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Vol 21; Issue 5; May 2023 4 BIO MAIL BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Scan QR code to access BioSpectrum India Digizine Vol 21; Issue 6; June 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 ‘Ashirwad’, 36/A/s, S. No. 270, Pallod Farms, Baner Road, Near Bank of Baroda, Pune - 411 045. Editor: Narayan Kulkarni. Website: www.biospectrumindia.com Reprinted for private circulation 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 NGS-Tech has seen a multi-fold growth in the past 5 years as compared to the last 20 years. This growth has been focused towards leveraging NGS-Tech in healthcare applications. The development of novel methodologies and tools has been aimed at cutting down on the resources and time required for processing samples for NGS data analysis. All this has been supported by fervent public and private funding. The article “Leveraging NGS-Tech in Healthcare Applications” in the May edition of BioSpectrum incorporates the voices of leading NGS scientists and experts from esteemed organisations with such finesse, pinpointing the current scenario and future direction of NGS-Tech. This article is a must read if you are involved in NGS technologies as a beginner or even as an expert. - The Genome Education, Bengaluru The next-generation sequencing (NGS) article looks awesome. It is very well written. Thank you BioSpectrum. - Deepak Modi, New Delhi The pharma industry is not only an asset to India but also to the world. The Prime Minister has been highlighting the importance of innovation, encapsulated in his inspiring words, “Jai Jawan, Jai Kissan, Jai Vigyan, Jai Anusandhan”. This vision underscores the need for innovation-driven growth and advancement in the pharmaceutical sector, emphasizing the critical role of research and development in shaping the industry and future landscape. - Sudarshan Jain, Mumbai
Letter from Publisher Ravindra Boratkar Publisher & Managing Editor, MD, MM Activ Sci-Tech Communications Pvt. Ltd. At the outset, let me apprise you about the upcoming BioSpectrum Excellence Awards 2023 event that will be held on June 30, 2023. You can read about the details of the awards function in the issue. Startups are the backbone of technology deployed in various sectors, particularly agriculture, IT and biotechnology. From mere 452 startups in 2016, we are now placed second globally with regard to the number of startups. Also, we are numero uno in the number of new startups added each day in a span of just eight years. There are approximately 8,000 startups in healthcare and life science. In 2021 the growth of startups in the biotech sector alone reached four digits when over 1,000 new startups were registered in just one year. There is much more potential for startups to grow in the Indian ecosystem and they will continue to grow. This positive thrust prompted our content team to do research and talk to several experts to understand if the number of startups in the biotech sector alone could reach 50,000? Knowing our progress in the startup ecosystem, the number is certainly achievable. But, it will require a lot of effort. What we need, primarily, is a world-class bioincubation space, providing cutting-edge infrastructure to transform innovative ideas into products. The giant leap to 50,000 startups requires scaling-up of existing bioincubation space in current biotech hubs or creation of new bioincubation space at nascent hubs that have the potential to become bigger biotech hubs in the next decade. Medical devices is another important rapidly-developing sector in the country. India is considered to be the fastest growing medical devices market. It was recognised as a sunrise sector under the ‘Make in India’ campaign of 2014. Recognising the need for its regulation, considering the rate of growth, the National Medical Devices Policy 2023 has been approved. We have talked to several experts to know how the policy will impact the sector. Our June issue also focuses on India’s pharma Cold Chain Logistics market, the challenges faced by the sector and the way forward. The importance of cold chain logistics was underlined during the COVID-19 vaccination period. Besides, it is an important industry asset in India, since it enables access to life-saving drugs, organs, etc, especially to far-flung areas. Cybersecurity in Pharma is another important topic brought to focus by an expert from the field, with deep insights into this sensitive subject. Cybersecurity has become indispensable for almost all companies and hospitals due to threats of data leaks and cyberattacks. Needless to say, you have another informative edition to dig into. Thanks & Regards, Ravindra Boratkar Publisher & Managing Editor BIOSPECTRUM | JUNE 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
BIOINCUBATORS SURVEY 2021-22 20 COVER DESIGN BY: DOMINIX STRATEGIC DESIGN PVT. LTD. 6 BIO CONTENT BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Can India Create 50K BIOTECH STARTUPS? KIIT TECHNOLOGY BUSINESS INCUBATOR retains No 1 position in the BioSpectrum BioIncubator Survey 2021-22 Bhubaneshwar-based Private BioIncubator KIIT Technology Business Incubator continues its leadership position in the BioSpectrum BioIncubator Survey as it retains No 1 position in 2021-22 survey followed by Public sector BioIncubator, Bengaluru-based C-CAMP gained its position to second rank and Private BioIncubator Entrepreneurship Development Center (Venture Center), Pune at third rank. Healthcare Cold Chain Can pharma cold chain market sustain its growth spurt? 30 Policy Will NMD Policy Unleash Sector’s Full Potential? 33 28 Bioincubators & their progressive journey in India Dr Vishal Gandhi, Founder & CEO, BioRx Venture Advisors & Indian Healthcare Angels
12 The Countdown Begins for BioSpectrum Excellence Awards 2023 Top Video Dr Sharook Mubarak, Chief Executive Officer & Founder, Dr Polaris shares his views on improving medical education and upskilling healthcare workers in India. Scan the QR Code » Zoya Brar, Founder, Core Diagnostics talks about the economic benefits of high-end diagnostics. Scan the QR Code » Dr Yogesh Patil, Chief Medical Officer, QMS Medical Allied Services reflects upon the growth of the wearable medical device sector in India. Scan the QR Code » BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com BIO CONTENT 7 Regulars BioMail ...........................................................................04 Letter from Publisher...................................................05 BioEdit ............................................................................08 Policy and Regulatory News.......................................10 Finance News................................................................14 Start-Up News...............................................................16 Company News ............................................................17 People News..................................................................44 R&D News ......................................................................45 Supplier News ...............................................................48 Let’s Talk Health............................................................50 Cybersecurity 42 Why Pharma Industry Must Focus On Cybersecurity Kush Kaushik, Co-Founder and Operations Lead, Scrut Automation Speaking With 40 “European regulators upgrade their compliances which is challenging for biosuppliers in India” Dr Gangadhar M Warke, Founder, Chairman and Managing Director, HiMedia Laboratories 36 “There’s a need for bringing in technology to 70,000 hospitals in India” Dileep Mangsuli, Development Centre Head, Siemens Healthineers 38 “More needs to be done to provide a conducive ecosystem for API manufacturing in India” Sanjeev Jain, Jt. Managing Director, Akums Drugs & Pharmaceuticals
8 BIO EDIT BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Why No ‘Drug Recall’? Continuing with the saga of repeated reports of contaminated or substandard drugs in the recent past, there is no incontrovertible link between contaminated cough syrups (Gambia) and the deaths of over 300 children in three African nations. The Indian drug regulator, Drugs Controller General of India (DCGI), however, has detected some major lapses in good manufacturing practices. A recent media report attributes the presence of lethal toxins in the syrup to the ingredient-supplying company, an unnamed importer from Mumbai. While the Indian drug regulator did not find contaminants, the Centers for Disease Control and Prevention (CDC), USA and Gambian Authorities in their joint probe found ‘strong links’ between the medicine and deaths. Hence, it is yet to be proved beyond the shadow of a doubt that the medicines were really responsible for deaths. But the Indian drug regulator has noticed some major lapses in good manufacturing practices. There have been complaints of a similar nature from countries like Vietnam, Ghana, Sri Lanka, and Nigeria. Allegations levelled by the African nations in question, the WHO and Indian regulator’s directives have brought disrepute to the Indian pharma industry, which was enjoying the ‘Pharmacy of the World’ title. Some reports even blamed the toothless regulations for this entire series of events. To restore confidence in Indian drugs and the regulation abroad, the government initiated some steps (BioSpectrum has covered it in the previous edition). The government has also started revising Schedule M of the Drug and Cosmetic Act, 1940 to ensure adherence to good manufacturing practices (GMPs). The revamped new drug legislation is on the cards and the draft of the same is ready. All these efforts are good to re-establish confidence in Indian medicines in drug-importing countries. But, India lacks one major weapon in the arsenal to combat inferior, spurious or fatal medicines - Drug Recalls. In the US it is a common occurrence, wherein a drug is recalled after adverse events are reported or even due to mislabelling or deficient quality. Even Indian drugs available in the US market were recalled. Recently, Lupin recalled its skin medicine in the USA over quality concerns and Sun Pharma recalled 34,000 bottles of a generic drug. India doesn’t have a law that makes drug recall mandatory, it is a voluntary course of action for manufacturers. Recently, two companies notified the public about the wrong labelling of one of their drugs via a newspaper. Since drug recalls are totally voluntary, even after the regulator finds a drug to be substandard and/or unfit to use, there is no system to withdraw the batch from the market across the country. For nearly four and a half decades the government has been thinking about enacting a law for the recall of medicines. The issue was raised several times during this period through different committee reports. At one point even draft guidelines were prepared, without a regulatory outcome. Experts believe that even the new draft Drug Act does not have any such provision. Experts have, time and again, written in the media explaining the need for a law to recall drugs. Such a need was further felt strongly when the reports of deaths linked to medicines manufactured by Indian pharma companies appeared in the media here. One of the reasons for not formulating such an Act could be that the country has two authorities – centre and states - when it comes to regulating the drugs. Such an arrangement may be creating obstacles. In a different context, Dr Krishna Ella, CMD of Bharat Biotech, had suggested merging the state and central drug bodies to make them one common authority. Such a step would definitely be welcome by the industry and will help in enacting and implementing the law for recall. But, even in the current dual authority arrangement also the mandate of the law can be given to one – central – authority for operation. Whatever could be the technical obstacles, it is necessary to have a regulation for drug recall. Milind Kokje Chief Editor [email protected]
The Cabinet Committee on Economic Affairs, chaired by PM Narendra Modi, has approved the establishment of 157 new nursing colleges in co-location with the existing medical colleges established since 2014. The step will add approximately 15,700 nursing graduates every year which will further ensure quality, affordable and equitable nursing education in India, particularly in underserved districts and States/ Union Territories. The total financial implication will be Rs 1,570 crore. The initiative aims to address the geographical and rural-urban imbalances in the healthcare sector, which have led to the skewed availability of nursing professionals and impacted healthcare services in underserved areas. The establishment of these nursing colleges will provide a significant boost to the availability of qualified human resources in healthcare. Co-location of these nursing colleges with existing medical colleges will allow optimal utilisation of the existing infrastructure, skill labs, clinical facilities, and faculty. This initiative is expected to provide better clinical exposure to nursing students and will also result in better care and service provision for patients in medical colleges. The use of green technologies will also be explored in these nursing colleges and will be adopted as per relevancy to ensure energy efficiency and reduction in carbon footprint. Centre to establish 157 new nursing colleges to fix rural-urban imbalance in healthcare 10 POLICY AND REGULATORY NEWS BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com National COVID-19 Vaccination Programme receives excellence award by PM Cabinet approves National Medical Devices Policy 2023 The Union Cabinet, chaired by PM Narendra Modi, has approved the National Medical Devices Policy 2023. The policy is expected to facilitate orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation. It lays down a roadmap for accelerated growth of the medical devices sector to achieve crucial goals including Access & Universality, Affordability, Quality, Patient Centred & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower. The medical devices sector will be facilitated and guided through a set of strategies that will cover six broad areas of policy interventions- Regulatory Streamlining, Enabling Infrastructure, Facilitating R&D and Innovation, Attracting Investments in the Sector, HR Development and Brand Positioning and Awareness Creation. The National COVID-19 Vaccination Programme of the Union Health Ministry received the Prime Minister’s Award for Excellence in Public Administration 2022 under the innovation category. Rajesh Bhushan, Secretary, Ministry of Health and Family Welfare Ministry received the award from PM Narendra Modi at a function organised on the occasion of 16th Civil Services Day at Vigyan Bhawan, New Delhi. A robust monitoring system based on a consultative approach was established through the State Steering Committee, State Task Force, District Task Force, and Block/Urban Task Force with a two-way feedback mechanism to ensure swift mid-course corrective measures. The development of the Co-WIN (Winning over COVID) platform for facilitating a smooth vaccination roll-out was critical to the success of the programme. The Co-WIN platform was a crucial factor in enabling India to achieve multiple milestones in vaccination which includes- 221 crore (2.21 billion) vaccine doses administered across India and tracked digitally. This is 17 per cent of the 13.34 billion COVID-19 vaccine doses administered worldwide.
