Union Health Ministry notifies 300 drug brands under Schedule H2, Details

The move comes in line with the recommendation of the Drugs Technical Advisory Board (DTAB) during a meeting held in November, 2021.

In March the Ministry had asked the Department of Pharmaceuticals (DoP) to shortlist the 300 drug brands that can be included for implementation of mandatory QR codes. The National Pharmaceutical Pricing Authority (NPPA) had identified the list of 300 drugs which include widely used medicines like pain-killers, contraceptives, vitamins, blood-sugar and hypertension medicines, etc.

Medical Dialogues Team had earlier reported that the Government had set up a committee to fine-tune the modalities and attribute a unique quick response (QR) code to medicine packs in a bid to ensure authenticity and enable tracking. Accordingly, 300 medicines were finalized to be included in the list.

Also Read: These 300 Medicines Have Been Finalised For QR Code

After considering the objections and suggestions received from the public on the draft rules, before finalizing the amendment, which is now called the Drugs (Eighth Amendment) Rules, 2022, the Government has now issued the final notification amending the Drugs Rules, 1945 and inserted Schedule H2, a new schedule, after Schedule H1, which contains 300 brands of formulations.

Certain strengths of Aciloc, Actemra, Allegra, Amlokind, Ascoril D Plus New, Asthalin inhaler, Becosules Capsules, Betadine ointment, solution and gargle, Calpol, Combiflam, Dolo 650 mg, Electral Sache, Fabiflu, Foracort, Gelusil, Glycomet, Janumet, Lantus are included in the list of 300 drugs among others.

The manufacturers of drug formulation products as specified in Schedule H2, under the new sub-rule 6, shall print or affix a Bar Code or Quick Response Code on their primary packaging label or, in case of inadequate space in the primary package label, on the secondary package label that stores data or information legible with a software application to facilitate authentication.

The Gazette issued in this regard read;

"In the Drugs Rules, 1945 (hereinafter to be referred as the said rules), in rule 96, after sub-rule (5) and before the explanation, the following sub-rules shall be inserted, namely:—
"(6) The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication."

A sub-rule 7 has also been inserted into the Rules, defining the details thus to be added in the Barcode or QR code as;

"(7) The stored data or information referred to in sub-rule (6) shall include the following particulars, namely:—
(i) unique product identification code;
(ii) proper and generic name of the drug;
(iii) brand name;
(iv) name and address of the manufacturer;
(v) batch number;
(vi) date of manufacturing;
(vii) date of expiry; and
(viii) manufacturing licence number."

Further, in the said rules, after Schedule H1, the following Schedule shall be inserted, namely:—

"SCHEDULE H2

[See sub-rules (6) and (7) of rule 96]

