A number of individual drugs as well as fixed dose combinations are banned in India.
Drugs undergo rigorous testing before they are introduced into the market. They are first tested in animals and then in human beings during clinical trials. The efficacy as well as safety profiles of the drug are tested. In spite of this, some adverse effects of drugs appear only after the drug is used in the general population. These adverse effects are detected though a process of regular monitoring after the drug is released called pharmacovigilance. If the adverse effects are severe or the risks of using the drug outweigh the benefits, or if the drug is ineffective, the country may ban the drug or the Drug Company may itself voluntarily withdraw the drug. Some drugs may cause adverse effects only when combined with particular drugs. In such cases, only the fixed dose combination is banned and not the individual drugs.
A number of single drugs as well as fixed dose combinations have been banned for manufacture, marketing and distribution in India. Some drugs banned in India are mentioned below:
1. Fenfluramine and dexfenfluramine
Fenfluramine and dexfenfluramine were used to treat obesity. They were widely used in slimming centers. However, they were withdrawn due to reports of diseases of heart valves, fibrosis of the heart and pulmonary hypertension. The combination of fenfluramine and phenteramine, another weight loss pill was particularly notorious for causing heart valve problems and sudden death.
2. Rimonabant
Rimonabant was particularly effective in causing weight loss. It inhibited the action of substances called cannabinoids in the brain. It has been withdrawn due to serious side effects like depression, suicidal tendencies and seizures.
3. Sibutramine
Sibutramine is a weight loss pill that has been recently banned since it caused heart related side effects.
4. Astemizole and terfinadine
Astemizole and terfinadine are antihistamines that were used to treat allergies. They were banned since they could cause a heart condition called polymorphic ventricular tachycardia and even death when used in high doses or with drugs like erythromycin, clarithromycin and ketoconazole.
5. Phenformin
Phenformin is an antidiabetic drug similar to metformin. It has been banned since it carries a high risk of lactic acidosis.
6. Rofecoxib and valdecoxib
Rofecoxib and valdecoxib were popular painkillers that were used for arthritis and other painful conditions. They resulted in pain relief without causing gastric side effects. However, they were withdrawn due to concerns of heart attack and stroke with their use.
7. Rosiglitazone
Rosiglitazone is a drug used in the treatment of type 2 diabetes. It has been banned due to an increased risk of heart attacks.
8. Gatifloxacin
Gatifloxacin is an antibiotic whose use as an oral and injectable drug has been recently banned in India. This is due to its risk for severe hyperglycemia or high blood sugar levels in the elderly.
9. Tegaserod
Tegaserod is a drug that is used to treat patients with irritable bowel syndrome with predominantly constipation. It was withdrawn from the market since patients taking this drug showed increased incidence of heart attack and stroke.
10. PergolidePergolide is a drug used for the treatment of Parkinson’s disease. It has been withdrawn from some countries since it causes damage to heart valves.
11. Furazolidone and Nitrofurazone
Furazolidone acts against some bacteria and protozoa that cause diarrhea. It is used alone as well as with other drugs such as metronidazole. It has been banned in some countries since it belongs to a class of drugs that could cause cancer. The combination of loperamide with furazolidone is banned in India.
Nitrofurazone is an antibacterial cream that belongs to the same class of drugs as furazolidone, thus there is a chance that it could also cause cancer. Hence it is banned in some countries.
12. Cerivastatin
Cerivastatin in a cholesterol lowering drug similar to atorvastatin. It was withdrawn since it caused several cases of rhabdomyolysis (damage to muscles) following which patients suffer from kidney failure. Unfortunately, it is still available in India.
13. Phenolphthalein
Phenolphthalein is a stimulant purgative. It produced cancers when tested in mice as well as damage to genes. Hence it has been banned in some countries.
14. Quinodochlor
Quinodochlor is an amoebicidal drug effective against diarrhea caused by amoebae. It caused a serious side effect called subacute myelo – optic neuropathy, initially seen in Japanese, a condition that caused nerve damage and loss of sight.
15. Tegaserod
Tegaserod is a drug that is used to treat patients with irritable bowel syndrome with predominantly constipation. It was withdrawn from the market since patients taking this drug showed increased incidence of heart attack and stroke.
16. Human Placental extract
Human placental extract is used in the cosmetic industry in the form of lotion, gel and injection. It is not permitted in some countries since it can transmit diseases to the user. It is under the scanner and may be banned in the future.
17. Thioridazine
Thioridazine is an antipsychotic drug. It causes adverse effects like arrhythmia (abnormal heart rhythm), eye damage, and a condition called neuroleptic malignant syndrome.
18. Phenylpropanolamine
Phenylpropanolamine is commonly found in cold and cough medications in India. It was also used to treat obesity in the US where it was found to increase the risk of hemorrhagic stroke (stroke due to a bleed in the brain). It also had the potential to worsen psychiatric problems. Though the dose used in cough and cold medicines is lower than that used in obesity, people buying the medication especially over the counter should be made aware of these adverse effects. This drug has come under the scanner and may soon be banned in India.
19. Metamizole (Analgin)
Analgin is a painkiller. It has been banned in some countries since it carries the risk of agranulocytosis (condition where the bone marrow does not produce certain types of white blood cells). Beside, safer painkillers that are equally effective are easily available and there is no need to take such as serious risk. Analgin itself is not banned in India but the combination of analgin with any other drug is banned.
20. Oxyphenbutazone
Oxyphenbutazone is a painkiller belonging to the same class of drugs as analgin. It has been banned in many countries since it causes bone marrow depression and other side effects. Its combination with any other drug is banned in India.
21. Nimesulide
Nimesulide is a painkiller that was not introduced in the American, UK or Australian market but is widely used in India. It has been found to cause liver failure and hence has been banned in some countries. Children with viral infection could be particularly susceptible. However, the ban has not been implemented even in children in India.
22. Cisapride
Cisapride is a drug that increases the motility of the gastrointestinal tract. It is used to treat acidity and constipation. It may cause arrhythmia when used in high doses or when combined with other drugs like erythromycin and ketoconazole; hence it is banned in some countries. Its use in India is under the scanner and it may soon face a ban.
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