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J Adv Pharm Technol Res. 2019 Jul-Sep;10(3):138-142. doi: 10.4103/japtr.JAPTR_389_18.

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

Author information

1
Central Drugs Standard Control Organization, Ghaziabad, 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.

Abstract

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.

KEYWORDS:

Act; Central Drugs Standard Control Organization; Rule 122D; Rule 122E; Rule 21; approved combinations; court; drugs; new drugs; nonapproved fixed dose combination

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