil Nadu South 76 Voxtur Bio Ltd. Diagnostics 26 38 -30 India Surat Gujarat West 76 Dano Vaccines and Biologicals Pvt. Ltd. BioPharma 26 29 23 India Hyderabad Telangana South 77 Recombigen Laboratories Pvt. Ltd. Diagnostics 24 17 43 India New Delhi New Delhi North 78 Vanguard Diagnostics Pvt. Ltd. Diagnostics 22 23 -5 India New Delhi New Delhi North 79 Biolab Diagnostics (India ) Pvt. Ltd. Diagnostics 19 11 78 India Mumbai Maharastra West 79 Advanced Vital Enzymes Pvt. Ltd. Enzyme 19 15 28 India Thane Maharashtra West 80 Diatek Healthcare Pvt. Ltd. Diagnostics 16 11 44 India Kolkota West Bengal East 80 Jainam Biomedical Diagnostics 16 14 14 India Ahmedabad Gujarat West 81 Anamol Laboratories Pvt. Ltd. Diagnostics 15 5 240 India Thane Maharastra West 81 Biogenix Inc. Pvt. Ltd. Diagnostics 15 8 87 India Lucknow UP North 81 CliniRx Research Pvt. Ltd. BioServices 15 14 10 India New Delhi New Delhi North 81 Allied Biotechnology India Pvt. Ltd. Diagnostics 15 India Mumbai Maharastra West 82 Achira Labs Pvt. Ltd. Diagnostics 14 3 347 India Bangalore Karnataka South 82 Enzyme India Pvt. Ltd. Enzyme 14 10 45 India Chennai Tamil Nadu South 83 Jeev Diagnostics Pvt. Ltd. Diagnostics 13 6 121 India Chennai Tamil Nadu South 84 Cosara Diagnostics Pvt. Ltd. Diagnostics 11 36 -68 India Ahmedabad Gujarat West 84 CPL Biologicals Pvt. Ltd. BioPharma 11 4 India Ahmedabad Gujarat West 84 Eurofins Advinus Pvt. Ltd. BioServices 11 214 -95 MNC Bangalore Karnataka South 85 ADS Diagnostic Ltd. Diagnostics 10 11 -2 India New Delhi New Delhi North 85 Vanta Bioscience Ltd. BioServices 10 10 -5 India Chennai Tamil Nadu South 85 Diagnostic System Diagnostics 10 8 27 India 86 Jana Med Tech Pvt. Ltd. Diagnostics 7 8 -17 India New Delhi New Delhi North 86 Excel Diagnostics Pvt. Ltd. Diagnostics 7 5 38 India Hyderabad Telangana South 87 XCyton Diagnostics Pvt. Ltd. Diagnostics 6 11 -43 India Bangalore Karnataka South 87 Asritha Diatech India Pvt. Ltd. Diagnostics 6 3 72 India Hyderabad Telangana South 87 Rapha Diagnostics Pvt. Ltd. Diagnostics 6 6 -8 India Mumbai Maharastra West 88 RK Medisolution Diagnostics 5 2 122 India Mumbai Maharastra West 88 Bio Vaccines (India) Pvt. Ltd. BioPharma 5 1 India New Delhi New Delhi North 88 Kaypeeyes Biotech Pvt. Ltd. Enzyme 5 6 -19 India Mysuru Karnataka South 88 Shanmukha Innovations Pvt. Ltd. Diagnostics 5 1 291 India Gurugram Haryana North 89 Iosynth Labs Pvt. Ltd. Enzyme 4 2 57 India Bangalore Karnataka South 89 Carewell Biotech Pvt. Ltd. Diagnostics 4 3 34 India New Delhi New Delhi North 90 Astam Diagnostics Pvt. Ltd. Diagnostics 3 2 104 India Delhi New Delhi North 90 Genenest Biotech Pvt. Ltd. Diagnostics 3 0 420 India New Delhi New Delhi North 91 Leucine Rich Bio Pvt. Ltd. Diagnostics 1 1 5 India Bangalore Karnataka South 91 Prantae Solutions Pvt. Ltd. Diagnostics 1 1 -16 India Bhubaneswar Odisha East 91 Vimek Bioconcept Pvt. Ltd. Diagnostics 1 India Mumbai Maharastra West BioSpectrum Top 62-91 Biotech Companies for 2021-22* BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com COVER 21

SERUM INSTITUTE OF INDIA PVT. LTD. CONTINUES TO LEAD THE INDIAN BIOPHARMACEUTICAL INDUSTRY AT No 1 POSITION BioSpectrum Top 20 Biopharma Companies 2022* Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth Category Location State Region 1 Serum Institute of India Pvt. Ltd. 25000 7201 247 India Pune Maharashtra West 2 Bharat Biotech International Ltd. 8352 1439 480 India Hyderabad Telangana South 3 Biocon Ltd. 5805 5163 12 India Bangalore Karnataka South 4 Biological E Ltd. 2,588 1418 82 India Hyderabad Telangana South 5 Reliance Life Science Pvt. Ltd. 1969 1404 40 India Mumbai Maharashtra West 6 Novo Nordisk India Pvt. Ltd. 1950 1467 33 MNC Bangalore Karnataka South 7 Intas Pharmaceuticals Ltd. 1340 1071 25 India Ahmedabad Gujarat West 8 Bharat Serums & Vaccines Ltd. 1240 942 32 India Mumbai Maharashtra West 9 Indian Immunologicals Ltd. 798 747 7 India Hyderabad Telangana South 10 Concord Biotech Ltd. 713 617 16 India Ahmedabad Gujarat West 11 Gennova Biopharmaceuticals Ltd. 343 260 214 India Pune Maharashtra West 12 Hetero Biopharma Ltd. 335 131 124 India Hyderabad Telangana South 13 Panacea Biotec Ltd. 235 228 3 India New Delhi New Delhi North 14 Haffkine Bio-Pharmaceutical Corporation Ltd. 172 102 69 India Mumbai Maharashtra West 15 Hester Biosciences Ltd. 162 154 5 India Ahmedabad Gujarat West 16 Indovax Pvt. Ltd. 92 80 16 India Gurugram Haryana North 17 Bharat Immunologicals And Biologicals Corporation Ltd. 79 87 -9 India Bulandshahr Uttar Pradesh North 18 VINS BIO Products Ltd. 76 76 India Hyderabad Telangana South 19 Brilliant Bio Pharma Pvt. Ltd. 53 67 -20 India Hyderabad Telangana South 20 Dano Vaccines and Biologicals Pvt. Ltd. 26 29 23 India Hyderabad Telangana South 21 CPL Biologicals Pvt. Ltd. 11 4 India Ahmedabad Gujarat West 22 Bio Vaccines (India) Pvt. Ltd. 5 1 India New Delhi New Delhi North * We have not covered some of the Biopharma companies as they are unable to participate in the BioSpectrum Survey 2021-22. Pune-based Serum Institute of India Pvt. Ltd. continues to lead the Indian biopharmaceutical industry with a revenue of Rs 25000 crore for the year 2021-22 as against Rs 7201 crore for the year 2020-21 followed by Hyderabad-based Bharat Biotech International Ltd with revenue of Rs 8352 crore registering a 480 per cent growth over last year at No 2 position and Bangalore-based Biocon Ltd with Rs 5805 crore with a growth of 12 per cent at No 3 position. 22 COVER BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com

BioSpectrum Top Biopharma Companies in South in 2022* BioSpectrum Top Biopharma Companies in North in 2022* BioSpectrum Top Biopharma Companies in West in 2022* BIOSPECTRUM BIOPHARMA SURVEY AND METHODOLOGY Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth Category Location State 1 Bharat Biotech International Ltd. 8352 1439 480 India Hyderabad Telangana 2 Biocon Ltd. 5805 5163 12 India Bangalore Karnataka 3 Biological E Ltd. 2,588 1418 82 India Hyderabad Telangana 4 Novo Nordisk India Pvt. Ltd. 1950 1467 33 MNC Bangalore Karnataka 5 Indian Immunologicals Ltd. 798 747 7 India Hyderabad Telangana 6 Hetero Biopharma Ltd. 335 131 124 India Hyderabad Telangana 7 VINS BIO Products Ltd. 76 76 India Hyderabad Telangana 8 Brilliant Bio Pharma Pvt. Ltd. 53 67 -20 India Hyderabad Telangana 9 Dano Vaccines and Biologicals Pvt. Ltd. 26 29 23 India Hyderabad Telangana Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth Category Location State 1 Serum Institute of India Pvt. Ltd. 25000 7201 247 India Pune Maharashtra 2 Reliance Life Science Pvt. Ltd. 1969 1404 40 India Mumbai Maharashtra 3 Intas Pharmaceuticals Ltd. 1340 1071 25 India Ahmedabad Gujarat 4 Bharat Serums & Vaccines Ltd. 1240 942 32 India Mumbai Maharashtra 5 Concord Biotech Ltd. 713 617 16 India Ahmedabad Gujarat 6 Gennova Biopharmaceuticals Ltd. 343 260 214 India Pune Maharashtra 7 Haffkine Bio-Pharmaceutical Corporation Ltd. 172 102 69 India Mumbai Maharashtra 8 Hester Biosciences Ltd. 162 154 5 India Ahmedabad Gujarat 9 CPL Biologicals Pvt. Ltd. 11 4 India Ahmedabad Gujarat Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth Category Location State 1 Panacea Biotec Ltd. 235 228 3 India New Delhi New Delhi 2 Indovax Pvt. Ltd. 92 80 16 India Gurugram Haryana 3 Bharat Immunologicals And Biologicals Corporation Ltd. 79 87 -9 India Bulandshahr Uttar Pradesh 4 Bio Vaccines (India) Pvt. Ltd. 5 1 India New Delhi New Delhi B ioSpectrum India, a leading B2B media platform in Lifesciences space since 2003, re-launched its ranking special edition in June 2019 after a gap of 2 years. In this survey we looked at only the Biopharma Industry with companies specialising in Biologics/Blood products/ Recombinant products/ mAbs/ Vaccines/ Insulin. We have highlighted the companies (both MNCs and domestic players) based on their achievements in the past financial years. A detailed questionnaire (survey form) was sent to the companies in biologicals space to capture the needed information for the analysis. This was done during January to March 2023 (Sales revenues of all the companies are in Rs Crore). Companies shared information with us to the extent it was possible by them. We have collected information about listed companies from stock exchange, financial agencies and speaking with industry experts and Ministry of Corporate Affairs (MCA) as well. #The revenues considered for the analysis are biologicals sales and service figures. In several cases, where revenue figures were not available, estimates were arrived at in discussion with industry experts. #For all the ranking purposes, we have taken the biopharma business only into consideration. Wherever ‘Revenue is mentioned, it means sales turnover from the biopharma division. Therefore, revenue wherever mentioned is not necessarily the total sales turnover of the company. BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com COVER 23 * We have not covered some of the Biopharma companies as they are unable to participate in the BioSpectrum Survey 2021-22.