Regency Ballroom, Hyatt Regency Hotel, New Delhi On Friday, 30th June 2023 at 6.00 pm BioSpectrum India “ Join the ranks of excellence with BioSpectrum Excellence Awards 2023 ” RSVP Kindly mail your connrmation to Apoorva Mahajan I [email protected]
12 BIOSPECTRUM EXCELLENCE AWARDS 2023 BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com The Countdown Begins for BioSpectrum Excellence Awards 2023 To appreciate the Indian companies and individuals for their commendable performances and achievements during FY 20-21 and FY 21-22, BioSpectrum is setting the tone for an exciting opportunity in the form of BioSpectrum Excellence Awards 2022-23, taking place on June 30, 2023 in New Delhi. These awards are an extension to observe and highlight the winners in the long battle to tackle the world’s emerging health problems and finding solutions. Since the years 2020 and 2021 were majorly affected by COVID-19, we saw the industry players in India relentlessly working towards developing novel solutions in the form of diagnostic tests, vaccines, monoclonal antibodies, drugs, etc. Through these awards, BioSpectrum India is playing the role of picking tomorrow’s winners, nudging today’s entrepreneurs to achieve greater glory and honouring the key players who laid the foundation for success. The BioSpectrum Excellence Awards 2023 will be divided into three segments- Jury, Industry Ranking and Special Recognition. JURY AWARDS The panel of experts within the jury consisted of six members from different industry verticals including academics, investments, policy makers, consultants and incubators. Chaired by Dr Renu Swarup, Former Secretary, Department of Biotechnology, Government of India, the jury panel members includedDr Nilima A Kshirsagar, National Chair of Clinical Pharmacology, Indian Council of Medical Research (ICMR); Dr Taslimarif Saiyed, Chief Executive Officer & Director, Centre for Cellular and Molecular Platforms (C-CAMP); Nitin Deshmukh, Advisor – Private Equity, Kotak Investment; Sujay Shetty, Global Health Industries Advisory Leader, Partner, PwC India; and Dr Pramod Garg, Executive Director, Translational Health Science & Technology Institute. The panel members picked out the winners for both FY 20-21 and FY 21-22 across six categories. YEAR 2020-21 Businessperson of the Year :- Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech Entrepreneur of the Year :- Hasmukh Rawal, MD, Mylab Discovery Solutions Woman Entrepreneur of the Year :- Dr Rachana Tripathi, Co-Founder, Huwel Lifesciences Product of the Year :- Covaxin by Bharat Biotech Young Woman Scientist of the Year :- Dr Ritu Trivedi, Principal Scientist, Central Drug Research Institute JURY AWARD WINNERS YEAR 2021-22 Businessperson of the Year :- Mahima Datla, Managing Director, Biological E Entrepreneur of the Year :- Dr Anand Anankumar, Co-founder, Bugworks Research Woman Entrepreneur of the Year :- Geethanjali Radhakrishnan, Founder, Adiuvo Diagnostics Product of the Year :- SSI Mantra Surgical Robotic System by SS Innovations Young Woman Scientist of the Year :- Dr Pragya D Yadav, Scientist-F, National Institute of Virology Lifetime Achievement Award :- Dr K I Varaprasad Reddy, Founder, Shantha Biotechnics
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com BIOSPECTRUM EXCELLENCE AWARDS 2023 13 Bioinnovation Leader of the Year :- Dr Jitendra Kumar, Managing Director, Bangalore Bioinnovation Centre Industry Leader of the Year :- Dr Gangadhar M Warke, Chief Executive Officer, HiMedia Laboratories Best Innovator for COVID-19 Solutions :– Dr Vishal G Warke, Director- R&D, Cell Culture & Immunology, HiMedia Laboratories Emerging Biostartup :- Qure.ai (Powered by Biostartups) Special Recognition in Cell & Gene Therapy :- ReGrow Biosciences Best Workplace in Bio & Health Science business :- Siemens Healthineers, India (Powered by Biojobs) Digital Disruptors of the Year :- Thermo Fisher Scientific, India Excellence in MedTech Innovation :- Dräger India Business Person of the Year in Life Sciences Industry :- Amit Sehgal, Managing Director and Country Head – Avantor India SPECIAL RECOGNITION AWARD WINNERS INDUSTRY RANKING AWARDS & SPECIAL RECOGNITION AWARDS Alongside the Jury Award winners, BioSpectrum Industry Ranking Award winners will also be felicitated during the event, to highlight the top companies across different verticals of the life sciences industry selected during the BioSpectrum surveys held in 2021 & 2022. Adding on, winners for the Special Recognition Awards will be announced to turn the spotlight onto companies we believe will lead the way in the near future, not only in India but globally. INDUSTRY RANKING AWARD WINNERS (FOR FY 20-21 & FY 21-22) BIOPHARMA SECTOR Top Indian Biopharma Company :- Serum Institute of India (For FY 20-21 & FY 21-22) Top MNC Biopharma Company :- Sanofi Healthcare (For FY 20-21) Top MNC Biopharma Company :- Novo Nordisk (For FY 21-22) INDUSTRIAL ENZYME SECTOR Top Indian Industrial Enzyme Company :- Rossari Biotech (For FY 20-21 & FY 21-22) Top MNC Industrial Enzyme Company :- Novozymes South Asia (For FY 20-21 & FY 21-22) BIOSERVICE SECTOR Top Indian BioServices Company :- Piramal Pharma Solutions (For FY 20-21 & FY 21-22) Top MNC BioServices Company :- IQVIA RDS (India) (For FY 20-21 & FY 21-22) MEDICAL DEVICES & DIAGNOSTICS SECTOR Top Indian Medical Devices & Diagnostics Company :- Transasia Bio-Medicals (For FY 20-21 & FY 21-22) BIOSUPPLIER SECTOR Top BioSupplier Principal Company :- Waters Corporation (For FY 20-21) Top BioSupplier Distributor Company :- Genetix Biotech Asia (For FY 20-21) BIOINCUBATOR Top Bioincubator (Private Sector) :- Venture Center Pune (FY 20-21) Top Bioincubator (Private Sector) :- KIIT Technology Business Incubator (FY 21-22) Top Bioincubator (Public Sector) :- Bangalore Bioinnovation Centre (FY 20-21) Top Bioincubator (Public Sector) :- Centre for Cellular and Molecular Platforms (FY 21-22)
14 FINANCE NEWS BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Tricog raises $8.5M to scale business across Asia, Africa Tricog has raised $8.5 million in a Series B2 funding round from Omron Healthcare and Sony Innovation Fund, in Japan. Existing investors UTEC - The University of Tokyo Edge Capital, Japan, Inventus Partners LLP and SG Innovate, Singapore, participated in this round. The round marks a total raise of $30 million. Tricog’s artificial intelligence (AI) platform, backed by medical experts, has touched the lives of more than 12 million patients globally, enabling half a million patients added to the care pathway due to critical diseases. Tricog aims to make a cardiac diagnosis and management accessible and affordable by deepening partnerships with government and large private healthcare networks and building state-of-the-art technology for next-generation products, enabling wider reach in patient populations and disease conditions. Founded in 2015, Tricog has recently developed the TriCare platform, an integrated solution for chronic disease management. The first focus will address the global healthcare challenge of heart failure within the US healthcare system and Asia. The TriCare platform enables remote management of heart disease using medical data from connected devices at home and wearable devices such as the Apple Watch. The TriCare platform addresses a growing $110 billion market segment opportunity. Lupin announces acquisition of French company Medisol CCI approves Suven Pharma’s acquisition by Berhyanda The Competition Commission of India (CCI), a statutory body within the Ministry of Corporate Affairs, Government of India, has approved the acquisition of up to 76.10 per cent of the voting share capital of Hyderabad-based Suven Pharmaceuticals Limited by Berhyanda Limited. Berhyanda is the wholly owned subsidiary of Berhyanda Midco Limited, meaning, in turn, the wholly owned subsidiary of Jusmiral Midco Limited, which is collectively controlled by the Advent International GPE IX Funds and the Advent International GPE X Funds, which are ultimately managed by Advent International Corporation. Suven Pharmaceuticals, a biopharmaceutical company incorporated on November 6, 2018, is an integrated contract development and manufacturing organisation that offers its services to global pharmaceutical and agrochemical majors in their innovation endeavours. Lupin, headquartered in Mumbai has entered into a definitive agreement to acquire the entire share capital of the French pharmaceutical company, Medisol, subject to approval from the French Ministry of Economy and Finance. Founded in 2011, Medisol specialises in generic injectable products and is engaged in developing and commercialising its products in France, in pharmacies and in hospitals. With this acquisition, Lupin will gain access to Medisol’s portfolio of seven injectable products across four therapeutic areas, including pain management, antiinflammatory, cardiovascular diseases, and obstetrics. This acquisition helps Lupin to expand its presence in the EU region and accelerate its Injectables franchise in France.
A team of researchers at the Department of Sensors and Biomedical Technology, School of Electronics Engineering (SENSE), Vellore Institute of Technology, Vellore have recently developed a highly flexible and wearable microelectrode array (MEA) bandage which aims at accelerating wound healing through electrical stimulation (ES) technique. As per the National Institutes of Health’s (NIH) report, the market for wound care devices could reach up to $22 billion by 2024 which demands the development of low cost effective solutions. Skin is an ingenious organ in the body which could regenerate itself after any injury or cut which starts from inflammation stage and end in remodelling of skin layers. However, during, this process, the wound healing may be inhibited by many factors like bacterial infections, environmental conditions as well as prevailing medical conditions particularly diabetes. Unlike regular bandages which use layers of absorbent material, antiseptic medications and hydrogels, present MEA bandage aims at wound healing through ES technique. Naturally, skin has an endogenous electric field which gets short circuit when a cut or injury occurs. Following this, the EF lines (current of injury), starts to travel from the wound edge to the wound bed. This flow of current is said to affect the movement of various cells (electrotaxis) engaged in the wound healing process and has been observed to assist their movement in wound closure when triggered by an external electric field (exogenous field). Here, the researchers have tried to recreate the current of injury through bio-mimicked electro therapy using the MEA bandage. This method uses a multi electrode array of miniaturized conformal electrodes fabricated using a low-cost screen printing technology over a highly flexible copper-polyimide film which could deliver exogenous EF directly over the wound site through applied external potentials as shown in the image. The normal as well as wounded skin was modelled using CAD tools and related EF was studied using finite element analysis through computer simulation models. Various design optimizations showed the effective distribution of EF lines using multiple electrodes rather than fewer ones. Animal study experiments under laboratory conditions were also conducted by the team at VIT, Vellore itself. The study showed over 30% faster healing of subcutaneous wounds in rat models than without the MEA bandage. Excellent correlation was observed between the simulation parameters and applied external potentials which demonstrated effectiveness of the developed patch. The present bandage is thus conformally wearable over the wound bed, is bendable, biocompatible and durable for long term application without replacement. Researchers suggest that this could be used as an alternate active wound care method which could remodel the standard of care in the treatments of acute and chronic wounds. Above MEA patch aims at overcoming the prevailing shortfalls of the current ES technique and make it a more acceptable technology by the common people aiding the traditional methods. Funding for the research was provides by the Department of Science and Technology, Science and Engineering Research Board, India. By Dr. Debashis Maji Accelerated Wound Healing by Bio-Mimicking Electro Therapy – MEA wound patch
Redcliffe Labs, a Noida-based diagnostics service provider, has recently launched its state-of-the-art diagnostic lab in Muzaffarnagar, to provide world-class diagnostics services to the doorsteps of the people of Uttar Pradesh (UP). With the launch of Muzaffarnagar Lab, the startup now has a network of 15+ diagnostic centres in Uttar Pradesh. The lab has a setup of all clinical laboratory departments, including Biochemistry, Hematology, Immunoassays, Clinical Pathology, Hormones, and more. Redcliffe Labs has made healthcare services accessible for the residents of Muzaffarnagar and nearby areas like Khatauli, Purquazi, Shamli, Jansath, Bhopa, and Bhadana. Redcliffe already has an impressive footprint in Himachal Pradesh, Punjab, Haryana, Uttar Pradesh, Jammu Kashmir, and Uttarakhand. Just like the entire network of Redcliffe labs, the lab in Muzaffarnagar has equipped with state-of-the-art, fully automatic instruments, ensuring the optimum levels of accurate reporting as per NABL & ISO guidelines. Redcliffe Labs extends reach in UP with new cutting-edge facility in Muzaffarnagar BestDoc expands to Dubai to set up regional headquarters BestDoc, an Indian health-tech provider offering a suite of omni-channel end-toend patient relationship management products, has expanded its operations to the city of Dubai. The startup established its regional headquarters in Dubai last year and the move was supported and facilitated by Dubai International Chamber. Within a short period of time, the company has already acquired associations with some of the most sought-after names in the UAE such as Burjeel Royal Hospital, Al Ain, and Emirates International Hospital and they are currently working on a pilot project with the Saudi German Hospital, Dubai. BestDoc has invested over $0.5 million in Dubai with a primary focus on establishing a robust brand presence, setting up a local entity, and building dedicated sales and support teams to better serve their customers in the region. The company is ambitiously planning to increase their investments in the Gulf Cooperation Council (GCC) region by three to four times over the next 3 to 5 years with a significant share earmarked for Dubai. Bonatra acquires women’s health and wellness startup MyAva Bonatra, a holistic health startup in Bengaluru that offers a unified health stack solution to treat, manage, and reverse chronic diseases, has acquired women’s health and wellness company MyAva, also in Bengaluru. Through this acquisition, Bonatra aims to expand its holistic healthcare programmes and become a one-stop platform for the management of chronic health conditions. Bonatra is a doctor-led IoMT (Internet of Medical Things) startup focused on treating and managing chronic diseases such as diabetes, hypertension, fatty liver, polycystic Ovarian Disease (PCOD), obesity etc. Over the next six months, Bonatra has plans to introduce newer IoMT devices including a smart ring in the Indian market to further strengthen its solutions which are a convergence of medical science, data science and technology. Very recently, the company raised Rs 5.5 crore in a Pre-Seed Round. 16 STARUPS NEWS BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com
Hyderabad-based MapMyGenome has announced the launch of BeautyMap, a revolutionary DNA-based test that provides personalised recommendations for skin and hair care products based on an individual’s unique genetic makeup. The test will be available in the Indian market at a price of Rs 6999. BeautyMap is the first of its kind in India and aims to help people achieve their beauty goals by understanding their genetic predispositions to 40 conditions related to skin and hair care such as acne, hair loss, sun damage, hydration, sleep habits, and vitamin levels, among others. BeautyMap also offers genetic counseling sessions with board-certified genetic counsellors who help individuals interpret their results and make informed decisions about their personalised beauty regimen from the BeautyMap report. The test is simple and non-invasive, requiring only a saliva sample. As part of MapMyGenome’s HarGharDna initiative, the test kit will be delivered directly to people’s homes. The sample is then analysed in MapMyGenome’s state-of-the-art laboratory. The results are delivered to the individual in an easy-to-understand report that includes personalised recommendations for skincare and hair care products through a genetic counselling session. MapMyGenome launches India’s first DNA test for personalised skin and hair care New Delhi-based Akums Drugs and Pharmaceutical has announced the launch of its latest formulation, a unique Combikit – (Amoxicillin + Clarithromycin + Esomeprazole). This Combikit is the first of its kind to be introduced in India by Akums. Combikit is approved by the Central Drugs Standard Control Organisation (CDSCO) for the healing of duodenal ulcers associated with Helicobacter pylori (H. pylori) and the eradication of H. pylori in patients with active or healed peptic ulcer. The H. pylori eradication therapy has shown efficacy in reducing the risk of ulcer recurrence, providing a great benefit for patients. H. pylori is a very common infection in India, implicated in the aetiology of gastritis and peptic ulcers in humans. This Combikit is a combination of three effective drugs - Amoxicillin, Clarithromycin, and Esomeprazole. This combination works by inhibiting the growth of H. pylori bacteria and reducing the production of gastric acid. The drug is available in a patient-convenient pack, for a complete course of therapy. Akums launches novel Combikit for treatment of Duodenal Ulcer and H. pylori infection Murata Vios, one of leading manufacturers of Remote Monitoring Devices, is planning to expand its operations to the Middle East, Europe and Japan in the next 12-18 months. Currently the company has operations in India and the US. The company is working on formalities of introducing the range of devices/ technologies it has to fulfil the stringent regulatory requirements in the developed markets such as Japan and Europe. With a mission to reduce healthcare facilitation costs, deliver greater clinician productivity, increase operational efficiency, and improve patient outcomes, the company has reached out to 15 hospital partners spread across Tier 1 cities and few Tier II cities such as Bangalore, Mangalore, Hyderabad, Mysore, Pune, Delhi etc. Murata Vios today specialises in medical-grade IoT sensors and remote monitoring services for clients such as hospitals, medical and surgical units, step-down units, specialty care units, long-term acute care hospitals, skilled nursing facilities, and ambulatory surgery centres. Murata Vios plans to expand to Middle East, Europe & Japan BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com COMPANY NEWS 17
AIIMS, Medtronic partner to open new surgical robotics training centre in New Delhi Sun Pharma launches novel therapy for Dry Eye Disease British firm GlaxoSmithKline (GSK) Pharmaceuticals has announced the launch of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) in India, for the prevention of shingles (herpes zoster) and post-herpetic neuralgia in adults aged 50 years and above. Shingrix is the world’s first non-live, recombinant subunit vaccine to be administered intramuscularly in two doses. Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox. A seroprevalence study in Indian subjects showed that by the age of 40 years, more than 90 per cent had this virus in their body and were vulnerable to shingles. Shingles causes a painful rash. In all cases, the rash disappears, but in a large number of cases, the pain persists for months or years. This pain is known as post-herpetic neuralgia (PHN). Shingrix was approved by the US Food and Drug Administration (FDA) for the prevention of shingles in adults 50 years of age or older in 2017. The European Commission gave Shingrix approval for the prevention of shingles in adults 50 years of age or older in 2018. GSK introduces shingles vaccine Shingrix Mumbai-based Sun Pharmaceutical Industries has announced that one of its wholly-owned subsidiaries has launched a novel ophthalmology treatment, CEQUA, in India for patients who have Dry Eye Disease (DED) with inflammation, a commonly occurring condition. CEQUA is the first dry eye treatment available in India that is delivered with nanomicellar (NCELL) technology. The technology includes an exclusive encapsulation that surrounds the active ingredient in CEQUA, cyclosporine. It allows the cyclosporine to travel through the layers of the tear film and releases it into the ocular tissues where it is needed the most. Once delivered, CEQUA starts to treat inflammation, the underlying cause of chronic dry eye. Dr Rohit Shetty, Vice Chairman of Narayana Nethralaya Eye Institute said that there has been an increasing number of cases of DED, which may be caused by increased screen time and other lifestyle changes. Dry Eye Disease certainly needs more treatment options. Global clinical trials have shown that CEQUA provides faster results and is comfortable to most patients right from the start of treatment. CEQUA is backed by years of clinical experience in the US and other geographies. It is a welcome addition to our treatment toolkit. All India Institute of Medical Sciences (AIIMS) New Delhi and India Medtronic, a wholly owned subsidiary of Ireland-based Medtronic plc, has announced the opening of a state-of-the-art surgical robotics training centre at AIIMS, New Delhi. The centre will provide surgeons with best-inclass training in robotic-assisted surgery. It is the first such centre at AIIMS utilising Medtronic’s Hugo robotic-assisted surgery (RAS) system, which was first introduced in India in September 2021. RAS is an emerging medical technology that can help standardise surgical procedures and enable surgeons in performing complex surgeries. The training centre will offer a broad spectrum of training to enhance the knowledge and skill set in RAS, ranging from basic skills training to procedural training to more advanced and specialised areas in soft-tissue surgery. The training will help impart procedural knowledge skills using surgical robotics among surgeons, fellows, and residents from across the country. 18 COMPANY NEWS BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com
20 BIOINCUBATORS SURVEY 2021-22 BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com 2021 was a landmark year for the startup ecosystem when for the first time biotech industry in India recorded over 1000 new startup registrations in a single year, as per the Bioeconomy Report 2022. Dr Jitendra Singh, Union Minister of Science & Technology, Government of India, has revealed that the number of Biotech startups in the country has increased from 50 to over 5,000 in the last 8 years, because of the support and enabling environment provided by Prime Minister Narendra Modi since 2014. It is expected to cross the figure of 10,000 by 2025, he said. Currently, there are around 95,000 startups listed on Startup India, out of which there are more than 5000 biotech startups. According to Dr Rajesh Gokhale, Secretary, the Department of Biotechnology (DBT), India has the potential to move from 5000 to 50,000 in the biotech startup sector. This clearly indicates the necessity of having a world-class bioincubation space in our country that can provide cutting-edge access for propelling innovative ideas towards productisation. The new growth in biotech startups requires either scaling of existing bioincubation space in current biotech hubs or creation of new bioincubation space at nascent hubs that have the potential to become bigger biotech hubs in the next decade. Further, the creation of new bioincubation space should address the differential needs of the varied nature of biotech startups- especially medtech, biopharma, agri-biotech and biomaterials. Over the years, the Department of Biotechnology (DBT), under the Ministry of Science and Technology, Government of India, has established many biotechnology parks and bio-incubators across the country to turn research into products and services by providing necessary infrastructure support. Down south, one of the earliest incubators was established in Hyderabad in 1999 as a notfor-profit research park- IKP Knowledge Park. Hyderabad is also home to a bio-incubator facility at the University of Hyderabad. Likewise, the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad has established the Atal Incubation Centre (AIC) within its campus. In addition, the first biotech park in South India was established in 2001 in Chennai, as the Golden Jubilee Biotech Park for Women, one-of-a-kind in the country. Within Karnataka, the Centre for Cellular and Molecular Platforms (C-CAMP), a DBT initiative located within the campus of the National Centre for Biological Sciences (NCBS) in Bengaluru, has been garnering appreciation right since its inception in 2010. DBT has also put in liberal support to another Bengaluru-based biotech startup hub Bangalore Bioinnovation Centre (BBC). It was started in 2015 by Karnataka Biotechnology and Information Technology Services (KBITS), Department of IT, BT and S&T, Government of Karnataka. Moving up to Central India, Pune is home to the largest science business incubator of the countryVenture Center, situated in the CSIR- National Chemical Laboratory (NCL) campus. Joining the league in the West is the Gujarat Government which has established a biotechnology park at the Savli Industrial Estate at Vadodara. On the eastern side, KIIT Technology Business Incubator (KIITTBI) has been incorporated as an initiative by the Kalinga Institute of Industrial Technology (KIIT) with support from the National Science & Technology Entrepreneurship Development Board in Odisha. Likewise, there are many more bioincubators and biotech parks supported by the private and public sectors that have been profiled and ranked in this edition, based on their achievement during FY 2021-22. Dr Manbeena Chawla [email protected] Can India Create 50K BIOTECH STARTUPS?
