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    Both India and Philippines are the subject of long-standing travel warnings from various embassies. Some say India is on the verge of nuclear war with Pakistan. In Philippines, terrorist bomb threats are all too common. Is it any wonder that Gartner Group cites security as a “key concern in outso
    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
    urcing?”

    If one only looks at the screaming headlines, then it is difficult to understand why so many intelligent people are building outsourcing operations in these apparently “unsafe” countries. But if we speak with the people actually leading the operations in Asia, we get quite a different per
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    eption of the risks involved.

    John Standring is the Manila-based General Manager of the IT outsourcing facility for Safeway, the huge American supermarket chain. He feels that while there are security risks in Philippines, they are not much different from those “of any big city in the world.” He
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    believes that with “proper security measures” there is little to worry about. It seems to me that this same advice would be appropriate for anyone visiting New York or Washington for the first time.

    Shaun Paterson is VP of Operations for the large outsourcing facility of Thomson Financial, the Can
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    dian global financial information powerhouse. He takes a similar view. Shaun feels the streets of Manila are “safer than those of London,” England (his home country) -- he says female friends visiting from Britain feel the same way. As someone with many years of Philippines experience in IT and B
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    siness Process Outsourcing, Shaun feels qualified to say that security risks are at most trivial.

    Almost all experienced managers I have spoken to make similar assessments. Some have said that the risk of personal injury is higher while driving a car to the airport for an overseas trip than it 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
    eing in the overseas country. One American manager made the point that he can’t understand why there aren’t travel warnings for the US since there is clearly a greater proven risk of terrorist attacks there. It seems to him that there have never been comparable terrorist attacks in either India or
    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
    Philippines.

    That all sounds good but Business Process Outsourcing is still a new concept to many people. Managers wishing to pursue outsourcing programs must spend a lot of time justifying their plans to skeptical department managers who face the loss of their staff. Security risk is always fla
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nted as a “key concern” in any outsourcing project – What happens if a bomb destroys our facility and kills our people? Will our senior staff be kidnapped? Aren’t these countries very corrupt? On and on.

    Another approach to explaining away the issue of Country Risk is to go back in time to an ear
    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
    ier generation of offshore outsourcing. Let’s talk about electronics.

    Intel, Philips, Toshiba and Texas Instruments are a few examples of electronics companies that have operated billion dollar facilities for decades in Philippines. Last year was Intel’s 30th year anniversary in the country. Dur
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ng that period, the company has seen a tedious parade of armed insurrections, volcanic eruptions, electricity black-outs and corruption scandals. Through all of it, they have continued supplying their critical components to the global supply chain without notable interruption.

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

    Following aspects would a
    consider themselves the “old-hands” of outsourcing and sometimes express derision at the sudden attention given to the “new-kids” of the concept, namely Business Process Outsourcing. The old-hands don’t understand why there is so much worry about spending $5M to setup a call center when for most of
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    them this is “peanuts” -- many have annual maintenance budgets that are larger than that.

    A semiconductor facility, they say, requires large buildings to be custom built, power and water supplies to be upgraded, training technical staff can take years, and so on. A BPO operation, by comparison, ha
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    a lot less to worry about.

    For these reasons, semiconductor managers sometimes refer to call centers as “outsourcing-lite” or “outsourcing-on-a-diet.” Jokes aside though, they are also full of advice and information for the younger generation of outsourcers.

    These old-hands say there are really
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    2 kinds of Country Risk to think about – one good and one bad. Country Risk that involves the threat of violence against employees or a complete breakdown of law and order (as what happens in war) is generally felt to be bad. It is reasonable to say that Haiti and Bosnia are not currently realisti
    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
    destinations for outsourcing operations for this reason. It is also reasonable to say that Philippines and India are realistic destinations since various generations of outsourcers have had successful long-term experience. Some say India is the higher risk of the 2 since it faces possible war wit
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    Pakistan – they’ve already fought 2 wars together and this time they both have nuclear weapons. But this hasn’t stopped India from becoming the King of Outsourcing, has it?

    Country Risk that affects currency values, on the other hand, can often be good for business. The head of one major semicon
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    uctor firm said it like this, “If the value of the local currency drops by 15%, then many of my costs also drop by 15%, and I know it sounds bad but this is good for my business.”

    With this in mind, countries like Philippines and India (less so) should be good long-term destinations for outsourcing
    .

    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 Philippine peso has dropped by 40% to the US dollar over just the past 5 years while the Indian rupee has not fallen to the same degree. So, does this make India a less attractive long term outsourcing option? The answer is not completely clear.

    But what is completely clear is that Security
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    Risk is not much concern to the people with experience leading outsourcing facilities in either India or Philippines. Most leaders feel the issue is over-blown almost to the point of ridiculousness. This view goes for both the current and especially the previous generations of outsourcing managers


    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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