All Escitalopram formulations to carry boxed warning: CDSCO tells 102 pharma firms
New Delhi: Through a recent notification, the Central Drugs Standard Control Organization (CDSCO) has directed all the manufacturers of Escitalopram and its combinational drug formulations to mandatorily add a boxed warning "Suicidality and Antidepressant Drug" to the package "prescribing information" or 'Package insert' for Escitalopram.Seeking scientific and medical justification,...
New Delhi: Through a recent notification, the Central Drugs Standard Control Organization (CDSCO) has directed all the manufacturers of Escitalopram and its combinational drug formulations to mandatorily add a boxed warning "Suicidality and Antidepressant Drug" to the package "prescribing information" or 'Package insert' for Escitalopram.
Seeking scientific and medical justification, the regulator asked all pharmaceutical companies engaged in manufacturing and marketing of subject drug are required to update their 'Prescribing Information" for the larger interest of public health safety.
As per the list prepared by the drug regulator, over 100 firms are engaged in the business of Escitalopram. Indicated to treat a major depressive disorder or generalized anxiety disorder, the formulation is an antidepressant of the selective serotonin reuptake inhibitor class.
Prominent drugmakers including Sun Pharma, Cipla, Alkem Labs, Lupin, and others are engaged in manufacturing and marketing the drug under different brand names.
The top 5 Escitalopram brands that make up 70% of the market share involve Sun Pharma as the market leader under the brand name Nexito, followed by Intas Pharma's Rexipra, Lupin's Stalopam, Torrent Pharma's Feliz S and Lundbeck's Cipralex.
In a notice issued to 102 pharma companies, CDSCO has directed to submit the details of the manufacturing facilities for the said formulations. Further, the drug regulator has asked the drugmakers to submit an original copy of the 'prescribing information (PI)" for its brand along with the 'Labels on the immediate container" and "Labels on carton/ Packs". A copy of the manufacturing Licence including the Loan Licence has also been asked for.
Drawing the attention of the manufacturers, CDSCO pointed out facts regarding Escitalopram as;
(i) In the " US FDA Prescribing Information" for "Escitalopram", there is a "Boxed Warning" as given below:
(ii) Using Clonazepam together with Escitalopram may increase side effects such as dizziness, drowsiness, confusion, & difficulty concentrating. Some people, especially the elderly, may also experience impairment in thinking, judgment, & motor coordination.
(iii) Escitalopram in combination with Etizolam may synergize the propensity of adverse drug reactions like dizziness, drowsiness, confusion, and difficulty concentrating. Some people, especially the elderly, may also experience impairment in thinking, judgment, and motor coordination etc. (Etinolam is 6-10 times more potent than diazepam.
The list of the company reads;
S. No | Company Name | S. No | Company Name |
1 | Aamorb Pharmaceuticals P. Ltd | 2 | Aarpik Pharmaceuticals Pvt. Ltd |
3 | Abbott Healthcare P. Ltd | 4 | Adamant Pharma |
5 | Alkem Laboratories Ltd. | 6 | Altius Life Sciences |
