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Deficiency-letter-94th-meeting-of-EEC-held-on-26-08-2021

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F.No.10-10/2021-OTC) (M-94)
Government of Pakistan
Ministry of National Health Services, Regulations & Coordination
Drug Regulatory Authority Of Pakistan
Health & OTC Products Division (Non-Drugs)
*****
Islamabad, the 13th December, 2021
“SAY NO TO CORRUPTION”
Subject:
Submission of deficient information / documents
The applications of following applicants were placed before the Enlistment Evaluation
Committee (EEC) in its 94th meeting held on 26th August, 2021 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 along with soft data as per Annexed Format at
the end of this letter/document. Replies received after given time will not be entertained:S.No
(1)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Brand name
(2)
Decision
(3)
M/s Paul Brooks Homoeo Labs
Plot No. A-69, S.I.T.E., Super Highway Phase-I, Karachi (Homoeopathy) (00088)
Graphites Complex Course
Deferred for clarification of two formulations in one application
Haemorrhoids course Drops
Deferred for clarification of two formulations in one application
Deferred for submission of fee of Ideal growth course capsule, slip
Ideal Growth No.1 Capsule
attached is of Ideal growth course tablet (1)
Ideal Growth No.2 Tablet
Deferred for submission of fee
Hair Growth Course (Drops)
Deferred for Clarification of two formulations in one application
BRORHEUMA COURSE Drops
Deferred for Clarification of two formulations in one application
Acne Removal Course
Deferred for Clarification of two formulations in one application
M/s Hinucon (E.No 0062 )
Plot No. 12/1, Sector 15, Korangi Industrial Area, Karachi
HINUBON-D3K SPRAY
Deferred for justification Clarification of spray dosage form
HINUBON-D3K PLUS SPRAY
Deferred for justification Clarification of spray dosage form
HINUBON-PREGNO TABLET
Deferred for N-acetyl cysteine
Deferred for Clarification DMAE (dimethylaminoethanol
REMEMO-B CAPSULE
bitartrate).
MAFLOR SACHET
Deferred for clarification is required for Fucosyllactose.
M/s Pharmasave Laboratories
Chak No. 103 RB, 7-Km Jaranwala Road, Tehsil Jaranwala, District Faisalabad
EEC decided to defer the application for enlistment due to
following reasons:
Lycoveg Tablet
Monogrpahs of alloxan, adamas and Ingluvin are required.
Provide evidence that the source of adamas being used in the
formulation is free from TSE/BSE.
EEC decided to defer the application for enlistment due to
following reasons:
The firm applied Dry Suspension in Dry Powder/ Sachet Section
(homoeopathic) and directed to be reconstituted with water for
Biotic-D Dry powder
which is justification of rationality is required for such method of
reconstitution. Since pharma-copoeia states that alcoholic / hydro
alcholic solvents to be used for preparing a homoeo-pathic
formulation.
Brand name needs to be changed.
Cofex Dry powder
EEC decided to defer the application for enlistment due to
following reasons:
Page 1 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
16.
Brand name
(2)
Dyropod Dry powder
17.
Feverish Dry powder
18.
Save Menthox Dry powder
19.
Vita Save Dry powder
20.
Piles-X Ointment
21.
Xefol Effervescent Tablet
Decision
(3)
The firm applied Dry Suspension in Dry Powder/ Sachet Section
(homoeopathic) and directed to be reconstituted with water for
which is justification of rationality is required for such method of
reconstitution. Since pharma-copoeia states that alcoholic / hydro
alcholic solvents to be used for preparing a homoeo-pathic
formulation.
Provide monograph of Grindelia squarrosa.
The firm submitted alternate brand name;
Congesto-D
Chestoline-D
EEC decided to defer the application for enlistment due to
following reasons:
The firm applied Dry Suspension in Dry Powder/ Sachet Section
(homoeopathic) and directed to be reconstituted with water for
which is justification of rationality is required for such method of
reconstitution. Since pharma-copoeia states that alcoholic / hydro
alcholic solvents to be used for preparing a homoeo-pathic
formulation.
EEC decided to defer the application for enlistment due to
following reasons:
The firm applied Dry Suspension in Dry Powder/ Sachet Section
(homoeopathic) and directed to be reconstituted with water for
which is justification of rationality is required for such method of
reconstitution. Since pharma-copoeia states that alcoholic / hydro
alcholic solvents to be used for preparing a homoeo-pathic
formulation.
Provide monograph of Cedron.
Brand name needs to be changed.
EEC decided to defer the application for enlistment due to
following reasons:
The firm applied Dry Suspension in Dry Powder/ Sachet Section
(homoeopathic) and directed to be reconstituted with water for
which is justification of rationality is required for such method of
reconstitution. Since pharma-copoeia states that alcoholic / hydro
alcholic solvents to be used for preparing a homoeo-pathic
formulation.
Provide monograph of Peppermint as homoeopathic preparation.