“Scientifically, a nasal vaccine is much more effective than an injectable one” « Adar Poonawalla, Chief Executive Officer, Serum Institute of India With another financial year coming to an end in March 2023, Serum Institute of India continues to shine as a leader in the biopharma sector. After generating a revenue of around Rs 25000 crore, owing to COVID-19 vaccine sales in FY 21-22, the company is now ready with new vaccine launches to stay ahead in the race. Adar Poonawalla, Chief Executive Officer, Serum Institute of India spoke in detail with BioSpectrum India about the company’s plans in 2023 and beyond. Edited excerpts; The industry is now shifting gears from vaccine manufacturing to vaccine R&D in India. How is Serum Institute leveraging this opportunity? What new launches are in the pipeline? Traditionally the Indian vaccine industry has been mainly manufacturing but now we are seeing that certain companies are developing or co-developing their own vaccines which involves a lot of clinical trials expense and detailed work which takes at least 4 to 5 years. For example, our HPV vaccine which we are planning to launch soon, along with our malaria vaccine. We have developed the process for both these vaccines in India. The malaria vaccine is particularly for the African continent because it deals with the falciparum parasite, not the other one which is found in India which we would work upon after a couple of years. Then, we also have our dengue vaccine in the pipeline in partnership with the National Institutes of Health (NIH) in the US for which we are doing a lot of the development work in India. We also have our pneumococcal vaccine which we developed with NIH and we got our own patents for it. It is a ten-valent pneumonia vaccine for children since this disease is a major killer in children below the age of 5, and we are planning to make a higher valency of this vaccine i.e. 20 or 21. The company had expanded its facilities for COVID-19 vaccine production. But now that the pandemic period is over, how do you plan to utilise that space for your new products? Due to COVID-19, we had increased our capacity from 1.5 billion to 4 billion doses. So now we have a lot of idle capacity lying around which we just have to rejig, to be able to handle this situation. In fact, the space would be under utilised by a factor of almost 50 per cent. Even with the launch of our new vaccines, it will take time to further utilise this space. We have spent more than Rs 11,000 crore in the last two years in building capacity, and we have spent another Rs 10,000 crore over the last five years in other activities such as developing our new campus which is about 45-50 acres. So, we have been investing in setting up new equipment and other manufacturing purposes. We have also invested in partnership with Aspen, to have a hold and right to use facilities in South Africa to make some vaccines in Africa. We have also got a tie up in the UK with Oxford Biomedica to make up to 100-150 million doses there. So, we do not know what we are going to do with this space at the moment, as it is available. In addition, we have a plant in Europe. In different geographies, about 5-10 per cent of our capacity has been spread out, outside of India and 90 per cent is in India. What are the company’s revenue projections for FY 22-23? Now that the COVID-19 sales have come down, we will be close to around $1 billion. During the COVID-19 period, we generated around $4 billion. So, this year, the non-COVID sales is around $900 million, and with these new launches coming up, we hope to add around $100 million with each vaccine to begin with. We hope to cross $1 billion in the nonCOVID vaccine revenue. 24 COVER BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com

Diagnostics has always been a weak spot where India has not been able to reach out quickly with accessibility and affordability. So, we are developing a lot of tests which were unavailable earlier. Also, most of the diagnostic tests require the presence of laboratories. Mylab is not only making a lot of kits, but also many compact machines which can be operated with 3-4 people and does not really require a full laboratory to perform the tests. With these machines, we are hoping to transform and change the way diagnostic tests are traditionally done. Is the company exploring new technologies for developing new vaccine products? Yes, we are exploring some new areas of technology. Traditionally, it has been viral vectors or sub unit protein vaccines or live attenuated vaccines which have proven to be safe. We are now exploring CRISPR technology for HIV vaccine development. It is an early stage of phase 1 in the US. If it works out well in phase 2 and 3, we might have something that does not fully take care of HIV from one’s system but quite substantially. We are waiting to see how it works out in a larger study. Then there is the mRNA technology for vaccine development which we are exploring in partnership with US-based GreenLight Biosciences. But, we still have to decide for which disease we should use the mRNA technology. Although mRNA as a therapeutic technology has been previously used for cancer, it has not been proven to be a stable option for vaccine development. Vaccines need to be stable for a period of two years in terms of shelf life. So, this area needs improvement. Besides these two technologies, we are also developing hepatitis B vaccine in the patch format. But the patch technology also has limitations since it is difficult to figure out the actual dose that needs to be incorporated. It also requires a transformation in the way we manufacture vaccines. It requires bulk of the vaccines to be absorbed on patches. We would have to invest in new filling lines. So, technologies like patch or nasal might only be applicable to a few vaccines. But of course, scientifically a nasal vaccine is much more effective than an injectable one. Serum Institute has forayed into the diagnostic testing space by investing in Pune-based Mylab Discovery Solutions? How do you plan to explore this space further? Diagnostics has always been a weak spot where India has not been able to reach out quickly with accessibility and affordability. So, we are developing a lot of tests which were unavailable earlier. Also, most of the diagnostic tests require the presence of laboratories. Mylab is not only making a lot of kits, but also many compact machines which can be operated with 3-4 people and does not really require a full laboratory to perform the tests. With these machines, we are hoping to transform and change the way diagnostic tests are traditionally done. For instance, with these machines you can get the test results of an RT-PCR test in 2-3 hours. Hospitals and diagnostic service providers can simply buy such machines and perform multiple tests. And now we are developing diagnostic tests for a number of diseases, such as sexually transmitted diseases, HIV, HPV, and much more. Mylab has already become the largest RT-PCR and rapid antigen tests kit manufacturer in India. Simultaneously, we are also looking at bringing these Indian diagnostic tests onto the global market. We have been accredited by the European authorities and will be exporting these diagnostic kits very soon. What role are you playing for enhancing tuberculosis (TB) diagnosis and elimination in India? We have developed a Cy-Tb kit which helps detect latent TB with ease and accuracy. We also have our recombinant BCG vaccine which would be far more effective. We should launch that very soon. We hope to make a good headway in fighting TB this way. Dr Manbeena Chawla [email protected] BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com COVER 25

PIRAMAL PHARMA SOLUTIONS RETAINS No 1 POSITION IN INDIAN BIOSERVICES INDUSTRY Mumbai-based Piramal Pharma Solutions is leading the BioServices Industry with sales revenue of Rs 3960 crore in 2021-22 registering a growth of 10 per cent over last year’s sales of Rs 3616 crore at No 1 position followed by Noida-based Jubilant Pharmova Limited with sales of Rs 3673 crore (Rs 3709 crore) at No 2 and Bangalorebased Syngene International Ltd with revenue worth Rs 2604 crore (Rs 2184 crore) at No 3 position respectively. ■ Piramal Pharma Solutions is a leading CDMO in India ■ Syngene International Ltd is a leading CRMO in India ■ IQVIA RDS (India) Private Limited is a leading MNC CLRO in India ■ Anthem Biosciences Private Limited is a leading CRISP company in India ■ Aurigene Pharmaceutical Services Limited is leading DDDS company in India ■ Labcorp Drug Development India Private Limited is a leading MNC CRO in India ■ Neuland Laboratories Limited is a leading CMS company in India ■ Vimta Labs Ltd isa leading Indian CLRO in India ■ Aragen Life Sciences Pvt. Ltd is a leading Indian CRDO in India ■ Aizant Drug Research Solutions Private Limited is a leading Indian CRO in India ■ Aurigene Oncology Limited (formerly, Aurigene Discovery Technologies Limited) is a leading Indian DDO in India ■ Shilpa Medicare Limited is a leading CRAMS in India * We have not covered some of the leading BioServices Companies as they are unable to participate in the BioSpectrum BioServices Industry Survey 2022 ■ CLRO - Clinical Research Organisation ■ CRO - Organisation ■ CDMO - Contract Development & Manufacturing Organisation ■ CMS - Contract Manufacturing Services ■ CRISP- Contract Research and Innovation Service Provider ■ CRMO -Contract Research & Manufacturing Organisation ■ CRDO- Contract Research & Development Organisation ■ DDDS- Drug Contract Research Discovery & Development Services ■ DDO- Drug Discovery Organisation ■ CRAMS - Contract Research & Manufacturing Services BioSpectrum Top BioServices Companies 2022* Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth over last year (%) Category Area of Operation Location State Region 1 Piramal Pharma Solutions 3960 3616 10 India CDMO Mumbai Maharashtra West 2 Jubilant Pharmova Ltd. 3673 3709 -1 India CDMO Noida UP North 3 Syngene International Ltd. 2604 2184 19 India CRMO Bangalore Karnataka South 4 IQVIA RDS (India) Pvt. Ltd. 2451 1803 36 MNC CLRO Bangalore Karnataka South 5 Suven Pharmaceuticals Ltd. 1320 1010 31 India CDMO Hyderabad Telangana South 6 Aragen Life Sciences Pvt. Ltd. 1236 950 30 India CRDO Hyderabad Telangana South 7 Anthem Biosciences Pvt. Ltd. 1231 1103 12 India CRISP Bangalore Karnataka South 8 Labcorp Drug Development India Pvt. Ltd. 461 330 40 MNC CRO Mumbai Maharashtra West 9 Aurigene Pharmaceutical Services Ltd. 361 191 89 India DDDS Bangalore Karnataka South 10 PPD Pharmaceutical Development India Pvt. Ltd. 322 214 50 MNC CRO Mumbai Maharashtra West 11 Labcorp Scientific Services & Solutions Pvt. Ltd. 304 207 46 MNC CRO Mumbai Maharashtra West 12 Aurigene Oncology Ltd. (formerly, Aurigene Discovery Technologies Ltd.) 290 306 -5 India DDO Bangalore Karnataka South 13 Neuland Laboratories Ltd. 286 269 6 India CMS Hyderabad Telangana South 14 Vimta Labs Ltd. 277 210 32 India CLRO Hyderabad Telangana South 15 Lambda Therapeutic Research Ltd. 253 472 -46 India CLRO Ahmedabad Gujarat West 16 Veeda Clinical Research Ltd. 224 196 14 India CLRO Ahmedabad Gujarat West 17 Aizant Drug Research Solutions Pvt. Ltd. 169 132 28 India CRO Hyderabad Telangana South 18 Kemwell Biopharma Pvt. Ltd. 107 55 94 India CDMO Bangalore Karnataka South 19 Eurofins Advinus Biopharma Services India Pvt. Ltd. 106 8 1267 India CDMO Bangalore Karnataka South 20 Ecron Acunova Ltd. 97 91 6 India CLRO Bangalore Karnataka South 21 QPS Bioserve India Pvt. Ltd. 78 48 60 MNC CRO Hyderabad Telangana South 22 Shilpa Medicare Ltd. 77 107 -28 India CRAMS Raichur Karnataka South 23 Siro Clinpharm Pvt. Ltd. 69 56 24 India CLRO Navi Mumbai Maharashtra West 24 Synapse Labs Pvt. Ltd. 59 43 36 India CRO Pune Maharashtra West 25 Vivo Bio Tech Ltd. 51 52 -1 India CRO Hyderabad Telangana South 26 Norwich Clinical Services Pvt. Ltd. 43 38 14 India CRO Bangalore Karnataka South 27 Novotech Clinical Research India Pvt. Ltd. 36 25 43 MNC CLRO Bangalore Karnataka South 28 Pharmaffiliates Analytics and Synthetics Pvt. Ltd. 34 25 38 India CRO Panchkula Haryana North 29 CliniRx Research Pvt. Ltd. 15 14 10 India CLRO New Delhi New Delhi North 30 Eurofins Advinus Pvt. Ltd. 11 214 -95 MNC CRO Bangalore Karnataka South 31 Vanta Bioscience Ltd. 10 10 -5 India CRO Chennai Tamil Nadu South 26 COVER BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com

