Pharmaceuticals Schedules & Prescription drugs convention for Telemedicine

1. Pharmaceuticals Schedules & Prescription
drugs convention for Telemedicine
Dr Pankaj Gupta, MD

2. What are the different schedules?

3. Drugs & Cosmetics Act 1940 and rules 1945
• The Drugs and cosmetic Act, 1940 was passed in British India to
regulate the manufacture, distribution, and sale of drugs in the
colony.
• This Act also governed the import of the drugs in the country. A
related Drugs Rules were passed in 1945. Later on, after Indian
independence, the Act underwent various amendments from time to
time and is now known as the Drugs and Cosmetics Act, 1940.
• It contains 168 rules from 1 to 168 and
25 Schedules from Schedule A to Schedule Y.
• The primary objective of this act is the drugs and cosmetics that are
sold in India should always be safe, effective and meet stringent
quality standards.
https://www.pharmaguideline.com/2010/10/drugs-cosmetics-act.html

4. Schedules in Pharmacy
Schedules Detail
Schedule A List of forms used for making applications for issuing licenses, granting licenses, sending memorandums
Schedule B Fees for test or analysis by the central drug laboratory or government analyst
Schedule C Biological and special products
Schedule C(1) Other special products ( the import, manufacture, and sale of schedule c and c(1) drugs governed by
special provisions)
Schedule D Cass of exempted drugs, which are exempted from a certain provision applicable to the import of drugs
Schedule E List of poisonous substances omitted (22-6-82)
Schedule E(1) List of ayurvedic, Siddha, and Unani poisonous substances
Schedule F Provisions applicable to blood bank requirements and licensing to process blood components
Schedule F(1) Provisions applicable to vaccines, antisera, and diagnostic antigens
Schedule F(2) Standards for surgical dressings
Schedule F(3) Standards for umbilical tapes
Schedule FF Standards for ophthalmic preparations
https://www.pharmaguideline.com/2010/10/drugs-cosmetics-act.html

5. Schedules Detail
Schedule H Prescription drugs that are required to be sold by retail only on the prescription of a
registered medical practitioner
Schedule I Calculation of the proportion of poisons in certain cases – ( omitted) (22-6-82)
Schedule J List of diseases and ailments which a drug may not claim to prevent or cure
Schedule K List of drugs exempted, from certain provisions applicable to the manufacture of drugs and
sale of drugs
Schedule L List of drugs to be sold on prescription only.(omitted) (22-6-82)
Schedule M Good manufacturing practices and requirements of factory premises, plant, equipment et.,
for the manufacture of drugs
Schedule M(1) Requirements of factory premises, plant, equipment, etc. for the manufacture of
homeopathic drugs
Schedule M(2) A requirement of factory premises, plant, equipment for the manufacture of cosmetics
Schedule M(3) Requirements of factory premises for the manufacture of medical devices
Schedule N List of minimum equipment for the efficient running of a pharmacy
Schedule O Standards for disinfectant fluids
Schedule P List of periods of drugs
Schedule P(1) Pack sizes of drugs
https://www.pharmaguideline.com/2010/10/drugs-cosmetics-act.html

6. Schedules Detail
Schedule Q List of coal tar, color permitted to be used in cosmetics and list of colors permitted to be used
in soaps
Schedule R Standard for condoms made up of rubber latex intended for single use
Schedule R(1) Standard for medical devices.– standard for cosmetics
Schedule S Standard for cosmetics
Schedule T Requirements for factory premises and hygienic conditions for the manufacture of ayurvedic
( including Siddha ) and Unani drugs
Schedule U Particulars to be shown in manufacturing and analytical records of drugs
Schedule U(1) Particulars to be shown in manufacturing records of cosmetics
Schedule V Standards for patent and proprietary medicines and for patent and proprietary medicines
containing vitamins
Schedule W List of drugs that shall be marketed under generic name only
Schedule X List of habit-forming, psychotropic, and other such drugs
Schedule Y Requirements and guidelines on clinical trials, for import and manufacture of new drugs
https://www.pharmaguideline.com/2010/10/drugs-cosmetics-act.html

7. What schedules are important for
prescribers?

8. Schedules Detail
Schedule H Prescription drugs that are required to be sold by retail only on the prescription of a
registered medical practitioner
Schedule J List of diseases and ailments which a drug may not claim to prevent or cure
Schedule W List of drugs that shall be marketed under generic name only
Schedule X List of habit-forming, psychotropic, and other such drugs
Schedule Y Requirements and guidelines on clinical trials, for import and manufacture of new drugs
https://www.pharmaguideline.com/2010/10/drugs-cosmetics-act.html

9. SCHEDULE H DRUGS
• This schedule contains a list of drugs that can be sold only against the prescription of a
registered medical practitioner. Another provision needs to be followed is that, only the
required amount of medications mentioned in the prescription can be dispensed. These
drugs can be supplied only to the licensed parties.
• The drug label must exhibit the text “Rx” and Schedule H drug warning: To be sold by
retails on the prescription of a Registered Medical Practitioner only.
• As per the notification on 16th March 2006 released by the Department of Health under
the Ministry of Health and family welfare there are 536 Schedule H drugs.
• The original list contained 510 drugs but this has been revised by the Drugs Technical
Advisory Board, and the present list includes about 551 drugs.
https://www.medindia.net/patientinfo/drugs-and-cosmetics-rules-schedule-h-schedule-h1-drugs.htm

