The Indian Central Government has recently issued a binding notification that bans 14 fixed-dose combination (FDC) medicines. These are frequently used to treat common health problems such as cough, fever, and infections. The ban, which is effective immediately, was made following suggestions from an expert committee assigned to evaluate these drug combinations’ effectiveness.
Understanding Fixed-Dose Combination Medicines
Fixed-Dose Combination (FDC) medicines, as defined by the Central Drugs Standard Control Organisation (CDSCO), are products that consist of one or more active ingredients intended for particular indications. The immediate ban on the 14 FDC medicines was a direct result of the recommendations put forth by the expert committee and the Drugs Technical Advisory Board. Their investigations led them to conclude that the banned FDCs lack therapeutic relevance and may pose risks to humans.
Challenges Presented by FDC Medicines
One significant drawback of FDC medicine is the increased risk of side effects. Combining several active ingredients in one FDC drug can enhance the likelihood of adverse drug interactions, leading to increased susceptibility to side effects. Certain patients might display heightened sensitivity or allergic reactions to one or multiple components of the FDC drug. Identifying and managing such reactions can be challenging due to the drug’s fixed combination.
For instance, a combination of Paracetamol, Bromhexine, Phenylephrine, Chlorpheniramine, and Guaiphenesin in a single FDC drug may heighten the risk of side effects like elevated blood pressure, drowsiness, and dizziness.
Regulatory Challenges with FDC Medicines
Regulation of FDC drugs presents challenges due to difficulties associated with evaluating the safety and effectiveness of multiple active ingredients in a single formula. Ensuring quality control and standardisation of FDC drugs is more demanding compared to medications with a single component.
FDC drugs also encourage the misuse and overuse of medications. Patients might unknowingly consume multiple active ingredients unnecessarily or in unsuitable combinations, leading to potential health risks.
Lack of Clinical Data on FDCs
Another concern with FDC medicine is the lack of evidence-based clinical data. Some FDC drugs might have been approved based on insufficient or limited clinical evidence that supports their safety and efficacy profiles. The absence of comprehensive scientific data can create doubts about the suitability and dependability of FDC drugs for specific medical conditions.
About Central Drugs Standard Control Organisation (CDSCO)
The CDSCO operates as the Central Drug Authority for carrying out functions given to the Central Government under the Drugs and Cosmetics Act 1940. Major responsibilities include regulating control over the import of drugs, new drug approvals and clinical trials, and approving certain licences as Central Licence Approving Authority.
The Drug Controller General of India (DCGI), under the Ministry of Health & Family Welfare, is responsible for approving licences of specified categories of drugs in India, such as blood and blood products, IV fluids, vaccines and sera.
Source: TH