BIOSPECTRUM BIOSERVICES SURVEY AND METHODOLOGY B ioSpectrum India is a leading B2B media platform in Lifesciences space since 2003. It has re-launched its ranking special edition in June 2019 after a gap of two years. In this survey we looked at BioServices Industry specialising in Clinical Research Organisation (CLRO), Drug Discovery & Development Services (DDDS), Contract Research Organisations (CROs); Contract Research & Development Organisations (CRDOs), Contract Development & Manufacturing Organisations (CDMOs), Contract Manufacturing services (CMS), Contract Research and Innovation Service Provider (CRISP) that support biotech and pharma from discovery through commercialisation. We highlighted the companies based on their achievements in the past financial years. A detailed questionnaire (survey form) was sent to over 100 companies (both MNC and Indian players) in this space to capture the needed information for the analysis. This was done during January – March 2023. Companies shared information with us to the extent it was possible by them. We have collected information about listed companies from stock exchange and financial agencies and Ministry of Corporate Affairs (MCA) as well. #The revenues considered for the analysis are of services part of the companies as noted above. In several cases, where revenue figures were not available, estimates were arrived in discussion with industry experts. #For all the ranking purposes, we have taken the CROs business only into consideration. Wherever ‘Revenue is mentioned, it means, sales turnover from CROs. Therefore, revenue wherever mentioned is not necessarily the total sales turnover of the company. * We have not covered some of the BioServices companies as they are unable to participate in the BioSpectrum Survey 2021-22 BioSpectrum Top MNC BioServices Companies 2022* Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth over last year (%) Area of Operation Location State Region 1 IQVIA RDS (India) Pvt. Ltd. 2451 1803 36 CLRO Bangalore Karnataka South 2 Labcorp Drug Development India Pvt. Ltd. 461 330 40 CRO Mumbai Maharashtra West 3 PPD Pharmaceutical Development India Pvt. Ltd. 322 214 50 CRO Mumbai Maharashtra West 4 Labcorp Scientific Services & Solutions Pvt. Ltd. 304 207 46 CRO Mumbai Maharashtra West 5 QPS Bioserve India Pvt. Ltd. 78 48 60 CRO Hyderabad Telangana South 6 Novotech Clinical Research India Pvt. Ltd. 36 25 43 CLRO Bangalore Karnataka South 7 Eurofins Advinus Pvt. Ltd. 11 214 -95 CRO Bangalore Karnataka South BioSpectrum Top 10 Indian BioServices Companies 2022* Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth over last year (%) Area of Operation Location State Region 1 Piramal Pharma Solutions 3960 3616 10 CDMO Mumbai Maharashtra West 2 Jubilant Pharmova Ltd. 3673 3709 -1 CDMO Noida Uttar Pradesh North 3 Syngene International Ltd. 2604 2184 19 CRMO Bangalore Karnataka South 4 Suven Pharmaceuticals Ltd. 1320 1010 31 CDMO Hyderabad Telangana South 5 Aragen Life Sciences Pvt. Ltd. 1236 950 30 CRDO Hyderabad Telangana South 6 Anthem Biosciences Pvt. Ltd. 1231 1103 12 CRISP Bangalore Karnataka South 7 Aurigene Pharmaceutical Services Ltd. 361 191 89 DDDS Bangalore Karnataka South 8 Aurigene Oncology Ltd. (formerly, Aurigene Discovery Technologies Ltd.) 290 306 -5 DDO Bangalore Karnataka South 9 Neuland Laboratories Ltd. 286 269 6 CMS Hyderabad Telangana South 10 Vimta Labs Ltd. 277 210 32 CLRO Hyderabad Telangana South 11 Lambda Therapeutic Research Ltd. 253 472 -46 CLRO Ahmedabad Gujarat West 12 Veeda Clinical Research Ltd. 224 196 14 CLRO Ahmedabad Gujarat West 13 Aizant Drug Research Solutions Pvt. Ltd. 169 132 28 CRO Hyderabad Telangana South 14 Kemwell Biopharma Pvt. Ltd. 107 55 94 CDMO Bangalore Karnataka South 15 Eurofins Advinus Biopharma Services India Pvt. Ltd. 106 8 1267 CDMO Bangalore Karnataka South 16 Ecron Acunova Ltd. 97 91 6 CLRO Bangalore Karnataka South 17 Shilpa Medicare Ltd. 77 107 -28 CRAMS Raichur Karnataka South 18 Siro Clinpharm Pvt. Ltd. 69 56 24 CLRO Navi Mumbai Maharashtra West 19 Synapse Labs Pvt. Ltd. 59 43 36 CRO Pune Maharashtra West 20 Vivo Bio Tech Ltd. 51 52 -1 CRO Hyderabad Telangana South 21 Norwich Clinical Services Pvt. Ltd. 43 38 14 CRO Bangalore Karnataka South 22 Pharmaffiliates Analytics and Synthetics Pvt. Ltd. 34 25 38 CRO Panchkula Haryana North 23 CliniRx Research Pvt. Ltd. 15 14 10 CLRO New Delhi New Delhi North 24 Vanta Bioscience Ltd. 10 10 -5 CRO Chennai Tamil Nadu South BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com COVER 27

ROSSARI BIOTECH LTD. GAINED No 1 POSITION BY PUSHING NOVOZYMES SOUTH ASIA PVT. LTD. TO No 2 POSITION IN THE INDIAN INDUSTRIAL BIOTECHNOLOGY (ENZYMES) INDUSTRY FOR 2021-22 Top 10 companies contribute 80.7% of the total Industrial Biotechnology (Enzymes) market Mumbai-based Rossari Biotech Ltd recorded 56% growth in 2021-22 with sales revenue of Rs 1073 crore to lead the table of BioSpectrum Top Industrial Biotechnology (Enzymes) Companies 2022 followed by Bengaluru-based Novozymes South Asia Private Limited with sales revenue of Rs 815 crore (second position) and Thane-based Advanced Enzyme Technologies Limited with sales revenue of Rs 536 crore (at third position). Top 3 companies contribute 69.3% of the total Industrial Biotechnology (Enzymes) market BIOSPECTRUM INDUSTRIAL BIOTECHNOLOGY (ENZYMES) SURVEY AND METHODOLOGY BioSpectrum Top Industrial Biotechnology (Enzymes) Companies 2022* Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth Category Location State Region 1 Rossari Biotech Ltd. 1073 688 56 India Mumbai Maharashtra West 2 Novozymes South Asia Pvt. Ltd. 815 731 11 MNC Bengaluru Karnataka South 3 Advanced Enzyme Technologies Ltd. 536 511 5 India Thane Maharashtra West 4 Titan Biotech Ltd. 154 143 8 India Delhi Delhi North 5 Tex Biosciences (P) Ltd. 61 42 47 India Chennai Tamil Nadu South 6 Lumis Biotech Pvt. Ltd. 45 50 -10 India Mumbai Maharashtra West 7 Aumgene Biosciences Pvt. Ltd. 28 24 15 India Surat Gujarat West 8 Enzyme Bioscience Pvt. Ltd. 27 19 39 India Surat Gujarat West 9 Fruzyme Biotech India Pvt. Ltd. 26 22 22 India Tirupur Tamil Nadu South 10 Advanced Vital Enzymes Pvt. Ltd. 19 15 28 India Thane Maharashtra West 11 Enzyme India Pvt. Ltd. 14 10 45 India Chennai Tamil Nadu South 12 Kaypeeyes Biotech Pvt. Ltd. 5 6 -19 India Mysuru Karnataka South 13 Iosynth Labs Pvt. Ltd. 4 2 57 India Bengaluru Karnataka South *We have not covered some of the leading MNC and local companies as they are unable to participate in the BioSpectrum Industrial Biotechnology (Enzyme) Survey 2022 B ioSpectrum India, a leading B2B media platform in Lifesciences space since 2003 has re-launched its ranking special edition in June 2019. In this survey we looked at only Industrial Biotechnology (Enzymes) Industry with companies specialising in food & beverage, textile, pharmaceutical, food processing, leather, detergents, paper and pulp and bioenergy. We highlighted the companies (both MNCs and domestic players) based on their achievements in the past financial years. A detailed questionnaire (survey form) was shared to companies in this space to capture the needed information for the analysis. This was done during December 2022-January 2023. Companies shared information with us to the extent it was possible by them. We have collected information about listed companies from stock exchange and financial agencies and Ministry of Corporate Affairs (MCA) as well. #The revenues considered for the analysis are of Industrial Biotechnogy (Enzymes) products sales. In several cases, where revenue figures were not available, estimates were arrived in discussion with industry experts. #For all the ranking purposes, we have taken the Industrial Biotechnogy (Enzymes) business only into consideration. Wherever ‘Revenue is mentioned, it means, sales turnover from Industrial Biotechnogy (Enzymes) products division. Therefore, revenue wherever mentioned is not necessarily the total sales turnover of the company. 28 COVER BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com

Mumbai based Transasia Bio-Medicals Ltd is a leading player in the Medical Devices and Diagnostics Industry with sales revenue of Rs 1298 crore for the year 2021-22 followed by Chennai-based Trivitron Healthcare Pvt Ltd with sales revenue of Rs 900 crore at No 2 position and Verna (Goa)-based Molbio Diagnostics Pvt Ltd with sales revenue of Rs 800 crore at No 3 position. TRANSASIA BIO-MEDICALS LTD RETAINS No 1 POSITION IN MEDICAL DEVICES AND DIAGNOSTICS INDUSTRY SURVEY 2022 BioSpectrum Top 20 Indigenous Medical Devices and Diagnostics Companies 2022* * We have not covered some of the indigenous and multinational medical devices and diagnostics companies as they are unable to participate in the BioSpectrum Survey 2022 Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth Category Location State Region 1 Transasia Bio-Medicals Ltd. 1298 1166 11 India Mumbai Maharastra West 2 Trivitron Healthcare Pvt. Ltd. 900 469 92 India Chennai Tamil Nadu South 3 Molbio Diagnostics Pvt. Ltd. 800 1272 -37 India Verna Goa West 4 Agappe Diagnostics Ltd. 441 275 60 India Ernakulam Kerala South 5 Meril Diagnostics Pvt. Ltd. 391 203 93 India Vapi Gujarat West 6 Mylab Discovery Solutions Pvt. Ltd. 300 840 -64 India Pune Maharastra West 7 Nureca Ltd. 263 216 22 India Mumbai Maharastra West 8 Beacon Diagnostics Pvt. Ltd. 196 113 74 India Navsari Gujarat West 9 J. Mitra & Co. Pvt. Ltd. 182 99 84 India New Delhi New Delhi North 9 Oscar Medicare Pvt. Ltd. 182 74 146 India New Delhi New Delhi North 10 Medsource Ozone BioMedicals Pvt. Ltd. 150 113 33 India Faridabad Haryana North 11 Peerless Biotech Pvt. Ltd. 145 83 74 India Chennai Tamil Nadu South 12 Advy Chemical Pvt. Ltd. 137 96 43 India Thane Maharastra West 13 BioSystems Diagnostics Pvt. Ltd. 94 63 51 India Kancheepuram Tamil Nadu South 13 Diasys Diagnostics India Pvt. Ltd. 94 49 90 MNC Mumbai Maharastra West 14 Paramount Surgimed Ltd. 82 60 36 India New Delhi New Delhi North 15 Athenese-Dx Pvt. Ltd. 80 52 55 India Chennai Tamil Nadu South 16 Immunoshop India Pvt. Ltd. 73 48 53 India Mumbai Maharastra West 17 Biosense Technologies Pvt. Ltd. 61 100 -39 India Thane Maharastra West 17 AGD Biomedicals Pvt. Ltd. 61 39 56 India Mumbai Maharastra West 18 Pathkits Healthcare Pvt. Ltd. 57 10 473 India Gurugram Haryana North 19 Accurex Biomedical Pvt. Ltd. 53 36 47 India Mumbai Maharastra West 20 Bhat Biotech India (P) Ltd. 50 93 -46 India Bangalore Karnataka South BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com COVER 29

BIOSPECTRUM MEDICAL DEVICES AND DIAGNOSTICS SURVEY AND METHODOLOGY B ioSpectrum India, a leading B2B media platform in Lifesciences space since 2003 has re-launched its ranking special edition in June 2019 after gap of 2 years. In this survey we looked at only the Medical Devices and Diagnostics Industry. A detailed questionnaire (survey form) was sent to over 100 companies in Medical Devices and Diagnostics space to capture the needed information for the analysis through associations. This was done during January -March 2023 (Sales revenues of all the companies are in Rs Crore). Companies shared information with us to the extent it was possible by them. We have collected information about listed companies from stock exchange and financial agencies as well. #The revenues considered for the analysis are Medical Devices and Diagnostics sales figures. In several cases, where revenue figures were not available, estimates were arrived in discussion with industry experts. #For all the ranking purposes, we have taken the Medical Devices and Diagnostics business only into consideration. Wherever ‘Revenue is mentioned, it means, sales turnover from Medical Devices and Diagnostics division. Therefore, revenue wherever mentioned is not necessarily the total sales turnover of the company. BioSpectrum Top 21-40 Indigenous Medical Devices and Diagnostics Companies 2022* Sr. No Company Revenue for 2021-22 (in Rs crore) Revenue for 2020-21 (in Rs crore) % growth Category Location State Region 21 Genuine Biosystem Pvt. Ltd. 49 27 80 India Chennai Tamil Nadu South 22 Aspen Laboratories Pvt. Ltd. 34 21 64 India Delhi New Delhi North 23 Reckon Diagnostics Pvt. Ltd. 31 20 54 India Vadodara Gujarat West 24 Voxtur Bio Ltd. 26 38 -30 India Surat Gujarat West 25 Recombigen Laboratories Pvt. Ltd. 24 17 43 India New Delhi New Delhi North 26 Vanguard Diagnostics Pvt. Ltd. 22 23 -5 India New Delhi New Delhi North 27 Biolab Diagnostics (India) Pvt. Ltd. 19 11 78 India Mumbai Maharastra West 28 Diatek Healthcare Pvt. Ltd. 16 11 44 India Kolkota West Bengal East 28 Jainam Biomedical 16 14 14 India Ahmedabad Gujarat West 29 Anamol Laboratories Pvt. Ltd. 15 5 240 India Thane Maharastra West 29 Biogenix Inc. Pvt. Ltd. 15 8 87 India Lucknow UP North 29 Allied Biotechnology India Pvt. Ltd. 15 India Mumbai Maharastra West 30 Achira Labs Pvt. Ltd. 14 3 347 India Bangalore Karnataka South 31 Jeev Diagnostics Pvt. Ltd. 13 6 121 India Chennai Tamil Nadu South 32 Cosara Diagnostics Pvt. Ltd. 11 36 -68 India Ahmedabad Gujarat West 33 ADS Diagnostic Ltd. 10 11 -2 India New Delhi New Delhi North 33 Diagnostic System 10 8 27 India 34 Jana Med Tech Pvt. Ltd. 7 8 -17 India New Delhi New Delhi North 35 Excel Diagnostics Pvt. Ltd. 7 5 38 India Hyderabad Telangana South 36 XCyton Diagnostics Pvt. Ltd. 6 11 -43 India Bangalore Karnataka South 36 Asritha Diatech India Pvt. Ltd. 6 3 72 India Hyderabad Telangana South 36 Rapha Diagnostics Pvt. Ltd. 6 6 -8 India Mumbai Maharastra West 37 RK Medisolution 5 2 122 India Mumbai Maharastra West 37 Shanmukha Innovations Pvt. Ltd. 5 1 291 India Gurugram Haryana North 38 Carewell Biotech Pvt. Ltd. 4 3 34 India New Delhi New Delhi North 39 Astam Diagnostics Pvt. Ltd. 3 2 104 India Delhi New Delhi North 39 Genenest Biotech Pvt. Ltd. 3 0 420 India New Delhi New Delhi North 40 Leucine Rich Bio Pvt. Ltd. 1 1 5 India Bangalore Karnataka South 40 Prantae Solutions Pvt. Ltd. 1 1 -16 India Bhubaneswar Odisha East 40 Vimek Bioconcept Pvt. Ltd. 1 India Mumbai Maharastra West * We have not covered some of the indigenous and multinational medical devices and diagnostics companies as they are unable to participate in the BioSpectrum Survey 2022 30 COVER BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com