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com BIOINCUBATORS SURVEY 2021-22 21 BIOSPECTRUM BIOINCUBATORS SURVEY AND METHODOLOGY BioSpectrum 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 BioIncubators (both private and public) spread across India based on their achievements in the past financial year- 2021-22. A detailed questionnaire (survey form) was sent to over 40 BioIncubators to capture the needed information for the year 2021-22 for the analysis. This was done during March – April 2023. BioIncubators shared information with us to the extent it was possible by them. # For all the ranking purposes we have taken four parameters - No. of incubatees joined, Funds raised, Space available, MoUs signed by the BioIncubator with other agencies to attract enterprises/ entrepreneurs during 2021-22. We have considered the names of the BioIncubators who have participated in the survey, as we didn’t received the filled in forms from some of other BioIncubators. KIIT TECHNOLOGY BUSINESS INCUBATOR retains No 1 position in the BioSpectrum BioIncubator Survey 2021-22 Sr. No Name Location Inception Category Total % point 1 KIIT Technology Business Incubator Bhubaneshwar 2010 Private 23.01 2 C-CAMP Bengaluru 2010 Public 13.84 3 Entrepreneurship Development Center (Venture Center) Pune 2007 Private 13.2 4 IKP Knowledge Park Hyderabad 2006 Private 12.93 5 Crescent Innovation and Incubation Council Chennai 2019 Private 6.86 6 Bangalore Bioinnovation Centre Bengaluru 2015 Public 5.97 7 Startup Incubation and Innovation Centre IIT, Kanpur Kanpur 2013 Private 5.8 8 Atal Incubation Centre – CCMB Hyderabad 2017 Private 5.64 9 Guwahati Biotech Park Guwahati 2008 Public 2.67 10 BITS BIRAC BioNEST, BITS, Pilani Goa 2019 Private 2.54 11 ASPIRE BioNEST, Hyderabad Hyderabad 2018 Public 2.19 12 Savli Technology and Business Incubator- Gujarat Savli 2017 Public 2.17 13 Manipal-GoK Bioincubator- Manipal Manipal 2019 Private 1.57 14 Golden Jubilee Biotech Park for Women Society – MS Swaminathan Bioincubation Centre, Chennai Chennai 2017 Private 0.87 15 IIT Madras Bioincubator Chennai 2014 Private 0.75 BioSpectrum Top BioIncubators 2021-22* * We have not covered some of the leading BioIncubators as they have not participated in the BioSpectrum BioIncubator Survey 2021-22. BIOINCUBATOR COMPANIES Bhubaneshwar-based Private BioIncubator KIIT Technology Business Incubator continues its leadership position in the BioSpectrum BioIncubator Survey as it retains No 1 position in 2021-22 survey followed by Public sector BioIncubator, Bengaluru-based C-CAMP gained its position to second rank and Private BioIncubator Entrepreneurship Development Center (Venture Center), Pune at third rank.
22 BIOINCUBATORS SURVEY 2021-22 BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com BioSpctrum Top BioIncubators (Funds raised in 2021-22) « Bengaluru-based C-CAMP leads the table in Funds Raised in life sciences space category with Rs 475 crore (including funds raised by startups) in 2021-22 followed by Hyderabad-based IKP Knowledge Park that raised Rs 339 crore and Pune-based Entrepreneurship Development Center (Venture Center) raising Rs 100 crore in 2021-22. BioSpectrum Top BioIncubators (Space available for incubation (sq ft) in 2021-22) « KIIT Technology Business Incubator, Bhubaneshwar with 90,000 sq ft leads the table of Space made available for incubatees for the year 2021-22 followed by Bangalore BioInnovation Centre, Bangalore with 60,000 sq ft and Startup Incubation and Innovation Centre IIT, Kanpur with 58,000 sq ft. BioSpctrum Top BioIncubators (MoUs Signed in 2021-22) « KIIT Technology Business Incubator Bhubaneshwar leads the table of Memorandum of Understandings (MoUs) signed in 2021-22 with 142 followed by Punebased Entrepreneurship Development Center (Venture Center) with 35 MoUs and Atal Incubation Centre (Centre for Cellular & Molecular Biology) (AICCCMB), Hyderabad with 33 MoUs. BioSpectrum Top BioIncubators (with highest no of incubatees joined in 2021-22) « Private BioIncubators are leading the table of No of incubatees joined in 2021- 22 category with Punebased Entrepreneurship Development Center (Venture Center), attracting 103 incubatees, followed KIIT Technology Business Incubator, Bhubaneshwar attracting 84 incubatees and Crescent Innovation and Incubation Council, Chennai attracting 56 incubatees. HIGHLIGHTS BioSpectrum Top BioIncubators 2021-22* (Private) Sr. No Name Location Inception Total % point 1 KIIT Technology Business Incubator Bhubaneshwar 2010 23.01 2 Entrepreneurship Development Center (Venture Center) Pune 2007 13.2 3 IKP Knowledge Park Hyderabad 2006 12.93 4 Crescent Innovation and Incubation Council Chennai 2019 6.86 5 Startup Incubation and Innovation Centre IIT, Kanpur Kanpur 2013 5.8 6 Atal Incubation Centre – CCMB Hyderabad 2017 5.64 7 BITS BIRAC BioNEST, BITS, Pilani Goa 2019 2.54 8 Manipal-GoK Bioincubator- Manipal Manipal 2019 1.57 9 Golden Jubilee Biotech Park for Women Society – MS Swaminathan Bioincubation Centre, Chennai Chennai 2017 0.87 10 IIT Madras Bioincubator Chennai 2014 0.75 * We have not covered some of the leading BioIncubators as they have not participated in the BioSpectrum BioIncubator Survey 2021-22. BioSpectrum Top BioIncubators 2021-22* (Public) Sr. No Name Location Inception Total % point 1 C-CAMP Bengaluru 2010 13.84 2 Bangalore Bioinnovation Centre Bengaluru 2015 5.97 3 Guwahati Biotech Park Guwahati 2008 2.67 4 ASPIRE BioNEST, Hyderabad Hyderabad 2018 2.19 5 Savli Technology and Business Incubator- Gujarat Savli 2017 2.17 * We have not covered some of the leading BioIncubators as they have not participated in the BioSpectrum BioIncubator Survey 2021-22.
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com BIOINCUBATORS SURVEY 2021-22 23 KIIT TECHNOLOGY BUSINESS INCUBATOR (TBI), BHUBANESWAR Started in 2009 as an initiative of Kalinga Institute of Industrial Technology (KIIT) with the support of the Department of Science & Technology (DST), Government of India, KIIT-TBI has always strived to boost the entrepreneurial ecosystem in the country. FY 21-22 saw the bioincubator winning a national award for Nurturing the IP. There was also a partnership developed with the Manipur Department of Information Technology (DIT) to establish a Manipur Technology Innovation Hub (MTI HUB) with KIIT-TBI on the public-private partnership (PPP) model to improve entrepreneurship in Manipur. In the coming years, KIIT-TBI plans to establish a Diagnostics Innovation Hub to catalyse manufacturing in this sector and position Odisha as a leading manufacturing destination. This hub would be dedicated to in vitro diagnostic (IVD) manufacturers and also promote research and development in the area. The occupants will be able to leverage the common support facilities at the medical devices park and will also be provided IVD-specific facilities. The bioincubator also intends to promote scientist-farmer partnership for agriculture innovation through participatory research to connect science laboratories with the farmers, and to find innovative solutions and technologies to be developed and applied at the farm level. 01 CENTRE FOR CELLULAR AND MOLECULAR PLATFORMS (C-CAMP), BENGALURU The Centre for Cellular and Molecular Platforms (C-CAMP), an initiative supported by the Department of Biotechnology, Government of India, has been a catalyst of cutting-edge research and innovation in the life sciences since 2009. C-CAMP is also a Bangalore Life Science Cluster (BLiSC) member. Till March 2022, C-CAMP supported 300+ startups/spin-offs through funding, incubation, mentorship and acceleration and was connected to about 2000 startups and entrepreneurs across the country in healthcare, agriculture and the environment. In the space of Life Science/Healthcare, C-CAMP startups had more than 40 products in the market, and 10 technologies were licensed till March 2022. C-CAMP also won 2 awards from the Govt of India during the 2021-22 period. During FY 22-23, the bioincubator plans to expand its physical space and innovation support facilities to foster more startups at the scale-up stage and address gaps in deep science innovation scale-up. More bridge funding programmes at the scale-up stage for startups are also on the cards. C-CAMP also plans to venture out into more areas of burning interest such as maternal and child health, sustainability, synthetic biology, and One Health. In COVID care augmentation, there are plans for healthcare infrastructure projects, COVID diagnostics and pandemic preparedness besides infectious diseases beyond COVID. 02 ENTREPRENEURSHIP DEVELOPMENT CENTER (VENTURE CENTER), PUNE Venture Center was founded in 2007 as an initiative of CSIR’s National Chemical Laboratory. It was incorporated as “Entrepreneurship Development Center” under Section 25 of the Companies Act, 1956 (now Section 8 under the Companies Act, 2013). Venture Center is an approved incubator of the National Science and Technology Entrepreneurship Development Board of the Department of Science and Technology, Government of India (DST-NSTEDB). During FY 21-22, incubatee companies (current and graduate residents) had 181 founders and 1000 direct employees creating additional 515 new jobs. Venture Center won the National Award for Incubators Nurturing IP in 2021-22 by National Intellectual Property Awards. For the future, Venture Center aims to be the organisation that will be credited with creating, shaping and sustaining a world-class cluster of innovative and knowledge‐intensive biotechnology and Biomed businesses in the Pune region with a significant economic impact regionally, nationally and globally by 2027. The core mission of the bioincubator is to nucleate and nurture technology and knowledge‐based bio-enterprises by leveraging the scientific and engineering competencies of the individuals and institutions in the Pune region, and to attract risk capital and funding into innovative startups from the region. 03
LIFE SCIENCE INCUBATOR - IKP KNOWLEDGE PARK, HYDERABAD Life Science Incubator (LSI) is set up within IKP Knowledge Park as a division with a key objective of nurturing startup companies and entrepreneurs working in the areas of healthcare, agriculture, food/nutrition, bio-energy, industrial & environmental biotechnology, etc. During FY 21-22, BIRAC partnered with IKP for the I-CO fund programme and a total of 23 innovations were supported. The funding for I-CO Fund Call 1,2 and 3 was around Rs 5 crore. In addition, IKP partnered with BIRAC for the Agri Grand Challenge programme to support innovations to enhance farmers’ income, with a total budget for the programme of Rs 7.70 crore. BIRAC has also selected IKP as an implementation partner for Amrit Grand Challenge JanCARE. The programme is aligned with the National Digital Health Mission (NDHM) and will attempt to support 90 digital health innovations that will contribute to improving Indian healthcare delivery and optimise the usage of digital infrastructure. In the future, the bioincubator would continue to work with life science innovators to scale up their technology solutions by providing best-in-class IP, regulatory, technical, and business mentoring. With a diverse team of scientists and product development expertise, the team at IKP will work with innovators to co-develop products. 04 CRESCENT INNOVATION & INCUBATION COUNCIL (CIIC), CHENNAI Started in 2019, Crescent Innovation & Incubation Council (CIIC) in Chennai has been established as a Section-8 not-for-profit company, acting as a ‘One Stop Shop – Technology Business Incubator (TBI)’ for startups. CIIC facilitates an entrepreneurial and innovative ecosystem for all the stakeholders including the students, faculty, industry, investors and society at large. CIIC is recognised as one of the Incubators in the Startup India Hub and Institutional Innovation Council in the Ministry of Human Resource Development (MHRD) Innovation Cell (MIC). During FY 21-22, the bioincubator announced the launch of CIIC Madurai Campus supporting Tier 2 & Tier 3 cities for the rural economy, especially in the agritech and food tech space. Expansion of CIIC infrastructure also took place in FY 21-22, by 10,000 sq ft. For the future, CIIC plans to create state-of-art centralised lab facilities for bioprocess, biosystems, animal house & mammalian cell culture and biomolecule synthesis lab under BIRAC BioNest phase 2. There are further plans to create a facility for mosquito research within the bioincubator. CIIC also plans to extend support through market & product validation for startups. 05 BANGALORE BIOINNOVATION CENTRE (BBC), BENGALURU Bangalore Bioinnovation Centre (BBC) is a joint initiative of the Department of Biotechnology, Government of India and the Department of Electronics, IT, BT and S&T, Government of Karnataka. It works closely with Karnataka Innovation & Technology Society (KITS), a nodal centre for implementing schemes of the Department of Electronics, IT, BT and S&T, Government of Karnataka & its startup cell. It is a State-of-the-art translational research and entrepreneurship centre catering to all the needs of startups in life science. During FY 2021-22, some startups incubated at BBC launched new products with high social value impact, while few others received recognition on global platforms. In the near future, BBC plans to set up new centres for augmenting the growth of startups and innovation in deep tech areas. For instance, the Centre for Pandemic Preparedness through a grant available from the state government is being built at a cost of Rs 10 crore; Farm Innovation Centre through a grant from Rashtriya Krishi Vikas Yojana is being established at a cost of Rs 20 crore; Second Floor Lab is to be constructed through a grant from Karnataka Innovation & Technology (KITS), Department of Electronics, IT, BT and S & T, Government of Karnataka at Rs 7.5 crore; and Drosophila Platform Technology through BBC’s Internal accruals & potential grant through BIRAC under ‘Preclinical Disease Model’ Programme, is also under consideration. 06 24 BIOINCUBATORS SURVEY 2021-22 BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com
STARTUP INCUBATION AND INNOVATION CENTRE (SIIC), INDIAN INSTITUTE OF TECHNOLOGY (IIT) KANPUR SIIC, IIT Kanpur came into existence when in 2000 Small Industries Development Bank of India (SIDBI) approached IIT Kanpur to form an incubation centre. The idea was to deepen the entrepreneurship and incubation culture of the institute. SIIC, IIT Kanpur aims to develop cutting-edge technologies grounded in science and engineering Innovations to solve pressing problems of the country, focusing on the underprivileged strata. It provides the right space and opportunities for converting startup ideas into products and businesses. During the second wave of COVID-19 in 2021, the incubation centre launched ‘Mission Bharat O2’ (MBO2)- an initiative focused on gathering startups, innovators and industry mentors for solving the oxygen crisis of the country at that time. In the coming times, the vision of the incubator is to become the most preferred incubation centre in life sciences. The plans include establishing medical device testing and validation labs at IIT Kanpur for conducting some biological functional testing of the devices and to provide mentorship on the regulatory framework for medical devices in the country. With the help of the cyber security centre of excellence at SIIC IIT Kanpur, the incubator aspires to facilitate innovations for preventing attack-proof cybersecurity systems for healthcare. 07 ATAL INCUBATION CENTRE - CENTRE FOR CELLULAR AND MOLECULAR BIOLOGY (AIC – CCMB), HYDERABAD A premier incubator focused on promoting entrepreneurship in life sciences and supporting startups in health, pharmaceuticals and biotechnology, AIC-CCMB is currently operating at 90 per cent occupancy and is now actively looking to expand beyond its 20,000 sq ft space at CCMB’s Annexe 2. With three new funding programmes introduced during FY 21-22 at the incubator, innovative startups now have access to seed funding right from the ideation stage. FY 2021-22 saw the execution of projects for indigenous kit development, which were supported by the Bill & Melinda Gates Foundation (BMGF) and Rockefeller on COVID-19 testing kits and mRNA project for the COVID-19 vaccine. The ecosystem at AIC-CCMB has also expanded with industry stalwarts joining its mentor pool for effective mentoring and training. In addition, the bioincubator has received sanction for Startup India Seed Funds Scheme (SISFS), for which the call is open all year round. A major plan in store is the establishment of the Centre of Excellence (CoE) at AIC-CCMB with renowned academic institutes, industry partners and government bodies. AIC- CCMB is further planning to upgrade the incubation centre by expanding the existing incubation space and incorporating newer lab facilities, prototyping facilities and regulatory support. There are also plans to create a commercialisation window for overseas companies in India and for supporting startups in deep-tech verticals. 08 TECHNOLOGY INCUBATION CENTRE, GUWAHATI BIOTECH PARK, GUWAHATI Guwahati Biotech Park’s Incubation Centre is the first milestone incubator of Guwahati Biotech Park, Northeast’s foremost Science and Technology Park. Critical to the definition of an incubator is the on-site management, which develops and orchestrates business, marketing and management resources, tailored to a company’s needs. The park provides the incubators with the option to expand their operations by providing up-gradable rental space at flexible leases, shared basic office services, technology support services and assistance in obtaining the financing necessary for a company’s growth. FY 21-22 saw the construction of the 107,718 Sq ft Technology Incubation Centre in the permanent campus getting completed. For the future, the bioincubator plans to develop the Business Enterprise Zone of Guwahati Biotech Park which is targeted to harness the life sciences/ biosciences/ healthcare industry potential of Assam and North East Region. This project is anticipated to have a direct impact on the economy of the state. There are plans to create a skilled manpower pool and next-generation startups through various capacity-building programmes. The bioincubator will be conducting market-oriented training programmes for the benefit of prospective entrepreneurs, and to accelerate the path of self-sustenance and self-reliance in terms of revenue. 09 BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com BIOINCUBATORS SURVEY 2021-22 25