Serial number Brand name of drug formulation

1. ACILOC 150 MG TABLET 30

2. ACILOC 300 MG TABLET 20

3. ACTEMRA 400 MG INJECTION 1

4. ACTRAPID HUMAN 40 IU INJECTION 10 ML

5. AEROCORT WITH DOSE COUNTER 50/50 MCG INHALER 200 MDI

6. AJADUO 25/5 MG TABLET 10

7. ALLEGRA 120 MG TABLET 10

8. ALLEGRA 180 MG TABLET 10

9. AMBISOME 50 MG INJECTION 20 ML

10. AMICIN 500 MG INJECTION 2 ML

11. AMLOKIND-AT 50/5 MG TABLET 10

12. ASCORIL D PLUS NEW 5/2/10 MG SYRUP 100 ML

13. ASCORIL LS 1/30/50 MG SYRUP 100 ML

14. ASCORIL PLUS 50/1.25/2 MG EXPECTORANT 120 ML

15. ASTHAKIND DX 5/2/15 MG SYRUP 100 ML

16. ASTHALIN 100 MCG INHALER 200 MDI

17. AUGMENTIN DUO 500/125 MG TABLET 10

18. AVOMINE 25 MG TABLET 10

19. AXCER 90 MG TABLET 14

20. AZEE 500 MG TABLET 5

21. AZITHRAL 500 MG TABLET 5

22. BECOSULES CAPSULE 20

23. BECOSULES Z CAPSULE 20

24. BETADINE 10 % OINTMENT 20 GM

25. BETADINE 10 % SOLUTION 100 ML

26. BETADINE MINT 2 % GARGLE 100 ML

27. BETNESOL 0.5 MG TABLET 20

28. BETNOVATE C 0.1/3 % CREAM 30 GM

29. BETNOVATE N 0.1/0.5 % CREAM 20 GM

30. BETNOVATE N 0.1/0.5 % CREAM 25 GM

31. BETT 0.5 ML INJECTION 0.5 ML

32. BEVON SYRUP 200 ML

33. BIO D3 MAX 500 MG/0.25MCG/400MCG/120MG CAPSULE 15

34. BRILINTA 90 MG TABLET 14

35. BRO ZEDEX 50/1.25/4 MG SYRUP 100 ML

36. BUDECORT 0.5 MG RESPULES 2 ML

37. CALCIROL 60000 IU GRANULES 1 GM

38. CALDIKIND PLUS 500 MG/0.25MCG/400MCG/60MG CAPSULE 10

39. CALPOL 500 MG TABLET 15

40. CALPOL 650 MG TABLET 15

41. CALPOL PEAD 250 MG SUSPENSION 60 ML

42. CANDIFORCE 200 MG CAPSULE 7

43. CCM 250 MG TABLET 40

44. CEFAKIND 500 MG TABLET 10

45. CEFTUM 500 MG TABLET 4

46. CEPODEM 200 MG TABLET 10

47. CHYMORAL FORTE 100000 IU TABLET 20

48. CIDMUS 24/26 MG TABLET 14

49. CILACAR 10 MG TABLET 15

50. CIPREMI 100 MG INJECTION 1

51. CLARIBID 500 MG TABLET 10

52. CLAVAM 500/125 MG TABLET 10

53. CLEXANE 40 MG INJECTION 0.4 ML

54. CLEXANE 60 MG INJECTION 0.6 ML

55. COBADEX CZS TABLET 15

56. CODISTAR 4/10 MG SYRUP 100 ML

57. COMBIFLAM 400/325 MG TABLET 20

58. CONCOR 5 MG TABLET 10

59. COREX DX 4/10 MG SYRUP 100 ML

60. CREMAFFIN PLUS SF 1.25 ML/3.75ML/3.33MG LIQUID 225 ML

61. CYPON 275/2 MG SYRUP 200 ML

62. CYRA D 30/20 MG TABLET SR 10

63. DALACIN C 300 MG CAPSULE 10

64. DECA DURABOLIN 50 MG INJECTION 1

65. DEFCORT 6 MG TABLET 10

66. DERIPHYLLIN 25.3/84.7 MG INJECTION 2 ML

67. DEROBIN 1.15/1.15/5.3 % OINTMENT 30 GM

68. DEXONA (VIAL) 4 MG INJECTION 2 ML

69. DEXORANGE 160 MG/0.5MG/7.5MCG SYRUP 200 ML

70. DOLO 650 MG TABLET 15

71. DOLONEX 20 MG TABLET DT 15

72. DOXINATE 10/10 MG TABLET 30

73. DOXT SL 100 MG/5BIU CAPSULE 10

74. DOXY 1 FORTE L DR 100 MG/5BIU CAPSULE 10

75. DULCOFLEX 5 MG TABLET 10

