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Vol 21; Issue 11; November 2023 4 BIO MAIL BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Scan QR code to access BioSpectrum India Digizine Acknowledgement/ Feedback Thanks a lot BioSpectrum for featuring my article on ‘Future of medical refrigeration’. It looks great! - Jesal Doshi, Mumbai Right intervention to delay the onset of diabetes and the related complication is key. Thank you for featuring a relevant story on diabetes. - Dr Uma Nambiar, Bengaluru Thank you BioSpectrum for the opportunity to speak on regulatory challenges that deep tech startups in India face, focusing on the recently enacted Digital Personal Data Protection Act and industry-academia linkage, during the webinar on ‘How AI is Revolutionising Drug Discovery’ organised by BioSpectrum India. And thank you for the excellent magazine feature in the November issue. - Reji K. Joseph, New Delhi Vol 21; Issue 12; December 2023 Publisher & Managing Editor: Ravindra Boratkar CEO Manasee Kurlekar [email protected] 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] Content Team: Singapore: Hithaishi C. Bhaskar [email protected] General Manager (Strategy and Marketing) Ankit Kankar [email protected] Social Media Communications: Poonam Bhosale [email protected] Operations and HR: Asmita Thakar [email protected] Production & Design: MM Activ Sci-Tech Communications Anil Walunj Subscription: Vipan Kumar [email protected] Circulation and Media Enquiry: Sudam Walekar [email protected] South Region Vrushti Kothari Business Development Executive “NITON”, No. 11/3, Block “C”, Second Floor, Palace Road, Bangalore, Karnataka- 560052 Mobile: +91-7798935660 [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 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 Apoorva Mahajan Marketing and Communication Specialist Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Baner Road, Pune-411045 Mobile: +91-7724025888 [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 General Manager (Strategy & Marketing) #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: +65 90150305 E-mail: [email protected]
Letter from Publisher Ravindra Boratkar Publisher & Managing Editor, MD, MM Activ Sci-Tech Communications Pvt. Ltd. Dear Readers, Synergy plays a key role in progress, growth and development. The Indian pharmaceutical sector seems to be on a tremendous growth trajectory, spurred on by this very synergy. No doubt the government has triggered various initiatives from the research perspective. But, added to that is the strategic initiatives like collaborations, investments, partnerships and MoUs by the managements of the pharma companies. Such strategic steps have even bypassed the negative effects of global challenges like Russia-Ukraine or Palestine-Israel conflicts and propelled the pharma sector’s rapid growth. Our content team has been tracking the progress of the pharma sector and the factors influencing its growth. As we come to the end of the calendar year, it became apparent that in 2023 alone over 30 important partnerships, MoUs and other collaborative initiatives have been forged. Major global and Indian pharma players are engaged in them, along with acquisitions, disinvestments and sales, to consolidate their financial growth. Some Indian companies are also eyeing the overseas market. Taking stock of all such developments, our content team is exploring whether, as projected, the Indian pharma product market will reach $130 billion by 2030. In healthcare, mental healthcare is a neglected area in several countries. When the need for mental healthcare soared post COVID-19, the mental health tech space globally, witnessed a 52.5 per cent decline in funding, from $1.5 billion in 2022 to $713 million in 2023. If compared to 2021, the decline is 79 per cent, from $3.43 billion. While it is going down, the increasing adoption of technology might give a boost to the mental healthcare sector in the coming months. Our content team has gone deeper to find out if Artificial Intelligence (AI) could further strengthen mental healthcare’s footprint. This issue has an article by an expert on an interesting and quite a different topic. It is related to pharma packaging and talks about the impact of attractive packaging in pharma. In addition, in an interview, Priyank Kharge, Minister of IT, BT, Karnataka, spoke at length about the state’s plan to come up with biotech accelerators to help startups scale up. Another interview is about the requirement of better and seamless interaction between industry and government for better economic growth. I’m sure this edition will be as interesting as the previous one. Happy reading. Thanks & Regards, Ravindra Boratkar Publisher & Managing Editor BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com 5 Looking for a job? See open roles at www.biospectrumjobs.com n Find Talent n Post Jobs n Attract Candidates Find the right people no matter what your hiring needs are... BIOSPECTRUM TALENT SOLUTIONS premier source of pharma healthcare & bio jobs
6 BIO CONTENT BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com COVER 20 COVER DESIGN BY: DOMINIX STRATEGIC DESIGN PVT. LTD. The Indian pharmaceutical industry is experiencing a dynamic growth landscape, marked by strategic initiatives such as partnerships, investments, Memoranda of Understanding (MoUs), and collaborations. Despite geopolitical uncertainties like the Israel-Palestine and RussiaUkraine conflicts lingering in 2023, the healthcare and pharma sector in India continues to gain momentum through new investments and collaborative efforts. Major global players are actively engaging in partnerships, MoUs, and collaborations to secure a substantial global market share. In 2023 alone, more than 30 partnerships, MoUs and other collaborations have been forged to boost India’s pharmaceutical growth trajectory. The Indian pharmaceutical products market is projected to hit $130 billion by the end of 2030. Let’s explore further. From Exponential Growth to PHARMA BOOM Mental Health 27 Can AI Significantly Improve Mental Healthcare? Speaking With 29 “Karnataka is coming up with biotech accelerators to help startups scale up” Priyank Kharge, Minister for IT & BT, Government of Karnataka
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com BIO CONTENT 7 Regulars BioMail ...........................................................................04 Letter from Publisher...................................................05 BioEdit ............................................................................08 Policy and Regulatory News.......................................10 Finance News................................................................12 Company News ............................................................13 Start-Up News...............................................................15 WHO News.....................................................................17 World News ...................................................................18 Academic News............................................................44 People News..................................................................45 R&D News ......................................................................46 Supplier News ...............................................................48 Let’s Talk Health............................................................50 Pharma Packaging 37 Impact of Artistic Packaging in Pharmaceuticals Nirupama Parate, Specialist I- Medicinal Products Division, Freyr Solutions Speaking With 30 “Govt is not extending support to SMEs dedicated to producing high-quality medicines that cater to the healthcare needs” Dr P V Appaji, Former Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil) 35 “The primary obstacle in reducing cancer mortality has been the absence of effective screening programmes” Dr Nitin Malekar, Director, Harae Dx Inc., California, USA 33 “We need seamless and quicker interactions between the industry and government for better economic growth” Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International Top Video BioSpectrum interacts with biotech industry experts on the Future of Healthcare Through Innovations at the Global Women’s Health Innovation Conference 2023. Scan the QR Code » Dr Amit Jaiswal, Associate Professor, School of Biosciences and Bioengineering, IIT Mandi, talks about reinventing implant safety with revolutionary antibacterial coating developed by his team Scan the QR Code » Cardiovascular Disease Can Cutting-edge Tech Reduce Rising CVD Burden? Neeraj Nitin Jadhav, Industry Analyst, Medical Devices and Imaging-TechVision, Frost and Sullivan 40
8 BIO EDIT BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com I ndia has recently proposed to Myanmar to set up a joint working group (JWG) to promote cooperation between the two countries in teaching and research of traditional systems of medicine. Dr Thet Khaing Win, Health Minister of Myanmar has reciprocated by promising all support for furthering cooperation. An MoU was signed by both the countries in New Delhi in August on cooperation in the field of traditional medicine when Myanmar’s Minister of State for Foreign Affairs, U Kyaw Tin visited India. A bilateral meeting was held in March 2023. India hosted the first B2B Global Conference & Expo on Traditional Medicine under Shanghai Cooperation Organisation (SCO) in Guwahati on March 2 wherein over 150 delegates from 17 SCO (4 virtually) countries and partners attended the conference. During the conference, Dr Thet Khaing Win said, “In Myanmar traditional medicines have been regarded as an invaluable national heritage, it has a significant role in our culture. With the increasing demand of traditional medicines we are supporting the development of traditional medicines in every aspect.” Recently in Myanmar, as a concrete gesture to move ahead in this direction, Vinay Kumar, Indian Ambassador to Myanmar, presented a set of books on the traditional medicine system to the health minister for the library of University of Traditional Medicine (UTM) at Mandale in October. India is proud of its over 5000-year-old Ayurveda and other traditional healthcare systems like Sidhha, Yunani, and Yoga. In its efforts to focus its attention and efforts on promoting the Indian traditional medicine systems, the government has created a separate Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy). After China and Japan, India holds the third-largest market share of Asia and ASEAN herbal medicines production. As in India, in Myanmar too, despite dramatic increase in use of modern medicines, traditional medicines play an important role due to various reasons including prohibitive cost and limited availability of modern medicines. There could also be reluctance to use modern medicines due to cultural differences and concerns over side effects. Hence, the Ambassador proposed to set up a JWG expeditiously to promote cooperation between the relevant institutions of the two countries. He also briefed the UTM faculty and students about Ayush scholarships and fellowships available in India. In August, India co-hosted with the World Health Organisation (WHO), the first WHO Traditional Medicine Global Summit in Gujarat. It also organised the Indo-ASEAN conference on traditional medicines in October in Delhi. A global conference on Ayurveda tourism was also organised in Kerala recently. India seems to be moving ahead in promoting its traditional medicine system and cooperating with the neighbouring countries in this direction at a crucial juncture. Experts observe that China has been using its 2015 initiative of Health Silk Road (HSR) for health diplomacy. Its declared objective is to generate ‘soft power and influence in the field of regional and global health governance,’ and to increase China’s ‘status as a major country’. It recently organised the 6th Belt and Road Forum for traditional Chinese medicine development, a sideline event held at China International Fair for Trade and Services (CIFTIS). Treatment camps of Traditional Chinese medicines (TCM) are being organised in Myanmar. The Returned Overseas Chinese Federation of Fujian Province and the Fujian General Chamber of Commerce in Myanmar established a charity clinic which provided free medical consultation, acupuncture and different TCM treatments. India can use its strength in traditional medicines to create a huge business across the world for herbal medicines, medicinal plants, other traditional drugs, etc. Therefore, such healthcare cooperation on traditional medicinal systems can be beneficial for both India and Myanmar, particularly when Indian medicines are still challenges breaking into the world market, despite the government’s efforts. Cooperating with Myanmar for joint research in traditional medicine, offering fellowships to students from Myanmar for research in Ayurveda, Siddha, among others, could prove fruitful & help in spreading Indian traditional medicines in the region. Dr Milind Kokje Chief Editor [email protected] Popularising Indian Traditional Medicine
The Biotechnology Industry Research Assistance Council (BIRAC), a Government of India enterprise, has partnered with WomenLift Health to launch a leadership development programme to empower women leaders working in Science, Technology, Engineering, and Mathematics (STEM) in India. The Women Leadership in STEM (WLS) programme, under the Grand Challenges India (GCI) initiative, aims to catalyse a systemic change towards gender equity in STEM leadership by investing in mid-career women professionals and providing them with the tools, networks, and mentorship needed to excel in their chosen fields. This part-time programme will bring together a cohort of 20 midcareer women leaders working in STEM institutions in India for three fully funded, five-day residential leadership workshops over the course of a year. The sessions have been designed, in collaboration with the Center for Creative Leadership, to support these women to realise their potential and grow as leaders and decision-makers as well as foster a strong network of champions and institutional partners. The WLS programme also includes a Leadership Project to address real-world challenges related to centering women and girls in STEM, catalysing institutional change, optimising pathways to leadership, building integrated & resilient health systems, & STEM innovation and policy in India. BIRAC announces women leadership in STEM programme 10 POLICY AND REGULATORY NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Godrej to provide strategic technical assistance to Maharashtra for malaria elimination Karnataka to accelerate lung cancer testing National Health Mission, Health & Family Welfare Services, Government of Karnataka has signed a Memorandum of Understanding (MoU) with AstraZeneca Pharma India to deploy Artificial Intelligence (AI) based lung cancer screening technology developed by Mumbai-based startup Qure.ai that will screen a patient for 29 lung diseases in one chest x-ray. This AI-powered chest X-ray system will help the government detect lung nodules, often precursors to lung cancer, in 19 district hospitals in Karnataka, overcoming a major early detection challenge. Hospitals where the technology will be deployed over the period of next 12 months are- District Hospitals at Bagalkote, Vijayapura, Dharwad, Gadag, Chkkaballapur, Chikkamagaluru, Chitradurga, Kalburgi, Ramanagaram, Tumkuru, Karwar, Udupi, Yadgiri, Haveri, Madikeri, Kolar, Koppal, Chigateri Hospital, Davanagere, Wenlock Hospital, Mangalore, K C General Hospital, Bengaluru. Godrej Consumer Products Limited (GCPL), along with Centre for Health research and Innovation (CHRI-PATH) and Family Health India (FH India) has entered into agreement with the Directorate of Health Services, Government of Maharashtra to support the government in malaria elimination, and dengue, chikungunya prevention and control programme. Malaria and other vector borne diseases are a major public health issue in Maharashtra which is a Category 2 state with most districts with an Annual Parasite Index (API) of less than 1 case per 1,000 population at risk but few districts that report an API of 1 or above. One such district is the eastern forest district of Gadchiroli with a high tribal population. The programme’s primary focus is to eliminate malaria, with particular attention given to Gadchiroli district. Additionally, the programme aims to control the rapid increase in dengue and chikungunya cases, focusing on the Thane-Palghar district. To achieve these goals, the support programme will appoint three state-level experts and 24 districtlevel human resources.
Centre launches global health innovation fellowship to promote medtech sector BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com POLICY AND REGULATORY NEWS 11 Union Minister for Science and Technology, Dr Jitendra Singh recently presided over the launch of the DBT and World Intellectual Property Organization (WIPO) supported Global Health Innovation Fellowship to promote medtech startups and innovators among youth. The Department of Biotechnology (DBT) and WIPO fellowships will be implemented in the DBT Bio-design centres at the Indian Institute of Technology (IIT) Delhi and All India Institute of Medical Sciences (AIIMS), New Delhi; IIT-B and Hinduja and Nanavati Hospital, Mumbai. WIPO has initiated a formal collaboration with the DBT to support four WIPO-supported Fellows to participate in the DBT Bio-design Programme. The partners received 157 applications from young professionals across the world including low- and middle-income countries. DBT has scaled up the Biodesign programme by twinning over 20 medical and technical institutions across the country and WIPO has recognised this programme for support under their Global Health challenges initiative. National Health Mission (NHM) Assam, in collaboration with Kamrup district authorities, has unveiled “Xushrukha” (meaning “Taking Care” in Assamese), an innovative 18-month research programme that will help reduce the rate of probable high-risk pregnancy (HRP) cases in the state. This first of its kind initiative in Assam, supported by the Piramal Foundation, is aimed at addressing and reducing high-risk pregnancies in the state, with a focus on the Chaygaon, Nagerbera, and Rangia blocks of Kamrup district. This research programme aims to assist state and district health authorities in reducing maternal mortality by proactively identifying and providing counselling for at-risk women in the eligible couple category. Approximately 1,26,000 women will participate in awareness sessions focused on adhering to the World Health Organization’s (WHO) recommendations for preconception care, ultimately enhancing their pregnancy experiences. NHM Assam to monitor high-risk pregnancy cases US FDA collaborates with Telangana Drug Control Administration In a significant development in the realm of pharmaceutical regulation, officials from the United States Food and Drug Administration (US FDA) recently paid a visit to the Drug Control Administration (DCA) of Telangana, located in Vengal Rao Nagar, Hyderabad. The meeting revolved around discussions on various initiatives aimed at ensuring the stringent implementation of regulatory standards to safeguard the quality and safety of drugs and medicines produced by the pharmaceutical, biotech, and related industries. Kamalasan Reddy, Director General, DCA disclosed that the US FDA authorities proposed the establishment of a ‘US FDA and Telangana DCA Regulatory Forum’ to foster future strategic collaboration and initiatives. The primary objective of this proposed regulatory forum would be to explore elements of observed inspections, with the intent to involve DCA Telangana inspectors as observers in US FDA-led inspections.
