What is Fixed-Dose Combination (FDC) Medicine?
Fixed-dose combination (FDC) medications are a concoction of two or more active pharmaceuticals administered in a single dose. They have been proven to significantly lower the likelihood of non-adherence to treatment, which is crucial for patients with chronic conditions. In India, there are several FDCs for dermatological medications, painkillers, and cough syrups. FDC is produced when paracetamol and ibuprofen are combined. Ibuprofen is a non-steroidal anti-inflammatory medicine, whereas Paracetamol is an analgesic (pain reliever) and an antipyretic (prevents fever). This combination relieves acute pain of several kinds, including toothaches and bodily aches.
FDCs are also given licences by state regulatory agencies, despite the Indian Drug Controller General’s opposition.
Benefits of Fixed-Dose Combination (FDC):
- Generally, FDC drugs are safe and effective.
- FDCs decrease inadvertent medicine errors and decrease the cost of therapy.
- The use of FDCs decreases the total daily dosages.
- The FDC’s total medicinal efficacy is influenced by a variety of substances.
- Manufacturing and logistics costs are lower for FDCs than other products.
- It ensures low cost, convenience, regimen adherence, and little danger of antibiotic resistance for patients.
- Simple dosage schedules improve the complaints.
- The following benefits make the development of FDCs significant from the standpoint of public health.
- In particular, diabetes, HIV, malaria, TB, and other disorders and diseases that are regarded as the top global health problems are treated using FDC medicines.
Drawbacks of Fixed-Dose Combination (FDC):
- Because the combined product’s negative effects differ from those of its parts, FDCs may not be safe to eat and pose health risks.
- Risks that were not present in the individual substances can occasionally appear in the combination.
- It might be highly challenging to determine which chemical triggered an unpleasant response in a patient.
- Numerous studies have shown many of these combinations offer little benefit over individual medications.
- Resistance to antibiotics in India has risen significantly as a result of the widespread usage of FDCs. The introduction of “ciprofloxacin resistant – Salmonella typhi strains,” which have made typhoid treatment extraordinarily challenging and expensive in India, is an excellent example.
- Antibiotic resistance in India has risen significantly as a result of the widespread usage of FDCs. In India, the introduction of “ciprofloxacin resistance – Salmonella typhi strains” has made treating typhoid more difficult and expensive.
- Dosage alteration of one medicine is not possible without alteration of the other.
- Different pharmacokinetics of constituent medicine poses the problem of frequency of administration.
- FDCs are well-known not for their medicinal effects but rather for the revenues they bring into the pharmaceutical industry because of low production costs and high demand.
Issues Related to Fixed-Dose Combination (FDC):
- The Ministry of Health & Family Welfare banned 349 FDCs in 2016 citing the availability of several safer and more efficient single medication alternatives. The Chandrakant Kokate committee’s suggestions formed the basis for the prohibition.
- In response to the restriction, pharmaceutical companies filed an appeal with the Supreme Court.
- Later, the Supreme Court ordered the Drug Technical Advisory Board (DTAB) to conduct a new investigation into the FDC drug problem.
What were the Drugs Technical Advisory Board’s key Conclusions and Recommendations?
- The majority of pharmaceutical companies that produced FDCs did not produce safety and effectiveness data for their FDCs.
- The FDCs’ security, sanity, or compatibility could not be proven by 95% of the appellants.
- Most FDCs are overused and frequently not necessary. Thus, instead of using just one substance, patients are exposed to the risks of many substances.
- DTAB tightened the regulations on 343 of the previously banned 349 medicines. The remaining 6 FDCs would also be allowed, but with restrictions.
When did Fixed-Dose Combination (FDCs) get Banned?
In 2018, the Drug Technical Advisory Board (DTAB) advises banning 343 fixed-dose combinations (FDC) drugs.
The Indian Supreme Court invalidated the federal government’s decision to restrict 344 FDC medications in 2017. The Kokate committee, established by the central government, provided recommendations, and the ban was put into effect in 2016. Major pharmaceutical corporations have already contested the limitation.
What Justifications are there for the Ban?
- The prohibition would negatively impact the leading pharma manufacturers in the nation since the market for the prohibited FDC medicines is estimated to be worth between Rs 20 and 22 billion.
- These FDCs account for around 1.8% of the total domestic medication market.
- In comparison to the rest of the domestic medicine industry, the FDC sector is already growing at a slower rate. The prohibition simply makes things worse.
The number of FDCs sold throughout the nation totals more than three times as many as these 343 FDCs.
Way Forward:
It is not advisable to prohibit all FDC medications due to the scale of the market. However, future FDCs should be rationalized based on the following important considerations.
- The mixture’s components ought to function through several processes.
- Ingredient pharmacokinetics—the way a medicine behaves in the body—must be very similar.
- Toxins shouldn’t be produced by a mixture of chemicals in FDC.