Context: A new study reveals that a huge volume of unapproved and even banned fixed dose combinations (FDC) of antibiotics are being sold in India.
In 2020, 60.5% FDCs of antibiotics were unapproved and another 9.9% were being sold despite being banned in India.
What are FDCs?
- Fixed Dose Combinations (FDCs) of drugs refer to pharmaceutical formulations that contain two or more active ingredients in fixed proportions in a single dosage form.
- These combinations can include drugs from the same therapeutic class or from different classes.
- Benefits: FDCs can be useful in the treatment of some diseases since the combination can improve patient compliance.
- For instance, if a patient has to take three different medications for a particular treatment, she may forget to take one. But if all three medications are combined into one tablet or one syrup, the chance of her forgetting to take one or two of the drugs is reduced.
- For diseases such as AIDS, it is well documented that FDCs have proven to be very useful in improving patient compliance, which at the end of day improves treatment outcomes.
Issues with FDCs:
- Increased Antimicrobial Resistance: Inappropriate use of FDCs can contribute to the development of antibiotic-resistant bacteria. This is because the fixed ratio may not be appropriate for all patients, and it may lead to the overuse of one or both antibiotics.
- Potential Side Effects: All drugs have side effects and when formulated together, there is a possibility that the active ingredient or even the excipients (inactive ingredients) may affect the way that each drug functions.
- E.g., The drugs may interact in a way to reduce the therapeutic efficacy of each active ingredient, or the drugs may interact with each other to create a more toxic element, often called metabolites.
- Regulatory Challenges: Pharmaceutical companies in India use FDCs to escape liability under multiple laws without much concern for public health.
- Government fixes the prices of individual drugs under the Drugs (Prices Control) Order (DPCO). Since drug combinations are traditionally not covered under the DPCO, it gives the pharmaceutical industry an easy way to escape the remit of the DPCO. As a result, the Indian market consists of various superfluous combinations of FDCs which are not found elsewhere, further being sold at high prices.
- Lack of specific FDC regulations and the sheer volume of FDCs available in the market can make it challenging to effectively ensure quality across the board.
- While there are no specific standards for FDC testing outlined in the Drugs & Cosmetics Act, 1940, the law empowers the Central Drugs Standard Control Organisation (CDSCO) to formulate guidelines and regulations for the manufacturing, testing, and quality control of all drugs, including FDCs.
- The CDSCO has established certain guidelines for FDC quality control, but these may not be as comprehensive or specific as those for individual drugs.