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Trend Analysis Of Import Refusals Of Indian Pharmaceutical Industry During The Period 2003-2023
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| Author:
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NIKITA VARSHNEY, VIJAY BHALLA, MANISH GUPTA
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| Abstract:
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All the drugs intended to be used for diagnosis, cure, mitigation treatment and/or prevention of disease must meet the same regulatory standards whether they are imported or produced locally. USFDA verifies and ensures compliance to the requirements of registration, listing, drug application, labeling, and good manufacturing practices. When one or many non-compliances happen, USFDA issues a notice of detention or refusal. The study presented here explored the drug import refusals issued to Indian Pharmaceutical Industry during the period of 2003 – 2023. Data about the refusals was extracted from the USFDA dashboard. An import refusal can impact a company in loss of reputation, trust, and finances. The major reasons identified from the study for refusals included unapproved new drugs, misbranding, adulteration, failure to comply with regulatory standards and non - English labeling and/ or inadequate labeling. The article enlists the reasons and few suggestive approaches to minimize import refusals.
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| Keyword:
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Import refusal, Pharmaceutical, Indian Pharmaceutical Industry, Adulteration, Misbranding, USFDA, New Drug, Human Drug Import
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2024.16.02.005
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| Download:
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Request For Article
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