Fixed dose drug combinations (FDCs) refer to pharmaceutical products that contain two or more active ingredients combined in fixed proportions in a single dosage form. These combinations are designed to treat multiple symptoms or conditions simultaneously, offering potential benefits such as enhanced efficacy, improved patient compliance, and reduced pill burden. By combining multiple drugs into a single formulation, FDCs aim to simplify treatment regimens, especially in chronic conditions where patients may need to take multiple medications daily. Moreover, FDCs can be particularly useful in addressing conditions that require synergistic effects from multiple drugs or when one component of the combination serves to mitigate the side effects of another. For example, combining an antihypertensive agent with a diuretic in a single pill can provide better control of blood pressure while minimizing adverse effects like hypokalemia. However, FDCs also have their drawbacks. One significant concern is the potential for inappropriate prescribing, as healthcare providers may opt for FDCs without considering individual patient needs or potential drug interactions. Additionally, FDCs may limit dosing flexibility, making it challenging to adjust the dosage of individual components based on patient response or changing clinical circumstances. Furthermore, safety issues can arise if one component of the combination is unnecessary or if the dosage of one drug is not appropriate for all patients within the target population. Therefore, while FDCs offer advantages in terms of convenience and therapeutic synergy, careful consideration of their appropriate use and monitoring for adverse effects is essential to maximize their benefits and minimize risks.
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Decoding the Question:
- In the intro try to define FDC’s.
- In Body,
- Write pros and cons (advantages and disadvantages of the FDCs) in two different parts of the answer.
- Try to conclude, by writing about the ban of the government and related controversies and underline India’s drug as a cheap but effective drug maker image world over.
Answer:
A Fixed-dose combination is a cocktail of two or more active drug ingredients in a fixed ratio of doses. According to IMS Health, almost half the drugs sold in India in 2018 were FDC, making it a world leader in combination drugs.Fixed-dose combination drugs can help improve adherence to an HIV treatment regimen by reducing the number of pills a person must take each day. An example of FDC HIV drug is Atripla (a combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate).
Merits of FDC’s:
- Reduced Pill Burden: Improved medication compliance by the pill burden of the patients. This will also improve drug delivery as all the needed doses are taken into one dose.
- Reduced Mental Burden: It also reduces the burden of keeping track of all the medicines, their time of taking, keeping related information in mind or remembering it is a very tedious task hence it will help patients release pressure from mind and take one pill and be assured.
- Reduce Effects of Single Drug: It is said that FDC’s help in reducing effects of single drugs or single dose on patients.
- Simplifying Drug Regime: FDC’s help in simplifying complex treatment drug regime and help in achieving desired results of drugs combination on patients.
- Treatment of type two diabetes: Four key benefits are identified and discussed in support of FDCs for treatment of patients with T2DM: Greater efficacy compared with higher dose monotherapy, Reduced risk of adverse reactions relative to higher dose monotherapy, Lower overall costs, and Improved medication concordance.
Disadvantages of the FDCs:
- Poor regulation: According to a study, of the 110 anti-TB FDCs available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator.
- Redundant Approval Process of CDSCO – Main amongst them are institutional problems such as understaffing, lack of skills, and inadequate infrastructure. However, the most significant issue is the issuance of manufacturing licenses by the State Licensing Authority without the prior clearance of the Drug Controller General of India DCG(I).
- Dangerous to human health: The FDCs formulated without due diligence can pose problems namely pharmacodynamic mismatch. One drug having additive/ antagonistic effect leading to reduced efficacy or enhanced toxicity and chemical no compatibility leading to decreased shelf life.
- No therapeutic justification: The Health ministry banned 344 FDC’s after the Drugs Technical Advisory Board recommended that there is no therapeutic justification; and involve risk to human beings;.
- Problem of plenty: The estimated number of FDCs in India is over 6000.The existence of unlimited brands of FDCs with different permutations and combinations leads to confusion rather than guiding the prescribing doctor.
Way Forward:
- Involving all stakeholders – consumers, physicians, regulatory authority, industry, and the academicians, is needed.
- Pharmaceutical companies shall be forced to uphold the ethical concepts while introducing an FDC product. They have to conduct detailed studies on such combinations.
- All the new and existing FDC products shall be subjected to a closely monitored national level post-marketing studies (Phase IV) involving identified community and hospital pharmacies in the country.
- The marketing approval for the new FDC shall be given by the DCGI only after subjecting for Pharmacoeconomic and pharmacovigilance studies for a specified period of time.
- The enforcement mechanism by the regulators needs to be strengthened. Both the central and state regulators must harmonize their procedures for licensing FDCs.
- Awareness generation over irrational use of FDCs must be enhanced to combat antibiotic resistance.
The controversy arose when the government banned these drugs due to criticism that these drugs may be dangerous to health. It is convinced a large part of the products sold as FDCs are “irrational” and lack “therapeutic justification”, besides risking the health of patients. The greater clarity on the issues is needed as it is related to public health and also it may harm India’s image as a cheap but good quality drug maker all over the world.
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