7 | Anikem Laboratories | 8 | Axis Life Sciences Pvt. Ltd |
9 | Baroda Pharmaceutical Pvt. Ltd. | 10 | Beekay Pharmaceuticals Pvt. Ltd. |
11 | Biomax Laboratories | 12 | Biosans Lifecare |
13 | Brawn Laboratories Ltd. | 14 | Cadila Pharmaceuticals Ltd. |
15 | Carise Pharmaceuticals Pvt. Ltd | 16 | Care Formulation Labs Pvt. Limited, Delhi |
17 | Captab Biotec | 18 | Cipla Limited |
19 | CFL Pharmaceuticals Ltd | 20 | Concern Pharma Limited |
21 | Concord Biotech Ltd | 22 | Crescent Therapeutics Ltd. |
23 | Crescent Formulations Pvt. Ltd | 24 | Cybele Bio Lifesciences Pvt. Ltd |
25 | Cure Quick Remedies | 26 | D.R. Johns Labs |
27 | Cyril Pharmaceuticals | 28 | East-West Pharma |
29 | Dycine Pharmaceuticals Ltd. | 30 | Elikem Pharmaceuticals Private Limited |
31 | Elder Pharmaceuticals Pvt. Ltd | 32 | Emenox Healthcare |
33 | Elite Pharmac Pvt. Ltd. | 34 | Eridanus Healthcare |
35 | Eris | 36 | Esteem Pharmaceuticals P. Ltd |
37 | Gentech Healthcare P. Ltd. | 38 | Glenmark Pharmaceuticals Ltd |
39 | Go-Ish Remedies Limited | 40 | Grownbury Pharmaceuticals Pvt. Ltd |
41 | Healing Pharma India Private Limited | 42 | Intas Pharmaceuticals Ltd |
43 | Icon Life Sciences | 44 | Invision Medi Sciences Pvt. Ltd. |
45 | Intra life (Doxis Laboratories) | 46 | J.B. Chemicals & P'ceuticals P. Ltd. |
47 | Infiga Healthcare | 48 | Kanad Labs |
49 | Laboratories Ltd | 50 | La Pharmaceuticals |
51 | Jpee Drugs | 52 | LifesaversRemedies |
53 | Konark Lifesciences P. Ltd. | 54 | Macleods Pharmaceuticals Pvt Ltd |
55 | La Renon Healthcare Pvt. Ltd. | 56 | Marc Laboratories Pvt.Ltd. |
57 | Lupin Laboratories Ltd. | 58 | Micro Labs Ltd. |
59 | Mankind Pharma Ltd | 60 | Modgal Pharmaceuticals (P) Ltd |
61 | Magnet Labs Pvt. Ltd. | 62 | Nexkem Pharmaceuticals Pvt.Ltd. |
63 | Mediez Pharma Pvt. Ltd. | 64 | Next Labs Pvt. Ltd. |
65 | Minova Life Sciences Pvt. Ltd | 66 | Nitro Organics |
67 | Molekule India Pvt.Ltd | 68 | Octane Biotech Pvt. Ltd |
69 | Nexus Biotech | 70 | Piramal Healthcare |
71 | Obsurge Biotech Ltd. | 72 | Psyco Remedies |
73 | Pharmakraft Therapeutics Private Limited | 74 | Reliance Lifecare Pvt. Ltd |
75 | Phoenix Pharmaceuticals | 76 | Rishab Healthcare Pvt. Ltd |
77 | Planishor Pharma | 78 | Sandhya Healthcare Remedies Impel P.Ltd |
79 | Proteger India | 80 | Suraksha Pharma |
81 | SWASTIK LIFESCIENCES | 82 | Symbiosis Pharmaceuticals Pvt. Ltd |
83 | Reliance Life science | 84 | Tas Med India Pvt. Ltd. |
85 | Rhombus Pharma P. Ltd. | 86 | Trigat Lifesciences P. Ltd. |
87 | RPG Lifesciences Ltd. | 88 | Ultra Healthcare Pvt. Ltd |
89 | Sun Pharmaceuticals Ltd. | 90 | Unimark Healthcare Pvt. Ltd. |
91 | Symbiosis Labs Pvt. Ltd | 92 | V8613 Healthcare |
93 | Talent Healthcare | 94 | Zuventus Healthcare Pvt. Ltd. |
95 | Torrent Pharmaceuticals Ltd. | 96 | Unichem Laboratories Ltd. |
97 | Tweet India Pharmaceuticals Pvt. Ltd. | 98 | Wockhardt Ltd. |
99 | USV Ltd | 100 | Talent India |
101 | Zydus Cadila Healthcare Ltd | 102 | Grownbury Pharmaceuticals Pvt. Ltd |
S. No | Company Name | Brand | ||
1 | Alwel 5 mg, 10 mg Tab | Zuventus Healthcare Pvt. Ltd. | ||
2 | Ambulax AD 5 mg, 10 mg Tab | Unimark Healthcare Pvt. Ltd | ||
3 | Anipram 5 mg, 10 mg, 20 mg Tab | Anikem Laboratories | ||
4 | Anxifree (10mg/0.5 mg) Tab | Obsurge Biotech Ltd | ||
5 | Anxiset Plus (10mg/0.5 mg) Tab | Obsurge Biotech Ltd. | ||
6 | Articalm 10 mg, 20 mg | Cadila Pharmaceuticals Ltd | ||
7 | Astodep-10 Tablet | Planishor Pharma. | ||
8 | Atpram 10 mg, 20 mg | Octane Biotech Pvt. Ltd | ||
9 | Axipram 10 mg, 20 mg | Axis Life Sciences Pvt. Ltd | ||
10 | C-Pram Plus, C-Pram S 5mg, 10 mg, 20 mg | Unichem Laboratories Ltd | ||
11 | Celexa S 10mg, 20 mg | Cyril Pharmaceuticals | ||
12 | Censpram 5 mg, 10 mg, 20 mg, Censpram Lite | USV Ltd. | ||
13 | Cilapam H Tab | Ultra Healthcare Pvt. Ltd | ||
14 | Cilapam H 0.25 mg/5 mg Tablet | Altius Life Sciences | ||
15 | Cilentra 5 mg, 10 mg, 20 mg | Ranbaxy Laboratories Ltd. | ||
16 | Cipralex 5 mg, 10 mg | CFL Pharmaceuticals Ltd. | ||
17 | Cit 10 mg, 20 mg | Biomax Laboratories | ||
18 | Cit Clo 0.5 mg/ 10 mg | Brawn Laboratories Ltd | ||
19 | Cita-S Plus, Forte | Crescent Therapeutics Ltd. | ||
20 | Cita-S Plus | Minova Lifesciences Pvt. Ltd | ||
21 | Cita-S 10 mg, 20 mg | Crescent Formulations Pvt. Ltd. | ||
22 | Citalop-S 5 mg, 10 mg, 20 mg | RPG Lifesciences Ltd. | ||
23 | Citel 5 mg, 10 mg, 20 mg | Magnet Labs Pvt. Ltd | ||
24 | Citofast 5 mg, 10 mg, 20 mg | Glenmark Pharmaceuticals Ltd | ||
25 | Citolex 10 mg, 20 mg | Lifesavers Remedies | ||
26 | Clotas EH 0.25 mg/5 mg Tablet | Tas Med India Pvt. Ltd. | ||
27 | Cypram 10 mg, 20 mg | Cybele Bio Lifesciences Pvt. Ltd. | ||
28 | Depran 5 mg, 10 mg, 20 mg, Forte | Intas Pharmaceuticals Ltd. | ||
29 | Deptune 5 mg, 10 mg, 20 mg | Baroda Pharmaceutical Pvt. Ltd | ||
30 | Dexanil 5 mg, 10 mg, 100 mg, Forte 0.5 mg/ 20 mg | Consern Pharma Limited | ||
31 | Dipwell 10 mg, 20 mg | Dycine Pharmaceuticals Ltd. | ||
32 | Ecit 10 mg | Talent Healthcare | ||
33 | Ecitalop 10 mg, 20 mg | East-West Pharma | ||
34 | Ecitmar 10 C | Nexmind(A division of Nexkem Pharma | ||
35 | Elcit 5 mg, 10 mg, 20 mg | Elite Pharmac Pvt. Ltd | ||
36 | Elpram S 10 mg | Kabir Lifesciences & Research Private | ||
37 | Elonzep 20 mg | Intra life (Doxis Laboratories) | ||
38 | Endeo 10 mg | Modgal Pharmaceuticals (P) Ltd | ||
39 | Erito Plus Tablet | Eridanus Healthcare | ||
40 | Escidant 10 mg | Adamant Pharma | ||
41 | Escigold 5 mg, 10 mg, 20 mg | Tweet India Pharmaceuticals Pvt. Ltd. | ||
42 | Escigress CZ 0.25 mg Tablet | La Renon Healthcare Pvt. Ltd | ||
43 | Escimax 5 mg, 10 mg | Invision Medi Sciences Pvt. Ltd. | ||
44 | Escirise 5 mg, 10 mg, 20 mg | Carise Pharmaceuticals Pvt. Ltd. | ||
45 | Escita 10 mg, 20 mg | Mediez Pharma Pvt. Ltd. | ||
46 | Escitacalm 5 mg, 10 mg | Reliance Lifecare Pvt. Ltd. | ||
47 | Escitalent 5 mg, 20 mg | Talent Healthcare . | ||
48 | Escitapax 5mg, 10 mg, 20 mg, Plus L Tablet | Reliance Life science | ||
49 | Escitozan 10 mg | V86B Healthcare | ||
50 | Escitrac 10 mg | Minova Life Sciences Pvt. Ltd | ||
51 | Esclo Plus 0.25 mg/5 mg Tablet | Escopam 10 mg, 20 mg | ||
52 | Icon Life Sciences | Beekay Pharmaceuticals Pvt. Ltd | ||
53 | Escopam 10 mg, 20 mg | Beekay Pharmaceuticals Pvt. Ltd | ||
54 | Esdep 5 mg, 10 mg, 20 mg | Abbott Healthcare Pvt. Ltd. | ||
55 | Esfancy 10 mg | Aamorb Pharmaceuticals P. Ltd | ||
56 | Esitopa 10 mg, 20 mg | Trigat Lifesciences P. Ltd | ||
57 | Esitor 5 mg, 10 mg, 20 mg | La Pharmaceuticals | ||
58 | Esivan 20 mg | Rhombus Pharma P. Ltd. | ||
