Schedule M: Good Manufacturing Practice

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z
 

Schedule M:

Schedule M describes Good Manufacturing Practices and Requirements of Premises.
Schedule M provides the insights to achieve the objectives listed in schedule, each licensee shall evolve appropriate methodology, system and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs.
Part 1: Describes Good Manufacturing Practices For Premises and MaterialPart 1A: Describes the Specific requirement for manufacture of sterile products. Parenteral preparations (Small Volumn Injections and Large Volumn Parenterals) and Sterile Ophthalmic Preparations

Part 1B: Describes the Specific requirements for manufacture of oral solid forms (Capsule and Teblets)

Part 1C: Describes the Specific Requirements for Manufacture of Oral Liquids (Syrups, Elixirs, Emulsions and Suspensions)

Part 1D: Describes the Specific requirements for Manufacture of Topical Products i.e. External Preparations (Cream, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products)
Part 1E: Describes the Specific requirements for manufacture of Metered Dose Inhalers (MDI)Part 1F: Describes the Specific requirements of premises, plant and material for manufacture of Active Pharmaceutical Ingredients (Bulk Drugs)

Part 2: Describes the Requirements of Plant and Equipment

Schedule M-1:

Schedule M-1 describes the Good Manufacturing Practice requirements of factory premises for manufacture of Homoeopathic preparations:

Schedule M-2:

Schedule M-2 describes the requirements of factory premises for manufacture of cosmetics

Schedule M-3:

Schedule M-3 describes the requirements of factory premises for manufacture of medical devices

(For detail analysis refer drug and cosmetic act and rules)

Eligibility of Open School Students For Pharmacist Registration

Query:
I am a student of D.pharmacy. I am completed my 12th from NIOS with pcm in 2016 and take admission in D. pharma but my friend told me NIOS student are not approved from PCI and someone told me from 2015 PCI approved NIOS student for D. pharmacy is this true information because I am taking admission please advice me soon what I do..
 

Response:

Pharmacy council of India issued two circulars in this regards, one in 2007 and second in 2009. Both confirmed the not approval of National School Qualification for admission in Pharmacy Courses. Click at below link to read it: PCI circular regarding National Open School Qualification But In year 2015, PCI has issues circulars related to Eligibility of Open School education system of the Central Govt. / State Govts. institutions for admission in Pharmacy courses for the purpose of registration as a Pharmacist under the Pharmacy Act, 1948. and approved open school system of central and state government institutions for admission in various pharmacy courses for purposing as a registered pharmacist. Read circulars by clicking below links:http://www.pci.nic.in/Circulars/14-2circular.pdf

http://www.pci.nic.in/Circulars/Eligibility_of_open_school.pdf

You are eligible for taking or continuing your admission in D. Pharmacy Course.
Hope this information will be helpful to you…

 

Schedule K:Exempted Drugs, Conditions and extent of exemption

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule K:
Schedule K describe the exempted drugs, conditions and extent of exemption from all the provisions of Chapter IV of the Act and the Rules thereunder subject to the conditions.
The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.Exemption is provided only against fulfillment of conditions specified in Schedule.

Few Exempted Drugs are as follow: 
  • Drugs Labelled as ‘Not for medicinal Use’
  • Quinine and other antimalarial drugs as per conditioned mention in Schedule
  • Drugs supplied by a registered medical practitioner to his own patient or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale of
  • All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the conditions mention in schedule
  • Drugs supplied by a hospital or dispensary maintained or supported by Government or local body as per conditions mentioned in schedule
  • Whole Human Blood I.P. and/or its components stored for transfusion by a First Referral Unit Community Health Centre, Primary Health Centre and Hospital as per conditions mentioned in schedule
  • Quinine Sulphate as per conditions mentioned in schedule
  • Magnesium Sulphate as per conditions mentioned in schedule
  • Some substances which are used both as articles of food as well as drugs as per conditions mentioned in schedule
  • Substances intended to be used for destruction of vermin or insects as per conditions mentioned in schedule
  • Mechanical and Chemical Contraceptives as per conditions mentioned in Schedule
  • Some household Asprin Tablets, Paracetamol Tablets, Analgesic Balms, Antacid Preparations, Gripe Water for use of infants, Inhalers, containing drugs for treatment of cold and nasal congestion, Syrups, lozenges, pills and tablets for cough, Liniments for external use, Skin ointments and ointments for burns, Absorbent cotton wool, bandages, absorbent gauze and adhesive
  • plaster, Castor Oil, liquid Paraffin and Epsom Salt, Eucalyptus Oil, Tincture Iodine, Tincture Benzoin Co.and Mercurochrome solution in containers not exceeding 100 ml, Tablets of Quinine Sulphate I.P., Tablets of Iodochlorohydroxy quinoline – 250 mg as per conditions mentioned in schedule
  • Cosmetics as per conditions mention in schedule
  • Ophthalmic ointments of the Tetracycline group of drugs as per conditions mention in schedule
  • Hair Fixers, namely mucilagenous preparations containing gums, used by men for fixing beard as per conditions mention in schedule
  • Radio Pharmaceuticals as per conditions mentioned in schedule
  • Tablets of Chloroquine Salts as per conditions mentioned in schedule
  • and Many more

