Home  |  About JAPTR |  Editorial board  |  Search |  Ahead of print  |  Current issue  |  Archives |  Submit article  |  Instructions  |  Subscribe  |  Advertise  |  Contacts  |Login 
Users Online: 358   Home Print this page Email this page Small font sizeDefault font sizeIncrease font size
Year : 2019  |  Volume : 10  |  Issue : 3  |  Page : 138-142

A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry

1 Central Drugs Standard Control Organization, Ghaziabad; Central Drugs Standard Control Organization, Ghaziabad, Director General of Health Services, MoHFW, Government of India, New Delhi, India
2 Central Drugs Standard Control Organization, Ghaziabad, Director General of Health Services, MoHFW, Government of India, New Delhi, India
3 Center for Pharmacology and Toxicology, Amity Institute of Indian System of Medicines, Amity University, Noida, Uttar Pradesh, India

Correspondence Address:
Mr. Krishan Kumar Bhardwaj
Center for Drug and Regulatory Affair, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/japtr.JAPTR_389_18

Rights and Permissions

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.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded262    
    Comments [Add]    

Recommend this journal