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List of Banned Drugs in India – Vaayath would be your one-stop for all the latest news and updates relevant to the pharmaceutical regulations in India. However in terms of the current division in Fixed Dose Combinations (FDC) and the list of banned drugs.
The regulation of FDCs is a highly subject regarding drug authorities in India. Moreover, tightening up regulations on the production of FDCs is being done by the government. However to ensure that each drug will not only be safe but also effective. However, this essentially entails scrutinizing every FDC to meet the required threshold to stay in the market.
Despite the campaigning that is being done, some of the FDCs have moved against them. However, that is due to concerns like their safety and efficiency. Another example is the licensing system introduced in 2018 by the Kokate Products DCGI License. However from selling some of its FDCs having failed to get a license. However, the reasons for this included both the protection of the public’s health. And also the prevention of the sale of potentially dangerous drugs.
The list of prohibited drugs in India is changed as per the advisories that has issued to incorporate the latest discoveries and to safeguard the consumers. However, healthcare professionals as well as consumers must remain informed of these changes. However, it will help them to make well-thought-out choices for their wellbeing and treatment approaches. Vaayath endeavors to filter and disseminate updated and factual information on illegal drugs. And also the regulatory environment around FDCs in India.
Why choose Vaayath to find the List of Banned Drugs in India?
- Vaayath, one of the Best Pharma Regulatory Consultant India provides accurate and up-to-date information on the list of banned drugs in India. And also ensuring that healthcare professionals and consumers stay informed.
- We offer insights into the FDC regularization process. And also helping users understand the regulations surrounding Fixed Dose Combinations in India.
- Vaayath informs you about Banned FDC in India, highlighting which combinations have deemed unsafe or lacking in efficacy.
- We provide detailed information on Kokate Products and their DCGI licensing process. And also giving users a comprehensive understanding of pharmaceutical regulations in India.
- Vaayath is a trusted source of pharmaceutical information. And also offering reliable and timely updates on regulatory changes and developments in the industry.
- Our platform is user-friendly and accessible, making it easy for healthcare professionals and consumers. However to access the information they need about banned drugs, FDC Banned FDC in India, and DCGI licensing in India.
What are the steps usually required for a new pharmaceutical product to be licensed by the DCGI in India?
It is the Drug Controller General of India (DCGI), which is a guiding force in drug authorization and responsible for controlling pharmaceutical products. However, attaining a DCGI license is the key requirement for Kokate Products DCGI License to sell their products within India.
The first and foremost step preceding authorization is the submission of a detailed application. However, that covers the safety and efficacy of the product as well as the manufacturing process. The DCGI reviews the application using the criteria mentioned above. And also performs the inspections of production plants. However to make sure that the appliance complies with the provisions.
Fixed combination medicines (FDCs) have a debate due to safety issues. The DCGI assesses each combination’s therapeutical justification and safety profile. FDCs that have proven not effective or vital for the treatment has banned. However the market spread in India and therefore removed.
The DCGI’s product licensing system is set up to ensure that pharmaceutical products has available in India. And meet or even exceed standards of safety and efficacy which ensures the health of consumers.
Are there specific regulations for Kokate Products regarding DCGI licensing?
- Kokate Products, like all pharmaceutical companies in India. And must adhere to specific regulations set by the Drug Controller General of India (DCGI) for licensing.
- The DCGI requires detailed documentation from Kokate Products regarding the safety, efficacy, etc. However also manufacturing processes of their pharmaceutical products.
- For Fixed Dose Combinations (FDCs), Kokate Products must justify the therapeutic rationale. However, also the safety of their combinations to obtain DCGI approval.
- Kokate Products must undergo inspections of their manufacturing facilities by the DCGI Consultants to ensure compliance with regulations.
- If any FDCs produced by Kokate Products has found to be unsafe or lacking in efficacy, they are also banned in India.
- Kokate Products DCGI License must stay updated with the DCGI’s regulations. However, also guidelines to maintain compliance. And also continue selling their products in the Indian market.