10. List of Schedule H Drugs-1
1. ABACAVIR
2. ABCIXIMAB
3. ACAMPROSATE CALCIUM
4. ACEBUTOL HYDROCHLORIDE
5. ACLARUBICIN
6. ALBENDAZOLE
7. ALCLOMETASONE
DIPROPIONATE
8. ACTILYSE
9. ACYCLOVIR
10. ADENOSINE
11. ADRENOCORTICOTROPHIC
HORMONE (ACTH)
12. ALENDRONATE SODIUM
13. ALLOPURINOL
14. ALPHACHYMOTRYPSIN
15. ALPRAZOLAM
16. ALPROSTADIL
17. AMANTADINE HYDROCHLORIDE
18. AMIFOSTINE
19. AMIKACIN SULPHATE
20. AMILORIDE HYDROCHLORIDE
21. AMINEPTINE
22. AMINOGLUTETHIMIDE
23. AMINOSALICYLIC ACID
24. AMIODARONE HYDROCHLORIDE
25. AMITRIPTYLINE
26. AMLODIPINE BESYLATE
27. AMOSCANATE
28. AMOXOPINE
29. AMRINONE LACTATE
30. ANALGIN
31. ANDROGENIC ANABOLIC, OESTROGENIC
& PROGESTATIONAL SUBSTANCES
32. ANTIBIOTICS
33. APRACLONIDINE
34. APROTININ
35. ORGANIC COMPOUND OF ARSENIC
36. ARTEETHER
37. ARTEMETHER
38. ARTESUNATE
39. ARTICAINE HYDROCHLORIDE
40. ATENOLOL
41. ATRACURIUM BESYLATE
INJECTION
42. ATORVASTATIN
43. AURANOFIN
44. AZATHIOPRINE
45. AZTREONAM
46. BACAMPICILLIN
47. BACLOFEN
48. BALSALAZIDE
49. BAMBUTEROL
50. BARBITURIC ACID
51. BASILIXIMAB
52. BENAZEPRIL HYDROCHLORIDE
53. BENIDIPINE HYDROCHLORIDE
54. BENSERAZIDE HYDROCHLORIDE
55. BETAHISTINE DIHYDROCHLORIDE
56. BETHANIDINE SULPHATE
57. BEZAFIBRATE
58. BICALUTAMIDE
59. BICLOTYMOL
60. BIFONAZOLE
61. BIMATOPROST
62. BIPERIDEN HYDROCHLORIDE
63. BIPHENYL ACETIC ACID
64. BITOSCANATE
65. BLEOMYCIN
66. PRIMONIDINE TARTRATE
67. BROMHEXINE HYDROCLORIDE
68. BROMOCRIPTINE MESYLATE
69. BUDESONIDE
70. BULAQUINE
71. BUPIVA CAINE HYDROCHLORIDE
72. BUPROPION
73. BUSPIRONE
74. BUTENAFINE HYDROCHLORIDE
75. BUTORPHANOL TARTRATE
76. CABERGOLINE
77. CALCIUM DOBESILATE
78. CANDESARTAN
79. CAPECITABINE
80. CAPTOPRIL

11. List of Schedule H Drugs-2
81. CARBIDOPA
82. CARBOCISTEINE
83. CARBOPLATIN
84. CARBOQUONE
85. CARISOPRODOL
86. L-CARNITINE
87. CARTEOLOL HYDROCHLORIDE
88. CARVEDILOL
89. CEFADROXYL
90. CEFATOXIME SODIUM
91. CEFAZOLIN SODIUM
92. CEFDINIR
93. CEFEPIME HYDROCHLORIDE
94. CEFETAMET PIVOXIL
95. CEFPIROME
96. CEFPODOXIME POXETIL
97. CEFTAZIDIME PENTAHYDRATE
98. CEFTIZOXIME SODIUM
99. CEFUROXIME
100. CELECOXIB
101. CENTCHROMAN
102. CENTBUTINDOLE
103. CENTPROPAZINE
104. CETIRIZINE HYDROCHLORIDE
105. CHLORDIAZEPOXIDE
106. CHLORMEZANONE
107. Omitted vide GSR 790 (E) dated
29.10.2009
108. CHLORPROMAZINE
109. CHLORZOXAZONE
110. CICLOPIROX OLAMINE
111. CIMETIDINE
112. CINNARIZINE
113. CIPROFLOXACIN HYDROCHLORIDE
MONOHYDRATE / LACTATE
114. CISPLATIN
115. CITALOPRAM HYDROBROMIDE
116. CLARITHROMYCIN
117. CLAVULANIC ACID
118. CLIDINIUM BROMIDE
119. CLINDAMYCIN
120. CLOBAZAM
121. CLOBETASOL PROPENATE
122. CLOBETASONE 17-BUTYRATE
123. CLOFAZIMINE
124. CLOFIBRATE
125. CLONAZEPAM
126. CLONIDINE HYDROCHLORIDE
127. CLOPAMIDE
128. CLOPIDOGREL BISULPHATE
129. CLOSTEBOL ACETATE
130. CLOTRIMAZOLE
131. CLOZAPINE
132. CODEINE
133. COLCHICINE
134. CORTICOSTEROIDS
135. COTRIMOXAZOLE
136. CYCLANDELATE
137. CYCLOSPORINS
138. DACLIZUMAB
139. DANAZOLE
140. DAPSONE
141. DESLORATADINE
142. DESMOPRESSIN
142. DESOGESTROL
143. DEXRAZOXANE
144. DEXTRANOMER
145. Omitted vide GSR 790 (E) dated
29.10.2009
146. DEXTROPROPOXYPHENE
147. DIAZAPAM
148. DIAZOXIDE
149. DICLOFENAC SODIUM/POTASSIUM/ACID
150. DICYCLOMIN HYDROCHLORIDE
151. DIDANOSINE
152. DIGOXINE
153. DILAZEP HYDROCHLORIDE
154. DILTIAZEM
155. DINOPROSTONE
156. DIPHENOXYLATE, ITS SALTS
157. DIPIVEFRIN HYDROCHLORIDE
158. DI-SODIUM PAMIDRONATE
159. DISOPYRAMIDE
160. DOCETAXEL

