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Bio Spectrum - November 2025

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En este número

CRO Reforms: Tilting Scale towards Accelerated Growth & Transparency
India’s clinical research ecosystem is undergoing a major transformation, driven by a wave of regulatory reforms and rapid market expansion. Valued at $2.05 billion in 2024, the country’s clinical trials market is projected to grow at a CAGR of 8.64 per cent through 2030. This momentum has made India the third-largest destination for clinical trials globally, with nearly 18,000 new studies registered in 2024, a 50 per cent increase over the year (Invest India). To further enhance the sector, the Central Drugs Standard Control Organisation (CDSCO) has introduced the New Drugs and Clinical Trials (NDCT) (Amendment) Rules, 2024. The new framework includes the mandatory registration of contract research organisations and proposed amendments that simplify test licence and bioequivalence (BA/BE) study approvals. These measures aim to shorten drug development timelines and strengthen India’s role in global clinical research. The launch of the SUGAM portal and the One Nation–One Drug Licensing System has replaced paper-based applications with online submissions, improving transparency, reducing delays, and standardising approvals across states. As India implements the new rule, the country’s clinical research landscape is entering a new phase. To understand how these changes are being viewed within the industry, BioSpectrum India gathered perspectives from organisations across the clinical research value chain. Their collective views reflect a cautiously optimistic sector that sees the reforms as both a compliance requirement and a growth opportunity.

Keeping Watchful Eye on US Pharma Tariffs

The axe has finally fallen — though not as harshly as feared, at least for the Indian pharmaceutical industry. The United States has dropped a bombshell on the global drug trade, with President Donald Trump announcing a 100 per cent tariff on imports of branded or patented pharmaceutical products effective October 1, 2025.

2 mins

Cabinet approves DSIR Scheme of Capacity Building and HR Development with outlay of Rs 2277 Cr

The Cabinet, chaired by the Prime Minister Narendra Modi, has approved the Department of Scientific and Industrial Research Council of Scientific and Industrial Research (DSIR/CSIR) Scheme on \"Capacity Building and Human Resource (HR) Development\" with a total outlay of Rs 2277.397 crore for the period of the Fifteenth Finance Commission Cycle 2021-22 to 2025-26.

1 mins

Ministry of Ayush to co-host 2nd Global Summit on Traditional Medicine with WHO

The Ministry of Ayush, Government of India has signed an agreement with the World Health Organization (WHO) to co-host the 2nd WHO Global Summit on Traditional Medicine on the theme “Restoring balance for people and planet: The science and practice of well-being”.

1 mins

DBT inks pact with Uttar Pradesh to boost biotech, pharma and medtech innovation

An official Memorandum of Understanding (MoU) has been signed between the Department of Biotechnology (DBT), Government of India and the Government of Uttar Pradesh.

1 mins

Ayush Ministry launches Integrative Oncology Research and Care Centre

The Ministry of Ayush inaugurated the Integrative Oncology Research and Care Centre (IORCC) at the All India Institute of Ayurveda (AIIA), Dhargal, Goa.

1 mins

Atal Innovation Mission's Frontier Region Programme paves way for 500 new Atal Tinkering Labs in J&K

In line with Prime Minister Narendra Modi's vision of building a Viksit Bharat by 2047, the Atal Innovation Mission (AIM), NITI Aayog, Government of India, in collaboration with the University of Kashmir, has launched the Atal Tinkering Labs (ATL) Sarthi and Frontier Region Programme at the Convocation Complex, University of Kashmir.

1 mins

Cabinet gives nod to Phase III of Biomedical Research Career Programme

The Union Cabinet chaired by the Prime Minister Narendra Modi has approved the continuation of the Biomedical Research Career Programme (BRCP), Phase III.

1 mins

Somerset Indus Capital Partners exits from Apex Hospitals, delivering 4x return

Somerset Indus Capital Partners has announced its full exit from Apex Hospitals, a leading multispecialty hospital group in Rajasthan renowned for advancing high-quality healthcare in the region.

1 mins

Poly Medicure announces acquisition of Citieffe Group for Rs 324 Cr

Delhi-based medtech firm Poly Medicure has announced signing of a definitive agreement to acquire 100 per cent stake in Medistream SA (Group) consisting of Citieffe SRL and its step-down subsidiaries in USA & Mexico, at an Enterprise Value of Rs 324 crore (EUR 31 million).

1 mins

Gaudium IVF and Women Health re-files DRHP with SEBI

Delhi-based Gaudium IVF and Women Health has refiled its Draft Red Herring Prospectus (DRHP) with the Securities and Exchange Board of India (SEBI).

1 mins

Alkem Foundation invests Rs 100 Cr towards opening radiotherapy centre in Bihar

Alkem Foundation, a wholly owned subsidiary and CSR arm of Alkem Laboratories Ltd., has supported the establishment of Samprada Singh Memorial Radiotherapy Centre in Muzaffarpur, Bihar, with an investment of Rs 100 crore.

