A fixed dose combination drug is a medicine containing two or more active components (Active pharmaceutical ingredients) in fixed proportions in a single dosage form. 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.

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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.

Popularity of FDCs are due to:

• 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.
• 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.
• Ease of Availability: Mostly sold as the Over the Counter drugs and needs no prescription.
• 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.

Reasons for the Government to ban FDC drugs:

• 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.

Problems in banning FDCs:

• The problem of unapproved FDCs mainly affects those who get treated in the private sector. In the absence of a strong pharmacovigilance mechanism in India, there is no data on adverse events of these unapproved FDCs.
• There are multiple deficiencies in the Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator’s approval process for FDCs.
• Main amongst them are institutional problems such as understaffing, lack of skills, and inadequate infrastructure.
• The most significant issue is the issuance of manufacturing licenses by the State Licensing Authority without the prior clearance of the Drug Controller General of India DCG (I), the head of CDSCO.
• According to a study, of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the CDSCO.
• The market size of the banned drugs is estimated to be around Rs 20-22 billion. The ban, if comes into force, will thus impact the country’s top drug-makers.
• Large pharma companies have reportedly said that the impact is expected to be negligible since the FDCs in question are less than 2% of the pie.
• They added that over the last couple of years, they have either phased out such drugs or changed the combination.

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.