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In dieser Ausgabe

India's Pharma Reforms Target Global Credibility
The Indian government has introduced several measures to simplify drug approvals and support innovation. Key reforms include updating the New Drug and Clinical Trial Rules (2019) and using digital platforms to handle regulatory submissions, with the goal of improving transparency, reducing approval timelines, strengthening pharmacovigilance, and maintaining quality standards. What do these reforms entail, how is the industry responding, and what steps lie ahead to make India’s pharmaceutical sector globally competitive?

Of Tariffs Reform & Resilience

Despite being under the looming threat of higher US tariffs on medicine imports—possibly as steep as 200 per cent, the Indian pharmaceutical sector has reasons to stay optimistic.

2 mins

ICMR licenses nine breakthrough health technologies to industry partners

In a landmark moment for India's healthcare innovation ecosystem, the Indian Council of Medical Research (ICMR) has licensed nine cutting-edge technologies to industry partners under its Medical Innovations- Patent Mitra initiative.

1 mins

Health Ministry to amend New Drugs and Clinical Trials Rules 2019

In accordance with the directions of Prime Minister Narendra Modi towards reducing the regulatory compliance and towards promoting ease of doing business in the pharmaceutical and clinical research sectors, the Union Health Ministry is set to amend the New Drugs and Clinical Trials.

1 mins

India joins HealthAI Global Regulatory Network to strengthen oversight of AI in healthcare

HealthAI - The Global Agency for Responsible AI in Health, has welcomed India as a pioneer country joining the HealthAI Global Regulatory Network (GRN), a global network of health regulators dedicated to the safe and effective use of artificial intelligence (AI) in healthcare.

1 mins

SAI and IIT Delhi sign MoU to give impetus to wider use of sports sciences

Under the guidance of the Union Minister of Youth Affairs & Sports Dr Mansukh Mandaviya to promote Government of India's Atmanirbhar Bharat vision, the Sports Authority of India's (SAI) National Centre of Sports Science Research (NCSSR) have signed a Memorandum of Understanding (MoU) with Indian Institute of Technology (IIT) Delhi to strengthen cooperation in the domains of sports sciences, advanced technology, and indigenous innovation.

1 mins

DBT-BIRAC unveils high performance biomanufacturing platforms

The Department of Biotechnology (DBT), Government of India, and the Biotechnology Industry Research Assistance Council (BIRAC) have announced the launch of India's first Biofoundry Network, a landmark initiative aimed at transforming the country's biotechnology landscape and achieving a $300 billion bioeconomy by 2030.

1 mins

Centre to strengthen research integrity and open access publishing in Tier 2 & 3 academic institutions

The Office of the Principal Scientific Adviser (PSA) to the Government of India and Springer Nature, a global leader in research publishing, have announced a strategic collaboration to increase awareness of the importance of research integrity, open access and other scholarly publishing practices across India's Tier 2 and Tier 3 academic institutions.

1 mins

Poly Medicure acquires PendraCare Group for Rs 188.5 Cr

Poly Medicure, a Delhi-based medical device company, has announced signing of definitive agreements to acquire 90 per cent stake in PendraCare Group consisting of PendraCare Holdings and Welling Medical from Welling Holdings B.V. at an Enterprise value of Rs 188.5 crore (Euro 18.3 million).

1 mins

Somerset Indus Capital Partners powers ahead as Fund III nears $250 M close

Somerset Indus Capital Partners has announced that Fund III is in the final stages of its close, nearing ~$250 million, with documentation completion underway.

1 mins

Laborate Pharma to Increase international revenue by $100 M over next 5 years

Laborate Pharmaceuticals, one of India's leading pharmaceutical manufacturing and export companies, is currently in advanced discussions with partners in the EU and UK for the co-development and commercial supply of finished formulations, with projected international revenue growth of over $100 million over the next five years.

1 mins

AstraZeneca makes third investment of Rs 176 crore in India

AstraZeneca, a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines, has announced a strategic investment of Rs 176 crore, the third such investment in the past two years in India.