Schedule J: Diseases which a drug may not purport to prevent or cure

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule J:

Diseases which a drug may not purport to prevent or cure.-

  1. No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule J.
  2. No drug may purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women. Explanation.

Diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure.

  1. AIDS
  2. Angina Pectoris
  3. Appendicitis
  4. Arteriosclerosis
  5. Baldness
  6. Blindness
  7. Bronchial Asthma
  8. Cancer and Benign tumour
  9. Cataract
  10. Change in colour of the hair and growth of new hair.
  11. Change of foetal sex by drugs.
  12. Congenital malformations
  13. Deafness
  14. Diabetes
  15. Diseases and disorders of uterus.
  16. Epilepticfits and psychiatric disorders
  17. Encephalitis
  18. Fairness of the skin
  19. Form, structure of breast
  20. Gangrene
  21. Genetic disorders
  22. Glaucoma
  23. Goitre
  24. Hernia
  25. High/low Blood Pressure
  26. Hydrocele
  27. Insanity
  28. Increase in brain capacity and improvement of memory.
  29. Improvement in height of children/adults.
  30. Improvement in size and shape of the sexual organ and in duration of sexual performance
  31. Improvement in the strength of the natural teeth.
  32. Improvement in vision
  33. Jaundice/Hepatitis/Liver disorders
  34. Leukaemia
  35. Leucoderma
  36. Maintenance or improvement of the capacity of the human being for sexual pleasure.
  37. Mental retardation, subnormalities and growth
  38. Myocardial infarction
  39. Obesity
  40. Paralysis
  41. Parkinsonism
  42. Piles and Fistulae
  43. Power to rejuvinate
  44. Premature ageing
  45. Premature greying of hair
  46. Rheumatic Heart Diseases
  47. Sexual Impotence, Premature ejaculation and spermatorrhoea
  48. Spondylitis
  49. Stammering
  50. Stones in gall-bladder, kidney, bladder
  51. Vericose Vein.

Schedule H : List of Prescription Drugs

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule H:

Schedule H includes drugs that shall be sold by retailer on prescription of the registered medical practitioners.

  • If Product contains a drug substance specified in Schedule H, be labeled with symbol Rx and
    conspicuously displayed on the left top corner of the label and shall also be labeled with the
    following words in legible black coloured font size in completely red rectangular box:

SCHEDULE H PRESCRIPTION DRUG – CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

  • If Product contains a drug substance specified in Schedule H and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) be labeled with symbol NRx, which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:

SCHEDULE H PRESCRIPTION DRUG – WARNING To be sold by retail on the prescription of a Registered Medical Practitioner only.

List of Prescription Drugs are as follow: (List of Schedule H Drugs)