12. List of Schedule H Drugs-3
161. DOMPERIDONE
162. DONEPEZIL HYDROCHLORIDE
163. DOPAMINE HYDROCHLORIDE
164. DOTHIEPIN HYDROCHLORIDE
165. DOXAPRAM HYDROCHLORIDE
166. DOXAZOSIN MESYLATE
167. DOXEPIN HYDROCHLORIDE
168. DOXORUBICIN HYDROCHLORIDE
169. DROTRECOGIN-ALPHA
170. EBASTINE
171. ECONOZOLE
172. EFAVIRENZ
173. ENALAPRIL MELEATE
174. ENFENAMIC ACID
175. EPINEPHRINE
176. EPIRUBICINE
177. EPTIFIBATIDE
178. ERGOT, ALKALOIDS OF WHETHER HYDROGENATED OR
NOT, THEIR
HOMOLOGOUES, SALTS
179. ESOMEPRAZOLE
180. ESTRADIOL SUCCINATE
181. ESTRAMUSTINE PHOSPHATE
182. ETANERCEPT
183. ETHACRIDINE LACTATE
184. ETHAMBUTOL HYDROCHLORIDE
185. ETHAMSYLATE
186. ETHINYLOESTRADIOL
187. ETHIONAMIDE
188. ETIDRONATE DISODIUM
189. ETODOLAC
190. ETOMIDATE
191. ETOPOSIDE
192. EXEMESTANE
193. FAMCICLOVIR
194. FAMOTIDINE
195. FENBENDAZOLE
196. FENOFIBRATE
197. FEXOFENADINE
198. FINASTERIDE
199. FLAVOXATE HYDROCHLORIDE
200. 5-FLUOROURACIL
201. FLUDARABINE
202. FLUFENAMIC ACIDS
203. FLUNARIZINE HDROCHLORIDE
204. FLUOXETINE HYDROCHLORIDE
205. FLUPENTHIXOL
206. FLUPHENAZINE ENANTHATE
AND DECANOATE
207. FLURAZEPAM
208. FLURBIPROFEN
209. FLUTAMIDE
210. FLUTICASONE PROPIONATE
211. FLUVOXAMINE MALEATE
212. FORMESTANE
213. FOSFESTRIL SODIUM
214. FOSINOPRIL SODIUM
215. FOSSPHENYTOIN SODIUM
216. FOTEMUSTINE
217. GABAPENTIN
218. GALANTHAMINE HYDROBROMIDE
219. GALLAMINE, ITS SALTS, ITS QUATERNARY COMPOUND
220. GANCYCLOVIR
221. GANIRELIX
222. GATIFLOXACIN
223. GEMCITABINE
224. GEMFIBROZIL
225. GEMTUZUMAB
226. GENODEOXYCHOLIC ACID
227. GLICLAZIDE
228. GLIMEPIRIDE
229. GLUCAGON
230. GLYCOPYRROLATE
231. GLYDIAZINAMIDE
232. GOSERELIN ACETATE
233. GRANISETRON
234. GUANETHIDINE
235. GUGULIPID
236. HALOGENATED HYDROXYQUINOLINES
237. HALOPERIDOL
238. HEPARIN
239. HEPATITIS B. VACCINE
240. HYALURONIDASE

13. List of Schedule H Drugs-4
241. HYDROCORISONE 17-BUTYRATE
242. HYDROTALCITE
243. HYDROXIZINE
244. IBUPROFEN
245. IDEBENONE
246. IINDAPAMIDE
247. IMIPRAMINE
248. INDINAVIR SULPHATE
249. INDOMETHACIN
250. INSULIN HUMAN
251. INTERFERON
252. INTRAVENOUS FAT EMULSION
253. IOBITRIDOL
254. IOHEXOL
255. IOPAMIDOL 4
256. IOMEPROL
257. IOPROMIDE
258. IRBESARTAN
259. IRINOTECAN HYDROCHLORIDE
260. IRON PREPARATION FOR
PARENTERAL USE
261. ISEPAMICINE
262. ISOCARBOXSIDE
263. ISOFLURANE
264. ISONICOTNIC ACID HYDRAZINE AND
OTHER-HYDRAGINE DERIVATIVES OF
ISONICOTINIC ACID
265. ISOSORBIDE DINITRATE/MONONITRATE
266. ISOTRETINOIN
267. ISOXSUPRINE
268. ITOPRIDE
269. KETAMINE HYDROCHLORIDE
270. KETOCONAZOLE
271. KETOPROFEN
272. KETOROLAC TROMETHAMINE
273. LABETALOL HYDROCHLORIDE
274. LACIDIPINE
275. LAMIVUDINE
276. LAMOTRIGINE
277. LATANOPROST
278. LEFUNOMIDE
279. LERCANIDIPINE HYDROCHLORIDE
280. LETROZOLE
281. LEUPROLIDE ACETATE
282. LEVAMESOLE
283. LEVARTERENOL
284. LEVOBUNOLOL
285. LEVOCETIRIZINE
286. LEVODOPA
287. LEVOFLOXACIN
288. LEVOVIST
289. LIDOFLAZINE
290. LINEZPLID
291. LITHIUM CARBONATE
292. LOFEPRAMINE DECANOATE
293. LOPERAMIDE
294. LORAZEPAM
295. LOSARTAN POTASSIUM
296. LOTEPREDNOL
297. LOVASTATIN
298. LOXAPINE
299. MEBENDAZOLE
300. MEBEVERINE HYDROCHLORIDE
301. MEDROXY PROGESTERONE ACETATE
302. MEFENAMIC ACID
303. MEFLOQUINE HYDROCHLORIDE
304. MEGESTROL ACETATE
305. MEGLUMINE IOCARMATE
306. MELAGENINA
307. MELITRACEN HYDROCHLORIDE
308. MELOXICAM
309. MEPHENESIN, ITS ESTERS
310. MEPHENTERMINE
311. MEROPENAM
312. MESTEROLONE
313. METAXALONE
314. METHICILLIN SODIUM
315. METHOCARBAMOL
316. METHOTRAXATE
317. METOCLOPRAMIDE
318. METOPROLOL TARTRATE
319. METRIZAMIDE
320. METRONIDAZOLE

