India has recently imposed a ban on 156 fixed-dose combination (FDC) drugs due to concerns about their irrationality and potential health risks.
About the recent ban:
- The 156 FDC drugs includes medications used for pain relief, fever, allergies, acidity, nausea, arthritis, and health supplements.
Reasons for the Ban
- Safety Concerns: The FDCs were banned due to potential risks to human health and the availability of safer alternatives.
- Previous Actions: India had previously banned 344 FDC drugs in 2016 and 14 FDCs in 2023, reflecting ongoing concerns about drug safety.
About FDCs
- Definition: FDCs are combinations of two or more active pharmaceutical ingredients (APIs) in fixed ratios, also known as ‘cocktail drugs.’
- Benefits:
- Improved Response Rates: Target multiple disease pathways.
- Minimized Pill Burden: Fewer pills lead to better adherence.
- Chronic Illness Management: Useful for diseases like tuberculosis and diabetes.
- Concerns:
- Chemical Reactions: Potential for enhanced toxicity or reduced efficacy due to opposing drug interactions.
- Shelf Life: Chemical incompatibility can shorten shelf life.
- Antibiotic Resistance: Risks from unapproved or banned FDCs containing antibiotics.
Regulatory Framework
- Drugs and Cosmetics Act, 1940: Section 26A allows the government to ban drugs in the public interest.
- Drugs and Cosmetics Rules, 1945: Appendix VI of Schedule Y outlines FDC approval requirements.
- Drug and Cosmetic (Amendment) Act, 2008: Grants powers to the Central Government to prohibit certain drugs.
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Frequently Asked Question:
What types of medications are included in the recent ban on 156 fixed-dose combination drugs in India?
The banned drugs include medications for pain relief, fever, allergies, acidity, nausea, arthritis, and health supplements.
What are fixed-dose combination drugs and why are they used?
Fixed-dose combination drugs are combinations of two or more active pharmaceutical ingredients in fixed ratios. They are used to target multiple disease pathways and minimize pill burden for better adherence.
What are the benefits of using fixed-dose combination drugs?
The benefits include improved response rates, minimized pill burden, and effective management of chronic illnesses like tuberculosis and diabetes.