156 Fixed-Dose Combination Medicines Banned! Check out Why

The drug policy in India has come under greater scrutiny after the recent ban on 156 fixed-dose combination (FDC) medicines. FDC drugs contain not one but two or more active pharmaceutical ingredients, rendering this method ‘safer’ and ‘more effective’. They are commonly known as “cocktail” drugs.

Such combinations are thought to enhance convenience and medication adherence, as they are designed to focus on several diseases and disorders, providing treatment with one single medicine; the recent ban highlights the question of their safety, therapeutic justification, and potential risks to public health.

Considering the suspension of the number of Fixed-Dose combination medicines, this blog will emphasise ‘why’ the government banned these drugs, which medicines have been targeted, the risks associated with these FDC drugs, and what this means for the health system in India.

What is a Fixed-Dose Combination Medicine?

Fixed-dose combination drugs are medications that contain two or more active pharmaceutical ingredients within a specified ratio, combined in one form, in the form of a tablet, capsule, or injection. Such drugs are prepared to offer several advantages, and these include:

• Improved patient compliance: Patients experience the ease of taking one medication instead of a number of pills or injections for their multiple symptoms and health conditions.
• Synergistic effects: Administering medication together may potentiate the effect of one or other medicines.
• Cost-effective: FDCs will be more affordable for the patient as they reduce the number of prescriptions one needs. Antibiotics and painkiller medicines can be combined to cure an infection related to pain, or antihistamines combined with decongestants could be given in one dose to treat allergy symptoms and signs of nasal congestion. However, not all combinations have provided therapeutic benefits. Several FDCs have elicited concerns because of the lack of efficacy or potential adverse drug reactions.

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Reason to Ban 156 Fixed-dose Combination Medicines

Growing concerns about the safety and therapeutic justification of FDC drugs and the potential risks to patients have led the Government of India to ban 156 such drugs. These were banned under Section 26A of the Drugs and Cosmetics Act of 1940, which enables the government to prohibit the manufacturing, selling, and distributing of any drug considered harmful to human health.

The government proceeded with the ban after the scrutiny by the two expert bodies. This expert Committee was appointed by the Central Government and the Drugs Technical Advisory Board (DTAB). The two organisations examined the safety and efficacy of the banned FDCs and recommended the ban based on the following key findings:

· Lack of Therapeutic Justification

One of the major reasons such a ban was imposed was that many of the FDCs did not provide adequate therapeutic justification. In other words, some FDCs offered very little advantage over the drugs taken individually. For example, some irrational combinations were found that contain drugs with rather unrelated mechanisms of action, rendering their combination unnecessary or even counterproductive.

One example in this direction was a combination of two pain-relieving medications, namely, Paracetamol and Aceclofenac. While both are pain and inflammation control medications, the rationale of their use in an FDC became questionable since it was not found to provide additional benefits but created the potential for increasing the adverse effects of such medications.

· Risk of Adverse Reactions

Another important reason for the ban was the possibility of adverse reactions. The use of combined drugs could unpredictably affect an individual or be harmful when taken simultaneously. This leads to severe side effects outweighing the purpose of the drugs. For example, drugs like Tramadol, an opioid painkiller given together with Paracetamol, raised several issues of increasing risks that include opioid dependency, gastrointestinal complications, and liver toxicity.

The other banned FDCs are Cetirizine, Phenylephrine, and Paracetamol. These drugs treat cold and allergy symptoms together, leading to drowsiness, a sudden increase in heart rate, and fluctuating blood pressure. Sometimes, this combination of more than one drug with similar actions can worsen the side effects or even trigger other unexpected adverse health effects.

· Unnecessary Exposure to Multiple Medications

Patients who consume an FDC containing several active ingredients are unconditionally exposed to all components. However, not all drugs are necessary for that patient. This constitutes increased exposure to potential side effects and even leads to organ damage in extreme cases.

