Another huge crack down by Drugs Technical Advisory Board (DTAB) to prevent use of common combination drugs against fever and pain.
Are you consuming the right combination of drugs during fever, allergy or pain? Amidst rising concerns about Indian spices and milk products, Indian government has taken strict measurements on common combination drugs. Let's understand the new guidelines and why it matters to the consumers.
Fixed-dose Combination or FDC are those drugs which are comprised of “two or more active pharmaceutical ingredients in a fixed ratio”. Sometimes, they are referred to as “cocktail drugs”. As this is a combination, how it will react inside the body remain uncertain. Sometimes, people get addicted to those FDCs which may lead to death due to over consumption. Some common side effects are insomnia, irritability, loss of mental focus, anxiety, unstable blood pressure, confusion and so on.
The Centre has decided to ban at least 156 fixed-dose combination (FDC) drugs, commonly used as antibacterial medicines, cold, allergies, fever or pain, as the combinations were detected to pose severe health risks.
According to a gazette notification issued by the Union health ministry, “the banned drugs include popular combinations such as 'Aceclofenac 50mg + Paracetamol 125mg tablet', Mefenamic Acid + Paracetamol Injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine, and Camylofin Dihydrochloride 25 mg + Paracetamol 300mg.”
Moreover, the “combination of Paracetamol, Tramadol, Taurine and Caffeine” was also prohibited, as Tramadol is a well-known opioid-based painkiller.
"The central government is satisfied that the use of the Fixed Dose Combination drug is likely to involve risk to human beings whereas safer alternatives to the said drug are available," the notification said.
It further noted “the matter was examined by an Expert Committee appointed by the Centre which considered these FDCs as irrational".
An expert committee and the apex panel in the Drugs Technical Advisory Board (DTAB) found that these combinations lacked therapeutic justification while posing risks to human health.
The ban was issued under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the “government to prohibit the manufacture, sale, and distribution of drugs deemed harmful or unnecessary”.
Meanwhile, the Centre has banned at least 344 drug combinations in 2016 after an expert panel discovered that the medicines were sold without any supportive scientific data. When this ban was further challenged by manufacturers, the DTAB recommended “328 of those combinations were irrational and should be prohibited”.
In June 2023, DTAB banned 14 FDCs, part of those 344 drug combos.
When we are suffering from fever or allergy, we tend to visit a pharmacy shop and opt for self medication. In urban India, nearly 37% of people prefer self medication. The rate is 17% in rural India. This is one major reason behind spread of disease as well as recurring health issues. The ideal approach should be consulting with experienced and authorised doctor. Remember fever or allergy is not a disease, they are simply the symptoms of bigger problems (diseases).
So, stay away from self medication and seek medical attention when you are unwell.