12 FINANCE NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com According to the Grant Thornton Bharat Pharma and Healthcare Dealtracker Report for Q3 2023, deal volumes and values decreased by 26 per cent and 14 per cent, respectively, compared to Q2 2023. The quarter saw 26 deals totalling $2.7 billion, with a 32 per cent decline in deal volumes compared to Q3 2022. Notably, the sector’s deal values surged by 298 per cent from Q3 2022, driven by two deals over $650 million each and four deals over $100 million each. Active Pharmaceutical Ingredients (API) and Contract Development and Manufacturing Organisation (CDMO) in the Life Sciences and Single Specialty in healthcare sectors emerged as focus segments with increased investor interest. The Mergers and Acquisitions (M&A) landscape in Q3 2023 exhibited a notable decrease of 50 per cent in deal volumes, hitting the lowest point for the year, with only eight transactions. However, the sector witnessed an unprecedented surge of 161 per cent in value. The standout transaction was Nirma’s acquisition of a 75 per cent stake in Glenmark Life Sciences for $689 million, accounting for more than half of the total M&A values for the quarter. Pharma and healthcare sector continue to attract investment despite volume dip in Q3 2023 Aragen, a Hyderabad-based Contract Research Development and Manufacturing Organisation (CRDMO) for small molecules and biologics, has announced that it is setting up a new biologics manufacturing facility in Bengaluru. The state-of-the-art facility is part of a $30 million investment, spanning nearly 160,000 sqm, and includes process development labs and multiple GMP manufacturing suites with supporting functions like quality control labs (analytical and microbiology). The manufacturing suites will be equipped for intensified processing using single-use bioreactors and advanced downstream purification capability to serve its rapidly expanding biologics customer base. The facility will offer integrated solutions from process development, process validation, analytical development, pilot production, large-scale drug substance (DS) manufacturing and stability services. It will have the capability to develop and manufacture monoclonal antibodies (mAbs), therapeutic proteins and fusion proteins to augment the company’s bioproduction capability in California, US. Ahmedabad-based Zydus Lifesciences, through its wholly owned subsidiary Zydus Pharmaceuticals UK Limited, has announced the acquisition of the UK headquartered LiqMeds Group of companies which has capabilities and specialisation in development, manufacturing and supply of oral liquid products for global markets, which it currently commercialises through partners. The group’s subsidiary LM Manufacturing Limited (LMML) has an oral liquids manufacturing site at Weedon, Northampton, UK, which supplies products to the US and UK markets. Zydus will pay an upfront consideration of GBP 68 million (Rs 688 crore approximately) and yearly earn-outs until 2026 depending on achievement of certain agreed milestones towards acquisition of the LiqMeds Group of companies. The transaction will be earnings per share (EPS) accretive for Zydus from the first year of acquisition. Zydus Lifesciences acquires UK-based LiqMeds Group for Rs 688 Cr Aragen to invest $30M for new bio-manufacturing site in India
Intas Pharma, Henlius Biotech strengthen oncology partnership for Europe & India BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com COMPANY NEWS 13 Ahmedabad-based firm Intas Pharmaceuticals has entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. for the development and commercialisation of serplulimab for Europe and India markets. Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius. It has been granted orphan drug designation by the US Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Small Cell Lung Cancer (SCLC). Its marketing application for the first-line treatment for extensivestage small cell lung cancer (ES-SCLC) is under review by the European Medicines Agency (EMA). This collaboration deepens the strategic partnership between the two companies and opens new development opportunities for serplulimab’s global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing, and supply upon launch. Serplulimab will be commercialised by Intas in India and by its subsidiary, Accord Healthcare in Europe. Lord’s Mark Biotech launches Tinefcon for psoriasis management Granules India, NIPER to establish CoE for sustainable pharma development Hyderabad-based pharmaceutical company Granules India and the National Institute of Pharmaceutical Education and Research (NIPER) in Mohali, Chandigarh have announced the signing of a Memorandum of Understanding (MoU) to establish Dr Chigurupati Centre of Excellence in Innovative and Sustainable Pharmaceutical Development (CCE-ISPD). This initiative aims to bring sustainability and innovation at the core of pharmaceutical research and development. The centre will focus on crucial areas such as exploring plantbased excipients, advancements in polymer-free pharmaceutical formulations, innovative methods in producing directly compressible crystals, promotion of solvent-free pharmaceutical processes, and the development of resourceefficient and energy-efficient pharmaceutical products. The collaboration will feature joint research initiatives, ensuring a seamless flow of knowledge between the industry and academia. Lord’s Mark Biotech, a subsidiary of Lord’s Mark Industries, has launched Tinefcon, a patented medicine for treating Psoriasis. Lord’s Mark Biotech has signed an exclusivity agreement with INVEX Health for the patented product developed by Piramal Life Sciences. Tinefcon is being launched as a total solution for Psoriasis in four forms such as tablet, cream, shower gel and scalp wash and is priced in the range of Rs 799 - Rs 3900. Lord’s Mark Biotech, the exclusive distribution partner for Tinefcon, is mentoring workers around the country through a scientific sales force exclusively recruited for Tinefcon to deliver a solution for Psoriasis. Lord’s Mark Biotech has invested Rs 20 crore to market and distribute it extensively in India, and the company is expecting a revenue of Rs 100 crore for Tinefcon by 2025.
14 COMPANY NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Kriya Medical receives manufacturing license for KRIVIDA Trivus Respi Panel RT-qPCR Kit Kriya Medical Technologies, a leading medical devices company headquartered in Chennai, has received its manufacturing license from the Central Drugs Standard Control Organization (CDSCO) for its product KRIVIDA Trivus Respi Panel RT-qPCR Kit, a first of its kind kit that has the unique capability to simultaneously identify Respiratory Syncytial Virus (RSV), Influenza viruses and SARS-CoV-2 in patients presenting with respiratory tract infections. KRIVIDA Trivus Respi Panel RT-qPCR kit has been validated by ICMR- National Institute of Virology, Pune, and the kit has shown 100 per cent specificity and 99.11 per cent sensitivity for the detection of all three viruses. A key feature of this kit is its ability to detect RSV, a virus that primarily causes viral pneumonia in children under the age of 5 and contributes significantly to hospitalisations. The Krivida Trivus Respi Panel RT-qPCR Kit also helps in early detection of influenza, thereby enabling the prompt initiation of specific antiviral medications. It is a valuable tool for improving diagnostic and infection control capacity. AstraZeneca Pharma India has inaugurated a dedicated Centre of Excellence (CoE) for severe asthma in Manipal Hospital, Goa. This state-of-the-art centre will serve as an exemplar hub for treatment and management of severe asthma patients, playing a crucial role in guiding and supporting evolving severe asthma centres. The centre will advocate a systematic and guidelines-based approach to identify and treat severe asthma patients. Asthma, a global concern affecting over 339 million people annually, with more than 15 million cases in India alone. Tropical cities like Goa, characterised by high humidity levels, frequently trigger asthma attacks in patients. Equipped with innovative technologies for asthma management, including biologics checklists and data-driven treatment approaches, the newly inaugurated CoE Goa is expected to screen approximately 7,500+ patients within the first 12 months. Piramal Pharma Solutions launches in vitro biology capabilities at Ahmedabad site AstraZeneca opens CoE at Manipal Hospital Goa for severe asthma patients Piramal Pharma Solutions (PPS), a leading pharmaceutical Contract Development and Manufacturing Organisation (CDMO), has officially announced the launching of a world-class highthroughput screening facility that augments existing in vitro biology capabilities at its Drug Discovery Services facility in Ahmedabad. This new expansion significantly increases the primary and secondary screening capabilities of compounds prepared at the Ahmedabad site. With this expansion, Piramal Pharma Solutions is uniquely positioned to provide its customers with an integrated set of discovery capabilities and leverage a broad range of in vitro screening technology tools to support its extensive portfolio of research services. The goal is to generate data that constitutes a superior data set for customers and increase the company’s value as an outsourcing partner. The benefits of this new investment will result in an improved experience for PPS discovery services customers. Integrating chemistry and biology services under one roof promises to increase the efficiency of the discovery process. To enable this expansion, PPS is recruiting experienced staff with a proven track record in biology services, to complement existing technical and operational expertise.
In a major boost to the Indian Electronics System Design and Manufacturing (ESDM) market, the Ministry of Electronics and Information Technology or MEITY’s Electropreneur Park (EP) has announced the exit of Univlabs, a Gurugram-based health-tech startup. UnivLabs Technologies has established its presence in 6 countries, offering innovative solutions to 2000+ hospitals in India and overseas. So far, the startup has applied for 11 patents while having 2 to its name. The startup received a valuation of Rs 20 crore and initiated an investor buyback from stakeholders of EP incubator worth Rs 94.64 lakh, marking a 36X growth for EP’s investment thereby marking a milestone in EP’s history. With this, UnivLabs’ successful exit leaves an impressive footprint of Electropreneur Park’s role in fostering innovation and entrepreneurship over the past seven years of its operations. UnivLabs vision is to become a leading company in the field of EndoVision in the next 10 years. The startup has developed a 4K Endoscope Tower and is in the advanced stage of developing a flexible endoscope. Molbio to collaborate with Niramai for AI-based non-invasive breast cancer solution Eyestem partners with RetinAI to innovate geographic atrophy clinical research MEITY’s Electropreneur Park announces financial exit for UnivLabs BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com STARUPS NEWS 15 Goa-based Molbio Diagnostics has announced the launch of a strong collaboration with Niramai Health Analytix, a Bengaluru-based deep-tech startup. This partnership aims to accelerate the adoption of Niramai’s innovative artificial intelligence (AI)-based non-invasive breast cancer screening solution in developing countries around the world. Portable point of care (POC) breast cancer screening solutions that enable efficient screening of large populations, especially in low-resource settings, is a critical healthcare need across many geographies today. Niramai’s Thermalytix can bridge these crucial gaps through its unique features. Through this collaboration, Molbio will promote and distribute Thermalytix in both public and private healthcare markets globally. The partnership builds on the strengths of the two companies to bring cuttingedge technology which would make high-quality diagnostics accessible to everyone. Eyestem Research, a Bengaluru-based biotechnology startup specialising in cell therapy approaches, has entered a strategic partnership with Ikerian AG and RetinAI Inc. in the US, a pioneer in clinical and imaging data management software and advanced artificial intelligence (AI)- driven analytics for ophthalmology. Leveraging RetinAI’s Discovery platform and AI tools will enable Eyestem to advance in its mission to revolutionise treatment for geographic atrophy with its innovative cell therapy, Eyecyte-RPE. Geographic atrophy, a late-stage form of dry agerelated macular degeneration (AMD), is a significant health concern worldwide. Currently, dry AMD affects 200 million individuals globally, contributing to irreversible vision loss. Compounded by an ageing population, the prevalence of this serious eye disease is escalating at an alarming rate. Eyestem is taking a significant step forward by preparing to initiate its Phase I/IIa clinical trials for EyecyteRPE. This multi-centre, dose escalation and expansion trial aims to assess Eyecyte-RPE’s safety and efficacy for geographic atrophy. This trial will benefit from RetinAI’s Discovery platform, which will centralise data management and image analysis for the study. Moreover, RetinAI’s advanced segmentation model will be leveraged for the identification and quantification of retinal biomarkers in geographic atrophy.
Bhubaneswar-based KIIT Technology Business Incubator (KIIT-TBI) has achieved an exceptional feat in IP commercialisation, by transferring two leading-edge technologies with support from the Biotechnology Industry Research Assistance Council (BIRAC) to Supriya Lifescience in Mumbai. Dr Swagatika Panda, a recipient of the prestigious BIG grant, has developed a game-changing Oral Cancer Screening Platform through her venture, Quickblue Oral Care. This technology promises early detection and prevention like never before, a potential lifesaver. The development of an oral cancer detection kit is in line with Supriya Lifescience’s vision of manufacturing niche products to meet unmet medical needs. On the other hand, Dr Ashok Sharon, another BIG Grantee from Birla Institute of Technology (BIT) Mesra, has unleashed an advanced Wound Care Therapy that can revolutionise wound treatment, speeding up healing and offering a ray of hope to countless patients. KIIT announces technology transfer of cancer diagnostic kit & wound therapy 16 STARUPS NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com ImmunoACT gets CDSCO approval for its CAR-T cell therapy for lymphoma and leukaemia Immunoadoptive Cell Therapy (ImmunoACT) has received marketing authorisation approval from the Central Drugs Standard Control Organization (CDSCO), for the first humanised CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product for relapsed / refractory (r/r) B-cell lymphomas and leukaemia in India. ImmunoACT is an Indian Institute of Technology (IIT) Bombay incubated company under the aegis of SINE (Society for Innovation and Entrepreneurship) and was founded in 2018. NexCAR19 is an indigenously developed CD19-targeted CAR-T cell therapy. It is the first-of-its-kind, a Madein-India product and puts the nation firmly on the world map of advanced celland-gene therapies. Hyderabad-based Laurus Labs has been the early backer of ImmunoACT and has invested over $18 million to support ImmunoACT to scale its R&D and commercialisation efforts. IIT-M develops intelligence platform on government funding schemes to boost startup sector Researchers from the Indian Institute of Technology Madras (IIT-M) at the Centre for Research on Startups and Risk Financing (CREST) have developed an ‘Intelligence Platform on Government Funding Schemes for Startups’ to boost the startup sector. Developed and implemented in partnership with YNOS, an IIT-M incubated startup, the government funding platform for startups brings together the entire spectrum of startup schemes from the government to the doorsteps of the entrepreneur. The platform has been developed based on several years of research and data collected by a team led by Prof. Thillai Rajan, Principal Investigator of CREST, and faculty, the Department of Management Studies, IIT-M. The portal will help entrepreneurs to get a comprehensive understanding of the government funding landscape for startups. The product integrates information on the various central government schemes, central public sector companies, and also that of various state governments. There are more than 100 different schemes by different agencies.
The World Health Organization (WHO), through its Department of Maternal, Newborn, Child, and Adolescent Health and Ageing (MCA), and the European Geriatric Medicine Society (EuGMS) have signed a three-year Memorandum of Understanding (MoU) to formalise a close collaboration and exchange aimed at improving care for healthy ageing. Under this MoU, the WHO and EuGMS will work together to raise awareness about the importance of reorienting health and social care services with the final goal of promoting the continuum of quality, integrated health and long-term care necessary for healthy ageing. In this context, they will also operate in synergy to build the capacities and skills of health and care workers on the principles of geriatric medicine and the WHO Integrated Care for Older People (ICOPE) approach. Through this MoU, the WHO will more closely interact with the many societies of geriatrics and gerontology active in the European region, finding in the EuGMS a unique partner for gathering information on the status of care for older persons in multiple countries. At the same time, the EuGMS will support the development and dissemination of improved care for healthy ageing. WHO inks MoU with European Geriatric Medicine Society The Health Sciences Authority (HSA), Singapore; the Ministry of Food and Drug Safety (MFDS), Republic of Korea; and the Swiss Agency for Therapeutic Products (Swissmedic), Switzerland are the first three countries to be listed as WHO-Listed Authorities. A WHO-Listed Authority (WLA) is a regulatory authority or a regional regulatory system which has been documented to comply with all the indicators and requirements specified by WHO for the requested scope of listing based on an established benchmarking and performance evaluation process. This represents a significant milestone for the Republic of Korea, Singapore and Switzerland, as the designation and public listing of MFDS, HSA and Swissmedic as WLAs, is a global recognition that these three regulatory authorities meet WHO and other internationally recognised regulatory standards and practices. HSA, MFDS, Swissmedic get global recognition with listings as WLAs The World Health Organization (WHO) calls on world leaders to increase political commitment and action to invest in the “One Health” approach to prevent and tackle common threats affecting the health and well-being of humans, animals, plants and the environment together. One Health is a proven approach to policy-making and crosssector collaboration to prevent zoonotic and vector-borne diseases from emerging and reemerging, ensuring food safety and maintaining sustainable food production; reducing antimicrobial-resistant infections; and addressing environmental issues to collectively improve human, animal and environmental health, among many other areas. It creates opportunities to mobilise the whole of society so that veterinarians, doctors, epidemiologists, public health practitioners, wildlife experts, community leaders, and people from different sectors can work together without silos to tackle major health threats. In addition to saving lives and promoting well-being, One Health actions offer huge economic benefits. The Food and Agriculture Organisation of the United Nations (FAO) and the World Bank estimate that One Health efforts could bring at least $37 billion per year back to the global community. World Health Organization urges investing in “One Health” actions for better health BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com WHO NEWS 17
World Bank provides $100M concessional loan to improve health system in Nepal The Government of Nepal and the World Bank have exchanged digitally-signed financing agreements for a $100 million concessional loan from the International Development Association and a $3.84 million grant from the Health Emergency Preparedness and Response Trust Fund to strengthen the quality, coverage, and resilience of Nepal’s health system. This is the first World Bank-financed project in Nepal that was digitally signed. The programme will be implemented by the Ministry of Health and Population in coordination with the Health Insurance Board at the federal level, and selected provincial and local levels in Koshi and Gandaki provinces. The programme emphasises improving the readiness of the health system for delivery of quality healthcare, enhancing coverage of health insurance, and strengthening health emergency preparedness and response capacity at the selected provincial and local levels. 18 WORLD NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com The World Health Organization (WHO) has announced elimination of visceral leishmaniasis as a public health problem by Bangladesh, and interruption of leprosy transmission by Maldives. Bangladesh has become the first country globally to be validated for elimination of visceral leishmaniasis or kala azar, a life-threatening neglected tropical disease. The country achieved the elimination target of less than one case per 10,000 population at the sub-district (upazilla) level in 2017 and has sustained it to date despite disruptions caused by the COVID-19 pandemic. On the other hand, Maldives is the first country to verify interruption of transmission of leprosy, having achieved the milestone of no child case detection for more than five consecutive years. In 2019 Maldives published a ‘Framework for Zero leprosy’ with clear milestones to reach leprosy elimination by 2030. An independent assessment team by WHO highlighted high political will and community motivation, along with strong health systems and minimal evidence of stigma and discrimination towards persons affected by leprosy, as the key factors for Maldives’ success. WHO to support universal health coverage programme in Pakistan Bangladesh eliminates visceral leishmaniasis, Maldives interrupts leprosy transmission The World Health Organization (WHO) has signed a Memorandum of Understanding (MoU) with the government of Pakistan to support the Universal Health Coverage Programme in the country. The WHO has committed to furthering its support by providing essential equipment and ambulances and facilitating the renovation of healthcare facilities, including both primary and secondary healthcare centres, along with the deployment of mobile units. Under the plan, the primary health care facilities would be computerised and equipped with around 70 modern facilities. The initiative is set to significantly enhance the accessibility and quality of healthcare services, reaching more than 90 per cent of primary healthcare facilities. This support will also contribute to the Sustainable Development Goals (SDGs) 3 for good health and also SDG 8 which is a decent work environment and economic growth.