Who Put the Brakes on Med Devices Sector Growth? BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com MEDTECH 31 The med devices sector in India seems to be lost somewhere when it comes to the concept of manufacturing devices under the ‘Make in India’ initiative. Though projected to reach $50 billion by 2025, the sector is largely import driven where medical devices worth Rs 63,200 crore were imported in 2021-22, up 41 per cent from Rs 44,708 crore in 2020-21. The Indian medical device market is driven by 70-80 per cent imports from countries such as the US, China and Germany. According to statistica.com, India’s medical devices segment is projected to touch $5.99 billion in 2023 and the market volume of the cardiology devices segment, the largest segment in the medical devices sector, is projected at $0.85 billion. The revenue is expected to show an annual growth rate (CAGR 2023-2027) of 8.35 per cent, resulting in a market volume of $8.26 billion by 2027. The government has set up a Medical Device Park Scheme with a total financial outlay of Rs 400 crore to establish common facilities across several states. The government has also provided various incentives, such as tax exemptions and subsidies, to promote the growth of the medtech sector. Additionally, the government is also making concerted and coordinated efforts on R&D and innovation in the pharma medtech sector to indiscriminately develop cutting-edge products and technologies. Medical device imports continued to grow at an alarming level by 41 per cent in FY22, on account of low duties and convenience to import. While initiatives like Make in India and Atmanirbhar Bharat Abhiyaan have given a much-needed thrust to the manufacturing of medical devices in the country, schemes like the Production Linked Incentive (PLI) Scheme and promotion of Medical Device Parks still need a boost for promoting domestic manufacturing of medical devices. Prime Minister Narendra Modi, during a recently held webinar on ‘Health and Medical Research’, said that several new schemes have been launched in the last few years given the possibilities in the pharma and medical device sector. More than Rs 30,000 crore have been invested in schemes like PLI whether it is the bulk drug park or developing the medical device park systems. The PM further mentioned that this market is going to touch Rs 4 lakh crore in the next two to three years. Work has begun to acquire skilled manpower for future medical technology, high-end manufacturing and research initiatives. Biomedical engineering or similar courses will also be introduced for training in the manufacturing of medical equipment, in IITs and other institutions. Himachal Pradesh recently signed 17 Memoranda of Understanding (MoU) amounting to Rs 2,110 crore at the pharma-expo in Mumbai. Himachal Pradesh showcased the pharma ecosystem of the state to invite potential pharma device players for investments in the upcoming Medical Devices Park in the state. The state has a 300-acre medical devices park in Nalagarh. According to the state government, it will provide liberal incentives and highly subsidised utility rates for manufacturers in medical devices parks. The growth story In March 2022, Wipro GE Healthcare announced a new 35,000 sq ft medical device manufacturing factory in Bengaluru. It will manufacture CT, ultrasound imaging devices, cath lab equipment, patient monitoring solutions, ECG machines and ventilators. In April of the same year, Siemens Healthineers started its new computed tomography scanners manufacturing facility in Bengaluru. Apart from this, the government-sanctioned four medical device parks (in Madhya Pradesh, Tamil Nadu, Himachal Pradesh, and Uttar Pradesh) of about 1,326 acres and will also provide a maximum Several of the trade associations already have or claim to have a large number of members, therefore it is not a matter of forming a larger group. Rather compelling arguments and actual investments should tilt the scale in favour of the side which has them. - Pavan Choudary, Chairman, MTaI

32 MEDTECH BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com Even though the government has created a policy for purchase preference for Made in India products, unfortunately in real life this policy has not worked. In 95 per cent of government purchases, there is no preference given to Made in India as the state governments are not implementing this policy. - Aravind Viswanathan, CEO, Transasia Bio-Medicals Unfortunately, associations like FICCI, CII, are dominated by overseas manufacturers with Indian offices. In many cases, they don’t even have a factory in India, but claim to be the voice of the industry and represent the industry, which is incorrect. Unless they produce in India, they cannot feel the pains of manufacturers in India. - Rajiv Nath, Forum Coordinator, AiMeD There are a few hurdles like coordination gap between Central and State Regulators, unavailability of complete ecosystem which includes testing labs and skilled manpower, willingness from industry to upgrade due to lack of capital. I believe if the above hurdles are taken care of, India can soon be a manufacturing hub for medical devices. - Dr Sanjeev Relan, Chairman, Preventive Wear Manufacturers Association of India (PWMAI) grant-in-aid of Rs 400 crore (Rs 100 per park) or 70 per cent of the common infrastructure cost, whichever is less. AMTZ in Andhra Pradesh supplied 1 million RT-PCR kits per day at the peak of the pandemic. Transasia Diagnostic Pvt Ltd (TDPL) launched the first-in-India Transasia-Erba Monkeypox RT-PCR kit in August 2022, and the company can manufacture more than 200 million Monkeypox RT-PCR kits per month. Sahajanand Medical Technologies (SMT) has set up Asia’s largest stent manufacturing and R&D facility at Hyderabad Medical Devices Park. The facility aims to manufacture more than one million stents and two million balloon catheters. However, there seems to be some mismatch between what the government is promoting and what the industry is demanding. Unheard voices of the industry Several associations that represent the medtech sector in India, such as the Association of Indian Medical Device Industry (AIMED) and the Medical Technology Association of India (MTaI), have been actively engaging with the government to address issues faced by the sector. While it may be beneficial for these associations to come together to form a larger lobby, it is important to recognise that each association has its own unique goals and objectives. Pavan Choudary, Chairman, MTaI says, “Several of the trade associations already have or claim to have a large number of members, therefore it is not a matter of forming a larger group. Rather, compelling arguments and actual investments should tilt the scale in favour of the side which has them. As far as we know, the biggest investments in the sector, whether in manufacturing or R&D, come from global investors. These remarkable contributions, which are spread across the country, have been instrumental in the growth of the medtech industry.” MTaI members have 12 state-of-the-art manufacturing units and eight research and development centres with footprints in states like Maharashtra, Haryana, Telangana, Tamil Nadu, Himachal, Gujarat, Karnataka, and Punjab. MTaI member companies also train more than two lakh healthcare workers annually. According to Jatin Mahajan, Secretary, Association of Diagnostic Manufacturers of India (ADMI) and MD, J Mitra & Company, “There is absolute unity in diversity. There are numerous associations within the overall ambit of medtech and they represent the unique subsets within it. Naturally, for all associations, it is paramount to first address their members’ problems and primary needs before looking at other associations’ issues or needs. The individual associations continue to make representations and recommendations to the Centre, seeking redressal. A primary problem for one segment may be secondary for another and nonexistent for the third. The associations continue to join hands and make collective representations for

BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com MEDTECH 33 The government exhorted the health sector to improve and upgrade manufacturing with the use of technology to reduce dependence on the large imports that India makes. Indian manufacturers can focus on innovation, R&D and quality to compete with imported medical devices. - Sachidanand Upadhyay, MD & CEO, Lord’s Mark Industries As we envision to become a global hub by 2047, I would request the government to seize this opportunity to expand and accept R&D in the Medtech sector done by local players, hence playing a pivotal role to revive the image of the domestic industry, who get intimidated by demands of US FDA/CE certifications. - Ganesh Sabat, CEO, SMT For all associations, it is paramount to first address their members’ problems and primary needs before looking at other associations’ issues or needs. The individual associations continue to make representations and recommendations to the Government to address their woes. A primary problem for one segment may be secondary for another and non-existent for the third. - Jatin Mahajan, Secretary – Association of Diagnostic Manufacturers of India (ADMI) and MD, J Mitra & Company common issues.” AiMeD is an umbrella association of Indian Manufacturers of Medical Devices and is quite vocal for the causes of the med devices sector. Alongside AiMeD there are associations like the All India Syringe & Needle Manufacturers Association (AISNMA), the association for needle manufacturers, a manufacturing association for surgical dressings, the manufacturing association for surgical blades, Preventive Wear Manufacturers Association of India (PWMAI) that takes care of PPE coveralls and gowns, masks etc. Says Rajiv Nath, Forum Coordinator, AiMeD, “We have a common agenda and we commonly seek these points and the smaller regional associations operate specific associations that look at AiMeD to lead the way and for wider leadership. Unfortunately, other associations like FICCI, CII, are dominated by overseas manufacturers having offices in India who, in many cases, don’t even have a factory in the country but claim to be the voice of the industry. Unless they produce in India, they cannot feel the pains of manufacturers in India.” According to Dr Sanjeev Relan, Chairman, Preventive Wear Manufacturers Association of India (PWMAI), the industry is gearing up for compliance with medical device reporting (MDR), which will help Indian manufacturers go global as MDR will give a boost to manufacturing of quality products which are at par with global standards. He further mentions, “There are a few hurdles like coordination gap between Central and State Regulators, unavailability of complete ecosystem which includes testing labs and skilled manpower, willingness from industry to upgrade due to lack of capital. I believe if the above hurdles are taken care of, India can soon be a manufacturing hub for medical devices.” Does the Govt favour Imported Products? The government has come up with multiple initiatives and policies to promote India’s medical device sector. A wide range of medical devices, from consumables to implantable medical devices that were not produced in India a decade ago, are now indigenously manufactured. However, a large number of devices and diagnostic equipment are still imported. Having said so, there is a need for the government to take some urgent steps to address the industry’s pain points. As we are aware that clubbing medtech with drugs and cosmetics within the regulatory structure has created a lot of grey areas, although there is nothing common between them. According to Aravind Viswanathan, CEO, Transasia Bio-Medicals, “Even though the government has created a policy for purchase preference for Made in India products, unfortunately, this policy has not worked. In 95 per cent of government purchases, there is no preference given to ‘Made in India’ as the state governments are not implementing this policy”. It is exactly not clear on why the government is

