Published on 17 Feb 2025
FDC drugs combine two or more active ingredients in a fixed ratio, improving patient compliance in treatment.
Benefits of FDC
✔ Simplified Regimens: FDCs make treatment plans easier for patients to follow.
✔ Enhanced Efficacy: FDCs are more effective than high-dose single-drug treatments.
✔ Reduced Adverse Reactions: FDCs lower the risk of side effects compared to high-dose monotherapy.
✔ Cost Efficiency: FDCs reduce overall treatment costs.
✔ Improved Compliance: FDCs boost adherence, especially in diseases like AIDS, leading to better outcomes.
Challenges of FDC
✔ Lack of Evidence and Standards: Some FDCs lack sufficient clinical evidence and established quality standards, raising efficacy and safety concerns.
✔ Price Inflation: The FDC strategy enables companies to charge higher prices.
✔ Regulatory Challenges: Evaluating FDCs is complex and complicates quality control, while companies may use them to bypass legal accountability and neglect public health.
✔ Potential Side Effects: FDCs with multiple ingredients can cause adverse interactions, such as drowsiness and elevated blood pressure.
✔ Overuse and Misuse: FDCs may lead to unnecessary intake of multiple ingredients, increasing misuse and health risks.
Govt initiatives
✔ New Drug Requirements: In 1988, the government mandated that all "new drugs," including FDCs, must have safety and efficacy approval from the DCGI.
✔ State Licensing Restrictions: State drug controllers cannot license "new drugs" without DCGI approval.
✔ FDC Bans: The Centre banned 14 FDC drugs under Section 26A of the Drugs and Cosmetics Act, 1940, due to lack of "therapeutic justification" and potential "risk" to health.
Way forward
✔ Standardization: Align central and state FDC licensing procedures for consistency.
● Example: The standardized process for combination drugs in the U.S.
✔ Amend Drug Laws: Update regulations to ensure FDCs meet high safety standards.
● Example: India’s recent clinical trial regulation amendments.
✔ Scientific Approval Process: Use a rigorous process to evaluate FDC drug interactions.
✔ Strictness on Licensing Process: Ensure rigorous evaluation before market release.
● Example: Recent bans on certain FDCs reflect stricter licensing.
✔ Strict Implementation of Laws and Regulations: Consistently enforce drug laws to uphold safety standards.
✔ Sensible Prescribing of FDCs by Doctors: Promote evidence-based prescription of FDCs to prevent misuse.
● Example: NICE guidelines in the UK support evidence-based prescribing practices.
PYQs
1. India’s Traditional Knowledge Digital Library (TKDL), which has a database containing formatted information on more than 2 million medicinal formulations, is proving a powerful weapon in the country’s fight against erroneous patents. Discuss the pros and cons of making this database publicly available under open-source licensing. (2015)
2. Can overuse and free availability of antibiotics without Doctor’s prescription, be contributors to the emergence of drug-resistant diseases in India? What are the available mechanisms for monitoring and control? Critically discuss the various issues involved. (2014)
3. What do you understand about Fixed Dose Drug Combinations (FDCs)? Discuss their merits and demerits. (2013)
Social Justice
Fixed Dose Drug Combinations
DCGI
Drugs and Cosmetics Act 1940
NICE guidelines
General Studies Paper 2
Social Justice
Related Articles