EEC decided to defer the application for enlistment due to
following reasons:
The firm applied Dry Suspension in Dry Powder/ Sachet Section
(homoeopathic) and directed to be reconstituted with water for
which is justification of rationality is required for such method of
reconstitution. Since pharma-copoeia states that alcoholic / hydro
alcholic solvents to be used for preparing a homoeo-pathic
formulation.
Cosmo Pharma International Pvt Ltd, Karachi
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Crystolite Pharmaceuticals, Islamabad
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Brand name needs to be changed
 Evidence of fee submission is required
 R&I receiving of dossier is required
Page 2 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
22.
Osteolite Tablet
23.
Zimag Effervescent Tablet
24.
Arthropex Capsule
25.
Obelite Capsule
26.
Welnite Capsule
27.
Vatical Effervescent Tablet
28.
Maca Plus Capsule
29.
E-Petit Syrup
30.
Numeros-M Syrup
Decision
(3)
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Brand name needs to be changed
 Evidence of fee submission is required
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Brand name needs to be changed
 Evidence of fee submission is required
 R&I receiving of dossier is required
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Brand name needs to be changed
 Evidence of fee submission is required
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Brand name needs to be changed
 Evidence of fee submission is required
 R&I receiving of dossier is required
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Brand name needs to be changed
 Evidence of fee submission is required
 R&I receiving of dossier is required
Evergreen Pharmaceuticals, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Differential fee is required as product applied for herbal
products
 Properly filled signed and stamped form 3 is required
 Revised form 3 w.r.t specification and strength is required
 Undertaking regarding content and brand name is required
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Differential fee is required as product applied for herbal
products
 Properly filled signed and stamped form 3 is required
 Revised form 3 w.r.t specification and strength is required
 Undertaking regarding content and brand
 Firm uses herbs in crude form
Page 3 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
31.
Flamcid Syrup
32.
Ciliren Syrup
33.
Iron Heal Syrup
34.
Kuf-Heal Dc Syrup
35.
Avinox Oral Liquid
36.
Hober Tablet
Decision
(3)
 Confirmation of herbal syrup section is required
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Differential fee is required as product applied for herbal
products
 Properly filled signed and stamped form 3 is required
 Revised form 3 w.r.t specification and strength is required
 Undertaking regarding content and brand name is required
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Silybum marinum
which is in the list of common molecule and deferred till
the finalization of policy decision
 Brand name needs to be changed
 Differential fee is required as product applied for herbal
products
 Properly filled signed and stamped form 3 is required
 Revised form 3 w.r.t specification and strength is required
 Undertaking regarding content and brand name is
required
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Differential fee is required as product applied for herbal
products
 Properly filled signed and stamped form 3 is required
 Revised form 3 w.r.t specification and strength is required
 Undertaking regarding content and brand name is required
EEC decided to the application for enlistment due to following
reasons:
 The applied formulation contains Ephedra vulgaris which
is controlled drug precursor
 The applied formulation contains Ammonium chloride
which is in the list of common molecule and deferred till
the finalization of policy decision
 Brand name needs to be changed
 Differential fee is required as product applied for herbal
products
 Properly filled signed and stamped form 3 is required
 Revised form 3 w.r.t specification and strength is required
 Undertaking regarding content and brand name is
required
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Caffeine which is
registered as a drug
 Brand name needs to be changed
 Differential fee is required as product applied for herbal
products
 Properly filled signed and stamped form 3 is required
 Revised form 3 w.r.t specification and strength is required
 Undertaking regarding content and brand name is required
Ferroza International Pharmaceutical Pvt Ltd, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Undertaking regrading content and brand name is required
 Properly filled signed and stamped form 3 is required
Page 4 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
37.
Fubon Active Feed Dry Yeast
38.
Nutriplex Sachet
39.
Calplus Tablet
40.
Q-Nate-D Tablet
41.
Q-Nate-D Suspension
42.
Multi Day M Syrup
43.
Helibye Capsule
44.
Solaid Tablet
45.
Solaid Plus Tablet
46.
Solaid Plus Ds Tablet
Decision
(3)
Ghazi Brothers, Karachi
 The application is for import purpose and discussed with
other import case agenda
 Global Laboratories Islamabad
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Confirmation of food supplement section is required
Glorious Laboratories, Islamabad
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains ossein mineral complex
which is in the list of common molecule and deferred till
the finalization of policy decision
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains ossein mineral complex
which is in the list of common molecule and deferred till
the finalization of policy decision
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Hinucon, Karachi
EEC decided to defer the application for enlistment due to
following reasons:
 Monograph of Zinc-L carnosine is required
 Provide certificate of analysis of each Probiotic
microorganism.
 Monograph of relevant / specific strain of each Probiotic
microorganism.
 Provide individual strength (CFU) of each strain on form3.
 Finished product specifications and testing methods
(Identification, Verification and Enumeration of specific
strain used in formulation and method for identification of
contaminant and pathogenic micro-organism).