14. List of Schedule H Drugs-5
321. MEXILETINE HYDROCHLORIDE
322. MIANSERIN HYDROCHLORIDE
323. MICONAZOLE
324. MIDAZOLAM
325. MIFEPRISTONE
326. MILRINONE LACTATE
327. MILTEFOSINE
328. MINOCYCLINE
329. MINOXIDIL
330. MIRTAZAPINE
331. MISOPROSTOL
332. MITOXANTRONE HYDROCHLORIDE
333. MIZOLASTINE
334. MOCLOBEMIDE
335. MOMETASONE FUROATE
336. MONTELUKAST SODIUM
337. MORPHAZINAMIDE HYDROCHLORIDE
338. MOSAPRIDE
339. MOXIFLOXACIN
340. MYCOPHENOLATE MOFETIL
341. NADIFLOXACIN
342. NADOLOL
343. NAFARELIN ACETATE
344. NALIDIXIC ACID
345. NAPROXEN
346. NARCOTICS DRUGS LISTED IN
NARCOTIC DRUGS & PSYCHOTROPIC
SUBSTANCES ACT, 1985
347. NATAMYCIN
348. NATEGLINIDE
349. N-BUTYL-2-CYANOACRYLATE
350. NEBIVOLOL
351. NEBUMETONE
352. NELFINAVIR MESILATE
353. NETILMICIN SULPHATE
354. NEVIRAPINE
355. NICERGOLINE
356. NICORANDIL
357. NIFEDIPINE
358. NIMESULIDE
359. NIMUSTINE HYDROCHLORIDE
360. NITRAZEPAM
361. NITROGLYCERIN
362. NORETH ISTERONE ENANTHATE
363. NORFLOXACIN
364. OCTYLONIUM BROMIDE
365. OFLOXACIN
366. OLANZAPINE
367. OMEPRAZOLE
368. ORNIDAZOLE
369. ORPHENADRINE
370. ORTHOCLONE STERILE
371. OXAZEPAM
372. OXAZOLIDINE
373. OXCARBAZEPINE
374. OXETHAZAINE HYDROCHLORIDE
375. OXICONAZOLE
376. OXOLINIC ACID
377. OXPRENOLOL HYDROCHLORIDE
378. OXYBUTYNIN CHLORIDE
379. OXYFEDRINE
380. OXYMETAZOLINE
381. OXYPHENBUTAZONE
382. OXYTOCIN
383. OZOTHINE
384. PACLITAXEL
385. PANCURONIUM BROMIDE
386. PANTOPRAZOLE
387. PARA-AMINO BENZENE SULPHONAMIDE,
ITS SALTS & DERIVATIVES
388. PARP-AMINO SALICYLIC ACID, ITS SALTS,
ITS DERIVATIVES
389. PARECOXIB
390. PAROXETINE HYDROCHLORIDE
391. D-PENICILLAMINE
392. PENTAZOCINE
393. PENTOXIFYLLINE
394. PEPLEOMYCIN
395. PHENELZINEH SULPHATE
396. PHENOBARBITAL
397. PHENOTHIAZINE, DERIVATIVES OF AND
SALTS OF ITS DERIVATIVES
398. PHENYLBUTAZINE
399. PIMOZIDE
400. PINDOLOL
401. PIOGLITAZONE HYDROCHLORIDE
402. PIRACETAM
403. PIROXICAM
404. PITUITORY GLAND, ACTIVE PRINCIPLES
OF, NOT OTHERWISE SPECIFIED IN THIS
SCHEDULE AND THEIR SALTS
405. POLIDOCANOL
406. POLYESTRADIOL PHOSPHATE
407. PORACTANT ALFA
408. PRAZIQUANTEL
409. PREDNIMUSTINE
410. PREDNISOLONE STEAROYLGLYCOLATE
411. PRENOXDIAZIN HYDROCHLORIDE
412. PROMAZINE HYDROCHLORIDE
413. PROMEGESTONE
414. PROPAFENON HYDROCHLORIDE
415. PROPANOLOL HYDROCHLORIDE
416. PROPOFOL
417. PROTRISTYLINE HYDROCHLORIDE
418. PYRAZINAMIDE
419. PYRVINIUM
420. QUETIAPINE FUMERATE