What is the current list of banned drugs in India?
| S.No. | List Of Banned Drugs in India |
| 1 | Fixed dose combinations of Strychnine and Caffeine in tonics. |
| 2 | Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins. |
| 3 | Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine. |
| 4 | Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs. |
| 5 | Phenacetin. |
| 6 | Fixed dose combinations of antihistaminic with antidiarrhoeals. |
| 7 | Fixed dose combinations of Penicillin with Sulphonamides. |
| 8 | Fixed dose combinations of Vitamins with Analgesics. |
| 9 | Fixed dose combinations of any other Tetracycline with Vitamin C. |
| 10 | Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use. |
| 11 | Fixed dose combinations of Corticosteroids with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers. |
| 12 | Fixed dose combinations of Chloramphenicol with any other drug for internal use. |
| 13 | Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches. |
| 14 | Letrozole for induction of ovulation in anovulatory infertility. |
| 15 | Serodiagnostic test kits for diagnosis of tuberculosis |
| 16 | **Dextropropoxyphene and formulations containing Dextropropoxyphene for human use ** |
| 17 | Fixed dose combination of Flupenthixol + Melitracen for human use |
| 18 | Analgin and all formulations containing analgin for human use Initial Suspension vide was revoked allowing the use of drug with certain condition vide |
| 19 | Pioglitazone and all formulations containing Pioglitazone for human use Initial suspension vide was revoked allowing the use of drug with certain condition vide |
| 20 | *** Aceclofenac + Paracetamol + Rabeprazole *** |
| 21 | Nimesulide + Diclofenac |
| 22 | Nimesulide + Cetirizine +Caffeine Nimesulide +Tizanidine |
| 23 | Paracetamol + cetrizine + caffeine |
| 24 | Rofecoxib and its formulations |
| 25 | Valdecoxib and its formulations |
| 26 | Diclofenac and its formulations (for animal use) |
| 27 | Rimonabant. |
| 28 | Rosiglitazone82. Nimesulide formulations for human use in children below 12 years of age. |
| 29 | Cisapride and its formulations for human use. |
| 30 | *Phenypropanolamine and its formulations for human use.* |
| 31 | Human Placental Extract and its formulations for human use except its 1. Topical application for wound healing, and 2. Injection for pelvic inflammatory disease. Substituted |
| 32 | Sibutramine and its formulations for human use. |
| 33 | R-Sibutramine and its formulations for human use. |
| 34 | “Gatifloxacin formulation for systemic use in humans by any route including oral and injectable”. |
| 35 | Tegaserod and its formulations |
| 36 | Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6). |
| 37 | Penicillin skin/eye Ointment. |
| 38 | Tetracycline Liquid Oral preparations. |
| 39 | Nialamide. |
| 40 | Practolol. |
| 41 | Methapyrilene, its salts. |
| 42 | Methaqualone. |
| 43 | Oxytetracycline Liquid Oral preparations. |
| 44 | Demeclocycline Liquid Oral preparations. |
| 45 | Combination of anabolic Steroids with other drugs. |
| 46 | Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet Estrogen content of more than 50 mcg (equivalent to EthinylEstradiol) and content of more than 3 mg(equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen andProgesterone. Substituted |
| 47 | Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics. |
| 48 | Fixed dose combination of Rifanpicin, isoniazid and Pyrazinamide, except those which Provide daily adult dose given below: DrugsMinimum Maximum Rifampicin 450 mg 600 mg Isoniazid 300 mg 400 mg Pyrazinamide1000mg 1500 mg Substituted |
| 49 | Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India. |
| 50 | The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia. |
| 51 | All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate. |
| 52 | Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200 mg. 600 mg. 300 mg. 800 mg. |
| 53 | Fixed dose combination containing more than one antihistamine. |
| 54 | Fixed dose combination of any anthelmintic with cathartic/purgative except for piperazine/Santonim. |
| 55 | Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine. |
| 56 | Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations. |
| 57 | Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol Substituted |
| 58 | Fixed dose combination of centrally acting, antitussive with antihistamine, also having high atropine-like activity in expectorants. |
| 59 | Preparations claiming to combat cough associated with asthma contain centrally acting antitussive and/ or an antihistamine. |
| 60 | Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and/or central nervous system stimulant and such preparations containing alcohol more than 20% proof. |
| 61 | Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combinations of Pectin and/or Kaolin with drugs not for combinations of Pectin and/or Kaolin with drugs not systemically absorbed. |
| 62 | Chloral Hydrate as a drug. |
| 63 | Dovers Powder I.P. |
| 64 | Dover’s Powder Tablets I.P. |
| 65 | Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal. |
| 66 | Antidiarrhoeal formulations containing PhthalylSulphathiazole or Sulphaguanidine or SuccinylSulphathiazole. |
