The U.S. Food and Drug Administration (FDA) is renowned as one of the world’s most stringent regulatory bodies. According to the FDA, drugs gain approval by demonstrating their safety and efficacy for specific indications. A drug is withdrawn from the market when its risks outweigh its benefits. This typically occurs due to safety issues that cannot be rectified. Surprisingly, the FDA exercises less rigorous oversight compared to drug regulators in Europe and other regions, as indicated by a 2012 study conducted at Temple University School of Pharmacy. Consequently, the FDA has sanctioned several drugs that other countries have banned due to evidence of ineffectiveness or potential risks. Here is a list of some significant drugs, ointments, or medications banned in the USA and other countries but still available in India.
India’s Approved, World’s Banned: 8 Controversial Medications:
Discover the controversial world of medications as we delve into eight drugs commonly used in India, yet banned in other countries. From Vicks VapoRub to powerful anabolic steroids, we explore the reasons behind these bans and the potential risks associated with these drugs that continue to be available in India. Learn about the differences in drug regulations across the globe and make informed choices about your healthcare.
Vicks (Used for Cough and Cold):
Vicks VapoRub, widely used to alleviate symptoms like the common cold, cough, and congestion, has been banned in North America and many European countries due to declared health risks such as the potential to cause asthma and tuberculosis. WHO classifies it as toxic. Similar medicines like D’cold and Vicks Action-500 are also banned outside India.
Reason for Ban: Reports indicate that an ingredient in Vicks has serious and hazardous side effects. Vicks Action 500 was one of 344 fixed-dose combinations banned by the Ministry of Health, including several antibiotics and analgesics.
Nandrolone Decanoate (Anabolic Steroid):
Nandrolone Decanoate, a well-known anabolic steroid popular among athletes and bodybuilders for converting excess weight into lean muscle, has been discontinued in the United States but is still used in India.
Generic Name: Nandrolone Decanoate
Pergolide (Brain-Acting Drug):
Pergolide mesylate, a dopamine agonist used for treating Parkinson’s disease, had to be withdrawn and is restricted in the USA due to recent studies finding that it caused damage to heart valves.
Brand Name: Permax
Use: Parkinson’s disease
Cerivastatin (Cholesterol-Lowering Drug):
Bayer A.G. withdrew the cholesterol-reducing drug Cerivastatin from the U.S. market in 2001 due to side effects like rhabdomyolysis (muscle destruction) leading to kidney failure. Unfortunately, it is still available in India.
Brand Name: Baycol
Furazolidone, used for treating bacterial or protozoal diarrhea, is banned in several countries due to potential carcinogenicity. In India, it is banned only in combination with loperamide + metronidazole and diphenoxylate + atropine + furazolidone.
Reason for Ban: Cancer-causing drug
Brand Names: Furoxone and Lomofen (anti-diarrheal)
Nitrofurazone, used to treat burns and infections, can possibly cause cancer and is banned in some countries but still available in India.
Pemoline (Liver-Acting Drug):
Pemoline (Cylert), used for attention deficit hyperactivity disorder (ADHD), was discontinued in the USA due to its association with life-threatening hepatic failure. However, it remains available in India.
Thioridazine (Brain-Acting Drug):
Thioridazine (Mellaril), an antipsychotic drug for treating schizophrenia, continues to be available in India despite side effects including eye damage, abnormal heart rhythms, and neuroleptic malignant syndrome.
Common Name: Mellaril
Among these banned medications, some commonly used drugs in India, such as Enteroquinal, Ciza, Syspride (for acidity and constipation), and Buclizine (an appetite stimulant), are still being sold. According to The Economic Times, antidepressant Droperidol has serious side effects only when administered in excessive doses.
It’s important to note that Vicks VapoRub is NOT banned in the United States or by WHO. However, it should be used strictly according to instructions, especially for babies, as improper use can have negative effects.