1 Abacavir 277 Latanoprost
2 Abciximab 278 Lefunomide
3 Acamprosate calcium 279 Lercanidipine hydrochloride
4 Acebutol hydrochloride 280 Letrozole
5 Aclarubicin 281 Leuprolide acetate
6 Albendazole 282 Levamesole
7 Alclometasone dipropionate 283 Levarterenol
8 Actilyse 284 Levobunolol
9 Acyclovir 285 Levocetirizine
10 Adenosine 286 Levodopa
11 Adrenocorticotrophic hormone (acth) 287 2[Levofloxacin]
12 Alendronate sodium 288 Levovist
13 Alopurinol 289 Lidoflazine
14 Alphachymotrypsin 290 Linezplid
15 2[Alprazolam 291 Lithium carbonate
16 Alprostadil 292 Lofepramine decanoate
17 Amantadine hydrochloride 293 Loperamide
18 Amifostine 294 Lorazepam
19 Amikacin sulphate 295 Losartan potassium
20 Amiloride hydrochloride 296 Loteprednol
21 Amineptine 297 Lovastatin
22 Aminoglutethimide 298 Loxapine
23 Amino salicylic acid 299 Mebendazole
24 Amiodarone hydrochloride 300 Mebeverine hydrochloride
25 Amitriptyline 301 Medroxyprogesterone acetate
26 Amlodipine besylate 302 Mefenamic acid
27 Amoscanate 303 Mefloquine hydrochloride
28 Amoxopine 304 Megestrol acetate
29 Amrinonelactate 305 Meglumine iocarmate
30 Analgin 306 Melagenina
31 Androgenic anabolic, oestrogenic & progestational substances 307 Elitracenhydrochloride
32 Antibiotics 308 Meloxicam
33 Apraclonidine 309 Mephenesin, its esters
34 Aprotinin 310 Mephentermine
35 Organic compound of arsenic 311 2[Meropenam]
36 Arteether 312 Mesterolone
37 Artemether 313 Metaxalone
38 Artesunate 314 Methicillin sodium
39 Articaine hydrochloride 315 Methocarbamol
40 Atenolol 316 Methotraxate
41 Atracurium besylate injection 317 Metoclopramide
42 Atorvastatin 318 Metoprolol tartrate
43 Auranofin 319 Metrizamide
44 Azathioprine 320 Metronidazole
45 Aztreonam 321 Mexiletine hydrochloride
46 Bacampicillin 322 Mianserin hydrochloride
47 Baclofen 323 Miconazole
48 Balsalazide 324 2[Midazolam]
49 Bambuterol 325 Mifepristone
50 Barbituric acid 326 Milrinone lactate
51 Basiliximab 327 Miltefosine
52 Benazepril hydrochloride 328 Minocycline
53 Benidipine hydrochloride 329 Minoxidil
54 Benserazide hydrochloride 330 Mirtazapine
55 Betahistine dihydrochloride 331 Misoprostol
56 Bethanidine sulphate 332 Mitoxantrone hydrochloride
57 Bezafibrate 333 Mizolastine
58 Bicalutamide 334 Moclobemide
59 Biclotymol monohydrate /lactate 335 Mometasone furoate
60 Bifonazole 336 Montelukast sodium
61 Bimatoprost 337 Morphazinamide hydrochloride
62 Biperiden hydrochloride 338 Mosapride
63 Biphenyl acetic acid 339 2[Moxifloxacin]
64 Bitoscanate 340 Mycophenolate mofetil
65 Bleomycin 341 Nadifloxacin
66 Primonidine tartrate 342 Nadolol
67 Bromhexine hydrocloride 343 Nafarelin acetate
68 Bromocriptine mesylate 344 Nalidixic acid
69 Budesonide 345 Naproxen
70 Bulaquine 346 Narcotics drugs listed in Narcotic Drugs & Psychotropic Substances Act, 1985
71 Bupivacaine hydrochloride 347 Natamycin
72 Bupropion 348 Nateglinide
73 Buspirone 349 N-butyl-2-cyanoacrylate
74 Butenafine hydrochloride 350 Nebivolol
75 Butorphanol tartrate 351 Nebumetone
76 Cabergoline 352 Nelfinavir mesilate
77 Calcium dobesilate 353 Netilmicin sulphate
78 Candesartan 354 Nevirapine
79 Capecitabine 355 Nicergoline
80 Captopril 356 Nicorandil
81 Carbidopa 357 Nifedipine
82 Carbocisteine 358 Nimesulide
83 Carboplatin 359 Nimustine hydrochloride
84 Carboquone 360 2[Nitrazepam]
85 Carisoprodol 361 Nitroglycerin
86 L-carnitine 362 Norethisterone enanthate
87 Carteolol hydrochloride 363 Norfloxacin
88 Carvedilol 364 Octylonium bromide
89 Cefadroxyl 365 Ofloxacin
90 Cefatoxime sodium 366 Olanzapine
91 Cefazolin sodium 367 Omeprazole
92 2[Cefdinir 368 Ornidazole
93 Cefepime hydrochloride 369 Orphenadrine
94 Cefetamet pivoxil 370 Orthoclone sterile
95 Cefpirome 371 Oxazepam
96 Cefpodoximepoxetil 372 Oxazolidine
97 Ceftazidime pentahydrate 373 Oxcarbazepine
98 Ceftizoxime sodium] 374 Oxethazaine hydrochloride
99 Cefuroxime 375 Oxiconazole
100 Celecoxib 376 Oxolinic acid
100 Centchroman 377 Oxprenolol hydrochloride
102 Centbutindole 378 Oxybutynin chloride
103 Centpropazine 379 Oxyfedrine
104 Cetirizine hydrochloride 380 Oxymetazoline
105 2[Chlordiazepoxide 381 Oxyphenbutazone
106 Chlormezanone 382 Oxytocin
107 3 [ * * *] 383 Ozothine
108 Chlorpromazine 384 Paclitaxel
109 Chlorzoxazone 385 Pancuronium bromide
110 Ciclopiroxolamine 386 Pantoprazole
111 Cimetidine 387 Para-amino benzene sulphonamide, its salts & derivatives
112 Cinnarizine 388 Parp-amino salicylic acid, its salts, its derivatives
113 Ciprofloxacin hydrochloride 389 Parecoxib
114 Cisplatin 390 Paroxetine hydrochloride
115 Citalopram hydrobromide 391 D-penicilamine
116 Clarithromycin 392 2[Pentazocine]
117 Clavulanic acid 393 Pentoxifylline
118 Clidiniumbromide 394 Pepleomycin
119 Clindamycin 395 Phenelzineh sulphate
120 Clobazam 396 Phenobarbital
121 Clobetasol propenate 397 Phenothiazine, derivatives of and salts of its derivatives
122 Clobetasone 17-butyrate 398 Phenylbutazine
123 2[Clofazimine] 399 Pimozide
124 Clofibrate 400 Pindolol
125 Clonazepam 401 Pioglitazone hydrochloride
126 Clonidine hydrochloride 402 Piracetam
127 Clopamide 403 Piroxicam
128 Clopidogrel bisulphate 404 Pituitory gland, active principles of, not otherwise specified in this schedule and their salts
129 Clostebolacetate 405 Polidocanol
130 Clotrimazole 406 Polyestradiol phosphate
131 Clozapine 407 Poractant alfa
132 2[Codeine] 408 Praziquantel
133 Colchicine 409 Prednimustine iothalamates
134 Corticosteroids 410 Prednisolone stearoylglycolate
135 Cotrimoxazole 411 Prenoxdiazinhydro-chloride
136 Cyclandelate 412 Promazine hydrochloride
137 Cyclosporins 413 Promegestone
138 Daclizumab 414 Propafenon hydrochloride
139 Danazole 415 Propanolol hydrochloride
140 Dapsone 416 Propofol
141 Desloratadine 417 Protristyline hydrochloride
142 Desogestrol 418 2[Pyrazinamide]
143 Dexrazoxane 419 Pyrvinium
144 Dextranomer 420 Quetiapine fumerate
145 2[* * *] 421 Quinapril
146 Dextropropoxyphene 422 Quinidine sulphate
147 2[Diazepam] 423 Rabeprazole
148 Diazoxide 424 Racecadotril
149 Diclofenac sodium/potassium/acid 425 Raloxifene hydrochloride
150 Dicyclomin hydrochloride 426 Ramipril hydrochloride
 151 Didanosine 427 Ranitidine
152 Digoxine 428 Rauwolfia, alkaloids of, their salts, derivatives of the alkaloids or rauwolfia
 153 Dilazep hydrochloride 429 Reboxetine
154 Diltiazem 430 Repaglinide
155 Dinoprostone 431 Reproterol hydrochloride
156 2[Diphenoxylate, its salts] 432 Rilmenidine
157 Dipivefrin hydrochloride 433 Riluzone
158 Di-sodiumpamidronate 434 Risperidone
159 Disopyramide 435 Ritonavir
160 Docetaxel 436 Ritodrine hydrochloride
161 Domperidone 437 Rituximab
162 Donepezil hydrochloride 438 Rivastigmine
163 Dopamine hydrochloride 439 Rocuronium bromide
164 Dothiepin hydrochloride 440 Ropinirole
165 Doxapram hydrochloride 441 Rosoxacin.
166 Doxazosin mesylate 442 Rosiglitazone meleate
167 Doxepin hydrochloride 443 Salbutamol sulphate
168 Doxorubicin hydrochloride 444 Salicyl-azo-sulphapyridine
169 Drotrecogin-alpha 445 Salmon calcitonin
170 Ebastine 446 Saquinavir
171 Econozole 447 Satranidazole
172 Efavirenz 448 Secnidazole
173 Enalapril meleate 449 Septopal beads & chains
174 Enfenamic acid 450 Serratiopeptidase
175 Epinephrine 451 Sertraline hydrochloride
176 Epirubicine 452 Sibutramine hydrochloride
177 Eptifibatide 453 Sildenafil citrate
178 Ergot, alkaloids of whether hydrogenated or not, their homologoues, salts 454 Simvastatin
179 Esomeprazole 455 Sirolimus
180 Estradiol succinate 456 Sisomicin sulphate
181 Estramustine phosphate 457 S-neominophagen
182 Etanercept 458 Sodiumpico sulphate
183 Ethacridine lactate 459 Sodium cromoglycate
184 2[Ethambutol hydrochloride] 460 Sodium hyaluronate
185 Ethamsylate 461 Sodium valproate
186 Ethinyloestradiol 462 Sodium and maglumine iothalamates
187 2[Ethionamide] 463 Somatostatin
188 Etidronate disodium 464 Somatotropin
189 Etodolac 465 Sotalol
190 Etomidate 466 2[Sparfloxacin]
191 Etoposide 467 Spectinomycin hydrochloride
192 Exemestane 468 Spironolactone
193 Famciclovir 469 Stavudine
194 Famotidine 470 Sucralfate
195 Fenbendazole 471 Sulphadoxine
196 Fenofibrate 472 Sulphamethoxine
197 Fexofenadine 473 Sulphamethoxypyridazine
198 Finasteride 474 Sulphaphenazole
199 Flavoxate hydrochloride 475 Sulpiride
200 5-fluorouracil 476 Sulprostone hydrochloride
201 Fludarabine 477 Sumatriptan
202 Flufenamic acids 478 Tacrine hydrochloride
203 Flunarizine hdrochloride 479 Tamsulosin hydrochloride
204 Fluoxetine ydrochloride 480 Trapidil
205 Flupenthixol 481 Tegaserod maleate
206 Fluphenazine enanthate and decanoate 482 Teicoplanin
207 Flurazepam 483 Telmisartan
208 Flurbiprofen 484 Temozolamide
209 Flutamide 485 Terazosin
210 Fluticasone propionate 486 Terbutaline sulphate
211 Fluvoxamine maleate 487 Terfenadine
212 Formestane 488 Terizidone
213 Fosfestril sodium 489 Terlipressin
214 Fosinopril sodium 490 Testosteroneun decoanoate
215 Fossphenytoin sodium 491 Teratolol hydrochloride
216 Fotemustine 492 Thalidomide
217 Gabapentin 493 2[Thiacetazone]
218 Galanthamine hydrobromide 494 Thiocolchicoside
 219 Galamine, its salts, its quaternary compound 495 Thiopropazate, its salts
220 Gancyclovir 496 Thymogene
221 Ganirelix 497 Thymosin-alpha1
222 Gatifloxacin 498 Tiaprofenic acid
223 Gemcitabine 499 Tibolone
224 Gemfibrozil 500 Timolol maleate
225 Gemtuzumab 501 Tinidazole
226 Genodeoxycholic acid 502 Tizanidine
227 Gliclazide 503 Tabramycin
228 Glimepiride 504 Tolfenamic acid
229 Glucagon 505 Topiramate
230 Glycopyrrolate 506 Topotecan hydrochloride
231 Glydiazinamide 507 2[Tramadolhydrochloride]
232 Goserelin acetate 508 Tranexamic acid
233 Granisetron 509 Tranylcypromine, its salts
234 Guanethidine 510 Trazodone
235 Gugulipid 511 Tretinoin
236 Halogenated hydroxyquinolines 512 Trifluperazine
237 Haloperidol 513 Trifluperidol hydrochloride
238 Heparin 514 Triflusal
239 Hepatitis b. Vaccine 515 Trimetazidine dihydrochloride
240 Hyaluronidase 516 Trimipramine
241 Hydrocorisone 17-butyrate 517 Tripotassium dicitrate bismuthate
242 Hydrotalcite 518 Tromantadine hydrochloride
243 Hydroxizine 519 Urokinase
244 Ibuprofen 520 Valsartan
245 Idebenone 521 Vasopressin
246 Indapamide 522 Vecuronium bromide
247 Imipramine 523 Venlafaxine hydrochloride
248 Indinavir sulphate 524 Verapamil hydrochloride
 249 Indomethacin 525 Verteporfin
250 Insulin human 526 Vincristine sulphate
251 Interferon 527 Vinblastine sulphate
252 Intravenous fat emulsion 528 Vindesine sulphate
253 Iobitridol 529 Vinorelbine tatrate
254 Iohexol 530 Xipamide
255 Iopamidol 531 Zidovudine hydrochloride
256 Iomeprol 532 Ziprasidone hydrochloride
257 Iopromide 533 Zoledronic acid
258 Irbesartan 534 2[Zolpidem]
259 Irinotecan hydrochloride  535 Zopiclone
260 Iron preparation for parenteral use 536 Zuclopenthixol
261 Isepamicine 537
262 Isocarboxside 538 Alclometasone
263 Isoflurane 539 Beclomethasone
264 Isonicotnic acid hydrazine and other-hydragine derivatives of isonicotinic acid 540 Betamethasone
265 Isosorbide dinitrate/ mononitrate 541 Desonide
266 Isotretinoin 542 Desoximetasone
267 Isoxsuprine  543 Dexamethasone
268 Itopride 544 Diflorasone diacetate
269 4[***] 545 Fluocinonide
270 Ketoconazole 546 Fluocinolone acetonide
271 Ketoprofen 547 Halobetasol propionate
272 Ketorolactromethamine 548 Halometasone
273 Labetalol hydrochloride  549 Methylprednisone
274 Lacidipine 550.Prednicarbate
275 Lamivudine  551 Triamcinolone acetonide”
276 Lamotrigine

