These 300 medicines have been finalised for QR code
New Delhi: Amending the Drug Rules 1945, through a recent Gazette Notification, the Ministry of Health and Family Welfare (MoHFW) has issued a draft of a certain rule, specifying 300 medicines which would be required to embed unique quick response (QR) codes on their packages in order to enable authentication more efficient.In accordance with the draft rule, the manufacturers of drug...
New Delhi: Amending the Drug Rules 1945, through a recent Gazette Notification, the Ministry of Health and Family Welfare (MoHFW) has issued a draft of a certain rule, specifying 300 medicines which would be required to embed unique quick response (QR) codes on their packages in order to enable authentication more efficient.
In accordance with the draft rule, the manufacturers of drug formulation products as specified in Schedule H2 of the Drug Rules shall print or affix Bar Code or Quick Response Code on their primary packaging label or, in the case of inadequate space on the primary package label, on the secondary package label that stores data or information legible with software application to facilitate authentication.
As per the recent draft notification, the unique quick response (QR) code shall contain the following particulars, namely: unique product identification code, proper and generic names of the drug, brand name, name and address of the manufacturer, batch number, date of manufacturing, date of expiry,manufacturing licence number.
This move came in order to guarantee authenticity and enable tracking of medicines.
Betadine, Aciloc, Allegra, Calpol 500 mg tablet , Calpol 650 mg tablet , Cypon 275/2 mg syrup, Dolo 650 mg tablet, Fabiflu 200 mg tablet , Fabiflu 400 mg tablet , fabiflu copack 800 mg tablet, Glycomet gp 1/500 mg tablet, Omez 20 mg capsule , Omez d 30/20 mg capsule, Pan 40 mg tablet , Pan D 30/40 mg capsule, Thyronorm 25 mcg tablet , Thyronorm 50 mcg tablet are among the brands on the list which would be required to embed unique quick response (QR) codes on their packages in order to guarantee authenticity and enable tracking.
The list includes widely used analgesics, pain relievers, anti-platelet, vitamin supplements, blood-sugar-lowering drugs, and contraceptive tablets.
Earlier, the Medical Dialogues Team had 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.
QR Codes help in tracking and tracing the origin of drugs and minimize the chances of spurious, sub-standard, or counterfeit drugs reaching patients.
The recent gazette notification states that in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board, the following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, is published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.
"Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.", the notice added.
As per the recent Gazette notification, the draft rules state,
1. (1) These rules may be called the Drugs (......Amendment) Rules, 2022.
(2) They shall come into force on the First day of May, 2023.
2. In the Drugs Rules, 1945 (hereinafter to be referred as the said rules), in rule 96, after sub-rule (5), the following sub-rule shall be inserted, namely:—
"(5A) The manufacturers of drug formulation products as specified in the Schedule H2 of the said rule, 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.
The stored data or information 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, Manufacturing licence number3. In the said rules, after schedule H1, the following Schedule shall be inserted, namely:—
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 |
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