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  • Advice You - What Is Outsourcing, And Is It Here To Stay?

    Outsourcing is the secondary product of the globalization phenomenon that swept the world in the 1990s. The immediate and most remarkable effect of globalization was that it resulted in many eco
    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
    nomies opening up for foreign investments, in a reciprocative basis, subsequently resulting in the economy of many countries becoming dependent on each other in some respect or the other. Also,
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    longside globalization came the communication revolution, which eventually bridged distances, as a result of which continents became accessible in the matter of a fraction of a second. The much
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    alked about outsourcing phenomenon of today is a result of the combination of both – globalization aided by communication revolution.

    Outsourcing can be best defined as a way of obtaining servi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    es from outside supplier – probably in a second country - predictably at a cheaper rate than possible in one’s organization or country.

    To look back to the early days of outsourcing, it started
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    off slowly by outsourcing back office works to English speaking third world countries. But, as the world started becoming more and more digitalized, and Information Technology the new buzz word,
    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
    it became necessary for multinationals involved in cutting edge technology to have more technology savvy brains at their service. When they felt a dearth of trained brains in the area/place of t
    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
    heir functioning, obviously they all turned to expert brains of the third world countries. Such a move weighed heavily on the existing economy equations of the corporate majors as outsourcing to
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    a developing country always incurred less expenditure than doing the same work at home. In fact, this was exactly the reason why corporate technical domain became more and more pro-outsourcing.
    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
    here logic is simple - if one could get quality workforce and expertise at a cheaper rate, why can’t use it to the fullest advantage?

    But the direct fall out of the trend for outsourcing – as o
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    served recently – is that it resulted in massive loss of job for employees in the developed countries, a sticky issue that had attracted a lot of political as well as public attention off late.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    n fact, economists had anticipated such an effect before hand, but now only it started taking its toll in large numbers. So what is the future of outsourcing? Will it be banned by law or is it t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ere to grow in the coming years?

    Well, there are certain jobs that need expert handling; the completion of the job at hand may need an expert in the respective domain to execute. In such cases,
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    companies are left with no choice, but either to hire one at a higher cost or outsource the work to some second company that has the resources to handle such work. Corporations support the latte
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    r option as there is a marked savings made in terms of expenditure by getting the work done at a third world country and that without compromising on the quality of the work. No wonder, it is th
    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
    big companies who are lobbying for pro-outsourcing.

    On a flip side, loss of jobs in millions is a concern for any government or country. So it is possible that some State at least will pass a
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ill that bans outsourcing to an extent, as a partial solution of loss of jobs to other countries. But how far and what all clauses it may have is what ultimately is going to make a difference. A
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    d that exactly is what all are waiting to have a look at as well.

    Mind you, something that affects the economy and on the other hand, its people, is a sticky issue of many dimensions. It implie
    .

    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
    that drawing conclusions is immature at this point of time. As of now, it is clear that outsourcing is going to stay. But it is also likely that government may step in to rein in the current tr
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nd if the loss of jobs continues in a bigger scale. As the outsourcing saga heads towards a thrilling climax, let us hope that everything will end well, without much damage to thorn and the leaf


    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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