The Netherlands commits €14 M towards pandemic preparedness The Netherlands Ministry of Health, Sports and Welfare has announced an additional EUR 14 million contribution to Norwaybased Coalition for Epidemic Preparedness Innovations (CEPI) to advance global vaccine R&D and manufacturing and better prepare for future epidemic and pandemic threats. The contribution was formalised at a signing ceremony held by Minister of Health, Welfare and Sports for the Netherlands, Ernst Kuipers, and Deputy CEO of CEPI, Frederik Kristensen, at the World Local Production Forum, a WHO event co-hosted by the Netherlands and Indonesia in The Hague. The increased investment, which builds on the initial EUR 50 million contribution from the Netherlands to CEPI in 2020, will enable Dutch and international researchers to accelerate their knowledge and scientific innovations gained during the COVID-19 pandemic and give the world a fighting shot of stopping the next pandemic, caused by an unknown or asyet-unidentified threat known as Disease X, in as little as 100 days. Spearheaded by CEPI and embraced by the G7, G20 and pharmaceutical companies, the 100 Days Mission seeks to develop new vaccines against future viral threats in a little more than three months, a third of the time it took to develop a COVID-19 vaccine. This is in direct alignment with the Dutch 2023-2030 Global Health Strategy which, through collaboration and innovation, seeks to provide a healthy world for all. Nigeria has introduced the human papillomavirus (HPV) vaccine into its routine immunisation system, aiming to reach 7.7 million girls. This is the largest number in a single round of HPV vaccination in the African region in a vaccination drive against the virus that causes nearly all cases of cervical cancer. A five-day mass vaccination campaign in schools and communities will be carried out during the inaugural rollout in 16 states and the Federal Capital Territory. The vaccine will then be incorporated in routine immunisation schedules within health facilities. The second phase of the vaccination introduction is set to start in May 2024 in 21 states. The vaccine is being provided for free by the Federal Ministry of Health through the National Primary Health Care Development Agency with support from Gavi, the Vaccine Alliance, United Nations Children’s Fund (UNICEF), World Health Organisation (WHO) and other partners. 31 life science firms jointly launch Alliance for mRNA Medicines Nigeria to vaccinate 7.7 M girls against cervical cancer 31 biotechnology, biopharma and life science companies and educational institutions at the forefront of mRNA and nextgeneration encoding RNA therapeutics and vaccine development have launched the Alliance for mRNA Medicines (AMM). AMM is the first and only scientific and policy organisation singularly focused on advancing and advocating for global mRNA innovation and the sector’s top policy priorities before legislative and regulatory bodies in North America, Europe and Asia. AMM’s founding members includeAcuitas Therapeutics; Akron Biotech; Arcturus Therapeutics; Australian National University; BioNTech; CSL; Curapath; CureVac; Cytiva; Cytonus; Danaher; De Novo Biotherapeutics; Etherna; Ethris ; Exothera; Ginkgo Bioworks; Johns Hopkins University; Maravai LifeSciences; MaxCyte; Mayo Clinic; MJH Life Sciences; Nutcracker Therapeutics; Precision for Medicine; Providence Therapeutics; Quantoom Biosciences; Replicate; Sail Biomedicines; Texas A&M Engineering Experiment Station; Vernal Biosciences; Verve Therapeutics; Why We Vax. BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com WORLD NEWS 19
The Indian pharmaceutical industry is experiencing a dynamic growth landscape, marked by strategic initiatives such as partnerships, investments, Memoranda of Understanding (MoUs), and collaborations. Despite geopolitical uncertainties like the Israel-Palestine and Russia-Ukraine conflicts lingering in 2023, the healthcare and pharma sector in India continues to gain momentum through new investments and collaborative efforts. Major global players are actively engaging in partnerships, MoUs, and collaborations to secure a substantial global market share. In 2023 alone, more than 30 partnerships, MoUs and other collaborations have been forged to boost India’s pharmaceutical growth trajectory. The Indian pharmaceutical products market is projected to hit $130 billion by the end of 2030. Let’s explore further. From Exponential Growth to PHARMA BOOM 20 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com I ndia is expected to remain one of the fastestgrowing major economies in the world due to robust domestic demand. The deal activity increased as the year progressed, with the life sciences and healthcare sector continuing to remain promising for further investments during the year. In Q1 2023, deals in the Mergers and Acquisition (M&A) and Private Equity (PE) space remained subdued. They are expected to improve in the latter part of the year. In the life sciences sector, the focus remained on acquiring products, licenses in regulated markets and building capacity in India, with an interest in contract development and manufacturing organisations (CDMO) and the active pharmaceutical ingredient (API) and biosimilar businesses. In the healthcare sector, health tech continues to account for a significant share of the volume of deals, according to the Grant Thornton Bharat dealtracker report for 2023. Compared to Q4 2022, while the volumes remained on par, Q1 2023 saw a 70 per cent decline in values owing to one marquee deal witnessed in the previous quarter (Q4 2022) – Biocon’s acquisition of Viatris Inc. valuing $3.3 billion, accounting for 88 per cent of M&A values for the quarter (Q4 2022).
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com COVER 21 “We expect deals to continue in the healthcare sector, although the volumes may be subdued. The key drivers for growth, such as increasing demand for healthcare services, growing adoption of new technology, digital health and sustained government support, are expected to remain in place.” - Bhanu Prakash Kalmath S J, Partner and Healthcare Services Industry Leader, Grant Thornton Bharat LLP Barring this deal, Q1 2023 saw a 50 per cent increase in values. The pharma and biotech segment accounted for 81 per cent of the values, for the last three quarters, across both the M&A and PE/ Venture Capital (VC) activity. The segment witnessed two top deals – Biocon’s acquisition of Viatris (Q4 2022) and Suven Pharma’s fundraising by Advent International (Q1 2023). Fuelled by an Aatmanirbhar Bharat push and growing preference for India-made pharmaceutical raw materials, the API sector remains in the spotlight. The PE firm Advent International has acquired 50.1 per cent of Suven Life Sciences Limited for $769.88 million to build a leading endto-end CDMO and merchant API player servicing the pharma and specialty chemical markets. TA Associates’ acquisition of Synokem Pharmaceuticals for $125 million also highlights the continued interest in the domestic market. Healthcare and life sciences witnessed a 17 per cent decline in deal volumes compared to Q2 2022. However, a few significant transactions led to a remarkable 146 per cent increase in deal values, from $1.3 billion in Q2 2022 to $3.1 billion in Q2 2023. There was an interest in PEs in Indian multispecialty hospitals. Temasek Holdings bought stakes in Manipal Health Enterprises from TPG Capital Management and National Infrastructure Investment Fund for $2 billion, marking the largest fundraiser in the sector in the last 13 years. In another notable transaction, Blackstone Group bought stakes in Quality CARE India Limited ─ Care Hospitals for $560 million, making it the third-largest fundraising ever recorded in India in the sector. Driven by these big-ticket investments, the PE activity reported a 158 per cent growth in deal values, taking the average ticket size from $32 million in Q2 2022 to $139 million in Q2 2023. However, the volumes declined by 41 per cent. The M&A activity reported a 60 per cent increase in deal volumes over Q2 2022, recording 16 deals. Deal values surged by 97 per cent to reach $487 million, resulting in an average ticket size of $30 million, compared to $25 million in Q2 2022. Serum Institute of India Ltd - Serum Institute Life Sciences bought a minority stake in Biocon Biologics Limited for $150 million, and IPCA Laboratories Limited acquired Unichem Laboratories Limited for $126 million, contributing around 57 per cent of overall M&A transactions. Bhanu Prakash Kalmath S J, Partner and Healthcare Services Industry Leader, Grant Thornton Bharat LLP, noted that the pharma and healthcare sector in India witnessed a few large M&A transactions in Q3 2023, indicating continued interest in the sector. However, the overall volumes declined by 26 per cent. The total value of the deals announced in Q3 2023 was over $2.7 billion, which reflects the positive sentiments from the investors. The API and CDMO segments in life sciences and single specialty in the healthcare sectors continue to be the focus segments for deals. This has led to a surge in investments in these segments, with several notable deals announced in Q3 2023,
22 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com aligning with our expectation that these segments will maintain momentum. There is a growing trend toward consolidation in the pharmaceutical sector, with pressure on margin. Additionally, the CDMO business is also attracting interest from both strategic investors and private equity funds. By volume, India is already the world’s third-largest pharmaceutical producer and the leading manufacturer of generic drugs. Bhanu Prakash Kalmath observed, “We expect deals to continue in the healthcare sector, although the volumes may be subdued. The key drivers for growth, such as increasing demand for healthcare services, growing adoption of new technology, digital health and sustained government support, are expected to remain in place.” Strategic Partnerships Leading Indian pharmaceutical companies, including Biocon, Advent International, Syngene, Eurofins, Foxx Life from the US, and Flanders from Belgium, are strategically involved in partnerships, acquisitions, sales, and divestments to consolidate their growth in 2023. Industry analysts highlight that companies like Dr. Reddy’s and Cipla are exploring opportunities in branded domestic assets or deals in emerging markets, while Sun Pharma is eyeing assets abroad. In a recent development, Biocon Biologics Limited, a subsidiary of Biocon Limited, based in Bengaluru, announced an agreement with Eris Life Sciences to divest its dermatology and nephrology branded formulations for Rs 3600 million. This move is expected to reduce debt and allow a focus on core biological therapeutics, with the deal set to conclude by the end of November 2023. International firm Advent International declared a $2 billion investment in Hyderabad’s Suven Pharmaceuticals on September 30, 2023, planning to establish its Cohance Lifesciences Platform in Genome Valley. This move follows the approval to acquire a 76.1 per cent stake in Suven Pharmaceuticals for Rs 9589 crore from the Union government. Syngene International Limited, a global contract research, development, and manufacturing services organisation, announced its expansion in the Genome Valley project in Hyderabad in September 2023. With an investment of Rs 788 crore, the company aims to provide 1000 jobs in the next five years Eurofins, a global leader in testing services, inaugurated its biopharma services centre in Genome Valley, Hyderabad, in partnership with Genome Valley, investing Rs150 crore in its second biopharma services campus in India. AG Poly Packs invested Rs 42 crore in a new facility in Himachal Pradesh, operational from June 2023, manufacturing flexible tubes for the cosmetic and pharmaceutical industries. Highlighting the conducive ecosystem provided by the Government of Telangana, Jayesh Ranjan, Principal Secretary of Industries and Information Technology, emphasised the importance of collaborations, partnerships, and MoUs for expanding the growth horizons of the pharma and healthcare sectors globally. The Government of Telangana collaborated with the Flanders region of Belgium in February 2023 to explore opportunities in the life sciences sector for its Pharma City Project. US-based Foxx Life Sciences also announced a Rs 200 crore investment in Hyderabad on February 27, 2023, to enhance pharmaceutical capabilities. Another firm, Surface Measurement Systems, a UK-based company, invested over $2 million in Particle Characterisation Laboratories Pvt Ltd (PCL) in Telangana in February, with plans to invest $3 million over the next three years. Eagle Genomics, a UK-based tech bio platform company, expanded its capabilities in Hyderabad and signed an MoU during the BioAsia 2023 event in February. In another strategic partnership, SGD Pharma and Corning announced a collaboration in February, attracting Rs 500 crore in investments to Telangana. This collaboration aims to bring cutting-edge technology to Mahabubnagar district, boosting innovation in the pharma packaging sector, with commercial production set to commence in 2024. In a significant development, Croda International Plc, an international company, inaugurated its Global FDI Flow in India Greenfield pharmaceutical undertakings in India permit 100 per cent foreign direct investment (FDI) through the automatic route. Brownfield pharmaceutical investments allow 100 per cent FDI, with 74 per cent under the automatic route and the remaining 26 per cent requiring approval from the Indian government. The cumulative FDI equity inflow into the drugs and pharmaceuticals industry in India from April 2000 to December 2022 was $21.22 billion, accounting for nearly 3 per cent of the total FDI inflow across all sectors. Major investors in India’s pharmaceutical industry include AstraZeneca, Dr. Reddy’s, GSK, Divi’s, Zydus, Novartis, Pfizer, Sun Pharma, Teva, Mylan, and Johnson & Johnson.
