government of pakistan ministry of national health ... letter of all deferred products... · eel...

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Government of Pakistan

Ministry of National Health Services, Regulations & Coordination

Drug Regulatory Authority Of Pakistan

Health & OTC Products Division (Non-Drugs)

*****

Islamabad, the 19th August, 2020

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 07th

September, 2020. Replies received after due date shall not be entertained:-

S.No Brand name Decision

(1) (2) (3)

M/s Herbion Pakistan Pvt, Ltd. (Eno 001)

Plot No. 30, Sector 28, Korangi Industrial Area, Karachi

1. Relenza Capsule

Deferred due to the following short comings:

Official testing methods of herbs not provided

Evidence of formulation required

Contains ephedra needs clarifications

Clarify if this plant of M/s Herbion has herbal sections or

nutraceutical section

M/s. Wilshire Laboratory (Pvt.) Ltd., (Eno 00155)

Plot No.5, Farooq Industrial Estate, 20-KM, Ferozepur Road, Lahore

2. INFERNO PLUS CAPSULE

Deferred due to the following short coming:

Official monograph of eurycoma longifolia root extract and

chrysin required

3. IMMUNE AE DROPS


Vitamin A above RDA

Clarification required as the product is presented in vials, while

pack size is from 1ml to 1000ml

4. PREG-2 CAPSULE


Clarify and give monographs of Citrus bioflavonoid complex,

Tummy Soothe blend,

Organic rainbow vibrant food blend and

Prebiotic and probiotic Digestive blend

Brand name to be changed

The firm does not possess probiotic section

5. PREG-3 CAPSULE



Tummy Soothe blend,

“SAY NO TO CORRUPTION”

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Clarify iodine from inactivated saccharomyces cerevisiae

6. PREG-1 CAPSULE



Tummy Soothe blend,





7. PRE PREG CAPSULE


Folic acid above RDA

Clarify and give monographs of Organic Food &Vaggie blend

Organic Liver Support blend

Gentle digestive Support blend


8. POST PREG

CAPSULE



Postnatal lactation Blend,

Organic rainbow vibrant food blend and Soothing Digestive

Support blend



Clarify iodine from inactivated saccharomyces cerevisiae

9. Wilyte R Sachet


Official monograph of trisodium dehydrate and rice solid syrup

required

Deferred till the finalization of decision regarding common

molecules

M/s Hinucon, (Eno 0062)

Plot No. 12/1, Sector 15, Korangi Industrial Area, Karachi

10. HANAKIN PLUS SACHET Deferred due to the following short comings:

Official monograph of fish collagen required

11. HANAKIN SHOT


Official monograph of fish collagen required

Clarify dosage form

M/s Dr. Masood Homoeopathic Pharmaceuticals (Eno 0016)

56-Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore

12.

Dr. Masood’s

KALIUM PHOS Ф

(3DH)

Kalium phos

(EHPI) (EHPI Specifications)


Mother tincture not mentioned in monograph

13. Dr. Masood’s

MAGNESIA PHOSPHORICAФ



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(4CH=8X)

Magnesium phosphoricum

(EHPI)

(EHPI Specifications)

14.

Dr. Masood’s

NATRUM PHOSPHORICUM Ф

(3DH)

Natrum phosphoricum (EHPI)




15.

Dr. Masood’s

Borax Ф

(1CH=2X)

Borax (EHPI)




16.

Dr. Masood’s

Kali Muriaticum Ф

(3DH)

Kali muriaticum (EHPI)




17.

Dr. Masood’s

BARYTA CARBONICAФ

Baryta carbonica

(EHPI)




18.

Dr. Masood’s

CALCAREA FLOURФ

(4CH=8X)

Calcarea fluorica

(EHPI)




19.

Dr. Masood’s

CALCAREA PHOSФ

(4CH=8X)

Calcarea phosphorica

(EHPI)




20.

Dr. Masood’s

CALCAREA SULPHФ

(4CH=8X)

Calcarea sulphurica

(EHPI)



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21.

Dr. Masood’s

FERRUM PHOSФ

(4CH=2X)

Ferrum phosphoricum (EHPI)




22.

Dr. Masood’s

MERC SOLUBILIS Φ

(4CH=8X)

Merc solubilis

(EHPI)




23.

Dr. Masood’s

Eel Serum Potencies

Anguilla rostrata (EHPI)



Monograph prescribes 6x and higher potencies. The firm has

applied for 3, 3x as well. Justify

24.

Dr. Masood’s

Apocynum Cannabinum Potencies

Apocynum cannabinum (EHPI)



Contains indian hemp

25.

Dr. Masood’s

Cannabis Sativa Potencies

Cannabis sativa (EHPI)



Contains cannabis

26.

Dr. Masood’s

Paraffinum Potencies

Paraffinum (EHPI)


Deferred due to the following shortcoming:

Monograph states “ used in crude form. Homeopathic proving

not available” whereas the firm has applied for dilutions. Justify.

M/s Nutra Biomed (Pvt.) Ltd., (Eno 0040)

Plot No. 17, Street E-3, National Industrial Zone, Rawat

27. Nutra Biomed’s

HEMNIL Cream

Deferred due to the following shortcomings:

Monograph of sulpher rich oil shale extract missing

Testing method and COA of peanut oil is submitted instead of

extract

Testing method and COA of clove oil is submitted instead of

extract

Testing method and COA of menthol is submitted instead of

extract


INSTAFLEX Cream


The list of ingredients indicate use of herbs, common names are

of oils while testing methods of active moieties are given. (ex

Eucalyptol, menthol etc) Clarify formulation.

Undertaking for stability studies missing

Evidence of formulation missing

Label missing

Deferred till the finalization of decision regarding common

molecules

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29. Emocare lotion Deferred since paraffin is added in schedule D (Repacking drugs) of

LRA rules 1976


MIGNIL POWDER


Testing methods of purple butter root extract and stevia leaf

extract are missing


MEGAMIN Powder


Testing methods of Chicory root ext,

Apple fruit juice powder Ext ,

Pear fruit juice powder extract,

Pineapple fruit juice powder Ext and

Carrot powder Ext are required

Testing method of finished dosage form require


Justification of formulation required

32.

Nutra Biomed’s

Nutrabust Powder

Deferred due to the following shortcomings

Testing methods of Whey protein,

PGX,

Bilberry Extract and

Stevia extract required

M/s Claudia Health care

Plot. 32-33, industrial triangle, kahuta road, Islamabad.

33. CLAGEM SYRUP

Deferred for following reasons:

Monograph of collagen is required.

Choindroitin and glucosamine are added in common molecules

list.

Stability of selenium sulphide in oral liquid dosage form is

required.

34. CLATHIONE TABLET


Monograph/ testing specfication of collagen is required.

Source of collagen is required.

Testing method of finished product is required.

35. CLYTE REHYDRATION LEMON

SACHET


Monograph of rice maltodextrin is required.

Product resembles with ORS formulation, added in common

molecules list.

36. SUBLING SACHET Deferred for following reasons:

Stability of cyanocobalmin in sachet form is required.

37. SALBERRY sachet Deferred for following reasons:

Firm uses silvia officinalis in crude form, needs clarification.

38. SILA VITALITY SYRUP


Justification regarding use of royal jelly in herbal product is

required.

Brand name needs to be changed.

39. DR TOSS SYRP Deferred for submission of Monograph of bharangyadikwath.

M/s AGP Limited (1112)

Plot No. F/46, S.I.T.E.-II, Phase – II Super Highway, Karachi.

40. Kosnate D Suspension Deferred for following reasons:

Owner/ CEO’s signature and stamp are required on form 3.

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Monograph/ testing specification of residual mineral salt is

required.

Brand name undertaking is required.

Owner/ CEO signature is required on content undertaking.

Ossein is added in common molecules list being dealt by PER

Division and HOTC Division.


41. Kosnate Suspension



Monograph/ testing method of residual mineral salt


Ossein mineral complex is added in common molecules list

being dealt by PER Division and HOTC Division.



42. Colidrop Drops Deferred for following reasons:

Monograph/ testing method of matricaria extract is required.

43. Q-BEFOL Tablet Deferred till finalization of common molecules list being dealt by

division of H&OTC products and division of PER.

44. Kosnate 800 Tablet



Monograph/ testing method of residual mineral salt is required.


Ossien mineral complex is added in common molecules list




45. Kosnate D Tablet









46. Tribumax Capsules


Monograph/ testing method of tribulus extract is required.


47. Rehyde Sachet



Monograph/ testing method of wheat dextrin is required.



ORS Formulation is added in common molecules list.

48. Kosnate-D Plus Sachet





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Stability of zinc oxide in sachet (powder/ granules) dosage form

is required.


M/s Phytocon International (Pvt) Ltd (Eno 0083)

339-A, Sundar Industrial Estate, Raiwind Road, Lahore

49. Day-Vit Syrup Deferred due to the following deficiency:

Fee of 250/ Rs is submitted instead of 2000/

50. Tridium Capsule Deferred due to the following deficiency:

Evidence of fee submission and R&I is missing

51. Somina Tablet

Deferred due to the following deficiencies:


Deferred till the finalization of policy regarding common

molecules

Testing method of L-ornithine L-Aspartate is not provided

Clarify/ justify use of metadoxine as nutritional supplement

52. Triwim Drops Deferred due to the following deficiency:


53. Biovin Sachet



Testing method of cranberry extract and D-mannose to be

provided

M/s Bless Laboratories (Eno 0063)

Factory No.179, 1.5-KM, Kattar Band Road, Off Multan Road, Thokar Niaz Baig, Lahore

54. Brain Plus


Form 3 not on prescribed format


Form 3 not signed

Undertakings not signed

55. Branex



Form 3 not signed


Testing method of onsoma extract is missing

56. Trumenol



Form 3 not signed


Testing method of ivy leaf extract missing

57. D-Liv



Form 3 not signed


Testing method of dandelion extract missing


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58. Leucon Capsule




Testing method of agnus castus extract and maca root extract

not provided

59. Lutex Plus Capsule


3 not on prescribed format


Testing method of ginseng extract not provided

60. Glaxy-D Drops




Testing method of L-methyl folate to be provided

61. Erisip Syrup


Evidence of fee submission and receiving missing

Testing method of ginkgo extract and ginseng extract required

M/s. Alpha Nutraceutical Research Laboratories, (Eno 00229)

21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore

62. Hitein



Testing method of iron bisglycinate missing

63. Hicocid



Formulation contains extracts while monographs of herbs are

provided. The firm may be directed to clarify if the product is

herbal or nutraceutical and accordingly submit testing methods

of all ingredients.

Contains sodium bicarbonate

M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)

Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi

64. Nutrigold


The firm is directed to clarify GMP status and production status

of the firm

Label is missing

Evidence of fee submission and R&I to be provided

65. Curevit



of the firm


66. Curelin



of the firm

Label is missing


Contains herb. The firm does not possess herbal section

67. Curevit Deferred due to the following deficiencies:

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of the firm


68. Primolon-E



of the firm

Label is missing



69. Irolife



of the firm

Label is missing



70. Kadin-F



of the firm

Label is missing


Contains N-acetyl cysteine

Testing method of L methyl folate required


71. Omixo



of the firm

Label is missing


72. Oxamin



of the firm


Label is missing

73. Vikron



of the firm


Sign stamp on form 3 is missing

Testing method of iron bisglycinate is missing

Label is missing

74. Eptovir



of the firm



Testing methods of herbal extracts required


Label is missing

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75. Tri B Plus



of the firm

Label is missing


76. Queze



of the firm

Label is missing


77. Ocu Vision



of the firm

Label is missing


Testing method of lutein and zeaxanthin to be provided


78. Normens



of the firm

Label is missing

Herbal preparation while the firm does not possess herbal

section

Testing methods of ingredients missing


79. Calsure D



of the firm


Label is missing

80. Ocu Vision



of the firm


Sign stamp of form 3 is missing

Label is missing


Testing method of lutein and zeaxanthin to be provided



81. Alpha-Zee Deferred due to the following deficiency:

Testing method of fennel extract is missing

82. Apezite


Testing method of alpinia galangal, piper nigrum, piper longum,

apium gravoelens, punica granatum, elettaria cardamomum,

mentha sylvestris are missing

Undertaking for safety required

83. Optic (120Ml) Deferred for further evaluation and clarification.

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84. Masvit


Fee of herbal products i.e 250/Rs submitted

Contains herbs and vitamins in the same formulation, the firm

has only herbal tablet section

85. Apetac-D


Testing method of piper longum and cinchorium intybus

missing

Undertaking for stability required

86. Dyso


Testing method of terminalia bellerica and mentha piperita are

missing




87. Tusin



of the firm

Label is missing

Contains crude amla while the firm does not possess herbal

section



88. Hmax-Sil



of the firm

Label is missing

Contains common molecule; sodium bicarbonate

Herbal preparation while the firm does not possess herbal

section



89. Foliqam Mf



of the firm

Label is missing



90. Opti-Cal 1000



of the firm

Label is missing


91. Curefys



of the firm

Label is missing

Evidence of fee submission required

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The product is herbal while the firm does not possess herbal

sections

M/s. Trends Pharmaceuticals (Nutraceuticals & Cam Division), (Eno 00305)

Plot 546/ 547, Sundar Industrial Estate, Lahore

92. Ulive Tablet Deferred due to the following deficiency:

Testing method of opti-zinc and tribulus extract required

93. Cintavit Syrup Deferred till the finalization of policy regarding common

molecules

94. Vietab Tablet


Contains yohimbine bark extract. Required clarification.

Testing methods of all herbal extracts and opti-zinc required


95. Oscure Tablet Deferred for further evaluation and clarification.

96. Joveen


Official monographs of marine collagen, horsetail powder,

grape seed extract and iron bisglycinate are missing



97. Milsure Food Supplement Deferred due to the following deficiency:

Provide evidence of food supplement section

Jawad Impex International, Lahore

98. Ioguard 300 Deferred for further evaluation and clarification.

M/s Novamed Healthcare (Pvt) Ltd (Health Care Division) (Eno 0018)

28-KM, Ferozepur Road, Lahore

99. Osteo Care



Form 3 incomplete and not signed stamped

Quantities of ingredients missing on form 3 and product profile

Label missing

Undertaking for stability, brand name and content is missing

100. Ut Sacal-D




Label missing


101. Coten E




Label missing


102. Irofer Sachet Deferred for further evaluation and clarification.

103. Irofer Syrup



Form 3 not signed stamped


Label missing

Testing method of iron bisglycinate to be provided


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104. Emetistop



of the firm

Evidence of formulation is missing

Label is missing


M/s Mac & Rains Health Care (Pvt) Ltd (Eno 0059)

540-D, Sundar Industrial Estate, Raiwind Road, Lahore

105. Anorex


Evidence of submission of fee and R&I is missing

Form 3 is not signed stamped

Evidence of formulation to be provided

Official monographs of herbal extracts missing

Common name not provided

Label is missing

Undertakings of brand name, stability and content is missing

106. Microlyte ORS Sachet




Clarify “probiotic powder”

Common name snot provided

Label is missing

Provide evidence of dedicated section for probiotic


molecules

107. Mac Colic







Label is missing


Mention quantity of ingredients per drop/ unit dose

108. Pakcid







Label is missing




109. Carot



of the firm

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Label is missing

110. Kindew



of the firm


Label is missing

111. Foly Plus



of the firm



Label is missing

112. Silyliv-L



of the firm


Label is missing

Testing methods of ingredients not provided


molecules

113. Curemine



of the firm

Label is missing



molecules


Testing methods of ingredients to be provided

114. Curexil



of the firm

Label is missing


The product is probiotic while the firm does not possess

probiotic section

Testing method of active ingredient missing

M/s Nutrimed Laboratories (Eno 0078)

Plot No. B-42, S.I.T.E. Super Highway, Karachi

115. Hepawar


Fee submitted is of herbal products 250/ Rs

Official testing methods of herbal extracts required


116. Lecorex




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117. Hepawar





118. Besom





119. Femi Chos


Evidence of fee and R & I is missing


120. Bycolic





121. Besom





122. Lecorex







123. Irowin Deferred for further evaluation and clarification.

124. Bresol



of the firm

Label is missing

Hyssopus herb is used whereas the firm does not possess herbal

section

Testing method of ingredients required

125. Foliqam Deferred for further evaluation and clarification.

126. Irowin



of the firm


Label is missing


127. Pherol



of the firm



Label is missing

128. Daily Multi Deferred due to the following deficiencies:

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of the firm


Label is missing

129. Famvid



of the firm


Label is missing

130. Maxtron



of the firm



Label is missing

131. Pure Folic Pearl



of the firm

Label is missing


Clarify the term ‘soft pearl capsule’



132. I V Tus Plus Cough


Evidence of fee and R & I is missing

Testing method of herbal extract to be provided

133. Vitamag


Sign stamp on form 3 missing

Testing methods of herbal extracts missing


Fee of herbal product i.e Rs 250/- submitted

134. Vitagesic



molecules

Official testing method of ingredients missing

M/s Polyfine Nutra-Sciences (Eno 0019)

Plot No. 39-40 D, Industrial Estate, Hayatabad, Peshawar

135. Loburna Deferred for further evaluation and clarification.

136. Apgrow Deferred for further evaluation and clarification.

137. Epitone Deferred for further evaluation and clarification.

138. Pectil Deferred for further evaluation and clarification.

139. Bless Baby

Carminative


Common names missing



Undertaking for safety missing

140. Beano Deferred due to the following deficiencies:

Testing method of galactosidase missing

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Undertaking for stability missing


molecules

141. Polyfine Liquid

Joshina


Quantities of ingredients not provided

Only common names are written. The firm may be directed to

submit scientific names and the testing method of each

ingredient accordingly.



142. Herbi-Coff


common names are written. The firm may be directed to submit

scientific names and the testing method of each ingredient

accordingly.



143. Polyfine Gripe Water


Only common names are written. The firm may be directed to

submit scientific names and the testing method of each

ingredient accordingly.



