Daijiworld Media Network – New Delhi
New Delhi, Apr 18: In a significant move to safeguard public health, the Central Drugs Standard Control Organisation (CDSCO) has ordered a ban on the sale and manufacture of 35 fixed-dose combination (FDC) drugs, citing safety and efficacy concerns. These drugs include painkillers, nutritional supplements, fertility medications, and anti-diabetics.
Fixed-dose combination drugs, often referred to as ‘cocktail medicines,’ consist of two or more active pharmaceutical ingredients (APIs) in a predetermined ratio. While they are commonly prescribed for convenience, several of them lack scientific validation and may pose serious health risks.
The banned list includes combinations such as Nefopam Hydrochloride 30mg + Paracetamol 325mg and Cefixime IP 200mg + Ofloxacin IP 200mg + Lactic Acid Bacillus 60 million spores. One of the key combinations under scrutiny is Glimepiride 1mg + Metformin 500mg, widely used by diabetic patients. Experts warn that taking these two drugs together at the same time can reduce their effectiveness and increase side effects, as they are meant to be administered at different intervals.
In a communication dated April 11, Drugs Controller General of India (DCGI) Dr. Rajeev Raghuvanshi referred to a 2013 directive that flagged the unchecked issuance of manufacturing licenses for new FDCs without proper evaluation. “It has come to the notice of this directorate that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy... This poses a serious risk to public health and safety,” the letter stated.
Under the New Drugs and Clinical Trials (NDCT) Rules, 2019, any new drug including fixed-dose combinations must undergo rigorous safety assessments before receiving approval. The sale of unapproved FDCs violates these rules and risks causing adverse drug reactions, harmful interactions, and long-term health consequences, the DCGI noted.
Welcoming the CDSCO’s decision, renowned endocrinologist and clinical researcher Dr. Deep Dutta posted on X, “Irrational combination of medicines correctly banned by CDSCO. Hope the order is implemented strictly. Need more awareness among doctors & patients. There should be some logic, scientific basis, proof of safety & efficacy based on the kinetics of the medicines before they are combined.”
The latest ban is part of a broader effort by India's top drug regulatory body to tighten oversight of drug approvals and protect consumers from potentially harmful pharmaceutical products.