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

2018 ◽  
Vol 24 (2) ◽  
pp. 238-246 ◽  
Author(s):  
Virendra S. Ligade ◽  
Tanmay M. Thakar ◽  
Swapnil J. Dengale
Paradigm ◽  
2002 ◽  
Vol 6 (2) ◽  
pp. 52-69
Author(s):  
Dilip Roy ◽  
Kaushik Mandal

This paper examines the attractiveness of Indian market keeping in mind the competitive role of the Chinese market. For doing so, multi-dimensional study has been undertaken covering economic, socio-human, infrastructure, communication, political and ethical aspects of these two countries. We further present SAW analysis for Indian market to depict the attractiveness potential and indicate the future path for strategic action.


Author(s):  
Vurimi Chaitanya Sai Manikanta

Type 2 diabetes mellitus (T2DM) is an enlightened diseases with multifactorial etiology. The first-line therapy includes monotherapy, which often fails to achieve effective glycemic control, necessitating the addition of add-on therapy. In this regard, multiple single-dose combinations called fixed-dose combinations (FDCs) have been evaluated for their safety, efficacy, and tolerability. To analyze the rationality of diverse FDCs used in the remedy Diabetes Mellitus and to find out the irrational FDCs existing in Indian market. A overall of 18 mixtures had been analyzed, amongst the ones 11 combinations had been irrational. Predominantly irrational FDCs are being circulated within the Indian market as a result thru analyses by way of prescribers is wanted earlier than prescribing to patients a good way to keep away from ADR. This requires a near scrutiny of advertised FDCs and educating prescribers to apply them with first rate care and caution also suggests an extreme evaluation of regulatory framework for drug production and marketing. An assessment of the pharmacology and scientific consequences from current hearings of the metformin-sitagliptin mixture and the way the mixture could in shape into the sort 2 diabetes remedy algorithms is obtainable on the evaluation.


Author(s):  
KUNTAL S THACKER ◽  
VIMESH R MISTRY ◽  
NEETA J KANANI

Objective: There are hundreds of brands in Indian markets for a single drug which is manufactured by various companies and thus leads to wide variation in prices for the same drug. Hence, we decide to evaluate the variation in price of different brands of the same drug available in Indian market. Methods: An analysis was done for comparing price variations among various drugs prescribed in diabetes mellitus. Indian Drug Review (IDR) (2019 Volume XXV Issue 4) and Current Index of Medical Specialties (CIMS) (July 2019–October 2019) were referred to know the maximum and minimum price in INR of drugs in all available strength and dosage forms being manufactured by different companies in India and percentage price variation was calculated. Results: Wide variation in the price of several brands of oral antidiabetics is found in Indian market. In single drug, highest price variation is found for glimepiride 1 mg tablet (1365.5%). In fixed-dose combinations (FDCs), highest price variation is found for glimepiride + metformin (2 mg + 500 mg) sustain release tablet (689.2%). Lowest price variation for FDCs was found for glimepiride + metformin (3 mg + 500 mg) tablet (4.8%). Furthermore, only few oral antidiabetic agents were included in the drug pricing control order 2013. Wide variation is seen in prices of brand and generic medicines. Conclusion: All the stakeholders should collectively make efforts to reduce price variation among the various brands so as to make them affordable and aim to improve the health status of the community.


Author(s):  
Mahesh N. Belhekar ◽  
Tejal C. Patel ◽  
Prasad R. Pandit ◽  
Kiran A. Bhave

Background: In the year 2016, Government of India had banned 350 fixed dose combinations (FDCs) for the safety and efficacy purpose. The present study was conducted to assess the knowledge, attitude and practices of the clinicians and residents about the use of FDCs at a tertiary care hospital.Methods: A questionnaire based study was conducted at a tertiary care hospital after getting approval from institutional ethics committee. A pre-validated questionnaire comprising of 30 items was distributed to 100 participants. The questionnaire focused on the prescribing behaviour, knowledge on therapeutic efficacy, advantages and limitations of FDC use, clinician perception regarding FDC use and the strategies to improve the awareness about the regulatory updates of the marketed drugs.Results: Total 52/100 clinicians responded. Out of these, 88% prescribed FDCs in their practice, 62% prescribed FDCs only after ensuring therapeutic efficacy and 50% prescribed WHO approved FDCs. 64% were aware of the recent ban on some FDCs by DCGI. Internet was the most common source of latest updates on the regulatory status of the drug, as stated by 55% clinicians. All clinicians agreed that efforts are needed to ensure that prescribers remain up to date about the post-marketing regulatory status of the drugs.Conclusions: Even though many clinicians prescribe FDCs regularly, they appreciated the step of banning some FDCs; however, the clinicians need to be trained to update themselves regularly. The source and relevance of these updates should be taught to the undergraduate students during their training period which can be reemphasized during post graduate training period.


Author(s):  
Supreet Kamni ◽  
Akram A Naikwadi ◽  
Anant Khot

Objective: To analyse the rationality of various FDCs used in the treatment Diabetes Mellitus and to find out the irrational FDCs existing in Indian market. Material and Methods: Study Design: Analytical study. Data on FDC's available in the Indian market was collected from Current Index of Medical Specialities (CIMS) and Monthly Index of Medical Specialities (MIMS) and their rationality was analysed using a pretested tool based on FDCs listed in WHO essential list of medicines and National List of Essential Medicines (NLEM), others based on their pharmacodynamic activity, Pharmacokinetic parameters and significant drug interactions occurring due to API (Active pharmaceutical ingredients) contained within the product Result: A total of 18 combinations were analysed, among those 11 combinations were irrational. Conclusion: Predominantly irrational FDCs are being circulated in the Indian market hence through analyses by prescribers is needed before prescribing to patients in order to avoid ADR. This calls for a close scrutiny of marketed FDC's and educating prescribers to use them with great care and caution also indicates a serious review of regulatory framework for drug manufacturing and marketing. KEYWORDS: Fixed Dose Combinations; Antidiabetics; Irrational.


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