1 Subs. by G.S.R. No.160(E), dated 16.3.2006 .

2 Omitted by G.S.R 588(E) dated 30-8-2013

3 Omitted by G.S.R 602(E) dated 19-7-2010

4 Omitted by G.S.R 724(E) dated 7-11-2013

Note:-

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

2 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 – taining antibiotics and/ or steroids) are also covered by this Schedule.

3 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.”

Latest schedule h drug list 2018

Schedule G: List of substances included

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule G
If a drug contains a drug substance specified in Schedule G, be labeled with following words
in legible black coloured font size in completely red rectangular box:
SCHEDULE G PRESCRIPTION DRUG – CAUTION
It is dangerous to take this preparation except under medical supervision.

List substances included in Schedule G is as below:

  • Aminopterin
  • L-Asparaginase
  • Bleomycin
  • Busulphan; its salts
  • Carbutamide
  • Chlorambucil;its salts
  • Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine
  • Chlorpropamide; its salts
  • Chlorthalidone and other derivatives of Chlorobenzene compound.
  • Cis-Platin
  • Cyclophosphamide; its salts
  • Cytarabine
  • Daunorubicin
  • Di-Isopropyl Eluorophosphate
  • Disodium Stilboestrol Diphosphate
  • Doxorubicin Hydrochloride
  • Ethacrynic Acid, its salts
  • Ethosuximide
  • Glibenclamide
  • Hydantoin; its salts; its derivatives, their salts
  • Hydroxyurea
  • Insulin, all types
  • Lomustine Hydrochloride
  • Mannomustine; its salts
  • Mercaptopurine; its salts
  • Metformin; its salts
  • Methsuximide
  • Mustine, its salts
  • Paramethadione
  • Phenacemide
  • Phenformin; its salts
  • 5-Phenylhydantoin; its alkyl and aryl derivatives; its salts
  • Primadone
  • Procarpazine Hydrochloride
  • Quinthazone
  • Sarcolysine
  • Sodium-2-Mercaptoethanesulfonate Tamoxiten Citrate
  • Testolactone
  • Thiotepa
  • Tolbutamide
  • Tretamine; its salts
  • Troxidone
  • Antihistaminic substances the following, their salts, their derivatives, salts of their derivatives
  • Antazoline
  • Bromodiphenhydramine
  • Buclizine
  • Chlorcyclizine
  • Chlorpheniramine
  • Clemizole
  • Cyproheptadine
  • Diphenhydramine
  • Diphenylpyraline
  • Doxylamine Succinate
  • Isothipendyl
  • Mebhydrolin Napadisylate
  • Meclozine
  • Phenindamine
  • Pheniramine
  • Promethazine
  • Thenalidine
  • Triprolidine
  • Substances being tetra-N-Subs. derivatives of Ethylene Diamine or Prophylenediamine.

Schedule D, D(I) and D(II): Import of medicinal substances in India

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule D:
Schedule D describe the requirement and formalities to import medicinal substances in India.Some Highlights of details covered under Schedule D is:

1. Substances not intended for medicinal use

All provisions of Chapter III of the Act and rules thereunder subject to the condition that if the substance is imported in bulk, the importer shall certify that the substance is imported for non-medicinal uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or or is of commercial quality.

Entry 2,3,4 has been omitted

5. The following substances, which are used both as articles of food as well as drugs:-

All provisions of Chapter III of the Act and rules thereunder.

  • All condensed or powdered milk whether pure, skimmed or malted, fortified with vitamins and minerals.
  • Farex, Oats, Lactose and all other similar cereal preparations whether fortified with vitamins or otherwise excepting those for parenteral use.
  • Virol, Bovril, Chicken essence and all other similar predigested foods.
  • Ginger, Pepper, Cumin, Cinnamon and all other similar spices and condiments unless they are specifically labelled as conforming to the standards in the Indian Pharmacopoeia or the official pharmacopoeias and the official compendia of the drug standards prescribed under the Act and rules made there under.

6. Drugs and cosmetics imported for manufacture and export by units situated in “Special Economic Zones” as notified by the Government of India from time to time.

The provisions of Chapter III of the Act and rules thereunder which required them to be covered by an import licence, import registration and import through notified port of entry, subject to the conditions that these drugs and cosmetics shall not be diverted for sale in the country:
Provided that such imported drugs and cosmetics may be permitted to the domestic area if they meet the requirements of standard procedure for import and registration as required under Chapter III of the Act and rules thereuder.]

Schedule D(I):

Schedule D(I) covers the information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a Computer Floppy.

  • Particulars of the manufacturer and manufacturing premises
  • Particulars of the manufactured drugs to be registered under Registration Certificate.
  • Undertaking to declaration

Schedule D (II)

Schedule D (II) covers Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a Computer Floppy

  • General
  • Chemical and Pharmaceutical Information of Drugs
  • Biological and Biopharmaceutical information of Drugs
  • Pharmacological and Toxicological information of Drugs
  • Clinical Documentation
  • Labelling and Packaging information of Drugs
  • Specific information required for the special products

Information to be submitted in Schedule D-II: 

Annexure A

Covers Specific information required for the blood products

Annexure-B

Covers Specific information required for the diagnostic Kits

Annexure-C

Covers Specific information required for vaccines

For Detail Drug and Cosmetic Act  and rule download in pdf at http://www.cdsco.nic.in/ by clicking here

Important aspects of Starting Pharma Marketing Company?

Query:
 
Now i have some more questions related to Pharma marketing company {own brand}.
I want to know about Drug License number registration for marketing company. And other documents require for this process. What about premises of shop for this type of business. And what are the process for GST registration? For whom I will have to contact. Kindly guide me.
 

Response:
For drug license number, you will have to visit drug inspector office. Complete all requirements of drug license as mentioned in our article: How to start pharma company? and visit to district drug inspector office.

GST can be applied online and check how can you apply for GST.here How to apply for GST?

Shop you required should be at least 10 square meter in space and shouldn’t be occupied by any other work. Area doesn’t impact more, it could be area where you can easily do work.Hope this information will be helpful to you…

Who can Donate Blood and Who can’t Donate Blood?

If you are going to donate blood or known is going to donate blood then you should be aware about following things:
Who can Donate Blood: 
  • A person in the age group of 18 to 60 years
  • Person should have weight more than 45 kilogram
  • Good in health, mentally alert and physically fit
  • Body Temperature and pulse should be normal
  • Person’s blood pressure should be normal without any medication
  • Blood Haemoglobin should be equal or more than 12.5 gram
  • Person should be free from any acute diseases
  • Person should be free from any blood transmissible disease
  • 12 months after recovery from Typhoid
  • 12 months after delivery
  • 15 days after immunization (Cholera, Typhoid, Diphtheria, Tetanus, Plague, Gammaglobulin)
  • 1 year after Rabies vaccination
  • Arms and forearms of the donor shall be free from skin punctures or scars indicative of professional blood donors or addiction of self injected narcotics.
Who can’t Donate Blood:
  • Person has been donated blood in last three months.
  • Having skin infection at site of phlebotomy
  • Person having inmates of jail can’t donate blood
  • Having multiple sex partners
  • Drug Addicts
  • Abortion history in last six months
  • History of blood transfusion in last six months
  • Surgery history in last 12 months
  • Tattoo history in last six months
  • Breast feeding
  •  History of Hepatitis in family or close contacts in last 12 months
  • Immunoglobulin history in last 12 months
  • History of malaria and duly treated. For Endemic it is 2 months and for non endemic area it is 3 years.

Diseased conditions when a person can’t donate blood:

  • Cancer
  • Heart disease
  • Unexplained weight loss
  • Diabetes-controlled on insulin
  • Hepatitis infection
  • Chronic nephritis
  • Signs and symptoms, suggestive of AIDS
  • Liver diseases
  • Tuberculosis
  • Polycythemia Vera.
  • Asthma
  • Epilepsy
  • Leprosy
  • Schizophrenia
  • Endocrine disorders etc.
Hope above information is helpful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Schedule E and Schedule E(1): Poisonous Substances under Ayush System

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z
Schedule E was omitted in 1982. Schedule E(1) contains the list of poisonous substances under Ayurvedic (including Siddha) and Unani System of Medicines.