76. DUOLIN 3 1.25 MG/500MCG RESPULES 3 ML

77. DUPHASTON 10 MG TABLET 10

78. DYDROBOON 10 MG TABLET 10

79. DYNAPAR AQ 75 MG INJECTION 1 ML

80. EASY SIX PREFILLED SYRINGE 0.5 ML

81. ECOSPRIN AV 10/75 MG CAPSULE 15

82. ECOSPRIN GOLD 75/20/75 MG TABLET 15

83. ELAXIM 40 MG INJECTION 1

84. ELECTRAL SACHET 21.8 GM

85. ELIQUIS 2.5 MG TABLET 10

86. ELIQUIS 5 MG TABLET 10

87. ELTROXIN 100 MCG TABLET 120

88. ENTEROGERMINA 2 BIU ORAL SUSPENSION 5 ML

89. EXHEP 40 MG PREFILLED SYRINGE 0.4 ML

90. FABIFLU 200 MG TABLET 34

91. FABIFLU 400 MG TABLET 17

92. FABIFLU COPACK 800 MG TABLET 18

93. FARONEM 200 MG TABLET 10

94. FARONEM 300 MG TABLET ER 10

95. FORACORT 20/500 MCG RESPULES 2 ML

96. FORACORT 6/200 MCG ROTACAP 30

97. FORACORT 6/400 MCG ROTACAP 30

98. FORXIGA 10 MG TABLET 14

99. GABAPIN NT 400/10 MG TABLET 15

100. GALVUS 50 MG TABLET 15

101. GALVUS MET 50/1000 MG TABLET 15

102. GALVUS MET 50/500 MG TABLET 15

103. GEFTINAT 250 MG TABLET 30

104. GELUSIL MPS 250/50/250 MG LIQUID 200 ML

105. GEMCAL 500 MG/0.25MCG/7.5MG CAPSULE 15

106. GEMER 2/500 MG TABLET 10

107. GIBTULIO 25 MG TABLET 10

108. GLUCONORM-G 2/500 MG TABLET 15

109. GLYCOMET GP 1/500 MG TABLET 15

110. GLYCOMET GP 2/500 MG TABLET SR 15

111. GLYNASE MF 5/500 MG TABLET 10

112. GLYXAMBI 25/5 MG TABLET 10

113. GRILINCTUS 60/2.5/5/50 MG SYRUP 100 ML

114. GUDCEF 200 MG TABLET 10

115. GUDCEF CV 200/125 MG TABLET 10

116. HCQS 200 MG TABLET 15

117. HEXAXIM INJECTION 0.5 ML

118. HUCOG HP 5000 IU INJECTION 1 ML

119. HUMINSULIN 30/70 100 IU CARTRIDGE 3 ML

120. INFANRIX HEXA INJECTION 0.5 ML

121. ISTAMET 50/500 MG TABLET 15

122. IVABRAD 5 MG TABLET 15

123. IVERMECTOL NEW 12 MG TABLET 2

124. JALRA M 50/500 MG TABLET 15

125. JANUMET 50/1000 MG TABLET 15

126. JANUMET 50/500 MG TABLET 15

127. JANUVIA 100 MG TABLET 7

128. JARDIANCE 10 MG TABLET 10

129. JARDIANCE 25 MG TABLET 10

130. KABIMOL 1000 MG INFUSION 100 ML

131. KARVOL PLUS CAPSULE 10

132. KENACORT 40 MG INJECTION 1 ML

133. KETOROL 10 MG TABLET DT 15

134. KETOSTERIL TABLET 20

135. LANTUS 100 IU CARTRIDGE 3 ML

136. LANTUS SOLOSTAR 100 IU DISPOSABLE PEN 3 ML

137. LEVERA 500 MG TABLET 15

138. LEVIPIL 500 MG TABLET 10

139. LIBRAX 2.5/5 MG TABLET 20

140. LIMCEE CHEW ORANGE 500 MG TABLET 15

141. LIPAGLYN 4 MG TABLET 10

142. LMWX 40 MG INJECTION 0.4 ML

143. LOBATE GM NEO 0.05/0.5/2 % CREAM 15 GM

144. LONOPIN 40 MG INJECTION 0.4 ML

145. LOSAR 50 MG TABLET 15

146. LOSAR H 50/12.5 MG TABLET 15

147. MACBERY XT 50/1.25/4 MG SYRUP 100 ML

148. MAGNEX FORTE 1000/500 MG INJECTION 1

149. MANFORCE 100 MG TABLET 4

150. MANFORCE 50 MG TABLET 9

151. MAXTRA 5/2 MG SYRUP 60 ML

