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In the late 90's and in early 2000 , people around the world realised the upcoming trend widely known as outsourcing that began its race slow and sporadic and gradually developing into a trend that made impacts into the length and breadth of economic landscapes around the word in tur

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

n at the same time creating job opportunities at one side of the globe and initiating vocational culling on the other side. It took some time for the common man of both sides of the process to come in terms with the concepts and to comprehend what was going on and what does happens a

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

Examples of combination products may in

d who and who all are engaged and engulfed in the process. In the corporate world , the process of outsourcing was used as an euphemism for cost cutting exercise and at times as an excuse for firing and employee without any apparent reason.

The basic notion underlying outsourcing i

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

plies shifting of jobs that does not bind the physical presence of an employee as mandatory for carrying out the respective work he is assigned with. For example a telephone operator's physical presence do not generally affects the relationship between him and the caller and the resu

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

t may be almost same if they are 10 miles or 1000 miles apart as far as the conversation goes smooth and the caller is fed with enough information. Concurrently , the same is applied for back end clerical jobs that does not involve any physical contact with a customer. So corporates

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

Combination pro

n US and UK found this trend lucrative and back end jobs were outsourced to cheaper labour destinations like India where they can have an army of workers at their disposal for the amount they pay for a bunch of workers in their corresponding countries.

Initially the tasks that were

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

utsources included predominantly data entry works that were not necessarily time bound and data collection that was termed as boring and time consuming yet costing same as any other jobs. But as the trend progressed and attained maturity in the years that came later, data paved the w

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

ay for voice and finally sensitive information like details of bank accounts and credit card numbers of overseas clients were processed through these out sourced man power. A lot of potential job opportunities where destroyed in the originating countries and at the same time in Indi

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

and other developing countries it resulted in mushrooming establishments widely known as call centres and directly created income generation for young and educated individuals and began to indirectly influence and stimulate their economy that desperately needed foreign investment f

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

r growth and infrastructural expansion.

Soon outsourcing began to make headlines in national and international media and this time it was for those bad reasons the feel good factor associated with that until could not but help. Of late , the customers who contacted call centres noti

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

ed consistent inconsistency with the nature and tone of the responder and they realised that the calls are not handled by a native who is familiar with the local slang's and terminology that often comes in a conversation. The final blow came when news leaked that an HSBC call center

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

Following aspects would a

mployee in India ,the largest beneficiary country of call center trend without much interruption took away sensitive financial information including details of bank accounts to organised group who in turn siphoned funds as part of a conspiracy that included people in different conti

dd to the challenges in developing combination products:

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

ents .The problems that followed resembled the opening of Pandora's box and the outsourcing industry soon began to find themselves standing in the dark side of the media and public spot light. There was public outcry in countries where the jobs where taken for outsourcing and labour

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

unions took the issue in parallel with the job loss sentiment and demanded outsourcing be stopped in the best interest of the clients and those negatively affected by this trend.

Outsourcing still goes on in spite of the threats that are inherent with it but the industry has also i

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

nitiated stringent measures like employee background check up and random scrutiny of activities , the governments on the receiving side on its part enacting competent laws that gives legal powers for prosecution. More and more companies and discarding outsourcing as far as call cent

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

rs are concerned and has found new pastures like medical transcription, market research and research and development for their upcoming products and a lot of foreign software companies opening up their R&D centers in destinations where cheap yet skilled human resource can be utilize

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

Professional from academic institutions, pharmaceutical industries, health care indust

.

Outsourcing is a subject with varied implications , thanks to a multitude of factors that represents entirely different dimensions for different people who have become affected in this emerging and fast catching up trend. While the merits of outsourcing are many and highlights its

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

feel good side, the potential threats and inherent vulnerabilities that lies hidden represents a dark hole that most in the field would hesitate to confirm and admit. while outsourcing is definitely a boon for certain tasks that pertains with data or activities that has negligible

.

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

ational, strategic or commercial implications ,it is not advisable in the best interest of the companies and their clients who leave their data to a third party who has de facto control over the use and destiny of this valuable information.

The trend of outsourcing has its roots i

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

Companies that provide selfless information through particip

the inevitable globalisation whose impact and influence surpassing geographical , political , and linguistic barriers and has reshaped economic landscapes. Outsourcing at present keeps going and time will witness what lies ahead for all those who are concerned and connected with it

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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