BITS GOA INNOVATION INCUBATION & ENTREPRENEURSHIP SOCIETY (BGIIES) – BITS BIRAC BIONEST, GOA The Birla Institute of Technology and Science (BITS) Goa Innovation, Incubation & Entrepreneurship Society (BGIIES) is a registered Society under the Societies Registration Act, 1860, in February 2020, having its office in BITS Pilani, K. K. Birla Goa Campus, Zuarinagar, Goa. Currently, the Society is supporting the BITS BIRAC BioNEST incubator, BITS Pilani, K. K. Birla Goa Campus. The Society has been set up with the aim to promote, encourage, and sustain activities and programmes contributing to innovation, incubation & entrepreneurship education and development, and to establish and administer Business Incubators (BIs) in any location in India in order to promote innovation-based startups. Amongst many achievements during FY 21-22, the bioincubator designed and released a Startup Compendium detailing the list of incubated startups and the startups that participated in the National Startup Day organised by BGIIES - BITS BIRAC BioNEST. The incubator also launched the ‘Know your Mentor’ programme, for BGIIES incubated startups. In the future, the incubator plans to introduce a skill development programme with iHUB DivyaSampark, Technology Innovation Hub, and IIT Roorkee in order to enable skill development in Goa. Space expansion by 10,000 sq ft is also in the pipeline, and onboarding more incubatees to take to 50 startups by 2024. 10 ASPIRE-BIONEST, HYDERABAD ASPIRE is a section-8, not-for-profit organisation that manages the innovation and entrepreneurial activities at the University of Hyderabad (UoH) through the incubation of startup companies in various disciplines of science and technology. Currently, there are 3 incubation centres (ICs) functioning under ASPIRE, i.e., ASPIRE-BioNEST, ASPIRE-TBI (Technology Business Incubator), and ASPIRE TIDE (Technology Incubation and Development of Entrepreneurs), providing incubation support in the areas of life sciences, pharma & chemistry as well as materials and IT & Electronics, respectively. TBI was established with the support of the Department of Science & Technology, TIDE, supported by the Department of Electronics and Information Technology (DietY) and the BioNEST was established with support from BIRAC/DBT. These ICs are equipped with state-of-the-art infrastructure and necessary instrumentation. ASPIRE-BioNEST, inaugurated on National Science Day, February 28, 2018, is a deep-tech life sciences incubator spread over 23,000 sq ft providing a plug-and-play laboratory space for startups. During FY 21-22, ASPIRE-BioNEST achieved 100 per cent occupancy in the incubator. Further, the bioincubator plans to expand the existing 23,000 sq ft incubation space to 35,000 sq ft to support 75 startups at any given point in time. There are plans for setting up a growth phase research park as well. 11 SAVLI TECHNOLOGY & BUSINESS INCUBATOR (STBI), VADODARA Savli Technology & Business Incubator (STBI) is set up within the Industrial estate of Vadodara with the vision to nurture the startup economy by facilitating support to budding entrepreneurs thereby contributing towards strengthening the nation. STBI aims to create a rich ecosystem that encourages synergetic development between scientists, technologists, entrepreneurs, and investors to spur technology-driven- entrepreneurship, initially in the field of biotechnology, life sciences and related disciplines having a socio-economic impact. During FY 21-22, the bioincubator conducted numerous events and roadshows for startups and also organised industry-academia meets for research commercialisation. In the coming years, STBI plans to establish bio-fabrication and animal cell culture facilities enabled by 3D bio-printer. There are further plans for setting up Satellite Centres / Preincubation Centres across the State. The bioincubator plans to enable activities such as the Conclave of Bioincubators and Bio-Startups to nurture deep-tech with Indian Science and Technology Entrepreneurs Parks (STEPs) and Business Incubators Association (ISBA) and Association of Biotechnology Led Enterprises (ABLE), along with a specialised consultation programme for technology-driven startups. With these plans in the pipeline, STBI intends to emerge as a fountainhead for an ecosystem of research, technology & innovation-based economy that impacts society & markets, at large. 12 26 BIOINCUBATORS SURVEY 2021-22 BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com
MANIPAL-GOK BIOINCUBATOR, MANIPAL Manipal - Government of Karnataka (GoK) Bioincubator, Technology Business Incubator, is an initiative by the Manipal Academy of Higher Education (MAHE) and the Government of Karnataka to facilitate the incubation of startups. This Incubation platform aims at upscaling innovations specialising in technology, propelling innovative ideas towards product commercialisation. Manipal-GoK Bioincubator also focuses on translational activities dedicated to promoting technology-based early-stage ideas, through mentorship, investment readiness support, technical assistance, business validation and networking opportunities. The goal of the Manipal-GOK bioincubator is to handhold and address the challenges of entrepreneurs to create technology-based enterprises to successfully commercialise business models. The bioincubator is keen to develop a strong entrepreneurial culture with good governance and an operational model. FY 2021-22 saw the initiation of the first international programme - Global Technology Solutions, with the support of J Herbert Smith Centre for Technology Management & Entrepreneurship, University of New Brunswick, Canada. This fourmonth programme was organised for technology innovators. In the coming times, the bioincubator plans to establish a strong network for innovators, bioresources and regulatory material library; and expand international programmes, incubation and industry support team and mentors. There are further plans for the development of a small-scale additive manufacturing facility, and for strengthening regulatory compliances. 13 GOLDEN JUBILEE BIOTECH PARK FOR WOMEN SOCIETY – MS SWAMINATHAN BIOINCUBATION CENTRE, CHENNAI Golden Jubilee Biotech Park for Women Society was established with a vision of encouraging and empowering Women Entrepreneurs almost 2 decades ago. This organisation is supported by the Department of Biotechnology, Govt of India, Govt of Tamil Nadu and technical support from M S Swaminathan Research Foundation (MSSRF) in the 20-acre land allotted by the Government of Tamil Nadu & implemented by Tamil Nadu Industrial Development Corporation (TIDCO). The park began its commercial operations in 2001 and over the years has proved to be a successful and unique venture in women entrepreneur development in the biotech sector. The park has been designed based on the principle of decentralised production supported by centralised services to develop the field of biotechnology. The park has set up an Incubation facility, the first of its kind, supported by BIRAC (Biotechnology Industry Research Assistance Council) with a central instrumentation facility. The bioincubator aims at providing opportunities for professionally qualified women to take on a career of remunerative self-employment through the organisation of biotechnological enterprises. FY 2021-22 saw the Golden Jubilee Biotech Park for Women Society being awarded as one of the Best Incubators during the Tamil Nadu Startups & Incubators Meet event. In the future, the bioincubator aims to cater to women entrepreneurs from rural areas. 14 INDIAN INSTITUTE OF TECHNOLOGY, MADRAS (IITM) BIOINCUBATOR, CHENNAI I ITM Bioincubator was established with the support of Biotechnology Industry Research Assistance Council (BIRAC) in 2014. It is housed in the Indian Institute of Technology (IIT) Madras Research Park, India’s first and leading university-based innovation ecosystem and falls under the purview of the IIT Madras Incubation Cell. Its excellent ecosystem enables collaboration between the startups, corporate houses, faculty and students of IIT Madras, with the objective to promote biotechnologybased innovation and entrepreneurship in India, and fostering the development of globally competitive products by startups for successful commercialisation. During FY 21-22, the bioincubator received a Corporate Social Responsibility (CSR) grant in the area of marine biotechnology from the US-based company Cytiva, previously known as GE Healthcare Life Sciences. The bioincubator also completed an Early Translational Accelerator programme supported by BIRAC in the area of industrial biotechnology during FY 21-22. In the future, there are plans to strengthen the industrial biotechnology domain; capacity-building activities for Tier-2 and Tier-3 cities; upgradation of infrastructure for boosting the technical ecosystem; hands-on training sessions in the area of bio-manufacturing; expand in the healthcare domain such as diagnostics and therapeutics; and proactive support for reaching out to potential incubatees in various domains of biotechnology/life sciences/biosciences/healthcare. 15 BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com BIOINCUBATORS SURVEY 2021-22 27
28 BIOINCUBATORS SURVEY 2021-22 BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Bioincubators & their progressive journey in India « Dr Vishal Gandhi, Founder & CEO, BioRx Venture Advisors & Indian Healthcare Angels I ndia has been witnessing steady growth in the biotechnology sector, with the industry expected to reach $150 billion by 2025. India has a strong talent base, with many highly qualified scientists and engineers, particularly in the biotech and life sciences sector. Additionally, the nation is investing more in R&D and has a growing number of research institutes, both of which have fuelled innovation in the industry. Additionally, there is a growing demand for healthcare solutions in India, driven by a growing population and an increasing burden of disease. As a result, we have seen a significant increase in biotech and life sciences startups in India over the past few years, with many innovative companies emerging in areas such as healthcare diagnostics, drug discovery, and medical devices. These firms are harnessing technology and scientific innovation to address some of the most critical healthcare concerns confronting the country, and are positioned to make a huge impact in the years ahead. A brief history The journey of bioincubators in India has been quite progressive, with the government and private players working together to create an ecosystem that fosters innovation and growth. The first bioincubator in India, the Society for Innovation and Development (SID), was set up in 1986 at the Indian Institute of Science, Bengaluru. Since then, several bioincubators have come up across the country, especially in the last decade. Bioincubators frequently provide access to a network of industry experts, investors, and possible partners together with physical facilities and support services. Young businesses can greatly improve their chances of success by overcoming the difficulties of introducing novel goods and services to the market with the aid of this ecosystem of support. The Department of Biotechnology (DBT) and the Government of India are constantly working to grow the biotechnology industry in India. There are numerous Indian biotechnology parks and incubators presently, expanding the field of biotechnology and generating employment in the biotech industry. The primary objective of governmental or private bioincubators, also known as biotech incubators, is to promote emerging biotech startups in the biobusiness. They support the expansion of biotech startups from a local to an international level. State governments also establish bioincubators for more growth of the biotech industry in their states. Telangana, Tamil Nadu, Andhra Pradesh and Maharashtra have more bioincubators than other states in India. Pro-bioincubator policies In India, there were approximately 160 bioincubators and 1,800 businesses functioning in these incubators as of March 2021, according to a report by the National Science and Technology Entrepreneurship Development Board (NSTEDB). The research also notes that more than 800 firms have left these bioincubators after receiving a degree and have raised more than Rs 5,000 crore (about $675 million) in capital overall. The Indian government has introduced a number of programmes and initiatives to promote bioincubators in recognition of their significance in fostering innovation and entrepreneurship. To assist biotech companies and SMEs, the DBT introduced the Biotechnology Industry Partnership Programme (BIPP) in 2016. A grant of up to Rs 50 lakh ($67,000) is made available to bioincubators under this programme for an 18-month term to support the incubation of biotech businesses. The Biotechnology Ignition Grant (BIG) programme was also introduced by the government to finance early-stage biotech firms. The programme offers a grant of up to Rs 50 lakh ($67,000) for an 18-month term to assist in proof-of-concept studies, prototyping, and other technological developmentrelated activities. The expansion of bioincubators in India has
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com BIOINCUBATORS SURVEY 2021-22 29 also been significantly aided by the private sector. To encourage innovation and entrepreneurship in the biotech industry, several powerful corporations, including Reliance, TATA, and Biocon, have established bioincubators. These bioincubators give businesses access to finance as well as mentorship, networking opportunities, and laboratory and office space. The Centre for Cellular and Molecular Platforms (C-CAMP) in Bengaluru is one of India’s renowned bioincubators. The life sciences industry has benefited greatly from C-CAMP’s promotion of innovation since its establishment in 2009. Startups get access to top-notch laboratory resources, mentoring, and networking opportunities thanks to C-CAMP. Over 200 firms have received incubation from the bioincubator, which also assisted them in raising more than $100 million in funding. The BIRAC Regional Innovation Centre (BRIC) at the Institute of Life Sciences (ILS), Bhubaneswar, is another bioincubator that merits note. BRIC was established in 2015 with assistance from the government of Odisha and the Biotechnology Industry Research Assistance Council (BIRAC). Startups can receive funding, mentorship, and laboratory and office space through the bioincubator. Over 30 firms have been nurtured by BRIC, and a number of them have since raised money from investors. Additionally, bioincubators have been effective at encouraging social entrepreneurship in the biotech industry. To encourage innovation in the life sciences industry, the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad established the CCMB Social Entrepreneurship Programme (CSEP), a social entrepreneurship programme. Startups can get lab and office space, mentoring, and financial support through CSEP. Several firms, including those trying to offer accessible healthcare solutions and those promoting sustainable agriculture, have been incubated through the programme. Performance indicators The number of startups incubated, the number of jobs created, the amount of investment raised by the startups, and the success rate of the startups can all be used to gauge how well a bioincubator is performing. Over time, India’s bioincubators have seen a considerable rise in the number of firms they are able to support. Incubated at various bioincubators across India as of 2021 are more than 200 biotech firms, according to BIRAC. Bioincubators in India have played a significant role in generating employment opportunities.There are two types of jobs generated by bioincubators in India: direct employment and indirect employment. Jobs created by incubated startups, such as those for scientists, engineers, technicians, and administrative personnel, are included in direct employment. Jobs created by the vendors, suppliers, and service providers who work with these startups are considered to be indirect employment. A study by the Association of Biotechnology Led Enterprises (ABLE) found that in India, the biotechnology industry produced more than 400,000 direct jobs and more than 1.2 million indirect jobs in 2019. While the exact number of jobs produced by bioincubators is unknown, it is plausible to conclude that a sizable fraction of them were. Additionally, a number of prosperous businesses that emerged from India’s bioincubators went on to significantly increase the number of job opportunities. For instance, MyLab Discovery Solutions, a business that specialises in medical diagnostics and graduated from Bangalore’s C-CAMP, has produced over 500 jobs. A biotech business called Stempeutics Research, which graduated from Hyderabad’s CCMB, has produced over 200 jobs. According to research by BIRAC, over 1,400 biotech firms were able to be incubated by BIRACfunded bioincubators in India between 2012 and 2020, and they were also able to raise over Rs 4,200 crore ($570 million) in funding. A number of other bioincubators in India, besides those supported by BIRAC, have been instrumental in helping biotech businesses raise money. For instance, between 2018 and 2021, entrepreneurs were able to raise around Rs 500 crore ($68 million) in finance thanks to C-CAMP bioincubator. More than 70 per cent of the firms nurtured in bioincubators, according to BIRAC research, have been successful in obtaining funding or commercialising their goods.