1 mins

Botanic Healthcare invests over Rs 25 Cr in liposomal manufacturing facility in Hyderabad

Botanic Healthcare, a global leader in natural ingredients and nutraceutical innovation, has launched its dedicated Liposomal Manufacturing Facility in Hyderabad with an investment of over Rs 25 crore.

1 mins

Cohance Lifesciences invests $10 M in cGMP Bioconjugation Suite in US

Hyderabad-based Cohance Lifesciences, a leading global Contract Research, Development & Manufacturing Organisation (CRDMO), has announced a strategic investment of $10 million to expand cGMP bioconjugation capabilities at its US based subsidiary, NJ Bio.

1 mins

Edwards Lifesciences launches next-gen transcatheter heart valve platform in India

US-based Edwards Lifesciences, a global leader in structural heart innovations, has announced the launch of its next-generation transcatheter heart valve platform in India, marking a significant milestone in the treatment of aortic stenosis.

1 mins

Canon Medical Systems India lays focus on advanced cancer diagnostics

Canon Medical Systems India has announced the signing of a Memorandum of Understanding (MoU) with Rajiv Gandhi Cancer Institute & Research Centre, further strengthening its footprint in the medical segment.

1 mins

Zydus unveils India's first trivalent influenza vaccine for flu protection

Ahmedabad-based Zydus Lifesciences has announced the launch of its trivalent influenza (Flu) vaccine VaxiFlu introduced for the first time in India, aligning with the global recommendations of WHO.

1 mins

Biocon inaugurates first US manufacturing facility in New Jersey

Bengaluru-based Biocon has announced the inauguration of its first US manufacturing facility in Cranbury, New Jersey, by its wholly owned subsidiary, Biocon Generics Inc (BGI).

1 mins

AliveCor introduces groundbreaking, AI-powered Kardia 12L ECG system in India

AliveCor, the global leader in artificial intelligence (AI)-powered cardiology, has announced the launch of its groundbreaking Kardia 12L electrocardiogram (ECG) system in India. Exclusively designed for use by healthcare professionals, Kardia 12L is the world's first AI-powered, handheld 12-lead ECG system with a unique single-cable design that can detect life-threatening cardiac conditions, including heart attack, with a reduced leadset.

1 mins

Dr. Reddy's strengthens CNS portfolio by foraying into anti-vertigo segment

Dr. Reddy's Laboratories, a global pharmaceutical company, has announced the completion of a definitive transaction with Johnson & Johnson, to acquire STUGERON and its locally recognised brands, STUGERON FORTE and STUGERON PLUS, across 18 markets in the APAC and EMEA regions, with India and Vietnam as key markets.

1 mins

"India is Shaping the Future of Global Life Sciences"

The Life Sciences industry in India is experiencing a remarkable surge, driven by a growing emphasis on precision medicine, biotechnology, and advanced diagnostics. We're seeing increased investment in research infrastructure, talent development, and innovation hubs across the country. At HORIBA, we're proud to support this momentum by providing analytical solutions that empower scientists, clinicians, and manufacturers to push boundaries and deliver meaningful outcomes.

4 mins

Platinum Rx raises $6 M to expand affordable medicine access in India

Bengaluru-based startup PlatinumRx, an online pharmacy making quality medicines affordable for chronic patients, has raised $6 million in a Series A round led by Stellaris Venture Partners, with participation from existing investor India Quotient.

1 mins

DPIIT signs MoU with Pfizer to strengthen healthcare innovation ecosystem

In a significant step towards strengthening India's healthcare innovation ecosystem, the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, has signed a Memorandum of Understanding (MoU) with Pfizer Limited.

1 mins

i-Hub Gujarat and India Accelerator launch Sanjeevan Healthcare Accelerator Programme

i-Hub Gujarat, the state's flagship startup and innovation hub under the Education Department, Government of Gujarat, in collaboration with India Accelerator (IA), India's leading fund-led accelerator, has launched the Sanjeevan Healthcare Accelerator Programme, a 12-week initiative to nurture and scale promising healthcare startups.

1 mins

Aodh Lifesciences gets support from TDB to redefine pneumonia treatment

The Technology Development Board (TDB), Department of Science and Technology, Government of India, has extended support to Aodh Lifesciences, a startup based in Hyderabad, for development of Indigenous Antibiotic Nebulisation Suspension for Pneumonia (AONEUM-04) and Antimicrobial Resistance (AMR).

