Subject: Submission of Deficient Information / Documents

F.No.
10-8/2020-OTC) (M-80)
Government of Pakistan
Ministry of National Health Services, Regulations & Coordination
Drug Regulatory Authority Of Pakistan
Health & OTC Products Division (Non-Drugs)
*****
Islamabad, the 24th August, 2020
“SAY NO TO CORRUPTION”
Subject: Submission of deficient information / documents
The applications of following applicants were placed before the Enlistment Evaluation
Committee (EEC) in its 80th meeting held on 26th June, 2020 and the same have been deferred being
deficient of the information / documents as specified in column (3) of the Table below which may be
furnished within 20 days of uploading of this letter on official website of DRAP but not later than 13th
September, 2020. Replies received after due date shall not be entertained:-
S.No Brand name Decision

(1) (2) (3)
Millennium Laboratories, Lahore
128/5, Shaikh Mohammad Raiz Road, Quaid-e-Azam, Industrial Estate Road, Kot Lakhpat, Lahore
Deferred for following reasons:
 Fee challan is not endorsed by concerned division of DRAP.
 Food supplement section availability is required.
1. Wiser Powder  Monographs of all ingredients are required.
 Information regarding source of carbohydrates, fats,
cholesterol and proteins is required.
 Testing method of finished product is required.
2. Xporen Syrup
 Monographs of all ingredients are required.
3. M-Cal Tablet
 Justification of 3 tablets as serving dose is required.
4. Mega Plus tablets  Monographs of all ingredients including blend are required.
 Justification of 2 tablets as serving dose is required.
5. Key Vit Tablets
 Stability of omega 3 and omega 6 in tablet is required.
6. Inomalt F Tablets  Fee challan is not endorsed by concerned division of DRAP.
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7. Geomilk Supplement  Monographs of all ingredients are required.
 Justification is required regarding use of zinc oxide in oral
dosage forms.
8. Ferton Tablets
9. Ferrosip Syrup
 Brand name needs to be changed.
10. Vox Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Brand names differ on form 3 and covering letter, needs
11. Calgrow Tablet
clarification.
 Monographs of vitamin K2 and red algae calcium are
required.
12. Chemcal Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Monograph of Co enzyme Q10 is required.
13. Ecocal Tablet
14. Heptolax Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Silymarin comes under common molecules list.
15. Ozcal Flash Tablet
16. Sureway Powder
 Monographs of full cream milk and whey milk are required.
 Dextrose comes under common molecules list.
17. Urone K Tablet
 Potaasium citrate as single ingredient is registered as urinary
alkalizing agent, added in common molecules list.
18. Calpar Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Monograph of L methyl folate is required.
19. Bioloba Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Monograph of ginkgo biloba is required.
20. Cozam Tablet  Fee challan is not endorsed by concerned division of DRAP.
21. Lycoz Tablet Deferred for following reasons:
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(1) (2) (3)
 Monograph of spirulina extract is required.
22. MontarVit Tablet
23. Geocal Tablet  Fee challan is not endorsed by concerned division of DRAP.
24. Spirovin Tablet
 Monograph of chiro inositol is required.
 N acetyl cysteine comes under common molecules list.
25. Inovit Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Monograph of ginger extract is required.
26. Glumin Tablet  Monographs of all ingredients are required.
 Chondroitin and glucosamine come under common molecules
list.
27. Irofol Tablet  Fee challan is not endorsed by concerned division of DRAP.
28. Oriseng Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Monograph of red ginseng extract is required
29. Cino Z Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Monographs of zinc, vitamin C are required.
 Monographs of tribulus extrtact, arginine, chlorophytum
30. Trox Forte Tablet
borivianum, ginseng extract, saffron and epimedium comp
extract are required.
31. Cino D Drops
 Drop filling machine availability is required as firm has
liquid(syrup) section only.
32. Sinum Tablet  Fee challan is not endorsed by concerned division of DRAP.
33. Permit Tablet  Monographs of vitamin E, iron bisglycinate and zinc is
required.
34. Cartimax Tablet
 Chondroitin, glucosamine and hyaluronic acid come under
common molecules list.
35. Oral C Tablet Deferred for following reasons:
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 Monograph of vitamin K2 is required.
36. Five C 1000 Tablet
 Monographs of zinc, vitamin C, boron, horsetail extract are
required.
37. Colisan Syrup
 Aluminium hydroxide and magnesium hydroxide are
registered as drugs, added in common molecules list.
38. Alfanase Drops
 Drop filling machine availability is required as firm hold
liquid (syrup) section only.
39. Zecop Syrup  Monograph of L-ornithine L-aspartate is required.
 Firm applied herbs in crude form while firm possess
40. Cofmaxl Syrup
nutraceutical facility.
41. Ezine Tablet
 Melatonin comes under common molecules list.
 Monograph of theanine is required.
42. Bon D Suspension
 Monographs of vitamin K2 and red algae calcium are
required.
43. Best Vit Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Monograph of inositol is required.
44. Plus D Syrup
 Monograph of ossien mineral complex is required, added in
45. Osical Tablet
 Monograph of ossien mineral complex is required, added in
46. Plus D Tablet  Fee challan is not endorsed by concerned division of DRAP.
47. Cranbest Sachet  Fee challan is not endorsed by concerned division of DRAP.
48. Minimax Drops
 Availability of drop filling machine is required as firm holds
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(1) (2) (3)
 Monographs of iron bisglycinate, cupric chloride, iodine,
chromium picolinate, molybdenum and codex alimentarious
49. Unimax Supplement Sachet are required.
 Availability of food supplement section is required.
 Strength of all ingredients per serving dose is required
according to their RDA values.
