Assessment of Rationality of Fixed Dose Combinations Approved in CDSCO List

Dalal, Krunal; Ganguly, Barna; Gor, Alpa

doi:10.7860/jcdr/2016/17856.7691

Cited by 17 publications

(23 citation statements)

References 4 publications

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“…Several studies have reported that the huge amounts of FDC's have no rational basis. 2,5,7,15,16 In a study done by Krunal Dalal et all, nearly 52% of the FDC approved between 2009-2014 are irrational.…”

Section: Series1mentioning

confidence: 99%

“…6 In a recent analysis, out of the 264 FDCs approved in India, only 54 FDCs were found to be rational and for the remaining FDCs, the safety and effectiveness remains a matter of investigation. 7 To be noted, although recently in March 2016, more than 324 Fixed Dose Combinations marketed in India are banned, still many of them are commonly prescribed and available as over the counter. 8 A study assessing knowledge of medical practitioners about rational fixed dose combination prescribing is needed because of the growing concern of irrational FDCs flooding the market.…”

Section: Introductionmentioning

confidence: 99%

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Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital

Ravichandran¹,

Balamurugan

Shankareshwari³

et al. 2017

Int J Basic Clin Pharmacol

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Background: Fixed dose combination (FDC) are currently most prescribed and misused drug forms. Although fixed dose combinations are clinically better than single dosage forms, improper prescription and large amounts of irrational FDC flooding leads to unwanted financial burden and increased resistance. Therefore a study was carried out to know about the existing scenario about Knowledge Attitude and Practice of Fixed dose combinations among the resident doctors and devise some suggestions for improving the rationality. The objective of the study was to evaluate the knowledge, attitude and prescriptional practice regarding fixed dose combinations among resident doctors working in a Government Theni medical college, Theni.Methods: A cross-sectional descriptive study involving 100 resident doctors was conducted using a pre validated questionnaire containing 21 questions to evaluate the knowledge and prescriptional practice of Fixed Dose Combination among the study participants.Results: Ninety-five percent of the study participants were aware of the Fixed dose combination. Increased compliance and synergistic drug effect are the commonly cited advantages, whereas difficulty in dose adjustment and increased side effects were the commonly told disadvantages. Only 13% of the participants could name a single banned drug. Antibiotics (63%), NSAIDS (18%) were the commonly prescribed FDCs among study participants. Internet (58%), followed by textbook (42%) and colleagues (37%) were the common sources of knowledge about FDCs. Increasing awareness about Essential Medicines List (63%), regular CME (55%) and prior notification (50%) are some of the measures recommended by study participants to improve the awareness.Conclusions: Although the participants are aware of basic knowledge of fixed dose combinations are acceptable, prescribing FDC them often, many of the study participants lack knowledge about the rationality of these drugs. From our study, conducting regular CME’s about new Fixed dose combinations in the medical colleges and periodic notification of FDC’s are some of the suggested approaches to improve the rationality of prescription. Since Internet is listed as the most common source of knowledge about FDC, information about FDC can be sent through mails, text messages, which will play a part in improving the rationality of FDC.

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Section: Series1mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital

Ravichandran¹,

Balamurugan

Shankareshwari³

et al. 2017

Int J Basic Clin Pharmacol

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“…Careful scrutiny of the Drugs and Cosmetics Act and subsequent amendments thereof, leads us to believe that there is no evident ambiguity in the licensing authorities of CDSCO and SLA, as the licensing powers have always been with CDSCO. This opinion is seconded in the academic reports [11,34,35].…”

Section: Discussionmentioning

confidence: 95%

Fixed dose combinations of anti‐tubercular, antimalarial and antiretroviral medicines on the Indian market: critical analysis of ubiquity, sales and regulatory status

