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  • Advice You - BPO - Whose Job is It, Anyway

    BPO (Business Process Outsourcing) has become a dirty word in the west. It signifies loss of jobs. It means some n
    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
    ondescript, incapable, dumb, less-than human creature sitting somewhere in the third-world is eating steadily into
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    the innards of a white-collared worker in the US or UK. Perhaps, there is some truth in that. Or, may be not. Ther
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    is another side to the whole controversy.

    For hundreds of years the west has held economic and military sway ove
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    most of the world. It's another matter that, for a period before that, the east was more advanced culturally and
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    economically. Over the past hundreds of years, those from the west looted, pillaged and exploited most of the worl
    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
    , especially the eastand Africa, in particular. But, fortune has wheels that turn and the wheel is turning and onc
    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
    again - economies of the east are poised to prosper.

    The populace from the east faced its unenviable fortune wit
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    grace and fortitude during the dark days when they were enslaved, exploited and treated with utmost contempt.

    If
    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
    things are changing and some in the US or UK or other parts of the west, are losing jobs to ‘cheap’ labour from t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e east, then let them look for sources of strength within their culture and, if they can, in their spirituality. T
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ere are millions of people starving across the world and there are consumers of useless drinks and junk food who s
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    are no thought for the hungry or lift a finger to help. Why, then, this sudden concern and paranoia?

    Are jobs and
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    employment, comfortable living and human rights the sole preserve of those from the west? Just because one belong
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    to the west does it give one an intrinsically more sacred or holy right right or privilege - a previlege just for
    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
    them and not others? These rights are equal to all the people of the world.

    The thus-far privileged ones need to
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ake up and grow up for the wheels are turning and nothing will stop the turning wheels of fortune...

    Those that s
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    poke of the mantra of free markets must now believe in it. Those that spoke of the right of might, must now accept
    .

    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
    the might of cheap labour that is equally or, maybe, more effective. Those that believed in the God of Laissez-Fai
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    e must know that the God is smiling upon their erstwhile poor brothers from the east - now, don't forsake that God


    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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