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Serratiopeptidase which
is in the list of common molecule and deferred till the
finalization of policy decision
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Serratiopeptidase which
is in the list of common molecule and deferred till the
finalization of policy decision
EEC decided to defer the application for enlistment due to
following reasons:
Page 5 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
47.
Alcuf Plus Syrup
48.
Nutrawhite Capsule
49.
Iris Syrup
50.
Feritos Tablet
51.
Control-D Tablet
52.
Calcivit Gold Powder
53.
Ct Spray
54.
Colic Free Syrup
55.
Calcofar Super
56.
Me Feed
57.
Urimax Sachet
58.
Lobaxen Syrup Syrup
Decision
(3)
 The applied formulation contains Serratiopeptidase which
is in the list of common molecule and deferred till the
finalization of policy decision
Innova Life Sciences, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Undertaking regarding content and brand name is required
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Undertaking regarding content and brand name is required
Innovatrium, Islamabad
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Undertaking regarding content and brand name is required
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Undertaking regarding content and brand name is required
Izfaar Nutraceutical Industries, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Justify the use of crude fat in formulation
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Justify the use of applied ingredient as topically
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 The applied formulation contains sodium bicarbonate and
ammonium bicarbonate which is in the list of common
molecule and deferred till the finalization of policy
decision
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 The applied formulation contains sodium bicarbonate and
ammonium bicarbonate which is in the list of common
molecule and deferred till the finalization of policy
decision
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
Mediformers Neutraceutical, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Undertaking regarding content and brand name is required
EEC decided to defer the application for enlistment due to
following reasons:
Page 6 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
59.
Mp Cran Sachet
60.
Super Vision Tablet
61.
Oraled Food Supplement
62.
Multikuff + Syrup
63.
Flexinate Ds
64.
Cozy Gut Drop
65.
Iu3 Drop
66.
Activin Syrup
67.
Bio-G10 Tablet
68.
Life-D Capsule
69.
Minco Tablet
70.
Big-3 Tablet
Decision
(3)
 Brand name needs to be changed
 Undertaking regarding content and brand name is required
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Undertaking regarding content and brand name is required
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Confirmation of food supplement section
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
Medinoon Research Laboratories, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Serratiopeptidase which
is in the list of common molecule and deferred till the
finalization of policy decision.
Miksons Healthcare SMC (Pvt) Ltd, Islamabad
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
Page 7 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
71.
Syner Tablet
72.
Bonez Tablet
73.
Galfer Syrup
74.
Calzin Ad
75.
Sunmax Tablet
76.
Xec-F Tablet
77.
Bonigrow Drop
78.
Appechil Syrup
79.
Bonigrow Syrup
80.
Lecofree Syrup
81.
Ostoflex Tablet
Decision
(3)
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Mod Herbs, Karachi
EEC decided to defer the application for enlistment due to
following reasons:
 Firm uses herbs in crude form
 Confirmation of herbal oral liquid section
 Brand name needs to be changed
 Differential fee is required , fee paid for herbal product
EEC decided to defer the application for enlistment due to
following reasons:
 Firm uses herbs in crude form
 Confirmation of herbal oral liquid section
 Brand name needs to be changed
 Differential fee is required, fee paid for herbal product
EEC decided to defer the application for enlistment due to
following reasons:
 Firm uses herbs in crude form
 Confirmation of herbal oral liquid section
 Brand name needs to be changed
 Differential fee is required, fee paid for herbal product
EEC decided to defer the application for enlistment due to
following reasons:
 Firm uses herbs in crude form
 Confirmation of herbal oral liquid section
 Brand name needs to be changed
 Differential fee is required, fee paid for herbal product
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
Page 8 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
82.
Nikof Syrup
83.
D-Well Tablet
84.
Multineu Syrup
85.
Antaneu Syrup
86.
Mintocid Syrup
87.
Calcium Plus Tablet
88.
Recran Capsule
89.
Fertigo Capsule
90.
Ortho-D Tablet
91.
Fitlacta Tablet
92.
Fasvit Tablet
93.
Fitfer Syrup
Decision
(3)
 The applied formulation contains Glucosamine and
Chondrition sulphate which are in the list of common
molecule and deferred till the finalization of policy
decision.
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Firm uses herbs in crude form
 Confirmation of herbal oral liquid section
 Brand name needs to be changed
 Differential fee is required, fee paid for herbal product
EEC decided to defer the application for enlistment due to
following reasons:
 Firm uses herbs in crude form
 Confirmation of herbal oral liquid section
 Brand name needs to be changed
 Differential fee is required, fee paid for herbal product
 The applied formulation contains Sodium bicarbonate
which is in the list of common molecule and deferred till
the finalization of policy decision.
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
Montis (Pvt) Ltd, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Ossein mineral complex
which is in the list of common molecule and deferred till
the finalization of policy decision.
MSG Nutraceuticals, Islamabad
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
Page 9 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
94.
Coughlin Syrup
95.
Qualifer Tablet
96.
Testmas Sachet
97.
Ere+ Tablet
98.
Contacid Syrup
99.
Minty Vits Tablet
100.
Zenten Ds Tablet
101.
Low-Chol Tablet
Decision
(3)
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Monograph of Chlorophytum borivillanum is required
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Neu Mex Healthcare Laboratories, Karachi
EEC decided to defer the application for enlistment due to
following reasons:
 Firm uses herbs in crude form
 The applied formulation contains Sodium bicarbonate
which is in the list of common molecule and deferred till
the finalization of policy decision
Novamed Healthcare, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 The firm applied the product on form 5
 Firm required to apply the product on form 3 with
specification and strength of each ingredients
Oasis Pharma, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Opal Laboratories, Karachi
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Phytocon International Private Limited, Lahore
Page 10 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
102.
Gascon Syrup
103.
Kiswa-D Tablet Tablet
104.
Pink Capsule
105.
Mi-Care Tablet
106.
Hitize Syrup
107.
Antispa Capsule
108.
Simkold Cream
109.
Zinclear Cream
110.
Nurex Tablet
111.
Scabro Lotion
112.
Puratin Tablet
113.
Ostico Syrup
Decision
(3)
EEC decided to defer the application for enlistment due to
following reasons:
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
Reign Nutro Pharma (Pvt) Ltd, Karachi
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Firm uses herbs in crude form
 Confirmation of herbal syrup section
Scotmann Pharmaceutical, Islamabad
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Simbro HealthCare, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation is intended for cosmetic purpose
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 The applied formulation contains Zinc oxide which is
registered as a drug
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Melatonin which is in
the list of common molecule
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
Page 11 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
114.
Ostico Tablet
115.
Ostocal Tablet
116.
Simjoba Cream
117.
Aloecam Lotion
118.
Multax Syrup
119.
Osteoflex Tablet
120.
Simthol Lotion
121.
Capsim Lotion
122.
Capsi Joint Lotion
123.
Rectus Tablet
124.
Vomixil Soft Gelatin Capsule
125.
Cosen Plus Syrup
Decision
(3)
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation is intended for cosmetic purpose
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 The applied formulation contains Chondrition sulphate
and Glucosamine which are in the list of common
molecule and deferred till the finalization of policy
decision.
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Sois Life Sciences, Karachi
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Tehseen Industries Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is required
 Brand name needs to be changed
Trends Pharmaceuticals Lahore
Page 12 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
126.
Pcosnil-T Tablet
127.
Cofli Syrup
128.
Neuron Syrup
129.
Mygrow Tablet
130.
Ferorich Tablet
131.
Vitmin Tablet
132.
Trauma Gel
133.
Calcirich Tablet
134.
Mucos Syrup
135.
Ferorich Syrup
136.
Crani Mox Sachet
137.
Iron Inn Tablet
Decision
(3)
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Melatonin which is in
the list of common molecule and deferred till the
finalization of policy decision.
Vermon Nutraceutical Pvt Ltd, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is
required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is
required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 The applied formulation contains Glucosamine and
Chondrotin which are in the list of common molecule
and deferred till the finalization of policy decision.
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Monograph of Matricaria Chamomilla extract is required
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
Well Grow Nutraceuticals Faisalabad
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is
required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
Page 13 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
138.
Iron Inn Syrup
139.
Maxin D Tablet
140.
Nspire Tablet
141.
Dusalac Syrup
142.
Wellslim Tablet
143.
Digm Plus Tablet
144.
Ovax Oral Suspension
145.
Evolax Syrup
Decision
(3)
 Firm uses herbs in crude form
 Confirmation of herbal tablet section
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
 Firm uses herbs in crude form
 Confirmation of herbal syrup section
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is
required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is
required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is
required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
The applied formulation contains
Diacerein,glucosamine,Chondrotin,hyaluronic acid which are in the
list of common molecule and deferred till the finalization of policy
decision.
Wilshire Laboratories Pvt Ltd, Lahore
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Provide certificate of analysis of each Probiotic
microorganism.
 Monograph of relevant / specific strain of each Probiotic
microorganism.
 Provide individual strength (CFU) of each strain on
form-3.
 Finished product specifications and testing methods
(Identification, Verification and Enumeration of specific
strain used in formulation and method for identification
of contaminant and pathogenic micro
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Brand name needs to be changed
Page 14 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
146.
Zelaz Capsule
147.
Mega Renal Powder
148.
Mega Liver Marine Liquid
149.
Mega Enzyme Powder
150.
Duraprep Solution
151.
Quali Drop
152.
Bisfolate Syrup
153.
Ade Roze Drop
154.
Glumem Tablet
155.
Bionerve Drop
156.
Flusaline Spray
Decision
(3)
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Provide certificate of analysis of each Probiotic
microorganism.
 Monograph of relevant / specific strain of each Probiotic
microorganism.
 Provide individual strength (CFU) of each strain on
form-3.
 Finished product specifications and testing methods
(Identification, Verification and Enumeration of specific
strain used in formulation and method for identification
of contaminant and pathogenic micro
Zainb Nutraceutical Industries, Arif Wala
EEC decided to defer the application for enlistment due to
following reasons:
 The applied formulation contains Ammonium chloride
which is in the list of common molecules and deferred
till the finalization of policy decision.
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is
required
 Brand name needs to be changed
EEC decided to defer the application for enlistment due to
following reasons:
 Properly filled signed and stamped form 3 is required
 Evidence of fee submission along with R&I receiving is
required
 Undertaking regarding content and brand name is
required
 Brand name needs to be changed
3M Pakistan, Karachi
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Adcok Pharmaceutical (Pvt) Ltd, Lahore
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for submission of fee evidence and change of brand name.
Deferred for following reasons:
 change of brand name.
 Fee evidence and its endorsement by concerned division
of DRAP is required.
Deferred for following reasons:
 Glucosamine is added in common molecules list.
 Monograph of egg shell membrane powder is required.
Deferred for following reason:
 Monographs of all ingredients in extract form are
required.
Deferred for following reasons:
Page 15 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
157.
Minti Suspension
158.
Suptize Syrup
159.
Epizo Syrup
160.
Hilcid Syrup
161.
Lexitose Syrup
162.
Ercidox Syrup
163.
Flusaline Drops
164.
Spasbid Drops
165.
Filcid Suspension
166.
Q-Xymes Plus Capsule
167.
Xen D3 Drop
168.
Cran-Q Sachet
169.
Big Berry Sachet
170.
Xecrab Sachet
171.
Crannx Sachet
172.
Amocid Suspension
Decision
(3)
 Justification of sodium chloride as single ingredient, as
health product is required.
 Fee evidence is required
Deferred for submission of fee evidence.
Deferred for submission of Monographs of all ingredients in extract
form.
Deferred for submission of following reasons:
 Monographs of acacia prebiotic fiber, spirulina seawees,
chichorium intybus and nasturtium officinale are required.
 Justification of use of acacia prebiotic fiber as health
product is required.
Deferred till finalization of common molecules list.
Deferred for submission of following reasons:
 Monograph of camellia sinensis extract is required.
 Brand name to be changed.
Deferred for following reasons:
 Sodium bicarbonate is added in common molecules list.
 Monograph of populus euphoritica extract is required.
Deferred for submission of Justification of use of sodium chloride
as single ingredient, as health product.
Deferred till finalization of common molecules list.
Alaq Laboratories, Lahore
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Sodium bicarbonate is added in common molecules list.
Page 16 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
173.
D-Cal Suspension
174.
Lecate Suspension
175.
Xen D Plus Suspension
176.
Loose-X Suspension
177.
Calwin Syrup
178.
Fe-Booster Syrup
179.
Xinco Plus Syrup
180.
Cicof Syrup
181.
Xen Vit-R Syrup
182.
Re'Gink Syrup
183.
Appisen Syrup
184.
Gynaxen Syrup
Decision
(3)
 Fee evidence is required.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required
Deferred for following reasons:
 Brand name to be changed.
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Kaolin is added in common molecules list.
 Undertaking are required.
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
Page 17 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
185.
Etamax Syrup
186.
Xenofer Syrup
187.
Pulmax Syrup
188.
Api-Mal Syrup
189.
Calwin Tablet
190.
So Cal-D Tablet
191.
Xemob Plus Tablet
192.
Energia Tablet
193.
Big-Vit Tablet
194.
Multininz Tablet
195.
Xen Vit-R Tablet
196.
Xwnofer Tablet
Decision
(3)
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
 Yohimbine is added in common molecules list.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
Page 18 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
197.
Xen D Plus Tablet
198.
Xebest-Co Tablet
199.
Rexanthin Tablet
200.
Sen-Q10 Tablet
201.
L-Xecal Tablet
202.
Xen D3-5000 Tablet
203.
Heptoxen Tablet
204.
Vime-Booster
205.
Zesia Tablet
206.
Momax Powder
207.
Evermax Tablet
Decision
(3)
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
 Signed Undertakings are required
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required
Al-Asar Enterprises, Multan
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Amarant Healthcare, Karachi
Deferred for submission of Evidence since zinc carnosine is
considered as health product or otherwise, signed and stamped
Form 3 and fee evidence.
Angel Human Health Nutraceutical, Faisalabad
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
Page 19 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
208.
Seri Forte Tablet
209.
Frolic Tablet
210.
Seri Forte Tablet
211.
Folic Tablet
212.
Evermax Tablet
213.
Momax Powder
214.
Neofol Tablet
215.
216.
Pentovit-P Syrup
Pentovit-P Tablet
217.
Tricid Syrup
218.
Ip Malt-Sf Syrup
219.
Ip Malt-Sf Tablet
220.
Pro-Mom Tablet
Decision
(3)
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for further clarification and evaluation.
Deferred for further clarification and evaluation.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
Page 20 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
221.
Alpha Man Tablet
222.
Nytol Drop
223.
Higher-G Syrup
224.
D-Mak 3 Tablet
225.
Mylin Syrup
226.
Rezinc Drop
227.
Epicure Syrup
228.
Calence Tablet
229.
Azen Tablet
230.
Bisnat-F Tablet
231.
Neovitea Tablet
232.
Hb Plus Tablet
Decision
(3)
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
Page 21 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
233.
Folixa Tablet
234.
Heamofer Tablet
235.
Ferinal Tablet
236.
Folic Tablet
237.
Bist Tablet
238.
Bist Syrup
239.
Iroz-F Tablet
240.
Pinker-F Syrup
241.
Pco'S Sachet
242.
De-One Drop
243.
Drop-3 Drop
244.
Afol Tablet
Decision
(3)
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for further clarification and evaluation.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
Page 22 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
245.
Neurogin Syrup
246.
Ofa-Plus Tablet
247.
Ad-One Drop
248.
Superior Heat Powder
249.
Special Life Stomach Powder
250.
Urine Easy Sachet
251.
Renova Tablet
252.
Era-Max Tablet
253.
Axis Da Drop
254.
Just-D3 Softgel
255.
Biocid Suspension
256.
Glotite Syrup
257.
Bioron Syrup
Decision
(3)
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Animal Life Care, Bahawalpur
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Brand name to be changed.
 Signed and stamped Form 3 is required.
Anza Pharma, Lahore
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
 Signed and stamped Form 3 is required.
Apple Laboratories, Islamabad
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
AR Nutraceutical Pharma, Karachi
Deferred for following reasons:
 Monographs of mucuna racemosus extract, gojiberry
extract, chlorophytum borivilanum extract are required.
 Brand name to be changed.
 Signed and stamped Form 3 is required
Arber Pharma, Lahore
Deferred for change of brand name and fee evidence.
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
Deferred for following reasons:
 Monograph of hyoscymaus niger is required.
 Fee evidence is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for submission of Monographs of all ingredients in extract
form and fee evidence.
Deferred for following reasons:
 Fee evidence is required.
Page 23 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
258.
Melan+ Tablet
259.
Gentione Tablet
260.
Cubic Tablet
261.
Ruban Tablet
262.
Ivy Syrup
263.
Caltreat Tablet
264.
Lite-D3 Drop
265.
Formax Tablet
266.
Bioron Tablet
267.
Fast-C Effervescent Tablet
268.
Glow Plus Tablet
269.
Axis-Da Drop
Decision
(3)
 Brand name to be changed.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Brand name to be changed.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Page 24 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
270.
Apimark Syrup
271.
Xen D Plus Tablet
272.
Waka 4 Tablet
273.
Odego-Ds Tablet
274.
Silygro Tablet
275.
Xinco Syrup
276.
Uth Tablet
277.
Evium Tablet
278.
Bliss-V Tablet
279.
T-Koline Syrup
280.
Calbokon Tablet
Decision
(3)
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Page 25 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
281.
282.
283.
284.
285.
286.
287.
288.
289.
290.
291.
292.
293.
294.
295.
Brand name
(2)
Decision
(3)
Deferred for following reasons:
 Fee evidence is required.
Xefolate Tablet
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
T-Koline Tablet
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
Re-Kof Syrup
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Asfar Healthcare, Kasur
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Thirty Plus Sachet
 Brand name to be changed.
 Signed Undertakings are required.
Atco HealthCare Pvt Ltd, Karachi
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Abeaz Oral Liquid
 Brand name to be changed.
 Signed Undertakings are required.
Avanza Health Care Pvt Ltd, Lahore
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Leadofer Syrup
 Brand name to be changed.
 Signed Undertakings are required.
Bio Life Enterprises Nutraceuticals, Rawalpindi
Slimaid Capsule
Deferred for change of brand name.
Bio Serve Pharma, Karachi
Aso B12 Capsule
Deferred till finalization of common molecules list.
Hivit Syrup
Deferred for change of brand name.
Multiflex Tablet
Deferred for change of brand name.
Bion Life Sciences, Lahore
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Prolate-Hb Syrup
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Herbo Natural Chocolate Maca Root Powder
 Brand name to be changed.
 Signed Undertakings are required.
Blossom Lab, Pvt, Ltd, Lahore
Colic-B Drop
Deferred for change of brand name.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
D-Max Drop
 Brand name to be changed.
 Signed Undertakings are required.
M-Max Powder
Deferred for following reasons:
Page 26 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
296.
Cadik-C Sachet
297.
B-Cran Sachet
298.
Ener-V Supplement
299.
Menso-Fit Syrup
300.
Luxevit Syrup
301.
Cuf-Tox Syrup
302.
Di-Gel Syrup
303.
Apilex Syrup
304.
Stomogel Syrup
305.
Calci-Bion Syrup
306.
B-Kuf Syrup
307.
Ginko-Vit Syrup
308.
D-Stop Syrup
Decision
(3)
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for submission of fee evidence.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for change of brand name.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
Page 27 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
309.
Iron-Bion Syrup
310.
D-Cid Syrup
311.
Zinc Plus Syrup
312.
Multi-Bion Syrup
313.
Sili-Max Syrup
314.
Consti-Fin Syrup
315.
Luxevit Tablet
316.
Multi Bion+ Tablet
317.
Q-Lex Plus Tablet
318.
Milko Max Tablet
319.
Fertilex Tablet
320.
Iro-Bion-F Tablet
Decision
(3)
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for submission of Monographs of Malt and barley extract.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Monograph of soyabean flavone and avena extract are
required.
 Brand name to be changed.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
Page 28 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
321.
Calci-Bion Tablet
322.
Fol Max Tablet
323.
Repalex Tablet
324.
Mak-Dc Tablet
325.
Sili Max Syrup
326.
D-Stop Syrup
327.
Multi-Bion Syrup
328.
Apizer Syrup
329.
Milko–Max Tablet
330.
Ginko-Vit Syrup
331.
B-Kuf Syrup
332.
Iro-Bion Syrup
Decision
(3)
 Signed Undertakings are required.
Deferred for change of brand name.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Page 29 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
Brand name
(2)
333.
Zinc Plus Syrup
334.
Calcibion Syrup
335.
D-Max Drops
336.
Admax Drops
337.
Fertilex Tablet
338.
Iro-Bion-F Tablet
339.
Calcibion Tablet
340.
Q Lex Plus Tablet
341.
B-Cran Sachet
342.
Apilex Syrup
343.
Di-Gel Syrup
344.
Cuftox Syrup
Decision
(3)
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Page 30 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
345.
346.
347.
348.
349.
350.
351.
352.
353.
354.
355.
356.
357.
358.
359.
360.
361.
362.
Brand name
(2)
Decision
(3)
 Brand name to be changed.
 Signed Undertakings are required.
Capex Cosmetic & Pharmaceutical, Islamabad
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Fecund-M Capsule
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
C-Folic Tablets Tablet
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Cal Plus Effervescent Tablet
 Brand name to be changed.
 Signed Undertakings are required.
Deferred for following reasons:
 Fee evidence is required.
Osteogen Tablet
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
Classic Nutraceutical Labs, Peshawar
Univit-Cd Liquid
Deferred for change of brand name.
Deferred for following reasons:
 Fee evidence is required.
 Signed and stamped Form 3 is required.
Bioflush Liquid
 Brand name to be changed.
 Signed Undertakings are required.
C-Electrolyte Liquid
Deferred for change of brand name.
C-Electrolyte Powder
Deferred for change of brand name.
Univit-Cd Powder
Deferred for change of brand name.
Deferred for following reasons:
 Fee evidence is required.
Cdek-A Powder
 Signed and stamped Form 3 is required.
 Brand name to be changed.
 Signed Undertakings are required.
M/s. Zestech Sciences (E. No. 00117)
Plot No. 48. Sector 23, Korangi Industrial Area, Karachi
Deferred with final opportunity for the provision of testing of
Perk Up Syrup
extracts form of each active ingredient
Deferred with final opportunity for the provision of Monograph of
7EVEN SEAS SYRUP
omega 3 fish oil
Deferred with final opportunity for the following reasons:
ZAMVIT ORAL DROPS

The formulation contains common molecule.

Stability studies undertaking contents are not correct.
M/s. Calgan Phyto Pharma (Pvt) Ltd., (E. No. 00146)
Plot No. 2, Green Park Road, Near Band Road Grid Station, Lahore
Deferred with final opportunity for the provision of monograph and
INSTACOL DROPS
COA of henbane
HERBOLIN DROPS
Deferred with final opportunity for Clarification of drops section
Deferred with final opportunity for Clarification of drops section
ATIZEEP DROPS
and for provisonof monograph for testing method of Nepetacataria
Deferred with final opportunity for provision of monograph of
ALGIUM TABLET
algea mineral complex
Deferred with final opportunity for clarification of real fruit juice
OSTEOBEST TABLET
blend as an active ingredient.
Page 31 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
363.
364.
365.
366.
367.
368.
369.
370.
371.
372.
373.
374.
375.
376.
377.
378.
379.
380.
381.
382.
383.
384.
385.
386.
387.
388.
389.
390.
391.
392.
393.
394.
Brand name
(2)
Decision
(3)
REO-99 TABLET
Deferred with final opportunity for provision of copy of Fee slip
PharmEvo Pvt Ltd, Karachi
Deferred till finalization of policy guidelines regarding common
Nu-ORS Sachet (Lemon Flavor)
molecules
Adfolic OD Tablet
Deferred with final opportunity for the change of brand name
Deferred with final oppertunity for provision of fee receipt
Adfolic tablet
endorsed by statistical officer and chnge of brand name
Uricran Sachet
Deferred till finalization of policy regarding common molecules
Greni Sachet
Deferred for verification of herbal sachet facility of the firm
Deferred with final opportunity for the provision of Official
Aller Tablet (New Brand Name: ReAct Chewable Tablet)
monograph of ovomucoids
Deferred with final opportunity for the provision of Official
Jontibon Tablet
monograph of ovomucoids
Deferred with final opportunity for the verification of herbal
Evofit 400mg Capsule
capsule facility of the firm
Gluck Laboratories Pvt Ltd, Lahore
Easysan Syrup
Deferred with final opportunity for change of brand name
M/s. Cosmo Pharma International (Pvt) Ltd, (E. No. 00259)
Plot No. 883, Block- 2, Azizabad, Bangoria Town, Industrial Area FB Area, Karachi
COSMO’S
Deferred with final opportunity for the provision of monographs of
FEMI-9 SYRUP
extracts of the herbs
Trends Pharmaceuticals Lahore
Deferred for the provision of original contents undertaking on
Vitazar Syrup
stamp paper
Deferred with final opportunity for submission of official
Vitazar Tablet
monograph of spirulina extract
Deferred for the provision of original contents undertaking on
Wesifer Tablet
stamp paper
Lena Natural Laboaratories, Risalpur
Psycho-Gin Tablet
Deferred with final opportunity for change of brand name
Vital Mark Laboratories Pvt Ltd, Fasialabad
Super vit Forte Oral Solution
Deferred with final opportunity for the change of brand name
Deferred with final opportunity for the submission of monographs
Vital Bio Jigreen Liquid
of extracts of actives and brand name
ADEKC Plus Liquid
Deferred with final opportunity for change of brand name
Roots Pharma Pvt. Ltd., Lahore
Roots Hemorine Tablet
Deferred with final opportunity for the change of brand name
Roots Hemo-Z Tablet
Deferred with final opportunity fr the change of brand name
Deferred for submission of safety profile of secale cor mother
Roots Mensodril Syrup
tincture since it poses health risk.
Roots CufNil Syrup
Deferred with final opportunity for change of brand name
Roots Hepa-C Syrup
Deferred with final opportunity for change of brand name
ROOTS GAS GO SYRUP
Deferred with final opportunity for change of brand name
ROOTS CP HEPA NIL SYRUP
Deferred with final opportunity for change of brand name
ROOTS CP NATURAL SLIM SYRUP
Deferred with final opportunity for change of brand name
ROOTS CP NUX VOMICA SYRUP
Deferred with final opportunity for change of brand name
ROOTS CP OVA TESTA TABLET
Deferred with final opportunity for change of brand name
ROOTS CP NATURAL SLIM TABLET
Deferred with final opportunity for change of brand name
Deferred for submission of evidence stating source of mephitis is
BHL COUGH GO SYRUP
free from TSE/ BSE, E-coli and salmonella contamination.
M/s. Blossom Laboratories (Pvt.) Ltd.,
30-KM, Badian Road, ½ K.M Off Roda Bohgal Road, Lahore Cantt
Blasmozyme syrup
Deferred for submission of monograph of Ayurveda anacardium.
Deferred with final opportunity to provide following documents:
 Official monograph of Orchitinum
BL-51 Drops
 Evidence stating source of Orchitinum is free from contemination
of TSE, E-COLI and salmonella.
Rose Homeo Lab, Charsadda
Page 32 of 33
F.No.10-10/2021-OTC) (M-94)
S.No
(1)
395.
Brand name
(2)
AESCULUS HIPPOCASTANUM
(GHP) 100 g
396.
BLATTA ORIENTALIS (GHP) 100 g
397.
CONIUM
398.
CROTALUS HORRIDUS
100 g (GHP)
Decision
(3)
Deferred with final opportunity to provide the strength of active
ingredients
Deferred with final opportunity to provide the strength of active
ingredients
Deferred with final opportunity to provide the strength of active
ingredients
Deferred with final opportunity to provide the strength of active
ingredients
(Ayyaz Ahmad)
Secretary, Enlistment Evaluation Committee
Page 33 of 33
F.No.10-10/2021-OTC) (M-94)
ANNEXURE
The firm is directed to submit soft data in both
MS Excel & MS Word on following formats in
USB ONLY.
MS Excel Format
Sr.
No.
1.
Company
name
(Company
name, City)
Without
address
Product
Name
XYZ
Dosage
Form
Tablet
Composition
Each tablet
contains:
Abc
(USP)...50mg
Common Recommended
name
use
XXX
XXX
Pack
Size
10’s
20’s
Date of R&I
submission
DD.MM.YYYY
2.
MS Word Format
Sr. No.
1.
Company
name
(Company
name, City)
Without
address
Product Name and
composition
XYZ Tablet
Each tablet contains:
Abc (USP)….50mg
Common
name
XXX
2.
Page 34 of 33
Recommended use
XXX
Pack
Size
10’s
20’s
Download