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com COVER 23 Technical Centre in Genome Valley, Hyderabad, in June 2023. Utilising smart science, the company focuses on creating high-performance ingredients and solutions to enhance lives. Croda International invests in developing advanced pharmaceutical ingredients and technologies for the life sciences sector. Additionally, the company has established a new Greenfield manufacturing plant in Dahej, Gujarat. In January 2023, Sun Pharmaceutical Industries Ltd agreed to acquire Concert Pharmaceuticals Inc. for $576 million, gaining access to the US company’s experimental drugs for treating skin diseases, including patchy hair loss. This strategic move is expected to bolster Sun Pharma’s global dermatology franchise, complementing its already robust specialty business in the US. Later during the year in September, Glenmark Pharmaceuticals finalised a deal with Nirma Limited, selling a 75 per cent stake in Glenmark Lifesciences at Rs 615 per share. Nirma, a detergent soap manufacturer, acquired the stake at an estimated enterprise value of Rs 7,500 crore. This transaction underscores the escalating investment interest in the healthcare and pharmaceutical industry, a rapidly growing global sector. Investor/Acquirer Investee/Target Deal Type Sub Sector USD mn stake% Advent International Suven Life Sciences Limited PE Pharma and biotech 770 50.1% Ta Associates Synokem Pharmaceuticals Ltd PE Pharma and biotech 125 N.A. Dr Reddy's Laboratories Ltd Mayne Pharma Group Limited - US prescription product portfolio Outbound acquisition Pharma and biotech 105 100% Kedaara Capital Sreyas Holistic Remedies Private Limited - Oliva Skin & Hair Clinic PE Hospitals 65 N.A. Alkem Laboratories Ltd, Eight Roads Ventures and F-Prime Capital. Enzene Biosciences Limited PE Pharma and biotech 50 N.A. Avataar Venture Partners, SIG Venture Capital, Lightspeed, JSW Ventures, Kalaari Capital and Chiratae Venture HealthPlix Technologies Pvt Ltd PE Health tech 22 N.A. Tata Capital Healthcare Fund Cellcure Cancer Centre Pvt Ltd - Mumbai Oncocare Centre PE Hospitals 10 N.A. India Alternatives Fund, Wipro Enterprises, RPG Ventures, Dharampal Satyapal Ltd, Alteria Capital and Fireside Ventures Gynoveda Femtech Private Limited PE Wellness 10 N.A. Morgan Stanley India Infrastructure - North Haven India Infrastructure Partners Athulya Assisted Living Pvt Ltd PE Homecare 9 N.A. 3one4 Capital, Accel, General Catalyst, Founder Bank Capital and Supermorpheus Aurogreen Health Pvt Ltd - Breathe Well-being PE Health tech 6 N.A. Stakeboat Capital Sukino Healthcare Solutions Pvt Ltd PE Homecare 6 N.A. Source: Grant Thornton Bharat Top Deals: Q1 2023 (Pharma and healthcare sector) Top deals accounted for 95% of PE deal values, constituting 28% of volumes
24 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Key MoUs The collaborative efforts between governments, private companies, academic, and research institutions have played a pivotal role in fostering the growth and expansion of the pharma sector in India. These MoUs, facilitating the exchange of knowledge, technology, and key materials, have led to a substantial increase in research and development spending by the top 10 pharma companies in India. Delhi Pharmaceutical Sciences and Research University (DPSRU) and Akums Drugs & Pharmaceuticals Limited (Akums) have entered into an agreement, collaborating to research and introduce novel products for Indian patients. This partnership aims to enhance pharmaceutical education and research opportunities for DPSRU students. The National Health Mission and the Karnataka Health & Family Welfare Services have signed an MoU with AstraZeneca Pharma India Ltd to deploy Artificial Intelligence (AI)-based lung cancer screening technology capable of screening a patient for 29 lung diseases in one chest X-ray. Boehringer Ingelheim India entered into an MoU with Pet Practitioners Association of Mumbai on September 22, to combat rabies in the Greater Mumbai area. The collaboration includes free vaccination camps, a donation of 30,000 doses of the anti-rabies vaccine Rabisin, and a month-long awareness drive. India and Saudi Arabia signed over two dozen MoUs on September 11, covering various sectors such as IT, agriculture, pharmaceuticals, petrochemicals, and human resources. The Maharashtra state health department signed an MoU with Boehringer Ingelheim India on June 22, to improve stroke care at government hospitals through Artificial Intelligence, including hands-on training for hospital staff. The Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Government of India, and Ministry of Health, Government of the Republic of Suriname, signed an MoU on June 4, aimed at extending cooperation in the field of Medical Product Regulation. The UK-based Centre for Process Innovation Limited (CPI) signed an MoU with India’s CSIR—National Chemical Laboratory in April to decarbonise the pharma industry. The Indian Pharmaceutical Alliance (IPA) signed an MoU with the Pharmacy Council of India (PCI) in June 2023 to provide industrial training to 300 teachers, building on their earlier agreement from May 2021. All these strategic business agreements and many more others pave the way ahead for laying a robust road map for further growth of the Pharma sector beyond 2023-24. Surge in R&D Investments Indian pharmaceutical powerhouses have demonstrated a remarkable commitment to innovation, as the top 10 leading companies in the sector collectively increased their Research and Development (R&D) spending by 7.6 per cent from 2022 to 2023. Sun Pharma Industries, a major generic manufacturer in India, notably allocated Rs 2368 crore towards R&D in the fiscal year 2022-23. This marked a significant uptick from the previous year’s investment of Rs 2,219 crore, aligning with their increased revenues of Rs 44,520 crore in 2022-23, compared to Rs 39,576 crore in 2021-22. In contrast, Aurobindo Pharma experienced a decrease in R&D spending, allocating Rs 1,412 crore in 2022-23, down from Rs 1,581 crore in 2021-22. Indian companies lead in US FDA approvals As of April 2023, India has secured the highest number of market authorisations granted by the US Food and Drug Administration (USFDA). Recent industry data reveals that Indian formulation companies obtained 6,316 market authorisations, surpassing other nations. Out of 107 First Time Generics authorisations, Indian-origin companies secured 41, highlighting the significance of the Indian drug industry globally. Ravi Uday Bhaskar, Director-General of the Pharmaceutical Export Promotion Council (Pharmexcil), emphasised India’s prominent position in the global pharmaceutical landscape.
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com COVER 25 Top Deals: Q2 2023 (Pharma and healthcare sector) Top deals accounted for 96% of overall deal values and constituted only 29% of volumes. Investor/ Acquirer Investee/ Target Deal Type Sub Sector USD mn Stake% Temasek Holdings Manipal Health Enterprises Pvt Ltd PE Hospitals 2,000 41% Blackstone Group Quality CARE India Limited - Care Hospitals PE Hospitals 560 70% Serum Institute of India LtdSerum Institute Life Sciences Biocon Biologics Ltd Domestic acquisition Pharma & Biotech 150 N.A. Ipca Laboratories Limited Unichem Laboratories Ltd Domestic acquisition Pharma & Biotech 126 33% ASG Hospital Pvt. Ltd. Vasan Eye Care Domestic acquisition Hospitals 64 100% LeapFrog Investments, Khosla Ventures, Unilever Ventures, Chiratae Ventures, Blume Ventures, HealthQuad, Finnfund and Van Lanschot Kempen HealthifyMe Wellness Pvt Ltd PE Wellness 30 N.A. Corona Remedies Pvt Ltd Sanofi India Limited’s- Myoril Domestic acquisition Pharma & Biotech 29 100% Fortis Healthcare Ltd Medeor Hospital Ltd - Manesar Domestic acquisition Hospitals 27 100% Sri Kavery Medical Care Pvt. LtdKauvery Hospital Fortis Healthcare Limited -Vadapalani in Chennai Domestic acquisition Hospitals 19 100% InvAscent - India Life Sciences Fund III Pregna International Ltd PE Pharma & Biotech 16 N.A However, their revenues demonstrated an upward trajectory, rising from Rs 23,456 crore to Rs 24,855 crore. Dr. Reddy’s Labs showcased a noteworthy increase in R&D expenditure, reaching Rs 1,938 crore in 2022-23 compared to Rs 1,748 crore the previous year. This correlated with revenue growth from Rs 21,139 crore to Rs 24,588 crore. Cipla also demonstrated a commitment to innovation by investing Rs 1,344 crore in R&D, up from Rs 1,122 crore, while witnessing a revenue shift from Rs 21,763 crore to Rs 22,753 crore. Other major players in the industry, including Zydus Lifesciences, Lupin, Glenmark Pharma, Alkem Labs, Biocon, and Torrent Pharma, similarly increased their R&D expenses, reinforcing their dedication to innovation and contributing to substantial revenue growth across the sector. Collectively, the R&D expenditure of these top 10 pharma companies surged to Rs 13,078 crore in 2022-23 from Rs 12,186 crore in 2021-22. This significant investment not only fuelled innovation but also led to a 7.6 per cent rise in total revenues, reaching Rs 195,557 crore in 2022-23 from Rs 176,717 crore in 2021-22. As of June 2023, the top 10 Indian pharma companies have witnessed a substantial 19.2 per cent increase in R&D expenditure, underscoring their unwavering commitment to innovation and advanced healthcare solutions. Sun Pharma Industries, in particular, significantly raised its R&D expenditure to Rs 668 crore in June 2023 from Rs 450 crore in June 2022, indicating a substantial leap in its dedication to research endeavours. In a notable trend, Aurobindo Pharma and Dr. Reddy’s Labs have both increased their R&D investments, allocating Rs 388 crore and Rs 498 crore, respectively. This showcases their unwavering dedication to pioneering pharmaceutical innovation. Cipla, Zydus Lifesciences, Lupin, Glenmark Pharma, Biocon, and Torrent Pharma have also intensified their R&D spending, symbolising a collective commitment to advancement and groundbreaking research within the industry. Overall, the cumulative R&D spend by these top 10 companies surged to Rs 3,452 crore in June 2023 from Rs 2,895 crore in the corresponding period of Source: Grant Thornton Bharat
26 COVER BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Top M&A deals : Q3 (Pharma and healthcare sector) Acquirer Target Sub Sector USD mn Deal Type %stake Domestic/ Cross -border Nirma Ltd Glenmark Life Sciences Ltd Pharma & biotech 689 Majority stake 75% Domestic Manipal Health Enterprises Ltd AMRI Hospitals Ltd Hospitals 280 Majority stake 84% Domestic IHH Healthcare BhdGleneagles Development Pvt Ltd Ravindranath GE Medical Associates Pvt Ltd Hospitals 90 Increasing stake to 100% N.A. Inbound Syngene International Ltd Stelis Biopharma Pvt Ltd's Bangalore manufacturing unit Pharma & biotech 86 Acquisition 100% Domestic Asia Healthcare Holdings Asian Institute of Nephrology and Urology Hospitals 73 Majority stake N.A. Domestic Top PE deals : Q3 (Pharma and healthcare sector) Investor Investee Sub Sector USD mn %stake BPEA EQT Indira IVF Hospital Pvt Ltd Hospitals 657 N.A. Temasek Holdings, TPG, Prosus, CDPQ, API Holdings Pvt Ltd - Axelia Solutions Pvt Ltd- Pharmeasy Health tech 244 N.A. Eight Roads, LGT, ADQ, Amansa, OrbiMed and angel investors Ind-Swift Laboratories Ltd' active pharmaceutical ingredients and contract research and manufacturing services business Pharma & biotech 201 N.A. Quadria Capital Maxivision Super Speciality Eye Hospital Hospitals 159 N.A. TPG Growth and Temasek Dr. Agarwal's Healthcare Ltd Hospitals 80 N.A. 2022, marking a substantial 19.2 per cent increase. Industry analysts assert that this remarkable upswing in investment reflects a collective effort to harness innovation, thereby driving the growth of the pharmaceutical sector. It ensures the development of superior healthcare solutions in the days ahead. Beyond 2023 India’s pharmaceutical industry is one of the leading global producers of cost-effective generic medicines and vaccines, supplying 20 per cent of the total global demand by volume and 60 per cent of the global demand for vaccines. With liberal foreign investment rules allowing 100 per cent FDI, the future of the industry appears promising. Currently ranked third globally for pharmaceutical production by volume and 14th by value, India has a well-established domestic pharmaceutical industry with around 3,000 drug companies and approximately 10,500 manufacturing units. The industry’s future trajectory is optimistic, with the Indian pharmaceutical products market projected to reach approximately $130 billion by the end of 2030. Concurrently, the global pharmaceutical products market is expected to surpass the $1 trillion mark by the end of 2023. The market share of the Indian pharmaceutical industry is currently valued at approximately $50 billion, with industry analysts projecting a compound annual growth rate (CAGR) of 10.7 per cent through 2030. The pharmaceutical market in India is anticipated to surge to $65 billion by 2024 and double by 2030, reaching $130 billion. India currently holds the second-largest share of the global biotech and pharmaceutical workforce. In conclusion, the pharmaceutical industry in India is abuzz with dynamic business strategies, including strategic partnerships, investments, new deals, and MoUs. These developments are not only shaping the industry’s future but also providing exposure to global markets. Amguth Raju Source: Grant Thornton Bharat Source: Grant Thornton Bharat
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com MENTAL HEALTH 27 I ndividuals and corporations across the globe are now cognizant of the importance of proper mental health in ensuring all-round wellbeing and steady development of the society. Over the past three years, mental health tech startups have helped in increasing the affordability and accessibility to mental healthcare. The World Federation of Mental Health had named the theme for the World Mental Health Day (WMHD) 2023, celebrated on October 10, as ‘Mental Health is a universal right’ and the startups innovating in this sector are playing a vital role in achieving this goal with the use of new technologies. As per a recent report by Tracxn Technologies, the global mental health tech space witnessed a peak in funding of $4.7 billion in 2021. Similar to other healthcare businesses, mental health startups saw a significant rise in demand in 2021 owing to the mental health issues brought on by the pandemic. However, the mental health tech space, globally, witnessed funding worth $713 million in 2023 yearto-date (YTD), exhibiting a decline in comparison to 2022 and 2021. This plunge in funding is primarily due to the ongoing economic slowdown and other macroeconomic factors affecting the cash flow globally. Can AI Significantly Improve Mental Healthcare? The evolution and expanding application of Artificial Intelligence (AI) in healthcare, and mental health in particular, has been profound in the past three years. The mental health tech space globally witnessed funding worth $713 million in 2023 year-to-date (YTD), a 52.5 per cent decline from $1.5 billion raised in the same period in 2022 and a 79 per cent decline from $3.43 billion in 2021. While the funding seems to be plummeting , the increasing use of technologies like artificial intelligence might have a boost lined up for mental healthcare in the coming months. Let’s delve deeper to find out if AI could further fortify mental healthcare’s footprint in a new realm. Most of the funding this year so far in this sector has come through late-stage investments, which stood at $340 million, a 35 per cent reduction compared to $527 million raised in the same period in 2022 and a decline of 85.8 per cent compared to $2.4 billion raised in the same period in 2021. Further, 2023 has witnessed 17 acquisitions till date, a drop of 22.7 per cent from 22 acquisitions in the same period in 2021. The numbers have remained consistent compared with 2022. At present, the US has the maximum number of companies in this space (2,360) followed by the UK (662) and India (429). “Beyond the monetary gains, investing in mental health startups can certainly garner profound societal benefits. By making mental healthcare more accessible and mainstream, the startups can be catalytic in busting the age-old myths and eradicating stigmas associated with mental health issues in India. On the home turf, traditional taboos around mental health are slowly being demolished. Additionally, the government and NGOs are becoming more proactive in addressing these issues, offering opportunities for startups to collaborate or receive support. In terms of customisation, artificial intelligence (AI) can analyse chunks of data throughput quickly. This
28 MENTAL HEALTH BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com means that AI-aided mental health solutions can potentially provide personalised feedback or therapeutic suggestions based on individual user data, thus enhancing the quality of care”, points out Ashutosh Kumar Jha, Chief Strategy Officer, Artemis Medicare Services. Tech tools & mental health Mental health teleconsultation and digital therapeutics for mental healthcare have been some of the top performing business models in 2023. For instance, teleconsultation has played a vital role in countries like India where there are 0.75 psychiatrists per 100,000 population which is significantly low compared to European countries like Germany with 27 per 100,000 inhabitants. Recent research by MIT’s Rosalind Picard and Massachusetts General Hospital’s Paola Pedrelli has shown that artificial intelligence (AI) can help reduce the rate of mental disorders. In fact, the use of technologies such as AI is greatly increasing the accessibility to mental health professionals and this sector can potentially see more investments going ahead as awareness rises among the masses. “By embracing AI, psychoanalysts are better equipped to concentrate on delivering direct patient care and doing in-depth research, which eventually improve patient outcomes, increase access to mental health services and augment general efficiency in the field,” comments Dr Malini Saba, psychologist, philanthropist, human rights activist, and the Founder and Chairman of Anannke Foundation. Sharing similar views, Dr Rahul Chawla, Neurology Department, All India Institute of Medical Sciences (AIIMS), New Delhi and an associate consultant in the neurology department of PSRI Hospital, Saket says, “AI tools use various mechanisms to diagnose matters of the mind and trace the alterations in behavioural patterns of the subjects under treatment, such as electronic health records, their activity on social media, and the use of search engines. Besides, there are mental health-specific questionnaires and mood-rating scales to help characterise and classify mental health illnesses, such as depression, bipolar disorders et al. If there are any red flags like suicidal ideation or possible attempts, thoughts and threats, the same can activate SOS alarms and send possible guidance. While most measures look effective on paper, in a practical sense, the majority of the tools are still in research phases. However, no FDA (Food and Drug Administration)-approved or FDA-cleared AI applications currently exist in psychiatry, as far as my knowledge goes.” It is often quizzed if AI can detect symptoms of neurological disorders before it is too late. Theoretically speaking, AI can help sift neurological disorders by scanning data obtained from patient files, dementia-screening questionnaires and even brain imaging. This could prove to be beneficial for patients suffering neurodegenerative conditions with progressive courses like dementia, namely Alzheimer’s disease or various forms of Parkinsonism. AI may also facilitate monitoring for compliance with and response to the treatment. Further, it can track changes in speech pattern, tremors and even limb stiffness in patients with parkinsonism through speech recognition and smart wearables. Futuristic element AI technology has so far been adopted by many Indian hospitals in their mental healthcare wings. AIIMS Delhi is designated as the Centre of Excellence for AI in healthcare. “There are actually many research projects running at AIIMS, Indian Council of Medical Research, Indian Institute of TechnologyDelhi, National Institute of Mental Health and Neuro-Sciences pertaining to mental health and AI. However, AI algorithms need validation in the real world setting. After all, these are all research projects, and their results and practical applications in the pragmatic world are yet to be viewed and verified,” cautions Dr Chawla. In contrast to humans, AI cannot read the human mind or thoughts. However, it may dissect data and decrypt patterns to draw conclusions or predictions about a person’s goals or his state of mind. Nevertheless, the application of AI into the field of mental health apparently has a bright future. AIdriven solutions will probably continue to develop and improve personalisation, accessibility and effectiveness of mental healthcare. “However, as AI technologies steadily make rapid advancements in this field, ethical issues, data protection and preserving the human connection in therapy will keep surfacing as primary focal points. Therefore, for AI to reach its optimal level of performance and maintain superlative standards of care, it is imperative to forge a partnership with the mental health practitioners,” believes Dr Saba. Pramita Bose
