Why did the Centre ban FDCs – “cocktail” drugs?
The Technical Advisory Board for Pharmaceuticals (DTAB) and an expert committee concluded that these FDCs were not therapeutically justified and posed “risks” to humans, according to an official notification from India’s health ministry, PTI reported.
What are these FDC drugs
FDC drugs, often referred to as ‘cocktail drugs’, contain a combination of two or more active ingredients in a fixed ratio. The banned drugs include ‘Aceclofenac 50 mg + Paracetamol 125 mg tablet’ – one of the popular combinations for pain relief, Mefenamic acid + Paracetamol injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorpheniramine maleate + Phenylpropanolamine and Camylofin dihydrochloride 25 mg + Paracetamol 300 mg, according to an official notification issued by the Union Health Ministry on August 12.
Complete ban on FDCs in the interest of public health
The ban was imposed based on Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to prohibit the manufacture, sale and distribution of drugs that are deemed harmful or unnecessary. The DTAB stressed that no form of regulation or restriction could justify the use of these FDCs on patients, leading to the decision for a complete ban in the interest of public health.
(With inputs from PTI)
