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    Substandard Products

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    SENDAGIRE ARNOLD
    Substandard pharmaceutical products are authorized medical products that fail to meet quality standards or specifications. They may have issues like improper dissolution, hardness, or active pharmaceutical ingredients. According to WHO, 10% of medical products in low- and middle-income countries are substandard or falsified, affecting anti-malarial and antibiotic drugs. Substandard drugs can harm patients and increase antimicrobial resistance. They occur due to a lack of adherence to good manufacturing practices and quality control guidelines, as well as weaknesses in regulatory systems. Measures to address the problem include strengthening regulation, improving quality control, and increasing awareness.

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    Substandard Products

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    SENDAGIRE ARNOLD
    10 views4 pages
    Substandard pharmaceutical products are authorized medical products that fail to meet quality standards or specifications. They may have issues like improper dissolution, hardness, or active pharmaceutical ingredients. According to WHO, 10% of medical products in low- and middle-income countries are substandard or falsified, affecting anti-malarial and antibiotic drugs. Substandard drugs can harm patients and increase antimicrobial resistance. They occur due to a lack of adherence to good manufacturing practices and quality control guidelines, as well as weaknesses in regulatory systems. Measures to address the problem include strengthening regulation, improving quality control, and increasing awareness.

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    Brief information on substandard pharmaceutical products

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    SUBSTANDARD PRODUCTS

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    Substandard pharmaceutical products are authorized medical products that fail to meet quality standards or specifications. They may have issues like improper dissolution, hardness, or active pharmaceutical ingredients. According to WHO, 10% of medical products in low- and middle-income countries are substandard or falsified, affecting anti-malarial and antibiotic drugs. Substandard drugs can harm patients and increase antimicrobial resistance. They occur due to a lack of adherence to good manufacturing practices and quality control guidelines, as well as weaknesses in regulatory systems. Measures to address the problem include strengthening regulation, improving quality control, and increasing awareness.

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    © All Rights Reserved
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    Download as pdf or txt
    10 views4 pages

    Substandard Products

    Uploaded by

    SENDAGIRE ARNOLD
    Substandard pharmaceutical products are authorized medical products that fail to meet quality standards or specifications. They may have issues like improper dissolution, hardness, or active pharmaceutical ingredients. According to WHO, 10% of medical products in low- and middle-income countries are substandard or falsified, affecting anti-malarial and antibiotic drugs. Substandard drugs can harm patients and increase antimicrobial resistance. They occur due to a lack of adherence to good manufacturing practices and quality control guidelines, as well as weaknesses in regulatory systems. Measures to address the problem include strengthening regulation, improving quality control, and increasing awareness.

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    SUBSTANDARD PHARMACEUTICAL PRODUCTS

    According to WHO, “Substandard also called "out of specification", are authorized medical
    products that fail to meet either their quality standards or specifications, or both.”

    Quality standards are set of guideline or requirements that products or service must meet to
    ensure that they are safe, reliable and of high quality.

    Specification is the detailed description of the design, material and performance requirement
    for the products or services i.e. focus on quantifiable and measureable attributes such as
    dimensions, tolerance, material etc.

    Mainly result from not complying GMP (Good manufacturing practices) which is a set of
    guideline and standards that governs the manufacturing, processing, packaging and testing of
    pharmaceutical products.

    Compliance to this GMP ensures consistence, safety and quality and prevent substandard products.

    Substandard drugs may have inappropriate dissolution, hardness, osmolality, improper API,
    impurities etc.

    According to WHO,

    • Worldwide spread with an estimated 1 in 10 medical products in low- and middle-income


    countries is substandard or falsified
    • Pharmaceutical products of all main therapeutic categories are affected but substandard
    anti-malarial and antibiotics are amongst the most common reported
    • Found on illegal street markets, via unregulated websites through to pharmacies, clinics
    and hospitals.

    Why are Substandard drugs are of concerned

    • May cause harm to patients and fail to treat the diseases for which they were intended.
    • They lead to loss of confidence in medicines, healthcare providers and health systems.
    • Increases the burden of antimicrobial resistance and drug-resistant infections.

    Common reasons for substandard pharmaceutical products


    1. Intent to make genuine pharmaceutical products but because the manufacturer decides to
    saves costs by not following GMP.
    2. Restricted access to affordable, quality, safe and effective medicinal products
    3. Low standards of management in medical institutes, like poor ethical and corruption
    leading to failure to follow proper guidelines for procurement to genuine producers
    encouraging substandard manufacturers
    4. Lack of the adequate equipment and staffing with competence to ensure quality control
    and distribution.
    5. Loop holes in regulatory activities with low capacity to detect these cases encourages
    substandard.

    Measures to curb substandard

    ✓ Strengthening the regulatory system and capacity of national medicines authorities


    ✓ Enhancing the quality control of medical products
    ✓ Improving the surveillance and reporting of substandard and falsified products
    ✓ Raising awareness and education among health workers and the public
    ✓ Promoting research and innovation to address the root causes and consequences of
    substandard and falsified

    Brief difference of substandard, counterfeit and falsified pharmaceutical products

    Substandard Counterfeit Falsified


    product
    Authorized Deliberate and Deliberate
    products that do fraudulently misrepresentation of
    not meet quality mislabeled their identity,
    standard and with respect to composition, or source
    specification and identity,
    in most cases composition or
    intent to make source.
    quinine product
    Compiled by

    SENDAGIRE ARNOLD

    BPH 2.2
    References

    Substandard and falsified medical products. 31 January, 2018. World Health Organization.

    https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-
    products#:~:text=Substandard%20and%20falsified%20medical%20products%20are%20often%2
    0produced%20in%20very,very%20nature%20difficult%20to%20detect.

    Reasons of Distribution of Counterfeit & Substandard Drugs. 2017. Pharmaceutical Track & Trace
    System
    https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.drugtra
    ckandtrace.com/reasons-of-distribution-of-counterfeit-substandard-
    drugs/%23:~:text%3DLow%2520standards%2520of%2520management%252C%2520from,in%
    2520quality%2520control%2520and%2520distribution&ved=2ahUKEwis6piLw7mBAxVtgv0H
    HSNuDhUQFnoECBsQBQ&usg=AOvVaw0OrNYxVBD6QXopquKEjbqD

    Countering the Problem of Falsified and Substandard Drugs. 4Causes of Falsified and Substandard
    Drugs. National Academies Press (US). 2013 May 20. National Library of Medicine.
    https://www.ncbi.nlm.nih.gov/books/NBK202531/

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