Ligade

Thakar

Dengale

2018

Tropical Med Int Health

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Objective To assess the proportion and sales of unapproved Fixed Dose Combinations (FDCs) of anti‐tubercular, antimalarial and antiretroviral medicines available on the Indian market. Methods Available FDCs of anti‐tubercular, antimalarial and antiretrovirals were screened against the Central Drugs Standard Control Organization (CDSCO) database of approved FDCs. The FDC sales information in the given categories was obtained from AIOCD AWACS PharmaTrac, a market database. FDCs available in India were also screened against the National List of Essential Medicines India 2015 and the Orange Book Database of products approved by USFDA. Results Of 110 available first‐ to fourth‐line anti‐tubercular FDCs, only 32 were approved. Of 20 antimalarial FDCs available, eight were approved. However, almost 95% of available antiretroviral FDCs and branded products were approved. The sales volume of all anti‐tubercular drugs was 730 million units of which 71% were unapproved, amounting to 14.30 billion rupees in sales value (58%). Almost half of the sales value and volume of antimalarials was generated by unapproved products. About 1% of sales volume of antiretroviral FDCs came from unapproved formulations, accounting for 5% of sales value. Conclusion A large proportion of FDC formulations available in India has never been approved by CDSCO, hence raising the doubts about their safety and efficacy. An opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned.

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“…The parameters in the toolkit state that the FDC should have a marketing status in different countries, clear ‘product information’ for the indicated diseases with information leaflets, a full high-quality data set, data for marketing authorization, well-characterized safety and efficacy including compliance with a suitable code of good manufacturing practice (GMP) during manufacture, etc. Such information on safety and effectiveness are crucial because study by Dalal et al assessing the pharmacokinetic and pharmacodynamic of FDCs concluded that many of the FDCs approved were lacked of rationality [24]. In general, preclinical or clinical safety and efficacy data are not required.…”

Section: Discussionmentioning

confidence: 99%

Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study

Poudel

Ibrahim

Mishra

et al. 2017

glob health res policy

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BackgroundThe medications that are registered and available in a country are meant for the prevention and treatment of ailments and diseases. However, a lack of effective regulatory bodies and operative control mechanisms, especially in developing countries, promotes irrational and inappropriate use of medicines. This study aims to evaluate the availability and rationality of unregistered fixed-dose drug combinations (FDCs) in Nepal.MethodsA snowball sampling method with visits to 20 retail pharmacies in each of five major cities in Nepal was used to assess the availability of unregistered FDCs. To justify the rationality of the FDCs obtained from these five cities, the toolkit developed by Health Action International Asia-Pacific (HAI-AP) was used.ResultsAltogether, 41 unregistered FDCs were obtained from the five cities. Among the total 41 FDCs, a majority were anti-inflammatory/analgesic/antipyretics. A maximum of eight drugs and a minimum of two drugs per combination were present among the total 41 FDCs, with a majority in the form of tablets followed by suspensions. The cost ranges from a minimum of 3.7 Nepalese Rupees (NRs) (= USD 0.05) to a maximum of 240 NRs (= USD 3.15). None of the FDCs fulfilled all the fundamental requirements as stated in the toolkit; thus, they were categorized as ‘irrational’.ConclusionsUnregistered FDCs are available in the Nepalese pharmaceutical market. All the unregistered FDCs found in our study were ‘irrational’ as per the HAI-AP toolkit. Regulatory authorities should initiate strict monitoring and appropriate regulatory mechanisms to prohibit the use of unregistered and irrational FDCs.

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Assessment of Rationality of Fixed Dose Combinations Approved in CDSCO List

Abstract: Introduction: Fixed Dose Combination (FDC) is highly popular in the Indian pharmaceutical market and has been particularly flourishing in the last few years. Though rationality status is not clear, the pharmaceutical industry has been manufacturing and marketing FDCs.

Cited by 17 publications

References 4 publications

Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital

Knowledge, attitude and prescriptional practice about fixed dose combinations among medical practitioners in tertiary care hospital

Fixed dose combinations of anti‐tubercular, antimalarial and antiretroviral medicines on the Indian market: critical analysis of ubiquity, sales and regulatory status

Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study

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