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com SPEAKING WITH 29 “Karnataka is coming up with biotech accelerators to help startups scale up” « Priyank Kharge, Minister for IT & BT, Government of Karnataka Biotechnology is a critical area of investment for the Karnataka government in the coming times as it plans to open Centres of Excellence (CoEs) in this sector. To find out more about the government’s focus on promoting the biotech sector, BioSpectrum spoke in detail with Priyank Kharge, Minister for IT & BT, Government of Karnataka. Edited excerpts: Karnataka is establishing CoEs for health science and medical devices. What is the strategy in place and how soon do we expect these establishments? Which are the industry partners in this project? Karnataka government is running the highest number of CoEs across sectors such as deep tech, IoT, cybersecurity, aerospace, and robotics, and now we are coming up with CoEs for health science and medical devices and also a circular economy lab, for all of which we wish to collaborate with ecosystems of countries from across the globe. By the end of this financial year, we would come up with probably India’s first life sciences and medical devices CoEs, to funnel the IT and biotech sectors together with one common infrastructure. We have many industry partners coming forward for this project such as GE Healthcare, Siemens Healthineers, Merck, GSK, Johnson & Johnson, and a few more companies that are working in the space of biotechnology, medical technology etc. The whole objective of these CoEs is to nurture talent, nurture leadership within the sector, provide incubation and ensure more innovations. This project will be directly linked with the Department of Health and Medical Education. Besides commercial products, we will also focus on research-based products. We have recently seen huge investments being made by global biotech/biopharma companies in Hyderabad with support from the government. How is Karnataka supporting the biotech/biopharma companies in a public-private partnership model, for better innovation & increased R&D investments? Hyderabad has a strong base in the pharmaceutical space with the presence of institutes like the National Institute of Pharmaceutical Education and Research (NIPER) while Karnataka has a better ecosystem for the biotech sector. We are upscaling the biotech sector with provisions like biofoundry and biobank. In the next 6 months, we will come up with biotech accelerators to help the startups scale-up, and make their products more viable. How do you view the role of deep tech startups for the growth of the biotech sector in India? Karnataka government has launched a deep tech cluster seed fund to nurture startups specialising in deep tech and artificial intelligence (AI). Also, Karnataka is set to introduce a preferential public procurement policy to enhance support for startups. Under this policy, the Karnataka government would be the primary customer, streamlining the purchase of products and services that possess distinctive intellectual property. For the biotech sector, we are pushing the industry’s priorities and preparing a framework to concentrate on the sector. The biotech sector is so vast and includes many newer areas such as genomics, longevity, drug discovery, pandemic preparedness etc. We need to eventually re-evaluate the priorities set by the industry, keeping in view what is best for the public at large. How is the government improving job opportunities and upskilling within the biotech sector? The Karnataka government has constituted a Skill Advisory Committee on Emerging Technologies which aims to contribute towards increased employability of graduates, larger and focused talent pool for companies as per their requirements. We want to produce most industry-employable candidates. We aim to engage with all the stakeholders in order to bridge the growing skill gaps between the industry requirement and Karnataka’s tech talent pool. Dr Manbeena Chawla [email protected]
30 SPEAKING WITH BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com “Govt is not extending support to SMEs dedicated to producing high-quality medicines that cater to the healthcare needs” « Dr P V Appaji, Former Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil) With five decades of experience in the industry, and also as one of the founder members of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), set up in Hyderabad in 2004, Dr P V Appaji served as the Director General (DG) of Pharmexcil from 2004 to 2016. During his term as DG, India witnessed the growth of pharma exports from $3.3 billion in 2003- 04 to $14.6 billion in 2012-13. In an interaction with BioSpectrum India Dr Appaji shares his views on the recent ‘Cough Syrup’ debacle and India’s dependence on excess imports of Active Pharmaceutical Ingredients (APIs) from China. Edited excerpts: How do you view the recent episode of Indian ‘Cough Syrup’ exported to some African countries, which killed small children after consuming it? Do you think our industry and regulators failed to meet the drug safety standards? The recent tragic incident involving cough syrup causing deaths of children in Gambia is a deeply unfortunate event. However, it is important to note that over 99.9 per cent of Indian pharmaceutical exports supplied to international markets adhere to rigorous and highly intricate international quality and safety standards. In the case of the recent cough syrup incident, it was not the drug itself that caused the fatalities but rather an excipient known as propylene glycol, commonly available in two forms: pharmaceutical grade and non-pharmaceutical commercial grade, the latter containing dangerous toxins that can harm the kidneys. The cough syrup in question was reported to have used non-pharmaceutical grade Ethylene Glycol and Diethylene Glycol. I believe the failure to detect this irregularity can be attributed to the manufacturer, testing chemists, and drug regulators. It seems they may have focused solely on the effects of the drug within the syrup and overlooked the impact of the excipient. It’s worth noting that such incidents have been reported in India in the 1970s, specifically in Maharashtra and Jammu & Kashmir, and even in the USA in the 1930s, where cough syrup toxins were linked to deaths. In India, the Lentin Commission was established to investigate cases of children’s deaths following the consumption of cough syrup, and it offered recommendations and suggestions. Despite these previous incidents, it appears that the development of Standard Operating Procedures (SOPs) was neglected. There were no alerts from regulatory authorities, manufacturing chemists, or quality control testing facilities regarding the dangers of these products. Furthermore, specific tests for the presence of ethylene glycol or diethylene glycol in finished cough syrup products were not prescribed. It appears that this issue was overlooked, and there was a lapse on the part of our regulators in identifying it. However, following this incident, the government has taken immediate steps to rectify these oversights, including conducting awareness programmes among regulators, industry professionals, and quality testing experts to ensure such issues are addressed in the future. Do you think that this incident has any impact on India’s pharma industry’s image and its exports in the international market? Definitely not, this incident is an isolated case. Recently I have been to the CPHI Barcelona conference. I had the opportunity to meet various pharma industry leaders there, and many are aware
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com SPEAKING WITH 31 of India’s capacity and capability as a quality global generic pharma manufacturer. They too identified this cough syrup incident as an isolated case and not many expressed their apprehensions on the overall capability of India’s pharma sector. However, as a responsible country, India needs to rectify the lapses and accordingly, even the regulators have taken steps to correct the gaps. The pharmacopoeia had identified and headed this issue. Regulators have also been alert. And even the Union Minister visited Hyderabad and conducted a brainstorming session with all stakeholders including leaders from National Pharma Industry Associations, Drugs Controller General of India and state Drug Controllers and key decisions were taken to further strengthen the drug regulatory system. As per the discussions, it is learnt that the government has decided to take up Risk Based Inspections regularly and accordingly will conduct inspections based on prior data, by testing sample collections and based on complaints and alerts indicated by regulators during the WHO GMP inspections. Overall, our regulatory system is further strengthened to ensure that all necessary quality and safety standards are followed during the manufacture of drugs and medicines in India. What steps have been taken to improve the bulk drug sector and reduce India’s dependence on excess imports of Active Pharmaceutical Ingredients (APIs) from China? Right from the beginning, the Government of India has been taking up various initiatives to support and extend a helping hand to lift the Indian pharmaceutical industry in the right direction. Particularly concerned with the issue of the industry’s excess dependence on imports of low-cost APIs from China, India has introduced the Production Linked Incentive (PLI) scheme recently. Earlier also many assistance programmes were implemented. However they did not yield much due to a lack of transparency. In the wake of this, the government of India has brought out a well thought of PLI Scheme. This scheme’s main aim is to strengthen our selfdependency and overcome the threat from our major competitor China. The government has recently published the revised PLI scheme and has come out with a proposal for supporting the production of 42 major identified products including APIs, Drug Intermediates and Fermentation products under the PLI scheme. For which the government has put aside Rs 15,000 crore budget to be spent over six years. The biggest tragedy for our country is the lack of domestic sourcing of fermentation products, which India and the whole world are heavily dependent on China. If China stops these key basic raw materials, not just India, the entire global pharma industry will starve. Keeping this in mind, India has taken bold steps in the form of PLI schemes to make the industry develop its strength and to stand on its own feet to compete with our major competitors like China in the coming days. Unlike earlier schemes to provide grants, the PLI scheme is very good, transparent and more accountable as incentives will be provided to the concerned manufacturer only if the promised quantification of said material is produced and based on this the central government will give the matching incentive to compensate the losses if any. Another big move by the government of India is the announcement of the setting up of three major bulk drug parks in the country with an outlay of Rs 1000 crore each for their development. Already foundations have been laid in Himachal Pradesh, Uttar Pradesh and the land acquisition process is under way for the bulk drug park in Andhra Pradesh. If the bulk drug parks are developed, the pharma industry will get support in the form of a common effluent treatment plant, continuous energy and power supply, low-cost land availability and adding to it the support of research-based incentives by the government that will revive India’s bulk drug sector and help it compete with big international competitors like China in the global markets.
32 SPEAKING WITH BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Why was India pushed into the turmoil of excess dependency on China for APIs, what went wrong that led Indian bulk drug companies to close down? The major reasons that led India to become over-dependent on China were the government’s policy decision to revise the pharmaceutical public sector units like IDPL, Hindustan Antibiotics Limited (HAL) and others. In the early 1950s, these PSUs supported by the government were able to meet the domestic API needs of the pharmaceutical sector. Unfortunately, due to some reason the Government of India revised its PSU policy and both IDPL and HAL closed down and following this, the government also decided to de-revise products like Pen-G and 6-ADA from the public list. I was also one of the people on the review panels of the policy decision. Later the government encouraged the private players to take up the responsibility of producing bulk drugs and invited them with their proposals. A few companies like Torrent Pharma, Themis and Madras Chemicals came forward, The Centre encouraged these companies and after analysing their technologies 3-4 companies with investments of Rs 150-300 crore, were given licenses to produce Penicillin-G and 6-APA bulk drugs which are important in the manufacture of vital antibiotic medicines. However, after a year or two, these companies reportedly faced intense competition from China. From $20 per kg in the open market, China continuously started reducing the price from $20 to $18 to $15 to $12 and now the APIs from China are sourced at as low as $5-8 per kg. Not able to face such intense international competition, these players again approached the Government of India for help, but the latter could not come to their rescue and they had no other option but to close down their units. That’s how our entire industry started sourcing APIs from China, and even today we are relying on China for all our major pharmaceutical needs. Now as times have changed, India realised its deficiencies and it wants our industry to reduce its dependence on China and has come out with handholding schemes like Production Linked Incentives (PLI) schemes, which are great initiatives to help our bulk drug sector become self-sustained to meet our future domestic and also the international needs. What kind of support do the SMEs in the pharma sector expect from the government? Small and Medium Enterprises (SMEs) within the pharmaceutical sector have been performing exceptionally well and significantly contributing to India’s exports. Regrettably, these SMEs have not been receiving the necessary support from the government. It is indeed paradoxical that the government, while allocating substantial funds for the welfare of the underprivileged, is not extending support to SMEs dedicated to producing highquality medicines that cater to the healthcare needs of these very citizens. If the government were to allocate at least 5-10 per cent of the amount it currently directs toward direct welfare programmes for the less fortunate to support SMEs, the Indian pharmaceutical industry could automatically align itself with international standards, matching countries adhering to the Pharmaceutical Inspection Convention (PICS), and also meet the requirements of the new World Health Organisation Good Manufacturing Practice regulations. Amguth Raju The major reasons that led India to become overdependent on China were the government’s policy decision to revise the pharmaceutical public sector units like IDPL, Hindustan Antibiotics Limited (HAL) and others. In the early 1950s, these PSUs supported by the government were able to meet the domestic API needs of the pharmaceutical sector. Unfortunately, due to some reason the Government of India revised its PSU policy and both IDPL and HAL closed down and following this, the government also decided to de-revise products like Pen-G and 6-ADA from the public list.
“We need seamless and quicker interactions between the industry and government for better economic growth” « Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International The first half performance in FY 23-24 at Rs 1718 crore for Bengaluru-based Syngene International was characterised by positive contributions from all divisions, as well as the achievement of several significant strategic goals namely the agreement to acquire the multimodal biologics facility from Stelis Biopharma; the purchase of a 17-acre land parcel in Genome Valley, Hyderabad, as an extension to the existing research campus; and the regulatory approval from the US Food and Drug Administration (FDA) for the commercial manufacturing facility in Mangalore. With continued growth at a lower level expected in the second half of the year, owing to temporary slowdown in US biotech funding, Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International interacted with BioSpectrum, unveiling the company’s growth plans for 2024 and beyond. Edited excerpts: Syngene has reported a strong set of results for the first half of the financial year. How would you sum up the key developments during FY 2023-24 so far? What more is in store for Syngene next year? I am pleased to report a strong set of results for the second quarter and first half of the financial year, particularly in our Development and Manufacturing Services. In Development Services, we also added a new non-GMP capability centre to meet market demand for agile, cost-efficient, early phase development and scale-up services. In Manufacturing, we made good progress on our long-term biologics partnership with Zoetis, as well as commissioning a state of the art, digitally-enabled Quality Control laboratory to support our growing biologics operations. The acquisition of a multimodal facility from Stelis Biopharma, announced last quarter, is progressing. Within research services, our Dedicated Centres made a steady contribution to growth and in Discovery Services, while global demand remained generally BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com SPEAKING WITH 33 healthy. We saw the US-based biotech segment showing signs of slowed growth year-on-year as companies adjust to a new funding environment. On the small molecule side, we have built a stateof-the-art facility in Mangalore. We have got a 40-acre site and we have developed about 25 per cent of that site which is up and running. It has passed its key US FDA regulatory inspection this year. That is a key milestone. So, we have got the infrastructure and the capacity now, and we need to build the business over the coming cycle, that is, the next three to five years. Regarding our extension in Hyderabad, scientific innovation does not happen in isolation: it is a multidimensional process and we have been able to make all the connections that we need at Genome Valley. Syngene started operations in Genome Valley in 2020 with the inauguration of our first research laboratory. Since then, we have gradually increased our presence encouraged by the good infrastructure and availability of scientific talent, which is ideal for fast-growing organisations like Syngene. In the last three years, our employee base has grown to over 900 scientists. In the next expansion phase, we plan to build worldclass research laboratories primarily focusing on drug discovery that will create up to another 1000 jobs. Speaking of the new job opportunities, is there a particular area of expertise that Syngene will be looking for? How soon would the recruitment and work start? I think the area of expertise will be research
34 SPEAKING WITH BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com focused predominantly, but it will cover all of the research disciplines, such as chemistry, biology, DMPK. It will grow as an integrated research centre rather than a single specialisation. We have got the capacity to create thousands of jobs. We just have to do that at the right rate and pace depending on market demand. The construction of the new facilities will begin in 2024, following the necessary statutory approvals. The company anticipates an investment of up to Rs 788 crore to develop the expanded campus in Genome Valley to its full potential, including the creation of up to 1000 jobs in science, in the next five years. It is a development site at the moment. It is a building project for approximately the next two years, but we do have capacity to grow already. Syngene has a presence in Hyderabad and Bengaluru, are you exploring any other city for your expansion in the future? No, not immediately. I would not rule it out, but if you look in India, we have got headroom for growth in Mangalore, we have got some headroom for growth in Bengaluru and then we have just acquired land in Hyderabad. In terms of India, beyond that, whether or not, if we see reason too, I think we may well open up operations in other regions of the world. How do you view the contract research/ manufacturing sector in India when compared to the global counterparts? What are the current challenges facing this sector in India? What are your expectations from the government to elevate the bioservices sector in India, in order to promote pharma innovation? There are many contract manufacturing organisations recognised in India, but they are sort of in the shadow of what is the world’s leading generics industry. But I think that is starting to change, and we are going to see a client-led acceleration in the demand for contract research, manufacturing and development services, and some of that is to do with learnings in the pandemic. The other element, of course, is a little bit of the geopolitics, particularly for Western side and I would say US based businesses to be more nuanced and balanced in their exposure to China. So I don’t see people coming away from China completely because there are some very good firms there that provide good services. But I do think it is a risk lens rather than a capability lens. It’s about not having everything in one place and therefore having more resilience built into your supply chain and that’s an opportunity for countries outside of that are not China and India is a strong contender there. But there are things that we have got to do and I think the Indian Government recognises this. If you look at some of their incentive programmes, some of their policies that the government is actively trying to promote, the creation of the sort of deep supply chain ecosystem that is needed if India is going to compete with and surpass China as a supply point. It is not just about the firms being able to do contract service, it is about integrated supply chain and ecosystem. Also, India has now become one of the most digitally enabled countries. We need more of that in business interactions with the governments. If you look at the regulatory environment, the Drugs Controller General of India (DCGI) is looking to really simplify and accelerate things, and more of the same would be good. The more seamless and quicker we can make those interactions, the more we can focus on our customers, the better we serve them, the more we grow, the better it is for the Indian economy. Dr Manbeena Chawla [email protected] There are many contract manufacturing organisations recognised in India, but they are sort of in the shadow of what is the world’s leading generics industry. But I think that is starting to change, and we are going to see a client-led acceleration in the demand for contract research, manufacturing and development services, and some of that is to do with learnings in the pandemic.