50. Minocal D Tablet
 Monographs of chiro-inositol, L methyl folate are required.
 Melatonin comes under common molecules list.
51. Bh Iron Syrup  Monographs of iron bisglycinate, copper sulphate and folic
acid are required.
52. D Myth Oral Drops
 Availability of drop filling machine is required.
 Monographs of DHA, vitamin E, vitamin K, vitamin B5,
biotin, sodium, chloride, calcium carbonate, copper sulphate,
53. Famisafe Powder iodine and iron bisglycinate are required.
 Source of fats, carbs and proteins are required.
 Monographs of folic acid, pantothenic acid and zinc are
54. Macmin Syrup
required.
 Sodium bicarbonate comes under common molecules list.
55. Dg Nex Suspension
 Firm uses ginger herb in crude form while firm possess
nutraceutical facility, needs clarification.
56. Biokof Drops  Drop filling machine availability is required as firm holds
57. Bh Iron Tablet  Monographs of iron bisglycinate and copper chloride is
required.
58. Infert Tablet  Monographs of tribulus, zinc and selenium are required.
dosage form.
59. Eco-X Tablet
 Aescin comes under common molecules list.
 Monograph of colchicum extract is required.
60. Maxifol Tablet
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61. Biofax Tablet  Vinpocetine comes under common molecules list.
 Monographs of all ingredients in extract form are required.
62. Silebro Syrup  Fee challan is not endorsed by concerned division of DRAP.
 Silymarin comes under common molecules list.
63. Kufset Syrup  Ammonium chloride is registered as drug.
 Use of ipecacacuanha extract is required as it also stimulates
emesis.
64. Chemvit Tablet
 Trypsin and chymotrypsin are proteolytic enzymes, come
under common molecules list.
65. Sinofeb Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Fenofibrate is registered as anti-hyperlipidemic drug.
66. Ferrofer Sachet
 Monograph of lipofer is required.
 Salt of iron and its monograph is required
67. Lutex Plus Tablet  Fee challan is not endorsed by concerned division of DRAP.
 Monographs of zeaxanthin and lutein are required.
68. Irobest Tablet
 Monographs of iron bisglycinate, L methyl folate and copper
sulphate are required.
69. Urosil D Sachet  Fee challan is not endorsed by concerned division of DRAP.
 Monographs of cranberry and mannose are required.
70. Mv Sip Syrup  Salt of calcium and its monograph are required.
dosage form.
71. Crantec Sachet  Monographs of cranberry extract, calcium phosphate (source
of calcium) and calcium phosphate (source of phosphorus)
are required.
72. Probex Sachet
 Monographs of wheat dextrin fiber is required.
 Senoside comes under common molecules list.
73. Sb-C Tablet Deferred for following reasons:
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 Caffeine is included in common molecules list.
 Monograph of guarana seed extract is required.
 Testing method of finished of finished product is required.
74. Alfabex Syrup
 Monographs of cranberry extract and ginger extract are
required.
 Monographs of zinc, Co enzyme Q 10, lutein, bacopin,
taurine, green tea extract, tribulus terrestris extract, macuna
75. Tribest Tablet extract, withania extract and epimedium saittatum extract are
required.
dosage form.
Oasis Pharma, Lahore
 Monograph of folium extract is required.
76. Apit Rise Syrup
 Product resembles with Apetar syrup with minor difference of
only one ingredient, needs clarification.
77. Neokol Syrup  Monographs of hederae folium extract and adhatoda vasica
are required.
78. Oci Tablet
 Monographs of red algae (calcium) and iron are required.
79. MN Zinc Syrup
 Monograph of zinc gluconate is required.
80. Ginkar Tablet  Monograph of ginkgo biloba extract is required
 Monographs of zingiber officinale extract, menthe piperata
81. Ramz Syrup extract, trachspermum ammi and foeniculum vulgare extract
are required.
 Monographs of horny goat weed extract, maca root extract,
82. Tresmen Capsule togkat ali extract, tribulus terrestris extract are required.

83. Sovyis Syrup  Monographs of hedera helix, morus nigra and adhatoda vasica
in extract form are required.
84. Oecin Tablet
85. Ozym-C Tablet
86. Othin Tablet Deferred for following reasons:
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(1) (2) (3)
 Monographs of bacopin, taurin, tribulus terrestris and
withania somnifera are required.
 Product resembles with apit rise syrup with minor difference
87. Apetar Syrup of only one ingredient, needs clarification.
 Monograph of folium extract is required.
 Fee evidence is required.
88. Osicure Sachet Deferred for further evaluation and clarification.
89. Magnovit Powder Deferred for further evaluation and clarification.
Paragon Herbal Laboratories, Lahore
Plot No. Kht 285, Ktn 570, Allah Hoo Industrial Area, Near Sabzi Mandi, Gujumatta, Ferozepur Road, Lahore
90. Pe-card syrup
91. PE-Nox capsule  Undertaking of contents of dossiers and brand name are
unsigned and un-stamped.
 Firm has submitted new proposed brand name i.e multikuff
92. Real cough syrup
syrup.
 Monograph of ivy leaf extract is required.
Deferred for following reason(s):
93. Revisal tablet
 Differential fee is required.
94. Spermodil-F capsule  Monograph of Eurycoma longofolia extract is required.
95. Stomofil syrup  Differential fee is required.
 Monograph of calcium lactate gluconate is required.
 Firm has submitted new proposed brand name i.e Fertika
96. Vagirena Tablet
tablet.
 Monographs of tribulus is required.
97. V-liver-X syrup  Differential fee is required.
 Silymarin is added in common molecules list.