34 MEDTECH BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com shying away from buying India-made products where data suggests that more imports are happening. One of the major reasons may be due to low quality products as compared to globally produced devices. It may be also due to lack of skilled manpower and high cost of equipment. Focus on Innovation & Quality The domestic manufacturing unit needs a big boost from the government. An urgent need to offer technologically advanced products that are customised for the Indian market is the need of the hour to improve the quality of products manufactured locally. Manufacturers need to ensure that the products are available to Indian patients at affordable rates. An increase in domestic manufacturing capacity and competitiveness would help the country don a new identity of ‘Making in India for the World’. This will also help India’s exports grow at a record pace. Sachidanand Upadhyay, MD & CEO, Lord’s Mark Industries (LordMed, healthcare division of Lord’s Mark Industries) says, “The government exhorted the health sector to improve and upgrade manufacturing with the use of technology to reduce dependence on the large imports that India makes. Indian manufacturers can focus on innovation, R&D and quality to compete with imported medical devices.” The government should further promote medtech parks with specific ecosystems, benefits and sops. There should be easy access to standard testing and infrastructure facilities through the creation of worldclass common infrastructure facilities for increased competitiveness. This will result in a significant reduction in the cost of production of medical devices leading to better availability and affordability of medical devices in the domestic market. Ganesh Sabat, CEO, SMT mentions, “As we envision to become a global hub by 2047, I would request the government to seize this opportunity to expand and accept R&D in the medtech sector done by local players, hence playing a pivotal role to revive the image of the domestic industry, who get intimidated by demands of US FDA/CE certifications. With innovation in this sector happening rapidly, R&D incentives need to be re-looked at in addition encouraging procurement of innovative devices in central and state government purchase programmes, tax exemptions in medical devices parks where shared infrastructure to support medtech innovation such as shared raw material supplier base, testing services, among others are available. Besides, government and private companies should collaborate and make an effort to manufacture products of all ranges. Key education institutes like IITs should be enabled to use their might and research to ensure a futuristic focus on medical research, collaborative research and R&D to develop state-of-the-art medical technology, which is core to enhanced care delivery. The road to success is not easy and several challenges need to be taken into account. One of the major challenges is the lack of monitoring of unscrupulous Chinese devices that are marketed as Made in India products, impacting Indian manufacturers and patients alike. Ease of doing business by providing access to infrastructure, balanced policies and the right training to young people are some of the measures that need to be taken into account before the medical devices sector can see the day of light in the long run and make India proud. Associations need to work together for the betterment of the industry. While the government may not have provided as much relief as some may have hoped for, it is important to acknowledge the progress that has been made in recent years. However, several policy changes are required to further accelerate the Medtech sector’s growth. Incentivising R&D should become a norm and a robust industry-academia collaboration model will give the sector the much-needed boost. Sanjiv Das [email protected] Associations No of members Revenue (In Rs Crore) approx Association of Indian Manufacturers of Medical Devices (AiMED) 400 + 10,000 Medical Technology Association of India (MTaI) 46 NA Association of Diagnostic Manufacturers of India (ADMI) 85 NA The All India Syringe & Needle Manufacturers Association (AISNMA) 30 1,200 Wear Manufacturers Association of India (PWMAI) 50 NA Associations in Indian med devices sector

BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com MEDTECH 35 How is the ‘Make in India’ MedTech transformation coming along? « Debarati Sengupta, Senior Industry Analyst/ Team Lead (Medical Device and Imaging), TechVision, Frost & Sullivan The government has taken several cautious steps to fuel this promising sector. Strategic decisions such as foreign direct investments (FDI) promoting medical device parks are aimed to drive business. Let us look at how the industry has come along with this ‘Make in India’ initiative. I n September 2014, the Government of India launched a major national programme called the Make in India initiative to boost the manufacturing sector by providing investments and incentives for best-in-class facilities and infrastructure. Medtech was recognised as the sunrise sector under the Make in India campaign. According to the India Brand Equity Foundation, the Indian Medtech sector is growing at a CAGR of 37 per cent and by 2050, it is expected to reach $50 billion. 100% FDI in medical devices through automatic route The Department of Industrial Policy and Promotion (DIPP) in 2014 allowed unconditional 100 per cent foreign direct investment (FDI) in medical devices to reduce imports and promote domestic manufacturing. The Reserve Bank of India clarified that the Medtech industry would have 100 per cent FDI through the automatic route, which differs from the pharmaceutical sector. This boosted the FDI for medical devices from $62.5 million in 2014 to $161 million in 2015 and $439 million in 2016. The government put a price cap on a few medical devices to make healthcare accessible and affordable to all. Though the price cuts benefited the patients, the Medtech industry was not encouraged. The FDI investment plunged to $184 million in 2017 and further dipped to $66 million in 2018. The price control made local manufacturers increase their imports and trades and build warehouse infrastructure rather than develop a manufacturing facility. Since Medtech is such a technology- and capital-dependent industry, a collaborative model such as publicprivate partnerships is essential for driving local manufacturing. In 2019-2020, the pandemic was vital in highlighting the high skill set and low manufacturing cost in India compared to the US, the UK, Europe, and Japan. This helped drive some of the medical devices FDI in the past two years. For example, in 2022, India and Japan discussed inviting Japanese companies to manufacture medical equipment in India. International companies can benefit from these policies and explore business expansion in this highgrowth market. In May 2020, the government launched the PLI (Production Linked Incentive schemes), in which some categories of medical devices will be given financial incentives to build infrastructure for largescale domestic medical equipment manufacturing. Categories include cancer care/radiotherapy medical devices, radiology and imaging medical devices (ionising and non-ionising radiation products), nuclear imaging devices, anaesthetics and cardiorespiratory medical devices, including catheters of the cardiorespiratory category and renal care medical devices, and all implants, including implantable electronic devices. The government declared to offer Rs 3,420 crore between 2020-21 and 2027-28. This has been a big boost for the large Medtech providers, and many have used this scheme to launch new manufacturing facilities. For example, in March 2022, Wipro GE Healthcare announced a new 35,000 sq ft medical device manufacturing factory in Bengaluru. This facility will manufacture CT, ultrasound imaging devices, cath lab equipment, patient monitoring solutions, ECG machines and ventilators. In April 2022, Siemens Healthineers started its new computed tomography scanners manufacturing facility in Bengaluru. These products are under the approved category of the medical devices segment of the PLI. Many more projects have been approved by the government under the PLI scheme, including Philips Global Business Services for MRI coils; Meril Healthcare, Envision Scientific and Bio India Interventional Technologies for manufacturing implantable electronics; and Allied Medical, Deck Mount Electronics and Microtek New Technologies

36 MEDTECH BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com for setting up manufacturing facilities for anaesthetics and cardio-respiratory medical devices. This scheme is boosting the Make in India initiative for the Medtech sector, promoting Atmanirbhar Bharat, or the selfreliant India campaign by the Indian government. The current PLI scheme’s eligibility PLI is that the company should have Rs 60 crore (FY 2022- 23) threshold minimum for incremental sales of manufactured goods, and the threshold minimum increases by almost Rs 60 crore every year. Despite its benefits, this PLI scheme misses out on incentivising the technology-driven startups or mid-sized Medtech companies in India that need funds for research and development. During the recent pandemic, we witnessed increased demand for technologically advanced, highquality, low-cost medical devices. Several Medtech startups with cutting-edge technologies emerged. Considering the large Medtech Indian market with diverse application opportunities, all large, small, and midsized companies need to be supported for a successful manufacturing ecosystem. Additional incentives for small- and medium-scale domestic companies will enable smaller institutions to thrive. R&D funding will also be imperative to support indigenous innovations. A recent Government of India central sector scheme towards the “Make in India” initiative is the promotion of medical devices parks. The Centre sanctioned four medical device parks (in Madhya Pradesh, Tamil Nadu, Himachal Pradesh, & UP) of about 1,326 acres and will also provide a maximum grant-in-aid of Rs 400 crore (Rs 100 per park) or 70 per cent of the common infrastructure cost, whichever is less. The rest of the costs will be covered by the state governments. This funding will help develop Medtech manufacturing state-of-art infrastructure and reduce the production cost of medical devices, improving affordability & availability. The tenure of this scheme is from FY 2020- 2021 to FY 2024-2025. This advanced infrastructure facility will benefit the small- & medium-scale industries by providing access to world-class common infrastructure & standardised testing facilities. These can significantly help the promotion of the Ministry of Micro, Small and Medium Enterprises (MSME). The World Association for Small and Medium Enterprises (WASME) entered a strategic collaboration with Andhra Pradesh MedTech Zone (AMTZ), where small manufacturers can use the AMTZ’s in-house, state-ofart scientific facilities, helping manufacturers reduce the cost of manufacturing. Over the years, many more medical device parks have emerged across the country, promoting R&D and manufacturing. For example, Sahajanand Medical Technologies (SMT) set up Asia’s largest stent manufacturing and R&D facility at Hyderabad Medical Devices Park. The facility aims to manufacture more than one million stents and two million balloon catheters. AMTZ in Andhra Pradesh supplied 1 million RT-PCR kits per day at the peak of the pandemic. Transasia Diagnostic Pvt Ltd. (TDPL) launched the first-in-India Transasia-Erba Monkeypox RT-PCR kit in August 2022, and the company has the capacity to manufacture more than 200 million Monkeypox RTPCR kits per month. In 2022, the Draft National Policy for Medical Devices 2022 was submitted. This policy tries to encompass all of the existing Medtech industry challenges, improve manufacturing for medical devices, & reduce import dependency from 75- 80 per cent to 30 per cent in the next 10 years. This latest draft policy streamlines the regulations & compliance requirements, simplifies the patent process, encourages innovation and R&D through publicprivate partnerships, and funds healthcare innovation hubs & medical parks. Working toward digital health, the Indian government is supporting startups in telemedicine and AI-enabled healthcare. The National Digital Health Mission (NDHM) was launched on August 15, 2020, to boost the digital infrastructure for digital healthcare services. This digital healthcare database will enable accessible & affordable healthcare for all. However, the recent Draft National Policy for Medical Devices doesn’t discuss the regulations on data privacy and cybersecurity in medical devices, and clear health data guidelines will be essential for digitalenabled Medtech industry growth. Future opportunities Today, India is a huge Medtech market; it’s the fourth largest in Asia. With a skilled, talented workforce, government incentives and resource availability, manufacturing costs can be optimised in India, but the country is still importing a majority of its medical device requirements. It is evident that the government is pushing to address this dichotomy with several schemes supporting the Make in India initiative for this high-capital, technology-dependent Medtech industry. The companies should benefit from the schemes and this favourable environment to grow their manufacturing setup in India. The Medtech sector in India has come a long way. Several large companies are setting up manufacturing hubs, and local manufacturers are growing their facilities. Some additional benefits to the small-tomedium domestic consumable segment players can help curb further imports. The latest Draft National Policy also aims to reduce the dependency on imports, improve the country’s health security, and make India a global manufacturing hub.

BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com RARE DISEASES 37 The death of a 13-year-old Ghaziabad boy suffering from Hunter Syndrome or MPS-II due to the non-availability of medicine and the right treatment is something to be pondered on. The boy was suffering from what is known as a rare disease or an orphan disease. Rare diseases are nothing new to us and according to the Ministry of Health and Family Welfare, there are about 450 diseases recorded so far in India. If we go by the estimates, 50 per cent of new cases are in children and are responsible for 35 per cent of deaths before the age of one year, 10 per cent between the ages of one and five years and 12 per cent between five and 15 years. The commonly reported rare diseases in India are Haemophilia, Thalassemia, Sickle-cell Anaemia and Primary Immuno Deficiency in children, autoimmune diseases, Lysosomal storage disorders such as Pompe disease, Hirschsprung disease, Gaucher’s disease, Cystic Fibrosis, Hemangiomas and certain forms of muscular dystrophies. According to the World Health Organisation (WHO), these diseases are debilitating, lifelong disorders whose prevalence is less than one per 1,000 persons. They include autoimmune disorders, congenital malformations, inherited cancers, and certain endemic infectious diseases that have very low prevalence. Hurdles Lack of awareness and the stigma attached are the two major concerns for rare disease patients and their families. Though the Ministry of Health and Family Welfare formulated a National Policy for Treatment of Rare Diseases (NPTRD) in 2017, the implementation was faced with a lot of challenges. Lack of clarity on the exact number of patients, costeffectiveness of interventions for rare diseases vis-avis other health priorities etc. took a toll on those who suffered from the disease. Poor awareness among Rare Diseases Needn’t Be Neglected Anymore India has over 450 types of rare diseases in India. Lack of awareness and stigma attached to rare diseases have added to the woes of patients suffering from them. The exorbitant cost of therapies makes many patients opt out altogether. Experts opine that the road ahead to make notable progress in this area of healthcare is long and the right policy measures will determine how this neglected space fares. the healthcare staff and lack of proper diagnostic facilities also compound the woes of the patients. The other major concern is the cost of treatment. The exorbitant cost of therapies prevents many patients from going in for the right treatment and many leave halfway. Ramaiah Muthyala, President and CEO, Indian Organisation for Rare Diseases opines, “Rare diseases are genetic disorders; for them, there are no cures, only treatments. Generic orphan drugs, about 350 APIs are manufactured by Indian pharma and all are being exported. They are formulated elsewhere and come back into India at an exorbitant price and import license requirement. As a result, none of them is easily accessible for Indian rare disease patients. Pulled up In December 2022, the Centre was directed by the Delhi High Court (HC) to release Rs 5.35 crore to enable clinical trials for medicines that can treat rare diseases such as Duchenne Muscular Dystrophy (DMD). The HC observed that the “magnitude of the problem suffered by children with rare diseases leaves no doubt in the mind of the court that the creation of treatment therapeutics for children with rare diseases would be considered as a nationally important project.” It also observed that the efforts for crowdfunding for treatment of DMD and other rare diseases had not yielded much results as the issue does not appear to have gained enough importance in the society in general. The Biotechnology Industry Research Assistance Council (BIRAC) with Hanugen Therapeutics was to conduct clinical trials, however, things were delayed due to lack of funds. The HC also directed BIRAC to release the above-mentioned fund to Hanugen Therapeutics to begin the trial.