| 67 | Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters. |
| 68 | Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing DiphenoxylateLorloperamide or Atropine or Belladona including their salts or esters or metabolitesHyoscyamine or their extracts or their alkaloids. |
| 69 | Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines. |
| 70 | Fixed dose combination of antidiarrhoeals with electrolytes. |
| 71 | Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters: (a) Patent and Proprietary oral rehydration salts on reconstitution to one litre shall contain: Sodium – 50 to 90 milliosmoles Total osmolarity – 240-290 milliosmoles Dextrose: Sodium molar ratio – Not less than 1:1 and not more than 3:1 (b) Patent and proprietary cereal based oral rehydration salts on reconstitution to one litre shall contain: Sodium – 50 to 90 milliosmoles Total osmolarity – Not more than 290 milliosmoles Precooked rice – equivalent to not less than 50gms and not more than 80gms as a total replacement of dextrose (c) Patent and proprietary oral rehydration salts (ORS) may contain amino acids in addition to oral rehydration salts conforming to the parameters specified above and labelled with the indication for “Adult Chloretic Diarrhea Only” (d) Patent and proprietary oral rehydration salts (ORS) shall not contain mono or polysaccharides or saccharin sweetening agent. |
| 72 | Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug. |
| 73 | Fixed dose combination of Analgin with any other drug. |
| 74 | Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal antiinflammatory drugs (NSAIDS). |
| 75 | Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the also said Act with an Ayurvedic, Siddha or Unani drug. |
| 76 | Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form also for use for female sterilization or contraception. |
| 77 | Fenfluramine |
| 78 | Dexfenfluramine. |
| 79 | Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride . |
| 80 | Cosmetics Licensed as toothpaste/tooth powder containing tobacco. |
| 81 | Parenteal Preparations fixed combination of streptomycin with Pencillin |
| 82 | Fixed dose combination of Vitamin B1Vitamin B6 and Vitamin B12 for human use |
| 83 | Fixed dose combination of haemoglobin in any form (natural or synthetic). |
| 84 | Fixed dose combination of Pancreatin or Pancrelipase containing amylase, also protease and lipase with any other enzyme. |
| 85 | Fixed dose combination of Nitrofurantoin and trimethoprim. |
| 86 | Fixed dose combination of Phenobarbitone with any antiasthmatic drugs. |
| 87 | Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine |
| 88 | Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona |
| 89 | Fixed dose combination of Haloperidol with any anticholinergic agent including Propantheline Bromide. |
| 90 | Fixed dose combination of Nalidixic Acid with any antiamoebic including Metronidazole. |
| 91 | Fixed dose combination of Loperamide Hydrochloride with Furazolidone |
| 92 | Fixed dose combination of Cyproheptadine with Lysine or Peptone. |
| 93 | Astemizole |
| 94 | Terfinadine |
| 95 | Phenformin |
FAQs
Q1. What is the List of Banned Drugs in India?
Ans- The list of banned drugs in India comprises pharmaceutical products that have prohibited from manufacture, and distribution. However, also sales due to safety, efficacy, or regulatory concerns.
Q2. What is FDC Regularization?
Ans- FDC regularization refers to the process through which Fixed Dose Combinations (FDCs) in pharmaceuticals has evaluated, regulated, etc. However, also approved by regulatory authorities to ensure their safety and efficacy.
Q3. What are Banned FDCs in India?
Ans- Banned FDCs in India has Fixed Dose Combinations that have prohibited from manufacturing, and distribution. However also sales due to safety, efficacy, or regulatory issues.
Q4. What is the DCGI License for Kokate Products?
Ans- The DCGI license for Kokate Products refers to the approval granted by the Drug Controller General of India (DCGI). However, that has for the manufacture, distribution, and also sale of pharmaceutical products by Kokate Products.
Q5. How often is the List of Banned Drugs in India updated?
Ans- The list of banned drugs in India has updated periodically based on new safety, efficacy, or also regulatory findings.
Q6. How does the DCGI ensure the safety and efficacy of FDCs in India?
Ans- The DCGI ensures the safety and efficacy of FDCs in India by evaluating their therapeutic rationale also safety profile, etc. And also manufacturing processes before approval.
Q7. What role does FDC Regularization play in the pharmaceutical industry?
Ans- FDC regularization plays a crucial role in ensuring the quality, safety, and also efficacy of pharmaceutical products in India. However, thereby protecting public health.
Conclusion
Through knowledge and being updated on new trends we can all be part of a well-regulated. And also the safe pharmaceutical industry in India. Trust Vaayath, a reliable source of information & also offers a List of Banned Drugs in India. Also, we keep you well-informed. However self-sufficient with the knowledge that you need.
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