Schedule-E (Omitted)
Schedule-E(1)

List of poisonous substances under the Ayurvedic (including Siddha)  and Unani Systems of Medicine

Ayurvedic System: 

Drugs of vegetable origin:

  • Ahipena (Papaver somniferum Linn.)
  • Arka  (Calotropis gigantea (linn.)R. Br. ex. Ait.
  • Bhallataka (Semecarpus anacardium Linn. F. )
  • Bhanga (Cannabis sativa Linn.)
  • Danti (Baliospermum montanum Mull. Arg.)
  • Dhattura (Datura metal Linn.)
  • Gunj (Abrus precatorium Linn.)
  • Jaipala (Jayapala) (Croton tiglium Linn.)
  • Karaveera (Rerium indicum Mill.)
  • Langali (Gloriosa superba Linn.)
  • Parasika Yavani (Hyoscyamus inibar Linn.)
  • Snuhi (Euphorbia neriifolia Linn.)
  • Vatsanabha  (Acontium chasmanthum Stapfex Holm.)
  • Vishamushti (Strychnox nuxvomica Linn.)
  • Shringivisha (Acontium chasmanthum Stapfex Holm.)

Drugs of Animal Origin:

  • Sarpa Visha (Snake poison.) 

Drugs of Mineral Origin: 

  • Gauripashana (Arsenic)
  • Hartala (Arseno sulphide)
  • Manahashila  (Arseno sulphide)
  • Parada  (Mercury)
  • Rasa Karpura  (Hydrargyri subchloridum)
  • Tuttha (Copper sulphate)
  • Hingula (Cinnabar)
  • Sindura (Red oxide of lead)
  • Girisindura (Red oxide of mercury)

 

Siddha System:
  • Abini (Papaver somniferum Linn)
  • Alari (Nerium indicum Mill.)
  • Azhavanam (Lawsonia inermis Linn.)
  • Attru thummatti (Citrullis colocynthis Scharad)
  • Anai Kunri (Adananthera pavonina Linn)
  • Rattha Polam (Aloe barbadensis Mill)
  • Ilaikalli (Euphorbia neriifolia Linn.)
  • Eezhaththalari (Plumeria acuminata Ait.)
  • Gomatthai (Datura stramonium Linn.)
  • Etti (Strychnos nuxvomica Linn.)
  • Ganja (Cannabis sativa Linn.)
  • Kalappaik Kizhangu (Gloriosa superba Linn.)
  • Kodikkalli (Euphorbia tiruqalli Linn.)
  • Chadurakkalli (Euphorbia antiquorium Linn.)
  • Karia polam (Aloe sp.)
  • Kattamanakku (Jatropha glandulifera Roxb.)
  • Kattu thumatti (Cucmis trigonus Roxb.)
  • Kunri (Abrus precatorusi Linn.)
  • Cheran Kottai (Semicarpus anacardium Linn.)
  • Thillai (Enoecaria agallocha Linn.)
  • Nabi (Aconitum feron Wall.)
  • Nervalam (Croton tiglium Linn.)
  • Pugai Elai (Nicotiana tobucum Linn.)
  • Marukkarai (Randia dumetorum Linn.)
  • Mansevikkalli (Euphorbia sp.)

 

Unani System:

Drugs of vegetable origin

Afiyun (Papaver somniferum Linn.)
Bazrul-banj (Hyoscyamus niger Linn.)
Bish (Aconitum chasmanthum Strapfex Holmes.)
Bhang (Cannabis sativa Linn.)
Charas (Canabis sativa Linn.)
Dhatura seeds (Datura metal Linn (seeds).)
Kuchla (Strychnos nuxvomica Linn.)
Shokran (Conium maculatum Linn.)Drugs of Animal origin Sanp (head) (Snake (head).
Telni makkhi (Mylabris cichori Linn.) (Mylabaris pustulata Thund.), (Mylabris macilenta)

Drugs of Mineral origin 

Darchikna (Hydrargryi perchloridum)
Hira (Diamond)
Ras Kapoor (Hydrargryi Subchloridum (calomel).
Shingruf  (Hydrargryi bisulphuratum)
Zangar (Cupri subacetas)
Sammul-Far –Abyaz, Asfar, Aswad and Ahmar (Arsenic (white, yellow, black and red).
Tootiya (Copper Sulphate)
Para (Hydrargyrum)
Hartal (Arsenic trisulphide (yellow)