Medicine has become an important part of our life. We take medicine for every condition including acute pain and chronic severe disease. The medicines are meant to prevent disease. Most of them are essential and lifesaving but some may end up causing more harm than good. Certain drugs are restricted for use in a particular country due to safety, efficacy, or misuse concerns. Some drugs in combination or interaction with other drugs, cause severe side effects, or risks that outweigh the benefits. The Regulatory authorities are responsible for analyzing the safety of the drug. These are governmental organizations that keep an eye on clinical trial data, post-marketing surveillance, and reports of adverse effects and decide whether the drug should be in the market for use or not.
In the early 20th century, officials began banning the drug in response to the elixir sulfanilamide tragedy, in which a toxic drug formulation caused the deaths of over 100 people.
The Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare are the regulatory authorities of India who regulate and ban drugs in India.

Contents
Global Ban Ignored: Illegal Drugs Thrive in India
Several countries ban certain drugs due to safety concerns, adverse effects, or lack of efficacy, but India still allows their availability. Different regulatory standards, delayed regulatory actions, and lengthy, time-consuming procedures for taking legal action against drugs may explain their presence in India. Regulatory bodies often make varying decisions across countries due to differences in population demographics, health priorities, and insufficient reporting of adverse effect about the drug to prove that drugs have more harmful side effects than benefits. Ban drugs are still available in developing countries like India due to a lack of law imposition. Here are some examples:
Nimesulide
People commonly use nimesulide to manage acute pain, bring down fever, and reduce inflammation. It is a valuable option, especially for patients who may not respond well to other NSAIDs.
Several countries have banned Nimesulide due to liver toxicity and other adverse effects, but it remains available in India, although authorities have prohibited its use in children.
Phenylpropanolamine (PPA)
Phenylpropanolamine acts as a decongestant and appetite suppressant but authorities banned it in the U.S., Canada, and European countries in the early 2000s due to the associated risk of hemorrhagic stroke, particularly in young women.
However, in India, the regulatory order on phenylpropanolamine has been different. Some over-the-counter medications, including Vicks Action 500, still contain the drug and have not been completely banned to treat colds and coughs. Regulators have not entirely banned the drug, and manufacturers still include it in some over-the-counter (OTC) medications, such as Vicks Action 500, to treat colds and coughs.
Dicyclomine
In India, doctors mostly use dicyclomine to treat irritable bowel syndrome and other gastrointestinal disorders, though some countries have banned it due to the potential for severe side effects, including breathing difficulties in infants.
Furazolidone
Authorities in the U.S., Canada, and European countries have banned them due to their potential to cause cancer (carcinogenic effects) and severe side effects like hemolysis in people with G6PD deficiency. Although it is available in India as an antidiarrheal and antibacterial drug.
Droperidol
Several other countries, including the US, banned droperidol in 2001 due to concerns about its safety profile, particularly its association with QT interval prolongation and the risk of potentially fatal arrhythmias.
However, in India, pharmacies do not widely sell droperidol as an over-the-counter medication; instead, hospitals primarily restrict its availability, and medical professionals use it under supervision.
Nitrofurazone
Nitrofurazone, also known as furacin, serves as an antibacterial agent frequently used in topical formulations for wound care, burns, and skin infections.
It belongs to the nitrofuran class of drugs, which poses certain health risks, including potential carcinogenicity. This risk has led many countries, including the United States and European nations, to ban the use of nitrofurazone, especially in food animals, because residues can remain in animal tissues and pose a risk to human health.
However in India for certain medical uses, such as topical application in humans and veterinary medicine (non-food-producing animals)
Analgin
Analgin, also known as metamizole or dipyrone, is a painkiller and antipyretic medication.
Due to the risk of serious side effects, particularly agranulocytosis, which can be life-threatening as it drastically decreases the white blood cell count and increases the risk of infections, many countries have taken action to ban it.
In India, specific guidelines recommend prescribing it only when other safer analgesics are ineffective or unsuitable for the patient.
Nefopam
Nefopam is a non-opioid analgesic use to treat moderate to severe pain, including post-operative pain, musculoskeletal pain, and chronic pain conditions.
But prohibited in many countries like the U.S., Canada, Australia, and New Zealand. There have been reports of adverse effects, such as an increase in heart rate, confusion, hallucinations, and convulsions.
Doctors in India prescribe it to patients who may experience respiratory depression and addiction associated with opioids or the gastrointestinal side effects common with NSAIDs.
Pioglitazone
Pioglitazone is a medication used to treat type 2 diabetes by improving insulin sensitivity.
Europe countries, Canada, Australia, and New Zealand have imposed restrictions on use because they associate it with the risks of bladder cancer and heart failure. Indian regulation may advise to be vigilant about the use of pioglitazone.
Ranitidine
Governmnt in other countries have banned Ranitidine, a popular medication used to treat heartburn and acid reflux, because the Ranitidine molecule can break down into N-Nitroso-dimethylamine (NDMA), which is carcinogenic.
Though Indian government removed the drug from the recent National List of Essential Medicines 2022, but it is still sold under the name Aciloc.
Ketorolac
Ketorolac is banned in India, nepal, Sri lanka in the oral formulation but allowed to used in injectable form but with restrictions on its duration of use, but still some hospital prescribed ketorolac tablet.
The reason behind banning is the associated risk of gastrointestinal bleeding, renal impairment, and cardiovascular risks.
Chlormezanone
In India, doctors use chlormezanone as a muscle relaxant and anxiolytic.
It is banned in the US and European countries due to risk of serious adverse effects, including dependence, sedation, and impaired motor function.
Although concerning to the Health Care Professionals before using Medicine is important to decrease the potential risks of Side effects. This step ensures proper assessment of the patient’s medical history, current condition, and potential drug interactions, leading to safer and more effective treatment outcomes. This approach helps in identifying any contraindication and ensures that the chosen medication is safe and effective. By doing so, it help for identify the harmful drugs to ban and play a important role in preventing adverse reactions and promoting safer options of drugs.
Reference
https://www.ijper.org/sites/default/files/IJPER_44_1_12.pdf
https://archives.ijper.org/article/249
https://www.indianjournals.com/ijor.aspx?target=ijor:ijphrd&volume=4&issue=2&article=016
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0225429
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4243254
Written by Rutuja Adake