35 fixed-dose combination drugs that include painkillers, nutrition supplements and anti-diabetics will not be sold and manufactured as directed by the apex drugs regulatory body CDSCO. Fixed-dose combination drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
These are also known as the cocktail medicines and comprise painkillers, supplements, and Fertility combinations like Nefopam Hydrochloride 30mg+, Paracetamol 325mg tablets, Cefiximeip 200mg + Ofloxacin IP 200mg Lactic acid bacillus 60 million spores tablets, etc. Some of these combinations pose a great risk to human health.
For example, taking glimepiride 1 mg with metformin 500 mg at the same time isn’t ideal because they work best when timed differently. Metformin is usually taken after food to reduce the risk of stomach upset, while glimepiride, being a sulfonylurea, should be taken before meals to help stimulate insulin release just as your blood sugar starts to rise. Taking them together can reduce their effectiveness and may increase the risk of side effects.
In a communication sent on April 11, Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi referred to the letter issued by his office on January 2013 where concerns were raised regarding the grant of manufacturing licenses for sale of FDC drugs that fall under the definition of a “New Drug” in the country without due approval from DCGI. “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 as per the provision of NDCT Rules 2019 under the Drugs and Cosmetics Act 1940. This poses a serious risk to public health and safety,” the letter stated. The approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation, the letter underlined.
Here’s the list of medicine
“Irrational combination of medicines correctly banned by CDSCO”
Welcoming the move, Dr Deep Dutta, Endocrinologist, Diabetes Super-specialist; Clinical Researcher urged people to be more careful of these mocktail medicines. “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,” he posted on X.
