Vol. 32 No. 3 July -
August 2024
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Advertisers'
Index
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Accuprec Research Labs Pvt. Ltd., India |
Ambica Medicare Engineering, India |
Bry-Air Asia Pvt. Ltd., India |
Celanese Corporation, India |
CLS Pvt.
Ltd., India |
Carclo Technical Plastics Pvt. Ltd.,
India |
ET Elastomer Technik, Germany |
Eewa Engineering Co. Pvt. Ltd., India |
I-Kare Polyalloys Pvt. Ltd., India |
KLJ
Group, India |
KSM Nanotech India |
Lubrizol Advanced Materials India Pvt.
Ltd. |
Milliken & Company, India |
MCPP India Private Limited |
GLR Laboratories
Pvt. Ltd., India |
HighRichja Precision Extrusion Machinery Co. Ltd., China |
Husky
Injection Molding Systems (India) Pvt. Ltd. |
Lakshmi Electrical Control Systems
Limited |
PVC Colouring Compounding & Processing,
India |
Rapidfacto Software, India |
Qosina,
USA |
Pharmadocx, Inida |
R.R. Patel Gases (P) Ltd., India |
Raumedic AG |
Sai Extrumech Pvt. Ltd., India |
Shibaura Machine India Pvt. Ltd. |
Shriram Polytech, India |
SMC Medical Manufacturing Pvt. Ltd.,
India |
Tekni-Plex India Pvt. Ltd., India |
Trustin Laboratories, India |
Yizumi India |
Alpha Medicare and Devices Ltd., India |
Alpha Therapeutics Pvt. Ltd., India |
Angiplast Pvt. Ltd., India |
Beacon Plastics, India |
Jain Rubbers Pvt. Ltd., India |
Life-O-Line Technologist, India |
Leelavathy
Medical Device Company, India |
SEC Global Consulting & Initiative LLP,
India |
Surgi Pack India Pvt. Ltd. |
Jimit Medico Surgicals Pvt. Ltd. |
Morrisons
Lifecare Pvt. Ltd., India |
S. Nath & Co., India |
Unikal Consultants, India |
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Editorial
Drug Device Combination Medical Devices
As per US FDA, Combination Products are therapeutic and diagnostic products that
combine drugs, devices, and/or biological products.
The maturity of combination products as a market category has led to 3 key
global trends: expanding adoption of medical devices for drug delivery,
increasing complexity and growing awareness of product experience and risk.
Integrated product risk management enables robust product development and
manufacturing strategies as well as efficient regulatory pathways.
Drug-device combination products (DDCs) can include a variety of plastics,
including those used for packaging and other components...
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Editorial |
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Cover Story
Apart from performance properties including
disinfection or sterilization requirements, the most
important material consideration is biocompatibility
(ISO 10993 test results). The selection of materials
also depends on the level and duration of body
contact...
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VUCA denotes
Volatility, Uncertainty, Complexity and Ambiguity, a
perfect cocktail prevailing in the medical devices
sector in India. Entrepreneurs always thrive in such
a testing time, and the same is happening in
India...
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Article |
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Manufacturing
Dr. Atul Sardana,
Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi
The Development of
Drug/ Device Combination entails the following steps
:
Unmet Need
Identification, Design Development, Classification
of Drug/Device combinations in the currently
prevailing law in India, Regulatory Approvals such
as EU MDR-, Legal and Intellectual Property Right
Issues...
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A Tribute
As founder Director of Sree Chitra Tirunal Institute
for Medical Sciences & Technology (SCTIMST),
Trivandrum, he identified the need and took
unprecedented efforts to develop high quality
medical devices and implants meeting international
standards. Had a vision of establishing a world
class Biomedical Technology Wing campus in the
country along with a hospital...
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Article |
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Quality
Dr. M R Murali,
Dr. S S Murugan, Dr. T S Kumaravel - GLR
Laboratories Pvt. Ltd.
The biological
evaluation ( BEP ) of medical devices is crucial for
ensuring patient safety and regulatory compliance,
guided by standards like ISO 10993-1. The BEP
outlines the evaluation strategy, including test
selection and risk assessment, to address potential
biological risks and ensure compliance.
By integrating post-market
surveillance data and new scientific findings, the
biological evaluation process remains relevant and
accurate, safeguarding patient health and
maintaining high standards of medical device
safety...
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Regulation
Anil Chaudhari, Founder, Operon Strategist
The article discusses what are
challenges manufacturers of combination product may
face when seeking regulatory approval for their
integral combination product and what are
requirements for EU and US markets...
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Book Review
Author: Dr Ajay
Padsalgikar has worked for different companies
including Huntsman Polyurethanes in Belgium, Tech
Biomaterials in Australia and Abbott in Minnesota,
DSM Biomedical, Pennsylvania. He has more than 30
published scientific papers and 10 patents...
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Article |
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Global Trends
This sector, valued at
USD 110.15 billion in 2023, is a testament to the
synergy between drugs, biologics, and medical
devices, providing targeted therapeutic effects...
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Global Market - Medical Devices
Mr. Amit Dave - M. Pharm, MBA,
Former CEO – Brazil operations/ Vice President
Export - Zydus Cadila Claris Lifesciences
Colombia Highlights : A fairly
large and stable market, A decent and growing
economy, More than 80% of devices requirements are
imported, Regulatory mechanism very clear and clean,
Very competitive pricing dynamics...
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AiMeD &
Regulatory Updates
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Government Working On A Scheme To Strengthen Indian
Medical Device Sector: Pharma Secretary
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CDSCO Mandates GMP Compliance For Sterile Equipment
Manufacturers
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DoP To Launch Scheme For Common Facilities In
State-Supported Medical Device Parks: DoP Secretary
Read Full Article |
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Industry News
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FDI Inflow Into Hospitals & Diagnostic Centres Grows
89 Per Cent in 2023-24
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Medical Device Import Grows In Last One Year In
India
Read Full Article |
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Product Gallery
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Press Release
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Did You Know?
Air from the device and its parts can enter the
patient's breathing passageways, exposing internal
tissues to chemical emissions and condensates...
Read Full Article |
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