- Adverse drug reactions - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6297296/)
- A study on drug safety monitoring program in India - (https://www.ijpsonline.com/articles/a-study-on-drug-safety-monitoring-program-in-india.html)
- Rise and fall of anti-obesity drugs - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083904/)
- Withdrawal of COX-2 selective inhibitors rofecoxib and valdecoxib: impact on NSAID and gastroprotective drug prescribing and utilization - (https://pubmed.ncbi.nlm.nih.gov/17605893/)
- Consensus Statement for the Diagnosis and Treatment of Urticaria: A 2017 Update - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838750/)
- Ban on Manufacture for sale and Distribution of Rosiglitazone and their formulations for human use - (https://www.dfda.goa.gov.in/media-1/158-ban-on-manufacture- for-sale-and-distribution-of-rosiglitazone-and-their-formulations-for-human-use)
- Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819028/)
- Cardiovascular safety of prokinetic agents: A focus on drug-induced arrhythmias - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6364982/)
- Gatifloxacin Ophthalmic Solution for Treatment of Bacterial Conjunctivitis: Safety, Efficacy and Patient Perspective - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619660/)
- Prohibition of 328 Fixed Dose Combinations by the Central Government vide Gazette notification nos. S.O. 4379 (E) to S.O. 4706(E) - (https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk1Mg==)
- List of Drugs Prohibited for Manufacture and Sale Through Gazette Notifications Under Section 26a of Drugs & Cosmetics Act 1940 by the Ministry of Health and Family Welfare With Their Present Status As On 22.11.2021 - (https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODE5Mg==)
- Substandard (contaminated) paediatric medicines - (https://www.who.int/news/item/05-10-2022-medical-product-alert-n-6-2022-substandard-(contaminated)-paediatric-medicines)
- Oxyphenbutazone - (https://pubchem.ncbi.nlm.nih.gov/compound/Oxyphenbutazone)
- Use of nimesulide in Indian children must be stopped - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1125612/)
- Propoxyphene and the Risk of Out-of-Hospital Death - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3694329/)
- Furazolidone therapy for Helicobacter pylori: Is it effective and safe? - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670425/)
- Detection, accumulation and distribution of nitrofuran residues in egg yolk, albumen and shell - (https://pubmed.ncbi.nlm.nih.gov/17164214/)
- Anabolic Steroids - (https://www.ncbi.nlm.nih.gov/books/NBK482418/)
- Discontinuation of thioridazine - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1124456/)
- Pergolide - (https://pubchem.ncbi.nlm.nih.gov/compound/Pergolide)
- Pemoline - (https://pubchem.ncbi.nlm.nih.gov/compound/Pemoline)
- Withdrawal of cerivastatin from the world market - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC59524/)
- Case series on a diversity of illicit weight-reducing agents: from the well known to the unexpected - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3040546/)
- Final report on the safety assessment of human placental protein, hydrolyzed human placental protein, human placental enzymes, human placental lipids, human umbilical extract, placental protein, hydrolyzed placental protein, placental enzymes, placental lipids, and umbilical extract - (https://pubmed.ncbi.nlm.nih.gov/12042062/)
Drugs 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 for their efficacy as well as safety. Despite all precautions, some adverse effects of drugs appear only when the drug is used in the general population after its approval. These adverse effects are detected though a process of regular monitoring after the drug is released into the market called pharmacovigilance(1✔ ✔Trusted Source
Adverse drug reactions
Go to source).
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(2✔ ✔Trusted Source
A study on drug safety monitoring program in India
Go to source).
A number of single drugs as well as fixed dose combinations have been banned for manufacturing, marketing and distribution in India. Some individual drugs banned in India are mentioned below:
Drugs Used for Obesity and Weight Loss - Fenfluramine, dexfenfluramine, rimonabant , sibutramine, phenylpropanolamine
The introduction of
Rise and fall of anti-obesity drugs
Go to source):
- Fenfluramine and dexfenfluramine affected the cardiovascular system and were associated with diseases of the heart valves, the formation of fibrous tissue in the heart, and pulmonary hypertension (high blood pressure in the lung circulation).
- Rimonabant was withdrawn due to its association with serious brain-related side effects like
depression , suicidal tendencies and seizures. - Sibutramine has been banned since it caused cardiovascular side effects like heart attack and stroke(3✔ ✔Trusted Source
Rise and fall of anti-obesity drugs
Go to source).
Non-steroidal Painkillers - Rofecoxib, Valdecoxib
Rofecoxib and valdecoxib were second generation non-steroidal painkillers. They claimed to provide pain relief without causing stomach ulcers unlike conventional painkillers like aspirin, ibuprofen and indomethacin. However, their use was eclipsed with a higher incidence of heart attack and stroke in patients taking the drugs and therefore, they were banned.
Patients taking valdecoxib were also at a higher risk for serious skin reactions. These adverse effects did not support the use of these drugs for pain relief when safer drugs are available(4✔ ✔Trusted Source
Withdrawal of COX-2 selective inhibitors rofecoxib and valdecoxib: impact on NSAID and gastroprotective drug prescribing and utilization
Go to source).