59 | Esjoy 10 mg, 20 mg | Gentech Healthcare P. Ltd | ||
60 | Eslika 10 mg, 20 mg | Symbiosis Labs Pvt. Ltd | ||
61 | Esok 10 mg | Unichem Laboratories Ltd | ||
62 | Esopam 5 mg, 10 mg, 20 mg | J.B. Chemicals 86 P'ceuticals P. Ltd | ||
63 | Esopram 10 mg, 20 mg | Marc Laboratories Pvt.Ltd. | ||
64 | Espancy 10 mg | Aamorb Pharmaceuticals P. Ltd | ||
65 | Espar 10 mg | Biosans Lifecare | ||
66 | Espram 5 mg, 10 mg, 20 mg | Esteem Pharmaceuticals P. Ltd. | ||
67 | Estal 10 mg | Jpee Drugs | ||
68 | Estadep- 10 | OSR Pharmaceuticals P. Limited | ||
69 | Estalonix 10 mg | Phoenix Pharmaceuticals | ||
70 | Estilo 10 mg, 20 mg | Next Labs Pvt. Ltd. | ||
71 | Estomine 5 mg, 10 mg, 20 mg | Psyco Remedies | ||
72 | ESETOPA-10 | CareFormulationLabsPLimited | ||
73 | Etibliss ES | La Renon Healthcare Pvt Ltd | ||
74 | Etifit Plus | Planishor Pharma | ||
75 | Etilopram 5 mg, 10 mg | Macleods | ||
76 | Etilaam S, DS | Intas Pharmaceuticals Ltd | ||
77 | Etinex LS, Plus | Next Labs Pvt. Ltd. | ||
78 | Etipex Forte 0.5+50 mg | Reliance Lifesciences Pvt. Ltd | ||
79 | Etizola Plus, Lite | Macleods Pharmaceuticals Pvt Ltd | ||
80 | Excita 5 mg, 10 mg | Elder Pharmaceuticals Pvt. Ltd | ||
81 | Exeity Tab | Sandhya Healthcare RemediesImpel.Ltd | ||
82 | Ezeepam 5 mg, 10 mg | Eris | ||
83 | Ezen-10 Tablet | Infiga Healthcare | ||
84 | Ezinite 5 mg, 10 mg | Intra Life | ||
85 | Ezolent Plus, Forte | Talent India | ||
86 | Feliz S 5 mg, 10 mg, 20 mg, Feliz-S Lite Tablet, Feliz S EZ | Torrent Pharmaceuticals Ltd. | ||
87 | Firsito 5 mg, 10 mg, 20 mg | Zydus Cadila Healthcare Ltd | ||
88 | Jolivel 5 mg, 10 mg, 20 mg | Torrent Pharmaceuticals Ltd | ||
89 | Jopram 10 mg | D.R. Johns Labs | ||
90 | Kopram 10 mg, 20 mg | Konark Lifesciences P. Ltd. | ||
91 | Lexaheal 10 mg, 20 mg | Healing Pharma India P. Ltd. | ||
92 | Loptal 10 mg | Proteger India | ||
93 | Monopram 10 mg | Captab Biotec | ||
94 | Mocita-5 | Go-Ish Remedies Limited | ||
95 | Nestilo 10 mg | Nitro Organics | ||
96 | Nexito 5 mg, 10 mg, 20 mg, Nexito LS Tablet | Sun Pharmaceuticals Ltd | ||
97 | Nexpram 10 mg | Nexus Biotech | ||
98 | Newcita Lite 0.25 mg/ 10 mg Tablet | Alkem Laboratories Ltd. | ||
99 | Placida Plus | Mankind Pharma Ltd | ||
100 | Pocital S 5 mg, 10 mg, 20 mg | Symbiosis Pharmaceuticals Pvt. Ltd | ||
101 | Pracidep S 10 mg, 20 mg | Aarpik Pharmaceuticals Pvt. Ltd. | ||
102 | Prasilex 5 mg, 10 mg, 20 mg | Molekule India Pvt. Ltd. | ||
103 | Prasilife 5 mg, 10 mg, 20 mg | Emenox Healthcare | ||
104 | Recita 5 mg, 10 mg, 20 mg, Recita Lite 0.25 mg/ 10 mg Tablet | IPCA Laboratories Ltd | ||
105 | Rexipra 5 mg, 10 mg, 20 mg | Intas Pharmaceuticals Ltd. | ||
106 | Rhopram S 10 mg | Cure Quick Remedies | ||
107 | S Celepra 5 mg, 10 mg, 20 mg | Micro Labs Ltd. | ||
108 | S Citadelm 10 mg, 20 mg | Concord Biotech Ltd. | ||
109 | S Citadep 5 mg, 10 mg, 20 mg | Cipla Limited | ||
110 | S Citlop 5 mg, 10 mg | Suraksha Pharma | ||
111 | S Zitalo 5 mg, 10 mg, 20 mg | Abbott Healthcare P. Ltd | ||
112 | SC Talo 5 mg, 10 mg, 20 mg | Alkem Laboratories Ltd. | ||
113 | Seatle 10, 20 mg Tablet | East Waltz Pharmaceuticals | ||
114 | S-Tilocor 10 mg | Choroid Laboratories P. Limited | ||
115 | S Citadep 5 mg, 10 mg, 20 mg | Cipla Limited | ||
116 | