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Drugs (Eighth Amendment) Rules, 2022

Drugs (Eighth Amendment) Rules, 2022

Drugs (Eighth Amendment) Rules, 2022

 

[17th November 2022]

Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 448(E), dated the 14th June, 2022, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas, copies of the said Official Gazette were made available to the public on the 15th June, 2022;

And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:-

Rule - 1.

(1)     These rules may be called the Drugs (Eighth Amendment) Rules, 2022.

(2)     They shall come into force on the 1st day of August, 2023.

Rule - 2.


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.

(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.".

Rule - 3.


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.’.