SCHEDULE – H (PRESCRIPTION DRUGS) – (THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945 )

SCHEDULE – H (PRESCRIPTION DRUGS) – (THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945 )

Abacavir

Abciximab

Acamprosate calcium

Acebutol hydrochloride

Aclarubicin

Albendazole

Alclometasone dipropionate

Actilyse

Acyclovir

Adenosine

Adrenocorticotrophic hormone (acth)

Alendronate sodium

Alopurinol

Alphachymotrypsin

Alprazolam

Alprostadil

Amantadine hydrochloride

Amifostine

Amikacin sulphate

Amiloride hydrochloride

Amineptine

Aminoglutethimide

Amino salicylic acid

Amiodarone hydrochloride

Amitriptyline

Amlodipine besylate

Amoscanate

Amoxopine

Amrinonelactate

Analgin

Androgenic anabolic, oestrogenic & progestational substances

Antibiotics

Antibiotics

Apraclonidine

Aprotinin

Organic compound of arsenic

Arteether

Artemether

Artesunate

Articaine hydrochloride

Atenolol

Atracurium besylate injection

Atorvastatin

Auranofin

Azathioprine

Aztreonam

Bacampicillin

Baclofen

Balsalazide

Bambuterol

Barbituric acid

Basiliximab

Benazepril hydrochloride

Benidipine hydrochloride

Benserazide hydrochloride

Betahistine dihydrochloride

Bethanidine sulphate

Bezafibrate

Bicalutamide

Biclotymol monohydrate /lactate

Bifonazole

Bimatoprost

Biperiden hydrochloride

Biphenyl acetic acid

Bitoscanate

Bleomycin

Primonidine tartrate

Bromhexine hydrochloride

Bromocriptine mesylate

Budesonide

Bulaquine

Bupivacaine hydrochloride

Bupropion

Buspirone

Butenafine hydrochloride

Butorphanol tartrate

Cabergoline

Calcium dobesilate

Candesartan

Capecitabine

Captopril

Carbidopa

Carbocisteine

Carboplatin

Carboquone

Carisoprodol

L-carnitine

Carteolol hydrochloride

Carvedilol

Cefadroxyl

Cefatoxime sodium

Cefazolin sodium

Cefdinir

Cefepime hydrochloride

Cefetamet pivoxil

Cefpirome

Cefpodoximepoxetil

Ceftazidime pentahydrate

Ceftizoxime sodium

Cefuroxime

Celecoxib

Centchroman

Centbutindole

Centpropazine

Cetirizine hydrochloride

Chlordiazepoxide

Chlormezanone

Chlorpromazine

Chlorzoxazone

Ciclopiroxolamine

Cimetidine

Cinnarizine

Ciprofloxacin hydrochloride

Cisplatin

Citalopram hydrobromide

Clarithromycin

Clavulanic acid

Clidiniumbromide

Clindamycin

Clobazam

Clobetasol propenate

Clobetasone 17-butyrate

Clofazimine

Clofibrate

Clonazepam

Clonidine hydrochloride

Clopamide

Clopidogrel bisulphate

Clostebolacetate

Clotrimazole

Clozapine

Codeine

Colchicine

Corticosteroids

Cotrimoxazole

Cyclandelate

Cyclosporins

Daclizumab

Danazole

Dapsone

Desloratadine

Desogestrol

Dexrazoxane

Dextranomer

Dextropropoxyphene

Diazepam

Diazoxide

Diclofenac sodium/potassium/acid

Dicyclomin hydrochloride

Didanosine

Digoxine

Dilazep hydrochloride

Diltiazem

Dinoprostone

Diphenoxylate, its salts

Dipivefrin hydrochloride

Di-sodiumpamidronate

Disopyramide

Docetaxel

Domperidone

Donepezil hydrochloride

Dopamine hydrochloride

Dothiepin hydrochloride

Doxapram hydrochloride

Doxazosin mesylate

Doxepin hydrochloride

Doxorubicin hydrochloride

Drotrecogin-alpha

Ebastine

Econozole

Efavirenz

Enalapril meleate

Enfenamic acid

Epinephrine

Epirubicine

Eptifibatide

Ergot, alkaloids of whether hydrogenated or not, their homologoues, salts

Esomeprazole

Estradiol succinate

Estramustine phosphate

Etanercept

Ethacridine lactate

Ethambutol hydrochloride

Ethamsylate

Ethinyloestradiol

Ethionamide

Etidronate disodium

Etodolac

Etomidate

Etoposide

Exemestane

Famciclovir

Famotidine

Fenbendazole

Fenofibrate

Fexofenadine

Finasteride

Flavoxate hydrochloride

5-fluorouracil

Fludarabine

Flufenamic acids

Flunarizine hydrochloride

Fluoxetine ydrochloride

Flupenthixol

Fluphenazine enanthate and decanoate

Flurazepam

Flurbiprofen

Flutamide

Fluticasone propionate

Fluvoxamine maleate

Formestane

Fosfestril sodium

Fosinopril sodium

Fossphenytoin sodium

Fotemustine

Gabapentin

Galanthamine hydrobromide

Galamine, its salts, its quaternary compound

Gancyclovir

Ganirelix

Gatifloxacin

Gemcitabine

Gemfibrozil

Gemtuzumab

Genodeoxycholic acid

Gliclazide

Glimepiride

Glucagon

Glycopyrrolate

Glydiazinamide

Goserelin acetate

Granisetron

Guanethidine

Gugulipid

Halogenated hydroxyquinolines

Haloperidol

Heparin

Hepatitis b. Vaccine

Hyaluronidase

Hydrocorisone 17-butyrate

Hydrotalcite

Hydroxizine

Ibuprofen

Idebenone

Indapamide

Imipramine

Indinavir sulphate

Indomethacin

Insulin human

Interferon

Intravenous fat emulsion

Iobitridol

Iohexol

Iopamidol

Iomeprol

Iopromide

Irbesartan

Irinotecan hydrochloride

Iron preparation for parenteral use

Isepamicine

Isocarboxside

Isoflurane

Isonicotnic acid hydrazine and other-hydragine derivatives of isonicotinic acid

Isosorbide dinitrate/ mononitrate

Isotretinoin

Isoxsuprine

Itopride

Ketoconazole

Ketoprofen

Ketorolactromethamine

Labetalol hydrochloride

Lacidipine

Lamivudine

Lamotrigine

Latanoprost

Lefunomide

Lercanidipine hydrochloride

Letrozole

Leuprolide acetate

Levamesole

Levarterenol

Levobunolol

Levocetirizine

Levodopa

Levofloxacin

Levovist

Lidoflazine

Linezplid

Lithium carbonate

Lofepramine decanoate

Loperamide

Lorazepam

Losartan potassium

Loteprednol

Lovastatin

Loxapine

Mebendazole

Mebeverine hydrochloride

Medroxyprogesterone acetate

Mefenamic acid

Mefloquine hydrochloride

Megestrol acetate

Meglumine iocarmate

Melagenina

Elitracenhydrochloride

Meloxicam

Mephenesin, its esters

Mephentermine

Meropenam

Mesterolone

Metaxalone

Methicillin sodium

Methocarbamol

Methotraxate

Metoclopramide

Metoprolol tartrate

Metrizamide

Metronidazole

Mexiletine hydrochloride

Mianserin hydrochloride

Miconazole

Midazolam

Mifepristone

Milrinone lactate

Miltefosine

Minocycline

Minoxidil

Mirtazapine

Misoprostol

Mitoxantrone hydrochloride

MizolastineMoclobemide

Mometasone furoate

Montelukast sodium

Morphazinamide hydrochloride

Mosapride

Moxifloxacin

Mycophenolate mofetil

Nadifloxacin

Nadolol

Nafarelin acetate

Nalidixic acid

Naproxen

Narcotics drugs listed in Narcotic Drugs & Psychotropic Substances Act, 1985.

Natamycin

Nateglinide

N-butyl-2-cyanoacrylate

Nebivolol

Nebumetone

Nelfinavir mesylate

Netilmicin sulphate

Nevirapine

Nicergoline

Nicorandil

Nifedipine

Nimesulide

Nimustine hydrochloride

Nitrazepam

Nitroglycerin

Norethisterone enanthate

Norfloxacin

Octylonium bromide

Ofloxacin

Olanzapine

Omeprazole

Ornidazole

Orphenadrine

Orthoclone sterile

Oxazepam

Oxazolidine

Oxcarbazepine

Oxethazaine hydrochloride

Oxiconazole

Oxolinic acid

Oxprenolol hydrochloride

Oxybutynin chloride

Oxyfedrine

Oxymetazoline

Oxyphenbutazone

Oxytocin

Ozothine

Paclitaxel

Pancuronium bromide

Pantoprazole

Para-amino benzene sulphonamide, its salts & derivatives.

