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Author : Dr. A. Ramkishan, M. Pharm., Ph. D., Asst. Drugs Controller (I/c), Govt. of India
Content Overview: March - April 2014

 Cover Story


Promotion Of Domestic Production Of High End Medical Devices
The Government is taking several steps to boost the domestic production of high end Medical Devices including Medical Devices Parks, creating nodal Institute for undertaking Research & Development , providing incentives as well as...


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The Medical Devices Sector In India : Task Force Recommendations


A Task Force headed by Secretary , Department Of Pharmaceuticals, has given recommendations to address concerns and constraints facing the sector and suggested measures that would augment domestic production. It includes...


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Editorial Advisory Board


“Medical Plastics Data Service” Thanks And Welcomes Mr. C. Balagopal To The Editorial Advisory Board....


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Drug Device Combination Products : Market Review And Future Trends


The therapeutic and diagnostic products that combine drugs, devices, and/or biological products are called Combination Products . The global market for such products has been differentiated into eight segments based on...


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Global Trends

Global Biomaterials Market For Implantable Devices Driven By Polymers


Biomaterials have a key requirement of being biocompatible .The global maket is estimated to be worth...


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Industry News

  • Medical Device Industry Welcomes Task Force’s Recommendations
  •  Health Ministry Okays Plan To Monitor Medical Devices; Vigilance Cells To Be Set Up Nationwide
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Product Gallery


2015 Qosina Catalog with Thousands of Stock Components


The New 2015 Qosina Catalog offers easy browsing of thousands of stock components on a one-centimeter grid. Qosina has the largest selection of parts for the medical OEM, kit packer and pharmaceutical industries, offering free samples, low minimums, and Justin-Time (JIT) delivery...


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Did You Know?

About Challenges Of Using Combination Products
Combination products have numerous advantages but convergent technologies also have many perceived risks. Industry experts recommend avoiding combination products unless there are no alternatives.
Converging genomics, diagnostics and therapies lead to personalized medicine but many hurdles scientific, regulatory, financial etc. must be overcome.
Another issue is changing regulatory environment. Historically medical devices and pharmaceutical sectors are operated under different sets of regulations in most developed countries. Regulators are now reviewing existing regulatory pathways as great number of innovative combination products appear on the market and in R&D pipeline offering challenges for any regulatory agency because of differing views of timelines, policies, development cycles and multiplicity of configurations. The normal review paradigm is difficult to apply to combination products because of their interactions.
The third is product development path wherein integration of research stage combination technologies & product development program is risky and tends to entail higher development and manufacturing costs. In addition, using components from disciplines not part of the core business require complex management structures and collaboration with unfamiliar business partners. This complexity, combined with higher costs of regulatory compliance, slows the introduction and increases the entry costs of new technologies.
Final concern is patient compliance. The drug-eluting stent is one such example where patients who receive stents without a drug coating have an occlusion of the vessel within 6 months, whereas rest enosis rates for patients with drug-eluting stents are in the low single digits. However, current drug-eluting stent treatments require long-term anti-platelet therapy—an offlabel use for drug manufacturers. The result may be problems with patient compliance and an increased risk of heart attacks.
It should thus be emphasized that adoption of convergent technologies and their increasing benefits will be accompanied by emergence of new risks.

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From the Archives...

Global Trends

Did You Know? Industry News

Medical Polymers Market Analysis


Increasing substitution of conventional materials coupled with growing demand for medical devices from the fast developing Asian healthcare market is expected to drive medical polymer demand over the next six years. Devices and equipments are the largest application markets...

About Polymers to Restore The Sound of Music?

The development could help those who have scarred vocal cords, such as children whose cords were damaged from intubation during surgery...
  • 100% FDI for Medical Devices Under ‘Automatic Route’ Now
  • Indian GMP Requirements For Medical Devices Could Soon Resemble ISO 13485
  • NPPA Issues Notices To Medical Devices
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