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India’s drugs standard control organisation has banned 156 popularly used fixed drug combinations, also called cocktail drugs, citing them as “irrational combinations”; that could have adverse effect on human health.
The drug combinations are used across ailments ranging from skin care, treating allergies, fever, acne, among others. Vastly used hair growth formulations have been banned too.
Popular combinations involving cetirizine – that include cetirizine HCI, paracetamol and phenlephrine (used to treat common cold and allergies), cetirizine and phenylephrine (another anti-allergic), among others – have been banned.
Popular skin-care combos – aloe (vera) and Vitamin E combination of medicated soaps; calamines-based cocktail drugs like calamine – aloe – allantoin, calamine – diphenhyramine hydrochloride – aloe-glycerine – camphor, among others stand banned too.
A popular combination of mefenamic acid and paracetamol - used to treat inflammation, migraine, headaches, toothaches, etc – has also been banned.
Minoxidil based combos, that are used to treat hair loss or are often used to claimed as hair regeneration / growth formulations have been banned. For instance, combinations involving minoxidil - azelaic acid - saw palmetto, minoxidil – aminexil – alcohol, minoxidil – aminexil, etc are to be withdrawn with immediate effect.
The newly banned cocktail drugs include levo-cetirizine and phenylephrine hydrochloride; paracetamol and pentazocine; and paracetamol, diclofenac potassium and caffeine anhydrous
Some of the drug combinations now prohibited were also a combination of commonly used active pharmaceutical ingredients (API) with herbs such as ginkgo biloba, and a mix of vitamins and enzymes.
The list also banned multi-enzyme complexes containing as many as 12-15 enzymes and over 20 formulations containing naphazoline, a decongestant commonly used in eye drops.
“Most of these drugs are in usage for over 10-15 years. And none of the banned ones are new drugs. Our committees found that these drugs have no therapeutic value or there was any scientific justification of these combos,” a Health Ministry official said adding that these drug combinations are used by a variety of pharma companies, and in some cases, used by products sold over the counter (OTC).
Some have previously been withdrawn by manufacturers already.
According to the official, State counterparts of the Central Drugs Standard Control Organisation (CDSCO) and other licensing authorities in States have been told not to grant approvals for any new drug(s) or combos. These have to be approved by the Centre.
Larger drive
The official added, that the current ban is a part of the larger drive that was set in motion post 2012. A report of the Parliamentary Standing suggested examination of drug combos licensed by the State Licensing Authority without prior approval of Drug Controller General of India (DCGI).
The Kokate Committee subsequently set up made suggestions on prohibition of various drugs. In all, 3,450 drugs were brought under its review and around 343 combinations have been prohibited previously.
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