Parp-amino salicylic acid, its salts, its derivatives

Parecoxib

Paroxetine hydrochloride

D-penicillamine

Pentazocine

Pentoxifylline

Pepleomycin

Phenelzineh sulphate

Phenobarbital

Phenothiazine, derivatives of and salts of its derivatives

Phenylbutazine

Pimozide

Pindolol

Pioglitazone hydrochloride

PiracetamPiroxicam

Pituitory gland, active principles of, not otherwise specified in this schedule and their salts

PolidocanolPolyestradiol phosphate

Poractant alfa

Praziquantel

Prednimustine iothalamates

Prednisolone stearoylglycolate

Prenoxdiazinhydro-chloride

Promazine hydrochloride

Promegestone

Propafenon hydrochloride

Propanolol hydrochloride

Propofol

Protristyline hydrochloride

Pyrazinamide

Pyrvinium

Quetiapine fumerate

Quinapril

Quinidine sulphate

Rabeprazole

Racecadotril

Raloxifene hydrochloride

Ramipril hydrochloride

Ranitidine

Rauwolfia, alkaloids of, their salts, derivatives of the alkaloids or rauwolfia

Reboxetine

Repaglinide

Reproterol hydrochloride

Rilmenidine

Riluzone

Risperidone

Ritonavir

Ritodrine hydrochloride

Rituximab

Rivastigmine

Rocuronium bromide

Ropinirole

Rosoxacin.

Rosiglitazone meleate

Salbutamol sulphate

Salicyl-azo-sulphapyridine

Salmon calcitonin

Saquinavir

Satranidazole

Secnidazole

Septopal beads & chains

Serratiopeptidase

Sertraline hydrochloride

Sibutramine hydrochloride

Sildenafil citrate

Simvastatin

Sirolimus

Sisomicin sulphate

S-neominophagen

Sodiumpico sulphate

Sodium cromoglicate

Sodium hyaluronate

Sodium valproate

Sodium and maglumine iothalamates

Somatostatin

Somatotropin

Sotalol

Sparfloxacin

Spectinomycin hydrochloride

Spironolactone

Stavudine

Sucralfate

Sulphadoxine

Sulphamethoxine

Sulphamethoxypyridazine

Sulphaphenazole

Sulpiride

Sulprostone hydrochloride

Sumatriptan

Tacrine hydrochloride

Tamsulosin hydrochloride

Trapidil

Tegaserod maleate

Teicoplanin

Telmisartan

Temozolamide

Terazosin

Terbutaline sulphate

Terfenadine

Terizidone

Terlipressin

Testosteroneun decoanoate

Teratolol hydrochloride

Thalidomide

Thiacetazone

Thiocolchicoside

Thiopropazate, its salts

Thymogene

Thymosin-alpha1

Tiaprofenic acid

Tibolone

Timolol maleate

Tinidazole

Tizanidine

Tabramycin

Tolfenamic acid

Topiramate

Topotecan hydrochloride

Tramadolhydrochloride

Tranexamic acid

Tranylcypromine, its salts

Trazodone

Tretinoin

Trifluperazine

Trifluperidol hydrochloride

TriflusalTrimetazidine dihydrochloride

Trimipramine

Tripotassium dicitrate bismuthate

Tromantadine hydrochloride

Urokinase

Valsartan

Vasopressin

Vecuronium bromide

Venlafaxine hydrochloride

Verapamil hydrochloride

Verteporfin

Vincristine sulphate

Vinblastine sulphate

Vindesine sulphate

Vinorelbine tatrate

Xipamide

Zidovudine hydrochloride

Ziprasidone hydrochloride

Zoledronic acid

Zolpidem

Zopiclone

Zuclopenthixol

Note:- 1. Preparations exempted under proviso to para 2 of Note to Schedule X shall also be covered by this Schedule.

  1. The salts, esters, derivatives and preparations containing the above substances excluding those intended for topical or external use (except ophthalmic and ear / nose preparations con – training antibiotics and/ or steroids) are also covered by this Schedule.
  2. The inclusion of a substance in this Schedule does not imply or convey that the substance is exempted from the provisions of Rule 122A/122B.”

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also

CIP & SIP OF MANUFACTURING TANK, HOLDING TANK,PRODUCT LINE, FILTER ASSEMBLY & FFS MACHINE

CIP & SIP OF MANUFACTURING TANK, HOLDING TANK,PRODUCT LINE, FILTER ASSEMBLY & FFS MACHINE 1.0   …