Subjects - Internet and Businesses Online

Offshore outsourcing to India is one of the most popular management practices today. Though it is generally perceived to be a cost re

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

duction practice, this is just one of the reasons one should consider offshore outsourcing. Most parties who outsource are unaware th

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

t Indian Service Providers do not just offer cost effective solutions, but also world class solutions living up to internet, CMM, ISO

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

and other global standards.

However, offshore outsourcing has come under attack recently. There has been an outcry by overseas

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

companies accusing Indian companies of spoiling the market rates and delivering below par quality products and services. This claim c

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

n partly be justified owing to the hoard of mom and pop outfits mushrooming in India.

But experts believe that outsourcing is

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ssential and the benefits outweigh the shortcomings by a long way. Low prices offered by markets such as India as compared to the US

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nd UK is surely one of the major reasons, the other being the cost saving in initial investment in infrastructure, training, and othe

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

such preliminaries.

There will be savings and along with these savings there is great value addition in terms of quality offe

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ed especially in markets such as India. Most who outsource only realize the quality and value addition after the offshore outsourcing

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

relationship begins. This is not usually the primary goal when deciding to outsource, and the creativity and talent in India comes as

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

a surprise to many.

Offshore Outsourcing to India is about quality and value at a reduced cost.

The f

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ct that so many companies continue to outsource is living proof of this. Along with the sheer volume of work that is pouring into the

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

country comes recognition of the talent and expertise possessed by Indian programmers and other man force. Indian software vendors ha

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

e developed more of a global services delivery capability than their counterparts in other countries. India's workforce also offers t

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

e largest pool of technical skills in the world, and the country universities add 180,000 engineering graduates to its ranks annually

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

Already many companies are outsourcing with quality rather than cost in mind.

So, the moral of the story is that outsourcing

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

s here to stay because it:

• Reduces overheads, free up resources
• Improves speed and service
• Reduces operating costs

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

> • Gets you access to specialized skills
• Saves on manpower and training costs
• Widens your skill set.
• Avoids

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

he cost of chasing technology
• Reduces the overall IT management burden while retaining control of strategic decision making

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Seeing that I hadn't the faintest idea about marketing consulting as a field, he proceeded to brief me about the industry. (Yes! It had become fashionable enough in the recent past to call the thing an industry by itself. I wonder how many people out there actually work in the industry of marketing consulting. According to my friend, they numbered in the hundreds of thousands!) But what exactly did someone in the marketing consulting industry do? Well, they did marketing like anyone else. What made their professions consulting as opposed to most of us is that they brought an element of analytics to the field.

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