A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry
Fixed-dose combinations (FDCs) dominating the global market because of better compliance. However, irrational combination can lead to human-made menace in terms of development of resistance, tolerance, drug abuse, and economy encumbrance. The US Food and Drug Administration defines a combination pro...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2019-01-01
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| Series: | Journal of Advanced Pharmaceutical Technology & Research |
| Subjects: | |
| Online Access: | http://www.japtr.org/article.asp?issn=2231-4040;year=2019;volume=10;issue=3;spage=138;epage=142;aulast=Bhardwaj |
| _version_ | 1818555922632409088 |
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| author | Krishan Kumar Bhardwaj K Bangarurajan Tanveer Naved Satyendra Kumar Rajput |
| author_facet | Krishan Kumar Bhardwaj K Bangarurajan Tanveer Naved Satyendra Kumar Rajput |
| author_sort | Krishan Kumar Bhardwaj |
| collection | DOAJ |
| description | Fixed-dose combinations (FDCs) dominating the global market because of better compliance. However, irrational combination can lead to human-made menace in terms of development of resistance, tolerance, drug abuse, and economy encumbrance. The US Food and Drug Administration defines a combination product as “a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product.” Unfortunately, many FDC being introduced in India are usually irrational. The need for the present study arises as the Indian drug regulatory system has been oscillating between central drug authorities versus state drug regulatory authorities. To assess the same fifty-six regulators and 70 other stakeholders including researchers, clinician, and industry people have exposed to 14 questions, and the same are used to get the insights of FDC among producers and consumers. All data were analyzed using Sigma plot Software. Data was presented in the form of percentage of response (responders vs. nonresponders, agree vs. disagree, yes vs. no). Most of the stakeholders (99%) stressed on Rule 122 to be strictly followed and same should be disseminated among all the stakeholders. Similarly, it was emphasized by more than 95% stakeholders that FDC contents should be tested as per official pharmacopoeia. |
| first_indexed | 2024-12-13T06:59:11Z |
| format | Article |
| id | doaj.art-7f02c00cf87747c6910f264af1959a4c |
| institution | Directory Open Access Journal |
| issn | 2231-4040 0976-2094 |
| language | English |
| last_indexed | 2024-12-13T06:59:11Z |
| publishDate | 2019-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Advanced Pharmaceutical Technology & Research |
| spelling | doaj.art-7f02c00cf87747c6910f264af1959a4c2022-12-21T23:55:58ZengWolters Kluwer Medknow PublicationsJournal of Advanced Pharmaceutical Technology & Research2231-40400976-20942019-01-0110313814210.4103/japtr.JAPTR_389_18A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industryKrishan Kumar BhardwajK BangarurajanTanveer NavedSatyendra Kumar RajputFixed-dose combinations (FDCs) dominating the global market because of better compliance. However, irrational combination can lead to human-made menace in terms of development of resistance, tolerance, drug abuse, and economy encumbrance. The US Food and Drug Administration defines a combination product as “a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product.” Unfortunately, many FDC being introduced in India are usually irrational. The need for the present study arises as the Indian drug regulatory system has been oscillating between central drug authorities versus state drug regulatory authorities. To assess the same fifty-six regulators and 70 other stakeholders including researchers, clinician, and industry people have exposed to 14 questions, and the same are used to get the insights of FDC among producers and consumers. All data were analyzed using Sigma plot Software. Data was presented in the form of percentage of response (responders vs. nonresponders, agree vs. disagree, yes vs. no). Most of the stakeholders (99%) stressed on Rule 122 to be strictly followed and same should be disseminated among all the stakeholders. Similarly, it was emphasized by more than 95% stakeholders that FDC contents should be tested as per official pharmacopoeia.http://www.japtr.org/article.asp?issn=2231-4040;year=2019;volume=10;issue=3;spage=138;epage=142;aulast=BhardwajActapproved combinationsCentral Drugs Standard Control Organizationcourtdrugsnew drugsnonapproved fixed dose combinationRule 122DRule 122ERule 21 |
| spellingShingle | Krishan Kumar Bhardwaj K Bangarurajan Tanveer Naved Satyendra Kumar Rajput A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry Journal of Advanced Pharmaceutical Technology & Research Act approved combinations Central Drugs Standard Control Organization court drugs new drugs nonapproved fixed dose combination Rule 122D Rule 122E Rule 21 |
| title | A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry |
| title_full | A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry |
| title_fullStr | A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry |
| title_full_unstemmed | A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry |
| title_short | A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry |
| title_sort | questionnaire based study to assess the status and perspective of fixed dose combination among the various stakeholders including regulators clinicians researchers and industry |
| topic | Act approved combinations Central Drugs Standard Control Organization court drugs new drugs nonapproved fixed dose combination Rule 122D Rule 122E Rule 21 |
| url | http://www.japtr.org/article.asp?issn=2231-4040;year=2019;volume=10;issue=3;spage=138;epage=142;aulast=Bhardwaj |
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