30 HEALTHCARE COLD CHAIN BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Can pharma cold chain market sustain its growth spurt? The pharma industry can heave a sigh of relief when it comes to advanced cold chain logistics deployed to transport temperature-sensitive drugs and vaccines, among others, within the stipulated time frame. Industry experts opine that aside from adopting technological innovations, overcoming certain challenges like a lack of skilled workforce and looking into regulatory compliance will prove to be a win-win situation for both the life sciences and cold chain logistic players. Let’s explore the present scenario and examine some measures that will address the concerns of this crucial industry. The pharma cold chain logistics market has an important role to play in India when it comes to transporting life-saving drugs, organs, vaccines, etc., especially to far-flung areas. India is a tropical country with unabated heat during most of the year, the cold chain logistics players ensure that deliveries are made well within the time and that too on certain occasions in refrigerated conditions. Gone are the days when it was unthinkable to transport temperature-sensitive life-saving items due to tropical weather conditions. COVID-19 put the focus on the cold chain logistic players, especially when temperature-sensitive vaccines were required to be transported to healthcare centres across India and also to foreign countries. India’s healthcare cold chain logistics market size was valued at $1.02 million in 2022 and is expected to reach $1.29 million by 2030, at a CAGR of 3 per cent from 2023 to 2030, as per greyviews.com. Rising demand for pharmaceuticals that need optimum temperature for storage is boosting the market growth. Furthermore, continuous research and development will create new opportunities for the market in terms of storage, shelf-life and transportation. Looking at these developments many leading logistics players such as Snowman Logistics, FedEx Express, Transys Global Forwarding, TCI Express, Gati Kausar India, Stellar Value Chain Solutions, Future Supply Chain Solutions, FleetX, Gubba Cold storage and DHL Express India have become active and making more inroads in the healthcare cold chain space. Bengaluru-based Snowman Logistics, a group company of Gateway Distriparks, has state-of-the-art temperaturecontrolled warehousing facilities in prime locations like Mumbai, Chennai and Bengaluru coupled with integrated distribution solutions. The company has increased its cold chain segment pallet capacity from 90K to 1.30K pallets since 2017 and has a presence in 17 major cities and 43 warehouses pan India. On the other hand Luxembourg-based B Medical Systems have made rapid strides in the last few years in terms of investments, building a solid distributor network and production of the most efficient cold chain solutions for the storage and transportation of vaccines, blood and its components and other biological. The company has focussed on introducing the most advanced cold chain equipment to the Indian market. The company’s Mundra facility can produce over 1,00,000 medical cold chain equipment annually. There are plans to launch a new version of Refrigerated Vaccine Transport Vehicle (RVTV) for the Indian market. The company is looking to launch -80°C mobile freezers that can work even in cars. Jesal Doshi, Deputy CEO, B Medical Systems mentions, “Technology adoption at scale is critical for building an efficient medical cold chain sector in the country. As medical cold chains deal with highly temperature-sensitive materials like vaccines, blood and its components, and other biological ingredients, poor temperature control can damage the molecular dynamics of many compounds and endanger lives. Global market The global healthcare cold chain logistics market size reached $17.1 billion in 2022. Looking forward, it is expected to reach $20.9 billion by 2028, exhibiting a CAGR of 3.4 per cent during 2022-2028. Source: ResearchAndMarkets.com
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com HEALTHCARE COLD CHAIN 31 Thankfully, technologies like Artificial Intelligence, Machine Learning, the Internet of Things and Data Analytics enable the healthcare and medical devices sectors to serve people unimaginably.” Similarly other global players such as FedEx Express, during the 2nd Annual Great Indian Biologics Festival 2023 held in Pune, showcased SenseAware M4, an advanced monitoring system that uses a multi-sensor device. It collects realtime data for critical shipments from the moment they are packed and picked up, to the time they are delivered. The device has an array of sensors, a FedEx-proprietary aeroplane mode, and the ability to operate inside and outside of FedEx transportation networks. Suvendu Choudhury, Vice President, Operations-India, FedEx Express says, “Healthcare providers need specialised shipping services that seamlessly support integrity, quality, precision and control. We have invested in a robust healthcare supply chain, cold chain capabilities and decades-long expertise to meet customer needs in the healthcare market, building more than 90 cold chain facilities across five continents.” On similar lines Bengaluru-based Transys Global Forwarding has recently commissioned a unique pharmaceutical cold chain preconditioning centre near the international airport in Hyderabad. The 25,000 sq ft located near Shamshabad is designed to meet the increasing demand for cold chain logistics services. Other players such as Trane Technologies, TCI EXPRESS and DHL that played critical roles during the pandemic, continue to offer their services to the pharma industry. Trane Technologies from Mumbai has contributed to strengthening India’s COVID-19 vaccination drive with its end-to-end refrigerated transportation and storage solutions namelyThermo King. Major logistics companies in the country like Coldrush Logistics, Snowman Logistics, Coldman Logistics, Geetee Carriers, Algor Supply Chain Solutions and Reema Transport, among others, are using Thermo King refrigeration units to move the life-saving drugs to vaccination sites. Kishor Patil, Country Head, Trane HVAC Business India & SAARC Markets, Trane Technologies says, “The development of vaccines and the vaccine campaigns are two of the most important contributing factors. The demand for vaccines may be low right now, but it is expected to grow owing to the continuous attempts to develop new vaccines and broaden current immunisation programmes. Overall, many factors, such as ongoing vaccine development and distribution efforts, the diversification of the cold chain industry, and the capacity to use existing infrastructure to support other temperaturesensitive products will determine the long-term viability of cold chain facilities.” DHL, played an important role when it came to the transportation of temperature-sensitive vaccines through its subsidiary, DHL Medical Express during the pandemic times. DHL Medical Express provides time and temperature-sensitive shipments ranging from investigational medicine/ drugs, vaccines, clinical supplies/kits and biospecimen samples to and from clinics/hospitals and clinical research organisations (CRO) and laboratories around the globe. Secunderabad-based TCI EXPRESS provides end-to-end logistics to the pharmaceuticals industry that includes temperature control movement (Bulk and Part), Dry Ice Shipment, ambient and frozen clinical shipments. It also provides a seamless order management service to Use of Drones The Indian Council of Medical Research (ICMR) successfully conducted a trial run of blood bag delivery by drones under its iDrone initiative. The trial run, as part of a path-breaking validation study, has been undertaken for the first time in the country by the collaborative efforts of ICMR, Lady Hardinge Medical College (LHMC), New Delhi, Government Institute of Medical Sciences (GIMS), Greater Noida and Jaypee Institute of Information Technology (JIIT), Noida. The inaugural trial flight carried 10 units of whole blood samples from GIMS and LHMC. Dr Rajiv Bahl, Director General, ICMR mentioned, “The ‘iDRONE’ was first used during COVID-19 by ICMR for distributing vaccines to unreachable areas. Today, we are transporting blood and bloodrelated products, which are supposed to be kept at a low temperature. After the experiment, we found that not only can we maintain the temperature, but there was also no damage to the products transported.”
companies entering and exiting the market at a higher rate compared with other nations. In India, it is a transactional and cost-conscious business segment that also is low on cold chain partnerships. Trucking margins are generally low while fuel prices are high in India, which is a challenge for shipping sensitive products. Chetan Shinde, AGM - Operations, Snowman Logistics opines, “Trucks get stuck in traffic for hours, and there have been cases where vehicles have been stuck at airports for three to four days. Since the products are highly temperature sensitive and goods are frequently unloaded/loaded at night, maintaining the temperature at locations is also necessary. There is also a lack of focus on quality orientation and training and the cost-conscious pharmaceutical sector must ensure and check in advance that people catering along the cold chain have received sufficient training and education to handle the product/shipment.” The absence of adequate infrastructure for cold chain storage and transportation is one of the main problems. There is a dearth of cold storage facilities in many areas of the country, and those that exist are either insufficient or out of date. Cost, supply chain fragmentation, lack of skilled workforce and regulatory compliance are some of the major challenges. Propelling India’s growth story The market for temperature-sensitive goods is expected to grow in the future, and new infrastructure and technological advancements are being made to strengthen the efficiency and dependability of cold chain logistics. Technological advancements, such as IoT and blockchain, will improve supply chain visibility, efficiency, and sustainability. The adoption of sustainable cooling solutions and the emergence of e-commerce will also impact the sector’s future. Udbhav Rai, Co-Founder, FleetX rightly mentions that technology adoption is the need of the hour when it comes to designing a robust cold chain infrastructure. With the industry recognising the importance of addressing cold chain challenges, it will be a promising sector for India’s growth story. Sanjiv Das [email protected] 32 HEALTHCARE COLD CHAIN BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com customers who want a critical medical supply to the stockists/dealers with a network of company owned branches across 40,000 pickup locations. The company has Airport Infrastructure to handle the increasing volumes in seven major Indian airports and expertise in handling 1000+ shipments per day just for the pharma industry. Addressing challenges The Indian pharmaceutical sector is highly fragmented and price sensitive, with Pharma cold chain logistics players in India ● Gati Kausar India- Haryana ● Snowman Logistics - Bengaluru ● Stellar Value Chain Solutions - Mumbai ● Future Supply Chain Solutions -Mumbai ● FleetX - Gurugram ● Gubba Cold Storage - Secunderabad ● DHL Express India - Mumbai Global healthcare cold chain logistics players ● Amerisource Bergen Corporation (World Courier) ● Deutsche Post DHL Group ● FedEx Corporation Services Inc. ● United Parcel Service of America Inc. ● Kuehne + Nagel International AG ● Cavalier Logistics Inc. ● DB Schenker ● Life ConEx ● American Airlines Cargo ● Continental Group ● Marken Ltd. Source: ResearchAndMarkets.com
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com POLICY 33 The medical devices sector was nothing short of thanking the government for the recently announced approved policy National Medical Devices Policy, 2023 by the Union Cabinet, chaired by Prime Minister Narendra Modi. The policy is expected to help the medical devices sector to grow from present $11 billion to $50 billion in next five years. It is being touted by experts in the medical devices sector as a positive step where the industry is likely to become Atmanirbhar which will help to make affordable high quality and safe medical devices accessible to the world. This Policy will be in addition to the existing Production Linked Incentive (PLI) schemes that are underway. Notably, till the recent 2023 Budget, the sector wasn’t all too pleased with the government’s position, as nothing substantial was announced for the sector. The sector had been seeking reforms since the past few years and ultimately it can now heave a sigh of relief. Key focus areas The current policy aims to put in place a comprehensive set of focus areas for the growth of the sector in a coordinated manner. The policy aims to bring a range of interventions in a coherent manner that would facilitate focussed and efficient support and facilitation for the sector by the respective agencies. The National Medical Devices Policy, 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation. This sector is expected to realise its full potential, with the strategies, including, building an enabling ecosystem for manufacturing along with a focus on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity building programmes and promoting higher education to foster talent and skilled resources in line with the industry requirements. Encouraging domestic Will NMD Policy Unleash Sector’s Full Potential? The National Medical Devices Policy, 2023 that got the approval of the government on April 26 seems to have made the medical devices sector happy. The slew of strategies mentioned in the policy assures a win–win outcome for the manufacturers as well as patients. Experts are upbeat about the projected growth of the sector in the near future. The policy aims to bring a range of interventions in a coherent manner that would facilitate focussed and efficient support and facilitation for the sector by the respective agencies. Let’s explore further. investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programmes. Ebullient industry Experts are content with the new policy announced with many mentioning that the move will unleash the sector’s full potential, facilitating the development of patient-centric solutions to meet evolving healthcare needs and making India a global leader in the manufacturing and innovation of medical devices. Veena Kohli, CEO, Vanguard, who previously served as the President of the Association of Diagnostics Manufacturers of India (ADMI), had the opportunity to submit recommendations regarding the challenges and growth opportunities for the Indian IVD industry to the concerned Parliamentary Standing Committees. She mentioned, “It is very encouraging to see that several of our inputs have been included and addressed in the recently released National Medical Devices Policy, 2023. The Indian IVD industry today, is at a point of inflection from where it could be catapulted to the next orbit of growth, quite like the IT industry of India post the year 2000 and the pharma industry after the global acceptance of generic formulations, in 1985. The policy encompasses all the necessary components to achieve Vision @2047. The policy’s focus on catalysing R&D and innovation will be pivotal to the growth of the sector and will help change these dynamics.” Going forward, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), who has been critical of the
34 POLICY BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com government’s initiatives for the sector hopes for the speedy implementation of the policy. He stated, “The Parliamentary Committee had recommended a separate law, separate department, tariff correction and price control and other measures which, if implemented, will give direct benefit to consumer and industry. If the government acts like a doctor, the patient will not remain in the ICU but will step out healthy and laugh from the ward itself.” Nath, however, raised the concern that consumers should reap the benefit from the policy. He goes on to add, “So far there is no restriction or capping on the MRP prices of medical devices from the government. Especially some private hospitals give the brand they want to the consumer of their own free will. Some hospitals are less concerned about the affordability needs of the patients and more concerned about their profit. They consume high MRP goods instead of low-cost options. Because of this, the manufacturer or importer in India is tied up in a system of market operating with artificially inflated MRP labelled on the device. We have been seeking a system whereby ethical manufacturers and importers can offer lowpriced MRP products and still, they can sell. We have been seeking MRP of imports to be monitored and compared with imports landed prices and steps taken to control when found irrationally excessive.” The newly laid policy will catalyse India’s emergence as a global hub for medical device manufacturing and innovation. This, according to Dr Sanjeev Relan, Chairman, Preventive Wear Manufacturers Association of India (PWMAI), will present a remarkable opportunity for collaboration between industry stakeholders, government bodies and healthcare professionals to collectively shape a future where advanced medical technologies are accessible, affordable, and seamlessly integrated into the healthcare ecosystem. Sharing his views, Jatin Mahajan, Secretary, Association of Diagnostic Manufacturers of India (ADMI) and MD, J Mitra & Company said, “The policy has several existing concerns. The most significant is the need for explicit provisions for training healthcare professionals and the end-users of these medical devices. This could result in mismanagement and incorrect usage, leading to potential health hazards, especially in rural and semi-urban regions with relatively low awareness and technical expertise. While stressing Salient Features of National Medical Devices Policy, 2023 The medical devices sector will be facilitated and guided through a set of strategies that will cover six broad areas of policy interventions: ● Regulatory Streamlining: To enhance ease of doing research and business and further balance patient safety with product innovation measures such as the creation of a Single Window Clearance System’ for Licensing of Medical Devices coopting all the stakeholder departments/organisations such as AERB, MeitY, DAHD, etc, enhancing the Role of Indian Standards like BIS and designing a coherent pricing regulation, will be followed. ● Enabling Infrastructure: The establishment and strengthening of large medical device parks, and clusters equipped with world-class common infrastructure facilities in proximity to economic zones with requisite logistics connectivity as envisioned under the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the ambit of PM Gati Shakti, would be pursued with the State Governments and Industry for better convergence and backward integration with medical device industry. ● Facilitating R&D and Innovation: The policy envisages promoting Research & Development in India and complements the Department’s proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector in India. It also aims at establishing Centres of Excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups. ● Attracting Investments in the Sector: Along with local manufacturing, the policy needs to provide a clear roadmap for technology transfer from global manufacturers. This lack of access to advanced technologies may hinder the production of high-end medical devices.” “Though we still have to go through the fine print, we are encouraged by the spotlight turned on R&D. While India has only 1.5 per cent of the global medical device market, it has an 8 per cent share of the MedTech R&D workforce already. This is a fertile and proven area to focus on,” said Pavan Choudary, Chairman, Medical Technology Association of India (MTaI). While praising the much-awaited policy Sachidanand Upadhyay, MD and CEO, Lords Mark Industries said, “The Indian government’s approval of the National Medical Devices Policy, 2023 is a significant move towards the growth and self-sufficiency of