1 mins

Dectrocel raises Rs 4 Cr funding led by IAN Grouppowered BioAngels

Dectrocel, a pioneering health-tech company developing artificial intelligence (AI)-powered diagnostic solutions, has raised Rs 4 crore in recent funding. The round was led by IAN Group-powered BioAngels, with participation from PadUp Ventures and Vinners.

1 mins

Reveal HealthTech secures $7.2 M to power next wave of AI-driven healthcare

Reveal HealthTech, a startup with operations in India and the US, has announced its $7.2 million Series A round led by Leo Capital with participation from Sanos Capital.

1 mins

WHO unveils updated guideline on HIV service delivery

WHO has released an updated guideline to support integrated HIV service delivery, promote long-term adherence to antiretroviral therapy (ART), and improve the overall health and well-being of people living with HIV.

1 mins

WHO updates list of essential medicines to include key cancer, diabetes treatments

The World Health Organization (WHO) has released updated editions of its Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLC), adding new treatments for various types of cancer and for diabetes with associated comorbidities such as obesity.

1 mins

WHO announces development of guidelines on multiplex testing

The World Health Organisation (WHO) is convening a Guideline Development Group (GDG) for the development of evidence-based recommendations on multiplex testing which will establish critical principles for integrated testing and address latest evidence specific to HIV, viral hepatitis and sexually transmitted infections (STIs).

1 mins

Engineering Contamination Out: Product-Led Innovation for a Safer, Smarter Pharma Floor

Across the pharmaceutical industry, regulatory auditors are voicing a consistent message: manual intervention must go. With new global guidelines such as EU GMP Annex 1 placing heightened emphasis on contamination control, manufacturers, particularly in sterile operations, are being urged to challenge longstanding practices.

2 mins

US FDA advances rare disease drug development

The US Food and Drug Administration (FDA) has introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.

1 mins

New global collaboration uses experts and AI to spot next pandemic

Global health and pandemic experts are banding together to combine their AI programmes and infectious disease knowledge to more accurately rank the viruses that have the potential to cause the next deadly pandemic.

1 mins

PAHO launches tool to monitor early child development in Latin America

The Pan American Health Organization (PAHO) has released the Spanish version of a package of measures to monitor child development up to 36 months of age.

1 mins

India's Pharma Reforms Target Global Credibility

The Indian government has introduced several measures to simplify drug approvals and support innovation. Key reforms include updating the New Drug and Clinical Trial Rules (2019) and using digital platforms to handle regulatory submissions, with the goal of improving transparency, reducing approval timelines, strengthening pharmacovigilance, and maintaining quality standards. What do these reforms entail, how is the industry responding, and what steps lie ahead to make India's pharmaceutical sector globally competitive? Let's find out.

7 mins

Navigating Cold Chain Challenges with AI Solutions

Artificial intelligence (AI) is playing a key role in driving the growth of the ever-demanding cold chain logistics sector, which caters to both the pharmaceutical and healthcare industries.

6 mins

Revitalising Cosmetic Standards & Compliance

A huge craze among consumers for cosmeceuticals, by going into marketing and brand appeal, is setting a dangerous precedent.

6 mins

“Despite high disease burden, there are no national screening guidelines for multiple myeloma in India”

France-headquartered Sebia, a global leader in specialty diagnostics, is continuing its geographic footprint to better serve its customers.

5 mins

How Waste Management Strategies Can Transform Indian Pharma Manufacturing

Sustainability will be a key success factor as India's pharmaceutical industry enters its next stage of expansion.

7 mins

Can DPDPA's Research Exemption Power Private Sector Breakthroughs?

India's Digital Personal Data Protection Act, 2023 (DPDPA), imposes uniform data protection obligations across sectors, significantly affecting healthcare, pharma, and biotech firms due to their use of sensitive personal data. Section 17(2) (b) provides limited exemptions for \"research, archiving, or statistical purposes,\" which some stakeholders interpret as broad immunity.

