The Indian government has recently banned 156 widely used fixed-dose combination (FDC) drugs, which are often prescribed for treating common conditions such as fever, pain, cold, and allergies. These drugs were found to be potentially harmful to human health, leading to the decision to prohibit their sale and distribution.
What Are FDC Drugs?
Fixed-dose combination (FDC) drugs contain a mix of two or more active pharmaceutical ingredients in a set ratio. These drugs are also known as “cocktail” drugs because they combine different medicines in one dose. While they are popular for treating multiple symptoms with a single pill, not all combinations are safe or effective.
Why Were These Drugs Banned?
The ban was implemented after an expert committee and the Drugs Technical Advisory Board (DTAB), the highest authority on drug safety in India, conducted a thorough review. The review revealed that many of these FDC drugs lacked proper therapeutic justification, meaning there was no strong evidence that the combinations were more effective than the individual ingredients. Furthermore, some combinations posed serious risks to human health.
A newspaper notification issued by the Union Health Ministry on August 12 outlined the details of the ban. It specified that popular combinations like ‘Aceclofenac 50mg + Paracetamol 125mg tablet’, Mefenamic Acid + Paracetamol Injection, and Cetirizine HCl + Paracetamol + Phenylephrine HCl, among others, were included in the list of banned drugs. These combinations were found to be potentially dangerous, leading to their ban.
The Role of Section 26A of the Drugs and Cosmetics Act
The ban was enforced under Section 26A of the Drugs and Cosmetics Act, 1940. This section allows the government to prohibit the manufacture, sale, and distribution of any drug that is considered harmful or unnecessary. The DTAB made it clear that there was no form of regulation or restriction that could justify the continued use of these FDC drugs. As a result, the government decided to ban these combinations entirely in the interest of public health.
According to the notification, the central government concluded that the use of these FDC drugs was likely to pose risks to human beings, especially when safer alternatives are available. The Expert Committee appointed by the Centre also examined these combinations and found them to be “irrational.” This term refers to drugs that are either unnecessary or ineffective for the treatment of the conditions they are meant to address.
The DTAB echoed these findings, stating that there was no therapeutic justification for the ingredients in these FDC drugs. They warned that these combinations could be harmful to human health. Given these concerns, the DTAB recommended a complete prohibition under Section 26A, which the government promptly implemented.
Previous Bans on FDC Drugs
This is not the first time the Indian government has taken action against FDC drugs. In 2016, the Centre banned 344 drug combinations after an expert panel found that they were being sold without proper scientific data to support their safety and efficacy. Pharmaceutical manufacturers challenged this ban in court, but the DTAB later reviewed the drugs again and concluded that 328 of those combinations were “irrational” and should be banned.
In June of last year, 14 FDCs from the original list were banned, and many of the drugs recently prohibited were also part of that list. Some of these drugs had already been discontinued by several manufacturers even before the latest ban was imposed.
The decision to ban these 156 FDC drugs highlights the government’s commitment to ensuring the safety and well-being of the public. By acting on the recommendations of expert committees and the DTAB, the government has taken a crucial step in protecting consumers from potentially harmful medications. As always, it is essential for patients to consult their healthcare providers for safe and effective alternatives to these banned drugs.
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