152. MEFTAL SPAS 10/250 MG TABLET 10

153. MEGALIS 20 MG TABLET 4

154. MEGANEURON OD PLUS 1500 MCG CAPSULE 10

155. MENACTRA INJECTION 0.5 ML

156. MERO 1000 MG INJECTION 1

157. MEROMAC 1000 MG INJECTION 1

158. MERONEM 1000 MG INJECTION 1

159. MEROZA 1000 MG INJECTION 1 ML

160. MIFEGEST KIT 200 MG/200MCG TABLET 1

161. MIKACIN 500 MG INJECTION 2 ML

162. MINIPRESS XL 5 MG TABLET XL 30

163. MIXTARD HM PENFILL 30/70 100 IU INJECTION 3 ML

164. MIXTARD HUMAN 30/70 40 IU INJECTION 10 ML

165. MIXTARD HUMAN 50/50 40 IU INJECTION 10 ML

166. MONOCEF 1000 MG INJECTION 5 ML

167. MONOCEF O 200 MG TABLET 10

168. MONOCEF SB 1000/500 MG INJECTION 1

169. MONTAIR LC 10/5 MG TABLET 15

170. MONTAZ 1000/125 MG INJECTION 1

171. MONTEK-LC 10/5 MG TABLET 10

172. MONTICOPE 10/5 MG TABLET 10

173. MOX 500 MG CAPSULE 15

174. MOX CV 500/125 MG TABLET 10

175. MOXCLAV 500/125 MG TABLET 10

176. MOXIKIND CV 500/125 MG TABLET 10

177. MUCAINE MINT 10/291/98 MG GEL 200 ML

178. MUCINAC SF ORANGE 600 MG TABLET 10

179. NEBICARD 5 MG TABLET 10

180. NEFROSAVE 150/500 MG TABLET 15

181. NEUROBION FORTE TABLET 30

182. NEXPRO 40 MG TABLET 15

183. NEXPRO RD 30/40 MG CAPSULE 10

184. NIKORAN 5 MG TABLET 20

185. NISE 100 MG TABLET 15

186. NITROCONTIN 2.6 MG TABLET CR 30

187. NOVOMIX 100 IU CARTRIDGE 3 ML

188. NOVOMIX 30/70 MG FLEXPEN 3 ML

189. NOVORAPID 100 IU CARTRIDGE 3 ML

190. NUROKIND LC 500 MG/1.5MG/1500MCG TABLET 15

191. NUROKIND PLUS RF 1500 MCG CAPSULE 10

192. O2 200/500 MG TABLET 10

193. OMEZ 20 MG CAPSULE 20

194. OMEZ D 30/20 MG CAPSULE SR 15

195. OMNIKACIN 500 MG INJECTION 2 ML

196. ONDERO 5 MG TABLET 10

197. ONDERO MET 2.5/500 MG TABLET 10

198. OROFER FCM INJECTION 10 ML

199. OROFER-XT 100/1.5 MG TABLET 10

200. OROFER-XT PLUS 30 MG/500MCG/500MCG SUSPENSION 200 ML

201. OTRIVIN OXY FAST RELIEF 0.05 % SPRAY 10 ML

202. OVRAL L 0.03/0.15 MG TABLET 21

203. OXRA 10 MG TABLET 14

204. PAN 40 MG TABLET 15

205. PAN D 30/40 MG CAPSULE 15

206. PANDERM PLUS PLUS 0.05/0.5/2 % CREAM 15 GM

207. PANTIN IV 40 MG INJECTION 10 ML

208. PANTOCID 40 MG TABLET 15

209. PANTOCID DSR 30/40 MG CAPSULE 15

210. PANTODAC 40 MG TABLET 15

211. PANTODAC DSR 30/40 MG CAPSULE 15

212. PANTOP 40 MG INJECTION 10 ML

213. PANTOP 40 MG TABLET 15

214. PANTOP D 10/20 MG CAPSULE 10

215. PANTOP D SR 30/40 MG CAPSULE SR 10

216. PHENSEDYL COUGH LINCTUS 4/10 MG SYRUP 100 ML

217. PIPZO 4000/500 MG INJECTION 10 ML

218. PRACTIN 4 MG TABLET 10

219. PREGA NEWS KIT 6

220. PREVENAR 13 INJECTION 0.5 ML

221. R.B TONE SYRUP 200 ML

222. RABLET-D 30/20 MG CAPSULE 10

223. RANTAC 150 MG TABLET 30

224. RAZO 20 MG TABLET 15

225. RAZO D 30/20 MG TABLET 15