144. Allure Plus


Contains herbal ingredients as well as arginine and zinc. Clarify

if the product is herbal or neutraceutical

Testing method of ginseng, L-arginine and asparagus are

missing




molecules

M/s. Derma Techno Pakistan (Eno 00272)

528-Sunder Industrial Estate, Lahore

M/s EON Pharmacy (Eno 0093)

Plot No. A/150, Sector 11-E, New Karachi

145. Ajwa Plus



Herbs and vitamins used in the same formulation. Clarify if the

formulation is herbal or nutraceutical. (Fee submitted 2000/-)

146. Bio Malt Deferred for further evaluation and clarification.

147. Calcibex600 Deferred due to the following deficiency:

Quantity of vitamin D in IU required

148. Calcibion 600 Deferred for further evaluation and clarification.

149. Ginkobion Deferred due to the following deficiency:


150. Ginko Plus Deferred due to the following deficiency:


151. Livabion Deferred for further evaluation and clarification.

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152. Bio Fort Tonic Deferred due to the following deficiency:


153. Bio Rex Deferred due to the following deficiency:


154. Colizyme Deferred due to the following deficiency:


155. Cool Cid

Deferred due to the following deficiency:



156. Hemo Plus Deferred due to the following deficiency:


157. Vitalac Tonic Deferred due to the following deficiency:


158. Flu Cough




159. Gastogel Plus Deferred due to the following deficiency:


160. Gyno Rex Deferred due to the following deficiency:


161. Gynofer Deferred due to the following deficiency:


162. Heparic



Testing method of tamarix dioica missing

163. Ipm Deferred for further evaluation and clarification.

164. Lycomerz Deferred due to the following deficiency:


165. Mensogen




166. Multi Fort Tonic Deferred due to the following deficiency:


167. Novacid


Receiving and fee are for novacid gel while the product is syrup


168. Pepcid



Receiving and fee of pepcid gel while product is syrup


169. Pepsogel




170. Pepsogen




171. Pepsogen Deferred due to the following deficiency:


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172. Eon’S Sharbat E Faulaad Deferred due to the following deficiency:




173. Relicof Drops



Testing method of herbal extract missing

174. Rosy Syrup



Official testing method of melatonin missing


molecules

M/s Polyfine Nutra-Sciences (Eno 0019)


175. Apgrow


Quantities of ingredients not given

Common names not mentioned

Testing methods of achillea milleforlium, tamarix gallica,

tribulus terrestris, cichorium intybus, terminalia chebula and

mentha sylvestris are not provided



176. Epitone


of ingredients not given

Common names not mentioned

Testing methods of achillea milleforlium, tamarix gallica,

tribulus terrestris, cichorium intybus and terminalia chebula are

not provided



177. Loburna


Quantities of extracts not provided

Testing methods of extracts missing





178. C-Active



of the firm

Label is missing


179. Cals D



of the firm

Label is missing


180. Q-Sten Deferred due to the following deficiencies:

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of the firm

Label is missing



M/s Stiflex Pharmaceuticals (Consumer Healthcare Division) (Eno 0012)

33-B, Small Industrial Estate, Bahtar Road, Wah Cant

181. Febriful Deferred due to the following deficiencies:

Official monograph of L-methyl folate required

182. Osais Deferred due to the following deficiencies:

Testing method of elemental zinc required

183. Progin Plus


Contains herbs, while the firm does not have herbal section


molecules

184. Ronadil F


Contains herbs, while the firm does not have herbal section


molecules

185. Biocit K Deferred till the finalization of policy regarding common molecules

186. Chestol Syp Deferred due to the following deficiencies:

Testing method of ivy leaf extract and thyme extract required

187. Ivolef Plus Deferred due to the following deficiencies:

Testing method of ivy leaf extract and thyme extract required

188. Colex Deferred due to the following deficiencies:

Testing method of cardamom extract and fennel extract required

189. Colex Deferred due to the following deficiencies:

Testing method of cardamom extract and fennel extract required

190. D-Ven Provide quantity of vitamin A in IU

191. Serodaze Ds Deferred till the finalization of policy regarding common molecules

192. Stiflex Gripe Water


Testing method of dill oil and ginger extract required


molecules

193. Curhoids


Testing methods of hesperidin and diosmin required

Evidence of formulation as herbal product required


194. Protec D Deferred due to the following deficiency:

Testing method of cranberry extract required

195. Mintvol Deferred due to the following deficiency:

Testing method of peppermint extract required

196. Tom Ad Deferred due to the following deficiency:


197. D Take Deferred due to the following deficiency:

Clarify quantity of vitamin D in IU

198. Roz B Deferred due to the following deficiency:

Testing methods of iron polymaltose complex required

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199. Skyvit M


Methods of iron polymaltose complex required

Clarify quantity of vitamin D in IU

200. Amore Deferred due to the following deficiency:

Testing methods of herbal extracts to be provided

201. Lactimax


Contains moringa herb while the firm does not have herbal

section

202. Getcalvit


Contains methylene chloride (Banned ingredient)

Testing method of ossein mineral complex missing

203. Liverin Deferred till the finalization of deficiencies regarding common molecules

204. Diabecinn


Contains raw cinnamon while the firm does not have herbal

section

205. Ageomore Deferred due to the following deficiency:

Contains herbs while the firm does not have herbal section

206. Skyvit M Deferred due to the following deficiency:

Testing methods of iron polymaltose complex required

207. Osteofit


Testing method of alphacalcidol required

Quantity of vitamin D in RDA required

208. Neutrofast


Testing method of blueberry extract and cranberry extract

required

209. Recco Deferred due to the following deficiency:


M/s EON Pharmacy (Eno 0093)


210. Anatacidgascon Gel




211. Broncos Cought


Testing method of morus nigra required


212. Diapium Deferred due to the following deficiency:


213. Biolac Deferred due to the following deficiency:


214. Flu Cold




215. Hemo Plus Deferred for further evaluation and clarification.

216. Plexo V Deferred due to the following deficiency:


217. Plexo V Repeat from S no 210

218. Rnicef Deferred due to the following deficiencies:


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Testing method of piper longum required

219. Sengofer Deferred due to the following deficiency:


220. Uribion Deferred due to the following deficiency:


221. Urigon Deferred for further evaluation and clarification.

222. Veravit Deferred for further evaluation and clarification.

223. Verazyme Deferred due to the following deficiency:


224. Viobex


Testing method of maca root missing


M/s Jawad Impex International, Lahore

21-Iftikhar Building, Chouburji, Lahore

Agent of M/s Zagro Singapore Pte Ltd Zagro Global Hub 5 Woodlands Terrace Singapore 738460

225. Anavite layer 0.25% premix


Prescribed form 5 is required.

CoA of finished product bearing all testing specification in

terms of physical, chemical and microbial is required.

Accelerated and long term stability studies data (physical,

chemical and microbial) of at least 3 batches conducted on

requirements of zone IV-A is required and it should bear

product name.

Notarized and countersigned copies of manufacturing license

and GMP certificate is required.

Pakistan embassy/ consulate attestation of Free sale certificate

of product is required. However, Free sale certificate submitted

by the firm does not indicate any statement depicting either

product is freely available in country of origin or otherwise.

Agency agreement between importer and principal manufacturer

is required.



226. L.C. Mag



of the firm

Label is missing


227. Calc U3



of the firm

Label is missing


228. Vita-L



of the firm

Label is missing


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Contains ginkgo biloba herb while the firm has no herbal

sections

229. 3D Deferred for further evaluation and clarification.



230. Hepa Guard Sachet



Evidence of use of L-ornithin L-aspartate as a nutraceutical

product

Testing method of L-ornithin L-aspartate missing



231. Pepeez


Testing method of ginger and fennel are missing


M/s Bless Laboratories (Eno 0063)

Factory No.179, 1.5-KM, Kattar Band Road, Off Multan Road, Thokar Niaz Baig, Lahore

232. Dro Vit-D


Form 3 and undertakings not signed


233. Hizyme




Testing method of ajwain extract required

234. M-Min


Evidence of submission of fee and receiving missing



235. Jovotil





236. Co-Ten




237. Retain Hns




Official testing methods of horsetail rush stem extract required

238. Olive Capsules




Testing method of tribulus extract required

239. H-Sil






F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

240. Apit


Form 3 not signed


The formulation contains extracts while testing of herbs is given

(articles) clarify if the formulation is herbal or nutraceutical

241. Vda




242. Oscal




243. Flow-D




244. Tribo Plus





Evidence of formulation provided is different from applied

formulation

245. Theranex-Q





246. C-Plus-D




247. Plus-D




248. BL-Folate Plus Deferred due to the following deficiencies:

Testing method and clarification of lipofer required

249. Brain-B Plus




250. Brain-B Deferred for further evaluation and clarification.

251. Branex


Official testing methods of herbal extracts and bioperine

required

252. Celmin-D


Official testing methods of bacopa and lavender extracts are

required

253. Db-Zinc Deferred for further evaluation and clarification.

254. D-Liv


Official testing methods of herbal extracts required (Although

the firm has herbal sections too, the form 3 states extracts of

herbs, therefore testing of the same is required)

255. Ever Bless Deferred due to the following deficiencies:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Official testing method of collagen required

Deferred till the finalization of policy on common molecules

256. Fyrobin Deferred for further evaluation and clarification.

257. Fyrobin


Official testing method of zeaxanthin required


258. Hepabion Deferred due to the following deficiencies:

Official testing method of herbal extracts required

259. H-Vit M


Evidence of formulation different from applied formulation

Deferred till the finalization of policy on common molecules

260. Liv-Chok Deferred till the finalization of policy on common molecules

261. Malt


Official testing methods of all ingredients required


262. Microloc


Official testing method of herbal extracts required


formulation

263. Microloc Deferred for further evaluation and clarification.

264. One-Z



Clarify formulation wrt energy, fats, proteins and carbohydrates

Justify all the minute quantities of vitamins being used (ex 0.127

IU vitamin A, 0.0469 mcg vit B6 etc)

265. R-Cof


Contains papaver somniferum



formulation

266. R-Vit





molecules

267. Re-Vit



Testing method of iron bisglycinate required

268. Rizer Deferred due to the following deficiency:


269. Rizer Deferred due to the following deficiency:

Official testing methods of herbal extracts to be provided

270. Roging Plus Deferred till the finalization of policy regarding common molecules

271. Sp-Ton


From 3 and undertakings not signed

Justify use of ‘talcum powder’ as inactive ingredient


272. Vital-30 Deferred due to the following deficiencies:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


Testing method of cranberry extract missing

273. G-Live Deferred due to the following deficienciy:


M/s Izfaar Nutraceutical Industries,[Nutraceutical] (Eno 00629)

Sun Lane 7th Km, Sundar Raiwind Road, Lahore-Pakistan

274. Sarooco



Undertakings for stability, content and brand name are missing

Fee submitted Rs 250/-

Testing methods of herbal extracts to be provided

275. Miracle







276. Vimin Gold




277. Hi-C-Vit




278. Vetifaar




Claims to be a topical antibiotic. Justify.

fee submitted Rs 250/-


279. Carminofaar





280. Kilworm






Contains herbs. Clarify if the firm has herbal section.

281. Baby Water





Contains herbs. Clarify is the firm has herbal section


molecules

282. Kilworm-P Deferred due to the following deficiencies:


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



Contains herbs. Clarify is the firm has herbal VETERINARY

section

M/s. Paragon Herbal Laboratories, (Eno 00186)

Plot No. Kht 285, Ktn 570, Allah Hoo Industrial Area, Near Sabzi Mandi, Gujumatta, Ferozepur Road, Lahore

283. Real-Cid Deferred for further evaluation and clarification.



284. Calidin Syrup Deferred due to the following deficiency:

Fee submitted of herbal product; 250/- Rs

285. Vitacon Suspension Deferred due to the following deficiency:


286. Ironase Tablet



Official testing method of iron bisglycinate required

287. Dbon Syrup Deferred due to the following deficiency:


M/s Scotmann Pharmaceuticals (Health & OTC Division), (Nutraceutical) (Eno00639)

5-D, I-10/3 Industrial Area, Islamabad-Pakistan

288. Lipocardin



Official monographs of ingredients are missing


289. Sunny D Marina




290. Truflor


Official monograph of probiotic is missing

Clarify if the firm has a probiotic section



291. Seacardin





292. Dairyhelp





molecules

293. Truflor


Official monograph of probiotic is missing




294. Sunny D CV Deferred due to the following deficiencies:


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


295. Align-Ut Deferred due to the following deficiency:


296. Sambuca



Official monograph elderberry is missing


297. Best Belly 50



Official monograph of probiotic blend is missing




298. Best Belly 10







299. Ps 100





300. Emkay-7 Deferred due to the following deficiency:


301. Sunny D 2K Deferred due to the following deficiency:


302. RLA 100





303. Best Belly 50







304. Best Belly 100 Capsule







305. Best Belly Jr Chewable





F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)





306. Calcinix Deferred for further evaluation and clarification.

307. Greenofer



of the firm

Label is missing

308. Calc Plus




of the firm

Label is missing


309. Calc Plus




of the firm

Label is missing


310. Vitafam



of the firm

Label is missing


311. Vitafam



of the firm

Label is missing

312. Multiban E



of the firm

Label is missing


313. Oso-D



of the firm

Label is missing

314. Multi Life



of the firm

Label is missing


Evidence of submission of fee required

315. Super One



of the firm

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Label is missing


316. Pc -Cure Plus



of the firm

Label is missing



Testing method of grape seed extract required



molecules

317. Dioqam



of the firm

Official testing methods of ingredients required

Label is missing

318. Cola-Gin



of the firm

Label is missing


Contains glucosamine and chondroitin

Testing method of collagen missing



319. Sonex Plus


Clarify quantity of potassium chloride (Units; IU)

Justify use of magnesium stearate as active ingredient

Testing method of iron bisglycinate and chromium picolinate

required

M/s Anza Pharma, (Eno 00540)

343-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore

320. Anchel-F


Applied on form 4 while no clinical data is provided

Official testing method of iron bisglycinate missing

321. Hepasun Deferred due to the following deficiency:


322. Hepasun Deferred due to the following deficiency:

Quantity of vitamin E in IU required

323. Vitasun Deferred due to the following deficiency:


M/s. Calgan Phyto Pharma (Pvt) Ltd.,00146

Plot No. 2, Green Park Road, Near Band Road Grid Station, Lahore

324. Brain-Max



Product is nutraceutical while fee of herbal product i.e 250/- Rs

submitted

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

325. Ocid Deferred for further evaluation and clarification.

326. Gastroset



Testing method of fenugreek extract and nepata cartaria extract

are required

327. Oscal-D Deferred due to the following deficiency:

Quantities of ingredients not mentioned

328. Vision




Testing method of L-theanine required

329. Rapid


Contains vitamin and herbs. Clarify if the formulation is herbal

or nutraceutical

Testing methods of all herbs to be provided


330. Iv-Tuss


Form 3 missing

Testing methods of ingredients are missing

Undertaking for brand name, stability and safety missing

331. Coral-One


Form 3 missing


Undertaking for brand name and stability missing

332. Zymogel-M


Form 3 missing


Undertaking for brand name, safety and stability missing

333. Arq-E-Sherien


Form 3 missing



334. Vitamark


Form 3 missing




335. Arq-E-Kasani


Form 3 missing



336. Xano Plus


Form 3 missing



337. Arq-E-Gauzaban




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


338. Eribion


Form 3 missing



339. Churqa


Form 3 missing



340. Apitite Ultra


Form 3 missing



341. Action


Form 3 missing



The product seems nutraceutical while fee of herbal is submitted


molecules

342. Sa Tonic


Form 3 missing




343. Gammet-S


Form 3 missing




344. Arq-E-Mako


Form 3 missing

Quantity of ingredient missing



345. Emvit-Z Protect


Form 3 missing



346. Malt Plus


Form 3 missing




347. Vitamark


Form 3 missing


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


348. Vitamark


Form 3 missing



349. Irospan Repeated on number 368

350. Bonifit-D


Form 3 missing



351. Edibone Plus


Form 3 missing



Evidence of fee submission and receiving are missing


352. Calgan Balam


The receiving and fee are of calgan balm while the dossier is of

arq-e-saunf.

Form 3 missing

Testing methods for either product are missing


353. Zymogel-M


Form 3 missing



354. Arq-E-Podina


Form 3 missing



355. Treblogen


Form 3 missing




356. Calgan Gripewater


Form 3 missing



357. Calif-D


Form 3 missing



358. Irospan


Form 3 missing



F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Undertaking for brand name content and stability missing

359. Calif-D Repeated on number 367

360. Cardiogen


Form 3 missing



361. Arq-E-Saunf


The receiving and fee are of arq-e-saunf while the dossier is of

calgan balam.

Form 3 missing



362. Edibone


Form 3 missing




363. Malto Max


Form 3 missing




364. Kaozin


Form 3 missing



M/s. Hiranis Pharmaceuticals (Pvt.) Ltd. (Eno 00174)

E-145-149, North Western Industrial Zone, Port Qasim, Karachi 75020

365. Myovite Deferred due to the following deficiency:


366. Cranactin


Applied on form 4 but no clinical data provided


Testing method of potassium amino acid complex missing


367. Neevo Dha Deferred due to the following deficiency:


368. Zeplate Dha 7.5Mg


Official testing method of L-methyl folate missing


369. Zeplate Dha 15Mg


Official testing method of L-methyl folate missing


M/s Novamed Healthcare (Pvt) Ltd (Health Care Division) (Eno 0018)


370. Vitral-M Capsule Deferred for further evaluation and clarification.



F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

371. Mefol Deferred due to the following deficiency:

Testing method of L-methyl folate missing

372. Lutex Syrup



Vitamin A above RDA

373. Vitren Tablet




Vitamin A above RDA

Testing method of iron bisglycinate, garlic extract and

chromium glycinate missing

374. Crano Powder Deferred till the finalization of policy regarding common molecules

375. Vitalex Syrup



Quantities per 5 ml or 10ml required


376. Ivycof Syrup



Testing method of ivy leaf extract missing


377. Folisip Syrup Deferred due to the following deficiency:


378. Ulina Capsule



Testing method of wild yam extract/ natural progesterone

missing

379. Sandil Syrup



Testing method of methyl folate calcium

380. D-Colic Drops.




molecules

381. Rosy Drops



Official testing method of melatonin missing


molecules

382. Florafix Tablet Deferred due to the following deficiency:


383. Alfacon Tablet Deferred due to the following deficiency:


384. Fitobact Tablet Deferred due to the following deficiency:


385. Fibogen ORS Deferred till the finalization of policy regarding common molecules

386. Cofix Deferred due to the following deficiency:

Testing method of herbal extract missing

387. Zecal Deferred due to the following deficiencies:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Applied on form 4


M/s Scotmann Pharmaceuticals (Health & OTC Division), (Nutraceutical) (Eno00639)

5-D, I-10/3 Industrial Area, Islamabad-Pakistan

388. Best Belly







389. Oral Biotic Chewable


Official monograph of probiotic missing

Clarify if the firm has probiotic section




390. Cal D Deferred for further evaluation and clarification.

391. Winmax Deferred for further evaluation and clarification.

392. Curelin



of the firm

Label is missing



393. Nutra Junior



of the firm

Label is missing


394. Pregnoease



of the firm

Label is missing


Testing method of ginger extract required


395. Ocu Vision + Plus




of the firm

Label is missing


Contains herbs while the firm has no herbal sections

396. Enofam



of the firm

Label is missing


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

397. Cappy



of the firm

Label is missing



398. C-Kas



of the firm

Label is missing


399. Delife



of the firm

Label is missing



400. Nutra L Deferred for further evaluation and clarification.

401. Femixa



of the firm

Label is missing



402. Epamol



of the firm

Label is missing


403. Reeon



of the firm

Label is missing



404. Ferfolate



of the firm

Official testing method of L-Methyl folate required

Label is missing


405. Dal-C



of the firm

Label is missing


406. Callus Deferred due to the following deficiencies:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

The firm as well as the field office Karachi may be directed to

clarify GMP status and production status of the firm

Label is missing


407. Prunox



of the firm

Label is missing



M/s. Calgan Phyto Pharma (Pvt) Ltd.,00146


408. Urinal



Fee of herbal product i.e 250/- Rs submitted


moelcules

409. E-Tizer


Testing method of nepata cartaria required


410. Aborax Deferred due to the following deficiency:


411. Erapid Deferred due to the following deficiency:


412. Ov-Fert



Fee of herbal product submitted while the product is

nutraceutical

413. Manadil



Testing method of epimedium missing

414. Livon


Testing method of glycyrrhiza extract and milk thistle extract

have been given while herb has been used

Testing methods of schisandra extract and Oregon grape extract

are missing


415. Vision




416. Menspro


Testing of milk thistle extract is given while herb is used in

formulation


Greenworld Wholesales Co Pvt Ltd Rawalpindi

Mezzanine Floor, 29-B, Mid-City Mall, Main Murree Road, Rawalpindi

Agent of M/s World (Tianjin) Nutrition Health Food Co., Ltd., China

417. Glucoblock capsule Deferred for following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Breakup of fee is required.