Anti-allergy Drugs - Astemizole, Terfenadine
Astemizole and terfenadine belong to a class of edications called antihistamines and were used to prevent and treat allergies. They have been withdrawn because they were linked to a problem with the heart rhythm called torsades de pointes, especially when used along with certain other drugs like erythromycin and ketoconazole(5✔ ✔Trusted Source
Consensus Statement for the Diagnosis and Treatment of Urticaria: A 2017 Update
Go to source).
Antidiabetes Drugs - Phenformin, Rosiglitazone
Phenformin, an anti-diabetes drug related to metformin, was banned because it caused lactic acidosis, where it increased the pH of the blood. In more recent times, rosiglitazone has been withdrawn because of its associated risk of heart attack(6✔ ✔Trusted Source
Ban on Manufacture for sale and Distribution of Rosiglitazone and their formulations for human use
Go to source).
Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013)(7✔ ✔Trusted Source
Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study
Go to source).
Gastrointestinal Drugs - Cisapride, Tegaserod
- Cisapride was a drug used in the treatment of acidity and constipation. It had the possibility of causing abnormal heart rhythms when used in high doses or when used along with other drugs like erythromycin and ketoconazole.
- Tegaserod was another drug acting on the digestive system that was used to treat patients with a condition called irritable bowel syndrome with predominantly constipation. Its association with cardiovascular events like heart attack and stroke have prompted its exit(8✔ ✔Trusted Source
Cardiovascular safety of prokinetic agents: A focus on drug-induced arrhythmias
Go to source).
Antibiotic - Gatifloxacin
Gatifloxacin, an antibiotic belonging to the class fluoroquinolone, has been banned due to its ability to cause high blood sugar levels when taken either orally or through injection. However, eye drops containing gatifloxacin are still available(9✔ ✔Trusted Source
Gatifloxacin Ophthalmic Solution for Treatment of Bacterial Conjunctivitis: Safety, Efficacy and Patient Perspective
Go to source).
Banned Fixed Dose Drug Combinations in India as of March 2016
The Central Drugs Standard Control Organization (CDSCO) in India has banned the manufacture and sale of more than 300 fixed dose drug combinations to prevent the misuse of drugs and to prevent drug resistance(10✔ ✔Trusted Source
Prohibition of 328 Fixed Dose Combinations by the Central Government vide Gazette notification nos. S.O. 4379 (E) to S.O. 4706(E)
Go to source).
A gazette notification by Ministry of Health and Family Welfare was issued on 10th March 2016 to ban these fixed drug combinations. The list includes common cough syrup solutions, analgesics and antibiotic combinations. Some of these drugs are sold over the counter. In 2014 a committee was set up to review over 6000 drug combinations that had entered the market based only on state regulators approval.
This ban is likely to affect many leading pharmaceutical drug manufacturers such as Pfizer, Abbott, Macleods Pharma and Glenmark Pharmaceuticals. Some of these companies have already appealed to the court and received interim injunctions.
Final Verdict as on 12th September 2018
The latest notification banned the manufacture along with the sale, and the distribution of more than 300 fixed-dose combinations (FDCs) under the section 26A of the Drugs and Cosmetics Act, 1940 as advised by the Drug Technical Advisory Board or DTAB(10✔ ✔Trusted Source
Prohibition of 328 Fixed Dose Combinations by the Central Government vide Gazette notification nos. S.O. 4379 (E) to S.O. 4706(E)
Go to source).
The reason for this ban is to stop the use of FDCs without a valid reason. Notably, there was no therapeutic justification found when these ingredients were used in combinations. Moreover, these fixed-dose combinations are not logical and may cause a risk to humans.
The complete list of banned drugs(11✔ ✔Trusted Source
List of Drugs Prohibited for Manufacture and Sale Through Gazette Notifications Under Section 26a of Drugs & Cosmetics Act 1940 by the Ministry
of Health and Family Welfare With Their Present Status As On 22.11.2021
Go to source) -
- Aceclofenac (SR) + Paracetamol
- Aceclofenac + Paracetamol + Famotidine
- Aceclofenac + Paracetamol + Rabeprazole
- Aceclofenac + Zinc Carnosine
- Acetaminophen + Guaifenesin + Dextromethorphan + Chlorpheniramine
- Acetaminophen + Loratadine + Ambroxol + Phenylephrine
- Acriflavine + Thymol + Cetrimide
- Acrivastine + Paracetamol + Caffeine + Phenylephrine
- Albuterol + Bromhexine + Theophylline
- Albuterol + Etofylline + Bromhexine + Menthol
- Alginic Acid + Sodium Bicarbonate + Dried Aluminium Hydroxide + Magnesium Hydroxide
- Allantoin + Dimethieone + Urea + Propylene + Glycerin + Liquid Paraffin
- Ambroxol + Levocetirizine + Phenylephrine + Guaiphenesin + Menthol
- Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine
- Ambroxol + Salbutamol + Choline Theophyllinate + Menthol
- Ambroxol + Salbutamol + Theophylline
- Ambroxol + Terbutaline + Dextromethorphan
- Ambroxol+ Guaiphenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + Menthol
- Ammonium Chloride + Dextromethorphan + Cetirizine + Menthol
- Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol
- Ammonium Citrate + Vitamin B 12 + Folic Acid + Zinc Sulphate
- Amoxicillin + Cefixime + Potassium Clavulanic Acid
- Amoxicillin + Dicloxacillin
- Amoxicillin 250 mg + Potassium Clavulanate Diluted 62.5
- Amoxycillin + Dicloxacillin + Serratiopeptidase
- Amoxycillin + Tinidazole
- Ascorbic Acid + Manadione Sodium Bisulphate + Rutin + Dibasic Calcium Phosphate + Adrenochrome monosemicarbazone
- Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + Pyridoxine
- Azithromycin + Acebrophylline
- Azithromycin + Ambroxol
- Azithromycin + Cefixime
- Azithromycin + Cefpodoxime
- Azithromycin + Levofloxacin
- Azithromycin + Ofloxacin
- Becloemthasone + Clotrimazole + Chloramphenicol + Gentamycin + Lignocaine Ear drops
- Beclomethasone + Clotimazole + Neomycin + lodochlorohydroxyquinone
- Beclomethasone + Clotrimazole + Gentamicin + lodochlorhydroxyquinoline
- Beclomethasone Diproprionate + Neomycin + Tolnaftate + lodochlorhydroxyquinoline +Chlorocresol
- Benfotiamine + Metformin
- Benzoxonium Chloride + Lidocaine
- Betahistine + Ginkgo Biloba Extract + Vinpocetine + Piracetam
- Betamethasone + Fusidic Acid + Gentamycin + Tolnaftate + lodochlorhydroxyquinoline (ICHQ)
- Betamethasone + Gentamicin + Tolnaftate + lodochlorhydroxyquinoline
- Betamethasone + Gentamycin + Zinc Sulphate + Clotrimoazole + Chlorocresol
- Betamethasone + Neomycin + Tolnaftate + lodochlorohydroxyquinoline + Cholorocresol
- Borax + Boric Acid + Naphazoline + Menthol + Camphor + Methyl Hydroxy Benzoate
- Bromhenxine + Phenylephrine + Chlorpheniramine + Paracetamol
- Bromhexine + Cetrizine + Phenylephrine IP+Guaifenesin + Menthol
- Bromhexine + Dextromethorphan
- Bromhexine + Dextromethorphan + Phenylephrine + Menthol
- Bromhexine + Phenylephrine + Chlorepheniramine Maleate
- Caffeine + Paracetamol + Chlorpheniramine
- Caffeine + Paracetamol + Phenylephrine + Cetirizine
- Calcium Gluconate + Chlorpheniramine + Vitamin C
- Calcium Gluconate + Levocetirizine
- Cefixime + Levofloxacin
- Cefixime + Linezolid
- Cefpodoxime Proxetil + Levofloxacin
- Cefuroxime + Linezolid
- Cephalexin + Neomycin + Prednisolone
- Certirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide
- Cetirizine + Acetaminophen + Dextromethorphan + Phenyephrine + Zinc Gluconate
- Cetirizine + Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine + Menthol
- Cetirizine + Dextromethorphan + Ambroxol
- Cetirizine + Dextromethorphan + Bromhexine + Guaifenesin
- Cetirizine + Dextromethorphan + Phenylephrine + Tulsi
- Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + Menthol
- Cetirizine + Dextromethorphan + Zinc Gluconate + Menthol
- Cetirizine + Diethyl Carbamazine
- Cetirizine + Phenylephrine + Dextromethorphan + Menthol
- Cetirizine + Phenylephrine + Paracetamol + Ambroxol + Caffeine
- Cetirizine + Phenylephrine + Paracetamol + Zinc Gluconate
- Cetririzine + Nimesulide + Phenylephrine
- Chlopheniramine Maleate + Dextromethorphan + Guaiphensin + Phenylephrine
- Chloramphenicol + Beclomethasone + Clomitrimazole + Lignocaine
- Chloramphennicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin + Antipyrine
- Chlorphaniramine + Ammonium Chloride + Sodium Chloride
- Chlorpheniramine + Ammonium Chloride + Chloroform + Menthol
- Chlorpheniramine + Ammonium Chloride + Noscapine + Sodium Citrate
- Chlorpheniramine + Codeine + Sodium Citrate + Menthol Syrup
- Chlorpheniramine + Dextromethorphan + Phenylephrine + Paracetamol
- Chlorpheniramine + Paracetamol + Pseudoephedrine + Caffeine
- Chlorpheniramine + Phenylephrine + Caffeine
- Chlorpheniramine + Phenylephrine + Dextromethophan + Menthol
- Chlorpheniramine + Phenylephrine + Paracetamol + Zink Gluconate
- Chlorpheniramine + Terpin + Antimony Potassium Tartrate + Ammonium Chloride + SodiumCitrate + Menthol
- Chlorpheniramine + Vasaka + Tolubalsm + Ammonium Chloride + Sodium Citrate + Menthol
- Chlorpheniramine + Vitamin C
- Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate
- Chlorpheniramine+Ammonium Chloride + Menthol
- Chlorpromazine + Trihexyphenidyl
- Chromium Polynicotinate + Metformin
- Cilnidipine + Metoprolol Succinate + Metoprolol Tartrate
- Ciprofloxacin + Fluocinolone + Clotrimazole + Neomycin + Chlorocresol
- Ciprofloxacin + Fluticasone + Clotrimazole + Neomycin
- Ciprofloxacin + Phenazopyridine
- Clidinium + Paracetamol + Dicyclomine + Activated Dimethicone
- Clindamycin + Clotrimazole + Lactic Acid Bacillus
- Clindamycin + Telmisartan
- Clobetasol + Gentamicin + Tolnaftate + lodochlorhydroxyquinone + Ketoconazole
- Clobetasol + Neomycin + Miconazole + Clotrimazole
- Clobetasol + Neomycin + Miconazole + Zinc Sulphate
- Clobetasol + Ofloxacin + Ketoconazol + Zinc Sulphate
- Clobetasol + Ofloxacin + Miconazole + Zinc Sulphate
- Clobetasol Propionate + Ofloxacin + Ornidazole + Terbinafine
- Clobetasole + Gentamicin + Miconazole + Zinc Sulphate
- Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin + Pyridoxine + Lycopene+ Selenium + Levocarnitine Tartrate + L-Arginine
- Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Aicd + Sodium Methyl Paraben +Propyl Paraben
- Clotrimazole + Beclomethasone + Ofloxacin + Lignocaine
- Clotrimazole + Ofloxaxin + Lignocaine + Glycerine and Propylene Glycol
- Codeine + Chlorpheniramine + Alcohol Syrup
- Codeine + Levocetirizine + Menthol
- Combikit of 3 tablets of Serratiopeptidase (enteric coated 20000 units) + Diclofenac Potassium & 2 tablets of Doxycycline
- Combikit of Azithromycin, Secnidazole and Fluconazole
- Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole Tablets
- Cyproheptadine + Thiamine
- Dextrometharphan + Chlopheniramine + Ammonium Chloride+ Menthol
- Dextrometharphan + Chlopheniramine + Ammonium + Sodium Citrate + Menthol
- Dextrometharphan + Phenylephrine + Guaiphenesin
- Dextromethophan + Chlopheniramine + Bromhexine
- Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine + Menthol
- Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine
- Dextromethorphan + Bromhexine + Guaiphenesin
- Dextromethorphan + Bromhexine + Guaiphenesin + Menthol
- Dextromethorphan + Cetirizine
- Dextromethorphan + Cetirizine + Guaifenesin + Ammonium Chloride
- Dextromethorphan + Chlorpheniramine + Chlorpheniramine Maleate
- Dextromethorphan + Chlorpheniramine + Guaiphenesin
- Dextromethorphan + Levocetirizine + Phenylephrine + Zinc
- Dextromethorphan + Paracetamol + Cetirizine + Phenylephrine
- Dextromethorphan + Phenylephrine + Ammonium Chloride + Menthol
- Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + Chlorpheniramine
- Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + Caffeine
- Dextromethorphan + Phenylephrine + Cetirizine + Zinc + Menthol
- Dextromethorphan + Phenylephrine + Guaifenesin + Certirizine + Acetaminophen
- Dextromethorphan + Phenylephrine + Guaifenesin + Triprolidine
- Dextromethorphan + Phenylephrine + Tripolidine + Menthol
- Dextromethorphan + Phenylephrine + Zinc Gluconate + Menthol
- Dextromethorphan + Tripolidine + Phenylephirine
- Dextromethorphan + Triprolidine + Phenylephrine
- Dextromethorphen + Bromhexine + Chlorpheniramine Maleate + Guaiphenesin
- Dextromethorphen + Promethazine
- Diclofenac + paracetamol + chlorpheniramine maleate + mgnesium Trisillicate
- Diclofenac + Paracetamol + Chlorzoxazone + Famotidine
- Diclofenac + paracetamol + magnesium Trisilicate
- Diclofenac + Paracetamol injection
- Diclofenac + Tramadol + Chlorzoxazone
- Diclofenac + Tramadol + Paracetamol
- Diclofenac + Zinc Carnosine
- Dicyclomine + Paracetamol + Domperidone
- Diethyl Carbamazine + Chlorpheniramine + Guaifenesin
- Diethylcabamazine Citrate + Cetirizine + Guaiphenesin
- Diethylcarbamazine + Cetirizine + Ambroxol
- Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + Menthol
- Diphenhydramine + Guaiphenesin + Ammonium Chloride + Bromhexine
- Diphenhydramine + Terpine + Ammonium Chloride + Sodium Chloride + Menthol
- Diphenoxylate + Atropine + Furazolidonee
- Disodium Hydrogen Citrate + Paracetamol