1 mins

New York State Emerges as a Global Biopharma Manufacturing Hub: Lessons from Garonit Pharma's Expansion

Changing Trade Landscape Signals a New Chapter in India-U.S. Pharma Ties

3 mins

Lupin strengthens global specialty ophthalmology biz with acquisition of VISUfarma

Mumbai-based pharma major Lupin Limited has announced that its wholly owned subsidiary, Nanomi B.V., has signed a definitive agreement for the acquisition of VISUfarma B.V., a portfolio company of global healthcare specialist investor GHO Capital Partners LLP.

1 mins

Medtronic unveils two advanced surgical energy generators in India

Medtronic, a global leader in healthcare technology, has announced the launch of two advanced surgical energy generators in India under the Valleylab FT10 series - the Valleylab FT10 Electrosurgical Generator (VLFT10FXGEN) and the Valleylab FT10 Vessel Sealing Generator (VLFT10LSGEN).

1 mins

Gene Solutions and AMPATH launch advanced genomics laboratory in Hyderabad

Gene Solutions, a leading genetic testing innovator in Asia, has partnered with AMPATH (American Institute of Pathology and Laboratory Sciences), a trusted provider of high-quality diagnostic services in India, to open a new advanced genomics laboratory in Hyderabad.

1 mins

India announces formation of Veterinary Vaccine India Manufacturers Association

In a significant development for India's animal health sector, veterinary vaccine manufacturers have come together to announce the formation of the Veterinary Vaccine India Manufacturers Association (VVIMA). VVIMA is a nongovernment, not-for-profit organisation that will serve as the collective voice of India's veterinary vaccine manufacturers.

1 mins

Molbio announces collaboration with UE LifeSciences to expand iBreastExam globally

Molbio Diagnostics, a Goa-based point-of-care (POC) diagnostics company focused on expanding access to accurate, rapid and cost-effective healthcare technologies, and UE LifeSciences, a Philadelphia-based innovator engaged in the business of developing and manufacturing health technology solutions, with a primary focus on enabling early cancer detection technologies, have announced an exclusive collaboration, seeking to make early breast cancer detection accessible to millions of women in over 50 countries across the developing world.

1 mins

Abbott launches world's first dual-chamber leadless pacemaker system in India

Abbott, a global healthcare company, has announced the launch of AVEIR dual chamber (DR) leadless pacemaker system - the first of its kind in the world.

1 mins

CRO Reforms: Tilting Scale towards Accelerated Growth & Transparency

India's clinical research ecosystem is undergoing a major transformation, driven by a wave of regulatory reforms and rapid market expansion.

10+ mins

Patient Consent - How is it different under medical ethics and data protection?

In the ethical and legal framework of medicine and law, consent has always existed. Within healthcare, it signifies the individual's right to be informed and to choose. However, in the digital era, consent assumes a broader function; it becomes the foundation for lawful processing of personal data. For the pharma and clinical-research sectors, this distinction carries significant implications. The Digital Personal Data Protection Act, 2023 (DPDPA), has redefined how personal and health-related data must be managed. This article explores why consent under data-protection law differs from medical consent, drawing lessons from the irregularities uncovered in the Ahmedabad clinical trials, and outlines the emerging compliance responsibilities under the DPDPA.

3 mins

Rethinking Accountability in Clinical Research: Building a Culture of Ethical Confidence

India's CROs are growing fast; sustaining trust requires strong ethics, transparency, and collaboration. Ethical integrity will be India's key differentiator and global advantage.

2 mins

Breaking Ground in Clinical Trials: India's Innovation Imperative

For decades, India has been a global powerhouse in pharmaceutical manufacturing. Yet in clinical trials, the crucial bridge between laboratory discoveries and patient access, the country’s performance has lagged behind its industrial capabilities.

5 mins

Working on our supply chain to set benchmarks in quality and further enhance India's position as a trusted clinical research supplier on a global scale

Abdos Lifesciences, which is committed to enabling science to thrive by delivering precision-engineered, high-performance laboratory consumables and instruments that meet the highest global standards, manufactures over 400 products across 12+ categories in automated cleanroom environments certified under ISO and CE-IVDR standards, ensuring sterility, traceability, and consistency crucial for decentralised and global clinical trials. Each product is barcoded, tamper-proof, and supported by easily accessible documentation such as Certificates of Analysis (COA), Technical Data Sheets (TDS). With a presence in more than 90 countries, Abdos Lifesciences ensures researchers worldwide receive reliable products and dedicated support, empowering science to advance seamlessly across borders and timelines. In an interview with BioSpectrum India Shrey Agarwal, CEO & Director, Abdos Lifesciences spoke to many issues including how the company is ensuring compliance with evolving global standards for products used in regulated clinical environments. Edited excerpts;

4 mins

The AI Job Loss Threat Conundrum

There are assumptions that Artificial Intelligence (AI) will take away pharma and healthcare jobs. But many are of the opinion that AI will help to transform jobs as well as create new ones in the long run. How much pharma and healthcare companies invest in AI and cope with the latest AI innovations will determine who can survive and who will perish. Let's find out.