CoAs of raw materials and finished products are required on

principal manufacturer’s cover letter.

Manufacturing process is required.

Master formulation is required.

Accelerated and long term stability studies data conducted on

requirements of zone IV-A is required.

Packaging and labeling is required.

Manufacturing license is required.

Approval of product registration or marketing authorization in

country of origin is required.

GMP certificate of principal manufacturer by local regulatory

authority is required.

Free sale certificate in the country of origin is required.agency

agreement between importer and principal manufacturer is

required.

Last inspection report by local regulatory authority is required.

418. Spirulina Capsule
















Free sale certificate in the country of origin is required.


is required.


419. Hepatsure capsule












F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)





Free sale certificate in the country of origin is required.agency

agreement between importer and principal manufacturer is

required.


M/s. Hale Pharma, (Eno 00255)

B-Kh No. 285 Kh No. 570 Allah Hoo Industrial Estate, Allah Hoo Pul 22 Km Ferozpur Road, Lahore

420. Zee Cal Deferred due to the following deficiency:

Undertaking for brand name missing

421. Cal-Z




422. Ten Days Deferred due to the following deficiency:


423. Ever 1



Testing method of garlic powder missing

424. Azorox Tablet Deferred due to the following deficiency:


425. Malt-Max




426. Poli-F




427. Bone Zee




428. True Sip Deferred due to the following deficiency:


429. Myeloid Tablet



Testing method of iron polymaltose missing

430. Jaxe Deferred due to the following deficiency:


431. Fast Vit




M/s. Hiranis Pharmaceuticals (Pvt.) Ltd. (Eno 00174)


432. Asvin Deferred due to the following deficiency:

Official testing method of rutin is required

M/s. Medinoon Research Laboratories, (Eno 00156)

28-KM, Soay Assal Stop, Ferozepur Road, Lahore

433. Vim-D Deferred due to the following deficiencies:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Undertakings of stability, brand name and content missing

Label missing


434. Co Line



Label missing

435. Senses


Official testing methods of ingredients missing


Label missing

436. Telsium



Label missing


molecules

437. Jelmin



Label missing

438. Ferbis




Label missing

439. Calmeg-Z



Label missing

440. Ris-D



Label missing

441. M-Cal




Label missing

442. Medivit-C



Label missing

443. Jemcal




Label missing

444. Xe Cor




Label missing

445. Xe Cor




Label missing

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

446. Folcid




Label missing

447. Capsovit




Label missing


molecules

448. Calmeg-Z




Label missing

449. Senses




Label missing

450. Maxvit-D Oral




Label missing

451. Medvit




Label missing

Deferred till the finalization of comments regarding common

molecules

452. Super Fit




Label missing

Contains common molecule; sodium bicarbonate

453. E-Ginko

Official testing methods of herbal extract required


Label missing

454. Ferotab Undertakings of stability, brand name and content missing

Label missing

455. Vim-D




Label missing

456. Femifrol




Label missing

M/s Millenium Laboratories (Eno 00274)

128/5, Shaikh Mohammad Raiz Road, Quaid-e-Azam, Industrial Estate Road, Kot Lakhpat, Lahore

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

457. Multizanta Deferred for further evaluation and clarification.

458. Xpro Deferred for further evaluation and clarification.

459. Sb Fer Deferred for further evaluation and clarification.

460. Cinosil Deferred for further evaluation and clarification.

461. Mini Gold Junior Deferred for further evaluation and clarification.

462. Aminolive


Evidence of receiving missing




Vitamin A mentioned twice in formulation

463. Best D




464. Bioglovit



Testing method of grape seed extract and natural mixed

carotenoids required

465. Byzberi Deferred due to the following deficiency:


466. Calceo D




467. Calceo D




468. Calceo




469. Colimox






molecules

470. Concieve Tablets





molecules

471. Crano Plus



Testing method of elderberry extract required

472. Eco Gold Tablets




Contains herbs while firm does not possess herbal section


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

473. Ecoba Tablets





474. Econa Tablets




The product contains herbs, whereas the firm does not possess

herbal section

475. Ozcal D Tablets





476. Ozcal D Syrup



Testing method of iron protein succinate required

477. Ozorex Syrup Deferred for further evaluation and clarification.

478. Mac D Syrup



Justify quantity of omega 3

479. Minocal Syrup




Quantity of vitamin A and D in IU required

480. Multira Tablets



Testing method of hydrolyzed marine collagen and grape seed

extract required

481. Occu Plus Tablets




482. Orra Forte Tablets




Quantities of ingredients per tablet required

Quantity of vitamin A in IU required


483. Sb Sure Powder




Quantities per serving required

Justify formulation wrt energy, proteins, fats, carbohydrates

The firm has sachet section(not powder) whereas the packing

size mentions tin pack

484. Silbest Forte Tablets Deferred for further evaluation and clarification.

485. Tribex Tablets Deferred due to the following deficiencies:


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Contains herbs with vitamins while the firm does not have

herbal sections

Polyfine Nutra-Sciences, Peshawar


486. Flugo Liquid

Deferred for following reason(s):

Monographs of raw material testing and finished product testing

are missing.

Competitor / safety undertaking is missing.

487. Kofgo Liquid


Dose per 5ml/10ml is not provided.


are missing.


488. Gikgofine Liquid


List of ingredients contain “Korean Ginseng” whereas testing

monograph provided is of “Powdered American Ginseng

Extract”.

Application is of a nutraceutical product whereas fee submitted

is 250/- rupees which is for herbal product

489. Brainwise Liquid


Ingredients provided in master formula are different from the

ones provided in Form-3 and master formula needs clarification.


are not provided.

490. Kalzi Liquid


Ingredients not provided as per 5ml/10ml dose in the product

profile.

Monographs of finished product testing are not provided.

491. Gasvin Liquid


Monographs of Carum copticum, Valerana jatamansi,

Cinnamomum bark and Menths piperita are missing

Monographs of finished product testing are missing.



492. Fine Colic Liquid




493. Q-Fex Liquid


Monographs of Licorice, Jujuba fruit, Hyssopus and Eucalyptus

oil are missing.



494. Q-Kof Liquid


Monograph of Hyssopus officinale is missing.

Monograph of finished product testing are missing.

Competitor / safety undertaking is not provided.

495. Coflet Liquid Deferred for following reason(s):

Dose per 5ml/10ml is missing.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monographs on Ephedra vulgaris. Ziziphus vulgaris, Hyssopus

officinalis, Adiantum capillus, Mentha piperita, and Eucalyptus

globules are missing.



496. Sunkof Liquid


Finished product testing monographs missing.


497. Resvoday Liquid


Application is of a nutraceutical product whereas fee submitted

is 250/- rupees which is for herbal product.

Monographs for finished product testing are not provided.

498. Kapec-Z Liquid


Monographs for raw material and finished product testinga re

missing.


499. Kao-Tin Liquid



are missing.



500. Multiplus-L Liquid


Raw material testing monographs of Lysine and Inositol are not

provided.


501. Epicolic Liquid


Dose per 5ml/10ml is not provided

Monograph of Dill oil and anise oil are not provided.


Competitor / safety undertaking is not provided.

502. Episeek Liquid



are missing.


503. Osteva Tablet


Product profile contains “Vitamin K1” whereas testing

monograph is provided for “Vitamin K3”.

504. Hivita Tablet


Monographs of Nicotinamide, Calcium Pantothenate, Vitamin

B1, Vitamin B6, Vitamin B12, and Folic acid are not provided.

505. Vitasun Liquid



are missing.


506. Calroot Tablet Deferred for following reason(s):

Stability of zinc oxide in tablet dosage form is required.

507. Bex Gold Tablet Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Product contains ingredients of herbal origin whereas firm does

not possess the herbal section.

508. Vilcal-D Tablet


Dose per tablet is missing.


monograph is provided for “Vitamin K3”.

509. Kalfine Tablet



monograph is provided for “Vitamin K3”

510. Hi-F Tablet


Quantities of active ingredients per tablet are not provided in

Form-3.

Raw material testing monograph of L-methyl folate is not

provided.

511. Viliron-F Tablet


Monograph of Iron (III) Hydroxide Polymaltose complex is

missing.

512. Enersitol Sachet Deferred till finalization of common molecules list.

513. Magfil Tablet Deferred for following reason(s):

Monograph of L-methyl folate is not provided

514. Introfer-F Tablet


Monograph of Iron (III) Hydroxy Polymaltose complex is not

provided

515. Fossa-D Tablet Deferred for following reason(s):

Dose per tablet is not provided.

516. Polyvit Tablet


Monographs of Iron, Magnesium, Copper and Manganese are

missing.

517. Bit-Folic 400 Tablet Deferred for submission of strength of elemental iron.

518. Ossgen chewable tablet


Product applied is a chewable tablet whereas on COA,

disintegration test results are given which are not performed for

chewable tablets.

519. Biosan liquid


Monograph of Dill oil, Chicorium intybus, Achillea millefolium,

Cassia occidentalis, and Tamarix gallica are missing.


520. S-Lax syrup


Monograph of Prune Juice extract is not provided.

Formulation is herbal in nature whereas testing monograph for

Senna leaf prowdered extract is provided.


Finished product testing is missing.

521. Hepasun Syrup


Monographs for raw material testing and application on Form-3

contains ingredients in the form of standardized extracts

whereas fee submitted is for herbal product i.e. 250 rupees.


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


522. Evermax D Sachet


Monographs of raw material and finished product testing are

missing.

523. Calvion Tablet


Quantity of ingredients not provided as “quantity per tablet” in

the product profile.

524. Vilvita tablet


Monographs of Vitamin D, Vitamin E, Vitamin B1,

Nicotinamide, Vitamin B6, Vitamin B12, Calcium pantothenate,

Iron, Magnesium, Copper, Manganese, Calcium and folic acid

are missing.

525. Carlo-3 tablet Deferred for following reason(s):


526. Evermax-D Sachet


Monographs of raw material and finished product testing are

missing.

527. Enersitol sachet Deferred till finalization of common molecules list.

528. Ossgen chewable tablet Deferred for following reason(s):


529. Kapec –Z suspension


Monographs for raw material and finished product testing are

missing.


530. Kao-tin suspension



are missing.

Competitor / safety undertaking is missing


531. Gasvin Syrup


Monographs of Carum copticum, Valerana jatamansi,

Cinnamomum bark and Menths piperita are missing




M/s Novamed Healthcare,


532. Vita Chewas Vita Deferred for further evaluation and clarification.

533. Vita A To Z tablets


Availability of softgel is required.

Monographs of all ingredients are required.

Strength of ingredients is required.

Form 3 is un-signed and un-stamped.

534. Vita E Capsule


Availability of soft gel is required.

Monograph of crodamol oil is required.

M/s Alpha Nutraceutical Research Laboratories


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

535. Procid Syrup




Solubility of calcium carbonate in syrup dosage form is

required.


536. Galdi-Fb Tablet Deferred for further evaluation and clarification.



537. Fybol Sachet



Stability of vitamin D in sachet is required

538. Umvit Tablet



Monographs of ingredients are required.


M/s Izfaar Nutraceutical Industries


539. Coffnol Liquid


Report regarding GMP compliance status is required.

Fee evidence is required.

Form 3 is without signature and stamp.

Ammonium chloride is added in common molecules list.

M/s Medi formers Neutraceutical

9-D Punjab Small Industrial Estate, 46-Km, District Kasur (Nutraceutical)

540. Omax Milk


Food supplement section alongwith its requirements are

required.

Dextrose is added in common molecules list.


Monograph/ testing specification of milk powder is required.



541. Omega Bright Capsule


Monograph of salmon fish oil is required.



542. Cod Vit Capsules


Availability of soft gel section is required.

Form 3 is unsigned and un-stamped.

Undertaking regarding contents of dossier and brand name are

required.

Monograph of cod liver oil is required.

543. Coten – E Capsule


Monograph of ingredient is required.


544. Coten Capsule Capsule Deferred for further evaluation and clarification.

545. D3-Up Capsule Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Availability of soft gel section is required.

Form 3 is unsigned and un-stamped.


required.

M/s Vega Pharmaceuticals (Pvt) Ltd,

Plot No. 4, Pharma City, 30-Km Multan Road, Lahore

546. Fovit Syrup



Stability of cyanocobalamin in syrup dosage form is required.


547. Fovit Plus Capsule





548. Fovit Capsule Deferred for further evaluation and clarification.

549. Glucho-Vit Tablet



Chondroitin and glucosamine are added in common molecules

list.


550. Osca-DTablet Deferred for further evaluation and clarification.

551. Osca-D Deferred for further evaluation and clarification.

552. Calcate Tablet Deferred for further evaluation and clarification.

553. Safe-D

Drop Deferred for further evaluation and clarification.

554. Safe-Ad

Drop Deferred for further evaluation and clarification.

555. Sach-C

Sachet Deferred for further evaluation and clarification.

556. Bio-10 Plus

Tablet Deferred for further evaluation and clarification.

557. Bio-10


558. Biogomad


559. Folvamin


560. Daid-P

Syrup Deferred for further evaluation and clarification.

561. Promise


562. Xtra Teen


563. Paids Pro

Deferred for further evaluation and clarification.

564. Cutcuo

Capsule Deferred for further evaluation and clarification.

565. Biocire Deferred for further evaluation and clarification.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Capsule

566. Calviro


567. Sillin


568. Hns


569. Geriatic


570. Aenel


571. Post Meno


572. Necentum


573. Uricran


574. Uricran-D


575. Uri-Dm


576. Xanthin-M


577. Xanthin-M


578. Xanthi Plus


579. Xanthi Plus


580. Xanthi


581. Xanthi


M/s Wilshire Laboratories Pvt Ltd,


582. Agnese Natural

Syrup


Original Form-3 is missing.

Documents required as per Form-3 are not provided.

Brand name undertaking is missing.

Differential fee is required.

583. Alcanlex D3

Suspension





584. Daze 10Mg (Enlisted As Sierra)

Tablet Deferred till finalization of common molecules list.

585. Exen-D Plus

Tablet




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


586. Iva

Syrup






587. Naozit

Syrup





588. Nufol

Tablet





589. Vakid Oral

Drops




Brand name undertaking is missing

590. Xiqrant

Capsule






591. Zinish

Tablet






M/s. Trends Pharmaceuticals (Nutraceuticals & Cam Division),


592. Cintavit Syrup Deferred for further evaluation and clarification.

593. C-Motion Syrup


Solubility and stability profile of wheat dextrin fiber in syrup is

required.


594. Ferosa Syrup


Monograph of calcium pantothenate is required.

Stability of cyanocobalamin in syrup is required.

595. Ferosa Tablet Deferred for following reason(s):

Monograph of L-methyl folate is required.

596. Hepatren Tablet


Monographs of horny goat weed extract, tribulus terrestris

extract, miura pauma extract, macca root extract, yohimbe bark

extract and pine bark extract are required.


597. Inosifem Sachet Deferred till finalization of common molecules list.

598. Insotren Tablet Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monographs of tribulus extract, garlic extract and L-optic zinc

are required.

Justification/ clarification of formulation is required.


599. Mensotren Tablet


Monographs of sage extract, dong quai extract, chasteberry, red

raspberry powder, wild yam extract and trans resveroterol are

required.



600. Nokabz Syrup


Monographs of zingiber extract, tracyspermum ammi extract,

foeniculum extract and wheat dextrin fiber are required.


601. Osdura Syrup Deferred for following reason(s):

Stability of calcium citrate in syrup dosage form is required.

602. Plumtran Syrup


Monographs of folate, zinc citrate, chromium picolinate,

Vitamin B8, hesperidine, cranberry extract and amino acid

complex are required.

Per serving dose of syrup (5ml, 10ml) is required.

Stability of cyanocobalamin in syrup is required.

testing method of finished product is required.

Availability of filling machine upto 900ml is required.

603. Tralcar Tablet


Monographs of hawthrone berry extract, damiania leaf extract,

catuba bark extract, miura pauma, cuscuta seed extract and

horny goat weed leaf extract are required.


604. Trencough Syrup


Monograph of ivy leaf extract is required.


605. Trencough-S Syrup


Monographs of ivy leaf extract and morus nigra are required.


606. Trendgink Syrup


Monograph of salvia officinalis extract is required.


607. Trendgink Tablet


Monographs of huperzia serrate extract, liom’s mane extract,

acetyl L-carnitine and alpha GPC are required.

Caffeine is added in common molecules list.


608. Vistren Syrup



Availability of inductively coupled plasma-optical emission

spectrophotometry technique for determination of zinc content

is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


609. Orthotren Tablet


610. Omalac Sachet


Monographs of acetyl L-carnitine is required.

Stability of zinc oxide in oral powder/ granules is required.

Role of use of fructose in formulation is required.

611. Vistren Tablet Deferred for following reason(s):

Monographs of L-optic zinc is required.

612. Mooder Tablet



Caffeine is added in common molecules list.

Monographs of tyrosine, passion flower aerial part extract,

GABA, L-theanine, rhodiola root extract, chamomile flowere

extract are required.

Justification about formulation is required.



613. Trend Husk Sachet Deferred for following reason(s):

Monograph of green tea extract is required.

614. Osdura Sachet


Stability of cyanocobalamin, zinc oxide and copper sulphate in

sachet is required.

N-acetyl cysteine is added in common molecules list.


615. Qtren-50 Tablet


Monograph of bromelain is required.


Glucosamine and chondriotin are added in common molecules

list.

616. Qtren-100 Tablet Deferred for following reason(s):

Stability of DHA in tablet is required.

617. Nokabz Tablet


Monographs of oat fiber and fennel are required.

Justification regarding use of guar gum and acacia gum is

required as these ingredients are not supposed to be active

ingredients.


618. Femotren Tablet




M/s Orbit Natural, Rawalpindi

22-KM, Adyala Road, Rawalpindi

619. Repavil

Ointment Deferred for further evaluation and clarification.

620. Repagesic

Spray Deferred for further evaluation and clarification.

621. Repagesic Deferred for further evaluation and clarification.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Ointment

622. Orifit Capsules


Monographs of glocomannan, tamarind seed extract and oak

galls are required.

Justification of formulation and its use is required.

623. Orimin


624. Calbone-D Tablet Deferred for following reason(s):

Signed shelf life data submission undertaking is required.

625. Nu-D3 Tablet Deferred for following reason(s):

Strength of vitamin D3 exceeds RDA and upper tolerable limit.

626. Osteopan Tablet


Monograph of vitamin K2 is required.


627. Calcip


628. Zer Tablet Deferred for following reason(s):

Monograph of di-calcium phosphate is required.

629. Orbit’S Citocholine Tablet


Monograph of citicholine is required.

Citicholine is added in common molecules list.

630. Multiplex


631. Mesub Tablet Deferred for following reason(s):

Monograph of methylcobalamin is required.

632. Nu Hope Tablet


Monographs of vitex agnus castus extract, cinnamon bark

extract, licorice root extract are required.

Stability of omega-3 in tablet dosage form is required.


633. Ori-Cough


634. Multiplex Syrup


Stability of zinc oxide in syrup is required.


un-signed.

Monograph of liquorice is required.

635. Iroglobin Plus Syrup


Monographs of iron bisglycinate and folic acid are required.


636. Oricid Syrup


Monographs of menthe piperata and emblica officinalis extract

are required.

637. Irogin Tablet


Monograph of iron bisglycinate is required.


638. Nurix Syrup Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monographs of ivy leaf extract, licorice, adhatoda vasica extract

and thyme are required.


639. Cufmed Syrup Deferred for following reason(s):


640. Hp-API Syrup




641. Dumax


642. Calcip Syrup Deferred for following reason(s):


643. Brain On Syrup


Monographs of panax ginseng, centella asiatica, piperine,

lavandula officinalis, medicago sativa, zinc, copper and sulphar

are required.


644. Procardin Capsules


Monograph of salvia miltirrhiza extract is required.


645. Nitrix

Capsules Deferred for further evaluation and clarification.

646. Menx Capsules




647. Regen Capsules


Monographs of all ingredients except for milk thistle extract are

required.


M/s Scotmann Pharmaceutical,

5-D, I-10/3 Industrial Area, Islamabad-Pakistan (Nutraceutical)

648. Sunny-D Pink Softgel


Stability of folic acid in softgel dosage form is required.


Form 3 is required.

Type/ kind of vitamin B12 is required

M/s Nutrimed Laboratories


649. Gartum Tablet Deferred for following reason(s):

Monograph of artichoke extract is required.

650. Colinorm Tablet


Availability of atomic absorption spectrophotometer is required

as firm claimed to perform test/ analysis of magnesium by such

technique.

Monographs of hawthorn extract and cleus forskohli extract and

Humulus lupulus extract are required.

651. Glymax Tablet Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Stability of soybean extract (soy isoflavone) in tablet dosage

form is required.

652. Sinufit Tablet


Monographs of Echinacea root extract are required.

Justification of use of echinacea herb powder in health product

is required.

Brand name undertaking is un-signed.

653. Mori Vit Syrup


Monograph of moringa olifera extract is required.

Undertaking regarding brand name and contents of dossier are

required to be signed by owner/ CEO.

654. Garsona Tablet Deferred for following reason(s):


655. Spirula Tablet


Monograph of spirulina extract is required.

Form 3 is without owner/ CEO’s signature.

656. Healcar Tablet


Monographs of Ester C, soybean extract, L-methyl folate and

green tea extract are required.


Availability of atomic absorption spectrophotometer is required

as firm claimed to perform test/ analysis of magnesium by such

technique.

Stability of soy bean extract in tablet dosage form is required.

657. Ov Drone Sachet


Melatonin and N acetyl cysteine are added in common

molecules list.

Stability of vitamin D3 in powder/ granules dosage form is

required.

658. Elumax Effervescent Tablet



Monograph of cranberry extract is required.

Manufacturing method of formulation w.r.t Effervescent

(modification) is required.

659. Nutriva Effervescent Tablet Deferred for following reason(s):

Stability of cranberry liquid extract in tablet is required.

M/s Miksons Healthcare SMC (Pvt) Ltd,

Plot No.30&31, St. No. Central Road, RCCI, Rawat, Rawalpindi

660. Glamour Drink



Hyaluronic acid is added in common molecules list.

Signed and stamped form 3 is required.

Monographs of collagen, black current seed oil, biotin, zinc and

selenium are required.

Stability of selenium sulphide in oral dosage form is required.


661. Real Max Tablet Deferred for following reason(s):


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



662. Z-Sense Syrup


Zinc sulphate is added in common molecules list.



M/s Viegen Pharma,

Plot No. 74-G, Sundar Industrial Estate, Sundar Raiwind Road, Lahore

663. Acurex-Br


M/s Sanofi aventis , Plot no.23, Sector no. 22, Korangi

664. Depura Plus Tablet Deferred for further evaluation and clarification.

M/s Neutra Cure,

SB-02 & 15, Sector 6-G, Korangi Township, Karachi

665. Neemed capsule


monograph of collagen is required.

Fee challan is endorsed by concerned division of DRAP.

form 3 is required to be signed by CEO/ owner.

M/s Mac & Rains Life Sciences Pvt Ltd, Lahore

537-A, Sunder Industrial Estate Lahore

666. Effer Tablet


signed and stamped form 3 is required.


Manufacturing process of effervescent dosage form is required.


Undertakings regarding brand name and contents of dossier are

required.

M/ Nutrimed Laboratories,


667. Revocep-D Sachet


Stability of vitamin D3 in powder/ granules is required.

Monographs of salts of zinc, magnesium and boron are required.

668. Nutri Vit Sachet


Dextrose is added in common molecules list.

Role of sodium chloride in formulation is required.

Justification of word “Ester C” is required.

Stability of vitamin D in powder/ granules is required.


669. Panto Vit Plus


M/s Scotmann Pharmaceutical, Islamabad


670. Folica Softgel 600mcg


Form 3 is required.

Monograph of quatrefolic (methyl tetrahydrofolate as

glucosamine salt) is required.

671. Folica Softgel Deferred for following reason(s):

Form 3 is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monograph of quatrefolic (methyl tetrahydrofolate as

glucosamine salt) is required.

M/s Izfaar Nutraceutical Industries, Lahore


672. Diaranil Liquid


Kaolin is added in common molecules list.

Firm uses crude form of punica granatum, needs clarification.

Contents and brand name undertakings are required.

Monograph of pectin is required.

673. Cranfar Ut Sachet




Product profile shows that dosage form is capsule while

evidence of in-complete fee depicts that dosage form is sachet,

needs clarification.

Stability of cranberry liquid extract in sachet (powder/granules)

is required.

Contents and brand name undertakings are required.

674. Folaad Liquid




Monograph of iron poylmaltose is required.

Signed and stamped undertakings regarding contents of dossiers

and brand name are required.

GMP compliance report needs to be submitted.

675. Hivit Liquid



Monographs of calcium gluconate and magnesium oxide are

required.


Signed and stamped undertakings regarding contents of dossier


676. Fortamin Liquid







677. Cranfar Ut Capsule



Monograph of cranberry extract is required.




678. Tribufar Capsule




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monographs of tribulus terrestris, panax ginseng, agnus castus,

damiana are required.

Stability of zinc oxide in capsule dosage form is required.

Mac & Rains Life Sciences Pvt Ltd, Lahore

679. Makky J-Fit Tablet


Chondrointin and glucosamine are added in common molecules

list.

Signed and stamped form is required.


brand name needs to be changed.



required.

Nutrabiotics Nutritional Life Sciences, Peshawar

680. Concebir Capsule



Monograph of respective salt of zinc is required.



681. Meliski Tablet


Sodium alginate and sodium bicarbonate are added in common

molecules list.



682. Genmax Capsule



Monograph of tribulus terrestris is required.




683. Impedo Capsule


Monographs of all ingredients are required except for vitamin E

and zinc sulphate.





684. Hustab Tablet




Stability of psyllium husk in tablet dosage form is required.

685. Nutralax Tablet





686. Nutragink Tablet




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


687. Nutralyte ORS sachet


Formulation is ORS, added in common molecules list.



688. Motaran Capsule


Stability of cyanocobalamin in capsule is required.



689. Algrace Tablet


Fee evidence is reduced.



690. Tablet Cd-3 Tablet




691. Qtenzyme Tablet



Undertakings regarding contents of dossier and brand name are

required.


692. Nutralax Tablet






Repetition of brand name is there.

693. Nutragink Syrup



Undertakings regarding contents of dossier and brand name are

required.


694. Pydra-X Tablet


Potassium citrate is added in common molecules list.



Monograph of ingredient is required.

Justification of use of methylene blue in dosage form is

required.

695. Figura Capsule


Monographs of garcinia combogia extract, green tea extract,

acaiberry extract and grape seed extract are required.




696. Nutragest 240 Syrup Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monographs of bromelain, fennel extract, ginger extract,

chamomile extract, artichoke extract, noni extract and

peppermint extract are required.




Papain and bromelain are added in common molecules list.

697. Xolestenil Capsule


Monographs of all ingredients are required except for calcium

carbonate and magnesium oxide.

Beta sitosterol is added in common molecules list.




698. Nutradol Capsule






699. Cranbio Sachet


Monograph of cranberry fruit extract is required.



700. Tebonin Syrup


Monograph of gingko biloba is required.


701. Subcran Sachet


prescribed form 3 is required.

Monographs of cranberry extract is required.


702. Ezocid-H Syrup


Brand name mentioned on Form 3 is “ Ezocid-H sodium free

while brand name on FIFO list is “ Ezocid-H syrup, needs

clarification.

Sodium bicarbonate is added in common molecules list.


703. Nutrakuf Syrup






704. Spacid-G 120 Syrup




Monographs of all ingredients in extract form are required.


Justification of rationale use of product is required.


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

705. Nutramax 120


706. Ferrium Syrup




707. Moloir Capsule



Monographs of tribulus terrestris, chlorophytum extract and

pine bark extract are required.


708. Semenator Capsule


Stability of B12 in capsule dosage form is required.

Monographs of withania somnifera extract, mucuna pruriens

extract, CoQ10, angelica sinensis and quercetin are required.




709. Skrill Syrup Deferred for following reason(s):


710. Tebonin 240Ml


711. Xinc-10 Syrup


Zinc sulphate is added in common molecules list.


712. XLE Capsule


Monographs of ginseng extract, chlorophytum borivillianum

extract, damiana and piperine are required.

Stability of cyanocobalamin in capsule dosage form is required.


713. Zelac Syrup


Monograph of prune juice concentrate is required.


714. Colifix Syrup


Monographs of zinger officinale extract, fennel, carium

copticum and chamomile are required.


715. Enduros Capsule


Monographs of tribulus terristris extract, chlorophytum extract,

pink bark extract and yohimbe bark extract are required.

Stability of cyanocobaamin in capsule dosage form is required.


716. Luzeb Tablet


fee evidence is required.


Monographs of bilberry fruit extract and citrus bioflavonioids

are required.

717. Profemin Syrup Deferred for following reason(s):


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



718. Coen-10 Tablet Deferred for following reason(s):


719. Algrace Syrup




720. Boncal-Z Syrup Deferred for following reason(s):


721. Calzia-3 Syrup Deferred for following reason(s):


722. Cidonil Syrup




723. Diod Tablet




724. Dorix Syrup Deferred for following reason(s):


725. Doraim Capsule



Monographs of tribulus extract, ginseng, withania somnifera

piper nigrum and chlorophytum are required.

726. Dutra Tablet



Form 3 to be revised w.r.t “5ml” as serving dose in tablet

dosage form.

727. Feriset F Syrup Deferred for following reason(s):


728. Feriset F Tablet Deferred for following reason(s):


729. Heptorack Syrup



Silymarin is added in common molecules list.


730. Heptorack Tablet


Monographs of silymarin and co-enzyme Q10 are required.



731. Impedo Plus Capsules


Monographs of chlorophytum extract and pine bark extract are

required.


732. Jointcalm Tablet



Glucosamine and chondroitin are added in common molecules

list.


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

733. Kaybone Syrup




734. Kaybone Tablet




735. Mintacid Syrup




736. Mioter Tablet


Stability of omega 3 fish protein in tablet dosage form is

required.


737. Multimine Tablet


Stability of omega 3 fish protein in tablet dosage form is

required.


738. Neocalvit Syrup Deferred for following reason(s):


739. Neocalvit Tablet Deferred for following reason(s):


740. Nacul-C


741. Nucal-C Tablet




742. Pregnamin Tablet


Stability of cyanocobalamin and magnesium oxide in tablet

dosage form is required.



743. O2-Plex Tablet





744. Perfecare Tablet


Monograph of chromium is required.



745. Perfective Capsule


Monograph of vitamin B12 is required.



746. Potencia Capsule


Monographs of chlorophytum extract and tribulus terrestris




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

747. Romical Syrup Deferred for following reason(s):


748. V-Minta Tablet


Monographs of all ingredients in extract form are required.


749. Volic Tablet Deferred for following reason(s):


750. Zoid Plus Tablet


Monograph of bacopa monniera is required.


751. Zoid Syrup


Monograph of gingko biloba extract is required.


752. Brona Syrup




753. Apti-Up Syrup





754. Apeton Syrup




755. Cal-3 Tablet


Monograph of boron is required.



756. D-Cuf Syrup


Monograph if ivy leaf extract is required.


757. Nutracid Syrup




758. Vitacare-F Syrup




759. Nutramax Syrup Deferred for following reason(s):


760. Everslim Capsule


Monographs of garcinia extract, acaiberry extract and hoodia

gordonii extract are required.





761. Zigot


762. Demento Syrup Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



Eon Pharmacy, Karachi


763. Florazyme Syrup Deferred till finalization of fate of common molecules being dealt by

H&OTC Division and PER Division.

764. Arcolic Syrup Differed due to following reasons:

Breakage of fee is required.

765. Folibion Drops

Differed due to following reasons:


Rationale for 10mcg dose per drop of folic acid in drops dosage

form.

Product specific testing (chemical) parameters of finished

product including chemical assay are required.

766. Saferva Tablet





767. Milk Safe Supplement Powder



Change of brand name is required.

Stability of cyanocobalamin, zinc oxide and selenium sulfide in

oral powder dosage form is required.

Monographs of L-methylfolate, Vitamin K1 USP

(Phylloquinone) and iron bisglycinate are required.

Strength of elemental manganese is required.

Clarification is required for ingredient “Calcium carbonate”,

firm mentioned its common name as “Molybdenum” on form-3.



768. Laxosafe Syrup



Safety undertaking is required.


Official monograph mentioning the testing specification of

Prunus Domestica Extract (prune juice) is required

Since the product seems to be nutraceutical the firm is directed

to submit an undertaking stating that the product “Laxosafe”

will only be manufactured either in nutraceutical facility or

herbal facility in order to comply GMP.



769. Gink Safe Syrup




Monographs of Ginko Biloba Extract and Withania somnifera


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



770. Anacid Syrup





771. Urigon Syrup





Monograph of Artimisia (Mugwort) is required.

772. Gynosue Syrup


Fifo list name is gynosue however name on from-3 is Gyno

Cure Syrup. Clarification is required.



773. Felxus Tablet




Zinc oxide stability is required in oral tablet dosage form.



774. Urimac Syrup





Monographs of Betula penula (BP), Curcuma longa (BP) and

Salvia rosmarinus (BP) are required.

775. Gasnol Sf Syrup





Monographs of Betula penula (BP), Curcuma longa (BP) and

Salvia rosmarinus (BP) are required.

776. Arsal Baby Balm





Conversion of strengths is required.



777. Arsal Balm





Conversion of strengths is required.



F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

778. Arsal Junior Cough Syrup





Monograph of Morus nigra (Mulberry) is required.

779. Diarro Syrup






780. Gasnol Plain Syrup





781. Eon’s Toot Siyah Syrup




Monograph of Morus nigra (Mulberry) is required.

782. Feroplex Syrup





Cyanocobalamin stability in syrup dosage form is required.

Strength of elemental zinc is required.

783. Vita Diet Tablet





Monographs of Pantothenic acid and Iron bisglycinate are

required.



784. Vita Diet Drops



Revise the form -3 w.r.t. monograph/specification of active.



785. Eg Card Syrup


Breakage of fee is required



Monographs of Pantothenic acid and Iron bisglycinate are

required.

786. Sinofer Tablet






F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

787. Eg Card

Syrup In duplication of product mentioned against serial number 1361

788. Sinofer

Tablet In duplication of product mentioned against serial number 1362

789. Eden Lac Powder


Label of product doesn’t correlate with the product applied in

sachet dosage fomr need clarification.

Magnesium Oxide, Zinc oxide and selenium sulfide stability is

required in oral dosage form.

Monographs of L-methylfolate and iron bisglycinate are

required.



790. Multi Need Syrup





Monograph of fish oil powder (providing omega 3 fatty acids,

EPA and DHA) is required, as the provided one is for omega - 3

acid ethyl esters.

791. Multi Need Tablet





Zinc oxide and selenium sulfide stability is required in oral

tablet dosage form.

Monographs of Vitamin A and iron bisglycinate are required.

Vitamin K exceeds RDA and upper tolerable limits.

Dose of elemental zinc (being border line on upper tolerable

limit) needs to be adjusted w.r.t. to labeled claimed daily dose

(submitted by the firm) i.e. 1-2 tablets per day.

Justification regarding use of sodium in the formulation is

required.

Strength of elemental boron used in the formulation as sodium

borate is required.

792. Karmin Syrup


Breakage of fee.



Monograph of Chicorium intybus, Trigonella foenum-graecum,

Zingiber officinale and Manganese gluconate

793. Eden Cid Syrup


Breakage of fee.

Monograph of all the ingredients except calcium carbonate in

extract form are required.

Calcium carbonate monograph also required.



F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

794. Sinofer Syrup






Cyanocobalamin stability in syrup dosage form is required.

795. Arofen Herbal Syrup





Common name of Ammonium chloride i.e. Noshadar to be used

in formulation and revised form-3 is required accordingly.

796. Minovit Syrup





Stability of Selenium sulfide in oral syrup dosage form.

Miksons Healthcare SMC (Pvt) Ltd, Islamabad

797. Tressmet Syrup



Monographs of cardamom oil, piper longum extract, emblica

officinale extract and vitamin A are required.


798. Hapicalm Syrup





Monograph of taraxacum officinale extract is required.

799. Hapicalm Tablet





Monograph of taracum officinale extract is required.

M/s. The Searle Company Limited,

First Floor, N.I.C.L Building, Abbasi Shaheed Road, P.O. Box 5696, Karachi-75530

800. Gutcare sachet Deferred for further evaluation and clarification.

Phytocon International Private Limited, Lahore

801. Octafol Capsule


Monographs of pyridoxine and DHA (omega 3) are required.

Signature of owner/ CEO on form 3 is required.


802. Arthrix Tablet Tablet


Glucosamine and chondroitin are added in common molecules

list.


803. X+Ovi Tablet Tablet



Monograph of L-methyl folate is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


Izfaar Nutraceutical Industries, Lahore

804. Listro Liquid


Methyl salicylate is added in common molecules list.

The product is intended for cosmetics purpose.brand name

needs to be changed.


required.


805. Pepikal Syrup


Sodium bicarbonate and sodium alginate are added in common

molecules list.


21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahor

806. Neustim Syrup



Source of amino acid is required and clarification is required

which type of amino acids are used and testing method also

required accordingly.

Monograph of magnesium is required.


M/s Wilshire Laboratories Pvt Ltd, Lahore


807. Thiavit

Tablet



Fee slip is missing.



808. Biot

Tablet






809. Ribovit

Tablet



Fee slip is not provided.



810. Argin 3Gm

Sachet






811. Argin 1Gm

Sachet






F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

812. Careon 3Gm

Sachet






813. Careon 1Gm

Sachet






814. Thiavit

Syrup






815. Ribovit

Syrup






816. Soben Syrup

Syrup






AR Nutraceutical Pharma, Karachi

817. Zinkor Plus Syrup Deferred for following reason(s):

Monograph of banana root extract is required.