226. REFRESH TEARS 0.5 % EYE DROPS 10 ML

227. REJUNEX-CD3 TABLET 10

228. REMDAC 100 MG INJECTION 1

229. ROSUVAS 10 MG TABLET 15

230. ROSUVAS 20 MG TABLET 10

231. RYZODEG 2.56/1.05 MG PENFILL 3 ML

232. SARIDON 250/50/150 MG TABLET 10

233. SEROFLO 50/250 MCG ROTACAP 30

234. SHELCAL 500 MG/250IU TABLET 15

235. SHELCAL XT 500 MG/2000IU/1500MCG/1MG/20MG TABLET 15

236. SILODAL 8 MG TABLET 10

237. SILODAL D 8/0.5 MG TABLET 10

238. SINAREST 125/5/1 MG SYRUP 60 ML

239. SINAREST NEW 500/10/2 MG TABLET 10

240. SINAREST NEW 500/10/2 MG TABLET 15

241. SKINLITE 2/0.1/0.025 % CREAM 25 GM

242. SOMPRAZ D 30/40 MG CAPSULE 15

243. SPASMO PROXYVON PLUS 10/325/50 MG CAPSULE 8

244. SPEGRA 50/200/25 MG TABLET 30

245. STAMLO 5 MG TABLET 30

246. STAMLO BETA 50/5 MG TABLET 15

247. STEMETIL 5 MG TABLET MD 15

248. SUCRAFIL O 1000/20 MG GEL 200 ML

249. SUMO 100/325 MG TABLET 15

250. SUMO L IV 1000 MG INFUSION 100 ML

251. SUPRADYN TABLET 15

252. SYNFLORIX INJECTION 1

253. T BACT 2 % OINTMENT 15 GM

254. T BACT 2 % OINTMENT 5 GM

255. TARGOCID 400 MG INJECTION 1 ML

256. TAXIM O 200 MG TABLET 10

257. TAZOMAC 4000/500 MG INJECTION 2 ML

258. TELEKAST-L 10/5 MG TABLET 15

259. TELMA 40 MG TABLET 30

260. TELMA AM 40/5 MG TABLET 15

261. TELMA H 40/12.5 MG TABLET 15

262. TELMIKIND 40 MG TABLET 10

263. TELMIKIND AM 40/5 MG TABLET 10

264. TELMIKIND H 40/12.5 MG TABLET 10

265. THROMBOPHOB OINTMENT 20 GM

266. THYRONORM 100 MCG TABLET 120

267. THYRONORM 25 MCG TABLET 120

268. THYRONORM 50 MCG TABLET 120

269. TOSSEX NEW 4/10 MG SYRUP 100 ML

270. TRAJENTA 5 MG TABLET 10

271. TRESIBA FLEXTOUCH 100 IU DISPOSABLE PEN 3 ML

272. TUSQ DX 5/2/15 MG SYRUP 100 ML

273. UDILIV 150 MG TABLET 15

274. UDILIV 300 MG TABLET 15

275. ULTRACET 325/37.5 MG TABLET 15

276. UNIENZYME TABLET 15

277. UNWANTED 72 1.5 MG TABLET 1

278. UNWANTED KIT 200 MG/200MCG TABLET 1

279. UPRISE D3 60000 IU CAPSULE 8

280. URIMAX 0.4 MG CAPSULE 20

281. URIMAX D 0.4/0.5 MG TABLET 15

282. URSOCOL 300 MG TABLET 15

283. VARILRIX INJECTION 0.5 ML

284. VELOZ D 30/20 MG CAPSULE SR 10

285. VELPANAT 400/100 MG TABLET 28

286. VERTIN 16 MG TABLET 15

287. VOLINI 1.16 % SPRAY 40 GM

288. VORIER 200 MG TABLET 4

289. VOVERAN SR 100 MG TABLET SR 15

290. VYMADA 24/26 MG TABLET 14

291. WYSOLONE 10 MG TABLET DT 15

292. WYSOLONE 5 MG TABLET DT 15

293. XONE 1000 MG INJECTION 5 ML

294. ZAVICEFTA 2000/500 MG VIAL 10 ML

295. ZEDEX 4/5/50 MG SYRUP 100 ML

296. ZERODOL P 100/325 MG TABLET 10

297. ZERODOL SP 100/325/15 MG TABLET 10

298. ZIFI 200 MG TABLET 10

299. ZORYL-M 2/500 MG TABLET 20

300. ZOSTUM 1000/500 MG INJECTION 1.".

To view the official Gazette, click on the link below: