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An Updated Review on Banned and Approved Fixed Dose Combination Drugs in India, 2016

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An Updated Review on Banned and Approved Fixed Dose Combination Drugs in India, 2016 ISSN 2395-3411 Available online at www.ijpacr.com 8 ___________________________________________________________Review Article An Updated Review on Banned and Approved Fixed Dose Combination Drugs in India, 2016 Dhanisiri Gnapika* and Maddi Ramaiah Department of Pharmacognosy, Hindu College of Pharmacy, Guntur – 522002, Andhra Pradesh, India. _______________________________________________________________________ ABSTRACT The Indian pharma industry ranks 14th in terms of value and 3rd in terms of volume in the world. There are 74 US FDA-approved manufacturing facilities in India. A dose is the quantity to be administered at one time, or the total quantity administered during a specified period. A combination of two or more actives in a fixed ratio of doses is known as fixed dose combination. The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. However, because of un-avoided dangerous adverse effects, Central Government of India banned about 344 FDCs on March 10th 2016 as per recommendations of six-member committee headed by CK Kokate. Banned drugs are still available in India due to lack of awareness and law enforcement. The present article provides a complete list of approved and banned FDCs in 2016. The pharmacist should play an active role in patient education of such banned and approved drugs regularly and then play an key role in maintain healthy India. Keywords: Dose, FDC, Banned drugs, Approved drugs. INTRODUCTION Department of Pharmaceuticals, Ministry of A dose is the quantity to be administered at Chemicals and Fertilizers3. one time, or the total quantity administered In terms of the global market, India currently during a specified period. Dosage implies a holds a modest 1–2% share, but it has been regimen; it is the regulated administration of growing at approximately 10% per year. India individual doses and is usually expressed as a gained its foothold on the global scene with its quantity per unit of time1. innovatively engineered generic drugs and A medication or medicine is a drug taken to active pharmaceutical ingredients, and it is cure or ameliorate any symptoms of now seeking to become a major player in an illness or medical condition. The use may outsourced clinical research as well as also be as preventive medicine that has future contract manufacturing and research. There benefits but does not treat any existing or pre- are 74 US FDA-approved manufacturing existing diseases or symptoms. Dispensing of facilities in India, more than in any other medication is often regulated country outside the U.S, and in 2005, almost by governments into three categories—over- 20% of all Abbreviated New Drug Applications the-counter medications, which are available (ANDA) to the FDA are expected to be filed by in pharmacies and supermarkets without Indian companies. Growth in other fields special restrictions; behind-the- notwithstanding, generics is still a large part of counter medicines, which are dispensed by the picture4. a pharmacist without needing a doctor's prescription, and prescription only medicines, Fixed dose combinations (FDCs) which must be prescribed by a A combination of two or more actives in a fixed licensed medical professional, usually ratio of doses is known as fixed dose a physician2. combination. It may be administered as single entity products given concurrently or as Pharmaceutical industry in India finished pharmaceutical product. The The Indian pharma industry ranks 14th in terms development of fixed-dose combinations of value and 3rd in terms of volume in the (FDCs) is becoming increasingly important world. The domestic market was from a public health perspective. Such worth US$13.8 billion in 2013 as per combinations of drugs are being used in the treatment of a wide range of conditions and International Journal of Pharma And Chemical Research I Volume 3 I Issue 1 I Jan – Mar I 2017 ISSN 2395-3411 Available online at www.ijpacr.com 9 are particularly useful in the management of at normal doses in humans for prophylaxis, HIV/AIDS, malaria and tuberculosis, which are diagnosis or therapy of disease or for the considered to be the foremost infectious modification of physiological function7. The disease threats in the world today. FDCs have fixed dose combinations are banned due to advantages when there is an identifiable they could artificially improve their patient population for whom treatment with a performance and shows various adverse particular combination of actives in a fixed effects more than therapeutic effects. Whose ratio of doses has been shown to be safe and production or use is prohibited or strictly effective and when all of the actives contribute controlled via prescription. Banned drugs are to the overall therapeutic effect. In addition still available in India due to lack of awareness there can be real clinical benefits in the form of and law enforcement. The government of India increased efficacy and/or a reduced incidence needs to enforce laws and provide information of adverse effects, but such claims should be to public and physicians about banned drugs, supported by evidence. Additional advantages approved drugs and the reasons through drug of FDCs are potentially lower costs of information centers. The pharmacist should manufacturing compared to the costs of play an active role in patient education of producing separate products administered drugs regularly and then play an important role concurrently, simpler logistics of distribution, on eliminating the market for banned drugs. improved patient adherence and reduced On the basis of the recommendations of the development of resistance in the case of Expert Committee appointed by the Central antimicrobials. Importantly, as for any new Government of India and in exercise of powers medicine the risks and benefits should be conferred by section 26A of the Drugs and defined and compared5, 6. Cosmetics Act, 1940 (23 of 1940), the Central Government of India prohibits/banned a total Banned and Approved Fixed dose of 336 drug fixed dose combinations for the combination drugs manufacturing, sale and distribution for human An adverse drug reaction (ADR) as defined by use with effect from 10th March, 2016. World Health Organization (WHO) is a noxious, unintended effect of a drug, occurring List banned fixed dose combination drugs in 20168 Statutory S. Orders Banned fixed dose combination No. (S.O.) 1 S.O.705(E) Aceclofenac + Paracetamol + Rabeprazole 2 S.O.706(E) Nimesulide + Diclofenac 3 S.O.707(E) Nimesulide + Cetrizine + Caffeine 4 S.O.708(E) Nimesulide + Tizanidine 5 S.O.709(E) Paracetemol + Cetrizine + Caffeine 6 S.O.710(E) Diclofenac + Tramadol + Chlorzoxazone 7 S.O.711(E) Dicyclomine + Paracetemol +Domperidone 8 S.O.712(E) Nimesulide + Paracetamol dispersible tablets 9 S.O.713(E) Paracetamol + Phenylephrine +caffeine 10 S.O.714(E) Diclofenac + Tramadol + Paracetamol 11 S.O.715(E) Diclofenac + Paracetamol + Chlorzoxazone + Famotidine 12 S.O.716(E) Naproxen + Paracetamol 13 S.O.717(E) Nimesulide + Serratiopeptidase 14 S.O.718(E) Paracetamol + Diclofenac + Famotidine 15 S.O.719(E) Nimesulide + Pitofenone + Fenpiverinium + Benzyl alcohol 16 S.O.720(E) Omeprazole + Paracetamol + Diclofenac 17 S.O.721(E) Nimesulide+paracetamol injection 18 S.O.722(E) Tamsulosin + Diclofenac 19 S.O.723(E) Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine 20 S.O.724(E) Diclofenac + Zinc carnosine 21 S.O.725(E) Diclofenac + Paracetamol + Chlorpheniramine maleate + Magnesium tri silicate 22 S.O.726(E) Paracetamol + Pseudo ephedrine + Cetrizine 23 S.O.727(E) Phenyl butazone + Sodium salicylate 24 S.O.728(E) Lornoxicam + Paracetamol + Trypsin 25 S.O.729(E) Paracetamol + Mefenamic acid + Ranitidine + Dicyclomine 26 S.O.730(E) Nimesulide + Dicyclomine 27 S.O.731(E) Heparin + Diclofenac 28 S.O.732(E) Glucosamine + Methyl sulfonyl methane + Vitamin D3 + Manganese + Boron + Copper + Zinc 29 S.O.733(E) Paracetamol + Tapentadol 30 S.O.734(E) Tranexamic acid + Proanthocyanidim 31 S.O.735(E) Benzoxonium chloride + Lidocaine 32 S.O.736(E) Lornoxicam + Paracetamol + Tramadol International Journal of Pharma And Chemical Research I Volume 3 I Issue 1 I Jan – Mar I 2017 ISSN 2395-3411 Available online at www.ijpacr.com 10 33 S.O.737(E) Lornoxicam + Paracetamol + Serratiopeptidase 34 S.O.738(E) Diclofenac + Paracetamol + Magnesium trisilicate 35 S.O.739(E) Paracetamol + Domperidone + Caffeine 36 S.O.740(E) Ammonium chloride + Sodium citrate + Chlorpheniramine maleate + Menthol 37 S.O.741(E) Paracetamol + Prochlorperazine maleate 38 S.O.742(E) Serratiopeptidase (Enteric coated 20000 units) + Diclofenac potassium & 2 Tablets of Doxycycline 39 S.O.743(E) Nimesulide + Paracetamol suspension 40 S.O.744(E) Aceclofenac + paracetamol + Famotidine 41 S.O.745(E) Aceclofenac + Zinc carnosine 42 S.O.746(E) Paracetamol + disodium hydrogen citrate + Caffeine 43 S.O.747(E) Paracetamol + DL Methionine 44 S.O.748(E) Disodium hydrogen citrate + Paracetamol 45 S.O.749(E) Paracetamol + Caffeine + Codeine 46 S.O.750(E) Aceclofenac (SR) + Paracetamol 47 S.O.751(E) Diclofenac+Paracetamol injection 48 S.O.752(E) Azithromycin+Cefixime 49 S.O.753(E) Amoxicillin+Dicloxacillin 50 S.O.754(E) Amoxicillin 250mg+Potassium Clavulanate Diluted 625mg 51 S.O.755(E) Azithromycin+Levofloxacin 52 S.O.756(E) Cefixime+Linezolid 53 S.O.757(E) Amoxicillin+Cefixime+Potassium clavulanic acid 54 S.O.758(E) Ofloxacin +Nitazoxanide 55 S.O.759(E) CefpodoximeProxetil+ Levofloxacin 56 S.O.760(E) Azithromycin+Secnidazole+Fluconazole
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