818. Malexeed Sachet


Monographs of selenomethionine, L-citruline and L-ornithine

are required.


819. Aptilex-B Syrup




Per serving dose (5ml or 10ml) is required.

820. Neurotone


821. Gain-D


822. Save-Baby

Drops Deferred for further evaluation and clarification.

823. Femi-Care Tablet


Monographs of smilax china extract and areca catechu are

required.




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

824. Life-Carrient Sachet


The firm does not possess probiotic section.

Stability of zinc oxide in sachet is required.

825. Essen-D Drop


Monograph of vitamin D3 is required.

Pack size is required.


826. Deracuf Syrup




827. Cranze Sachet


Monograph of cranberry extract is required.]

Stability of zinc oxide in sachet dosage form is required.

828. Adon Drop


Availability of drop filling machine is required.

Form-3 is un-stamped and un-signed.

Pack size is required.


829. Vitalife Tablet




M/s Wilshire Laboratories Pvt Ltd, Lahore


830. Calci Vit

Tablet





Wrong fee is submitted i.e. 250 rupees is submitted for

nutraceutical product.

831. Calci Vit Plus

Tablet







832. Bio Vit

Tablet







833. D-Flor

Capsule







834. Ferti-W Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Capsule Original Form-3 is missing.





835. B-12 1000Mcg

Capsule







836. Penemia

Capsule







837. Qubenza

Capsule







M/s Izfaar Nutraceutical Industries,


838. Icough Rex Liquid


Monograph of piper longum extract is required.





839. Pepragem Liquid



Monograph of cardamom oil is required.




840. M. Vit Liquid







841. Belgeri Powder




Monograph of aegle marmelos extract is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



M/s Hiranis Pharmaceuticals (Pvt) Limited,


842. Neevo Drops


stability of cyanocobalamin in oral drop is required.

Stability of zinc oxide in oral dosage form is required.

Monographs of vitamin B3, pantothenic acid, iron, lysine and

malt extract are required.

843. Min-D 2000 I.U Sachet


Firm applied on form 4 without clinical evidence, needs

justification.


844. Min-D 4000 I.U Sachet



justification.


845. Urisan Sachet



justification.

846. Uticleanse Sachet



justification.


847. Zeplate DHA 7.5Mg Tablet


Monograph of DHA is required.


848. Hilyte Sachet Deferred for following reason(s):

ORS is added in common molecules list.

M/s Calgan Phyto Pharma Pvt Ltd,


849. Kofless Tablet



Justification of 2 tablets per serving is required.


850. Armax Tablet



Monograph of ginger extract is required.

M/s AR Nutraceutical Pharma, Karachi

Plot No. F-4/C, S.I.T.E., Phase-II, Super Highway, Karachi

851. Xseed Tablet



Form 3 is unsigned and unstamped.

Monograph of pycogenol is required.




852. Mecfem Tablet Deferred for following reason(s):

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


Monographs of all ingredients are required except for vitamin

D, chromium piconilate, magnesium oxide, L-carnitine and

arginine.


853. Vegrite-X Tablet


Signed and stamped Form 3 is required.

Monographs of tribulus extract, Korean ginseng and zinc

chelated are required.




854. AP Conception Sachet



N-acetyl custeine is added in common molecules list.

Monographs of Acetyl L-carnitine, arginine, iron salt and

selenium salt are required.

Stability of zinc oxide and vitamin B12 in sachet dosage form is

required.


855. Memrite Tablet Deferred for following reason(s):

Monograph of medicago sativo is required.

856. Rositol Sachet



Monograph of chiro-inositol is required.



857. Calci-4 Tablet





858. Heracal-D Tablet



Monograph of collagen is required.


859. Faliq Aid Tablet



Form 3 is unsigned and unstamped.

Product file bears name “ faliq acid” while brand name given on

form 3 is “ Heracal-D tablets, needs clarification.

Signed and stamped undertaking regarding contents of dossier

And brand name are required.

860. Germixeed Tablet



Monographs of all ingredients are required except for L-

carnitine, arginine, Vitamin C, folic acid and vitamin B12.



F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Signed and stamped undertakings are required.


861. Lasta Tablet



Signed and stamped Form 3 is required.



862. Nu-Sitol Sachet



Stability of vitamin D3 and cyanocobalamin in sachet dosage

form is required.



863. Collapep Sachet


Form 3 is unstamped and unsigned.

Monograph of collagen and its stability in sachet dosage form

are required.




864. Artholex Tablet




Glucosamine, chondroitin and hyaluronic acid are added in

common molecules list.

Monograph of methylsulfonylmethane is required.

M/s Phytocon International Private Limited


865. Ora-A Drops Drops



Signature of owner/ CEO of firm is required on form 3.

M/s Otsuka Pakistan Ltd., Karachi

866. Proten gold supplement Deferred for further evaluation and clarification.

Nutris Laboratories, Lahore

867. Aciloc Deferred for Justification of minute quantities.


5-D, I-10/3 Industrial Area, Islamabad-Pakistan (Nutraceutical

868. Sunny Dee 10000IU Softgel


Form 3 is required.





869. Action Spray


Monograph of menthol is required.

Clarification regarding spray is required

M/s Amarant Healthcare,

Plot No. 168, Sector 23, Korangi Industrial Area, Karachi

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

870. Gerox-C


M/sHiranis Pharmaceuticals (Pvt) Limited,


871. Lomis 5Mg Tablet Deferred for following reason(s):

Serratiopeptidase is added in common molecules list.







875. Lomis 30Mg Tablet. Deferred for following reason(s):


M/s Phytocon International Private Limited,


876. Ubicare Tablet




M/s Cibex (Private) Limited,

F-405, SITE Area, Karachi

877. Cibcos-Ch (Honey)


878. Cibcos-Ivy


879. Cibcos-Ivy Plus


M/s Incepta Pharma,

17-A, Punjab Small Industrial Estate, Taxila

880. Megamin Tablets Deferred for following reason(s):

Monograph of boron is required.



881. Folica Plus Softgel Deferred for further evaluation and clarification.

882. Scotmann'S Alpoc 600 Softgel



Form 3 is required.

883. Scotmann'S Agex Tablet



Form 3 is required.

Monograph of resveratrol is required.

Justification regarding use of both vitamin A and beta carotene

in same formulation is required.

884. Scotmann'S Folica Plus Softgel



Stability of methlycobalamin in soft gel dosage form is required.

M/s Hi-Nutrition (Eno 0077)

Hashim Park, 9.5-KM, Sheikhupura Road, Lahore

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

885. Lactofer-S Syrup

Deferred due to following reasons:

Official monograph of ferrochel required

Undertaking of content and stability missing

M/s Genbiotech Nutraceuticals (Eno 00263)

Plot No. 24, Street No. NS-2, NIZ RCCI, Rawat, Rawalpindi

886. Hierro Syrup


Official monograph of iron bisglycinate missing


887. Gencholine Capsule Deferred due to following reasons:


888. Bio-D Chewable Tablet Deferred for further evaluation and clarification.

889. Bio Sachet


Clarify if the firm has a probiotic sachet section


890. Myo F Sachet Deferred due to following reasons:


M/s MPC Health & Food, Karachi

SF-13, 5th Floor, Shahnaz Arcade, Main Shaheed-e-Millat Road, Karachi

Is an agent of M/s Weihai Baihe Biology Technological Co. Ltd. No. 522, Chengda Toad, Swan Lake Economic

Technology Development Zone, Rongcheng, Shandong, China, 264321

891. Ginkgo biloba 120 softgel


CoA of active ingredient in raw form is required.

Brand name given on Form 5 and on CoA of finished product

does not match, needs clarification.

Accelerated and long term stability studies (physical, chemical,

microbial testing) data of at least 3 batches conducted in zone

IVA is required.

Manufacturing license of the principal manufacturer in the

country, issued by regulatory body is required.


the country of origin, issued by regulatory authority is required.

Copy of free sale certificate issued by FDA of china, submitted

by firm does not depict name of product and its availability in

country of origin. Free sale certificate of said product issued by

regulatory authority of country of origin is required.

Last inspection report issued by regulatory body is required.



is required.

892. Pine bark plus tablets


Brand name mentioned on Form 5 is “ pine bark plus tablet”

while brand name given on CoA of finished product is “ picno

plus tablet”, needs clarification.



IVA is required.



F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)






is required.

CoA of active ingredients (pine bark extract, beta carotene) in

raw form is required.

Justification of role of calcium carbonate in formulation is

required either it is used as active ingredient or inactive

ingredient.

Free sale certificate issued by regulatory body, notarized and

countersigned by embassy/ consulate of Pakistan in country of

origin is required.

893. Mint oil 300 softgel




IVA is required.








is required.

CoA of active ingredients (pine bark extract, beta carotene) in

raw form is required.



origin is required.

894. Cranberry+ hibiscus softgel




IVA is required.












is required.

895. Pine bark extract 150 tablet Deferred for following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Brand name mentioned on Form 5 is : pine bark plus tablet:

while brand name given on CoA of finished product and

accelerated stability studies is “ pine tablet”, needs clarification.



IVA is required.








is required.

CoA of active ingredient in raw form is required.

Testing specification/ monograph(s) of active ingredient(s) is

required.

Justification of role of calcium carbonate in formulation is

required either it is used as active ingredient or inactive

ingredient.



origin is required.

896. Epo 500 Softgel Deferred for further evaluation and clarification.

897. EPO 500 softgel




IVA is required.








is required.

Composition mentioned on Form 5 and given label claimed are

different from each other, needs clarification.

898. Liquid filled absorbable calcium softgel


Brand name mentioned on Form 5 is “ liquid filled absorbable

calcium softgel” while CoA of finished product bears “ liquid

calcium softgel, needs clarification.



IVA is required.





F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



is required

899. Milk thistle tablet


Brand name (milk thistle tablet) mentioned on Form 5 and

brand name (silymarin) on CoA of finished product do not

match, needs clarification.

CoAs of balck radish, beet root, beet root, dandelion root, egg

albumin and methionine are required.

CoA of finished product should depict physical, chemical,

microbial and any other test (if required).



IVA is required.












is required.

M/s. Kaap Pharmaceutical (Pvt) Ltd (Eno 00306)

18 Km Ferozepur Road, Lahore

900. Thera-Vit Jr. Tablet


Undertaking for stability, content and brand name missing

Contains zinc oxide (Unstable orally)

901. Senalax Plus Tablet


Fee submitted is 250/- Rs

Contain common molecule; sennosides



Elaborate the ingredient “Phospholipid

902. Hi-Z Plus Suspension


Herbal supplement while the firm does not have herbal sections

Official monographs and undertakings not present in file

903. Thera-Vit Gold Tablet


Contains phytonadione which is used in bleeding disorders

Contains zinc oxide (Unstable orally)

Official monograph of grape seed extract required


904. No Loss Capsule


Applied on form 4 while no clinical data provided

Fee submitted is 250/- Rs

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Official testing method of ginkgo extract required


905. Be-Mom Tablet

New name: oval vit

Deferred till finalization of fate of common molecule list being dealt by

Division of H&OTC and Division of PE&R.



906. Ova-D Sachet


Differential fee is required,


Rationale of dose of Myo-inositol i.e. 2000mg is required.

Form-3 needs to revised w.r.t. specification of L-methylfolate as

well as common names of all ingredients are required.

Undertaking Signed by the owner regarding submission of

Stability data is required on company letter head.

Signed and stamped undertaking regarding brand name stating

the name is not enlisted under DRAP Act, 2012, on notarized

stamp paper is required.



907. Co-Cell Capsule Capsule Deferred due to following reasons:

Fee submitted 250/- Rs

908. D-Move Tablet Deferred due to following reasons:


909. Ubicare Syrup



Official monograph of iron bisglycinate required

910. Biofolic Capsule




Contains tribilius herb in nutraceutical product

Contains zinc oxide (unstable orally)

911. Bestage Capsule Deferred due to following reasons:


Alpha Nutraceutical, Lahore


912. Salberri Sachet



Form-3 need revision w.r.t. specification of active ingredients.

Formulation needs revision w.r.t. cranberry juice extracts.

Monograph of cranberry extract.

Product specific monograph is required including assay of

product.



Evaluator: Arslan Tariq (AD-I)

913. Cystinum Tablet Deferred due to following reasons:

Form-3 need to be revised w.r.t. specification of ingredient.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Rationale of dose of active ingredient is required in same dosage

form.

Justify the use of Cranberry Liquid Extract in tablet dosage

form.

Product specific monograph and testing methods of finished



Stability data is required.

Signed and stamped undertaking regarding brand name on

notarized stamp paper is required.

M/s. Filix Pharmaceuticals (Pvt) Ltd. (Dedicated Section) (Eno 00120)

Plot No. 4-B, Main Road, RCCI, Rawat, Rawalpindi

914. Kolin Capsule



Official monographs of choline bitartarate required

Undertaking for stability, content and brand name required

915. Exebrain Capsule




916. Bio-Seng Capsule Deferred for further evaluation and clarification.

917. Glossy Capsule



Official monographs of ingredients required

Undertaking for stability and content not signed



918. Triseng Capsule


Formulation contains ginseng and ginkgo herbs while testing of

ginkgo extract and ginseng herb is given. Clarify.





919. Osovit D Syrup


Form 3 not signed

Official testing method of ossein mineral complex

M/s Tarrot Health Care (Eno 0085)

595, Sundar Industrial Estate, Raiwind Road, Lahore

920. Gestrophin Suspension

Deferred for further evaluation and clarification. 921. Unical Syrup

922. Gestrophin Syrup

923. Acnotil-D Cream

Trends Pharmaceuticals Lahore


924. Ferment-S Tablet



Rationale of dose of each ingredient is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Form-3 needs to be revised w.r.t. specifications of each

ingredient.

Stability of selenium sulfine in tablet dosage form is required.

Product specific monograph for testing of finished product

including quantitative assay of each ingredient is required.



925. K-Zyme 100 Tablet


Safety of methylene chloride as coating ageing is required.

Form-3 needs to be revised w.r.t. specification of Co-enzyme

Q10 is required.


Stability data is require

926. Ferment-S Tablet Duplicate entry

927. K-Zyme 100 Tablet Duplicate entry

M/s. Blossom Laboratories (Pvt.) Ltd.,

30-KM, Badian Road, ½ K.M Off Roda Bohgal Road, Lahore Cantt

928. Sharbat-E-Joshanda Syrup


Revision of form-3 is required w.r.t. brand name according to

section granted for homeopathic production.


Since the product is a homeopathic combination therefore

requirements laid down in para 2 of notification vide F.No.04-

02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.

Conversion of strength of Drosera Rotundifolia 1CH, Bryonia

alba 3CH and Belldonna 3CH are required according to the

monograph either it is given in mother

tincture/solution/trituration or in respective potency.

Monographs of all ingredients except Drosera Rotundifolia

1CH, Bryonia alba 3CH and Belldonna 3CH are required.

929. Blasmozyme Syrup


Availability of Syrup/Drop (Liquid) Section (Homeo) is

required or justify.






Conversion of strength of Nat Phos 12C(EH), Silica 6C(EH),

Carboveg 6C9EH) is required according to the monograph

either it is given in mother tincture/solution/trituration or in

respective potency.

Monograph of Avena Sativa (Oat), Asafoetida (Hing),

Anacardium (Bhallatak) and Robina (Black locust), are

required.

930. BL 35 Drops





F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)




Monograph of Kali Carb is required.

931. BL-36 Drops








Monographs of Baryta mur D4, Kalium iod D6 and Arnica

Montana D2 are required.

932. BL-39 Drops








Monographs of all ingredients except for pulsatilla are required.

933. BL-34 Drops





Conversion of strength of Kali Phos 6x is required according to

the monograph either it is given in mother





Monographs of all ingredients except for Kali Phos and Sepia

are required.

934. BL-37 Drops








Monographs of all ingredients except Podophylum are required.

935. BL-38 Drops








F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monographs of all ingredients except Belladona, Bryonia and

Cantharis are required.

936. Liverton Syrup




Undertaking regarding Safety of product is required.

937. Blossom’s Pipra Mint Syrup





Monograph of Croton Tig 30 and Ipecac 30 are required.




938. BL-33 Drops








Monographs of Borax, Merc Sol and Zinc Sulph are required.

939. BL-30 Drops








Conversion of strength of Zinc met and Kali phos are required

according to the monograph either it is given in mother


Monographs of Belladona, Physostigma, Zincum sulphate and

Euphrasia are required.

940. BL-29 Drops








Conversion of strength of Meg Phos D2 (Magnesium

Phosphate) is required according to the monograph either it is

given in mother tincture/solution/trituration or in respective

potency.

Monographs of all ingredients except Belladona and Meg Phos

D2 (Magnesium Phosphate) are required.

941. BL-28 Drops Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)







Conversion of strength of Santonine (Worm seed) is required

according to the monograph either it is given in mother


Monographs of China off and Cinnabaris are required.

942. BL-27 Drops








Monographs of all ingredients except for Aconite Net and

Bellanoda D4 are required.

943. BL-26 Drops








Monographs of Bryta mur D4, Kalium Iod D6 and Arnica

Montana D2 are required.

M/s. Xecutive Pharma (Eno 00312) 171-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore

944. Silnergy Tablet

Deferred till finalization of fate of common molecule list being

dealt by Division of H&OTC and Division of PE&R.

Contains common molecules: melatonin, glucosamine

Official testing method of melatonin required

945. Cvm Tablet

(new name fertilaid) Tablet


Contains zinc oxide (orally unstable)

Official monograph of L methyl folate required

946. Cidus Tablet

(new name winfol) Tablet



947. Cobin Tablet

(new name perinef) Tablet


Quantity per tablet required


948. Q-Tel Plus (new name ardin)

Syrup


Evidence of formulation provided is different form applied

formulation

949. Mt5 (new name folitek)

Tablet



950. Cyodine (New name mensolex) Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Tablet Testing method of herbal extracts required


951. Apogent (new name spasmo)

Syrup



Testing methods of emblica extract and ginger extract required

952. Kufeze (new name respivil)

Syrup


Herbal formulation while firm does not have herbal sections

953. Aescuvin (new name pregnatin)

Tablet


Evidence of formulation provided is different form applied

formulation

Testing method of flax seed extract and alfafa extract required

954. Stoneby (new name orthocal)

Tablet


Official testing method of algae calcium required

955. Acidiconil (New name Lowcid)

Syrup



956. Codil-P (new name A+farfly)

Syrup


Undertaking for stability not signed

957. Trigogen (new name menoper)

Tablet



Form 3 mentions tribulus and ginkgo herb. Testing of ginkgo

extract is given.

Official testing method of tribulus extract required

958. Cozas (new name mediov)

Tablet



Official monograph of tribulus extract required


959. Zygotin (new name Ambrosia F)

Tablet



960. Neodine (new name neorobal tablet)

Tablet



961. Neubaron Plus (new name neuroberg)

Tablet



Official testing method of bacopa monnieri extract and guarana

seed extract required


30-KM, Badian Road, ½ K.M Off Roda Bohgal Road, Lahore Cantt.

962. Shafa Sadar Syrup





Firm applied on Form-4 with submission of any clinical

evidence.

Revision of Form-4 is required w.r.t. monograph of active

ingredients.




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monographs of all ingredients except Ephedra vulgaris and

Glycyrrhiza glabra are required.

963. Gastomex Drops









Monograph of Robina pseudacacia is required.

Conversion of strengths of ingredients is required according to



964. B30 Drops








Monographs of all ingredients Cactus grandiflorus, Arnica

Montana, Spartium, Glonoium, Plumbium acetic and Aur. Mur.

Nat. are required.



tincture/solution/trituration or in respective potency, where

applicable.

965. Gasto Off Syrup




Monographs of Baharay (terminelia belerica) required.


966. Blossom’s Colic Drops





Firm applied on Form-4 with submission of any clinical

evidence.




Conversion of strength of Nat Phos (Natrum Phosphoricum),

Santonine (Worm seed) are required according to the



Monographs of Colocynth (Bitter apple) and Dioscorea (purple

yam) are required.

967. Blosmo Gel Syrup Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



Form-3 needs to be revised w.r.t. monographs of active

ingredients.






Monographs of all ingredients except Carboveg and Nux

Vomica are required.

Strengths of all ingredients are required according to the


tincture/solution/trituration or in respective potency

968. Coughnol Syrup


Brand name needs to be changed

Breakage of fee is required

Safety undertaking is required

Monographs of Zizphys sativa/Ziziphus jujube, Menthapiperita,

Hyssopus officinalis, papver somniferum and ammonium

chloride

969. Dyro Stop Dry Syrup









Monographs of all ingredients except Podophyllum and china

off are required.

970. Worm Iex Syrup









Conversion of strength of Nat Phos (Natrum Phosphoricum),

Santonine (Worm seed) are required according to the



Monographs of Cina, Cinnabaris, Cucurbita pepo and Teucrium

are required.

971. B20 Drops




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)





Monographs of Carduus mar, Thymus serpyllum, Chionanthus

and Nat sulph are required.

972. Fevotox Syrup



Monograph of Viola Odorata, Borago officinalis amd Fumaria

officinalis are required.

Undertaking regarding Safety of product is required.

973. B10 Drops








Monograph of Calc renalis, Berberis vul, Epigea rep,

Sarsaparilla, Rubia tinc and Hydrangea are required.

974. Bl-42 Drops








Monograph of Kali Bich (Kali Bichromicum) and Bellis per

(Daisy) are required.

975. Bl-44 Drops








Monograph of Cenathus (Buckbrush) and Cholestrinum

(Chloesterine) are required.

976. Bl-41 Drops








Monographs of all ingredients except Dulcamara and Syphlinum

are required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)




977. Bl-45 Drops








Conversion of strengths of Calc flour is required according to



978. Bl-4 Drops








Monograph of Aurum met, Spartium, Lycopus and Gloninum

are required.

979. Bl-46 Drops








Monograph of Pulsatilla, Clematis vit and Populous trem are

required.

980. Bl-47 Drops











Monographs of atropine sulphate is required.

981. Bl-1 Drops








F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Conversion of strength of Lachesis, Calc iod and Mercurius are

required according to the monograph either it is given in mother


Monograph of Hepar sulph and Kali bisc are required.

982. Bl-9 Drops








Conversion of strength of Graphites, Calc Carb and Nat sulf are



Monograph of Phytolacca (Pokeweed) is required.

983. Bl-5 Drops








Conversion of strength of Sulpher, Ars brom, Kali brom and

Hepar Sulfuris are required according to the monograph either it

is given in mother tincture/solution/trituration or in respective

potency.

984. Bl-52 Drops








Conversion of strength of Silicae (Silica) is required according

to the monograph either it is given in mother


Monographs of all ingredients except Echinacae, Sulphur and

Silicae are required.

985. Bl-51 Drops








Monographs of Avena sativa, Orchitinum and Agnus cactus are

required.

986. Bl-50 Drops Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)







Monograph of Rhus tox, Urtica uren, Caulophyllum and Apis

mel are required.

987. Bl-49 Drops








Monographs of Apid mel and Pulsatilla (pasque flower) are

required.

Conversion of strengths of Nat mur (sodium chloride) is



988. Bl-48 Drops








Monographs of all ingredients except Nux vomica, lycopodium

and sulphur are required.




989. Bl-13 Drops








Monograph of Serenoa repens and Champaphilla are required.

990. Bl-14 Drops








Monograph of Magnesia Chlor (Magnesiumm Chloride) is

required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Conversion of strength of Chlosterinum is required according to



991. Bl-2 Drops








992. Bl-3 Drops








Monograph of Anamrita Cocculus (Moonseed) and Cratageus

monogyna (Hawthorn) are required.

993. Bl-7Drops








Conversion of strength of Arsenicum Bromatum (Bromide of

Arsenic) is required according to the monograph either it is

given in mother tincture/solution/trituration or in respective

potency.

Monograph of Nat Sulph (Natrum sulphuricum) is required.

994. Bl-11 Drops








Monograph of Coffea Crub (Coffe Scrub) is required.

995. Bl-10 Drops








Conversion of strength of Calcarea Phosphorica (Calcium

Phosphate), Kali Phos ( Potassium Phosphate), Thyroidium

(Thyroid Extract), Mag Phos (Magnesium Phosphate), Natrum

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Phos (Sodium Phosphate) and Ferrum Phos (Iron Phosphate) are



Monograph of Barium Carb (Barium Carbonate) is required.

Undertaking to be submitted stating source of Thyroidium D8

(Thyroid Extract) is free from TSE/BSE.

996. Bl-17 Drops








Conversion of strength of Sepia D7 (Cuttle Fish), Ferrum Phos

(Iron Phosphate), Mag Phos (Magnesium Phosphate) is



Monographs of Pulsatilla vulgaris D4 and Viburnum Opulus are

required.

997. Bl-43 Drops








Conversion of strength of Calc Flor is required according to the



Monographs of Redium bromat and Aconite nep are required.

998. Bl-16 Drops








Conversion of strength of Calc Flour is required according to



Monographs of Pulsatilal (Pasque Flower) and Clematis

vitabulis are required.

Acti Health food,

Suite no. 1 Shireen Arcade plot A-41, K.U.C.H.S Block 7-8, Karachi

999. Ultra Cranberry Tablet Already enlisted



1000. Cogen E Tablet Deferred due to following reasons:


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)




1001. Fertidl-F Capsule


Contains zinc oxide(unstable orally)

Official testing method of tribulus extract, epimedium extract

required

1002. Rozana Capsule



Official testing method of tribulus extract required

1003. Iodomom-Z Tablet Deferred due to following reasons:


M/s Apple Laboratories (Eno 0076)

National Industrial Zone, RCCI Road, 1.5-KM, Rawat, Rawalpindi

1004. Basil Plus Tablet


Quantity of zinc is above RDA (mention elemental quantity)

Clarification and official testing method of citrus biflavonoids

1005. Ginzee Syrup


Official testing method of ginkgo extract, bacopa extract,

tribulus extract and testofen required

1006. Antacil Syrup



1007. Opti-M Tablet




1008. Ezee Kuff Syrup


Testing method of morus alba extract and viola odorata extract

required

M/s. Medwell Pharmaceuticals, (Dedicated Section), (Eno 00124)

1-Km, Terbella Road, Lawrencepur District, Attock

1009. Q Max Tablets / Procor Tablet


The file has no required documents except form 3 and evidence

of fee submission.

1010. Qualifit Tablets



of fee submission.



1011. Robitus Tablet



Official monograph of ribwort extract required

1012. Robitus Syrup



Official monograph of ribwort extract required

1013. Ayron Syrup Deferred for further evaluation and clarification.

1014. Iodomom-Z Tablet Deferred due to following reasons:

Master formula not provided

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

1015. Balwel Sachet




Zinc quantity above RDA

1016. Balwel Tablet



Zinc quantity above RDA

M/s. Nutris Laboratories (Eno 00262) 46(B)-M Block, Quaid-e-Azam Industrial Estate, Lahore

1017. Soelab Pass Powder Deferred for further evaluation and clarification.



1018. Calceon Drops


Confirmation regarding availability of drop manufacturing

facility is required as part of liquid (nutraceutical) section.

Rationale of dose of vitamin A and Vitamin D3 is required,

Conversation of strengths of each active ingredient is required

from “IU” to “weight units”

Safety of methyl paraben and propyl paraben is required in

children.

Quantitative assay of each ingredient in finished product is

required,

M/s Heal The World, Karachi

Located at City Shopping Mall, Suite No.l07, Marston Rd, Karachi

an agent of M/s Alaska Sprin Pharmaceuticals 609-1 Cantiague Rock Road Westbury, NY 11590, United States

1019. Vitabay multi softgel Considered and decided by EEC in its 72nd meeting.

1020. Vivioptal Women Softgel Capsule Considered and decided by EEC in its 72nd meeting.



1021. Bifernate Syrup

Syrup


Official testing method of iron biosglycinate required

1022. Colic Drops



of fee submission

1023. Cough Syrup


The product is herbal while the firm does not have herbal

sections


of fee submission.


1024. Gastonil Syrup Deferred till finalization of fate of common molecule list being dealt by


1025. Glucomin Tablet Deferred till finalization of fate of common molecule list being dealt by


1026. Liverex Tablet




of fee submission

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

1027. Niswaani Syrup



sections


of fee submission.

1028. Relexa Tablet



sections

Undertakings and testing methods missing

1029. Shaafi Syrup



sections


of fee submission.

1030. Sharbat E Folad Syrup



of fee submission.

1031. Toot Syah Sharbat Syrup



sections


of fee submission.

1032. Welgink Syrup


Undertaking for brand name and content missing

1033. Pro Go Cream



sections


of fee submission.

Cure Inn Phytoceuticals Pvt Ltd, Lahore

Plot No. 10,11-C ,Punjab Small Industrial Estate,44-Km from Lahore,Ferozepur Road, Kasur

1034. Vitanour Tablet


Stability of Zinc oxide in oral tablet dosage form is required,

Safety of methylene chloride as tablet coating agent is required.

Safety and rational of using rectified spirit in coating of tablet is

required,

Submission of source of Be 95% proanthocynidins is required

along with monograph or otherwise revise Form-3 accordingly.


required.







1035. Lizbone Tablet Deferred due to following reasons:

Stability of zinc oxide in oral solid dosage form is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Conversion of strength of Vitamin D3 from “IU” to “weight

units” is required in Master formula.


required.



1036. Abm plus Supplement Powder




Testing methods of gugulsterones, synephrine and bioperine

required

Undertaking for stability, brand name and content missing

1037. Anagen Supplement Powder


Contains synephrine; justify use as supplement

Contains herbs (ephedra viridis, schisandra berry, hordia

gordoni ext) while firm does not have herbal section


1038. Be App Syrup

(new name cholino) Syrup



Clarify if ginkgo herb or extract is used

Undertaking for stability and content missing

1039. Berry Gold Sachet Powder


The file has no required documents except form 3, master

formula and evidence of fee submission.

1040. Corum D Syrup



1041.

Eatmore Plus Syrup

(new name tricod)





1042. Enzimax Syrup



sections

1043. G I Releif Syrup


Testing method of herbal extracts to be provided

1044. Heamolyte Syrup



Undertaking for content, stability and brand name missing

1045. Heamolyte Tablet


Contains banned ingredient; methylene chloride


1046. Kof Fight Syrup


Formulation contains herbs



1047. Libidonil Capsules



sections

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


Evidence of submission and fee deposit missing

1048. Pain Go Cream




2 different form 3 with different formulations are present in file.

Clarify.

1049. P-Cure

Cream



1050. Q Zee 10 Tablets



Contains methylene chloride; banned ingredient

Undertaking for brand name and content missing

1051. Rise O Vit Tablet


Quantity of vitamin D is above RDA

Revise form3 as the quantities and ingredients are jumbled


of fee submission.

1052. Saint Berry Tablets


Testing method of cranberry extract required

1053. Snooz Tablets



1054. Succeed Tablet


Is a sweetner. Does not fall in the purview of SRO 142 (I)


of fee submission.

1055. Succeed Tablet


1056. Sylivel Tablets



of fee submission.

1057. Sillyvel Syrup



of fee submission.

1058. Take A Day Syrup



1059. Take A Day Tablets


Contains herbs and drug; vinpocetine

1060. Tokocid Syrup


1061. Tonseez Tablets



sections


of fee submission.

1062.

Tusso V Syrup

(new name braintronix)



F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


sections



1063.

Viskeez

(New name napwel)

Drops



sections

1064.

Vita-Moul Tablets

(new name D-chiro wel)



Undertaking for content, brand name and stability missing

1065. Vitomax Tab

(new name Maxwell) Tablet





1066. Bio Malt Syrup Deferred for further evaluation and clarification.

Nutrimed Laboratories, Karachi


1067. Ferti Vit Capsule


Form-3 need to be revised w.r.t. specification of active

ingredient including elemental equivalents in their respective

salts..

Dose of Zinc i.e. 20mg per capsule is exceeding RDA/ upper

tolerable limits according to recommended dose of 2 capsule

per day as per label claim, need clarification.

Master Formula stating batch size mentioning quantities of in-

active ingredients is required.

Product specific testing method of finished product is required

including assay of product.

Stability of cyanocobalamin as capsule dosage form is required.

Justify use of pure iodine and salenium in capsule dosage form.

1068. Sacroflor Sachet


Form-3 need to be revised w.r.t. specification of active

ingredient i.e. Sachharomyces boulardii (lyophilize powder).


Monograph of Sachharomyces boulardii (lyophilize powder) is

required.

Product specific monograph and method of testing of finished

product is required.

Signed and stamped undertaking regarding brand name and

contents on notarized stamp paper is required.

Patient information leaflet under packaging and labeling

information is required as per checklist of form-3.

1069. Gas Ref Syrup


Form-3 need to be revised w.r.t. specification of each ingredient.


As per monograph attached firm is using peppermint oil instead

of mentha piperata extract as mentioned on form-3. Clarification

or revision of form-3 is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monograph of Cuminium Cyminum Extract, Foeniculum

vulgare extract, Mesua Ferrea Extract are required.



Safety profile of Methyl Paraben and Propyl Paraben in children

is required.





1070. Ib Fer Syrup


Form-3 need to be revised w.r.t. specifications of each

ingredient are required.


is required.

Monograph of all ingredients except Zingiber officinalis extract,

Emblica officianlis extract, Peppermint extract and

Cinnamomum cassia are required.









1071. Tums Lozenges



Monographs of all ingredients except Adhota Vasica Extract

and Glycerrhiza Glabra Extract are required.




contents on notarized stamp paper are required.



1072. Divazin Syrup


Zinc Gluconate is registered as single ingredient drug product

by the Registration Baord.




is required.







F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

1073. Fikar Cough Syrup




Monograph of Ivy leaf extract is required.




is required.





1074. Heptomin Syrup





Monograph of L-Ornithine is required.

Stability of zinc oxide in syrup dosage form is required.




is required.





1075. Hydrofit Effervescent Tablet





Monograph of Vitamin B2 is required.

Stability of vitamin B2 in effervescent tablet is required.

Role of citric acid as active ingredient is required.







1076. Pregner Tablet Deferred till finalization of fate of common molecules being dealt by


1077. Simrin Syrup






is required.


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)







1078. Clasteon Tablet


Form-3 need to be revised w.r.t. specifications, scientific names

of chaste berry extract, salt alongwith elemental equivalent in

their respective salts are required.

Stability of Zinc oxide in oral tablet dosage form is required,

Monograph of Chaste Berry Extract is required.







1079. Fincor Tablet




Rationale and evidence of dose for supplementation of D-Chiro

inositol and myo inositol.

Monograph of D-Chiro inositol is required.







1080. Oxytrol Tablet





Monograph of all ingredients except Zingiber officinalis extract

are required.







1081. Merabol Tablet Deferred till finalization of fate of common molecules being dealt by


1082. Bilonic Tablet




Product Profile as per check list is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Master Formula stating batch size mentioning quantities of

active and inactive ingredients.







1083. Hydrofit Sachet





Role of citric acid as active ingredient is required.







1084. Berymax Forte Sachet





Monograph of all ingredient are required.





Patient informatio n leaflet under packaging and labeling


1085. Gasfer Syrup






is required.

Monograph of all ingredients except Zingiber officinalis extract

are required.







1086. M-Plex M Syrup


Form-3 need to be revised w.r.t. specifications, salts alongwith

elemental equivalents of each ingredient are required.

Monograph of folic acid is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Stability of zinc oxide in syrup dosage form is required.




is required.





1087. Iv Tus Lozenges


Form-3 need to be revised w.r.t. specifications, of each



Monographs of all ingredients except licorice extract are

required.







1088. Cufkir Cough Syrup





Monographs of Alpinia galangal extract, Hyoscyamus niger

extract, Cordia latifolia extract and Ocimum bacilicum extract

are required.




is required.





1089. Zinot Syrup Deferred till finalization of fate of common molecules being dealt by


1090. Cufkir Lozenges


Form-3 need to be revised w.r.t. specification and salts of each

ingredient.

Monograph of Ivy leaf extract is required.

Formulation in product profile and master formula is different

need clarification.



1091. Bonazer Syrup



ingredient.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


Monographs of respective salt of zinc is required.




is required.



Packaging and labeling information is required as per checklist

of form-3.

1092. Multi 365 Syrup


Form-3 need to be revised w.r.t. specifications, salt alongwith

respective elemental equivalents are required.


is required.


Stability of zinc oxide in oral syrup dosage form is required.







1093. Tuscor Drops


Availability of Liquid Drop facility (Nutraceutical) is required

or justify.



Monograph of Ivy Leaf Extract (Hydera helix) is required.


is required.




notarized stamp paper are required.



1094. Simrin Tablet












F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

1095. Ceretec Capsule


Form-3 need to be revised w.r.t. specifications of Natural Egg

Shell membrane.

Monograph of Natural Egg Shell membrane is required.

Rationale and evidence of dose is required.

Signed undertaking regarding submission of stability data is

required.





1096. D-Tan Od Tablet


Form-3 need to be revised w.r.t. specification of each ingredient

is required.








1097. Metanx Tablet


Form-3 need to be revised w.r.t. specification of each ingredient

is required.

Strength of folic acid in L-methyl folate is required.

L-methylfolate and mecobalamin dose is exceeding RDA/ upper

tolerable limits according to recommended dose of 2 tablets per

day as per label claim, need clarification.







1098. Cofca Plus Syrup




Monographs of Ivy leaf extract and thyme extract are required.




is required.





1099. Cereban Tablets Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)





Monograph of all ingredients are required.





1100. Bilonic Syrup





is required.







1101. Licozer Capsule




Monograph of all ingredients except Emblica officinalis extract

are required.







Hale Pharma, Lahore

B-Kh No. 285 Kh No. 570 Allah Hoo Industrial Estate, Allah Hoo Pul 22 Km Ferozpur Road, Lahore

1102. Endo-Plus Tablet



Form-3 is unsigned by the owner/MD/CEO of the firm.

Form-3 need to be revised w.r.t. elemental equivalents in their

respective salts.

The safety profile of methylene chloride as coating agent is

required.

Stability of zinc oxide in tablet oral dosage form is required.

Signed and stamped undertaking regarding submission of

stability data is required by the owner/MD/CEO of firm.

Signed and stamped undertaking regarding brand name is

required on notarized stamp paper.

Paragon Herbal Laboratories, Lahore

Plot No. Kht 285, Ktn 570, Allah Hoo Industrial Area, Near Sabzi Mandi, Gujumatta, Ferozepur Road, Lahore

1103. Pee-Cid Syrup Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


Form-3 is unsigned and unstamped.

Monograph of Zingiber officinale is required.

Packaging and labeling information in required as per checklist

of form-3.

Method of testing of finished product is required.

Signed and stamped undertaking by the owner is required

regarding submission of stability data.


contents are required on notarized stamp paper

Alaq Laboratories, Lahore

5-Main Road, Amir Town, Lahore"

1104. Khaba Syrup




Monograph of Piper longum Extract, Tribulus terrestis extract,

Zingiber officinale extract and cardamom oil are required.

Confirmation regarding availability of Gas Chromatography

facility is required as mentioned on monograph of Bitter Fennel

Fruit Oil (BP).

Packaging and labeling information is required as per checklist

of form-3.

1105. Khaba Tablet




Monograph of Piper longum Extract, Tribulus terrestis extract,

Zingiber officinale extract and cardamom oil are required.

Confirmation regarding availability of Gas Chromatography

facility is required as mentioned on monograph of Bitter Fennel

Fruit Oil (BP).

Disintegration time and dissolution testing are missing from

finished formulation testing.



1106. Ad-More Drops




Products on Form-3 need to be applied by the owner/MD/CEO

of the firm.

Confirmation of availability of drop manufacturing facility as

part of liquid section is required.




required stating this brand name is not registered under DRAP

Act, 2012.

1107. E-M0Re Tablet Deferred for further evaluation and clarification.

1108. Sacro-B Sachet Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


of the firm.

Form-3 need to be revised w.r.t. elemental equivalent of calcium

in calcium carbonate.

Monograph of algea calcium is required.

Strength of zinc (BP) i.e. 50mg mentioned on Form-3 is

exceeding RDA/ upper tolerable limits.





Act, 2012.

1109. Calgee Syrup





of the firm.




is required.





Act, 2012.

1110. Qutrix Capsule



Form-3 is unsigned by the owner/MD/CEO of the firm.

Undertaking stating that gelatin capsules are free from

TSE/BSE.

Monograph of tribulus terrestris extract (BP) is required.




required on notarized stamp paper.



1111. Ed-4 Tablet




Salt of selenium is required.


Form-3 needs to be revised w.r.t. authentic specifications of

each ingredient along with its monographs are required.



Xecutive Pharma, Lahore

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


1112. Osteoline-D Syrup Deferred for further evaluation and clarification.

1113. Pencid Syrup


Form-3 needs to be revised w.r.t. specifications of each

ingredient.


Monograph of all ingredient except Fennel Oil, Sodium

Bicarbonate and Mentha pipperita oil are required.

Label of product contradict the formulating applied on

prescribed form-3 w.r.t herbal extract/oil ingredients.

1114. Fusa-D Tablet


Firm applied for FOSA-D Tablet on prescribed form-3 and

breakage of fee challan (No.:0578041 dated:08-02-2017,

however in FIFO list @ sr. no. 1798 ‘Fusa-D Tablet’ is

mentioned.

Rational of dose of each ingredient is required.

Dose of L-lysine is different on form-3 i.e. 100mg than master

formula i.e. 50mg, need clarification.

Monograph of calcium carbonate (EP) is required.

Testing of quantitative method of each ingredient in finished


1115. Mycyt Tablet


Formulation and evidence of competitor availability in the local

or international market. Rationale of dose of each ingredient is

required.

Form-3 needs to be revised w.r.t. specification of L-methylfolate

from EP to JECFA.

Product specific testing methods of finished product including

quantitative assay is required.

1116. W Kix Tablet



Form-3 needs to be revised w.r.t. mentioning “Tribulus

Extract” instead of “Tribulus”.


Monograph of Tribulus extract, Tongat Ali extract, Mcca Root

Extract, Cayenne Pepper Extract and Sodium Borate are

required.

Testing method of quantitative assay of each ingredient in

finished product is required.

1117. X Zofil Tablet


Product specific monograph of finished product is required.

Calculations of vitamin B6 and B12 in master formula are

wrong.

Monographs of all ingredients are missing.


Product specific method for testing of finished product

including quantitative assay is required.

1118. Lac-D Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

(new name PH PRO)

Tablet Contains zinc oxide; orally unstable

1119.

Q-Mayo

(new name: Quat-F)

Tablet



1120.

Ocitol C

(new name ; R colin)

Tablet



1121.

Vitacure

(new name: livton Tab)

Tablet



1122.

Grolak

(new name Sepep)

Tablet



1123.

Ovacure

(new name: fertive-F)

Tablet



1124.

Cystol

(new name; adfast)

Tablet



1125.

Q-Tel Plus

(new name Greet)

Tablet



1126. Eko Pllus Cough Syrup

Deferred for further evaluation and clarification. 1127. Ergo Syrup

1128. Eko Cough Syrup

1129.

X-Zed

(new name multipro-M)

Tablet


Contains zinc oxide (unstable orally)

Testing method of fennel and ginger extract missing

1130.

Sextra

(new name multinex)

Tablet


Contains zinc oxide; orally unstable

Testing method of ginkgo extract, ginseng extract and garlic

powder extract required


1131.

Ov Bost

(new name algenox syrup)

Tablet


Testing method of ginger extract and chamomile extract

required


The Best Laboratories Lahore

Plot No.348, Sunder Industrial Estate, Lahore

1132. Feerest Syrup


Form-3 need to be revised w.r.t. specifications all ingredients

are required.

Stability of cyanocobalamin in oral syrup dosage form is

required.

Safety profile of Methyl paraben and Propyl Paraben in children

is required.

Quantitative method for identification of each ingredient in

finished dosage form is required.\

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)





1133. Danical Syrup


Form-3 need to be revised w.r.t. elemental equivalent of calcium

in calcium carbonate. The given strength i.e. 375mg/5ml is

exceeding the RDA/upper tolerable limits as per recommended

dose on label i.e. 15ml twice daily.


is required.

Product specific method of finished product is required

including assay.





1134. Danical Tablet


Form-3 needs to be revised w.r.t. to specification of calcium

carbonate and elemental calcium in this salt. The dose of

calcium i.e. 600mg is exceeding the RDA/upper tolerable limits

as per maximum recommended dose i.e. 3 tablets per day.

Safety of methylene chloride as coating agent in tablet dosage

form is required.

Method of assay of each ingredient in finished product is

required.




contents on notarized stamp paper is required

1135. Feerest Tablet


Form-3 needs to be revised w.r.t. specification of ingredients are

reqired.

The dose of folic acid i.e. 400mcg and iron i.e. 26mg is

exceeding the RDA/upper tolerable limits as per maximum

recommended dose i.e. 3 tablets per day.


form is required.

Product specific monograph of finished product including assay

is required.





1136. Rohmest Tablet


Rationale of dose of each ingredient w.r.t. clinical significance

is required.

Stability of tri-calcium phosphate and zinc oxide in oral solid


F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Dose of iodine i.e. 700mcg is exceeding the RDA/upper

tolerable limits.

Justification is required for using single salt i.e. tri-calcium

phosphate as a source of Calcium (90mg) and Phosphorus

(31mg) w.r.t to equivalency of each element.

Safety profile of methylene chloride as coating agent is

required.

Salt of potassium used in the formulation is required.

Product specific method of finished product including assay is

required.





1137. Rohmest Syrup


Form-3 need to be revised w.r.t. specifications, salt alongwith

respective elemental equivalents are required.

Safety of Copper as Cupric sulphate (CuSO4) in given strength

and dose of 4mg twice daily is required.

Stability of zinc oxide and cyanocobalamin in oral syrup


Monograph of vitamin C is required.


is required.

Quantitative method for identification of each ingredient in

finished dosage form is required.\

Patient information leaflet is required as per approved checklist

of form-3.


Stability data is required on 7company letter head.



Alpha Nutraceutical, Lahore

1138. Bay-Kuf Syrup Deferred for further evaluation and clarification.

1139. Citrocran Sachet

M/s. Convell Laboratories (Dedicated Section),

Saidu Sharif, Swat

1140. Kidvell Baby Drops


Evidence regarding fee submission of Kidvell Baby Drops as

firm attached evidence of fee submission for “Kidvell Drop”,




facility as part of oral liquid (syrup) section is required,

Strength of ingredient per unit delivery volume is required.

Form-3 needs to be revised w.r.t. elemental equivalents of iron

and zinc in their respective salts.

Monograph of malt extract USP (maltodextrin) is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


is required.

Stability of cyanocobalamin in oral liquid dosage form is

required.

Stepwise Manufacturing process in-detail, testing

methods/specification of raw and finished product,

recommended conditions for use and packaging & labeling

information of product is required as per check list of form-3.





1141. Convell-D Drop



facility as part of oral liquid (syrup) section is required,

Stepwise Manufacturing process in-detail, testing

methods/specification of raw and finished product,

recommended conditions for use and packaging & labeling

information of product is required as per check list of form-3.





1142. Hileaf Junior Syrup





is required.

Manufacturing process, testing methods/specification of raw and

finished product, recommended conditions for use and

packaging & labeling information of product is required as per

check list of form-3.





1143. Ginkovell Capsules


Firm possess only Capsule (Nutraceutical) Section. Therefore,

Form-3 need to be revised w.r.t Bacopa monnieri extract rather

than Bacopa monnieri.

Monograph of Bacopa monnieri extract is required.









F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

1144. Ginkovell Syrup


Firm possess only Oral Liquid (Syrup) Section. Therefore,

Form-3 need to be revised w.r.t Bacopa monnieri extract rather

than Bacopa monnieri.



is required.









1145. Velmarine Syrup Deferred till finalization of fate of common molecules being dealt by


1146. Hileaf Plus Syrup






is required.









1147. Ovavell Plus Capsules



Form-3 needs to be revised w.r.t. mentioning Tribullus

terristress extract rather then Tribullus terristress.

Monograph of Tribullus terristress extract is required.









1148. Nilcough Junior Syrup





F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


is required.









1149. Convit-D Tablets


Form-3 needs to be revised w.r.t elemental equivalent of

calcium in calcium carbonate.









1150. Optivell –Z Capsules



Form-3 needs to be revised w.r.t. mentioning Ginko biloba

extract rather than Ginko biloba. The dose of folic acid i.e.

1.5mg and Zinc sulphate i.e. 40mg needs to be revised. The

elemental equivalents of each ingredient in their respective salt.

Monograph of Tribullu s terristress extract is required.

Stability of selenium sulfide or selenium sulphate in capsule









contents on notarized stamp paper is required

1151. Multi –Vell Capsules


Evidence of fee submission is required.

Brand names needs to be changed.

Form-3 needs to be revised w.r.t. specifications of selenium.

Elemental equivalent in their respective salt is required.



Monograph of Vitamin B12 is required. Specify

methycobalamin or cyanocobalamin as source of vitamin B12 in

the formulation.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Stability of methycobalamin/cyanocobalamin in capsule dosage

form is required.









1152. Cardiovell Plus Capsules


Brand names needs to be changed.

Elemental equivalent in their respective salt is required.



Monographs of Garlic extract and alpha lipoic acid are required.










1153. Ncad3 Tablets

Deferred to seek justification from the firm for applying same

formulation with different brand name i.e.

Convit-D Tablet (FIFO No. 1836).

1154. Denvel Ds Tablets Deferred till finalization of fate of common molecules being dealt by


1155. Berry Sip Sachets



Monograph of Cranberry extract is required.









Kaap Pharmaceuticals Pvt Ltd, Lahore

18 Km Ferozepur Road, Lahore

1156. Enzokap 10Mg Tablet Deferred till finalization of fate of common molecules being dealt by



30-KM, Badian Road, ½ K.M Off Roda Bohgal Road, Lahore Cantt

1157. Blossom Colic Syrup Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Firm applied for blossom colic tablet on prescribed form-3 and

fee challan (No.:0848039 dated:070-02-2019, however in FIFO

list @ sr. no. 1845 ‘blossom colic syrup’ is mentioned.



Fomr-3 needs to be revised w.r.t. to specifications and complete

scientific names of each ingredient.




As per manufacturing processes submitted on form-3 the

applied tablet is a “coated” one however no coating material is

mentioned in list of excipients/inactive ingredients. Need

clarification.

Monograph of all ingredinets except ipecac, aethusa and alfalfa

are required.



Testing method for qualitative assay of each ingredient in

finished product is required,

M/s Greektec (Pvt) Ltd (Eno 0091)

Plot No. D-30/A (First Floor), S.I.T.E,-II, Phase-I, Super Highway, Karachi

1158. Multiflex Tablet Deferred due to following reasons:

Form 3 missing

1159. Macfer Tablet


Form 3 missing

Contains banned ingredient; methylene chloride


1160. Q-Mag Tablet


Form3 missing

Undertaking for stability and brand name missing

Official monograph of spirulina extract, horsetail extract

required


1161. Femeline 2 Tablet


Form 3 missing


1162. Liprolex Tablet


Form 3 missing


Testing methods of plant sterols/ stanols required

Provide salt of sodium

Undertaking for stability and brand name missing

1163. Ceebrox Tablet Deferred due to following reasons:

Form 3 missing



1164. Gencordin Capsule Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Official monograph of danshenform compound, salvia extract

and borneol required


Fee submitted per product is 250/-

Phytotia Laboratory, Peshawar

1165. Flex-Jo Tablet

Deferred for further evaluation and clarification. 1166. Ekovit Tablet

1167. Malt-C Sachet



1168. Algaewam Tablets




of the firm.


respective salts.


Strength of zinc (BP) i.e. 50mg mentioned on Form-3 is

exceeding RDA/ upper tolerable limits.





Act, 2012.

1169. Ferrowam Tablet




of the firm.






Act, 2012.

1170. Men-Force Tablet


Prescribed form-3 is required signed an stamped by the

owner/MD/CEO of the firm.


respective salts.


Stability of zinc oxide is required in oral tablet dosage form.

Strength of zinc oxide i.e. 50mg is exceeding RDA/ upper

tolerable limits.

Specific test w.r.t tablet dosage form are required including

weight variation.

Confirmation of availability of drop manufacturing facility as

part of liquid section is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)





Act, 2012.

1171. Gestrowim Syrup





of the firm.

Firm uses Zingiber officinale (USP) and Mentha pierita (USP)

crude form while it possess only oral liquid section.




is required.





Act, 2012.

M/s. Medwell Pharmaceuticals, (Dedicated Section), (E No 00124)


1172. Glucofit Tablets



1173. Hemonil Tablets


Methylene chloride (banned ingredient) used


1174. Hicin Ds Tablets


Contains methylene chloride (banned ingredient)


1175. Juvile Tablets


1176. Lactofid Capsules


Contains probiotics while the firm does not have a probiotic

section


1177. Lactofid Sachets Powder


Contains probiotics while the firm does not have a probiotic

section


1178. Sea Cool Syrup




Testing method of herbal extracts required


1179. Surty Hair Supplement Powder Deferred due to following reasons:

Contains minoxidil; registered as drug

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Undertaking for content and brand name missing

Nayas Impex, Lahore

Suit No.18-A, 2nd floor Gohar Center, Wahdat Road, Lahore-Pakistan

an agent of M/s Eurobio 9, Lotissement Le Bois 22340 Treffrin, France [Principal Manufacturer: M/s Artimon, 5 rue

Brindejonc des Moulinais, 22190 Plerin, France] (Veterinary)

1180. Euro Vita Mix


CoAs of all active ingredients and CoA of finished product are

required from principal manufacturer.

Accelerated and long term stability studies data of at least 3

batches conducted on requirements of zone IV-A is required

from principal manufacturer.





GMP issued by regulatory authority is required.



is required.

Document is required from principal manufacturer stating

relationship between former and M/s Eurobio 9, Lotissement Le

Bois 22340 Treffrin, France as an agent.

1181. Euro E Sel 20%




Composition of active ingredients mentioned on master

formulation and CoA of finished product is different, needs

clarification.


batches conducted on requirements of zone IV-A is required.









is required.




1182. Euro Vit C








F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)






is required.




1183. Hepa Euro













is required.






1184. Calcifan D Tablet




The dose of calcium i.e. 750mg is at upper border of RDA/upper

tolerable limits as per label claim dose i.e. two tablets a day.

Monograph of Bromelain Extract is required.


1185. White Extra Tablet

Deferred due to following reasons;


Form-3 needs to be revised w.r.t. specification of active

ingredient.

Rationale of dose of glutathione i.e. 500mg is required.

Monograph of glutathione is required.

Product specific testing method of finished product including

quantitative assay.

1186. Guteez Syrup




is required.


1187. Ascilex Deferred for further evaluation and clarification.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Syrup

1188.

Xecos

(new name pencid)

Syrup





1189. Astaberry Sachet


1190. Astalax Syrup



of the firm.


The dose of elemental iron i.e. 27mg is exceeding the

RDA/upper tolerable limits as per label claim dose i.e. three

times daily.


is required.





Act, 2012.

The Best Laboratories Lahore

1191. Kranberry Sachet





ingredient.

Monograph of Cran berry extract is required.

Quantitative identification of each ingredient in finished dosage

form is required.





1192. Colky Drops


Confirmation regarding availability of drops manufacturing

facility as part of syrup (herbal) section is required.

Justification regarding strengths of each ingredient is required

w.r.t. decoction process as mentioned in manufacturing process

submitted on form-3.

Safety undertaking regarding product on notarized stamp paper

is required.


is required.

Monographs of Mentha arvensis, Foeniculum vulgare and

Cuminum cyminum are required.

Method of assay of each ingredient in finished product is

required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)





1193. Aracure Syrup


Form-3 need to be revised mentioning United State

Pharmacopoeia as specification of Silybum marianum.





is required.





1194. Health-33 Tablet



Form-3 needs to be revised w.r.t. salt of potassium along with

its monograph is required.

Stability of zinc oxide in oral tablet dosage form is required.


form is required.

Justification of chloride in formulation is required.

Justification is required for using single salt i.e. tri-calcium

phosphate as a source of Calcium (162mg) and Phosphorus

(125mg) w.r.t to equivalency of each element.

Monographs of potassium dichromate and niacin are required.

Product specific monograph of finished product including assay

is required.





1195. Bestocid Syrup





Safety profile of Propyl Paraben in children is required.

Firm mentioned mentha piperita/viridis (API,Vol-V) in product

profile on form-3. Need clarification.

Monograph of Cuminum cyminum (API, Vol I) is required.

Qualitative/identification test of ingredients in finished product

is required.





F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

1196. Aracin-Ds


1197. Leaf Up Syrup


Form-3 need to be revised mentioning European Pharmacopeia

as specification of Hedra Helix.





is required.





1198. Apitizer Syrup




submitted on form-3..

Safety profile of Methyl paraben in children is required.

Monographs of Achellia mellefolium, Anethum soye oil and

cassia occidentalis are required.

Qualitative/identification testing method for ingredients in






1199. Gink Up Syrup


Form-3 needs to be revised w.r.t. mentioning of “Ginkgo Biloba

Extract (USP)” instead of “Ginkgo Biloba (USP)”

Safety profile of Methyl paraben and propyl paraben in children

is required.

Quantitative/identification testing method for ingredients in






1200. Sencof Syrup


Form-3 need to be revised mentioning European Pharmacopeia

as specification of Hedra Helix and Glycyrrhiza glabra.





is required.



F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



1201. D-Card Capsule


Clarification is required regarding whether firm want to use

Salvia militorrhiza or its extract.

o If using extract then differential fee is required.

o If using herb then confirmation regarding availability

of capsule section (herbal) is required.

Form-3 needs to be revised w.r.t. specification of active

ingredient.

Master Formula stating batch size mentioning quantities of

inactive ingredients is required.







1202. Qtrefol-B6 Tablet Deferred till finalization of fate of common molecules being dealt by


Sind Medical Stores, Karachi

13-B, Block-6, PECHS, Shahrah-e-Faisal, Karachi-Pakistan

Is an agent of Agent of M/s Martinez Nieto S.A., Pol. Ind. Los Camachos Sur, Avda. Del Carboneo, 96 30369 Los

Camachos, Cartagena, Spain

1203. Cistomar Capsule



Form 5 is required.

Testing specification/ monographs are required.

Master formulation or batch manufacturing record is required.


GMP certificate issued by regulatory authority is required.

Accelerated and long term Stability studies conducted on

requirements in zone IV-A are required.

CoAs of active ingredients and finished product are required.

Label claim and clinical safety of product are required.

Manufacturing license issued by regulatory authority in English

language, is required.

Justification is required to establish relationship between

Martinez Nieto S.A and Marnys.

Agency agreement bearing signature of principal manufacturer

in the country of origin and importer in Pakistan, is required.


1204. Trazamin ClordetoxVials


Testing method/ monographs of chlorella, broccoli and zin

gluconate and iron (salt) are required.

Form 5 to be revised w.r.t salts of active ingredients and

botanical name of herbs.

CoA of finished product is required on principal manufacturer’s

cover letter.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Formulation is applied in vial dosage form without mentioning

either route of administration is oral or parenteral, needs

clarification in this regard and CoA of finished product should

bear conformity of sterility testing.

Accelerated and long term Stability studies data comprising of

chemical testing (identification) of herbs being used in

formulation in addition to other information that have been

provided, is required.








1205. Memory Plus Capsule


Strength of active ingredients per single capsule is required.

Form 5 to be revised w.r.t salts of active ingredients.

CoA of choline citrate, phosphotidylserine, sodium and

selenium are required.

CoA of finished product depicting chemical assay or test of

active ingredients is required.

Accelerated and long term stability studies data (chemical

testing of active ingredients) in addition to other information

that have been provided, are required.

Evidence of clinical safety and efficacy and packaging and

labeling mockup of said product is required.

Monograph/ testing specification of phosphotidylserine is

required.









"Plot No. 32-33, Small Industrial Estate, Kohat Road, Peshawar"

1206. A-Q Drops



Confirmation regarding availability of drops manufacturing

facility as part of syrup section.

Form-3 needs to be revised w.r.t. specifications of Vitamin A.

Viscosity/specific gravity test is missing in finished product

testing specification.

1207. Cv-Q10 Tablet



Form-3 needs to be revised w.r.t. specifications of ingredients.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Global Vets Corporation

1208. Global Vi-C 95


1209. Casoline

1210. Ewha E-10 Sel Sol

1211. Ewha Adek Sol

1212. Ewha Adek Sol

M/s Siddiqui Pharma (Pvt) Ltd.,

located at the address 2055 W-9 Opp. Fatima Jinnah Hospital Abdali Road, Multan

1213. Lifeguard-T


1214. Hepatonic-L

1215. Vigomax-G

1216. Vital Chorus Forte

M/s Zaidi Chemist, Peshawar

15 Soekarno Square, Khyber Bazar, Peshawar

Agent of M/s Rowa Pharmaceuticals Ltd, Newtown, Bantry, Cork, Ireland

Evaluator: Zain Ul Abidin, AD-V)

1217. Rowatinex Drop Deferred for further evaluation and clarification.

1218. Rowachol soft capsules



Form 5 is required.












Zestech Sciences, Karachi

1219. Floriva Tablet Deferred for further evaluation and clarification.



1220. Bronkof Syrup




Form-3 needs to be revised w.r.t. mentioning glycyrrhiza glabra

extract instead of glycyrrhiza glabra

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Monograph of morus nigra extract is required.

Product specific testing method of finished product including

quantitative assay is required

1221. Brooklyn International, Rawalpindi

1222. Orenda Sachet Deferred for further evaluation and clarification.

Ghazi Brothers, Karachi

1223. Addcon Xlm Deferred for further evaluation and clarification.

1224. Kofa Grain Ph.5

Hinucon, Karachi

1225. Fe-Max Sachet Deferred for further evaluation and clarification.

Novae Nutraceuticals, Hattar

1226. Mela Bright Tube

Deferred for further evaluation and clarification. 1227. Prolex Cream

1228. Urelia Ointment

1229. Cosalik Cream


1230. Vitaderm-M Tablet Deferred for further evaluation and clarification.

M/s Zaidi Chemist, Peshawar

15 Soekarno Square, Khyber Bazar, Peshawar

Agent of M/s Rowa Pharmaceuticals Ltd, Newtown, Bantry, Cork, Ireland

1231. Rowachol oral drops Deferred for further evaluation and clarification.

1232. Rowatinex Capsules



Form 5 is required.














1233. Rego-V Syrup

Deferred due to following grounds.

Calculation of Ginseng extract is wrong in master formula w.r.t

to given strength on form-3 i.e. 130mg/5ml.

Quantitative Assay of each ingredient in finished product is

required as part of testing methods.

Ghazi Brothers, Karachi

1234. Addcon Xf Superfine Deferred for further evaluation and clarification.

Innova Life Sciences, Lahore

1235. Gasmet Syrup

Deferred for further evaluation and clarification. 1236. Gasmet Drops

1237. Peefer Junior Sachet

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Bio Life Enterprises Nutraceuticals, Rawalpindi

1238. Cali + Tablet Deferred for further evaluation and clarification.

AR Nutraceutical Pharma, Karachi.

Plot No. F-4/C, S.I.T.E., Phase-II, Super Highway, Karachi

1239. Memrite-X Tablet


Fee challan and evidence of fee submission including breakage

of fee are not attached with application.

Form-3 is unsigned and un-stamped.

Form-3 need to be revised w.r.t. specification and salts/extracts

of each ingredient.


Herbal drugs the scientific name and species name of plant

along with following:-

o State part used, nature of ingredient i.e. powder

drugs,extracts (aqueous, alcoholic or any other solvent

used for extraction)

o In case of standardized extracts state the percentage of

active ingredient(s) case may be.

In case of extracts state Drug Extract Ratio if the extract is not

standardized.

Monograph of Medico sativa (alfalfa) is required.


1240. Memrite-X Syrup






of each ingredient.


Monograph of Medico sativa (alfalfa) is required.

Herbal drugs the scientific name and species name of plant

along with following:-

o State part used, nature of ingredient i.e. powder

drugs,extracts (aqueous, alcoholic or any other solvent

used for extraction)

o In case of standardized extracts state the percentage of

active ingredient(s) case may be.

In case of extracts state Drug Extract Ratio if the extract is not

standardized.

Strength of Methyl Paraben and Propyl Paraben and its safety

profile in children is required.

De-ionized water advantages over RO water use in formulation,



Form-3 need revision regarding ”recommended use” as the firm

has applied for syrup but given data of tablet.

Packaging and labeling is required:

i. Primary and secondary labels

1241. Vegrite-X Tablet Deferred for further evaluation and clarification.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

1242. Agnum Syrup

1243. Brainite Syrup

1244. Bycof Syrup

1245. Movrise Tablet

1246. Moveplex Syrup

1247. Recol Syrup

1248. Zigut Sachet

1249. Ostomove Syrup

1250. Femol Tablet

1251. Bycof Drop

1252. Moverise Drop

1253. Milkyvit Sachet

1254. Vilter-I Tablet


Fee challan and evidence of fee submission are not attached

with application.



ingredient.


1255. Vitrite Tablet



with application.




Form-3 also need to be revised w.r.t. submission of salts of

mineral (Copper) and its monographs.


Manufacturing process mentions Starch, iron bisglycinate, L-

methylfolate, vitamin B12, Vitamin C, however the same are

not given in list of active or in-active ingredients in master

formula. Needs clarification.

Manufacturing process mentioned tablet coating however no in-

active coating material is given in master formula, need

clarification.

Monograph of Zinc Oxide is required.

Label of firm states a warning: “if you are pregnant, nursing

women or if taking any medications, consult your doctor

before use. All ingredients are of Food Grade from Natural

Source & all statements has been evaluated by the Food &

Drug Administration”. Need clarification.


1256. Agnum Tablet




Stability studies of omega-3 in tablet dosage form is required.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


of each ingredient.

Patient information leaflet needs revision.


1257. Brainite Tablet






of each ingredient.

Monograph of piperine is required. Product specific monograph

of finished product is required.


1258. Vilter Syrup

Deferred for further evaluation and clarification. 1259. Vilter-I Syrup

1260. Vigrite Tablet

1261. Memrite Tablet






of each ingredient.



of each ingredient.

Monographs of ginseng and piperine are required.

Letter of commitment for shelf life studies is unsigned and

unstamped.

Undertaking regarding brand name is unsigned and unstamped.


1262. Memrite Syrup






of each ingredient.


Monographs of ginseng and piperine are required.


is required.

Patient information leaflet needs revision.

Species name of herbal ingredients.


Packaging and labeling is required:

i. Primary and secondary labels

1263. Vitrite Syrup




F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



Strength of elemental ingredients in their respective salts is

required.

Safety profile of Methyl Paraben and Propyl Paraben in

children is required.


of each ingredient.

Form-3 need revision regarding ”recommended use” as the firm

has applied for syrup but given data of tablet.


1264. Sidium Syrup Deferred for further evaluation and clarification.

1265. Viterite-D Tablet



with application.



In FIFO list the name is “Viterite-D Tablet” however on form-3

“Vitrite Tablet” is mentioned. However, firm also applied

another formulation with same name “Vitrite Tablet” given at

FIFO Sr. No. 1947.

As per form-3, Vitamin D3 dose is 15000IU which exceed the

RDA/Upper Tolerable Limits.


1266. Viterite-D Syrup


Fee challan as evidence of fee submission is not attached with

application.

Firm applied for Vitrite-D Syrup however Brand name needs to

be changed.

attached all documents of Vitrite-D drops Needs clarification

and revision of complete Form-3.

Keeping in view the difference of emulsion and syrup dosage

forms stability of Vitamin-D in syrup dosage form is required.


1267. Viterite-D Drop



application.


Composition mentioned in product profile is different as given

in master formula and certificate of analysis (finished product).

Needs clarification and revision of complete Form-3.

Specifications and rationale strength of vitamin D3 per unit drop

is required.

Strength of Methyl Paraben and Propyl Paraben and its safety

profile in children is required.


1268. Lungest Syrup Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)


application.


Form-3 having name of product with signed and stamped by the

owner/CEO is required.

Strength and specification of all active ingredients


The formulation contains ephedra which is a controlled

substance/precursor.


1269. Prolite Syrup Deferred for further evaluation and clarification.

Awacs Laboratories, Rawalpindi

1270. Awacs-D Syrup Deferred for further evaluation and clarification.

Innova Life Sciences, Lahore

1271. A2D Sachet Deferred for further evaluation and clarification.


1272. Diva Tablet Deferred for further evaluation and clarification.

Bion Life Sciences, Lahore

1273. D-Plus Drop Deferred for further evaluation and clarification.

1274. Promeg Syrup

Aulton Neutraceuticals, Hattar

Plot No. 84/1, Block A/1, Phase V, Industrial Estate, Hattar

(Evaluator Arslan Tariq, AD-I)

1275. Brovit Syrup



of the firm.

Form-3 needs to be revised w.r.t. strength of folic acid i.e.

500mg to 500mcg as given in master formula.


Safety of methyl paraben and propyl paraben is required in

children.

Strengths of ingredients are given as per 15ml of syrup however

dose is recommended as per teaspoon “5ml”, need clarification.

Product specific monograph is required including quantitative

assay of all vitamins and mineral elements.



Signed and stamped undertaking by the owner regarding brand

name and contents on notarized stamp paper is required.

Bion Life Sciences, Lahore

1276. Omvit Tablet Deferred for further evaluation and clarification.

1277. D-Plus Tablet

Gerishon International, Karachi

Plot No. 146, St-13/1, Sector 6-B, Abdulllah Industrial Estate, North Karachi, Industrial Area, Karachi

1278. Leuconor Syrup


Form-3 needs to be revised w.r.t. to specification of active

ingredients.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Justify that the manufacturing process will deliver desired

strength of each ingredient as mentioned on form-3.

Safety profile of Propyl Paraben in children is required.

Qualitative/identification test of ingredients in finished product

is required.

Product specific testing methods are required including assay of

finished product.

1279. Cilavit-D Tablet Deferred for further evaluation and clarification.

1280. Incepta Pharma, Taxila

1281. Eat More Syrup Deferred for further evaluation and clarification.


1282. Nephcit-K Tablet Deferred till finalization of fate of common molecule list being dealt by


1283. Multi-G Tablet


Form-3 needs to be revised w.r..t elemental equivalents in their

respective salts.


Safety of methylene chloride as coating agent is required.

Monograph of calcium pentothenate (USP), Ferrous fumarate

(USP) and Potassium Sulphate (BP) are required.

1284. Ovacure Sachet Deferred till finalization of fate of common molecule list being


1285. Melatris Tablet Deferred till finalization of fate of common molecule list being


PCP Healthcare, Okara

98-KM, Multan road, Akhtarabad, Okara

1286. Vitron Capsule


Form-3 is unstamped.



Justify the dose of each ingredient.


Calculations in master formula are not in accordance with form-

3.





Zahi Nutraceutical Laboratories, Peshawar

C-16, Hayatabad Industrial Estate, Peshawar

1287. Zahi Max Capsule




Monographs of all ingredients in their extract form are required.

Form-3 needs to be revised w.r.t. mentioning Yohimbe bar

extract instead of Yohimbine bark extract.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)



As per checklist of form-3 testing specifications of Raw

Material and Finished Products are required, as follows:

Identity, Purity and strength

Acceptable limits, ranges and criteria

Testing procedures and methodology.

Certificate of Analysis (COA)


98-KM, Multan road, Akhtarabad, Okara

1288. Ortholex-G Gel Deferred till finalization of fate of common molecules being dealt by


1289. Capsinol Spray Deferred till finalization of fate of common molecules being dealt by


1290. Capsinol Gel Deferred till finalization of fate of common molecules being dealt by


1291. Irofol Capsule






Monograph of Mecobalamin is required.







1292. Calzee-M Capsule





Strength of Calcium Carbonate i.e. 800 mg an Zinc sulphate i.e.

22mg mentioned on Form-3 is exceeding RDA/ upper tolerable

limits.

Monograph of magnesium sulphate is required.





Following packaging and labeling information is required as per

checklist:

Primary and secondary labels

Patient information leaflet





1293. Omofer Capsule Deferred due to following reasons:

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

The formulation is herbal, clarify if the firm has herbal section

1294. Ottimochel Capsule


Brand name on form 3 ism Hierro whereas all the documents are

of ottimochel

1295. Sanobac Capsule Deferred due to following reasons:

The formulation is herbal, clarify if the firm has herbal section

1296. Macula Guard Tablet Deferred due to following reasons:

Official testing method of EPA and DHA required

1297. Ik-Vit Tablet Deferred due to following reasons:


1298. Reosso Sachet Deferred due to following reasons:

Monograph of calcium from algae required


"Plot No. 32-33, Small Industrial Estate, Kohat Road, Peshawar"

1299. Diacin Tablet Deferred till finalization of fate of common molecules being dealt by


M/s Paramount HealthCare, (Eno 00395)

36-Industrial Triangle, Kahuta Road, Islamabad

1300. Deferred for further evaluation and clarification.

1301. Osson Suspension



Testing method of ossein mineral compelx required


1302. Calvid-3 Capsules








3.

Label needs to be revised w.r.t. composition of ingredients in

the light to form-3

Justify the assay limits of Vitamin D3 i.e. 90-165% in finished

product.





1303. Calvit-S Capsules








3.

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Justify the assay limits of Vitamin D3 i.e. 90-165% in finished

product.





1304. Ortholex-S Spray Deferred till finalization of fate of common molecules being dealt by


Well Grow Nutraceuticals Faisalabad

1305. Chestec D (well grow) Syrup Deferred due to following reasons:


1306. Mr. Cufy (well grow) Syrup





1307. Chestnol (well grow) Syrup Deferred due to following reasons:



1308. L-Crana

Deferred for further evaluation and clarification. 1309. Joint Inn

1310. Fere'Soin

1311. Paramount Healthcare, Islamabad

1312. Juene (Pramount) Sachet


Testing methods of fish collagen and black pepper extract

missing

1313. Osson Tablet



Testing method of ossein mineral compelx required


1314. Viss Deferred for further evaluation and clarification.


1315. Reston Tablet Deferred till finalization of fate of common molecule list being dealt by


1316. Reston Drops Deferred till finalization of fate of common molecule list being dealt by


1317. Reston Syrup Deferred till finalization of fate of common molecule list being dealt by


1318. Protolax Syrup Deferred till finalization of fate of common molecule list being dealt by


1319. Actizer Syrup Deferred due to following reasons:


1320. Q-well Syrup


Contains herbs, whereas the firm does not have herbal section

Undertaking for content, label and stability missing

1321. Vesoril Tablet


Contain Yohimbine (form 3 mentions yohimbine bark extract

while testing method of yohimbine HCl is given)

F.No.10-8/2020-OTC) (M-80)

of 144


(1) (2) (3)

Testing method of epimedium grandiflorum extract, muira

puama extract, L-opti-zinc and sodium selenate are missing

Clarify “arginine extract”


1322. Glytofer Tablet Deferred for further evaluation and clarification.

Adcok Pharmaceutical (Pvt) Ltd, Lahore

1323. Incal-C Tablet Deferred for further evaluation and clarification.

Bion Life Sciences, 19/40, St-13, Al-Faisal Town, Lahore

Lakhoki, off 4km Bandia Road, (1-E Alamdar Road, Near Ranger Head Quarter Al-Faisal Town) Lahore

1324. Adon oral drops


Confirmation of drop (nutraceutical) manufacturing facility is

required,

Quantitative method of each ingredient in finished product is

required.



Nutrifactor Laboratories (Pvt) Ltd, Faisalabad

1325. Glucofactor Plus Deferred for further evaluation and clarification.

Paramount Healthcare, Islamabad

1326. ACD (Paramount) Drops


Quantities per 5 ml or per drop required


1327. Emolen Deferred for further evaluation and clarification.

1328. Viton Tablet Deferred till finalization of fate of common molecule list being dealt by


1329. Mintox Deferred for further evaluation and clarification.

Route 2 Health (Pvt) Ltd Lahore

1330. Confido Tablet Deferred for further evaluation and clarification.

Hi-Tech Pharma, Lahore

1331. Strolitin Deferred for further evaluation and clarification.

(Muhammad Abdul Ghaffar)

Secretary, EEC