- Doxycycline + Serratiopeptidase
- Doxylamine + Pyridoxine + Mefenamic Acid + Paracetamol
- Dried Alumnium Hydroxie Gel + Prophantheline + Diazepam
- Drotaverine + Clidinium + Chlordiazepoxide
- Enrofloxacin + Bromhexin
- Ergotamine Tartrate + Belladona Dry Extarct+Caffeine + Paracetamol
- Ethylmorphine + Noscapine + Chlorpheniramine
- Famotidine + Oxytacaine + Magaldrate
- Flunarizine + Paracetamole + Domperidone
- Flupentixol + Escitalopram
- Furazolidone + Metronidazole + Loperamide
- Gabapentin + Mecobalamin + Pyridoxine + Thiamine
- Gentamicin Sulphate + Clotrimazole + Betamethasone + Lignocaine
- Gentamycin + Dexamethasone + Chloramphenicol + Tobramycin + Ofloxacin
- Glibenclamide + Metformin (SR)+ Pioglitazone
- Gliclazide 40mg + Metformin 400mg
- Gliclazide 80 mg + Metformin 325 mg
- Glimepiride + Pioglitazone + Metformin
- Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin 1000mg/1000mg/1000mg
- Glimepiride 1mg/2mg+ Pioglitazone 15mg/15mg + Metformin 850mg/850mg
- Glipizide 2.5mg + Metformin 400 mg
- Glucosamine + Methyl Sullfonyl Methane + Vitamin D3 + Manganese + Boron + Copper + Zinc
- Guaifenesin + Bromhexine + Chlorpheniramine + Paracetamol
- Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase(as enteric coated granules) 10000 SP Units
- Guaifenesin + Dextromethorphan
- Guaifenesin + Diphenhydramine + Bromhexine + Phenylephrine
- Heparin + Diclofenac
- Imipramine + Chlordiazepoxide + Trifluoperazine + Trihexyphenidyl
- Ketoconazole + Tea Tree oil + Allantion + Zinc Oxide + Aloe Vera + Jojoba oil +Lavander oil + Soa noodels
- Ketotifen + Cetirizine
- Ketotifen + Levocetrizine
- Ketotifen + Theophylline
- L-5-Methyltetrahydrofolate Calcium + Escitalopram
- L-Arginine + Sildenafil
- Levocetirizine + Ambroxol + Phenylephrine + Guaiphenesin
- Levocetirizine + Ambroxol + Phenylephrine + Paracetamol
- Levocetirizine + Dextromethorphan + Zinc
- Levocetirizine + Montelukast + Acebrophylline
- Levocetirizine + Paracetamol + Phenylephirine + Caffeine
- Levocetirizine + Phenylephrine + Ambroxol + Guaiphenesin + Paracetamol
- Levocetirizine + Ranitidine
- Levofloxacin + Bromhexine
- Levofloxacin + Ornidazole + Alpha Tocopherol Acetate
- Levothyroxine + Phyridoxine + Nicotinamide
- Lignocaine + Clotrimazole + Ofloxacin + Beclomethasone
- Lornoxicam + Paracetamol + serratiopeptidase
- Lornoxicam + paracetamol + Tramadol
- Lornoxicam + paracetamol + trypsin
- Magaldrate + Famotidine + Simethicone
- Magaldrate + Papain + Fungul Diastase + Simethicone
- Magaldrate + Ranitidine + Pancreatin + Domperidone
- Mebeverine & Inner HPMC capsule (Streptococcus Faecalis + Clostridium butyricum + Bacillusmesentricus + Lactic Acid Bacillus)
- Menthol + Anesthetic Ether
- Metformin (SR) 500mg + Pioglitazone 5mg
- Metformin (Sustainded Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mg
- Metformin + Atorvastatin
- Metformin + Bromocriptine
- Metformin + Gliclazide + Chromium Polynicotinate
- Metformin + Gliclazide + Piogllitazone + Chromium Polynicotinate
- Metformin + Glimepiride + Methylcobalamin
- Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride 1/2/1/2mg
- Metformin 500mg/500mg+Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mg
- Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mg
- Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mg
- Metformin ER + Gliclazide MR + Voglibose
- Metronidazole + Norfloxacin
- Metronidazole + Tetracycline
- N-Acetyl Cysteine + Ambroxol + Phenylephrine + Levocertirizine
- Naphazoline + Carboxy Methyl Cellulose + Menthol + Camphor + Phenylephrine
- Naphazoline + Chlorpheniramine + Zinc Sulphate + Boric Acid + Sodium Chloride + Chlorobutol
- Naproxen + Paracetamol
- Neomycin + Doxycycline
- Nimesulide + Certirizine + Phenylephrine
- Nimesulide + Cetrizine + Caffeine
- Nimesulide + Diclofenac
- Nimesulide + Dicyclomine
- Nimesulide + Loratadine + Phenylephrine + Ambroxol
- Nimesulide + Paracetamol + Cetirizine + Phenylephrine
- Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine
- Nimesulide + paracetamol Injection
- Nimesulide + Paracetamol Suspension
- Nimesulide + Phenylephrine + Caffeine + Levocetirizine
- Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol
- Nimesulide + Serratiopeptidase
- Nimesulide + Tizanidine
- Nimorazole + Ofloxacin
- Norfloxacin+ Metronidazole + Zinc Acetate
- Oflaxacin + Ornidazole Suspension