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com POLICY 35 industry in India, make India self-sufficient and reduce import dependency to a large extent. We can expand both markets and exports, where one can hope to see exponential growth in the coming years to achieve Vision 2047.” The way forward In another recent development, the Department of Pharmaceuticals, government of India announced the scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF). The scheme aims to strengthen medical device clusters by providing financial assistance and strengthening and/or establishing more testing laboratories for medical devices to improve quality and sustainable growth. For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters, the limit of support will be 70 per cent of the approved project cost or Rs 20 crore, whichever is less, as per the approval of the Scheme Steering Committee (SSC). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs 20 crore per cluster or 90 per cent of the project cost of the CIF, whichever is less. While Medical Devices Parks, as planned clusters with shared common manufacturing and testing or warehousing and clearing facilities are being encouraged to help reduce the capital expenditure (CAPEX) of manufacturers, it is also important to strengthen the existing manufacturing natural clusters in different parts of the country. More so, Dr Manshukh Mandaviya, Union Health Minister, who was in Tokyo on May 16 to attract investments, while emphasising the crucial role of the medical devices sector in India’s healthcare industry, urged Japanese medical device manufacturers to take the advantage of the ‘Make in India’ initiative. Dr Mandaviya also projected a four-fold growth in the medical devices sector by 2030, from its current size of $11 billion. He stressed that India’s industry could emerge as a global leader in medical device manufacturing and innovation over the next 25 years, in line with India’s G20 Presidency aims. The policy has been announced with much fanfare and experts in this field are excited about it. With the new policy in place, the Centre aims to reduce India’s import dependence to nearly 30 per cent in the next couple of years; and become one of the top five global manufacturing hubs. However, the time frame of implementation of the policy will determine when the benefits accrued by the medical device players can ultimately be passed onto the consumers. Sanjiv Das [email protected] recent schemes and interventions like Make in India, Ayushman Bharat program, Heal-in-India, Start-up Mission, the policy encourages private investments, a series of funding from Venture Capitalists, and also Public-Private Partnership(PPP). ● Human Resources Development: To have a steady supply of skilled workforce across the value chain such as scientists, regulators, health experts, managers, technicians, etc., the policy envisages: ● For skilling, reskilling and upskilling of professionals in the medical device sector, we can leverage the available resources in the Ministry of Skill Development and Entrepreneurship ● The policy will support dedicated multidisciplinary courses for medical devices in existing institutions to ensure the availability of skilled manpower for futuristic medical technologies, high-end manufacturing and research, to produce future-ready MedTech human resources and to meet the evolving needs of the Sector ● To develop partnerships with foreign academic/ industry organisations to develop medical technologies to be at an equal pace with the world market. ● Brand Positioning and Awareness Creation: The policy envisages the creation of a dedicated Export Promotion Council for the sector under the Department which will be an enabler to deal with various market access issues: ● Initiate studies and projects for learning from best global practices of manufacturing and skilling systems to explore the feasibility of adapting such successful models in India. ● Promote more forums to bring together various stakeholders for sharing knowledge and build strong networks across the sector. the country’s medical devices sector. The policy is a comprehensive approach towards accelerating the growth of the medical devices sector in India.” Expressing his thoughts Dr G S K Velu, CMD, Trivitron & Joint Coordinator IVD (Diagnostic Vertical Group) AiMed opined, “We do hope this gives the necessary impetus to reduce import dependency in the medical devices sector and make India a global medical device manufacturing destination. If implemented along with a preference for buying locally made products, I am sure the medical devices sector will grow like the pharmaceuticals industry in the next 10 to 15 years.” In the same vein, Ganesh Sabat, CEO, Sahajanand Medical Technologies stated, “The domestic industry is optimistic that together in a PPP mode, we would be able to create an ecosystem for the holistic growth of overall healthcare
36 SPEAKING WITH BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com “There’s a need for bringing in technology to 70,000 hospitals in India” « Dileep Mangsuli, Development Centre Head, Siemens Healthineers With the National Medical Devices Policy 2023 receiving the government’s approval, the medtech industry players are further getting encouraged to make India the global manufacturing hub for medical devices. One such player is Germany-headquartered Siemens Healthineers, which has recently inaugurated a new manufacturing facility for Magnetic Resonance Imaging (MRI) machines in Bengaluru. The company has also recently laid the foundation stone for its new campus in Bengaluru, which is a part of its Rs 1,300 crore investment plan up to 2025. In conversation with BioSpectrum, Dileep Mangsuli, Development Centre Head, Siemens Healthineers shares more details about the company’s growth and hiring plans in the medtech sector. Edited excerpts How is Siemens Healthineers driving the Make in India Medtech transformation with the new MRI facility and campus? I’m a big believer in creating India as an innovation and healthcare hub for the world. There are definitely challenges out there. While we have fantastic tertiary care hospitals in all large cities, if you go to villages, healthcare is still not accessible. And affordability is still a challenge for many people. Although the government has taken a lot of steps in terms of building insurance schemes as well as providing the ability to get the right healthcare possibilities, challenges still exist. India has more than 70,000 hospitals, and many of these hospitals still do not have all the equipment that is needed to rightly diagnose any disease. There’s a need for bringing in technology to these hospitals. Another point is affordability, which is all about eliminating waste. Globally, the estimated numbers on healthcare waste in the US alone will be in the hundreds of billions of dollars through misdiagnosis and wrong treatments. If you consider global numbers, it will run into several trillion dollars. If that is eliminated, it will bring affordability. It also brings access to all the people and catches the disease early on, and that is what can change the world. That’s where several technologies can help in bringing up affordability, accessibility, and accuracy. With our new facility, the company will currently manufacture MAGNETOM Free.Star, a disruptively simple approach to high-quality MRI in India. The MAGNETOM Free.Star MRI, which is going to be a game changer for the country as well, is a 0.55 Tesla MRI, which is affordable from the cost perspective and accurate from the diagnosis perspective. And in terms of maintenance, it takes less than one litre of Helium. Typically, 1.5 tesla MRI requires 1000 litres of Helium. And this takes less than 1 litre. So, that is a big game changer. And this we will be making it in India. Then we have our C-arms, which are being made in India, and they are sold in 54 countries today. We are looking at expanding our manufacturing footprint also. We are already making computed tomography (CTs) in India for the local market as well as South Asian markets. We are going to be looking at more products in the coming years. We are building our new campus into a very large manufacturing site. Also, this will be our integrated site for manufacturing, Development Centre as well
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com SPEAKING WITH 37 as our headquarters function. This will be the largest campus of Siemens Healthineers outside Germany. So, we are not only looking at ‘Make in India’ for India, but we are looking at ‘Make in India’ for the world. With the new products being developed within India, for the world, are there specific disease areas or challenges being targeted, to improve the healthcare delivery in India? Our company came together with Varian, which is a cancer specialty company. We acquired Varian and today Varian and Siemens are one company. Varian is known for its ability to manage cancer from end to end from early detection, to therapy, to post-therapy management of patients. That is a strength that we find is very strong and very relevant for us. There are three diseases which are actually making the world today a challenging space- cancer, cardiovascular diseases, and stroke. India is the capital of these diseases. About a year and a half back, we came together, about 70 leaders of the company, to talk about what should we be doing for managing these diseases. Two things that emerged were that we need to really look at these three diseases as a growth vector and try to address technologies around that. Secondly, we need to look at the healthcare access part. For example, not every hospital has a great radiologist. I know of one hospital in the northern belt of Karnataka where there is only one doctor who looks through a lot of patients. He can’t see every scan. But with technology, a lot can change. But there are challenges such as skill set and funding which need to be addressed. Today, technology can be made available everywhere but the right skill that is required to interpret that technology is missing. The data that is shown by a lot of equipment or technology, needs someone to interpret it properly. Today, the US Food and Drug Administration (FDA) does not allow artificial intelligence (AI) to be used for interpretation. It can be used for verification, but you need to still interpret it. So, skill is a challenge. I think building skills is something that has to be of foremost importance for many of the companies to look at. We are focusing on that in a big way and also want to partner with the Indian Institute of Science (IISc), in building this. Are you hiring more skill sets for the new facility and campus, especially the PhDs in the life sciences sector? We have several doctors working here, several radiologists, people working on software and digital technologies, and many others who have a PhD. They come from the Indian Institute of Science (IISc) and the Indian Institutes of Technology (IITs). What we are looking at as a company is to make it into an innovation hub. It is not about what happens in those four walls of a building that we construct, but it is about what happens with the ecosystem around us, i.e. the academicians, large hospitals and startups. One thing that excites me about the ecosystem in India is that the hospitals are becoming even more open and more willing to work on research topics to co-create possible new workflows or a possible new way of treating cancer or a possible new way of identifying what is a better way of treating cancer. Yes, we are looking at growing the teams, bringing in technologists, and bringing in people who have a passion for healthcare. It is not only about technology, it’s about passion for changing the world. That is what we are looking at. Dr Manbeena Chawla [email protected] Today, technology can be made available everywhere but the right skill that is required to interpret that technology is missing. The data that is shown by a lot of equipment or technology, needs someone to interpret it properly. Today, the US FDA does not allow artificial intelligence (AI) to be used for interpretation. It can be used for verification, but you need to still interpret it. So, skill is a challenge.
38 SPEAKING WITH BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com “More needs to be done to provide a conducive ecosystem for API manufacturing in India” « Sanjeev Jain, Jt. Managing Director, Akums Drugs & Pharmaceuticals New Delhi-based contract drug manufacturing company Akums Drugs & Pharmaceuticals is all set to expand its presence and enhance its product range as it looks to more than double its turnover to Rs 10,000 crore by 2028, from the current level of Rs 4,000 crore. With 12 manufacturing plants and 3 API plants, the company is responsible for manufacturing approximately 12.5 per cent of all drugs consumed in India. Sanjeev Jain, Jt. Managing Director, Akums Drugs & Pharmaceuticals spoke in detail with BioSpectrum about the new initiatives being taken by the company. Edited excerpts What were the key highlights at Akums Drugs & Pharmaceuticals during FY 22-23? FY22-23 marked yet another year for Akums to consolidate its presence in the Indian pharmaceuticals contract manufacturing space. Akums increased its wallet share with leading Indian pharma companies; and added 250+ pharmaceutical and wellness companies to its clientele. The cosmetics and nutraceuticals space is attracting positive interest from consumers who are making considered choices on what they eat and how they look. During the fiscal, Akums received 74 new product approvals from the Drugs Controller General of India (DCGI) and 135 approvals from the Food Safety and Standards Authority of India (FSSAI). With this, as of March 31, 2023, the total DCGI product approvals with Akums stood at 929 and 696 FSSAI approvals. Akums invested significantly in growth capex during the year, including an oral liquid facility, a new penam block, and gummies. However, the highlight of the year was the receipt of EU-GMP for two of Akums facilities – oral solids (Plant 1) and sterile (Plant 3). Akums is now prepared to leverage its strengths by expanding into regulated markets. 2022 marked multiple collaborations with research institutions and industry partners across drugs, nutraceuticals, and cosmetics. The year also marked the first full year of operations for the API division. The vertical has taken off well and we expect to continue the momentum. Further, we undertook contract research projects for leading global players in regulated markets. Akums won several accolades including “Excellence in Operations – Manufacturing” at India Pharma Awards, Excellence in Formulations by Economic Times, and Excellence in Nutraceutical Category by IHW amongst others. What major plans are in store for 2023? What new initiatives are being taken by the company for its growth & expansion? Which new areas or verticals are you exploring? How much growth is expected this year? 2023 is an exciting year for us. The growth capex we did last fiscal will get operational this year. In addition, we will have an expansion of our exports and API business. Currently we are evaluating new opportunities and will do capex accordingly. We further aspire to consolidate our presence in the Indian contract development and manufacturing organisation (CDMO) space across dosage forms and therapeutic areas. We’ve expanded our business for oral liquids, gummies and penam. Are you planning new partnerships & investments this year, both domestic and international? The opportunity in the Indian contract manufacturing space is immense. With the enforcement of stricter quality and pharmacovigilance norms by the government., the sector is expected to witness rapid growth. We already did significant capex in the last 18 months
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com SPEAKING WITH 39 and plan to do more in the next 1-2 years as well. Additionally, we are looking to expand in areas we are currently not present, including lyophilised injectables, and further working on upcoming delivery formats in nutraceuticals and expansion capacities in production of injectables, oral solids, and liquids. At Akums, quality is the core of its operations. Armed with our highly skilled R&D team, we are constantly innovating and adopting international standards to stay relevant in the competitive market. The goal is to continually exceed quality expectations to remain a trusted brand in the industry. We are open to global and domestic partnerships across product development, product tech licensing and manufacturing. What are the challenges facing the contract research and manufacturing space in the pharma sector? How is Akums helping to address those? The contract manufacturing industry for pharma in the industry has gone through several challenges in the last three years. Supply and price volatility, margin pressures, and increased manufacturing costs have impacted the profitability of the industry. While Production Linked Incentive (PLI) schemes by the government are a welcome move, the industry expects more initiatives on research and development (R&D) and large-scale manufacturing of APIs. What are your views on harnessing India’s API potential and reducing API dependency? Are you satisfied with the government’s initiatives in this situation, for instance with new bulk drug parks coming up? India has enormous potential for active pharmaceutical ingredients (APIs) and key starting materials (KSMs) manufacturing to support domestic formulation manufacturing as well as for exports. It will help reduce the dependency on imports and bring in robustness to the supply chain. With the government’s “Make in India” initiative, PLI schemes, and the focus on setting up new bulk drug parks, we see encouraging steps toward achieving self-sufficiency in the pharmaceutical industry. While we appreciate the government’s efforts, we believe that more needs to be done to provide a conducive ecosystem for API manufacturing. The establishment of more supportive policies, funding, and infrastructure development is critical to enable API manufacturing to reach its full potential. We are committed to supporting the government’s initiatives in this regard and look forward to contributing to the growth of the Indian pharmaceutical industry. How is Akums exploring new technologies like robotics, AI, cloud to enhance the company’s operations? Is there enough skilled labour for this digital transformation in India? Digitalisation in manufacturing operations in Indian pharma is still in the nascent stages. We have taken steps forward to digitalise our Sales and Operations Planning (S&OP) across various functions. The industry is fast realising the benefits of new-age technologies with several service providers providing innovative solutions, catering to specifics of the pharmaceutical industry. The next 5 years would be interesting in this domain which will help in better production output, quality monitoring, cost-optimisation, and management decision-making. Dr Manbeena Chawla [email protected] India has enormous potential for active pharmaceutical ingredients (APIs) and key starting materials (KSMs) manufacturing to support domestic formulation manufacturing as well as for exports. It will help reduce the dependency on imports and bring in robustness to the supply chain. With the government’s “Make in India” initiative, Production Linked Incentive (PLI) schemes, and the focus on setting up new bulk drug parks, we see encouraging steps toward achieving self-sufficiency in the pharmaceutical industry.