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com SPEAKING WITH 35 “The primary obstacle in reducing cancer mortality has been the absence of effective screening programmes” « Dr Nitin Malekar, Director, Harae Dx Inc., California, USA Headquartered in California, USA, Harae Dx, a medical diagnostics company, is all set to introduce the next generation Artificial Intelligence (AI) enabled automated multi-cancer early detection system in India, China and the US in a three years-time period. The company holds strategic patents in its core technology platform, and the development and manufacturing of the entire diagnostics system will be executed through strategic partnerships using an outsourced model. In an exclusive interview with BioSpectrum, Dr Nitin Malekar, Director, Harae Dx Inc., shared while talking about the market, the untapped market potential and the unmet medical need for early detection of cancers with the commonest and amongst the most challenging one being the Breast Cancer in females. Edited excerpts: What’s the burden scale of cancer and cancer testing in India and globally? Globally, cancer has surpassed its most formidable adversary cardiovascular diseases in killing more human beings as per a Lancet study. It surges ahead of the combined forces of AIDS, tuberculosis, and malaria, making it a critical global health concern. In cold, hard figures, cancer claims a staggering one in every six lives across the planet, as reported by the American Cancer Society. The current landscape of cancer testing is at a crossroads, predominantly reliant on imaging technology and surgical tissue biopsies. While these methods are formidable, they are not without their limitations. Imaging technology’s resolution is confined to detecting only larger tumours, often yielding inconclusive results. Surgical biopsies, while invaluable, are invasive and cannot be repeatedly administered throughout a patient’s care journey. The key to positive health outcomes hinges on timely and accurate diagnoses. In the quest to reduce cancer mortality, the primary obstacle has been the absence of effective screening programmes, exacerbated by mounting cost pressures within the healthcare system. The cancer biomarkers market, with a valuation of $10.9 billion in 2019, is projected to soar to $27 billion by 2027, boasting an impressive CAGR of 11.8 per cent from 2020 to 2027. These numbers paint a compelling picture of the rising demand for innovative diagnostic solutions that can transform healthcare. In India, the cost of a Liquid Biopsy Test ranges from Rs 23,000 to Rs 30,000, depending on various factors, including the specific markers screened and the testing laboratory. It’s a substantial investment for individuals and healthcare systems, and that’s where Harae Dx enters the scene with a revolutionary approach. Our Harae Dx system, ‘Nidaan Biolab,’ is a gamechanger in itself. It minimises the need for extensive human intervention, as lab technologists simply need to introduce a small blood sample onto a specially designed disposable disc. This disc is then placed into the automated Nidaan Biolab, which orchestrates the entire diagnostic process, swiftly delivering accurate results. Gone are the days of cumbersome and time-consuming manual testing, thanks to this technological marvel. We all understand the scourge of cancer, but as per your understanding how serious is the threat of cancer? While unveiling the Alarming Realities of Cancer, numbers have an uncanny way of shedding light on the gravity of a situation. And when it comes to the battle against cancer, they tell a story that demands our immediate attention. Delve deeper into the statistics, and the magnitude of the issue becomes even more apparent. Approximately 1,958,310 new cancer cases are anticipated worldwide, equating to a staggering 5,370 new cases each day. This is not a
36 SPEAKING WITH BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com battle waged by a few; it’s a global war that touches every corner of our world. Closer home, it is essential that we grasp the urgency of this narrative. Let’s focus our lens on India, where the cancer battlefront is becoming increasingly intense. Here, we anticipate a daunting 800,000 new cancer cases each year, which translates to a staggering 2,200 new cases every single day, according to the Indian Cancer Registry. The National Institutes of Health (NIH) data for 2022 reveals an estimated 1,461,427 new cancer cases, equivalent to 100.4 cases per 100,000 populations. Shockingly, one in nine people in India is destined to confront cancer in their lifetime. However, it’s crucial to emphasise the good news in this grim scenario. Many cancers are preventable if people make crucial lifestyle modifications and steer clear of habits that heighten their risk of this formidable disease. But cancer detection is done only in labs in hospitals and is available to less than 10 per cent of the world’s population which is the economically affording. The beacon of hope in this battle is to take screening/ detection up to the patient’s doorstep. The key is ‘Early & Easy Detection.’ It’s not just a matter of saving lives; it’s about saving invaluable resources, sparing individuals from costly treatments, surgeries, and diagnostics. The numbers may be staggering, but they also hold the key to a solution. We want to harness this knowledge to drive change, promote awareness, and save lives, by taking the lead in the fight against cancer, advocating for early detection, lifestyle modifications, and a brighter, healthier future for all. Where does India stand in early detection of cancer? The reality is stark and unsettling. A staggering 75 to 80 per cent of diagnosed patients confront advanced-stage disease upon diagnosis. It’s a crisis that demands immediate, forceful action. Early cancer detection is the need of the hour. India takes the lead in oral cavity cancer cases, with a shocking 119,992 reported cases, constituting 33.8 per cent of the global total (International Cancer Society). The nation also ranks second in breast cancer cases, with 162,468 (17.8 per cent), and cervix uteri cancers, with 96,922 cases (30.7 per cent) in the entire Asian subcontinent. In India, every four minutes, a woman faces a breast cancer diagnosis, making up a staggering 14 per cent of all tumours in Indian women. In this pressing context, the need for wellorganised Early Detection services at outpatient settings cannot be overstated. Every patient who walks into a hospital displaying early signs and symptoms should have seamless access to screening, diagnosis, and treatment. It’s a mission that requires continuous research and practical strategies to ensure early screening and detection services remain available, effectively reducing mortality rates across the population. COVID-19, while subsiding after two arduous years, has wreaked havoc on essential health services, not only in India but globally. Early cancer detection services have suffered significantly, with routine screenings plummeting in both developed and developing countries. Take an example of the largest cancer killing women across the world, which is, Breast Cancer. The standard of care for detecting breast cancer is either a physical exam or mammogram, which is available only to less than 10 per cent of the world’s population due to various reasons like cost, availability etc. Based on mammography (which is only 60 million mammograms), currently only 2.3 million women are found to have breast cancer and half of these women succumb to the disease. As we understand, there are over 1.6 billion women over the age of 40 (age with the highest probability of getting breast cancer). If we extrapolate this figure, the results can be terrible. Statistics for men are also unknown. The imperative of early cancer detection cannot be emphasised enough. It’s the linchpin to improving survival rates, diminishing mortality and morbidity, and alleviating the societal disease burden. Our foremost goal in screening programmes is to identify cancer at its nascent stages, particularly when individuals are asymptomatic or have a family history of the disease. Early detection not only boosts cure rates but also makes treatment more accessible, thus guiding doctors and patients toward optimal outcomes. Bhagwati Prasad
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com PHARMA PACKAGING 37 The pharmaceutical sector must stay at the forefront of cutting-edge packaging techniques as the market continues to change. Pharmaceutical firms may pave the way for a healthier and more connected future where packaging serves as a medium for improving lives and well-being in addition to being a container by placing a high priority on patient-centric care, regulatory compliance, and sustainability. Digital technology has revolutionised pharmaceutical packaging, reshaping labeling and artwork. This shift explores the profound impact of creative packaging on the pharmaceutical industry. It assesses the influence of digital innovations on the future of pharmaceutical packaging, encompassing interactive experiences and sustainability. Utilising QR codes, NFC tags, and augmented reality fosters patient engagement, education, and adherence. Personalised packaging enhances patient-centered care by customising pharmaceutical information. The industry grapples with regulatory demands while balancing compliance and aesthetics. The quest for eco-friendly materials aligns with social responsibility. The fusion of art and technology holds great potential for the future of pharmaceutical packaging, promoting better patient outcomes and a sustainable industry in the evolving technological landscape. The packaging that houses life-saving pharmaceuticals has experienced a remarkable shift in the fast-paced and ever-changing landscape of the pharmaceutical industry. The market for pharmaceutical packaging is anticipated to reach $156.12 billion in 2030, growing at a CAGR of 5.83 per cent from an estimated $105.01 billion in 2023. Labelling and artwork packaging developed as effective instruments for improving patient experiences, maintaining regulatory compliance, and encouraging sustainability. The global pharmaceutical industry’s growth is driven by rising demand and the increasing use of generic drugs in emerging markets. Additionally, innovative technologies have revitalised pharmaceutical packaging in the digital era, turning it into an interactive and personalised medium that fosters stronger connections between patients and their medications. As pharmaceutical businesses prioritise patient-centric care, packaging branding Impact of Artistic Packaging in Pharmaceuticals « Nirupama Parate, Specialist I- Medicinal Products Division, Freyr Solutions and artwork play an essential role in conveying trust, empathy, and transparency. Consistent branding increases brand recognition, while captivating artwork elicits emotional responses from patients, underlining the human element of healthcare. Furthermore, as the public’s understanding of environmental issues rises, the industry’s dedication to sustainability is reflected in eco-friendly materials and environmentally responsible package designs. Pharmaceutical firms are making significant progress toward a greener and more sustainable future by striking a balance between innovation and social responsibility. The Art of Attraction: Engaging Patients through Interactive Packaging The pharmaceutical industry continuously seeks innovative methods to engage patients and enhance medication adherence. Interactive packaging, achieved through augmented reality, QR codes, NFC tags, or interactive features, offers a more engaging experience compared to standard packaging. There are several benefits to using interactive packaging in the pharmaceutical industry.
38 PHARMA PACKAGING BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com There are several different ways to create interactive packaging for pharmaceuticals such as: Augmented reality: Overlaying digital content onto the real world through smartphones or tablets for interactive education and medication reminders. QR codes: Two-dimensional barcodes for smartphone access to various content, from medication info to coupons. NFC tags: Providing interactive information on smartphones, like dosage-related videos. Interactive packaging features: Such as peeloff stickers, hidden compartments, or puzzles, enhance patient engagement and packaging memorability. Overall, interactive packaging is a promising new way to engage patients and encourage them to take their medication as prescribed. This interactivity fosters a deeper connection between patients and their drugs, promoting medication adherence and patient education. Branding in Healthcare: Communicating Values through Artwork Healthcare branding is beyond logos; it’s about conveying principles to patients, providers, and the community. Artwork wields emotion, builds trust, and conveys beliefs. A hospital, for example, could employ nature artwork to communicate a sense of serenity and tranquillity. A cancer treatment centre may utilise flower or butterfly artwork to symbolise hope and rejuvenation. To demonstrate its dedication to the community, a mental health clinic may utilise artwork depicting individuals interacting with one another. The right artwork can help to create a positive impression of your organisation and make it more appealing to patients, providers, and the community. When choosing artwork for your healthcare branding, it’s important to consider the following factors: Personalised Packaging: A Prescription for Patient-Centric Care Personalised packaging is tailored to the individual patient’s needs, such as their medication regimen, dosage, and frequency of administration. This can help to improve patient compliance and adherence to their medication regimen. There are several benefits to using personalised packaging: Pharmaceutical companies use data analytics to create personalised packaging with patient-specific information, improving engagement and medication adherence. This personal touch empowers patients to manage their health proactively. Navigating Regulatory Challenges: Compliance and Innovation Hand in Hand Pharmaceutical packaging must adhere to legal standards, including clear labeling, tamper-evidence, and child resistance. Meeting these regulations can challenge healthcare companies’ innovation efforts. Yet, finding a balance between compliance and innovation is essential for creating packaging that meets both patient and healthcare practitioner needs. There are several ways for pharmaceutical companies Pharmaceutical packaging must adhere to legal standards, including clear labeling, tamper-evidence, and child resistance. Meeting these regulations can challenge healthcare companies’ innovation efforts. Yet, finding a balance between compliance and innovation is essential for creating packaging that meets both patient and healthcare practitioner needs. There are several ways for pharmaceutical companies to balance compliance with innovation in pharma packaging. One way is to work closely with regulatory agencies to understand the requirements and to get feedback on new packaging concepts. Another way is to use new technologies and materials that can help meet regulatory requirements while also providing new features and benefits.
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com PHARMA PACKAGING 39 to balance compliance with innovation in pharma packaging. One way is to work closely with regulatory agencies to understand the requirements and to get feedback on new packaging concepts. Another way is to use new technologies and materials that can help meet regulatory requirements while also providing new features and benefits. Sustainability and Responsible Packaging: A Pillar of Social Responsibility Pharmaceutical companies, renowned for lifesaving work, are now committed to environmental conservation. They are rethinking packaging methods to adopt sustainable alternatives, aligning with increased environmental awareness, escalating raw material costs, and the imperative to reduce waste, a demand shared by patients, healthcare providers, and regulators. There are several ways pharmaceutical companies can adopt to reduce their environmental impact: Here are some benefits of using sustainable and responsible packaging: Pharmaceutical companies display social responsibility through eco-friendly and sustainable packaging, benefiting the environment, healthcare costs, and patients. This aligns with the industry’s commitment to social responsibility and enhances its consumer reputation. The Future of Packaging: The Convergence of Art and Technology In the next decade, the pharmaceutical industry will witness major changes in primary packaging. These shifts will emphasise sustainability, greater adoption of smart packaging, personalisation, safety measures, and digital technology use. These changes aim to enhance supply chain efficiency, bolster patient safety, reduce waste, and mitigate the risk of counterfeit drugs. Increased use of smart packaging: RFID tags and sensors are poised to grow in the pharmaceutical industry, improving supply chain efficiency through real-time drug tracking and swiftly addressing issues like loss or theft. Smart packaging enhances patient safety with critical information, and these technologies, including RFID and security features, authenticate products and counter counterfeit medications. Greater emphasis on sustainability: Pharmaceutical firms will focus on sustainable packaging with eco-friendly materials, like bioplastics, and minimised designs to reduce waste, costs, and environmental impact. More personalised packaging: Technological advances allow patient-specific packaging with userfriendly features like larger text for older or disabled patients and tailored drug regimen instructions. More emphasis on safety features: To combat counterfeit drugs, pharmaceutical companies will prioritise tamper-evident packaging with advanced security features such as holograms, colour-shifting inks, and micro text to prevent replication. Greater use of digital technologies: AR, QR codes, and digital watermarks are on the rise in the pharmaceutical sector. They improve patient experience, offer critical information from packaging, enhance supply chain efficiency with real-time tracking, and reduce counterfeit medication risks through tamper-proof validation. Conclusion As the pharmaceutical landscape continues to evolve, the industry needs to remain at the forefront of innovative packaging practices. By prioritising patient-centric care, regulatory compliance, and sustainability, pharmaceutical companies can forge a path toward a healthier and more connected future, where packaging becomes not only a container but also a medium for enhancing lives and well-being. As the pharmaceutical landscape continues to evolve, the industry needs to remain at the forefront of innovative packaging practices. By prioritising patientcentric care, regulatory compliance, and sustainability, pharmaceutical companies can forge a path toward a healthier and more connected future, where packaging becomes not only a container but also a medium for enhancing lives and well-being.
40 CARDIOVASCULAR DISEASE BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Each year World Heart Day is observed to increase awareness about cardiovascular diseases (CVDs), after all defeating them is something that matters to every beating heart. CVDs are disorders of the heart and blood vessels and are often referred to as “silent killers” because most of the patients with underlying heart ailments do not exhibit any obvious symptoms. Development and deployment of cutting-edge technologies backed by requisite government policy support and direction will help in bolstering the fight against CVDs and thus improving the quality of the individuals’ heart and also their lives. Let’s take a closer look. I ndia is rapidly becoming the global CVDs epicentre which is primarily attributed to a mix of genetics, poor cultural practices and lifestyle factors among Indians such as increased trans fatty acids content in foods due to repeated use of cooking oil, unique pattern of atherogenic dyslipidaemia, consumption of processed and read-to eat foods, physical inactivity, obesity, high tobacco use, and increased stress levels that have contributed towards the increased prevalence of CVDs. According to the Lancet’s Global Burden of Disease study, India has an age-standardised CVD death rate of 282 per 100,000 population which is remarkably higher than the global average of 233 deaths per 100,000. The key to managing CVDs is early detection which can help identify the risk of cardiovascular diseases before it becomes too late. The industry is making tremendous efforts to reduce the disease burden, technology advancements in digital health and MedTech have enabled disease detection at an early stage, and also helped disease management of high-risk patients. Can Cutting-edge Tech Reduce Rising CVD Burden? « Neeraj Nitin Jadhav, Industry Analyst, Medical Devices and Imaging-TechVision, Frost and Sullivan Technologies such as artificial intelligence (AI)- based medical imaging analysis and precise screening solutions, continuous monitoring wearables and digital therapeutics have emerged as key enablers for the prevention and management of CVD in India. These technologies can play a vital role in lowering CVD risk and reducing the associated mortality rate which is especially important for a country that accounts for 60 per cent of the world’s disease burden. Some of these technologies to reduce cardiac disease burden are given below. AI-based medical imaging analysis and screening solutions AI-based medical imaging analysis solutions can precisely analyse and interpret cardiac-related abnormalities on medical imaging outputs including chest X-rays, computed tomography (CT) and ultrasounds. The AI algorithms in the solutions can quantify heart function, fluid buildup, valve anatomy, carotid artery stenosis grading, atherosclerotic plaque identification and characterisation which can help in the detection of CVDs such as heart failure, heart attack and stroke. These algorithms can rapidly process chest X-rays, CT and echocardiogram images within 60 seconds thus enabling early diagnosis of CVDs in the patients which can greatly
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com CARDIOVASCULAR DISEASE 41 enhance the chances of successful treatment in them. Furthermore, the AI algorithms can detect cardiac-related anomalies with high accuracy and are less prone to manual errors which can reduce misdiagnosis risk which is of paramount importance as delayed treatment can negatively affect health outcomes in the patients and also lead to potentially serious medico-legal consequences for the clinicians. Startups, such as Mumbai-based Qure.ai, have successfully deployed solutions for early detection of heart failure, heart attack and stroke. Furthermore, companies such as Aarthi Scans and Labs are leveraging AI-Rad Companion, a state-of-the-art CT coronary calcium scanning technology developed by Siemens Healthineers to detect early signs of coronary artery disease in patients. Besides CVDs detection, market participants have also developed AI-based screening solutions that leverage patients’ historical lifestyle attributes including smoking and tobacco preferences, psychological stress, anxiety, diet, and physical activity to predict the risk of CVDs among them. Apollo Hospitals, among India’s biggest hospital chains, has developed the Apollo AI-powered Cardiovascular Disease Risk tool that provides risk scores to the doctors based on all contributor factors allowing them to offer pre-emptive, proactive and preventive care for at-risk cardiac patients. Nonindustry bodies such as the Cardiological Society of India, are focusing on developing preventive cardiology solutions that use deep neural networks which can accurately identify patients who can potentially develop heart disease in the future. Wearable devices Continuous Remote Cardiac Monitoring Wearables including smartwatches have already gained popularity among individuals in India endeavouring to improve their physical fitness and overall well-being. However, the use of medical-grade wearables such as electrocardiogram (ECG) and cardiac patches and smart wearables including smart rings and smart bands for enabling 24x7 remote cardiac monitoring are also rapidly gaining traction in the country. These devices are equipped with an array of sensors including triaxial accelerometers, biomechanical, heart rate and rhythm sensors for monitoring physical activity, heart rate, electrocardiography, photoplethysmography, heart rate variability, cardiac output, blood pressure and heart rhythm measurement. The prominent advantage of these wearables is their ability to continuously track the above parameters, automatically detect cardiac anomalies using AI and share the data with the clinicians thus enabling them to detect underlying cardiac conditions and accordingly initiate early intervention and treatment. SmartCardia’s 7L Patch launched in India in August 2022, is a 7-Lead ECG patch that continuously monitors P-wave, QRS beat morphology along with vitals such as pulse rate, oxygen saturation and heart rate of the patient. The data is analysed by AI algorithms to detect cardiac arrhythmia events and accordingly, the information is transmitted in realtime to the cloud allowing the clinicians to make wellinformed decisions to prevent clinical deterioration in the patients. Impacting Lifestyle Choices Another benefit of the wearables is their ability to impact the individual’s lifestyle choices and overall well-being by providing insights and healthy recommendations about daily habits. These devices can track the physical activity levels of the user and accordingly provide gentle nudges if prolonged periods of inactivity are detected to break the individual’s sedentary habit. Furthermore, these devices also allow users to log in food intake and calorie consumption and subsequently provide insights about their dietary habits thus empowering them to make healthier choices and achieve their nutritional goals. India-based wearable companies such as boAt and Noise have launched smart rings that can monitor a range of health parameters of the user including heart rate, blood oxygen and physical activity levels and accordingly provide insights to the individual to help them live a healthier life. GOQii Technologies has launched GOQii Heart Care in India through which individuals using its GOQii tracker can share heart rate and other health data with
42 CARDIOVASCULAR DISEASE BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com cardiac specialists allowing them to provide specific nutrition advice and personalised coaching to the users to maintain good heart health. Digital therapeutics Digital therapeutics (DTx) uses evidence-based software that is clinically validated to prevent and manage chronic conditions including mental health, diabetes, and CVDs. In India, DTx are increasingly taking centre stage owing to their ability to improve patient-reported outcomes through monitoring, medication reminders, real-time customised health recommendations and personalised health coaching. Enabling Behavioural Modifications The DTx solutions use disease-specific programmes to encourage positive behaviour and lifestyle changes in individuals to mitigate heart ailments in them. The solutions offer disease-specific health education videos, recipes, and daily tasks to allow the individuals to respond better to symptoms, optimise their diet and adopt a positive physiological approach to improve sleep, reduce stress and enhance overall mental well-being. Through behavioural changes, the DTx solutions empower users to build positive daily habits which significantly improve their quality of life. Bengaluru-based Credo Health’s Cardiac Wellness and Rehabilitation programme enables the users to adopt heart-healthy behaviours including following a healthy diet, maintaining optimal weight, curbing habits such as smoking, and managing their stress levels to reduce the risk of heart disease. Mumbaibased Wellthy Therapeutics multi-lingual clinically validated DTx platform leverages behavioural science, and real-world clinical evidence to provide personalized recommendations and actionable information to the users to facilitate meaningful, sustainable behaviour change to better manage their conditions. Improving Patient Engagement One of the substantial advantages of DTx is its potential to improve patient engagement and compliance levels. Through multi-channel targeted outreach including reminders, motivational messages and rewards, DTx bolsters the patients’ commitment towards their health goals. This approach to enabling structured lifestyle changes in patients is essential for the prevention and management of CVDs. Lyfe, launched by Mumbai-based Lupin Digital Health is an evidence-based, heart care DTx that offers medication reminders, exercise, and diet regimens, online and in-person modules and expert interventions through dedicated health coaches and care managers for cardiac patients. By leveraging guidelines and protocols designed by prestigious medical societies such as the American College of Cardiology, Lyfe provides holistic heart care programmes aimed at reducing heart attack risk and improving health vitals among cardiac patients. The efficacy of the heart care DTx has been clinically proven through an ongoing research study with more than 90% of subjects adhering to the recommended diet, medications, and exercise and 83.3 per cent patients maintaining their vitals in the normal range. Challenges and Recommendations Though AI-based medical imaging and screening solutions offer an invaluable diagnostic tool to healthcare professionals, they have their share of limitations. Difficulty faced by clinicians in interpreting the decision-making process of the AI algorithms coupled with the lack of access to a large number of curated datasets for the training of the models has hampered the wide-scale adoption of the tools in cardiac care. Through the implementation of explainable modelling or post-hoc explanations, the internal functioning of the algorithms can be provided to clinicians to improve their trust levels. Market participants can partner with government agencies to get access to substantial curated imaging data sets that are technically and demographically diverse. Furthermore, there is a vast shortage of AI-trained professionals in India a country that otherwise produces thousands of IT professionals every year which is hampering the rapid development of medical imaging and screening algorithms. To Though AI-based medical imaging and screening solutions offer an invaluable diagnostic tool to healthcare professionals, they have their share of limitations. Difficulty faced by clinicians in interpreting the decision-making process of the AI algorithms coupled with the lack of access to a large number of curated datasets for the training of the models has hampered the widescale adoption of the tools in cardiac care. Through the implementation of explainable modelling or posthoc explanations, the internal functioning of the algorithms can be provided to clinicians to improve their trust levels.
BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com CARDIOVASCULAR DISEASE 43 mitigate this issue the companies can partner with universities in India to introduce AI-based offline and online courses that would allow upskilling workforces to address the talent crunch. The use of wearables in India for health monitoring has grown significantly in recent years, however, they face challenges related to maintaining patient data privacy and data security. The lack of clear understanding among the patients regarding the privacy of their critical health information and what measures are adopted to protect their data stored on the cloud from unauthorised access due to security breaches can hamper the adoption of the wearables. The enactment of the Digital Personal Data Protection (DPDP) Bill, 2023 successfully passed through the Indian parliament and received final assent from the President of India in August 2023 is a step in the right direction as obtaining explicit consent from the individuals before collecting or utilising their health data and display of notice regarding the purpose of the processing of the information is made mandatory for the wearable and digital health players which can address patients’ data privacy concerns. Going forward the government can also add additional sections to the current DPDP bill on similar lines to that of the US Health Insurance Portability and Accountability Act (HIPAA) which provides individuals the right to see their health data and request or change the information if it is incomplete or inaccurate. Additionally, the wearable and digital health players can also focus on the implementation of robust security measures such as consistently updating security protocols, encrypting patient data and deploying stringent controls to ensure patient health data is protected on the cloud from unauthorized access, theft or misuse. Despite the innovations happening in the DTx space, the lack of a proper regulatory pathway for the approval of DTx is a prominent challenge faced by companies that have hampered the development of these products in India. To overcome this issue, the Central Drugs Standard Control Organisation (CDSCO) can develop alternative regulatory approaches wherein DTx products approved by CDSCO’s reference regulatory agencies (US FDA, Health Canada, and EU Notified Bodies) should be provided abridged evaluation route or expedited review route which can help in facilitating accelerated regulatory approval for them. Outlook Considering the enormous patient population suffering from CVDs in India and the current gaps regarding the precise understanding of these conditions, the medical device industry in India needs to boost technology development to address these challenges. The industry can step up partnerships with leading local and foreign universities leveraging their research to improve the companies’ expertise in cardiac care. Furthermore, the industry can also adopt breakthrough innovations used in developed countries including voice-based technologies and AI-based chatbots for detecting and predicting cardiovascular events in individuals. Finally, the companies should also work with the Government of India to identify any regulatory roadblocks that hinder the ease of doing research and business related to cardiac care medical devices and subsequently address them to accelerate the development of these products. The development and deployment of these cutting-edge technologies, backed by requisite government policy support and direction, will help in bolstering the fight against CVDs and thus improving the quality of life. Despite the innovations happening in the DTx space, the lack of a proper regulatory pathway for the approval of DTx is a prominent challenge faced by companies that have hampered the development of these products in India. To overcome this issue, the Central Drugs Standard Control Organisation (CDSCO) can develop alternative regulatory approaches wherein DTx products approved by CDSCO’s reference regulatory agencies (US FDA, Health Canada, and EU Notified Bodies) should be provided abridged evaluation route or expedited review route which can help in facilitating accelerated regulatory approval for them.
44 ACADEMICS NEWS ACADEMIA NEWS BIOSPECTRUM BIOSPECTRUM | | DECEMBER 2023 AUGUST 2021 | www.biospectrumindia.com | www.biospectrumindia.com Delhi Pharmaceutical Sciences and Research University (DPSRU) and Akums Drugs & Pharmaceuticals have embarked on a collaborative journey to research on specific therapy-gaps and introduce novel products for Indian patients. This industry-academia partnership will also enhance pharmaceutical education and research opportunities for DPSRU students. The Memorandum of Understanding (MoU) sealing this partnership was recently signed by Dr Harvinder Popli (Registrar & Dean - DPSRU) and Arushi Jain (Director - Akums). The collaboration represents a step towards equipping students with practical, industryrelevant knowledge and experience, fostering a brighter future for the pharmaceutical sector. This partnership aims to empower the next generation of pharmaceutical professionals, for them to contribute to the growth and development of the nation. DPSRU inks MoU with Akums Drugs to promote pharmacy education The College of Physicians and Surgeons (CPS) has announced the inauguration of its state-of-the-art high fidelity Simulation Lab, the first-of-its-kind in Mumbai. The Simulation Lab, a testament to CPS Mumbai’s commitment to cutting-edge medical education, is equipped with modern technology and resources. It serves as a hub for training in various medical disciplines, through the induction of simulation manikin namely Ares (Male adult manikin), Lucina (Female adult manikin), and Arya (Paediatric manikin). The students and the medical practitioners can be trained on various medical scenarios on these simulation manikins. These innovative training modalities are designed to enhance the clinical skills and competence of medical practitioners, ensuring they are better prepared to deliver high-quality patient care. One of the standout features of the Simulation Lab is its hospital-like facility. Within this setting, the students or a medical practitioner can be supervised continuously from a glass room. In this room, students engage in hands-on training while the teachers are monitoring their activities from behind the glass. This setup allows for a unique and realistic training experience, as students are immersed in life-like medical scenarios, while teachers can observe and evaluate their performance. This innovative approach enhances the learning process, fostering a more practical and comprehensive understanding of clinical practice. College of Physicians and Surgeons launches simulation lab in India The Apollo Hospitals Group has signed a Memorandum of Understanding (MoU) with the University of Leicester, UK. The MoU will strengthen existing links with the UK and sets out a mutual desire to promote international cooperation and explore collaborative education and research programmes, particularly in the fields of healthcare management, healthcare and data science. This agreement with the University of Leicester will explore the creation of education programmes, cutting edge research and global mobility opportunities for Indian students to excel in their area of interest. Building a healthcare workforce to global standards has been the cornerstone of Apollo’s education and skilling initiatives. As one of only 20 institutions in the UK, the University of Leicester Biomedical Research Centre was awarded £26 million of funding by the National Institute for Health and Care Research. Apollo Hospitals Group partners with University of Leicester to transform global education
Bengaluru-based Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd has announced that the Board of Directors of Biocon Biologics have appointed Kedar Upadhye as the new Chief Financial Officer (CFO) and the company’s current CFO, MB Chinappa, will transition to take on a strategic finance role at Biocon Group. Upadhye brings with him over 23 years of experience in senior global leadership roles spanning Corporate Finance, Strategy, Accounting, FP&A, Business Finance, Governance and Investor Relations at leading Pharma, Energy and FMCG players such as Cipla, Dr. Reddy’s, PepsiCo, and Thermax. He joins BBL from ReNew Energy Global Plc, a NASDAQ-listed decarbonisation & renewable energy company, where he was CFO. Prior to ReNew, he was the Global CFO at Cipla where he was instrumental in setting up a strong global finance footprint with a focus on capital allocation, strategic partnership with the business, governance, and risk management in addition to driving the organisation towards the next level of growth and delivering a superior return profile. He has a proven track record of overseeing value creation, strengthening investor relations and acting as an enabler of business. Kedar Upadhye steps in as new CFO of Biocon Biologics BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com PEOPLE NEWS 45 Zydus names Punit Patel as President and CEO to lead business in North America Arunish Chawla, IAS, previously serving as Officer on Special Duty, Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers has taken over the charge of Secretary, Department of Pharmaceuticals, effective November 1, 2023. Chawla has worked as Additional Chief Secretary, Planning and Development, with additional charge of Secretary, Bihar State Planning Board, Patna/ Project Director, Bihar Disaster Rehabilitation and Reconstruction Society, Patna; and Additional Chief Secretary, Urban Development and Housing and MD, Patna Metro Rail Corporation. He has also worked as a Senior Economist in the Institute of Capacity Development of the International Monetary Fund (IMF), Washington DC, US for a period of two years in 2020. S Aparna, a 1988-batch IAS officer of Gujarat cadre, was previously working as Secretary, DoP, from October 1, 2020. Aparna had then replaced Dr PD Vaghela who superannuated on September 30, 2020. Arunish Chawla steps in as Secretary, Department of Pharmaceuticals Ahmedabad-based Zydus Lifesciences has announced the appointment of Punit Patel as President and Chief Executive Officer (CEO), Americas. He will be responsible for the business operations of all Zydus entities in North America which include generics, injectables and specialty business, rare and orphan disease portfolio and also future forays into novel therapeutics. He will be based out of the group’s office in Pennington, New Jersey, US. A licensed pharmacist who earned his Doctorate of Pharmacy from Massachusetts College of Pharmacy and Allied Health Sciences, Patel has more than 20 years of experience in the generics and branded pharmaceutical marketplace. His deep understanding of the complex generic pharmaceutical market (specialty, 505b2, injectables & biosimilars), coupled with his people leadership and results-driven style, unlocks value by enabling long-term strategy to be translated into actionable plans. Prior to his joining Zydus, Patel was the President of Red Oak Sourcing, helming a multi-billion-dollar generic portfolio.