- Ofloxacin + Clotrimazole + Betamethasone + Lignocaine
- Ofloxacin + Metronidazole + Zinc Acetate
- Ofloxacin + Nitazoxanide
- Ofloxacin + Ornidazole + Zinc Bisglycinate
- Olmesartan + Hydrochlorothiazide + Chlorthalidone
- Omepraozle + Paracetmaol+ Diclofenac
- Oxetacaine + Magaldrate + Famotidine
- Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets)
- Paracetamol + Ambroxol + Phenylephrine + Chlorpheniramine
- Paracetamol + Caffeine + Codeine
- Paracetamol + Caffine + Phenylephrine + Chlorpheniramine
- Paracetamol + Cetrizine + Caffeine
- Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine
- Paracetamol + Codeine + Chlorpheniramine
- Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + Diphenhydramine
- Paracetamol + Dextromethorphan + Chlorpheniramine
- Paracetamol + Diclofenac + famotidine
- Paracetamol + Disodium Hydrogen Citrate + Caffeine
- Paracetamol + DL Methionine
- Paracetamol + domperidone + Caffeine
- Paracetamol + Levocetirizine + Phenylephirine + Zink Gluconate
- Paracetamol + Levocetirizine + Pseudoephedrine
- Paracetamol + Loratadine + Dextromethophan + Pseudoepheridine + Caffeine
- Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + Caffeine
- Paracetamol + mefenamic Acid + ranitidine + Dicyclomine
- Paracetamol + Pheniramine
- Paracetamol + Phenylephrine + Chlorpheneramine + Dextromethorphan + caffeine
- Paracetamol + Phenylephrine + Chlorpheniramine + Zinc Gluconate
- Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + Ambroxol
- Paracetamol + Phenylephrine + Levocetirizine + Caffeine
- Paracetamol + Phenylephrine + Triprolidine
- Paracetamol + Phenylephrine + Triprolidine + Caffeine
- Paracetamol + Prochloperazine
- Paracetamol + Prochlorperazine Maleate
- Paracetamol + Promethazine
- Paracetamol + Propyphenazone + Caffeine
- Paracetamol + Pseudoephedrine + Cetrizine
- Paracetamol + Pseudoephedrine + Dextromethorphan + Cetirizine
- Paracetamol + Tapentadol
- Paracetamol+Phenylephrine+Levocetirizine+Sodium Citrate
- Paracetamol+Pseudoephedrine+Certirizine+Caffeine
- Permethrin + Cetrimide + Menthol
- phenylbutazone + sodium salicylate
- Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + Caffeine
- Pholcodine + Phenylephrine + Promethazine
- Pioglitazone 15mg + Metformin 850 mg
- Pioglitazone 30 mg + Metformin 500 mg
- Pioglitazone 7.5/7.5mg + Metformin 500/1000mg
- Pseudoephedrine + Bromhexine
- Pseudoephedrine + Cetirizine
- Pseudoephedrine + Dextromethorphan + Cetirizine
- Rabeprazole + Diclofenac + Paracetamol
- Rabeprazole + Zinc + Domperidone
- Rabeprazole + Zinc Carnosine
- Ranitidine + Domperidone + Simethicone
- Ranitidine + Magaldrate
- Ranitidine + Magaldrate + Simethicone
- Roxithromycin + Serratiopeptidase
- Salbutamol + Aminophylline + Guaiphensin
- Salbutamol + Bromhexine + Guaiphenesin + Menthol
- Salbutamol + Certirizine + Ambroxol
- Salbutamol + Choline Theophylinate + Ambroxol
- Salbutamol + Choline Theophylinate + Carbocisteine
- Salbutamol + Theophylline + Bromhexine
- Salbutamol+Hydroxyethyltheophylline (Etofylline) + Bromhexine
- Sildenafil + Estradiol Valerate
- Tamsulosin + Diclofenac
- Telmisartan + Metformin
- Terbutaline + Ambroxol + Guaiphenesin + Zinc + Menthol
- Terbutaline + Bromhexine + Etofylline
- Terbutaline + Bromhexine + Guaiphenesin + Dextromethorphan
- Terbutaline + Etofylline + Ambroxol
- Terbutaline + N-Acetyl L-Cysteine + Guaifenesin
- Terpinhydrate + Dextromethorphan + Menthol
- Thyroid + Thiamine + Riboflavin + Phyridoxine + Calcium Pantothenate + Tocopheryl Acetate +Nicotinamide
- Thyroxine + Pyridoxine + Folic Acid
- Tranexamic Acid + Proanthocyanidin
- Ursodeoxycholic Acid + Silymarin
- Voglibose + Pioglitazone + Metformin
- Voglibose+ Metformin + Chromium Picolinate
- Zinc Carnosine + Magnesium Hydroxide + Dried Aluminium Hydroxide + Simethicone
- Zinc Carnosine + Oxetacaine
- Zinc Carnosine + Sucralfate
List of Drugs Banned in 2019(11✔ ✔Trusted Source
List of Drugs Prohibited for Manufacture and Sale Through Gazette Notifications Under Section 26a of Drugs & Cosmetics Act 1940 by the Ministry
of Health and Family Welfare With Their Present Status As On 22.11.2021
Go to source)
- Activated charcoal + Fungal diastase + Lactic acid
- 5-bromosalicyl-4-chloranilide + Salicylic acid
- Allobarbitone + Phospho-dimethyl-isopropyl-pyrazolone
- Artesunate + Arteether + Artemether
- Atorvastatin + Acetyl Salicylic acid + Caffeine
- Chlormezanone + Paracetamol+ Diclofenac sodium