40 SPEAKING WITH BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com “European regulators upgrade their compliances which is challenging for biosuppliers in India” « Dr Gangadhar M Warke, Founder, Chairman and Managing Director, HiMedia Laboratories On the verge of completing five decades in the biotechnology industry, Mumbaibased HiMedia Laboratories was one of the prominent players during the global fight against COVID-19. After overcoming all the challenges brought about by the pandemic on the nation and on the industry’s growth, the company is now set to venture out into new areas towards portfolio expansion and greater opportunities. During a detailed conversation with BioSpectrum, Dr Gangadhar M Warke, Founder, Chairman and Managing Director, HiMedia Laboratories talks about the company’s growth plans and the future of the Indian biotechnology sector. Edited excerpts: In the last two decades, HiMedia has diversified into 7 business divisions that include Microbiology, Cell Biology, and Molecular Biology. What new plans are in store for the company’s growth, and what are the revenue projections for FY 23-24? For the cell biology division, we are currently focusing on cutting-edge research and new product development for bioinks and bioscaffolds for 3D bioprinting; serum-free media for cultured meat, viral vaccine production platform, cell culture; biosimilars and monoclonal antibodies as anticancer therapy; multicompendial biochemicals; and automation. Our latest achievement has been the development of serum-free media for many applications and chemically defined serum- NuSeraTM for reducing the batch-to-batch variation and enabling consistency in the results. As a new initiative now, we provide Custom Testing Services for drug screening, cell line authentication, scaling up of cells, mycoplasma detection in cell lines, and bioproduction platform (spent media analysis, media development and media optimisation by scaling up). Alongside, we provide teaching and skill development modules for understanding regulatory affairs, in vitro culture, karyotyping, and cytogenetics. Our molecular biology division takes pride in becoming the One-Stop Shop for all the molecular biology products. Lately, we inaugurated an advanced sequencing and bioinformatics facility that provides services for Sequencing (Sanger and NGS for microbial identifications); Genotyping; Omics (Proteomics, Genomics, and Transcriptomics); and Bioinformatics. We have also developed indigenous solutions in complete forensics processes for humans and wildlife. This process involves novel IT software-based on Forensic Human Identification for the increasingly growing Forensics and Molecular Diagnostics Sector in India. We also have begun to provide teaching kits on the basic experiments of various life sciences fields. HiMedia also ventured into the microbiology services and training sector this year. Our microbiology division has started providing a wide range of services: microbial identification by MALDITOF MS, antimicrobial susceptibility testing, quality testing of disinfectants, bacterial endotoxin testing, strain development and improvement, customised media development, etc. We provide training courses for microbial counts, pathogen detection, environmental sampling, water testing, bioburden tests, etc. We have set up our own Gamma irradiation facility to facilitate sterilisation in-house. Revenue projections for FY 22-23 are around Rs 950 crore. Expected growth in new Fiscal year 23-24 is around 25 per cent taking our total revenue to Rs 1200 crore. We have also ventured into an ambitious agro-based project, which may boost the revenue further by approx. 60 per cent. Are you looking at new investments, facility expansions or partnerships to expand your business?
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com SPEAKING WITH 41 As a rapidly diversifying biotech company, we are looking for new investments. As HiMedia has expertise in different aspects of biotechnology, we want to convert this expertise into our service provision segment. As mentioned prior, we have expanded our portfolio by launching various Advanced Services in Microbiology, Molecular Biology, and Cell Biology. Any diversification needs additional capex for facility build-up and investing in advanced instruments and biological resources. We have invested about 10 per cent of the FY-21-22 profit in these new segments such as probiotic innovation facility at Nagpur, genome sequencing service, Maldi-TOF Mass Spectrometry (MS) services for identification of microbes, 3D bioprinting and Liquid chromatography–mass spectrometry (LCMS). We are also involved in partnering with academic or research institutions to develop new technologies or processes. Recently, we also got a tech transfer of diagnostic technology from Bhabha Atomic Research Centre. We are expanding facilities to increase production capacity and improve efficiency. This involves building new facilities, upgrading existing ones, implementing automation or other technological advancements. We are setting up a C-GMP manufacturing facility at Nashik with the capacity of 20 tonnes per batch of culture media. One of our recent projects revolves around drug repurposing to deal with genetic diseases like sickle cell anaemia. We are also venturing into pre-biotics, probiotics, and post-biotics for humans, livestock, and agricultural crops. We are also venturing into indigenous agar manufacture in collaboration with CSIR – Central Salt and Marine Chemicals Research Institute, Bhavnagar. What are your views on pushing the concept of ‘Make in India’ in the biotechnology sector? Since the inception of HiMedia in 1974, it has been practising ‘Make in India’ to build a strong substitute to the MNCs. We have been successful in many areas till now. ‘Make in India’ is a continuous process, and we are proud that we are part of this to make India stronger. As we know, India is among the top 12 destinations for biotechnology worldwide and 3rd largest destination for biotechnology in the Asia Pacific. In 2022, India’s Biotechnology industry crossed $80.12 billion, growing 14 per cent from the previous year. The Indian Bioeconomy has witnessed a many-fold increase in valuation in the past ten years; with COVID-19 giving the industry a much-needed push. For me, pushing the idea of ‘Make in India’ in biotechnology (encompassing Microbiology, Cell biology, Molecular biology and Plant tissue culture) field means making the Indian market a reliable source of various raw materials substituting foreign imports. What are the current challenges facing the biotechnology industry, and what is the way forward? The biotechnology industry faces several challenges, both technological and regulatory. European regulators upgrade their regulatory compliances every year and impose the same on all biosuppliers. These put challenges on biosuppliers and importers in India. Biotech companies often must navigate complex regulatory environments, especially when it comes to getting regulatory approval for their products. The regulatory process can be lengthy, expensive, and unpredictable. Moreover, biotech companies rely heavily on patents to protect their products and innovations. Biotech research and development can be extremely expensive, especially in areas like drug discovery and development. This makes it difficult for smaller companies to compete with larger companies that have more resources. To overcome these, biotech companies can either collaborate with each other or with academic and research institutions; to share resources, knowledge, and expertise. This can help to reduce costs and accelerate the pace of innovation. For example, we have been collaborating with two German partners in our Indo-German [IGSTC 2+2] project. ICT-Mumbai is our Indian academic partner. Moreover, biotech companies should continue to invest in research and development to stay ahead of the curve. By embracing new technologies and exploring new areas of research, companies can stay competitive and create new opportunities for growth. In India, government funding agencies are supporting such innovation through significant funding apart from private funding. Biotech companies can diversify their portfolios to reduce risk and increase revenue streams. This can involve expanding into new markets or developing products in different therapeutic areas. Overall, the biotechnology industry faces several challenges. However, by adopting a collaborative, innovative, and progressive approach, companies can overcome these challenges and continue to drive growth and innovation in the field. If we consider the past financial year, pharma exports declined to some extent due to various reasons. This affected HiMedia as well. We foresee that it will improve this year. Dr Manbeena Chawla [email protected]
42 CYBERSECURITY BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Why Pharma Industry Must Focus On Cybersecurity « Kush Kaushik, Co-Founder and Operations Lead, Scrut Automation The recent instances of cyberattacks experienced by some of the biggest names in the pharmaceutical industry have raised the alarm concerning the poor state of cybersecurity in the pharmaceutical industry in India. Hence, it is imperative to integrate a more robust cybersecurity infrastructure to support the foundation of the Indian pharmaceutical industry, which is predicted to develop in the coming years. The Indian pharmaceutical industry has grown by leaps and bounds in the past decade. The steady functioning of the large end-to-end network is governed by reliable data, which correctly reflects market requirements, both domestically and globally. Today, data, as the guiding light of the Indian pharmaceutical industry, demands to be protected and secured. However, the recent instances of cyberattacks experienced by some of the biggest names in the pharmaceutical industry, including Sun Pharma (hit by ALPHV Ransomware Group), All India Institutes of Medical Sciences (AIIMS) and Safdarjung Hospital, have raised the alarm concerning the poor state of cybersecurity in the pharmaceutical industry in India. Against the backdrop of the recent security breaches, the need for a robust cybersecurity infrastructure in the pharmaceutical industry has drawn the spotlight towards itself. Need for Cybersecurity As per data published by CyberPeace Foundation and Autobot Infosec Private Limited, the healthcare industry in India has been victim to 1.9 million cyberattacks till November 28, 2022. Sensitive information, including information on patented drugs, advances, technologies and even sensitive patient information, might be weaponised by the attackers, eroding customer trust and brand goodwill as a consequence. The need for a cybersecurity upgrade in various sections of the pharmaceutical industry is urgent. Fortunately, the stakeholders in the industry have registered the importance of such an upgrade and are rooting towards comprehensive cybersecurity solutions, which are also tailored to their needs. The points below further explain the key factors for the need for urgent cybersecurity upgrades in the pharmaceutical industry: Rapid Digitalisation Rapid upgrade through digitalisation is the norm in every sector. As the pharma industry keeps pace with emerging technologies like the Internet of Things (IoT), big data, cloud computing, artificial intelligence, machine learning, and blockchain, it faces new cybersecurity risks. Although these technologies hold considerable advantages, it’s vital for pharma companies to take into account their cybersecurity implications and implement suitable measures to mitigate potential risks. Increasing Awareness With the growing number of high-profile cyber attacks, the importance of cybersecurity is becoming increasingly evident to businesses in India. As a result, more companies recognise the need to invest in cybersecurity solutions to protect their assets and reputation. One of the best ways to bolster an organisation’s cybersecurity posture is via effective employee awareness and training programmes. Attackers frequently use phishing and social engineering tactics to exploit employees and gain unauthorised access to systems. Educating employees on cybersecurity best practices, including creating robust passwords, identifying suspicious emails, and reporting incidents promptly, is therefore crucial. Rising Cyber Threats The pharmaceutical industry is greatly prone to cyberattacks owing to its ownership of sensitive
BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com CYBERSECURITY 43 and valuable data, including data on clinical trials, research and development data, patents and intellectual properties. It also faces a range of cybersecurity threats, including ransomware attacks, phishing scams, malware infections, social engineering tactics, insider threats, and supply chain attacks. These attacks can result in data breaches, system downtime, critical data loss, and damage to the company’s reputation. Thus, investment in securing the cybersecurity ecosystem is the need of the hour. Regulatory Requirements The Indian healthcare industry is subjected to many regulatory requirements, which mandate implementing robust cybersecurity measures to protect personal data. In response to the rising cybersecurity challenges, the Indian government has introduced several cybersecurity regulations, including the National Cyber Security Policy, the Data Protection Bill, and the General Data Protection Regulation. These regulations set rigorous cybersecurity requirements and standards that companies must comply with to enhance their cybersecurity posture and avoid severe penalties. Cybersecurity Measures: The Way Forward While it is encouraging to see more companies in the pharmaceutical industry recognising the need for investment in cybersecurity solutions, a proactive approach is necessary. Collaborating with cybersecurity experts can help create and implement a comprehensive cybersecurity roadmap that mitigates potential risks, including financial losses, reputational damage, and legal penalties. Major industry players can also actively invest in preventive measures like multi-factor authentication, firewalls, and intrusion detection systems to create an impenetrable cybersecurity ecosystem. While multi-factor authentication requires multiple forms of identification for system access to reduce the risk of fraudulent activities, firewalls and intrusion detection systems are deployed to regulate network traffic, detect unusual activities, and alert administrators against potential cyberattacks and unauthorised access. Adopting a zero-trust approach and developing a clear roadmap (which around 70 per cent of pharma companies have used to get results in the next two years) is another method to secure data, networks, and access. This approach considers all users, devices, and applications as potential threats until proven otherwise, necessitating continuous monitoring and logging of all network activity. Pharma companies can also implement robust third-party risk management programmes that meet appropriate cybersecurity standards to minimise the risk associated with thirdparty vendors with access to sensitive data and systems. Effective incident response and business continuity plans are also essential to mitigate the impact of potential cyberattacks and ensure critical business functions can continue. Pharma companies can even incorporate effective incident response and business continuity plans to mitigate an attack’s impact. These plans should encompass procedures for detecting, containing, and remedying incidents, ensuring that critical business functions can continue even in the event of a disruption. Lastly, the pharmaceutical industry should recognise the importance of customised cybersecurity solutions tailored to their unique needs. In conclusion, it is imperative to integrate a more robust cybersecurity infrastructure to support the foundation of the Indian pharmaceutical industry, which is predicted to develop in the coming years. The use of cybersecurity in healthcare has significantly decreased during the past ten years. Unfortunately, rather than decreasing, these trends in healthcare cyberattacks are predicted to rise. Because they can directly impact both the security of systems and information as well as people’s health and safety, healthcare cyber attacks are particularly significant to the sector. Numerous cybersecurity problems in the healthcare sector plague the sector. These issues range from malware that endangers the security of systems and patient information to distributed denial-of-service (DDoS) assaults that limit hospitals’ ability to provide medical care. Despite the fact that other critical infrastructure sectors experience similar cyber attacks, the healthcare industry faces unique challenges because of the nature of its mission. Cyberattacks on the healthcare sector could have more severe repercussions than just financial damage and data breaches. Ransomware, for instance, is a particularly awful type of malware for hospitals since the loss of medical data can put lives in peril. Additionally, there are various cyberattacks in the healthcare industry. The most typical forms of cyberattacks in the healthcare industry are mentioned above.