For example, some of the irrational FDCs of multivitamins include fixed-dose combinations of Taurine, Caffeine, and Paracetamol, which have limited therapeutic justification and invite risks of liver damage or sleep disturbance. Similarly, 34 other combinations of multivitamins are presently under review by the government regarding their safety and efficacy.

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Previous Bans on Fixed-Dose Combination Medicines

This ban is not an isolated event but rather a part of a broader effort by the government of India to regulate FDCs. In 2016, the government banned 344 drug combinations for being either irrational or unsafe. This ban was implemented after recommendations by an expert panel appointed by the Supreme Court to review the safety and efficiency of these combinations.

Similarly, in June 2023, it banned 14 other FDCs on similar grounds, a signal that the governmental organisation is still willing to take measures to remove unsafe, unnecessary drug combinations from the market. The recent banning of 156 drugs follows these regulatory moves to protect public health by ensuring only safe and effective drugs are made available to consumers.

Specific FDCs on the Ban List

Among the banned FDCs, some of the most notable combinations include:

• Amylase + Protease + Glucoamylase + Pectinase, among other digestive enzymes, lacked therapeutic justification and presented risks of allergic reactions.
• Mefenamic Acid + Paracetamol Injection: this fixed combination is very frequently prescribed in practice for pain relief; it presents a risk for gastrointestinal bleeding and kidney problems.
• Ergotamine tartrate + caffeine + paracetamol + prochlorperazine maleate was used especially for the treatment of migraine, which created side effects such as vertigo, stomach irritation, and insomnia.

It also banned popular over-the-counter combinations that many drug manufacturers had already voluntarily withdrawn from the market.

Why is an FDC Controversial?

FDCs have been a contentious issue in India for several years. Even though they are popular largely because of the perceived convenience a single dose with multiple drugs is believed to achieve, their safety and efficacy have often been questioned. The important concerns related to FDCs are as follows:

· Inadequate Quality Control

Sometimes, poor quality control in manufacturing FDCs may result in variable dosing and, hence, the effectiveness of active ingredients.

· Overprescription

In India, health professionals usually practice FDC overprescription. Some FDCs are prescribed without full consideration of the individual needs of the patients or the interactions between the combined drugs.

· Inadequate Research

Most FDCs have reached the market without sufficient clinical trials and evidence to support their uses. The lack of research leaves the safety and efficacy of this combination undetermined for different populations.

Implications of the Ban of Fixed-Dose Combination Medicines

The ban on these 156 FDCs has been a big step in improving how pharmaceutical regulation is carried out in India. There are a few major implications of this move:

· Stricter Regulation of the Pharmaceutical Industry

The ban is a stern word to pharmaceuticals that safety and efficiency are foreseen when developing a new drug combination. It also urges the government to take firm action regarding public health.

· Ensuring Patient Safety

A ban helps keep unsafe and irrational drug combinations off the market, reducing the risk of adverse drug reactions. Hence, patients should be offered only drugs that may be considered comparatively safer.

· Increased Scrutiny for FDCs

The ban highlights the need for increased research and review concerning FDCs already in the market. The ongoing review of 34 multivitamin FDCs represents the government’s determination to examine such drugs’ safety and necessity thoroughly.

Drug License is essential for fixed-dose combination medicines. Entities with this license adheres to the standards and guidelines showcased in the Drugs and Cosmetics Act 1940. Thus, entities must secure this license to run their venture in a compliant manner. If you are involved in the retail sale of drugs, you must secure a retail drug license.

Summing Up

The Indian government’s recent pronouncement declaring a ban on 156 FDC drugs has been a proactive measure in ensuring that only efficacious and sensible therapies are available on the market. FDCs benefit patients by being more convenient and possibly less expensive than separate medicines for the same indications. Still, the danger of irrational combinations and poor evidence cannot be overlooked.

This symbolises the overall attempt of enhancement of drug control in India to ensure that the population is kept safe and health institutions are spared unnecessary risk of harm caused by ineffective treatments available to them. Globalisation enjoys both advantages and disadvantages, and it is critical to balance both, as every positive has a negative.

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