- Chlormezanone +Paracetamol + Ibuprofen
- Chlorzoxazone + Ibuprofen + Paracetamol + Diclofenac + Oxyphenbutazone + Magnesium hydroxide
- Chlorzoxazone + Paracetamol + Ibuprofen + Diclofenac sodium
- Ciprofloxacin + Tinidazole + Dicyclomine
- Dicyclomine + Dextromethorphan + Paracetamol
- Dicyclomine + Paracetamol + Chlordiazepoxide
- Dicyclomine +Paracetamol +Phenylisopropyl Pyrazolone
- Dicyclomine + Serratiopeptidase
- Ibuprofen + Colchicine
- Ibuprofen + Dextropropoxyphene + Paracetamol
- Ibuprofen + Paracetamol + Colchicine
- Ibuprofen + Paracetamol+ Magnesium trisilicate
- Mebeverine + Alprazolam
- Mecobalamin + Methenamine mandelate
- Norfloxacin +Tinidazole +Dicyclomine
- Norfloxacin+Tinidazole+Loperamide
- Ondansetron +Paracetamol
- Paracetamol + Alprazolam
- Paracetamol + Diclofenac Sodium + Amoxicillin + Cloxacillin + Pantoprazole + Lactic Acid Bacillus + Serratiopeptidase
- Paracetamol + Diclofenac sodium + Magnesium Trisilicate + Chlorpheniramine Maleate
- Paracetamol + Ketoprofen + Dextropropoxyphene
- Ranitidine + Dicyclomine + Clidinium bromide
- Ranitidine + Omeprazole
- Acriflavine + Gentian violet + Brilliant green
- Allantoin + Triclosan + Vitamin E + Zinc Oxide
- Allantoin + Vitamin E + Camellia Sinensis
- Atorvastatin + Omega 3 Fatty Acid 250mg
- Atorvastatin + Ubidecarenone
- Cefixime + Lactobacillus + Clavulanic Acid
- Cefixime + Ornidazole
- Ceftriaxone + Vancomycin
- Cefuroxime + Ornidazole
- Diclofenac + Pitofenone Hydrochloride + Fenpiverinium Bromide + Paracetamol
- Dicyclomine + Paracetamol + Dextropropoxyphene + Chlordiazepoxide
- Dicyclomine + Paracetamol + Dimethylpolysiloxane
- Dicyclomine + Paracetamol+ Simethicone
- Doxycycline + Tinidazole
- Drotaverine + Omeprazole
- Fenpiverinium Bromide + Diclofenac sodium + Pitofenone hydrochloride
- Glucosamine + Ascorbic Acid
- Glucosamine + Boswellia Serrata
- Glucosamine + Calcium Carbonate
- Glucosamine + Cetyl Myristate Oleate
- Glucosamine + Chondroitin sulphate +Methyl sulfonyl methane
- Glucosamine + Chondroitin sulphate + Vitamin C+ manganese
- Glucosamine + Chondroitin + Vitamin C + Vitamin E + Manganese
- Glucosamine + Chondroitin + Vitamin C
- Glucosamine + Chondroitin + Vitamin C + Vitamin E + Manganese sulphate + Sodium borate + Selenium dioxide
- Glucosamine + Cholecalciferol + Manganese + Ascorbic acid
- Glucosamine + Manganese
- Glucosamine +Mecobalamin + Dimethyl Sulfone
- Glucosamine + Mecobalamin
- Glucosamine + Mecobalamin + Milk calcium
- Glucosamine + Methyl sulfonyl methane
- Glucosamine + Methyl sulfonyl methane + Cetyl Myristate
- Glucosamine + Vitamin C + Calcium + Methyl Sulfonyl Methane + Chondroitin + Manganese
- Glucosamine + Vitamin C+ Vitamin E + Chondroitin sulphate + Methyl sulfonyl methane + Manganese sulphate
- Glucosamine sulphate + Chondroitin sulphate + Vitamin E + Manganese
- Glucosamine + Calcium + Vitamin D3
- Ornidazole + Doxycycline
- Ornidazole + Fluconazole + Azithromycin
- Propranolol + Hydralazine
- Propranolol + Hydrochlorothiazide + Dihydralazine
- Ranitidine + Dicyclomine + Nimesulide
- Ranitidine + Dicycloverine + Simethicone
- Ranitidine + Drotaverine
- Telmisartan + Ramipril + Hydrochlorothiazide
- Ibuprofen + Paracetamol+ Phenylephrine + Chlorpheniramine maleate
- Nimesulide + Phenylephrine + Chlorpheniramine maleate + Caffeine
- Nimesulide + Pitofenone + Fenpiverinium Bromide
- Nimesulide+ Pseudoephedrine + Cetirizine
- Ofloxacin + Diclofenac + Lignocaine
- Ondansetron + Omeprazole
- Hydrochlorothiazide + Ramipril +Losartan Potassium
Fixed dose compositions of corticosteroids with any other drug [excluding Tamsulosin HCl 0.4mg (as film coated modified release tablet) + Deflazacort 30mg in hard gelatin capsule] for internal use, except formulations for meter dose inhalers and dry powder inhalers.
List of Cough Syrups Banned in India
- Promethazine Oral Solution
- Kofexmalin Baby Cough Syrup
- Makoff Baby Cough Syrup
- Magrip N Cold Syrup
This WHO Medical Product Alert concerns four subpar goods discovered in The Gambia and submitted to WHO in September 2022. Substandard medical items are products that fail to satisfy either their quality standards or specifications and are, therefore "out of specification".The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). The claimed producer has not yet given WHO any assurances regarding the reliability and safety of these products.
