India Bans 156 Fixed-Dose Combination Drugs Over Safety Concerns
In August 2024, the Indian government took action by banning 156 fixed-dose combination (FDC) drugs, which included painkillers, multivitamins, and antibiotics typically used for treating ailments like fever and the common cold. This isn’t the first time the authorities have acted against FDCs—back in 2016, the Ministry of Health restricted the sale of 344 FDC drugs. However, after legal challenges from pharmaceutical companies, only 14 of those drugs remained banned. Over the years, FDCs have been increasingly criticized for being harmful and scientifically unsound, posing a growing risk to public health in India.
What Are Fixed-Dose Combination Drugs?
Fixed-Dose Combination (FDC) drugs consist of two or more active pharmaceutical ingredients (APIs) combined in a single dose. According to the Central Drugs Standard Control Organisation (CDSCO), FDC drugs are formulations designed to treat specific conditions by combining multiple active ingredients in one dose. FDCs are often used to make treatment plans simpler, enhance patient compliance, and address several health issues at once, such as in managing HIV, tuberculosis, or hypertension.
By reducing the number of pills a patient needs to take, FDCs improve adherence to medical treatments. When used appropriately, they can enhance the efficacy of medicines, allowing them to work in synergy while reducing the dosage required compared to when taken separately. For example, an FDC that combines metformin and glyburide has been shown to effectively manage diabetes with lower doses compared to using the drugs individually. This can help improve patient outcomes and minimize potential side effects.
Why Are Some FDCs Being Banned?
Despite the potential benefits, the government has banned certain FDCs due to concerns regarding their safety, efficacy, and misuse. Some combinations may include drugs that are incompatible, leading to ineffective treatment or serious side effects. Many of these FDCs have not undergone the necessary clinical trials to establish their safety or effectiveness, raising significant health concerns.
Dr. Pawan Gupta, a senior consultant in pulmonary medicine at BLK-MAX Super Speciality Hospital, New Delhi, points out that some of these combinations can result in adverse effects such as arrhythmia, tachypnea, hypotension, or even life-threatening allergic reactions. Meanwhile, Dr. Narender Saini, former Honorary President of the Indian Medical Association, highlights that many of the banned FDCs consist of antibiotics, painkillers, and anti-allergic mixtures, which offer little therapeutic benefit but come with increased risks of side effects.
In India, the widespread use of FDCs was initially driven by their affordability and convenience. However, concerns arose over their irrational use, as many were approved at the state level without proper oversight from central regulatory bodies. This led to a 2018 Supreme Court order that banned 328 FDCs due to the associated health risks.
The Growing Threat of FDCs
Though FDCs can make it easier for patients to manage multiple medications, they can also increase health risks. One issue is that if a patient needs to adjust the dosage of just one component of the FDC, they would have to change the entire combination, potentially leading to under-treatment or over-treatment. Additionally, combining multiple active ingredients increases the likelihood of adverse effects, making it harder to pinpoint which ingredient is responsible for the side effects.
In the case of antibiotics, FDCs may contribute to antimicrobial resistance if some of the components are ineffective against the target infection. As India faces growing concerns over antimicrobial resistance, the decision to ban several FDCs could help curb the misuse and over-the-counter sale of these drugs. Dr. Vibhu Kawatra, a pulmonologist and allergy specialist, notes that this move could be crucial in addressing the rising threat of drug-resistant infections.