38 RARE DISEASES BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com promoting collaborations with patient organisations, e.g., Rare Disease International (RDI), European Organization for Rare Diseases (EURORDIS), National Organization for Rare Diseases (NORD), the International Rare Diseases Research Consortium (IRDiRC), the International Collaborations on Rare Diseases and Orphan Drugs (ICORD). Creating awareness Advancements in medical research and technology will be the key drivers for the development of innovative drugs for the treatment of rare diseases. AI is also being used to improve the diagnostic process. Apart from this, developments in the precision of genetic testing and the clinical use of genome sequencing are now also accelerating the diagnosis of rare diseases. The Department of Biotechnology has set up Nidan Kendras under the Unique Methods of Management and Treatment of Inherited Disorders (UMMID) project for genetic testing and counselling services. These Nidan Kendras perform screening, genetic testing and counselling for rare diseases. Recently, the Government of Karnataka launched a research and training unit for rare diseases. The unit will strengthen diagnosis, counselling and treatment, including developing the service facility for prenatal diagnosis for early identification of genetic disorders in pregnancy. The activities to be undertaken at the Research and Training Unit for Rare Diseases include comprehensive genetic counselling facilities for around 2,500 families with rare disorders, to be evaluated annually; increasing the capacity of diagnostic testing, including exome sequencing; and developing training and service facility for prenatal diagnosis for early identification of genetic disorders in pregnancy. It will also provide hands-on training in laboratory genetics and incubate startups in developing low-cost therapies for rare disorders along with conducting regular educational modules in Kannada, English and Hindi for raising awareness of human genetic disorders, their early recognition, and treatments available, among preuniversity college students in the state. The unit will be around 40,000 sq ft with three floors. Dr Sheela Nampoothiri, Clinical Professor, Department of Pediatric Genetics, Amrita Hospital, who recently joined ICMR’s Rare Diseases National Consortium’s expert committee as co-chair says, “It is really important if we are starting treatment from a very early stage. Hence, it is extremely important to have such medical treatment facilities to be made available in India. Regarding the rare disease policy, as the cost of therapy is exorbitant, the policy statement is suggesting crowdfunding as the model to Rare diseases are genetic disorders for which there are no cures, only treatments. Generic orphan drugs, about 350 APIs, are manufactured by Indian pharma and all are being exported. They are formulated elsewhere and come back into India at an exorbitant price and import license requirement. As a result, none of them are easily accessible for Indian rare disease patients. - Ramaiah Muthyala, President and CEO, Indian Organisation for Rare Diseases It is really important if we are starting treatment from a very early stage. Hence, it is extremely important to have such medical treatment facilities to be made available in India. - Dr Sheela Nampoothiri, Clinical Professor, Department of Pediatric Genetics, Amrita Hospital It will be instrumental to build innovative access initiatives and strategic partnerships across the rare disease landscape to bring customised solutions for patients with targeted education, awareness, diagnosis, and treatment for effective disease management. - Ruchi Sogarwal, Head, Public Affairs and Patient Advocacy, Takeda Biopharmaceuticals Modern therapies for rare diseases, including gene editing, gene therapy, ASOs, RNAi, mRNA, and ERT are highly promising but unaffordable and inaccessible to the Indian patient community. Although a small percentage of rare disease patients need expensive drugs, others can be managed by alternate therapies such as diet, medical foods, the Indian system of medicines (AYUSH), social support, and medical devices, which improves the quality of life.” Indian Organisation for Rare Diseases has been

BIOSPECTRUM BIOSPECTRUM | | APRIL 2023 APRIL 2023 | www.biospectrumindia.com | www.biospectrumindia.com RARE DISEASES TUBERCULOSIS 39 raise funds for patients.” Amrita Institute is currently treating seven patients with Pompe disease apart from treating 17 patients with five types of treatable Lysosomal Storage Disorders and these patients are being treated through a charitable access programme. Recently, the institute has started enzyme replacement therapy (ERT) for a patient with Niemann Pick B disease and this is the first patient to be started with ERT from India. According to the institute, before 2008, there was no availability of treatment and these babies were all dying before the age of one year. ERT needs to be started at the earliest in the newborn period itself and treatment is given as an intravenous infusion once every two weeks. The therapy should be given for life because they lack the enzyme alpha-glucosidase in their body. The SAT Hospital in Thiruvananthapuram Medical College has started the registration process for treating diseases as part of the centre of excellence programme. All rare disease cases will be registered with SAT hospital even if the disease was diagnosed in other hospitals. The registered patients will be provided the benefits of the centre of excellence programme at the treating hospital. In partnership with the All India Institute of Medical Sciences (AIIMS) Jodhpur and the Dystrophy Annihilation Research Trust (DART), the Indian Institute of Technology (IIT), Jodhpur has established a research centre for Duchenne Muscular Dystrophy (DMD). It is characterised by advancing muscle weakness and degeneration as a result of changes to a protein called dystrophin. Exploring treatment methods Pfizer is exploring options for some early-stage treatments for rare diseases in a bid to focus on high-impact medicines. According to the company, there are plans to focus on internally developing rare disease treatments using technologies such as gene editing, while exploring external opportunities for early-stage gene therapy programmes. The Subject Expert Committee functional under Central Drug Standard Control Organisation (CDSCO) has given a waiver to Cipla to conduct Phase IV study of Tocilizumab Injection for giant cell arteritis, a form of rare disease. Takeda Biopharmaceuticals has launched two medicines namely Adynovate, an extended half product for the treatment of haemophilia patients and Cinryze to treat hereditary angioedema (HAE) in India. Ruchi Sogarwal, Head, Public Affairs and Patient Advocacy, Takeda Biopharmaceuticals, says, “It will be instrumental to build innovative access initiatives and strategic partnerships across the rare disease landscape to bring customised solutions for patients with targeted education, awareness, diagnosis, and treatment for effective disease management. Takeda is committed to introducing medicines in focus areas that have a huge unmet need. With this aim in mind, we launched two of our innovative medicines.” Researchers at the Indian Institute of Technology (IIT), Madras, Tel Aviv University and Columbia University are working on developing a drug to treat a rare genetic brain disease known as GNB1 Encephalopathy, which affects individuals at the foetal stage. The research is supported by an IndoIsrael Binational grant offered by Israel Science Foundation (ISF) and India’s University Grants Commission (UGC). The way forward Affordable medicines are the need of the hour. Epidemiological data needs to be in place with proper policy measures. Awareness among the ASHA workers who can go to the interiors to update on the exact number of rare disease patients across the country will help to create a database which will eventually help to come up with certain policies needed. Pharma companies need to re-look at strategies to do more clinical research for rare diseases. On a good note, the Government of Tamil Nadu offered to treat a girl diagnosed with Systemic Lupus Erythematosus free of cost. Sanjiv Das [email protected] Centre of Excellence Treating Rare Diseases ● All India Institute of Medical Sciences, New Delhi ● Maulana Azad Medical College, New Delhi ● Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow ● Post Graduate Institute of Medical Education and Research, Chandigarh ● CDFD with Nizam Institute of Medical Sciences, Secunderabad ● King Edward Memorial Hospital, Mumbai ● Institute of Post- Graduate Medical Education and Research, Kolkata ● Center For Human Genetics (CHG) with Indira Gandhi Hospital, Bengaluru ● All India Institute of Medical Sciences, Jodhpur ● Institute of Child Health and Hospital for Children, Chennai

40 RARE DISEASES BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com Addressing ‘Orphaning’ of Rare Diseases « Ravi Shet, Clinical Data Management Professional To tackle any disease requires sustained research and development (R&D), to help us learn more about it and to create effective treatments. However, when it comes to R&D around rare diseases, there are few key challenges which ultimately impact patient outcomes. The most important challenge is how unevenly spread rare diseases are among populations. We don’t have a complete picture of how many people are affected by rare diseases in India, because most of the time these are not reported properly from the patient or their relatives. It becomes more difficult for the pharmaceutical companies to prioritise, since most of the rare diseases are clinically dissimilar and require unique treatments. Another big challenge is funding to develop drugs for treating these rare diseases. Since it affects a small number of people in comparison with cancer, cardiovascular disease and diabetes, they are often considered low priority when it comes to allocating funds. Drugs needed to treat rare diseases are known as Orphan Drugs which essentially means that they treat medical conditions so rare that it would not be profitable to produce and develop them. Conducting clinical trials for rare diseases can be equally challenging in terms of recruiting patients for the particular rare disease as well as time taken to complete the trial for the same, which in turn costs millions of dollars. Post approval follow-up process takes on an even greater role to ensure that the drugs work effectively on the patients. To promote more efficient and effective research into rare diseases, new epidemiological and clinical trial methods have also been developed. This could benefit and make it much easier and affordable to run clinical trials for rare diseases. Game Plan Advancements in medical research and technology will be the key drivers for development of innovative drugs for the treatment of rare diseases. AI is also being used to improve the diagnostic process. Developments in the precision of genetic testing and the clinical use of genome sequencing are now also accelerating the diagnosis of rare diseases. With lower costs, they are becoming more widely available, and this is leading to a paradigm shift in public health which is termed as ‘precision public health.’ This is enabling screening for rare diseases much earlier and leading to better outcomes overall, which eventually reduces the lengthy journey to an accurate diagnosis. India Roadmap The Government of India has launched National Policy for Rare Diseases (NPRD), 2021 in March 2021 for the treatment of rare disease patients. As per the NPRD, rare diseases have been identified and categorised into 3 groups namely Group 1, Group 2 and Group 3. ● Group 1: Disorders amenable to one-time curative treatment ● Group 2: Diseases requiring long term/lifelong treatment having relatively lower cost of treatment and benefit has been documented in literature and annual or more frequent surveillance is required ● Group 3: Diseases for which definitive treatment is available but challenges are to make optimal patient selection for benefit, very high cost and lifelong therapy The NPRD, 2021 has provisions for promotion of R&D for diagnosis and treatment of rare diseases; promotion of local development and manufacture of drugs and creation of a conducive environment for indigenous manufacturing of drugs for rare diseases at affordable prices. In addition to these, financial incentives for the patients as well as set-up of testing and counselling centres are part of the policy. Conclusion No doubt, India has the potential as well as the talent pool to cater the demand for more innovations in producing drugs to treat rare diseases. Also, the policies set by the Government of India will be a game changer for companies going for more R&D in this domain that might benefit patients with rare diseases. At the same time, we should continue to support the improvements and innovations with proper cross collaboration towards the common goal of attacking rare diseases for patient’s better health and longevity.

BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com SPEAKING WITH 41 “We’ve been working with global stakeholders to make Encephalitis a public health priority” « Dr Ava Easton, CEO, The Encephalitis Society, UK The Encephalitis Society is a multi-awardwinning charity and the leading global resource providing support and information, raising awareness of the condition and collaborating in research. It also funds and collaborates on ground-breaking research and raises awareness through various campaigns including World Encephalitis Day which is held annually on February 22. In an interaction with BioSpectrum India, Dr Ava Easton, CEO of the Encephalitis Society, UK shared her views on the activities of the society and programmes / projects that are being funded by the society in the country. Edited excerpts; Established in 1994, what have been the key achievements of the Encephalitis Society till now? Encephalitis is an inflammation of the brain. It can occur at any age, in any part of the world and is caused either by infection, usually viral, or by a person’s own immune system going wrong. There are over 5,00,000 reported cases of encephalitis around the world each year with mortality up to 40 per cent depending on the cause. People might be more familiar with meningitis, which is inflammation of the lining of the brain. But this is inflammation of the brain cells, and it is caused either by infection, invading the brain. This can be an ordinary, everyday infection that people will be familiar with, such as the measles or the cold sore virus, or it can be through the immune system attacking the brain in error. It’s often a devastating neurological condition and sadly in many cases can have a high death rate. But for many who survive the condition, it can result in injury to the brain and in some cases, life changing disabilities for people. At the encephalitis society, we operate in three different ways. We provide information and support for people that have been affected by the condition and also for their family, their friends and their caregivers wherever they live in the world. We raise awareness of encephalitis. And our primary global campaign for that is World Encephalitis Day on February 22. And we also participate in research both funding and collaborating on research around the world to change and to heighten the encephalitis agenda. More recently, we’ve been working with global stakeholders, including the World Health Organisation, trying to develop a plan to change the landscape, encephalitis around the world, and make it seen more as a public health priority, and that encephalitis really matters, no matter where people live in the world. What kind of projects have you been working on in the Asia Pacific region? We’re involved in lots of projects, but certainly in Australia you’ll be aware that in February and March of last year they had a Japanese encephalitis outbreak. We mobilised very quickly to develop a masterclass for professionals and we did lots of public awareness around then. The Encephalitis Society is doing lots of projects and lots of work around the world to try and change the landscape of encephalitis. Do you have direct operations in other countries and how do you look at working in other countries besides the UK? We don’t have chapters in different countries. But my team is a global team and they can help and support patients wherever they are in the world. If those patients need specific in-country treatment or support. And we will source that and we will signpost them to who can help in that country. What is the current status of Encephalitis in India? In India, outbreaks of acute encephalitis syndrome pose a major public health problem,

42 SPEAKING WITH BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com affecting thousands of people every year. Since 2005, the overall incidence of acute encephalitis syndrome in India has not decreased, with 10,867 - 13,672 cases reported each year to the National Vector Borne Disease Control Programme (NVBDCP) between 2014 and 2017. Overall, incidence of encephalitis is suspected to be 3,00,000 cases a year. Among individuals who develop acute encephalitis syndrome, case fatality is as high as 40 per cent and long-term neurological or psychiatric conditions can occur in 30-50 per cent of patients. More dramatic is the long-term brain damage that these patients suffer leading to Epilepsy, memory loss, loss of attention, personality changes, paralysis, sensory loss such as loss of hearing or vision, depression, speech and movement difficulties. How are you spreading your activities in India? We don’t have a chapter in India at the moment, but our team at the Encephalitis Society people can contact us and our team will put them in touch with people that it depends on what their needs are. But I think it’s important to mention that for World Encephalitis Day we’ve got famous landmarks and buildings around the world lighting up, and colleagues, Dr Netra and colleagues at the National Institute of Mental Health and Neurosciences (NIMHANS) are lighting up some buildings, and our colleagues at Christian Medical College,Vellore are lighting up buildings. If I had all the money and all the time in the world, I would have a chapter in every country. But we are a small team trying to do the very best that we can. I hope one day we will get there. That will be our dream. But at the moment we’re doing what we can with the small resources that we have. To develop a novel diagnostic test that can differentiate scrub typhus from other causes of acute encephalitis syndrome (AES) in children, a project from India received seed funding in 2022. What is the current status of the project? The scrub typhus project was only started on December 1, 2022. They’ve just received ethical approval, patient samples have been collected and they’re currently checking their quality control before processing the rest of the patient samples. So early stages, but good progress being made by then. We, the Encephalitis society, have funded this project. With a seed funding, the project, we would normally expect to hear the results usually about 12 months from the start of the project. Hopefully by the end of this year we can see some good results. Similarly in 2021 Dr Priyanka Madaan, Pediatric Neurology Unit, Department of Pediatrics, Post graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India received seed funding for Validation of the Paediatric Autoimmune Encephalitis Severity Score (PASS) in children with autoimmune encephalitis. What is the progress of the study so far? The start of the project was postponed due to long delays at receiving the necessary authorisations. So that project actually started in October 2022. They’ve got ethical approval. Their recruitment began in Chandigarh in November with five children and they’re currently undergoing assessments. New Delhi is the next centre that’s going to begin recruiting very shortly. So again, good progress and we should see some results from both of those studies this year. Dr Netravathi M, Professor of Neurology – NIMHANS, Bangalore and I are working as part of a consortium called Brain and Flow Infections Global. And, over the last five years, we’ve been looking at the diagnosis and treatment of encephalitis in low to middle income countries such as Malawi and Brazil. And we’ve been working in India, so we’ve worked on and supported that project for the last five years, and it’s hoped that we’re going to have some results from that study over the next few months. Some are really exciting and really good projects that have been created and that we’ve been collaborating on in India. Narayan Kulkarni [email protected] We raise awareness of encephalitis. And our primary global campaign for that is World Encephalitis Day on February 22. And we also participate in research both funding and collaborating on research around the world to change and to heighten the encephalitis agenda. More recently, we’ve been working with global stakeholders, including the WHO, trying to develop a plan to change the landscape, encephalitis around the world, and make it seen more as a public health priority, and that encephalitis really matters, no matter where people live in the world.

BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com ACADEMIA NEWS 43 New Delhi-based Jamia Hamdard University has signed a Memorandum of Understanding (MoU) with Dalhousie University, Canada, to promote academic and research cooperation between the two universities. Dalhousie VP Global, Matt Hebb, and Jamia Hamdard University Vice-Chancellor Afshar Alam have signed the MoU by kicking off a partnership that will focus first on collaborations in nursing. The MoU seeks to establish a collaborative research and degree programme for the nursing students of School of Nursing and Allied Health, Jamia Hamdard. According to Hebb, the coming together of these two institutes of international repute will further increase the quality of research, education and opportunities for students and help them become global citizens. Jamia Hamdard University inks MoU with Dalhousie University, Canada for nursing courses The University of Michigan Medical School and Aster DM Healthcare have signed a Memorandum of Understanding (MoU) that will allow Indian doctors access to the most cutting-edge information and abilities in the field of healthcare worldwide. This MoU signed with Aster Medcity, a division of Aster DM Healthcare situated in Kochi, Kerala incorporates a variety of collaborative procedures, creating enormous possibilities to support academic and scientific endeavours while empowering healthcare providers. The University of Michigan Medical School is the first medical school in the US to establish a university hospital for the purpose of training future doctors. They were among the first institutions to alter the role of the student from one of a passive observer to one of an active participant in the learning process through the adoption of the current science-based curriculum and the introduction of high-quality laboratory instruction and clerkships. Aster DM Healthcare, University of Michigan sign MoU for collaborative academic efforts

Dr Renu Swarup receives Dr B S Bajaj Memorial FABA Excellence Award-2023 The Appointments Committee of the Cabinet has approved the appointment of Rajeev Raghuvanshi as the new Drug Controller General of India (DCGI). Raghuvanshi, who is currently the Secretary-cum-Scientific Director at Indian Pharmacopoeia Commission, has been given the DCGI charge for a three-year period ending on February 28, 2025. A Senior Executive with a proven track record in leading the Indian Pharmaceutical industry, he has demonstrated the capability of establishing, growing and taking R&D organisations to the next level. He is experienced in generics, nanotechnology, innovative platform technologies, open innovation, outsourcing, cost cutting, lean development, international and national collaborations. He has served as the Senior Vice President and Head, Differentiated Formulations R & D / BRaIN at Dr. Reddy’s; Director at Ranbaxy Research Laboratories; Scientist at the National Institute of Immunology; and Research Associate, Formulation Development at Dabur Research Foundation. Rajeev Raghuvanshi steps in as new Drug Controller General of India Prof. L S Shashidhara appointed as new director of TIFR-NCBS 44 ACADEMICS NEWS PEOPLE NEWS BIOSPECTRUM BIOSPECTRUM | | AUGUST 2021 APRIL 2023 | www.biospectrumindia.com | www.biospectrumindia.com Dr B S Bajaj Memorial FABA Excellence Award-2023 has been conferred upon to Dr Renu Swarup, former Secretary, Department of Biotechnology (DBT), Government of India for her outstanding contribution in promoting science and technology in the country. Federation of Asian Biotech Associations (FABA) is a non-profit society, which represents 20 Asian countries with a common interest in promoting human health through advances in biotechnology. The award was conferred during the Hyderabad Life Sciences innovation cluster meeting on February 23, 2023 at the Indian council of medical research - National Animal Resource Facility for Biomedical Research (ICMR-NARFBR) situated in Genome valley, Hyderabad. Dr Renu Swarup has been instrumental in the planning and implementation of national programmes and actively engaged in the formulation of National Biotechnology Vision & Strategy. She served as a member of the Task Force on Women in Science by the Scientific Advisory Committee to the Prime Minister. As the Secretary of DBT, she led a Network of 16 Autonomous Research Institutes, 2 Public Sector Undertakings, and R&D Network of more than 5000 projects across 100 research institutes, Universities & Laboratories. Bengaluru-based National Centre for Biological Sciences (NCBS), a part of the Tata Institute of Fundamental Research (TIFR) under the Department of Atomic Energy of the Government of India, has announced the appointment of its new director- Prof. L S Shashidhara. Specialised in Genetics, Molecular Biology and Evolutionary biology, Prof. Shashidhara takes charge of the new position earlier held by Prof. Satyajit (Jitu) Mayor. He has been very much involved in the promotion of science and science education and has had many experiments in this area, including working with the Ministry of Education on the training of high school and undergraduate teachers in adopting inquiry-based teaching methods. Beyond conventional education and research, he has organised several career workshops for scientists in science journalism, science policy, climate education, administration and management.

TB Alliance, a New York based global not-for-profit organisation, has appointed Ratan P Watal to its Board of Directors. Watal is presently the Chairman, Central Vista Oversight Committee, Ministry of Housing and Urban Affairs, Government of India. He has more than four decades of experience working in and advising the Indian government, including in the areas of health and finance. He has earlier held various key positions that included - Member Secretary of the Economic Advisory Council to the Prime Minister, Government of India, Principal Adviser (Social sector, including health) in NITI Aayog and Secretary (Expenditure) in the Ministry of Finance, Government of India. Watal was appointed as the Principal Adviser for social sector in the Niti Aayog in 2016. A retired IAS officer of Andhra Pradesh cadre, Watal had been the Finance Secretary between August 2015 and April 2016. Ratan P Watal joins Board of TB Alliance Ahmedabad-based Zydus Lifesciences has announced the appointment of Upasana Kamineni Konidela as an Independent Director for the first term of five consecutive years. Through meticulous analysis of Upasana’s skill set, knowledge and experience in Healthcare and Philanthropy, the Nomination and Remuneration Committee (NRC), recommended her appointment for the efficient functioning of the company with her expertise particularly in the areas of, Human Resources, Corporate Social Responsibility and Information Technology. Upasana is a thirdgeneration entrepreneur and philanthropist from the Apollo Hospitals family in India. During her long stint in the healthcare sector, she successfully handled the responsibilities such as Founder of URLife, Vice Chairperson CSR, Apollo Hospitals Group and Managing Director of Family Health Plan Insurance TPA Limited and continues to play her significant role in these organisations. Upasana Kamineni Konidela takes charge as Independent Director of Zydus Lifesciences Bengaluru-based Skan Research Trust, founded by Ashok Soota, has announced the appointment of Dr Paul Salins as Vice Chairman of the Trust. Dr Salins is the Medical Director and Sr Vice President of Narayana Health – Mazumdar Shaw Medical Centre and also Managing Director, Mazumdar Shaw Medical Foundation. Dr Salins work on the systems approach to drug discovery to arrest or reverse lifestyle and ageing-related chronic diseases early, during its continuum has led to a genre of interceptive therapeutics. In the area of computation, Dr Salins terms his work “predictability before knowability” creating intuitive artificial intelligence (AI)/machine learning systems for the analysis of large, complex data clusters and adaptive systems as the foundation for pattern-based topologic analytics and inverse kinematics. He has also made key contributions in facial aesthetic surgery and his surgical work has restored self-respect and dignity to numerous people with deformities and mutilations of the facial region. He is a Fellow of the American College of Oral Maxillofacial Surgeons. Dr Paul Salins steps in as Vice Chairman of Skan Research Trust BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com PEOPLE NEWS 45