Laboratory examination of samples from each of the four items reveals impurities such as diethylene glycol and ethylene glycol at prohibited concentrations. These four products have so far only been found in The Gambia, but they may have travelled to other nations or areas via unofficial markets. When ingested by humans, diethylene glycol and ethylene glycol are poisonous and can be fatal. Toxic consequences can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, changed mental state, and acute kidney injury, which can result in death(12✔ ✔Trusted Source
Substandard (contaminated) paediatric medicines
Go to source).
Drugs Banned in other Countries but Available in India
Several drugs that are prohibited or withdrawn from other countries like the United States are still widely available in India. Some of these include the following:
Painkillers - Oxyphenbutazone, Nimesulide, Propoxyphene
- Oxyphenbutazone is a non-opioid painkiller that has been banned in many countries since it causes bone marrow depression thereby reducing the number of blood cells in the body, and other side effects. Its combination with any other drug is banned in India though it is available as a single drug(13✔ ✔Trusted Source
Oxyphenbutazone
Go to source). - Nimesulide is a non-opioid painkiller that was found to cause liver failure and was never introduced in the US. Children with viral infection were particularly susceptible to this adverse effect of nimesulide. In India, its use in children below 12 years of age is banned though it can be used in adults(14✔ ✔Trusted Source
Use of nimesulide in Indian children must be stopped
Go to source). - Propoxyphene is an opioid painkiller that may alter the electrical activity of the heart, causing problems in heart rhythm. It is not banned in India(15✔ ✔Trusted Source
Propoxyphene and the Risk of Out-of-Hospital Death
Go to source).
Antibacterials - Furazolidone, Nitrofurazone
- Furazolidone is used in the treatment of diarrhea caused by bacteria or protozoa, alone or in combination with another drug, metronidazole. Studies indicate that its use has a possibility of causing cancer, and it is therefore not used in several countries. In India, only its combination with loperamide, an anti-motility drug used in the treatment of diarrhea, is banned(16✔ ✔Trusted Source
Furazolidone therapy for Helicobacter pylori: Is it effective and safe?
Go to source). - Nitrofurazone is a topically used antibacterial similar to furazolidone and therefore, could also possibly cause cancer. It is banned in some countries, but not yet in India(17✔ ✔Trusted Source
Detection, accumulation and distribution of nitrofuran residues in egg yolk, albumen and shell
Go to source).
Anabolic Steroid - Nandrolone decanoate
Nandrolone decanoate is a drug that is used in the treatment of anemia due to kidney disease and osteoporosis. The drug is commonly abused by athletes to build muscle mass. It has been discontinued in the United States but is still used in India(18✔ ✔Trusted Source
Anabolic Steroids
Go to source).
Drugs Acting on the Brain - Thioridazine, Pergolide, Pemoline
- Thioridazine is an antipsychotic drug used in the treatment of conditions like schizophrenia. Its side effects include abnormal heart rhythms or arrhythmia, eye damage, and a condition called neuroleptic malignant syndrome where the patient suffers from high temperature and muscle rigidity. It continues to be available in India(19✔ ✔Trusted Source
Discontinuation of thioridazine
Go to source). - Pergolide is a drug used for the
treatment of Parkinson’s disease , a condition that affects the nervous system resulting in stiffness and tremors. For a long time, levodopa and carbidopa were the only drugs effective in this condition. The availability of new drugs provided hope for the patients. Pergolide was among these newer drugs, however it had to be withdrawn because it caused damage to heart valves(20✔ ✔Trusted Source
Pergolide
Go to source). - Pemoline, a drug used in the treatment of attention deficit hyperactivity disorder, has been withdrawn in the United States due to its liver toxicity risk. However, it is not discontinued in India(21✔ ✔Trusted Source
Pemoline
Go to source).
Cholesterol Lowering Drug - Cerivastatin
Cerivastatin is a cholesterol-lowering drug that caused several cases of rhabdomyolysis (destruction of skeletal muscles). With this side effect, patients suffered from damage to muscles followed by kidney failure. Unfortunately, it is still available in India(22✔ ✔Trusted Source
Withdrawal of cerivastatin from the world market
Go to source).
Constipation - Phenolphthalein
Phenolphthalein belongs to a group of drugs called stimulant purgative, which are useful in the treatment of constipation. Studies in mice have indicated that its use may be associated with cancer or genetic damage, due to which it is not available in several countries. Though available in India, it is not frequently used(23✔ ✔Trusted Source
Case series on a diversity of illicit weight-reducing agents: from the well known to the unexpected
Go to source).
Human Placental Extract
The human placental extract is derived from the placenta obtained during delivery of a baby and finds use in the cosmetic industry. As other tissues of human origin, it may transmit infections like hepatitis B and HIV if adequate precautions are not taken, and is therefore not used in several countries. It is only allowed for two conditions in India - to be used locally for wound healing, and to be injected for pelvic inflammatory disease(24✔ ✔Trusted Source
Final report on the safety assessment of human placental protein, hydrolyzed human placental protein, human placental enzymes, human placental lipids, human
umbilical extract, placental protein, hydrolyzed placental protein, placental enzymes, placental lipids, and umbilical extract
Go to source).