4 mins

How AI Is Accelerating Drug Repurposing & Therapeutic Innovation in India

With India facing increasing disease burdens and deficiencies in healthcare infrastructure, AI is becoming a driving force for quicker, more intelligent therapeutic advancements. Indian startups and institutions are making significant contributions through drug repurposing, enhancing diagnostics, genomics, and clinical research.

4 mins

ShardaCare Healthcity ropes in Dr Kousar Shah as Group CEO

ShardaCare Healthcity has appointed Dr Kousar Shah as the Group Chief Executive Officer (CEO), effective immediately.

1 mins

Antara Senior Care names Mukesh Ghuraiya as Chief Marketing Officer

Antara Senior Care, a fully integrated senior care ecosystem, has appointed Mukesh Ghuraiya as the Executive Vice-President and Chief Marketing Officer (CMO).

1 mins

GN Hearing India appoints new Country Managing Director

GN Hearing, a subsidiary of Denmark-based GN Group, has appointed Anju Kadam as its Country Managing Director for India.

1 mins

IASST synthesises new compound to combat aggressive breast cancer

A newly designed nitro-substituted organoselenium compound by Guwahati-based Institute of Advanced Study in Science and Technology (IASST), an autonomous institute under the Department of Science and Technology (DST), can reduce the invasiveness of aggressive triplenegative breast cancer cells by modulating various Se Se signalling pathways.

1 mins

Scientists in Kolkata explore therapeutic potential of accessory proteins

A hidden protein that protects our cells from mechanical stress could provide a new direction to therapeutic strategies for diseases where protein stability under force is compromised like heart muscle disease or genetic disorders called laminopathies.

1 mins

IIT-M and Danish University study reveals genetic 'switches' to transform disease research

Researchers at the Indian Institute of Technology Madras (IIT-M) and Danish University have shown how interactions between genetic variants can act like \"switches\" to unlock hidden cellular pathways.

1 mins

Revvity establishes in vivo imaging Centre of Excellence in North Carolina

Revvity, Inc. has announced the opening of its new In Vivo Imaging Centre of Excellence in Morrisville, North Carolina, the heart of the state's Research Triangle.

1 mins

Thermo Fisher introduces next-generation expression system to expand protein research

Thermo Fisher Scientific has introduced the Gibco Expi293 PRO Expression System, a next-generation HEK293 transient expression system designed to deliver exceptional protein yields for a wider variety of proteins, including low-yield and challenging proteins, with higher throughput and speed.

1 mins

Qiagen secures European CE-IVDR certification for Full QIAstat-Dx Portfolio

Qiagen has achieved CE-IVDR certification for its full portfolio of QIAstat-Dx syndromic testing systems and panels, including an expanded Meningitis/Encephalitis (ME) Panel that sets a new benchmark in the diagnosis of central nervous system (CNS) infections.

1 mins

Agilent's MMR IHC Panel pharmDx (Dako Omnis) receives European IVDR Certification

Agilent Technologies Inc. has announced that its MMR IHC Panel pharmDx (Dako Omnis) has received class C companion diagnostic (CDx) certification under EU in vitro diagnostic regulation (IVDR)1 as a CDx test for colorectal cancer.

1 mins

Sciex launches new native fluorescence detection on the BioPhase 8800 system

US-based Sciex, a global leader in life science analytical technologies, has announced the launch of new native fluorescence detection on the BioPhase 8800 system.

1 mins

Cytiva & WhiteLab Genomics join hands to use AI to accelerate cell line development

US-based Cytiva, a Danaher company and a global leader in the life sciences industry, and WhiteLab Genomics, a Paris-based techbio company specialising in artificial intelligence (AI) for genomic medicine research and development, have announced a collaboration to accelerate the development of next-generation genomic medicines.

1 mins

The Science Behind Peak Athletic Performance

Focusing on how the body works during physical exercise and how sport and physical activity encourage physical, social, and mental health, the concept of sports science and technology is garnering more attention than ever across the world.

2 mins

The Science Behind Peak Athletic Performance

2 mins

Lesen Sie alle Geschichten von Bio Spectrum

Bio Spectrum Description:

Herausgeber: MM-Activ-Sci-Tech-Communication

Kategorie: Business

Sprache: English

Frequenz: 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.