98. V-liver-X tablet  Monograph of milk thistle extract is required.
 Firm has submitted new proposed brand name i.e ADE care
99. Colic drops drops.
 Monographs of all ingredients are required according to BP
compendium as mentioned against each ingredient on Form 3.
 Monographs of iron bisglycinate and L methyl folate are
100. Gynolec capsule required.
 Firm has submitted new proposed brand name i.e Mediferr
Syrup.
101. Menc on syrup Deferred for following reasons:
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(1) (2) (3)
 Conversion of strength of vitamin D from micro gram to
International units is required.
102. Mency capsule
 Stability of omega 3 in hard capsule is required.
 Firm has submitted new proposed brand name i.e Medevit
103. Real-Vit Tablet tablet.
 Monograph of iron bisglycinate is required.
 Section availability of food supplement alongwith required
facilities is required.
 Monographs of protein, fat, linoleic acid, linolenic acid,
104. Revive Food supplement DHA, FOS, taurine,carnitine, inositol and codex
alimentatrious are required.
 Halal certification of fat and protein is required.
 Unit dose strength is required.
 firm has submitted new proposed brand name i.e Preg-Med
105. Sharbat Foulad
tablet.
 Firm has submitted new proposed brand name i.e Med-D
Insta drop.
106. Viron-S Syrup
 Firm applied said product in syrupform initially and has
changed brand name along with dosage form later, needs
clarification.
107. Cal-Max Sachet
 firm has submitted new proposed brand name i.e Calvita Pro
108. Chew sip Tablet
Syrup.
 Monograph of iron bisglycinate is required.
 firm has submitted new proposed brand name i.e Med-D
109. Cor-Vit D tablet
chewable tablet.
 Master formula of chewable tablet as dosage form is needed.
 firm has submitted new proposed brand name i.e Calvita Pro
110. Lycovit syrup
Syrup.
 Monograph of calcium lactate gluconate is required.
 has submitted new proposed brand name i.e Myo-Med
111. Mango-C sachet
Sachet.
 Monograph of L-methyl folate is required.
 firm has submitted new proposed brand name i.e Mede-Cal
112. Choarqa tablet
tablet.
113. Olive oil drop Deferred for further evaluation and clarification.
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(1) (2) (3)
 Firm has submitted new proposed brand name i.e Sea-Med
114. Arq-e-Badaniya tablet.
 Monographs of red algae calcium and vitamin K2 are
required.
 firm has submitted new proposed brand name i.e Medeferr
tablet.
115. Araq-e- gulab Spray
 Firm applied said product in oral liquid form initially and has
changed brand name along with dosage form later, needs
clarification.
116. Ginco Plus tablet
 firm has submitted new proposed brand name i.e M-Cal 1000
117. Pe-Cal Effervescent Tablet effervescent tablet.
 Manufacturing process regarding effervescent tablet is
required.
Phytotia Laboratory, Peshawar
27/28-C, Small Industrial Estate, Kohat Road, Peshawar
 Clarification is required either zinc oxide is recommended for
oral use.
118. Ortho-A Tablet
 Differential fee is not endorsed by concerned division of
DRAP.
 Brand name undertaking is required.
DRAP.
 Sodium bicarbonate comes under common molecules list.
119. Dycacia Tablet
 Stability of anise oil and cinnamon Bark oil in tablet dosage
form is required.
 Monograph of powdered ginger extract is required.
 Monographs of iron polymaltose and folic acid are required.
120. V-Plex Tablet  Differential fee is not endorsed by concerned division of
DRAP.
121. Cal-Star Tablet
DRAP.
122. Zuka-M Tablet DRAP.
123. Ab-One Tablet  Differential fee is not endorsed by concerned division of
DRAP.
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(1) (2) (3)
124. Silym Tablet DRAP.
 Silymarin is added in common molecules list.
125. V-Plex Syrup
DRAP.
126. Enerton-S Syrup
DRAP.
 Sodium bicarbonate is added in common molecules list.
127. Dycalia Syrup
DRAP.
128. Ab-One Syrup DRAP.
129. Fenertac Syrup
DRAP.
130. Phytotia Saarbat Toshanda Plus
DRAP.
131. Ener-P Syrup
DRAP.
132. Plex-Plus Syrup
DRAP.
133. Sharbat Podina Syrup DRAP.
134. Phytocid Syrup
DRAP.
135. Phytotia Colic Syrup Deferred for following reasons:
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(1) (2) (3)
DRAP.
 Unit dose strength is required as 20ml given by firm is not
rational.
136. Phytotia Sharbart Joshanda Syrup DRAP.
 Monograph of ivy leaf extract is required.
SOIS Life Sciences, Karachi
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
137. Zeeova Capsule  Monographs of magnesium sulphate, chromium are required.
138. Fertil-Z Capsule  Monographs of tribulus, alpha Lipoic acid, Taurine, pine bark
extract and selenium are required.
 Monographs of ginkgo biloba, phosphorus and chloride are
139. Cubex Tablet
required.
140. Zeecran Sachet  Sodium bicarbonate comes under common molecules list.
141. Myo-Vit Sachet
142. Hm-Folvit Tablet  Monograph of iron bisglycinate is required.
143. Infacure Drops  Fee evidence is required.
 Monographs of all ingredients in extract form are required.
144. Ironexen Tablet  Fee evidence is required.
 Monograph of iron chelated is required.
Stiflex Pharmaceuticals Wahcantt
33-B, Small Industrial Estate, Bahtar Road, Wah Cantt
 Monograph of iron polymaltose is required.
 Justification of use of zinc oxide in oral dosage form is
145. Imune Plus Syrup
required.
146. Fa Plus Syrup Deferred for further evaluation and clarification.
147. Rest Syrup  Product contains melatonin, comes under common molecules
list.
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(1) (2) (3)
148. Coral Max Tablet
 Monograph of red algae (calcium) is required.
149. Coral Max Sachet  Conversion of strength of vitamin D from mg/g to
international unit is required.
Wilshire Laboratories Pvt Ltd, Lahore
Plot No.5, Farooq Industrial Estate, 20-KM, Ferozepur Road, Lahore
 Dossier is devoid of all requirements laid down in form 3 of
Beano (Brand Name Changed To
150. SRO 412(I)/2014 except submission of undertaking of
Rytil) Tablet
contents of dossier.
151. Geano Tablet SRO 412(I)/2014 except submission of undertaking of
152. Gasrel Tablet SRO 412(I)/2014 except submission of undertaking of
153. B12 1000Mcg Tablet SRO 412(I)/2014 except submission of undertaking of
154. Penemia 1000Mcg Tablet SRO 412(I)/2014 except submission of undertaking of
155. Qubenza 1000Mcg Tablet SRO 412(I)/2014 except submission of undertaking of
156. Benzim Natural Tablet SRO 412(I)/2014 except submission of undertaking of
157. Abdorex Tablet SRO 412(I)/2014 except submission of undertaking of
158. Tummy Care Tablet
SRO 412(I)/2014 except submission of undertaking of
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159. Senna-Col Tablet SRO 412(I)/2014 except submission of undertaking of
160. Docsen Tablet SRO 412(I)/2014 except submission of undertaking of
161. C-Rich 500Mg Tablet SRO 412(I)/2014 except submission of undertaking of
162. C-Rise Tablet SRO 412(I)/2014 except submission of undertaking of
163. C-Rose Tablet SRO 412(I)/2014 except submission of undertaking of
164. D-Tab Tablet SRO 412(I)/2014 except submission of undertaking of
165. Bon-Med Tablet SRO 412(I)/2014 except submission of undertaking of
166. D-Lux Tablet SRO 412(I)/2014 except submission of undertaking of
167. E-Plus Tablet SRO 412(I)/2014 except submission of undertaking of
168. Finergy Tablet SRO 412(I)/2014 except submission of undertaking of
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169. D+C Tablet SRO 412(I)/2014 except submission of undertaking of
170. Aktiv-D Tablet SRO 412(I)/2014 except submission of undertaking of
171. G-Lite Tablet SRO 412(I)/2014 except submission of undertaking of
172. G-Lean Tablet SRO 412(I)/2014 except submission of undertaking of
173. G-Trim Tablet SRO 412(I)/2014 except submission of undertaking of
174. Laxante Tablet SRO 412(I)/2014 except submission of undertaking of
175. Nutralax Tablet SRO 412(I)/2014 except submission of undertaking of
176. Ultralax Tablet SRO 412(I)/2014 except submission of undertaking of
177. 2G Plus Tablet SRO 412(I)/2014 except submission of undertaking of
178. Xtrim Tablet SRO 412(I)/2014 except submission of undertaking of
179. Livell Tablet Deferred for following reasons:
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180. Actiliv Tablet SRO 412(I)/2014 except submission of undertaking of
181. Mvg Gold Tablet SRO 412(I)/2014 except submission of undertaking of
182. Revamaxv Tablet SRO 412(I)/2014 except submission of undertaking of
183. Multi-G Tablet SRO 412(I)/2014 except submission of undertaking of
184. New Viogenic Tablet SRO 412(I)/2014 except submission of undertaking of
185. Synergize Tablet SRO 412(I)/2014 except submission of undertaking of
186. Vitina Tablet SRO 412(I)/2014 except submission of undertaking of
187. Cleanze Tablet SRO 412(I)/2014 except submission of undertaking of
188. Senacarb Tablet SRO 412(I)/2014 except submission of undertaking of
189. Vigforce Tablet Deferred for following reasons:
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190. X-Fire Tablet SRO 412(I)/2014 except submission of undertaking of
191. Zamcal D Tablet SRO 412(I)/2014 except submission of undertaking of
192. Dv-Cal Tablet SRO 412(I)/2014 except submission of undertaking of
193. Bonost Tablet SRO 412(I)/2014 except submission of undertaking of
194. Herbatrim Capsule SRO 412(I)/2014 except submission of undertaking of
195. Slender Capsule SRO 412(I)/2014 except submission of undertaking of
196. Craneze Capsule Deferred for further evaluation and clarification.
197. Urisept Capsule SRO 412(I)/2014 except submission of undertaking of
198. Cranuti Capsule SRO 412(I)/2014 except submission of undertaking of
199. D-Cap Capsule SRO 412(I)/2014 except submission of undertaking of
200. Bon-Med Capsule Deferred for following reasons:
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201. D-Lux Capsule SRO 412(I)/2014 except submission of undertaking of
202. Livimax Capsule SRO 412(I)/2014 except submission of undertaking of
203. V.V Plus Capsule SRO 412(I)/2014 except submission of undertaking of
204. Vimax Capsule SRO 412(I)/2014 except submission of undertaking of
205. Colace 100Mg Soft Gel SRO 412(I)/2014 except submission of undertaking of
206. Senna-Col Soft Gel SRO 412(I)/2014 except submission of undertaking of
207. Docsen Soft Gel SRO 412(I)/2014 except submission of undertaking of
208. Enermax Soft Gel SRO 412(I)/2014 except submission of undertaking of
209. E-Plus Soft Gel SRO 412(I)/2014 except submission of undertaking of
210. Finergy Soft Gel Deferred for following reasons:
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211. Evita 1000Iu Soft Gel SRO 412(I)/2014 except submission of undertaking of
212. Elevita Soft Gel SRO 412(I)/2014 except submission of undertaking of
213. Esteem Soft Gel SRO 412(I)/2014 except submission of undertaking of
214. J-Plus Soft Gel SRO 412(I)/2014 except submission of undertaking of
215. Jointace Soft Gel SRO 412(I)/2014 except submission of undertaking of
216. Jointeze Soft Gel SRO 412(I)/2014 except submission of undertaking of
217. Pregnacare Soft Gel SRO 412(I)/2014 except submission of undertaking of
218. Neo-Care Soft Gel SRO 412(I)/2014 except submission of undertaking of
219. Gestat Soft Gel Deferred for further evaluation and clarification.
220. Prizma Soft Gel SRO 412(I)/2014 except submission of undertaking of
221. Domena Soft Gel Deferred for following reasons:
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222. X-Dame Soft Gel SRO 412(I)/2014 except submission of undertaking of
223. Quvert Soft Gel SRO 412(I)/2014 except submission of undertaking of
224. Nutrigenic Soft Gel SRO 412(I)/2014 except submission of undertaking of
225. Vital-B Soft Gel SRO 412(I)/2014 except submission of undertaking of
226. Vit-Hair Soft Gel SRO 412(I)/2014 except submission of undertaking of
227. Nutri Hair Soft Gel SRO 412(I)/2014 except submission of undertaking of
228. Gro-Hair Soft Gel SRO 412(I)/2014 except submission of undertaking of
229. Zamcal Forte Soft Gel SRO 412(I)/2014 except submission of undertaking of
230. Dv-Cal Forte Soft Gel SRO 412(I)/2014 except submission of undertaking of
231. Bonost Forte Soft Gel Deferred for following reasons:
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232. Zomega Soft Gel SRO 412(I)/2014 except submission of undertaking of
233. Xtend Life Soft Gel SRO 412(I)/2014 except submission of undertaking of
234. Vitafish Soft Gel SRO 412(I)/2014 except submission of undertaking of
235. Apperize Syrup SRO 412(I)/2014 except submission of undertaking of
236. Appemax Syrup SRO 412(I)/2014 except submission of undertaking of
237. Eatmax Syrup SRO 412(I)/2014 except submission of undertaking of
238. Abdorex Syrup SRO 412(I)/2014 except submission of undertaking of
239. Tummy Care Syrup SRO 412(I)/2014 except submission of undertaking of
240. Boost Up Syrup SRO 412(I)/2014 except submission of undertaking of
241. Ignize Syrup Deferred for following reasons:
Page 21 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
242. Enzest Syrup SRO 412(I)/2014 except submission of undertaking of
243. Urisept Dry Suspension SRO 412(I)/2014 except submission of undertaking of
244. Cranuti Dry Suspension SRO 412(I)/2014 except submission of undertaking of
245. Urisept Sachet SRO 412(I)/2014 except submission of undertaking of
246. Cranuti Sachet SRO 412(I)/2014 except submission of undertaking of
247. D-Drop SRO 412(I)/2014 except submission of undertaking of
248. Bon-Med Drops SRO 412(I)/2014 except submission of undertaking of
249. D-Lux Drops SRO 412(I)/2014 except submission of undertaking of
De-Flu (Name Changed To Pronto
Natural) Syrup
251. Flugo Syrup Deferred for following reasons:
Page 22 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
252. Codral / 4 Flu Syrup SRO 412(I)/2014 except submission of undertaking of
253. De-Tuz Syrup SRO 412(I)/2014 except submission of undertaking of
254. Novacold Syrup SRO 412(I)/2014 except submission of undertaking of
255. Cofnorm Syrup SRO 412(I)/2014 except submission of undertaking of
256. D-Flor Sachet SRO 412(I)/2014 except submission of undertaking of
257. Florestore Sachet SRO 412(I)/2014 except submission of undertaking of
258. Lacoten Sachet SRO 412(I)/2014 except submission of undertaking of
259. Bon-Med Oral Liquid SRO 412(I)/2014 except submission of undertaking of
260. D-Lux Oral Liquid SRO 412(I)/2014 except submission of undertaking of
261. Enermax Sachet Deferred for following reasons:
Page 23 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
262. E-Plus Sachet SRO 412(I)/2014 except submission of undertaking of
263. Finergy Sachet SRO 412(I)/2014 except submission of undertaking of
264. Exen D Dry Suspension SRO 412(I)/2014 except submission of undertaking of
265. D+C Dry Suspension SRO 412(I)/2014 except submission of undertaking of
266. Aktiv-D Dry Suspension SRO 412(I)/2014 except submission of undertaking of
267. Fiore Natural Syrup SRO 412(I)/2014 except submission of undertaking of
268. Ferovina Syrup SRO 412(I)/2014 except submission of undertaking of
269. Iron Up Syrup SRO 412(I)/2014 except submission of undertaking of
270. Hushh For Adults (Sugar Free) Syrup SRO 412(I)/2014 except submission of undertaking of
271. Chestal Syrup Deferred for following reasons:
Page 24 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
272. Qurex Syrup SRO 412(I)/2014 except submission of undertaking of
273. Laxante Syrup SRO 412(I)/2014 except submission of undertaking of
274. Nutralax Syrup SRO 412(I)/2014 except submission of undertaking of
275. Ultra-Lax Syrup SRO 412(I)/2014 except submission of undertaking of
276. Little'S Cold For Children Syrup SRO 412(I)/2014 except submission of undertaking of
277. Vanikuf Syrup SRO 412(I)/2014 except submission of undertaking of
278. Nocold Syrup SRO 412(I)/2014 except submission of undertaking of
279. Liv-Long Syrup SRO 412(I)/2014 except submission of undertaking of
280. Livell Syrup SRO 412(I)/2014 except submission of undertaking of
281. Actiliv Syrup Deferred for following reasons:
Page 25 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
282. Mvg Gold Syrup SRO 412(I)/2014 except submission of undertaking of
283. Revamax Syrup SRO 412(I)/2014 except submission of undertaking of
284. Multi-G Syrup Deferred for further evaluation and clarification.
285. Revamax Syrup SRO 412(I)/2014 except submission of undertaking of
286. Multi-G Syrup SRO 412(I)/2014 except submission of undertaking of
287. Cepacol Syrup SRO 412(I)/2014 except submission of undertaking of
288. Zepacol Syrup SRO 412(I)/2014 except submission of undertaking of
289. Ferogin Syrup SRO 412(I)/2014 except submission of undertaking of
290. Hemowel Syrup SRO 412(I)/2014 except submission of undertaking of
291. Zamcal D Dry Suspension SRO 412(I)/2014 except submission of undertaking of
292. Dv-Cal Dry Suspension Deferred for following reasons:
Page 26 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
293. Bonost Dry Suspension SRO 412(I)/2014 except submission of undertaking of
294. Zegut Sachet SRO 412(I)/2014 except submission of undertaking of
295. Evora Sachet SRO 412(I)/2014 except submission of undertaking of
296. Theralac Sachet SRO 412(I)/2014 except submission of undertaking of
297. Crystal Light Sachet SRO 412(I)/2014 except submission of undertaking of
298. Vit-Light Sachet SRO 412(I)/2014 except submission of undertaking of
299. K-Shot Oral Liquid SRO 412(I)/2014 except submission of undertaking of
300. K-Lux Oral Liquid SRO 412(I)/2014 except submission of undertaking of
301. K-Max Oral Liquid SRO 412(I)/2014 except submission of undertaking of
302. Fastrel Ointment Deferred for following reasons:
Page 27 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
303. Flexel Ointment SRO 412(I)/2014 except submission of undertaking of
304. Proflex Ointment SRO 412(I)/2014 except submission of undertaking of
305. De-Tuz (Sugar Free) Lozenge Tablet Deferred for further evaluation and clarification.
306. Novacold Lozenge Tablet SRO 412(I)/2014 except submission of undertaking of
307. Cofnorm Lozenge Tablet SRO 412(I)/2014 except submission of undertaking of
308. Coldeze Lozenge Tablet SRO 412(I)/2014 except submission of undertaking of
309. Raspeze Lozenge Tablet SRO 412(I)/2014 except submission of undertaking of
Smootheze (Sugar Free) Lozenge
Tablet
311. Coldeze Lozenge Tablet SRO 412(I)/2014 except submission of undertaking of
312. Raspeze Lozenge Tablet SRO 412(I)/2014 except submission of undertaking of
313. Actigel (Oral) Gel Deferred for following reasons:
Page 28 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
314. Adora Powder Milk Powder SRO 412(I)/2014 except submission of undertaking of
315. Neo Milk Powder Milk Powder SRO 412(I)/2014 except submission of undertaking of
Apple Laboratories, Islamabad
National Industrial Zone, RCCI Road, 1.5-KM, Rawat, Rawalpindi
316. Aperex Syrup (837)
 Form 3 attested and stamped by owner/ CEO is required.
 Sodium bicarbonate is added in common molecules list.
317. Hepqure Capsule Deferred for further evaluation and clarification.
318. Api-Up Syrup (839)  Monographs of foeniculum extract, trigonella foenum-gracum
extract and zingiber extract are required.
319. Casigeno Cream (840)
 Methyl salicylate is added in common molecules list.
 Availability of gas chromography instrument for test/ analysis
of turpentine oil is required as mentioned in dossier.
320. Ava-C Sachet (841)  Fee evidence is required.
321. Apsure Adult Milk (842)
 Dextrose is added in common molecules list.
 Food supplement availability is required.
 Monograph of skimmed milk powder is required.
Etihad Herbal Industries, Lahore
9.5-KM, Sheikhupura Road, Lahore-Pakistan
322. Sharbat Faulad Syrup (843)
 Monograph of iron compound (folad patri) is required and
clarification of its use in health products.
323. Fresh Bloom Syrup (844)  fee evidence is required.
 Salt of iron and its monograph are required.
Page 29 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
324. GinkoBext Syrup Deferred for further evaluation and clarification.
 Breakup of fee is required.
 Monograph of menthe slyvestris is required.
325. Arq-E-Mehzal Arq (846)
 Safety undertaking of product is required.
 Stability of all ingredients in water (only) as an inactive
ingredient is required.
326. Gluta-D Capsule (847)
 Monographs of magnesium oxide is required.
327. D-Call Supplement (848)
 Unit dose per serving is required.
 Stability of formulation in powder/ granules is required.
 Jar filling machine availability is required.
328. D-Chiro Plus Capsule
329. Myomelat Sachet (850)
 Melatonin is added in common molecules list.
 Stability of formulation in powder/ granules is required.
330. Ginbest Syrup (851)
 Citicholine is added in common molecules list.
 Monograph of gingko extract is required.
331. Link-D (1000IU) Deferred for further evaluation and clarification.
332. Elliko Syrup
 Monographs of ginseng and ginkgo biloba extract are
required.
333. Elli-D Softgel  Stability confirmation of vitamin K2 in softgel preparation is
required.
 Glucosamine, chondroitin and hyaluronic acid are added in
334. Orthorid Super Tablet
 Monograph of collagen is required and also provide type of
collagen which is to be used in formulation.
 Justification of use of methylene chloride as inactive
335. QoloniTaryaq-e-Badan Capsule Deferred for further evaluation and clarification.
336. Mactose Syrup  Fee evidence is required.
 Firm uses herbs in crude form.
337. Maca Capsule
Page 30 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
 Monograph of lepidium meyenii is required.
338. Milk Pro Capsule  Breakup of fee is required.
 Firm uses herbs in crude form.
339. Amino-Health Capsule
 Monographs of L-arginine and L-ornithine are required.
340. Colic Drop  Beta galactosidase (lactase) is added in common molecules
list.
 Drop filling machine availability is required.
341. Eryon Softgel
342. Zippy-D (10000IU) Softgel  Breakup of fee is required.
 Brand name undertaking is unsramped and un-signed.
343. Bi-Digas Syrup  Clarification is required either said formulation covers under
Arq (herbal) or Syrup (nutraceutical) section as firm uses
herbs in crude form.
344. Bone Fol Syrup  Breakup of fee is required.
345. Brodil Syrup
 Monographs of ivy leaf extract and licorice extract are
required.
346. E-Coline Syrup
347. Zie-Cid Syrup  Clarification is required either said formulation covers under
348. Etihad Ghutti Syrup  Clarification is required either said formulation covers under
 Clarification is required either said formulation covers under
349. Heparax Syrup
350. Ibofen Syrup
Page 31 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
 Clarification is required either said formulation covers under
351. Colic Syrup  Clarification is required either said formulation covers under
352. Dyromax Syrup  Clarification is required either said formulation covers under
353. Fefivit Tablet
 Justification of use of methylene chloride as an inactive
354. E-Flu Tablet  Breakup of fee is required.
 Firm uses herbs in crude form, needs clarification.
355. Spongel mouth gel 25gm Gel
 The product is claimed to be pain relieving.
 Oral (gel) section availability is required.
356. Capsiloc 30gm Gel  Breakup of fee is required.
 Justification of use of capsicum oleoresin is required.
357. Fitness Super Tonic Syrup  Clarification is required either said formulation covers under
358. G-Lec Capsule

359. Phaki  Breakup of fee is required.
360. Dreamset Tablet  Safety profile of valerian extract is required.
 Justification of use of methylene chloride as an inactive
361. Power Max Capsule  Breakup of fee is required.
 Firm uses tribulus in crude form, needs clarification.
362. Protect Capsule Deferred for further evaluation and clarification.
363. Glucose-D Plus sachet Deferred for following reasons:
Page 32 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
 Glucose is added in common molecules list.
 Form 3 is un-stamped and un-signed.
 Stability of vitamin D in powder/granules form is required.
364. Miti Chore Suspension
 Monograph of copper and its salt is required.
365. Fix Balm
 Winter green is added in common molecules list.
 Monographs of turpentine oil and menthol are required.
Phytocon International Private Limited, Lahore
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
366. Arbucon Cream Deferred for further evaluation and clarification.
 Paraffin is added in schedule D of LRA rules, 1976, needs
367. Emolin Cream
clarification of its use in health products.
SOIS Life Sciences, Karachi
368. Evanol Softgel  Fee evidence is required.
 Stability of formulation in softgel dosage form is required.
369. Caltramag-D Tablet
 Prescribed form 3 to be changed w.r.t addition of salts against
each vitamins and minerals.
Opal Laboratories, Karachi
Plot LC 42, Lite Landhi, Karachi
 Firm has changed brand name i.e femalt syrup.
370. Hb-Booster Syrup
 Monographs of iron bisglycinate and malt extract are
required.
 Prescribed form 3 is required.
371. Caripill Syrup
 Carica papaya leaf extract monograph is required.
372. Caripill Tablet
 Carica papaya leaf extract monograph is required.
 The product is claimed to be cosmetic.
373. Ceramon Lotion
 Hyaluronic acid is added in common molecules list.
Scotmann Pharmaceutical, Islamabad
5-D, I-10/3 Industrial Area, Islamabad
Page 33 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
 Monographs of genistein and teavigo are required.
374. Profemme Tablet
 Justification of use of both beta carotene and vitamin in same
formulation is required.
 2 tablet per serving dose justification is required.
375. Probono Tablet
 Monographs of genistein and magnesium are required.
 2 tablets per serving dose is required.
 Monographs of vitamin B1, vitamin B2, vitamin B3, vitamin
B6, zinc and teavigo are required.
376. Obino Tablet
 2 tablets per serving dose justification is required.
377. Behold Tablet
B6, teavigo, hydroxyl tyrosol are required.
 Beta carotene exceeds RDA, needs clarification.
378. Curcuma Softgel  Prescribed form 3 is required.
 Stability of turmeric in softgel dosage form is required.
379. Hitrax Tablet  Monographs of vitamin B1, vitamin B2, vitamin B3 are
required.
 Monographs of vitamin B1, vitamin B6 are required.
380. Brainy Tablet  Beta carotene exceeds RDA, needs clarification.
 Caffeine is added in common molecules list.
 Monographs of vitamin B2, vitamin B6 teavigo are required.
381. Hartiest Tablet  Clarification of use of teavigo is required.
382. Imuna Tablet  Monographs of vitamin B1, vitamin B6, vitamin D,zinc,
teavigo are required.
383. Ocupro Tablet  Prescribed form 3 is required.
 Monograph of genistein is required.
Page 34 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
384. Nutrion Tablet B6, iodine are required.
 Clarification is required which type/ kind of vitamin K is used
in formulation.
 2 tablets per serving dose is required.
Sois Life Sciences, Karachi
385. Ocupure Softgel  Monographs of lutein and zeaxanthin are required.
 Monographs of Echinacea, elderberry and white willow are
386. Tufcuf Softgel
required.
387. Emkay Plus Softgel  Prescribed form 3 is required.
 Monograph of red algae calcium is required.
Alpha Nutraceutical, Lahore
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
388. Kufpro Syrup  Monographs of banafsha extract, cinamom extract, glychhriza
extract and lasoodi extract are required.
 testing method of finished product is required.
389. Glosil Plus Syrup  Differential fee is required.
 Monograph of foeniculum vulgare is required.
390. Prochel Tablet Deferred for further evaluation and clarification.
391. Propol-G Syrup Deferred for further evaluation and clarification.
392. Axio Syrup  Differential fee is required.
 Monographs of ginger extract and fennel extract are required.
393. Myderm Lotion
 Sulphur is added in common molecules list.
394. Propol-G Tablet
 Stability of omega 3 fatty acids in tablet dosage form is
required.
Page 35 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
 Justification of stability and use of zinc oxide in oral dosage
form is required.
395. Moringa Capsule Deferred for further evaluation and clarification.
M/s Phytocon International Private Limited
 Monographs of vitamin D3, ferrous gluconate, manganese
396. Hi-Vit Tablet sulphate are required.
dosage form.
Viegen Pharma, Lahore
Plot No. 74-G, Sundar Industrial Estate, Sundar Raiwind Road, Lahore
397. Pholx Tablet Deferred for further evaluation and clarification.
398. Jufex Syrup  Fee evidence is required.
 Monograph of hedera folium extract is required.
399. LCT Tablet
 Justification of use of zinc oxide in oral dosage form is
required.
400. Go-Stress Capsule
 Monograph of withania somnifera extract is required.
401. Unipep Tablet
 Serratiopeptidase is included in common molecules list.
402. P-Glyce Capsule
 Justification is required regarding use of licorice liquid
extract in hard shell capsule.
403. Kiddy-D Softgel Deferred for further evaluation and clarification.
Nutritional Food Works and Chemicals, BWP
Plot No.66-67-A, Small Industrial Estate, Bahawalpur
 Dextrose is added in common molecules list.
 Clarification of “ each tube contains” in calvit-C sachet is
404. Calvit-C Sachet
required, needs correction.
 Justification of role of anhydrous citric acid as an active
Huzaifa International, Sargodha
Commerical Area, Aziz Bhatti Town Sargodha
M/s SUPER’S DIANA, S.L., ubicada a Ctra. C-17, KM 17, del municipi de Parets del Valles, (Barcelona)
 Form 5 is un-stamped.
405. Eli-Plus Liquid (veterinary)  Photocopy of Free sale certificate is attached. Original FSC
notarized by law representative and countersigned by
Pakistan embassy/ consulate in country of origin, is required.
Page 36 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
 According to real time and accelerated stability data of
required batches, range of assay results of vitamin E is from
95.45g/L to 93.24g/L at 18 months’ time point to 36 months’
time points, clarification/ justification is required either assay
of vitamin E at above mentioned time points falls within
specified limit or otherwise.
 CoA of finished product is required.
 Contents undertaking is required.
 Manufacturing license is required.
 Last inspection report is required.
M/s. Agro Poul Vet International,
1/12-A, Sheet No. 24, Model Colony, Karachi
Agent of M/s Inner Mongolia Huatian Pharmaceutical Co., Ltd. Economic Development zone, Yuanhbaoshan District,
ChiFeng city, Inner Mongolia, P.R. CHINA
Vitamino Plus Feed Supplement
406. Deferred for further evaluation and clarification.
Liquid Solution
Nutrimed Laboratories, Karachi
Plot No. B-42, S.I.T.E. Super Highway, Karachi
407. Geri Phos Syrup Deferred for further evaluation and clarification.
Calgan Phyto Pharma Pvt Ltd,
Plot No. 2, Green Park Road, Near Band Road Grid Station, Lahore
408. Algium Tablet Deferred for further evaluation and clarification.
409. Vitamix Liquid  Fee evidence is required.
410. Gyne-5 Tablet  Fee evidence is required.
 Strength of ingredients is required.
411. Marticid Liquid Deferred for further evaluation and clarification.
412. Calpan-D Tablet  Monograph of vitamin K2 is required.
 Monograph of algae mineral complex is required.
413. Oscal Insta Sachet  Stability of vitamin D3 in powder/ granules dosage form is
required.
414. Fosgink Liquid
 Form 3 to be revised w.r.t omission of sorbitol as it is an
inactive ingredient.
Nutrimed Laboratories, Karachi
Plot No. B-42, S.I.T.E. Super Highway, Karachi
Evaluator: (Zain Ul Abidin, AD-V)
415. Refort-M Syrup
 Monograph of fish oil is required.
416. Renobex-M Syrup
417. Enzilact Drops Deferred for following reasons:
Page 37 of 38
F.No.10-8/2020-OTC) (M-80)

(1) (2) (3)
 Lactase is added in common molecules list.
PolyfineNutra-Sciences
Plot No. 39-40 D, Industrial Estate, Hayatabad, Peshawar
418. Calrex-D Liquid
 Formulation contains large amount of calcium carbonate i.e
12gm in 120ml, needs justification.
419. Vitora-D Liquid  Fee evidence is required.
 Strength of ingredients are required.
420. Cytaplex Liquid  Fee evidence is required.
421. Incomin Syrup
422. Vitazee Liquid  Unit dose strength is required.
423. Iron-F Liquid
424. Zybex-L Liquid
(Muhammad Abdul Ghaffar)

Secretary, EEC
Page 38 of 38

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S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

Deferred for following reasons:

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

Deferred for following reasons:

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

S.No Brand name Decision

(Muhammad Abdul Ghaffar)

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