The government of India has banned 14 fixed-dose combination (FDC) drugs, which are used for treating common infections, cough and fever. The decision was taken after the Central Drugs Standard Control Organization (CDSCO) found that these drugs may involve risk to human beings and have no therapeutic justification.
What are FDC drugs and why are they banned?
FDC drugs are those that contain two or more active ingredients in a single dosage form. They are intended to provide greater convenience and compliance to patients, as well as to reduce the cost of treatment. However, some FDC drugs may have adverse effects, such as drug interactions, increased toxicity, or reduced efficacy.
The CDSCO, which is the national regulatory authority for drugs and medical devices in India, has the power to ban any drug that is found to be unsafe or ineffective. The CDSCO has banned 14 FDC drugs after reviewing their safety and efficacy data, and consulting with an expert committee. The banned drugs include:
- Nimesulide + Paracetamol dispersible tablets
- Chlorpheniramine Maleate + Codeine Syrup
- Pholcodine + Promethazine
- Amoxicillin + Bromhexine
- Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
- Paracetamol + Bromhexine+ Phenylephrine + Chlorpheniramine + Guaiphenesin
- Salbutamol + Bromhexine
- Nimesulide + Cetirizine + Caffeine
- Nimesulide + Dicyclomine
- Nimesulide + Serratiopeptidase
- Diclofenac + Serratiopeptidase
- Diclofenac + Paracetamol + Chlorzoxazone + Famotidine
- Naproxen + Paracetamol
- Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol
The CDSCO has stated that these FDC drugs may involve risk to human beings and have no therapeutic justification. The ban will come into effect immediately and the manufacturers, distributors, and retailers of these drugs will have to stop their sale, distribution, and supply.
What are the implications of the ban?
The ban on 14 FDC drugs will affect the pharmaceutical industry, as well as the consumers and healthcare providers. According to some estimates, the market size of these drugs is around Rs 800 crore, and some of them are popular brands in the Indian market. The ban will result in a loss of revenue and market share for the manufacturers of these drugs, and may also lead to legal challenges and disputes.
The consumers and healthcare providers will also face some challenges due to the ban. Some of these drugs are widely used for common ailments, such as cough, cold, fever, pain, and inflammation. The ban will limit the availability and choice of these drugs, and may force the consumers to switch to alternative medicines, which may be more expensive or less effective. The healthcare providers will also have to revise their prescription practices and educate their patients about the risks and benefits of different drugs.
How to ensure safe and rational use of FDC drugs?
The ban on 14 FDC drugs is a step towards ensuring the safety and rationality of drug use in India. However, there are still many FDC drugs that are available and prescribed in the country, some of which may not have adequate scientific evidence or regulatory approval. Therefore, it is important to follow some guidelines and precautions while using FDC drugs, such as:
- Consult a qualified and registered medical practitioner before taking any FDC drug, and follow the prescribed dosage and duration of treatment.
- Check the label and the package insert of the FDC drug, and read the information about the active ingredients, indications, contraindications, warnings, precautions, side effects, and interactions.
- Avoid self-medication and over-the-counter purchase of FDC drugs, especially those that contain narcotics, steroids, or antibiotics.
- Report any adverse reaction or side effect of FDC drugs to the nearest pharmacovigilance centre or the CDSCO.
- Seek medical advice if the symptoms persist or worsen after taking FDC drugs, or if there is any doubt or confusion about the drug.
FDC drugs can be beneficial if they are used appropriately and rationally, but they can also be harmful if they are used indiscriminately and irrationally. Therefore, it is essential to be aware and cautious about the use of FDC drugs, and to follow the regulatory guidelines and the medical advice.