A fixed dose drug combination is a medicine containing two or more active components (Active pharmaceutical ingredients) in fixed proportions in a single dosage form. Several cough syrups, painkillers and dermatological drugs in India are FDCs. A good example of FDC is the combination of Paracetamol with Ibuprofen. Paracetamol is an analgesic (painkiller) and antipyretic (preventing fever), while Ibuprofen is a non-steroidal anti-inflammatory drug. This combination cures the acute pain of many types like toothache, body ache etc. Some are marketed with licenses approved only by state regulatory agencies instead of the Drug Controller General of India.

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According to US healthcare provider IMS Health, almost half the drugs sold in India in 2014 were FDC, making it a world leader in combination drugs. The Chandrakant Kokate-led expert panel, which was probing the efficacy of about 500 fixed dose combination (FDC) drugs, suggested quite a number of FDCs are irrational and hence recommended them to be banned.

Merits of FDCs:

• The basic rationale of making “fixed-dose combination” medicinal products is either to improve patient compliance or to benefit from the synergistic effects of the two medicinal products given together.
• Cost to customer: Instead of buying two, or more, separate medicines, a patient can buy just one FDC medicine to treat multiple illness symptoms, which typically works out easier on the wallet.
• Cheaper Manufacturing cost: Pharma companies, meanwhile, love them because it is far cheaper and quicker to combine existing active ingredients to make new products than to discover new medicines and manufacture them separately.
• Ease of Availability: Mostly sold as the Over the Counter drugs and needs no prescription.
• FDCs are known to offer specific advantages over the single entity preparations, such as increased efficacy, and/or a reduced incidence of adverse effects.
• FDCs have shown to be particularly useful in the treatment of infectious diseases like HIV, malaria and tuberculosis, where giving multiple antimicrobial agents is the norm.
• FDCs are also useful for chronic conditions especially, when multiple disorders co-exist.

Demerits of FDCs:

• Evades Price Control: pharma companies preferred them to circumvent price control rather than single-ingredient drugs which fall under price control.
• Market capture: Companies vie with one another for a share of the market for the same class of drugs. In order to provide something ‘new’ to prescribers, they develop and market FDCs (often irrational, but promoted as a unique and innovative product by each company) purely for commercial reasons, and support its sales through sophisticated (and often unethical) marketing strategies.
• Therapeutic benefits of many combination drugs could be doubtful and some may even pose health risks. Side effects like dizziness, nausea, hallucinations. It is also addictive.
• FDC drugs are the highest self medication drugs in India. Consumed without prescriptions (especially cough syrups) – Not safe for patients.
• FDC drugs especially Cough syrups with Codeine are suppressants rather than Curative. Hence, it distorts the perception of patients (that is the better medicine).
• With FDC drugs, side effects cannot be traced out to a single API. Hence, it may lead to lot of adverse effects on patients. It can leads to complications resulting from adverse interactions of the drugs
• Antibiotic resistance can be reduced – Since, multiple combinations of same therapeutic value are clubbed together, it provide chance for microbes to develop resistance. Ban may bring some relief in this respect
• Elimination of irrational drug combinations and control the irrational prescriptions
• Encourages the use of home remedies having same result without side effects like use of Honey, pepper, turmeric to remedy against Cough and cold.

Way forward:

• It is not advisable to ban each and every FDC drug considering the huge market size. However, the rationality of FDCs in the future should be determined based on certain key aspects as follows
• The ingredients in the combination should work by different mechanisms.
• The pharmacokinetics (effect of the drug in the body) of ingredients must not be widely different.
• FDC should not have toxins created due to a combination of ingredients.
• Only those FDCs approved by WHO can be made available