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    A country is potentially eligible for the HIPC Initiative if it meets income and indebtedness criteria. Its annual per capita income must be below the threshold for eligibility for conces
    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
    sional borrowing from both the World Bank and the IMF and external public debt must exceed 150 percent of its exports (or in certain cases 250 percent of fiscal revenues). There are 40 suc
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    h potentially eligible HIPCs. To become eligible, the country must also have had a program with the IMF at some point since the start of the Initiative in 1996.

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

    ef then depends on policies being in place to ensure that it effectively contributes to poverty reduction. The fraction of debt that creditors’ are asked to forgive (the common reduction f
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    actor) is then calculated to bring the country’s debt ratio back to a sustainable level (150 percent of exports or in certain cases 250 percent of fiscal revenues).

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

    Combination pro
    lification is the decision point, at which the country must have a current track record of satisfactory performance under an IMF program, a Poverty Reduction Strategy (PRS) or an interim P
    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
    RS in place, and an agreed plan to clear any arrears to foreign creditors. At the decision point, many creditors, such as the World Bank, the IMF, multilateral development banks, and Paris
    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
    Club bilateral creditors, begin to provide debt relief, although many of these institutions maintain the right to revoke this if policy performance falters.

    Debt relief from participatin
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    g creditors becomes irrevocable at the completion point. At the decision point, the country agrees on a short list of completion point triggers, upon which the country will “graduate” from
    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
    the HIPC Initiative. These include a continued track record of satisfactory performance on an IMF program and the implementation for at least one year of the PRS. Some triggers may relat
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e to progress in social areas such as health and education, while others may relate to improving governance or fighting corruption to give donors sufficient confidence that debt relief ass
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    istance will be well-used.

    Twenty-two countries have reached the completion point: Benin, Bolivia, Burkina Faso, Cameroon, Ethiopia, Ghana, Guyana, Honduras, Madagascar, Malawi, Mali, Mau
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ritania, Mozambique, Nicaragua, Niger, Rwanda, S?o Tom? and Pr?ncipe, Senegal, Sierra Leone, Tanzania, Uganda, and Zambia. Eight countries have reached the decision point: Burundi, Chad,
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the Democratic Republic of Congo, the Republic of Congo, The Gambia, Guinea, Guinea-Bissau and Haiti.

    Ten countries remain potentially eligible: Central African Republic, Comoros, C?te d’
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    Ivoire, Eritrea, the Kyrgyz Republic, Liberia, Nepal, Somalia, Sudan, and Togo. Many of these have been beset by civil war, cross-border armed conflict, and governance challenges (includin
    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
    g in some cases the buildup of substantial arrears on external debt).

    The design of the HIPC Initiative also takes into account changes in economic circumstances brought on by external fa
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ctors beyond the government’s control during the interim between the decision point and the completion point. When the country reaches the completion point, additional debt relief (toppin
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    g up) may be granted to mitigate the impact of external shocks and ensure that the debt ratio at the completion point is sustainable.

    A review of the HIPC Initiative by the World Bank Gro
    .

    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
    up’s Independent Evaluation Group found that it has enabled higher spending on countries’ social programs and poverty reducing investments but also noted the need to manage expectations of
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    what debt relief can realistically achieve. Long-run debt sustainability ultimately relies on countries’ broader success in building the institutions to support sustained economic growth.


    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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