44 ACADEMICS NEWS PEOPLE NEWS BIOSPECTRUM BIOSPECTRUM | | AUGUST 2021 JUNE 2023 | www.biospectrumindia.com | www.biospectrumindia.com THB, a leading Enterprise Healthcare SaaS company, has appointed Dr Chirag Adatia as the Chief Executive Officer (CEO) of India and South Asia. Akansh Khurana, Co-Founder of THB, has been appointed as the Managing Director (MD) and Group CEO. Dr Adatia, a doctor by education, joins THB from McKinsey, where he has spent over 15 years helping healthcare enterprises across topics, with a specific focus on growth and digital transformation. As a Partner at McKinsey, he handled the Digital Health and Sales & Marketing practice for healthcare, pharmaceuticals, and med-tech across Asian markets. As India CEO, Dr Adatia would be responsible for scaling the core business to its next orbit and establishing THB as the preferred revenue acceleration technology partner for leading healthcare enterprises across the country. THB onboards former McKinsey Partner Dr Chirag Adatia as CEO Mumbai-based B2B platform for healthcare procurement solutions, Medikabazaar, has appointed Vishal Chaturvedi as its Chief Technology Officer (CTO). Chaturvedi will work towards further scaling up current tech stack and focus towards developing newer technology products whilst continue to solve complex healthcare supply chain issues and leveraging digital monetisation for the company. Chaturvedi brings strong tech and business experience of close to two decades. An alumnus of the Massachusetts Institute of Technology (MIT) and the Indian Institute of Technology (IIT), he was previously associated with giants such as Samsung, Amazon, British Telecom, Jio and BlackBuck where he was last associated with. Founded in 2015 by Vivek Tiwari and Ketan Malkan, Medikabazaar is a digital platform that connects sellers with medical establishments for streamlined and cost-effective procurement. Medikabazaar appoints Vishal Chaturvedi as CTO Bengaluru-based Healthium Medtech, a global player in medical devices, focused on products in surgical, postsurgical & chronic care, has announced the appointment of Prashant Krishnan, an experienced leader and veteran in the medtech industry, as their new global business head for its advanced wound care and surgery portfolio. Krishnan joins Healthium after his stint at Medtronic. As Healthium expands its presence in India and beyond, Krishnan will continue to raise the bar in operational excellence and business growth. His appointment comes at a juncture when the company is strengthening its portfolio in advanced surgery, wound care, orthopaedics and post-surgical care through organic and inorganic routes. An industry veteran, Krishnan brings more than 27 years of experience and has an excellent track record of leading businesses across India, South Asia and the US in various leadership positions across surgery, cardiology and orthopaedics medical devices. Previously, Krishnan has been associated with companies like Medtronic, Johnson & Johnson, Godrej & Boyce and has delivered significant transformations for the businesses that he has led; his key role in working with Niti Aayog & USIBC for the ventilator project during the COVID period has been recognised globally. Healthium Medtech picks Prashant Krishnan to head Advanced Wound Care and Surgery biz
A team of researchers at the Indian Institute of Technology Madras (IIT-M) has developed a novel, non-invasive device to assess the health and age of blood vessels and thereby provide early screening for cardiovascular diseases. Called ARTSENS, it is designed such that it can be used in routine medical examination by even non-experts, to assess and predict vascular health. It is powered by a proprietary non-imaging probe and an intelligent computing platform and is developed by the Healthcare Technology Innovation Centre (HTIC) at IIT-M. The device has been assessed on more than 5,000 human subjects. The technology already has five utility patents in the US, European Union and India, 10 design patents and awaits awarding of 28 patents in various jurisdictions. The product is ready for technology transfer and commercialisation after extensive testing. The IIT-M team intends to deploy this to conduct over a million vascular screenings per year. ARTSENS has been approved for clinical studies in India, US, and Europe. IIT-M develops screening device to assess blood vessel health BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com R&D NEWS 45 IISc designs smart gel-based sheet for non-invasive nerve repair Scientists at the Institute of Advanced Study in Science and Technology (IASST), Guwahati, an autonomous institute of North-East India under the Department of Science and Technology, have fabricated monolayers of pure myelin basic protein (MBP), a major protein component of myelin sheath, which is a protective membrane that wraps around the axon of nerve cells and acts as a model protein in studying diseases like multiple sclerosis (MS). MBP helps in compactification of the myelin sheath, and the fabricated tailored monolayers can give an in-depth understanding of the role of MBP in forming multi-lamellar myelin sheath structure as well as preserving the integrity, stability, and compactness of the sheath. The research group used a technique called the Langmuir-Blodgett (LB) technique to form monolayers of pure myelin basic protein at the air-water and air-solid interfaces. The behaviour of the protein under variable pH conditions was investigated from different areas of the monolayer formed at the air-water interface. IASST fabricates protein to help study diseases like multiple sclerosis A new smart gel-based sheet using threedimensional (3D) printing technology, by researchers at the Indian Institute of Science (IISc) in Bengaluru, that can self-roll into a tube during surgery to form a nerve conduit could help reduce the complexity of surgeries and aid rapid healing of nerve injuries. The gold standard for the treatment of peripheral nerve injuries is still autografts. Bioresorbable polymerbased conduits are being explored for clinical use as alternatives. But these treatment strategies suffer from several limitations, such as donor site morbidity in the case of autografts and the necessity for sutures that demand highly skilled microsurgeries, and additional complications posed by sutures. The team at IISc worked closely with researchers at the Indian Institute of Technology at Roorkee and Maharishi Markandeshwar University to test the conduits for repairing and regenerating a 2 mm gap in the sciatic nerve of rats.
Guwahati develops new device for wearable sensors and POC testing Researchers from the Indian Institute of Technology, Delhi (IIT-D) have demonstrated a procedure for estimating the probability of infection of a healthy occupant when living in the same enclosed space as a COVID-19 infected person breathing out pathogens. This is one of the first demonstrations of estimating the likelihood of infection from a purely fluid dynamics perspective and considers the role of many occupants that affects the pathogen’s spread. Despite sufficient indications of its culpability, there has been a lack of data to quantify the role played by the breathing-out of pathogens in the spread of SARS-CoV-2 since the beginning of the COVID-19 pandemic. In this work, the researchers established the role of aerosol dispersion of the SARS-Cov-2 virus and similar airborne pathogens on the spread of the disease in indoor spaces. They performed realistic simulations of air flow in two representative IIT Delhi classrooms along with a large number of occupants. IIT-D researchers simulate risk of indoor COVID-19 transmission IIT-G designs programmable liquid marbles for controlled drug delivery 46 ACADEMICS NEWS R&D NEWS BIOSPECTRUM BIOSPECTRUM | | AUGUST 2021 JUNE 2023 | www.biospectrumindia.com | www.biospectrumindia.com A new flexible bio-electronic uric acid detecting device has been fabricated by the researchers from the Institute of Advanced Study in Science and Technology (IASST), Guwahati that can be used for various applications such as wearable sensors and pointof-care (POC) diagnostics. Uric acid is one of the most important antioxidants that maintain blood pressure stability and reduce oxidative stress in living beings. However, the fluctuation of uric acid levels due to the lack of balancing between the production and excretion causes several diseases like hyperuricemia, which in turn may lead to gout disease, type 2 diabetes, increase risk of cardiovascular diseases, Lesch–Nyhan syndrome, hypertension, and renal disorders. The fabricated device shows reversibility in interaction with the uric acid, which repeatedly enables the use of the device for sensing experiments. It outperforms all currently available ones in terms of effectiveness and cost because it doesn’t need any enzymes. The response of the fabricated device was investigated with real samples like human blood serum and artificial urine. The device thus developed is simple, portable, cost-effective, and easy to fabricate for detecting uric acid with a limit of about 0.809 µM. Researchers at the Indian Institute of Technology Guwahati (IIT-G) have developed liquid marbles using nano clay that can be preprogrammed for drug delivery and cascade chemical reactions. Conventionally, for treating any disease, we take medicines in the form of tablets, capsules, syrups, ointments, etc. A controlled drug delivery system is a more efficient technique to deliver the required dose at the specific site gradually over the desired period of time. Loading and release of drugs in its soluble form is another important aspect—which can be achieved with this liquid marble. The IIT-G team has used the liquid marbles approach for the controlled release of drugs and programmed chemical reactions. The team has engineered liquid marbles to have a ‘time bomb’ type release effect and to carry out a spontaneous chemical reaction. The nano clay marbles were made of a shell of nanoclay that holds the liquid. To programme the marbles for timed release of the content, the researchers modified the nanoclay with chemical groups that were either water-loving (hydrophilic) or water-hating (hydrophobic).
Merck has announced the launch of its Ultimus Single-Use Process Container Film, designed to provide extreme durability and leak resistance for single use assemblies used for bioprocessing liquid applications. Bag leaks have long been a top pain point for biomanufacturers, with the cost of a single leak ranging from €45,000 to €511,000. To protect against such leaks, abrasions, tears, and material fatigue, Ultimus film is designed with a proprietary woven nylon structure and provides enhanced bag strength, improved durability, and resilience. Maintaining the film’s integrity is crucial to ensure product quality, sterility, and reliable manufacturing operations in single-use bioprocessing. To achieve this, Ultimus film has undergone rigorous testing and demonstrated exceptional performance compared to the average results of five other singleuse bioprocessing films. This includes 10 times greater abrasion resistance, 2.8 times greater tensile strength, and twice as much puncture strength. Ultimus film provides an animal origin free contact resin that demonstrates a low extractable profile and supports healthy cell growth performance. Merck unveils Ultimus Film for leak resistance in single-use assemblies Qiagen launches QIAseq Targeted cfDNA Ultra Panels to advance cancer research Chinese firm Fapon Biotech Inc. has announced its innovative chemiluminescence onestop solution strategy at the 28th edition of Medical Fair India, in April 2023. Fapon chemiluminescence one-stop solution is designed to provide a complete range of chemiluminescence products and services, consisting of different levels of fully automatic chemiluminescence analysers with open system platforms, reagent development support, as well as high quality core raw material in bulk production. Fapon Biotech aims to help local in-vitro diagnostic (IVD) partners quickly extend their product portfolio and streamline their production processes, as well as accelerate their business in the chemiluminescence immunoassay industry. During the fair, Fapon Biotech showcased a series of high performance automatic chemiluminescence analysers: Shine i1000, the smallest fully automatic chemiluminescence immunoassay analyser, and Shine i2000, the compact yet robust and large capacity analyser. Fapon Biotech launches Chemiluminescence One-Stop Solution in India 48 SUPPLIERS NEWS BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Qiagen, a global provider of sample and assay technologies for molecular diagnostics, applied testing, academic and pharmaceutical research, has announced the launch of QIAseq Targeted cfDNA Ultra Panels that will enable researchers studying cancer and other diseases to turn cell-free DNA (cfDNA) liquid-biopsy samples into libraries ready for next-generation sequencing (NGS) in less than eight hours. The new kit adds another innovation to the QIAseq Targeted DNA product portfolio. Liquid biopsy centred on cfDNA has become a vital tool in the diagnosis, outcome prognosis and treatment monitoring of cancer and other diseases. The QIAseq Targeted cfDNA Ultra Panels enable reliable detection of somatic genetic variants in challenging detection scenarios as low as 0.1 per cent variant allele frequency (VAF) by enhanced chemistry, reduced enzymatic error rates, and an optimised bioinformatics pipeline.
Bio-Rad launches PTC Tempo 96 and PTC Tempo Deepwell Thermal Cyclers BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com SUPPLIERS NEWS 49 Bio-Rad Laboratories, a global leader in life science research and clinical diagnostic products, has launched PTC Tempo 96 and PTC Tempo Deepwell Thermal Cyclers, designed to optimise PCR applications such as sequencing, cloning, and genotyping. The PTC Tempo 96 and PTC Tempo Deepwell Thermal Cyclers are a new generation of conventional PCR thermal cyclers from Bio-Rad. The latest design is built with a refreshed, intuitive user interface and flexible connectivity features for streamlining protocol management. A motorised lid allows for automation compatibility and modern instrument control for workflows. The PTC Tempo Thermal Cycler is engineered to maintain superior thermal performance, delivering accurate results alongside the flexibility to expand and grow within the laboratory. These PCR instruments offer enhanced usability with features designed to support academic, commercial, and biopharma labs in conducting basic and translational research, process development and quality control. Agilent Technologies Inc. has announced the release of the Agilent 8697 Headspace Sampler -XL Tray with 120 vial capacity. Customers now have the choice of either 48 vial capacity, or an increased capacity of 120 vials through the new -XL Tray option. This new Agilent 8697 -XL Tray also includes the latest instrument intelligence features for increased uptime and operator ease-of-use compared to its predecessor, the 7697A Headspace Sampler. The 8697 Headspace Sampler -XL Tray includes instrument intelligence that eliminates downtime and increases efficiency by self-monitoring operation and guiding operators through dozens of troubleshooting and maintenance procedures—step-by-step, on the GC touch screen. The 8697 Headspace Sampler -XL Tray performs automated system checks, including leak checks, early maintenance feedback (EMF), and self-diagnostics to ensure the system is ready to run. The system also checks QC samples to provide the highest data quality and that samples will not need to be rerun. Adopting this new high-capacity sampler is quick and easy, requiring no method redevelopment or change in SOP from the earlier 7697A or 8697 Headspace Sampler models. Agilent expands family of Intelligent Gas Chromatography Systems Thermo Fisher partners with ALPCO-GeneProof to broaden CE-IVD molecular assay portfolio ALPCO-GeneProof, a global leader in diagnostics, and Thermo Fisher have announced a strategic partnership that brings the TaqPath Menu | GeneProof PCR kits to market. The partnership combines the strengths of ALPCO-GeneProof’s expertise in molecular diagnostics with Thermo Fisher’s robust supply chain and support systems. The portfolio to be delivered by Thermo Fisher is composed of 37 CE-IVD molecular diagnostic assays from ALPCO-GeneProof’s portfolio, built on its innovative “one workflow” technology allowing for ease of use and compatibility with a wide range of qPCR instruments. Thermo Fisher plans to release the TaqPath Menu | GeneProof PCR kits in phases beginning with a panel for bloodborne and sexually transmitted infections (STIs).
50 LET’S TALK HEALTH BIOSPECTRUM | JUNE 2023 | www.biospectrumindia.com Good Blood, Bad Blood While we know that blood transfusion can save many lives and improves health, many patients requiring transfusion do not have timely access to safe blood. Data reveals that of the 118.5 million blood donations collected globally, 40 per cent of these are collected in high-income countries, i.e. home to 16 per cent of the world’s population. In low-income countries, up to 54 per cent of blood transfusions are given to children under 5 years of age; whereas in high-income countries, the most frequently transfused patient group is over 60 years of age, accounting for up to 76 per cent of all transfusions. Besides the fact that there is a marked difference in the level of access to blood between low- and highincome countries, the major challenge lies within the unnecessary transfusions and unsafe transfusion practices that expose patients to the risk of serious adverse transfusion reactions and transfusiontransmissible infections such as HIV, hepatitis B, hepatitis C, syphilis, etc. The introduction of blood donor screening by virus nucleic acid amplification technology (NAT) took place in the mid to late 1990s that was driven by the so-called AIDS and hepatitis C virus epidemic, with thousands of recipients of infected blood products and components. Studies reveal that German transfusion centres were the first to start inhouse NAT testing of their donations in pools of up to 96 samples for hepatitis C virus (HCV), hepatitis B virus (HBV), and human immunodeficiency virus-1 (HIV-1). Years later, the global diagnostics industry provided commercial HCV and HIV-1 and later HBV NAT tests on automated platforms. NAT tests for HIV-2, hepatitis A virus, and Parvovirus B19 followed, again driven by transfusion centres with their in-house tests. Subsequent automation including sample preparation has significantly reduced the costs and complexity of the procedure and made it affordable to middle-income countries as well. Currently, more than 60 million donations per year are NAT-tested worldwide and the remaining residual risk of virus transmission by blood components and products could be reduced to almost zero. There are new technologies on the horizon like digital droplet PCR, next-generation sequencing, lab-on-a-chip, and digital antigen assays, which are comparably sensitive. As a result of which, the global blood screening market is expected to reach $4.6 billion by 2028, growing at a CAGR of 11.9 per cent from 2021 to 2028. However, each of these technologies has limitations, either in throughput, costs, automation, time to result, specificity, or the need for NAT as an integral part of the technology. At the same time, a more appropriate biosafety protection strategy can be used to prevent crosscontamination among samples and reduce biosafety risks. Accurate, fast, easy-to-use, real-time disease diagnosis technology is thus becoming the focus of research across the globe. Amidst these challenges lies another hurdle that NAT is not yet a mandatory test for screening blood units in India. According to a study published in the International Journal of Contemporary Medical Research in 2019, only around 2 per cent of blood banks in our country are carrying out NAT and approximately 7 per cent of all collected blood units are NAT tested. In particular, there are 2550 public and private blood banks in the country and only 58 blood banks are undertaking some type of NAT testing. Studies have also revealed that for the 58 blood banks that are doing NAT testing using different technologies, results from all of them are not in the public domain. The data shows that highly risky blood transfusions take place across India despite the availability of technology to provide safer alternatives. World Blood Donor Day, which falls on June 14, brings forth the challenges associated with the services providing safe blood and blood products as an essential element of the global healthcare system. Dr Manbeena Chawla Executive Editor [email protected]