5 mins

‘Minicircle DNA will become a cornerstone of modern gene and cell therapy"

PlasmidFactory GmbH, based in Bielefeld, Germany, is recognised as a leading CDMO for the production of plasmid and Minicircle DNA. Over the past 25 years, the company has evolved from a small academic spin-off into a global reference for DNA manufacturing in gene and cell therapy. Following the launch of its new GMP facility and the clinical success of several Minicircle-based therapies, PlasmidFactory is entering a new phase—expanding its impact from plasmid DNA manufacturing toward next-generation, virus-free gene delivery. In an interation with BioSpectrum India Dr Ram Shankar, Chief Scientific Officer at PlasmidFactory, shares his insights into the company’s latest developments and the growing importance of Minicircle technology in cell and gene therapy. Editd excerpts;

5 mins

"When domestic and global players stand together, it strengthens the entire diagnostics ecosystem"

The Association of Diagnostics Manufacturers of India (ADMI), the apex body representing the country's in vitro diagnostics (IVD) industry, has announced the election of Jatin Mahajan, Managing Director of J. Mitra & Co., as its new President recently. In an interaction with BioSpectrum India Mahajan explains how ADMI can create inclusive working groups and open forums within the association, allowing MNCs and Indian firms to share perspectives and align on goals. Edited excerpts:

7 mins

What will the export scenario be by 2030?

Indian diagnostic manufacturers export widely today - depending on the size of the Indian IVD company, most Indian players ship to anywhere between 40 and 100 countries worldwide, spanning Asia, Africa, the Middle East, Latin America, and more.

5 mins

‘Our API sector can remain competitive and play a critical role in the global supply chain”

With over 35 years of expertise in manufacturing bulk drugs and APIs, A P Rameswara Rao, has recently taken charge as the National President of Bulk Drugs Manufacturers Association of India (BDMAI). In an interaction with BioSpectrum India Rao talks about strengthening India's self-reliance in APIs and reducing import dependency, promoting global quality standards and compliance across the industry, advocating policy reforms with government and regulatory bodies and supporting sustainable growth through innovation, R&D, and environmental responsibility. Edited excerpts:

2 mins

"Absence of specific safety standards for printing inks used in pharma packaging is a critical issue

Siegwerk, a German leader in printing inks and coatings for packaging applications and labels, with annual Indian revenue of over Rs 1000 crore, has recently announced an investment of Rs 350 crore over the next three years to expand its operations in India. Further, the firm is making a foray into the pharmaceutical market in India with mineral oil-free inks, designed specifically to reduce health risks associated with ink migration in medicine packaging. In an exclusive conversation with BioSpectrum, Jatin Takkar, Head, Product Safety & Regulatory, Siegwerk India, talks about how these inks are making pharma packaging safer, and about the company's growth plans in this space. Edited excerpts:

4 mins

When Spectra Speak: Letting AI Read the Fine Print of Biologics

Biologic characterisation has historically relied heavily on spectroscopy, which transforms chemical complexity into comprehensible fingerprints. Through the careful use of AI, supported by strict data procedures and scientific supervision, these fingerprints may be read more quickly & thoroughly.

5 mins

We aim to make bio-based industries a key pillar of the state's GSDP by 2030: Kerala CM

Kerala recently set the spotlight on its growing life sciences ecosystem with Bio Connect 3.0 – International Life Sciences Conclave & Expo, held on October 9 & 10, 2025, in Thiruvananthapuram. The event brought together global innovators, researchers, investors, and industry leaders to explore opportunities, collaborations, and advancements across biotechnology, healthcare, digital health, and allied sectors. Organised by the Kerala Life Sciences Industries Park (KLIP) and the Kerala State Industrial Development Corporation (KSIDC), this conclave featured thought-provoking discussions, visionary keynote sessions, and cutting-edge technology showcases.

3 mins

MOFs for Next-Gen Therapies

Susumu Kitagawa, Richard Robson and Omar M Yaghi have been awarded the Nobel Prize in Chemistry 2025 for the development of a new type of molecular architecture called metal-organic frameworks (MOFs), opening new avenues for applications such as drug delivery, biomedical imaging and personalised medicine.

2 mins

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Bio Spectrum Description:

Editor: MM-Activ-Sci-Tech-Communication

Categoría: Business

Idioma: English

Frecuencia: Monthly

India's leading publication that covers the business of bio-technology. With comprehensive analyses of policy issues, products and services across the bio-pharma, bio-informatics, bio-infrastructure and bio-agriculture segments, it is the industry's most authoritative source of information.