IISER Bhopal develops clear synthetic, biomedical adhesive to repair injured tissues A team of researchers at the Indian Institute of Science Education and Research (IISER) Bhopal has developed a clear synthetic biomedical adhesive that can effectively seal and repair injured and dissected tissues. This adhesive, which is biodegradable and biocompatible, is capable of binding different surfaces such as tissues, bones, eggshells, and wood in both air and underwater and requires no additional crosslinking agents or metal ions. The researchers used a mixture of oppositely-charged watersoluble polyelectrolytes that are known for their biodegradability and biocompatibility. These polymers have multiple amide groups and thiol residues that lead to strong adhesion due to the formation of hydrogen bonds and disulfide bonds. The resulting adhesive layer is colourless and transparent. The adhesive formulations developed by the IISER team will find use in cosmetics and biological applications. The researchers are working towards optimising these adhesives for such real-life applications. An interdisciplinary team of researchers from the Indian Institute of Science (IISc), Bengaluru has uncovered how the stiffness of a cell’s microenvironment influences its form and function. The findings provide a better understanding of what happens to tissues during wound healing. Inefficient wound healing results in tissue fibrosis, a process that can cause scar formation, and may even lead to conditions like cardiac arrest. Changes in the mechanical properties of tissues like stiffness also happen in diseases like cancer. In this study, the team cultured fibroblast cells, the building blocks of our body’s connective tissue, on a polymer substrate called PDMS with varying degrees of stiffness. They found that a change in the stiffness altered cell structure and function. Fibroblast cells are involved in extensive remodelling of the extracellular matrix (ECM) surrounding biological cells. The ECM, in turn, provides the mechanical tension that cells feel inside the body. To pinpoint the “master regulator” that drives changes in the cell when substrate stiffness changes, the team focused their attention on an important signalling protein called Transforming Growth Factor-β (TGF-β). The researchers found that when substrate stiffness increased, TGF-β activity also increased, in other words, the levels of the active form of the protein started rising. IISc uncovers link between cell biomechanics and wound healing Researchers from the Indian Institute of Technology (IIT) Mandi, the Institute for Stem Cell Science and Regenerative Medicine in Bengaluru, have discovered the biochemical processes that enable the eggs of the dengue-causing mosquito to survive harsh conditions and rejuvenate when favourable conditions return. This research marks a significant stride in our battle against mosquito-borne diseases, offering hope for more effective vector control measures. The collaborative team reared Aedes aegypti mosquitoes, studying their eggs through a series of innovative experiments. By subjecting the eggs to dehydration and subsequent rehydration, they discovered that the developing larvae undergo specific metabolic changes required for survival. The implications of this research are far-reaching. Understanding these survival mechanisms provides a foundation for innovative mosquito control strategies. By disrupting the desiccation tolerance of mosquito eggs, researchers anticipate a significant reduction in mosquito populations and disease transmission. New research unveils innovative mosquito control strategies 46 R&D NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com
The effectiveness of any drug molecule depends on how well it interacts with the internal environment inside our body. Its pharmacokinetic (PK) properties determine how successfully it escapes degrading enzymes as it travels through the digestive system or the bloodstream, crosses biological barriers like the cell membrane, and reaches the desired target. Researchers at the Molecular Biophysics Unit (MBU), Indian Institute of Science (IISc), Bengaluru describe a novel method for improving the pharmacokinetic properties of “macrocyclic peptides” – drug molecules that are pursued heavily by pharmaceutical industries worldwide. The IISc team, in collaboration with Anthem Biosciences, has demonstrated that substituting just a single atom – oxygen with sulphur – in the backbone of a macrocyclic peptide can make it more resistant to digestive enzymes, and can increase its permeability through cell membranes, boosting its bioavailability. The researchers plan to use this technology to make peptides with better pharmacological properties. MBU, IISc develop novel method to improve pharmacokinetic properties of “macrocyclic peptides” BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com R&D NEWS 47 IIT-M builds steambased sterilisation system for dental tools Gait and postural deformities are incapacitating and common in the present world. Studies indicate that the most prominent deformities include splay foot, flat foot, unstable hind foot with protruding heels, high arches, and irregular gait. Researchers at the Indian Institute of Technology Delhi (IIT-D) have developed a scalable wearable pressure sensor based on a nanocomposite material, that has unique combination of light-sensitive polymer and piezoelectric nanoparticles, which offers the advantage of easy array design for pixelated sensing over large area, simple process flow, and low-cost implementation for human movement monitoring and injury rehabilitation. The researchers in their study found the reported sensor as fully flexible that can be implemented as a sensor array considering a robust design that comfortably fits inside the insole of varying sizes. It can also be easily attached at the palm or any body part where localised pressure sensing can be useful. IIT-D designs scalable wearable pressure sensor to analyse gait patterns and postural deformities A team of researchers at the Indian Institute of Technology Madras (IIT-M) has developed a solar-thermal steam-based sterilisation system for dental tools to help conduct medical camps in remote and rural areas, where access to electricity and water could be an issue. This social project was funded by the Climate Change and Clean Energy (C3E) Division, Department of Science and Technology, Government of India. In the project, a team from IIT-M developed a new way to sterilise medical equipment using portable steam cylinders charged by renewable energy-based stations (like solar energy) that are placed strategically in rural areas for power generation, steam generation and other uses. The team also designed special sterilisation chambers to utilise such portably stored steam and effectively sterilise the tools. The researchers have already tested the steam sterilisation unit for sterilising infected dental equipment and the results were found successful. Pilot activities will be scheduled to supply portable steam cylinders for remote areas during the dental camp activities.
Qiagen N.V. has announced that its NeuMoDx human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) quantitative assays for blood-borne virus (BBV) testing has received Central Drugs Standard Control Organization (CDSCO) approval in India. These blood-borne virus assays are the first to be registered in India with additional NeuMoDx infectious disease assays to follow. The NeuMoDx HIV-1 Quant Assay is designed for the quantitation and detection of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma. It can be used as an aid in the clinical management of HIV-1 infected patients and monitoring the effects of antiretroviral treatment, as measured by changes in plasma HIV-1 RNA levels, and as an aid in the diagnosis of HIV1 infection, including acute or primary infection. The NeuMoDx HBV Quant Assay is designed for the quantification of hepatitis B virus (HBV) DNA in human plasma and serum specimens for HBV genotypes A through H of HBV-infected individuals. It is intended to be used as an aid for determining the proper course of treatment for patients with HBV infection. On the other hand, the NeuMoDx HCV Quant Assay is designed for the quantitation of hepatitis C virus (HCV) RNA genotypes 1 through 6 in human plasma and serum specimens from HCV antibody-positive individuals. It is intended to be used as an aid in the management of patients with HCV infections. Qiagen receives CDSCO approval for blood-borne virus testing assays 48 SUPPLIERS NEWS BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Germany-headquartered manufacturer of laboratory instruments and consumables Eppendorf has launched Mastercycler X40 for daily lab routines that will not only be reliable and efficient but elevated. The new product offers proven reliability and the highquality thermal cycler is now available for every lab. Reproducible nucleic acid amplification and reliable temperature homogeneity are a must for the Mastercycler X40 PCR cycler. Combined with the intuitive touch-screen user interface and ergonomic one-hand operation, the new Mastercycler X40 raises the standard in PCR. 0.1 mL, 0.2 mL tubes or tube strips and any type of 96-well PCR plate can be used. The SafeLid securely protects the samples from evaporation. The 12-column gradient facilitates the optimisation of different temperature steps in the PCR protocol. With its borosilicate glass being the gold standard for storing life-saving medications for more than a century, German firm Schott is now taking the next step by introducing improved glass tubing to the global pharma market. FIOLAX Pro is a new type I borosilicate glass, designed to meet three major trends in the industry: increasingly complex pharmaceuticals, sustainable products and circular economy, and digitalisation. FIOLAX Pro has superior chemical quality, such as an improved Extractables & Leachables (E&L) profile and hydrolytic resistance and is completely free of heavy metals. The company plans to produce the new FIOLAX Pro with green energy and significantly reduce the Product Carbon Footprint (PCF). Schott just recently received funding from the German Federal Ministry for Economic Affairs and Climate Action to build the first climate-friendly glass melting tank. The pilot tank will be constructed at the company’s site in Bavaria, Germany, and produce the pharmaceutical glass largely without causing greenhouse gas emissions. Eppendorf unveils Mastercycler X40 for daily lab routine work Schott introduces improved glass tubing for global pharma market
Revvity, Element Biosciences to improve NGS research workflow BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com SUPPLIERS NEWS 49 American firms Revvity, Inc. and Element Biosciences, Inc., a developer of the AVITI System, an innovative and emerging genomic sequencing platform, have announced a collaboration to introduce workflow solutions that save time and effort required for genomic analysis of samples. Genomic data generated by next-generation sequencing (NGS) plays an increasingly important role in scientific innovation and research. The NGS process encompasses a series of detailed steps, including sample collection and processing, nucleic acid extraction, library preparation, quality control, sequencing, data analysis and integration into laboratory information management systems. This process can be daunting, especially for labs that are new to NGS. Earlier this year, Element Biosciences announced a new throughputbased option for its AVITI System that provides the highest quality sequencing on a benchtop for as low as $200 a genome, or $2 per gigabase. Revvity Omics has recently adopted Element’s AVITI platform for its global service business, demonstrating improved technology capabilities, flexibility and speed. Revvity and Element Biosciences plan to make the combined solution available to an expanded customer base interested in the full workflow or specific modules. American company Thermo Fisher Scientific Inc. and Sweden-headquartered Olink Holding AB have announced that their respective boards of directors have approved Thermo Fisher’s proposal to acquire Olink for $26 per common share in cash, representing $26 per American Depositary Share (ADS) in cash. The transaction values Olink at approximately $3.1 billion which includes net cash of approximately $143 million. Olink is on track to deliver over $200 million of revenue in 2024 and, as part of Thermo Fisher, is expected to grow mid-teens organically. Upon completion of the acquisition, Olink will become part of Thermo Fisher’s Life Sciences Solutions segment. Olink offers leading solutions for advanced proteomics discovery and development, enabling biopharmaceutical companies and leading academic researchers to gain an understanding of disease at the protein level rapidly and efficiently. Olink’s proprietary technology, Proximity Extension Assay (PEA), provides high throughput protein analysis for the very large installed base of qPCR and next-generation sequencing readout systems in the market. Thermo Fisher acquires Olink to enhance capabilities in proteomics market Waters launches OligoWorks SPE kits US-headquartered Waters Corporation has announced the launch of OligoWorks SPE (solid phase extraction) kits and components to improve sample preparation for LC-MS-based bioanalytical quantitation of therapeutic oligonucleotides. Pharma and biopharma companies developing oligonucleotide therapeutics and the Contract Research Organisations (CROs) that support them can now realise up to a 2x increase over competing products in oligonucleotide recovery from biofluids. The kits deliver greater reproducibility and LC-MS sensitivity, enabling lower quantitation limits and reducing the need for repeat experiments. The pipeline for oligonucleotide therapeutics is rapidly expanding with 13 FDA-approved oligonucleotide therapeutics and 500+ in the pipeline. While potent, these highly modified oligonucleotides are challenging to precisely quantify during dosing, metabolism, and tissue distribution studies. OligoWorks SPE Kits also use an innovative, enzymeenhanced, and detergent-free sample pretreatment that reduces washing steps and improves mass spectrometer compatibility, thus enabling direct injection LC-MS analysis and lower limits of quantitation.
50 LET’S TALK HEALTH BIOSPECTRUM | DECEMBER 2023 | www.biospectrumindia.com Ruling the Roost in Biomanufacturing With India poised to be among top 5 global biomanufacturing hubs by 2025, as stated by Dr Jitendra Singh, Union Minister of Science & Technology, the biotech industry has been rapidly responding to this sector. Based on this response, the Department of Biotechnology is working on a national project to foster high performance biomanufacturing, as an integrated approach towards promoting circular economy, which will establish world-class expertise, facilities, and skilled workforce in synthetic biologybased sustainable manufacturing methods. Biomanufacturing, an old technique, is the engine by which innovative bio-products can be brought to commercial scale. Recent transformative advances in fundamental biotechnology, including gene editing, CAR-T and other cell therapies, metabolic engineering and synthetic biology, and mRNA vaccines are creating enormous new opportunities to grow the global bioeconomy. For instance, the world’s response to COVID-19 depended on the rapid production of new vaccines through biomanufacturing, but biomanufacturing is not only about vaccines or gene therapies. It also includes alternative proteins, plant-based oils and biofuels, bioplastics and innovative products such as bio-concrete, etc. For instance, methane-based biomanufacturing has the potential to improve the economic viability of biosynthesis. According to market reports, artificial intelligence (AI), machine learning, and augmented reality, among other advanced technologies, are continuously being used in biomanufacturing processes across the globe, taking it to the next-generation level. Reports also suggest that the global next-generation biomanufacturing market which was $20.08 billion in 2021, would soar to $42.58 billion by 2029, with a projected CAGR of 9.85 per cent. Undoubtedly, the development of a next-generation biomanufacturing process can allow for the production of biological medication for the treatment of many crucial ailments. However, huge capital expenditure, associated unpredictable costs, lack of skilled professionals, operational complexity and compatibility challenges are hindering the growth of this sector. One approach being explored by India, to excel in this space is the establishment of biofoundries. The biofoundries can contribute to the development and strengthening of a Design-Build-Test-Learn approach for developing new high-throughput biological solutions using cutting-edge automation technologies such as robotics, AI algorithms, highthroughput analytical equipment and software, etc. Biofoundries can rapidly develop tools and datasets to enable and improve rational strain improvement in biomanufacturing. Apart from adequate financial and technical resources, establishing and running a biofoundry requires integrating physical and digital infrastructures and taking care of the organisational and operational issues. Nevertheless, biofoundries with appropriate automation and equipment are especially well-suited for designing vaccines. Although technology can offer a big support to the biomanufacturing sector, the field needs investment in human capital. Besides keeping up with the latest biology and engineering technologies, the technicians and leadership in biomanufacturing need to understand and use new advances in automation and data science. And this requires constant contribution from the government, industry and academia to build a strong workforce for the biomanufacturing sector, thereby contributing to the bioeconomy of the country. Ultimately, the ability to translate the many promising biotechnologies from lab to a manufacturing relevant scale requires a strong and technically advanced biomanufacturing base; a skilled and diverse workforce at every level; and shared infrastructure that can support development of different bioprocesses. Developing capacity to rapidly manufacture bio-engineered solutions in all areas of the world, including diagnostics, vaccines, materials and industrial catalysts, has the potential to revolutionise the global bioeconomy. India must bring all stakeholders together to emerge as a leading player in biomanufacturing by 2025. Dr Manbeena Chawla Executive Editor [email protected]