IIT-M, GIC Re to jointly develop urine-based TB diagnosis tech A research team from the Indian Institute of Technology Guwahati (IIT-G) has developed a ‘Recombinant Protein Toolbox’ comprising of six special proteins, which can be used to convert healthy skin cells or any somatic cells from an adult human body into heart cells, specifically cardiomyocytes. The heart cells created using this tool box can have the same function as the original heart cells and can be used to regenerate damaged heart tissues. Importantly, this toolbox can facilitate the generation of autologous heart cells in a lab. The team has collaborated with Dr Vishwas Kaveeshwar from the Central Research Laboratory at SDM College of Medical Sciences and Hospital in Dharwad, Karnataka, to validate the biological activity of the recombinant fusion proteins. According to Dr Rajkumar P Thummer, Assistant Professor, Department of Biosciences & Bioengineering, IIT Guwahati recombinant protein based cellular reprogramming is a promising alternative and the safest approach among other available non-integration approaches. IIT Guwahati develops ‘Recombinant Protein Toolbox’ to fix damaged heart tissues ARCI designs non-cytotoxic nano composite coating to prevent post-surgical infections 46 ACADEMICS NEWS R&D NEWS BIOSPECTRUM BIOSPECTRUM | | AUGUST 2021 APRIL 2023 | www.biospectrumindia.com | www.biospectrumindia.com The Indian Institute of Technology Madras (IIT-M) has partnered with General Insurance Corporation of India (GIC Re), a public sector undertaking, to develop a urine-based tuberculosis (TB) diagnosis or screening technology. The envisaged product for urine-based TB screening/ diagnosis is anticipated to be faster and far more affordable than the existing point-of-care diagnostic kits available for various diseases such as blood glucose monitors. The key beneficiaries of this project, which is getting CSR funding from the GIC Re, will be primary, secondary, and tertiary healthcare centres besides the health departments in State and Central Governments. IIT-M has partnered with over 180 entities under Corporate Social Responsibility (CSR) and has raised over Rs 250 crore to implement 200+ projects till date. The Biosensors Laboratory at llT-M is developing a novel plasmonic fiber optic absorbance biosensor (P-FA8) technology. They have established a laboratory-level proof-of-concept for the detection of a well-reported tuberculosis biomarker in urine, known as ‘Lipoaabinomannan (LAM).’ In parallel, the associated technologies for the fabrication of fiber optic sensor probes and readout device schemes have been designed and developed and the technology is transferred to two start-ups based in India and US. The next step towards bringing the urinary marker-based TB diagnosis is the systematic clinical validation study of the P-FAB diagnostic technology with TB patient samples. Researchers from Hyderabad-based International Advanced Research Centre for Powder Metallurgy and New Materials (ARCI), an autonomous institute of the Department of Science and Technology (DST), have developed a nanocomposite coating (named as ATL) by combining water repellence and biocidal property, which exhibits both hydrophobic and biocidal behaviour. The developed coating not only inhibits biofilm formation by restricting bacterial and water adhesion but also kills attached bacteria. The coatings developed in the present study can be used as a non-cytotoxic alternative to the commercially available antibacterial coatings, especially for healthcare applications on surgical sutures/surgical instruments to prevent the rise of multidrug-resistant bacteria.

Sciex, US-based global leader in life science analytical technologies, has announced a new collaboration with HighRes Biosolutions, a leading global laboratory automation company, also based in the US. Complete automation solutions from HighRes Biosolutions, powered by Cellario software, adds automation benefits to the Echo MS system, built on Acoustic Ejection Mass Spectrometry technology from Sciex. This combined offering aims to provide comprehensive and customisable workflows for high-throughput screening, HT-ADME and synthetic biology studies. Cellario integrates all the devices and software within a laboratory, enabling scientists to customise and implement the best possible technologies to produce data and execute their work. It provides a single connection point for all data integration needs in a lab, meaning the lab’s asset base can grow without increasing in complexity. Customers with Cellario can connect to the Echo MS system and data collection software to help seamlessly manage large amounts of sample handling and analysis. Sciex collaborates with HighRes Biosolutions Agilent makes electron capture dissociation tech available for biopharma researchers Sophia Genetics, a Switzerland-based cloudnative software company in the healthcare space, has announced a new partnership with Qiagen that will pair QIAseq reagent technology with the SOPHiA DDM platform to enhance tumour analysis through next-generation sequencing (NGS). The partnership will allow customers to order QIAseq panels that can be processed through SOPHiA DDM, a cloud-based platform that analyses data from various sources to enable entirely new research perspectives. The partnership will initially support somatic variant detection (an alteration in DNA that occurs after birth) using QIAseq Targeted DNA Pro panels for homologous recombination repair (HRR), a special type of biomarker test to find tumours that have certain mutations that may make them sensitive to PARP inhibitors in oncology. The partnership with Sophia Genetics is planned to be expanded to other areas of analysis, including the use of QIAseq panels custom-made solutions. It is the inaugural partnership in Qiagen’s QIAseq Platform Partnership. NGS has the potential to revolutionise the diagnosis & treatment of cancers & rare diseases but creates extremely large, complex, & noisy datasets for analysis. Qiagen forges partnership with Sophia Genetics 48 SUPPLIERS NEWS BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com Agilent Technologies has announced the acquisition of e-MSion, an early-stage company behind the innovative electron capture dissociation (ECD) technology known as the ExD cell. The ExD cell is a compact device for mass spectrometers that enables biological researchers to develop biotherapeutic products more quickly to treat disease. This is done by more comprehensively and precisely breaking the chemical bonds of complex biomolecules, enabling more complete, accurate, and detailed structural information to be obtained from them. The ExD cell is compatible with instruments common in many labs, such as Agilent’s 6500 LC/Q-TOF series, which will make this powerful characterisation technology, previously limited to only a few high-end mass spectrometers, more accessible to a larger share of labs and biopharma researchers worldwide.

Thermo Fisher introduces new low-flow HPLC columns for proteomic research BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com SUPPLIERS NEWS 49 Thermo Fisher Scientific is providing proteomics and biopharmaceutical research laboratories with a new line of low-flow HPLC columns that improve separation performance and stability of biologically complex samples. Using a unique micro-pillar separation structure, the Thermo Scientific µPAC Neo HPLC Columns enable researchers to investigate proteomics samples in greater detail, from accurate identification of peptides to determination of protein quantities, discovery of disease biomarkers and posttranslational modifications. µPAC Neo columns are manufactured by micromachined etching of silicon wafers, resulting in highly reproducible separation paths. For proteomics researchers, this provides higher column-to-column consistency and longer column lifetimes compared to packed-bed columns, allowing for more robust development and validation of methods and easier study of larger sample batches. The newest addition to the portfolio is the µPAC Neo low-load trapping column which is ideally suited for the smallest sample sizes in singlecell proteomics separations and features built-in nanoViper connections to the Vanquish Neo UHPLC systems for ease of use and reduced risk of errors. Users of all µPAC Neo columns benefit from excellent column reproducibility, allowing for more reliable data interpretation and confidence in their results. PerkinElmer, has launched the EnVision Nexus system, its fastest and most sensitive multimode plate reader to date, designed for demanding high-throughput screening (HTS) applications and to accelerate drug discovery efforts. The EnVision Nexus platform, with complementary microplates and optimised reagents from PerkinElmer’s drug discovery reagents portfolio, including proprietary HTRF and AlphaLISA technologies and latest reagent kits, provides researchers increased assay flexibility. The EnVision Nexus system features high-throughput, exceptionally fast dual detectors, enabling researchers to screen millions of samples with the increased accuracy, speed and sensitivity. For walkaway convenience, the system can be equipped with a plate stacker for 20 or 50 plates or can also be fully automated and integrated for 24/7 workflow-driven automation. The solution’s design draws on the company’s experience and success with its leading EnVision system, a workhorse in laboratories around the world for more than 20 years. PerkinElmer introduces EnVison Nexus Multimode Plate Reader Amar Equipment launches ‘NanoMake’, India’s first microfluidic platform Mumbai-based firm Amar Equipment launched ‘NanoMake’, India’s first microfluidic platform for fast-track preclinical development of mRNA vaccines and nano-formulations, at Institute of Chemical Technology’s “Biosimilar Workshop”, one of the largest gatherings of biopharmaceutical researchers in India, held on February 2-3, 2023, in Goa. Formulating nanomedicine is one of the major challenges towards translation. The in-vivo distribution, uptake, and clearance of nanoparticles are influenced by their size, making it a vital parameter to regulate. The formulation of nanomedicine normally possesses batch-to-batch variability by conventional methods, restricts translation and results in procedures that are difficult to scale from the discovery stage of a study through animal testing, clinical testing, and eventually commercial manufacturing.

50 LET’S TALK HEALTH BIOSPECTRUM | APRIL 2023 | www.biospectrumindia.com Early Tracking Diagnostic Tech for DFU With India now surpassing China as the world’s most populous nation, we can’t afford to ignore the indication that our country might soon have the highest number of diabetes cases globally. This also means that the complications associated with diabetes are going to increase, requiring urgent attention. To mention one, diabetic foot ulcers (DFUs) are a common complication of long-standing diabetes and the lifetime risk of developing a DFU is 19-34 per cent in patients with diabetes. DFUs contribute to a large part of the morbidity and mortality in patients with diabetes. But the worst part is that around 20 per cent of the patients with DFUs need a lower limb amputation. According to studies throughout the world, it is estimated that every 30 seconds one leg is amputated due to diabetes. In one study, research showed that following an amputation, up to 50 per cent of people with diabetes will die within two years. The incidence of DFU is approximately 1.5 times higher among men than women with diabetes. The incidences of minor and major amputation are also higher among men, with risk estimates for men ranging from 1.4 to 3.5 times higher in several large studies. In fact, in low and middle income countries barefoot walking, lack of awareness, delay in seeking care, and shortage of trained healthcare providers and foot care services are common factors that add to the burden of this foot disease. Three more factors that are usually involved in DFUs formation include diabetic neuropathy, trauma with secondary infection, and arterial occlusive disease. Patients with diabetes often have an altered lipid profile and apolipoproteins, which contributes to the appearance of these factors. Further, recurrence of the DFUs is common, with around 40 per cent of patients having a new ulcer within one year after a healed ulcer and almost 60 per cent within three years. Also, pre-ulcerative lesions or minor wounds remain unnoticed and are repeatedly retraumatised, resulting in ulcer formation and, often, in delayed diagnosis of incident or recurrent ulcers. Adding to the burden is the fact that DFUs are mainly exposed to skin commensal bacteria that can colonise the wound as multi-layered microbial communities surrounded by a self-produced protective extracellular biofilm. The biofilm makes wound healing and infections very difficult to resolve, as local access for antimicrobial agents and the host’s immune system is hampered. These observations clearly indicate that major efforts are needed to develop health system-wide improvements in DFU prevention, treatment and early diagnosis. Typically, a non-removable kneehigh offloading device is the first choice of offloading treatment to improve healing in DFUs. Fitting footwear combined with felted foam is considered as another choice of offloading treatment. But gradually over the years, technology is now being deployed innovatively to address this issue. For instance, an Indian biotech company Mylab Discovery Solutions has recently partnered with a UK-based firm to develop a diabetic foot ulcer detection kit. It is one of the world’s first point-ofdecision molecular technology solutions, delivering early identification of the spectrum of microbial flora in the ulcer and supporting clinicians to plan appropriate antimicrobial therapy regimes. Another Indian player, Alkem Laboratories, is exploring the use of 4D bioprinting technology in collaboration with a South Korean company to treat the deep, non-healing, chronic wounds. On the other hand, researchers in the US have developed a new software to improve diabetic foot care. The app detects the presence of ulcers and tracks whether the conditions of the ulcers can worsen. With technology offering a range of new solutions, a paradigm shift toward DFU prevention might soon be possible which is required to produce meaningful reductions in DFU, major lower-extremity amputation and mortality. Dr Manbeena Chawla Executive Editor [email protected]