A new study has been published by academics from India, Qatar, and the United Kingdom. The study focuses on the sale of unapproved and banned fixed dose combination (FDC) antibiotics in India.
Findings From The Study
- The study uses sales data from the pharmaceutical industry.
- The report shows that in 2020, 60.5% of antibiotic FDCs sold in India were unapproved. This equates to 239 formulations.
- Furthermore, 9.9% of the FDCs, or 39 formulations, were sold despite being banned in the country.
- The Impact on Antibacterial Microbial Resistance: The high volume of unapproved or banned antibiotic FDCs is a concern due to the rising prevalence of antibacterial microbial resistance (AMR) in India.
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Understanding FDCs
Fixed Dose Combinations, or FDCs, are pharmaceutical products. They contain two or more active substances. The substances are in fixed proportions. They come in a single dosage form.
- Variety in FDCs: FDCs can include drugs from similar or different therapeutic classes.
- Advantages of FDCs: FDCs can enhance a patient’s adherence to treatment. This is because all required medications are combined into one single pill or syrup.
- Role of FDCs in Diseases: Forgetting to take one or more drugs is less likely with FDCs. In AIDS treatment, the use of FDCs are well-documented. They help improve patient compliance. This leads to better treatment outcomes.
Issues With FDCs
- Antimicrobial Resistance: The misuse of FDCs can cause antibiotic-resistance in bacteria. This occurs because the fixed ratios of the antibiotics might not suit every patient. As a result, one or both antibiotics may be overused.
- Potential Side Effects: Drugs often have side effects. When they are combined, the active ingredient or even the inactive ones (excipients) can affect each other. This interaction can change how each drug works. When two drugs are combined, their inactive ingredients can interact. This interaction might decrease the healing power of the drugs or produce harmful byproducts known as metabolites.
- Regulation Loopholes: In India, fixed-dose combinations (FDCs) help pharmaceutical firms avoid certain laws. These companies aren’t overly concerned about public health impacts.
- Pricing Perks: The Indian government sets prices for individual drugs under the Drugs (Prices Control) Order (DPCO). But, FDCs largely stay out of this pricing order’s reach. This loophole allows the industry to sell numerous unnecessary FDCs at high prices.
- Regulatory Challenges: Without specific FDC regulations, it’s tough to ensure consistent quality. The Drugs & Cosmetics Act of 1940 doesn’t have explicit FDC standards but allows the Central Drugs Standard Control Organisation (CDSCO) to create guidelines for all drugs. The CDSCO has set up some FDC guidelines, but they may not be as detailed or thorough as those for individual drugs.
Source: India’s alarming ‘fixed dose combination’ problem (Source: The Hindu December 09, 2023)