List out the merits and demerits fixed dose combinations (FDCs). (10 marks)
- Introduce with what FDCs are
- Enumerate their merits
- Enumerate their demerits
- Conclude with the recent sub-committee of DTAB’s recommendation to again ban FDCs
Fixed dose combination (FDC) drugs are combinations of two or more active drugs in a single dosage form. In 2016, the government of India banned 344 FDCs based on Kokate committee recommendations. The ban was later lifted by the Delhi High Court.
- Simpler dosage schedule improves compliance and therefore improves treatment outcomes
- Reduces inadvertent medication errors
- Prevents and/or slows attainment of antimicrobial resistance by eliminating monotherapy
- Reduces drug shortages by simplifying drug storage and handling, and thus lowers risk of being “out of stock”
- Procurement, management and handling of drugs is simplified
- Side effects of a drug may be reduced by using another drug in combination
- Potential for drug abuse can be minimized by using one drug of the combination for this purpose (i.e., excessive use of the antidiarrheal narcotic diphenoxylate is discouraged by side effects of atropine in the FDC atropine + diphenoxylate)
- Dosage alteration of one drug is not possible without alteration of the other drug.
- Differing pharmacokinetics (action of drugs in the body) of constituent drugs pose the problem of frequency of administration of the formulation
- There are increased chances of adverse drug effects and drug interactions compared with both drugs given individually.
- Dosing mismatches could result in toxicity
- Pharma companies are not providing the “safety and efficacy data” of their own FDCs, and thus making these drugs potentially dangerous.
Recently, the sub-committee of Drugs Technical Advisory Board, formed on the directions of the Supreme Court, recommended banning of 343 FDCs and restrictions on 6 others after reviewing the “safety, efficacy and therapeutic justification” of FDCs. FDC in India is treated as new drug as per the Rule 122 E of Drugs and Cosmetics Rules and DCGI is the licensing authority. The office of DCGI must examine the rationality of an FDCs in a transparent manner and bring better ways to regulate their introduction in the market (and ban the existing ones as necessary).
Subjects : Current Affairs