Government bans 156 fixed-dose combination drugs; doctors explain why

Earlier this month, the Union Ministry of Health and Family Welfare announced a ban on 156 fixed-dose combination drugs (FDCs) through a Gazette notification. The notice prohibits the manufacture, sale and distribution of these drugs in the country.

An FDC includes more than one active ingredient i.e., it contains two or more drugs in a single pill or capsule. According to the notification, an Expert Committee appointed by the Central Government and the Drug Technical Advisory Board (DTAB) found these 156 drugs to be ‘irrational' and ‘no therapeutic justification' was found for the ingredients used in them. It even stated that these may cause risk to human life.

"In the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of these FDCs under Section 26A of Drugs and Cosmetics Act 1940," the statement read.

The banned drugs include antibiotics for cold, fever, etc., anti-allergy medicines, painkillers and multivitamins. Some banned FDCs are Mefenamic Acid + Paracetamol Injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine, Camylofin Dihydrochloride 25 mg + Paracetamol 300 mg, Meclizine HCl + Paracetamol + Caffeine and Tramadol HCl + Paracetamol + Caffeine + Taurine.

Given this development, we speak to Dr. Aklesh Tandekar, Head Consultant - Critical Care, Wockhardt Hospitals, Mira Road, and Dr. Pradeep Kwatra, Senior Consultant- Internal Medicine, Apollo Spectra Hospital, Delhi, to understand how FDCs work and why they have been banned.

What are FDCs and how do they function?
Tandekar: FDCs include a combination of medicines i.e., active ingredients. These are taken together in one pill/capsule/injection. They are available in different combinations, but fixed combinations. This is generally done to avoid taking multiple medicines and to improve the adherence by the patient.

These drugs work by different mechanisms. They have different pathways. And these pathways synchronise with each other so that they have enhanced effects. For example, I have pain. For pain, you have multiple receptors. If you use different drugs together, multiple receptors will receive the effect and together, you will have enhanced action of this medicine and the patient will have better pain relief. When these medicines work synergistically, the amount of concentration of the drug required is reduced. So, the dosages of these medicines are also reduced.

FDCs do have some benefits.
- The efficacy is improved. Patients will have targeted and more definitive forms of benefits from these medicines.
- The most important advantage is patient compliance. If there is one medicine to consume, the patient usually doesn't skip it. And then the patient's response to the treatment is enhanced.

Kwatra: Fixed combination drugs (FDCs) are a type of medication that combines two or more active ingredients into a single pill or dosage. They are specially designed to treat several symptoms or conditions like HIV, AIDS, diabetes, tuberculosis and high blood pressure. The primary goal of combination drugs is to treat a particular disease by taking one single tablet or capsule to make the patient more compliant and to reduce the pill burden and cost of medication.

Why has the government banned these 156 FDCs?
Tandekar: Several other reasons led to the banning of these medicines. Some of these medicines may have adverse reactions and increased risk of side effects. This is not the case with all FDCs but some have been banned. These medicines are found to have safety or efficacy concerns. These medicines may not be as effective as taking the drugs individually and there may be a chance of misuse by the patient. Sometimes, the patient can become dependent on the medicine. That is very harmful.

We cannot always monitor the benefits or adverse effects of these medicines, so pharmaceutical vigilance is compromised and there may be a risk-benefit imbalance. The benefits may be less compared to the drawbacks.

Sometimes, there is no flexibility in terms of adjusting the dosage and some agents may even be in an excessive level. In order to avoid these drawbacks, the government has scrutinised a few medicines. Also, some of these medicines do not meet regulatory standards or guidelines, so they have been banned from the market.

Kwatra: The government has significantly banned the usage of FDCs because some combinations are not helpful for the patient. We make the fixed-dose combination to have a synergistic action. But sometimes when we want to increase the dose in FDC, it can lead to toxicity and dosage adjustment becomes difficult. When these drugs interact with other medications it can significantly exacerbate one's symptoms.

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What are the risks associated with FDCs?
Tandekar: Some combinations are particularly concerning. There are medicines codeine, which has been abused in combination and has a safety concern. Some combinations have some life-threatening complications related to the heart in the form of angina or sudden cardiac death. Some agents may have effects on the kidneys or even cause liver failure. Some patients may have hypersensitivity reactions. Some of these medicines can have overdose risks also.

Sometimes, these combinations mask symptoms. If a patient is already on a beta blocker combination drug, and if they get fever or tachycardia, the symptoms may not be seen. So, the treatment or the diagnosis may be delayed in some of these patients. Some of these combinations have side effects in the form of drowsiness, dizziness and GI symptoms.

Kwatra: The risks associated with FDCs can vary from person to person depending on the amount of dosage consumed. Dosage adjustment becomes difficult and some combinations are not fruitful. The fixed combination of drugs with paracetamol or other painkillers can lead to unintentional overdose. Paracetamol is widely used in various drugs, capsules, and pills. So, taking multiple FDCs can be concerning and lead to liver and kidney damage. It can further lead to side effects like dizziness, drowsiness, gastrointestinal problems, and body pain.

Are there any alternatives to these medicines?
Kwatra: Consult a doctor to ask your concerns related to FDCs for treating a particular condition. Instead of recommending FDCs, your doctor may prescribe single ingredient medications separately. This significantly allows them to effectively control the dosage of each drug/medication.

Are medical practitioners generally aware of the effects of these drugs?
Tandekar: There has been significant awareness about these combination drugs among medical practitioners. The clinical experience also matters. Also, this is the world of specialisation and super specialisation. The primary care physicians, specialists, pharmacists have all developed their expertise and each one focuses on that particular specialty only. Earlier, general practitioners used to give medicines for different diseases also. But we now have specialists for GI disease, cardiovascular, kidney issues, etc. Staying updated is the most crucial thing.

Kwatra: Qualified practitioners do know about the effects of these drugs. FDCs are not preferred world over. In India, FDCs are used to reduce the drug cost and make the patient more compliant.

Disclaimer: This content is for informational purposes only and should not be considered professional medical advice.