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Status of Genuine Quality of Drugs in Delhi and Their Regulations
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| Author:
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ATUL K.NASA, ARTI R. THAKKAR, ROOP K KHAR, SHYAM SUNDAR AGRAWAL, WILLIAM SELVAMURTHY
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| Abstract:
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Poor quality drugs/medicines pose a threat to the patient’s health and reputation of any Country. Effective legislative and regulatory systems are the only way to combat poor quality drugs. There are many stakeholders such as Government, Manufacturers, Distributors, Regulators and Consumers, who can control the menace of spurious/Not of Standard Quality (NSQ) drugs. Usually in cases, manufacturing and distribution of such drugs is through un-authorised channels and tracking of them require concentrated efforts. In the present study, authors have collected specimen samples (verification of their genuineness from the original manufacturer, whether the said product is being manufactured by them or not) and survey samples (qualitative analysis) of therapeutic drugs from Delhi hospitals, retailers, distributors and Bhagirath Palace market over 36-42 months. Total 5341 survey samples and 211 specimen samples were collected. It was found that out of 211 specimen samples 11 (5.21%) were spurious samples from Unlicensed manufacturer / distributors and 07 (3.31%) samples were spurious from Licensed manufacturer. These results clearly indicates that the spurious drug manufacturers are doing malpractices in a smart manner, as the none of the sample failed in identification test (qualitative analysis – survey sample) but failed in physical parameters related to packaging, printing and labelling etc. which could only be confirmed by sending the Specimen samples to the original manufacturers, who in turn compare/analyse them with their control samples retained by them. Therefore, it is required to have a proper vigil and strict cGMP regulations for supplying quality drugs to the consumers. Further we have given the various recommendations to be performed by each stakeholder to control the spurious and NSQ drugs.
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| Keyword:
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Genuine quality, survey samples, specimen samples, regulations, Delhi
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP2.299
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| Download:
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