15. List of Schedule H Drugs-6
421. QUINAPRIL
422. QUINIDINE SULPHATE
423. RABEPRAZOLE
424. RACECADOTRIL
425. RALOXIFENE HYDROCHLORIDE
426. RAMIPRIL HYDROCHLORIDE
427. RANITIDINE
428. RAUWOLFIA, ALKALOIDS OF, THEIR
SALTS, DERIVATIVES OF THE ALKALOIDS
OR RAUWOLFIA
429. REBOXETINE
430. REPAGLINIDE
431. REPROTEROL HYDROCHLORIDE
432. RILMENIDINE
433. RILUZONE
434. RISPERIDONE
435. RITONAVIR
436. RITODRINE HYDROCHLORIDE
437. RITUXIMAB
438. RIVASTIGMINE
439. ROCURONIUM BROMIDE
440. ROPINIROLE
441. ROSOXACIN
442. ROSIGLITAZONE MELEATE
443. SALBUTAMOL SULPHATE
444. SALICYL-AZO-SULPHAPYRIDINE
445. SALMON CALCITONIN
446. SAQUINAVIR
447. SATRANIDAZOLE
448. SECNIDAZOLE
449. SEPTOPAL BEADS & CHAINS
450. SERRATIOPEPTIDASE
451. SERTRALINE HYDROCHLORIDE
452. SIBUTRAMINE HYDROCHLORIDE
453. SILDENAFIL CITRATE
454. SIMVASTATIN
455. SIROLIMUS
456. SISOMICIN SULPHATE
457. S-NEOMINOPHAGEN
458. SODIUM PICOSULPHATE
459. SODIUM CROMOGLYCATE
460. SODIUM HYALURONATE
461. SODIUM VALPROATE
462. SODIUM AND MAGLUMINE
IOTHALAMATES
463. SOMATOSTATIN
465. SOTALOL
466. SPARFLOXACIN
467. SPECTINOMYCIN HYDROCHLORIDE
468. SPIRONOLACTONE
469. STAVUDINE
470. SUCRALFATE
471. SULPHADOXINE
472. SULPHAMETHOXINE
473. SULPHAMETHOXYPYRIDAZINE
474. SULPHAPHENAZOLE
475. SULPIRIDE
476. SULPROSTONE HYDROCHLORIDE
477. SUMATRIPTAN
478. TACRINE HYDROCHLORIDE
479. TAMSULOSIN HYDROCHLORIDE
480. TRAPIDIL
481. TEGASEROD MALEATE
482. TEICOPLANIN
483. TELMISARTAN
484. TEMOZOLAMIDE
485. TERAZOSIN
486. TERBUTALINE SULPHATE
487. TERFENADINE
488. TERIZIDONE
489. TERLIPRESSIN
490. TESTOSTERONE UNDECOANOATE
491. TERATOLOL HYDROCHLORIDE
492. THALIDOMIDE
493. THIACETAZONE
494. THIOCOLCHICOSIDE
495. THIOPROPAZATE, ITS SALTS
496. THYMOGENE
497. THYMOSIN-ALPHA 1
498. TIAPROFENIC ACID
499. TIBOLONE
500. TIMOLOL MALEATE
501. TINIDAZOLE
502. TIZANIDINE
503. TABRAMYCIN
504. TOLFENAMIC ACID
505. TOPIRAMATE
506. TOPOTECAN HYDROCHLORIDE
507. TRAMADOL HYDROCHLORIDE
508. TRANEXAMIC ACID
509. TRANYLCYPROMINE, ITS SALTS
510. TRAZODONE
511. TRETINOIN
512. TRIFLUPERAZINE
513. TRIFLUPERIDOL HYDROCHLORIDE
514. TRIFLUSAL
515. TRIMETAZIDINE DIHYDROCHLORIDE
516. TRIMIPRAMINE
517. TRIPOTASSIUM DICITRATE BISMUTHATE
518. TROMANTADINE HYDROCHLORIDE
519. UROKINASE
520. VALSARTAN

16. List of Schedule H Drugs-7
521. VASOPRESSIN
522. VECURONIUM BROMIDE
523. VENLAFAXINE HYDROCHLORIDE
524. VERAPAMIL HYDROCHLORIDE
525. VERTEPORFIN
526. VINCRISTINE SULPHATE
527. VINBLASTINE SULPHATE
528. VINDESINE SULPHATE
529. VINORELBINE TATRATE
530. XIPAMIDE
531. ZIDOVUDINE HYDROCHLORIDE
532. ZIPRASIDONE HYDROCHLORIDE
533. ZOLEDRONIC ACID
534. ZOLPIDEM
535. ZOPICLONE
536. ZUCLOPENTHIXOL
537. Etizolam
538. Alclometasone
539. Beclomethasone
540. Betamethasone
541. Desonide
542. Desoximetasone
543. Dexamethasone
544. Diflorasone diacetate
545. Fluocinonide
546. Fluocinolone acetonide
547. Halobetasol propionate
548. Halometasone
549. Methylprednisone
550. Prednicarbate
551. Triamcinolone acetonide

17. Schedule H1 drugs
• Schedule H1 drugs introduced under the drugs and cosmetics ( 4th amendment) rules
2013, by MOHFW( ministry of health welfare and family welfare) on 30 august,2013
vide GSR( General Statutory Rules) 588(E) to regulate the sale of antibiotics.
• The schedule H1 drug includes 3rd & 4th generation antibiotics, anti-tuberculosis drugs
and certain habit-forming drugs like psychotropic drugs.
• To dispense these drugs two main criteria have to be followed strictly.
– The drug supplied under the schedule H1 specification should be recorded in a separate register
at the time of supply, mentioning the name and address of the prescriber, name of the patient,
and the name of the drug along with the quantity supplied. This register has to be maintained
confidentially up to three years and should be open for inspection.
– The schedule H1 drugs should be labeled with the symbol Rx in red, clearly displayed on the left
top corner of the drug label. The label should also bear the following words in a box with a red
border.
• "Schedule H1 Drug-Warning
-It is dangerous to take this preparation except in accordance with the medical advice.
-Not to be sold by retail without the prescription of a Registered Medical Practitioner."
https://www.medindia.net/patientinfo/drugs-and-cosmetics-rules-schedule-h-schedule-h1-drugs.htm

18. List of Schedule H1 Drugs
• Alprazolam
• Balofloxacin
• Buprenorphine
• Capreomycin
• Cefdinir
• Cefditoren
• Cefepime
• Cefetamet
• Cefixime
• Cefoperazone
• Cefotaxime
• Cefpirome
• Cefpodoxime
• Ceftazidime
• Ceftibuten
• Ceftizoxime
• Ceftriaxone
• Chlorodiazepoxide
• Clofazimine Sodium
• Codeine
• Cycloserine
• Diazepam
• Diphenoxylate
• Doripenam
• Ertapenem
• Ethambutol
Hydrochloride
• Ethionamide
• Feropenam
• Gemifloxacin
• Imipenem
• Isoniazide
• Levofloxacin
• Meropenem
• Midazolam
• Moxifloxacin
• Nitrazepam
• Para-
aminosalicylate
• Pentazocine
• Prulifloxacin
• Pyrazinamide
• Rifabutin
• Rifampicin
• Sparfloxacin
• Thiacetazone
• Tramadol
• Zolpidem
https://www.medindia.net/patientinfo/drugs-and-cosmetics-rules-schedule-h-schedule-h1-drugs.htm

19. Schedule H1 drugs divided into 3 major parts
• ANTIBIOTICS: problem of resistance
• TB DRUGS(TUBERCULOSIS): missing one dose is
dangerous as well a double dose also can be lethal
• NRX DRUGS
– NRx drugs include sleeping pills like alprazolam, and other CNS drugs.
– if these drugs will provide without prescription they can be used for murders,
theft, rape, etc.
https://www.medindia.net/patientinfo/drugs-and-cosmetics-rules-schedule-h-schedule-h1-drugs.htm

20. Conditions
• The Supply of a drug specified in Schedule H1 shall be recorded in a
separate register at the time of the supply giving the name and
address of the prescriber, the name of the patient, the name of the
drug and the quantity supplied and such record shall be maintained
for three years and be open for inspection.
• If it contains a drug substance specified in Schedule H1, the drug
formulation shall be labelled with the symbol Rx which shall be in
Red and conspicuously displayed on the left top corner of the label
and shall also be labelled with the following word in a box with red
background as mentioned below in warning section.
https://www.medindia.net/patientinfo/drugs-and-cosmetics-rules-schedule-h-schedule-h1-drugs.htm

21. Difference between Schedule H and
Schedule H1
• There is not any major difference between schedule H and schedule
H1 drugs but antibiotics, anti-TB drugs and habit forming that were
fall under schedule H category was moved to a new sub category
that is known as Schedule H1.
• Schedule H and H1, both categories shall be sold under prescription
of a Registered Medical Practitioner only but norm regarding drug
fall under Schedule H1 are strict.
• A proper record of every sale, purchase, prescription copy, patient
detail, doctor details under which prescription drugs are sold out etc.
shall be maintained for at least three years for schedule H1 drugs
where there is no requirement for maintaining record for drug which
fall under schedule H drugs.
https://www.medindia.net/patientinfo/drugs-and-cosmetics-rules-schedule-h-schedule-h1-drugs.htm

22. Schedule H Schedule H1
• Under prescription of a RMP • Under prescription of a RMP
• Record of every sale need not to be maintained • Record of every sale must be maintained in a separate
register which includes-
• Name of Prescriber
• Name of Patient
• Name of drug
• Quantity of Drug
• Record must be maintained for 3 years
• Open for inspection
• The drug label must exhibit the text “Rx” • Should be labeled with the symbol Rx in red
• Label should also bear the following words in a box
with a red border.
Schedule H drug warning:
“To be sold by retails on the prescription of a
Registered Medical Practitioner only”
• Label should also bear the following words in a box
with a red border.
"Schedule H1 Drug-Warning
-It is dangerous to take this preparation except in
accordance with the medical advice.
-Not to be sold by retail without the prescription of
a Registered Medical Practitioner."
https://www.medindia.net/patientinfo/drugs-and-cosmetics-rules-schedule-h-schedule-h1-drugs.htm

23. Why there is need of Schedule H1
• In recent time, number of cases of antibiotic resistance
diseases are increasing. One of the main cause of
antibiotic resistance is easy availability and self
medication. There was urgent requirement of
implementation of any strict laws that Schedule H was not
available to implement.
https://pharmafranchisehelp.com/list-of-schedule-h1-drugs-medicines-molecules/

24. SCHEDULE X DRUGS LIST
• Amobarbital
• Amphetamine
• Barbital
• Cyclobarbital
• Dexamphetamine
• Ethclorvynol
• Glutethimide
• Meprobamate
• Methamphetamine
• Methaqualone
• Methylphenidate
• Methyphenobarbital
• Pentobarbital
• Phencyclidine
• Phenmetrazine
• Phenobarbital
• Secobarbital
https://www.pharmamad.com/schedule-x-drugs/

25. SCHEDULE X DRUGS
• Substances specified in schedule X should not be sold by retail and sold only in accordance
with the prescription of RMP.
• In the case of substances specified in schedule X, the prescription should be in duplicate, one
copy of which retained by the licensee and preserved at least for two years.
• Drugs from schedule X, supplied to registered medical practitioners, hospitals, dispensaries,
and nursing homes, shall be supplied only against signed written order and such order should
be preserved at least for two years.
https://www.pharmamad.com/schedule-x-drugs/

26. Schedule H Schedule H1 Schedule X
• Under prescription of a RMP • Under prescription of a RMP • Under prescription of a RMP
• Record of every sale need not
to be maintained
• Record of every sale must be maintained in a
separate register which includes-
• Name of Prescriber
• Name of Patient
• Name of drug
• Quantity of Drug
• Record must be maintained for 3 years
• Open for inspection
• Prescription should be in duplicate, one
copy of which retained by the licensee
and preserved at least for two years.
• STORAGE OF SCHEDULE X DRUGS
• Under lock and key in a cupboard or
drawer solely reserved for storage of
substances.
• In a part of the premises, separate
from the remainder of the premises
and which will have access to only by
responsible persons.
• RECORDS OF PURCHASE
• SUPPLY OF SCHEDULE X DRUGS
• The drug label must exhibit the
text “Rx”
• Should be labeled with the symbol Rx in red • Be labelled with the symbol XRx which
shall be in red conspicuously displayed
on the left top corner of the label
• Label should also bear the
following words in a box with a
red border.
Schedule H drug warning:
“To be sold by retails on the
prescription of a Registered
Medical Practitioner only”
• Label should also bear the following words in a box
with a red border.
"Schedule H1 Drug-Warning
-It is dangerous to take this preparation except in
accordance with the medical advice.
-Not to be sold by retail without the prescription
of a Registered Medical Practitioner."
• be also labelled with the following
word
• “Schedule X drug -Warning: To be sold
by retail on the prescription of a
Registered Medical Practitioner”

27. Telemedicine guidelines for RMPs

28. Definition of Telemedicine
World Health Organization defines telemedicine as
“The delivery of health-care services, where distance is a critical factor, by all health-care
professionals using information and communications technologies for the exchange of
valid
information for diagnosis, treatment and prevention of disease and injuries, research and
evaluation, and the continuing education of health-care workers, with the aim of advancing
the
health of individuals and communities.”
Definition of Registered Medical Practitioner (RMP)
For the purpose of this document a ‘Registered Medical Practitioner’ is defined as a person
who is
enrolled in the State Register or the National Register under the IMC Act 1956.
https://www.mohfw.gov.in/pdf/Telemedicine.pdf

29. • A Registered Medical Practitioner is entitled to provide telemedicine
consultation to patients from any part of India
• RMPs using telemedicine shall uphold the same professional and ethical
norms and standards as applicable to traditional in-person care, within the
intrinsic limitations of telemedicine.
• The professional judgment of a Registered Medical Practitioner should be
the guiding principle for all telemedicine consultations: An RMP is well
positioned to decide whether a technology based consultation is sufficient
or an in-person review is needed. Practitioner shall exercise proper
discretion and not compromise on the quality of care.
• RMPs must make all efforts to gather sufficient medical information about
the patient’s condition before making any professional judgment.
https://www.mohfw.gov.in/pdf/Telemedicine.pdf

30. TYPES OF CONSULTATION
First Consult
– The patient is consulting with the RMP for the first time; or
– The patient has consulted with the RMP earlier, but more than 6
months have lapsed since the previous consultation; or
– The patient has consulted with the RMP earlier, but for a different
health condition
Follow-Up Consult(s) means
– The patient is consulting with the same RMP within 6 months of
his/her previous in-person consultation and this is for
continuation of care of the same health condition.
However, it will not be considered a follow up if:
– There are new symptoms that are not in the spectrum of the
same health condition; and/or
– RMP does not recall the context of previous treatment and advice
https://www.mohfw.gov.in/pdf/Telemedicine.pdf

31. PATIENT MANAGEMENT IN TELEMEDICINE
– If the condition can be appropriately managed via telemedicine,
based on the type of consultation, then the RMP may proceed
with a professional judgement to:
• Provide Health Education as appropriate in the case; and/or
• Provide Counseling related to specific clinical condition; and/or
• Prescribe Medicines
https://www.mohfw.gov.in/pdf/Telemedicine.pdf

32. PRESCRIBING MEDICINES IN TELEMEDICINE
• Prescribing medications, via telemedicine consultation is at the
professional discretion of the RMP. It entails the same professional
accountability as in the traditional in-person consult. If a medical condition
requires a particular protocol to diagnose and prescribe as in a case of in-
person consult then same prevailing principle will be applicable to a
telemedicine consult.
• RMP may prescribe medicines via telemedicine ONLY when RMP is
satisfied that he/ she has gathered adequate and relevant information
about the patient’s medical condition and prescribed medicines are in the
best interest of the patient.
• Prescribing Medicines without an appropriate diagnosis/provisional
diagnosis will amount to a professional misconduct.
https://www.mohfw.gov.in/pdf/Telemedicine.pdf

33. Specific Restrictions
• There are certain limitations on prescribing medicines on consult via telemedicine depending upon the type
of consultation and mode of consultation. The categories of medicines that can be prescribed via tele-
consultation will be as notified in consultation with the Central Government from time to time.
• The categories of medicines that can be prescribed are listed below:
• List O: It will comprise those medicines which are safe to be prescribed through any mode of tele-
consultation. In essence they would comprise of
– Medicines which are used for common conditions and are often available ‘over the counter’. For instance, these
medicines would include, paracetamol, ORS solutions, cough lozenges etc
– Medicines that may be deemed necessary during public health emergencies.
• List A: These medications are those which can be prescribed during the first consult which is a video
consultation and are being re-prescribed for re-fill, in case of follow-up.
– This would be an inclusion list, containing relatively safe medicines with low potential for abuse Is a list of medication
which RMP can prescribe in a patient who is undergoing follow-up consult, as a refill.
• List B: Is a list of medication which RMP can prescribe in a patient who is undergoing follow-up
consultation in addition to those which have been prescribed during in-person consult for the same medical
condition.
• Prohibited List: An RMP providing consultation via telemedicine cannot prescribe medicines in this list.
These medicine have a high potential of abuse and could harm the patient or the society at large if used
improperly
– Medicines listed in Schedule X of Drug and Cosmetic Act and Rules or any Narcotic and Psychotropic substance
listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985.
https://www.mohfw.gov.in/pdf/Telemedicine.pdf

34. List O
• Common over-the counter medications such as
• Antipyretics: Paracetamol
• Cough Supplements: Lozenges,
• Cough/ Common-cold medications (such as combinations of Acetylcysteine, Ammonium
Chloride, Guaifensen, Ambroxol, Bromhexene, Dextromethorphan)
• ORS Packets
• Syrup Zinc
• Supplements: Iron & Folic Acid tablets, Vitamin D, Calcium supplements
• Medications notified by Government of India in case from time to time on an Emergency basis
• Such as Chloroquine for Malaria control for a specific endemic region, when notified by
Government
https://www.mohfw.gov.in/pdf/Telemedicine.pdf

35. List A
• First Consult Medications (Diagnosis done on video mode of consultation) such as
• Ointments/Lotion for skin ailments: Ointments Clotrimazole, Mupirocin, Calamine
Lotion, Benzyl Benzoate Lotion etc
• Local Ophthalmological drops such as: Ciprofloxacin for Conjunctivitis, etc
• Local Ear Drops such as: Clotrimazole ear drops, drops for ear wax etc.
• Follow-up consult for above medications
• Follow-up medications for chronic illnesses for ‘re-fill’ (on any mode of consultation) such as
medications for
• Hypertension: Enalapril, Atenolol etc
• Diabetes: Metformin, Glibenclamide etc
• Asthma: Salmetrol inhaler etc
List B
• On follow-up, medications prescribed as ‘Add-on’ to ongoing chronic medications to
optimize management such as for hypertension: Eg, add-on of Thiazide diuretic with
Atenolol
• Diabetes: Addition of Sitagliptin to Metformin
https://www.mohfw.gov.in/pdf/Telemedicine.pdf

36. TELEMEDICINE FAQs

37. • If I am on a follow-up care for a Chronic condition (say Diabetes), for how long can I continue to
request for refill for my medications to my RMP?
• The Guidelines define follow-up consultation for a maximum period of 6 months. After this period, an in-
person consultation is mandatory.
• What are the prerequisites to be for doing a telemedicine consultation?
• The MCI is in process of developing an online telemedicine course for ensuring uniformity. Once the
course is developed, it will be mandatory for all RMPs to undertake this course within three years of its
notification. Thereafter, it will be compulsory for all RMPs who wish to tele-consult to have undergone
such a course.
• As on date, all RMPs can tele-consult, provided they follow the Telemedicine Practice Guidelines notified
under IMC Act, 1956.
https://covid.aiims.edu/frequently-asked-questions-faqs-on-telemedicine-practice-guidelines/

38. • In case I feel the patient requires a physical examination, how do I ensure that?
• The RMP has the right to pause his/her tele-consultation and recommend an in-patient consultation.
Besides, if during the teleconsultation it appears that a physical examination is mandatory but not
feasible on the mode being used for the consultation, the tele-consultation should be aborted and the
patient referred for an in-person review.
• The RMP may advise beyond his jurisdiction, for which he may not have specialization. How to
take care of this issue?
• Once a tele-consultation has been initiated on a mutual consent between a patient and a consulting
RMP, then the RMP can advise on the health issues to the best of his knowledge. All RMPs can
practice modern medicine and are also aware of the jurisdiction of their specialization.
https://covid.aiims.edu/frequently-asked-questions-faqs-on-telemedicine-practice-guidelines/

39. • Can schedule H class of Drugs be prescribed by tele-consultation? Which classes of
drugs have been enabled by the guidelines for tele-prescription?
• The drug prescription in Telemedicine guidelines is based on the clinical scenario, judgement
of the RMP and the mode of consultation, as specified in the framework. Hence, specific
nomenclatures such as Schedule H etc. classes of drugs have been avoided.
• The classification of list of drugs provided in the document is based on practical clinical
pathways.
• A prohibited list of drugs is also given and this is specified as to include Schedule X of Drug
and Cosmetic Act and Narcotic, Psychotropic substances. As such these lists of drugs
mentioned in guidelines can be amended from time to time based on directions of the MCI
and MoHFW.
https://covid.aiims.edu/frequently-asked-questions-faqs-on-telemedicine-practice-guidelines/

40. • Can I prescribe antibiotics on tele-consultation?
• Antibiotics can be prescribed by the RMP, if he/she is strongly convinced about the
same based on the type and mode of tele-consultation. As such, all tele-consultations
mandate a clear documentation of provisional diagnosis and reasons for prescription
of particular drug. This is as well applicable for antibiotics. As in all scenarios, the
RMP will be responsible for his/her prescriptions.
https://covid.aiims.edu/frequently-asked-questions-faqs-on-telemedicine-practice-guidelines/

41. • Can I prescribe injectable medications on tele-consultation?
• Prescriptions for injectable medicines can only be given if the consultation is
between an RMP with another RMP. In certain circumstances, it may be prescribed to
a Health Worker for administration to a given patient. In such a scenario, the RMP
must be confident of the setting of the facility and the technical expertise of the
Health Worker.
• The exceptions to these would be prescribing some follow-up medications which are
available only as injections such as Insulin, Low Molecular Weight Heparin,
Vaccines etc.
https://covid.aiims.edu/frequently-asked-questions-faqs-on-telemedicine-practice-guidelines/

42. THANKS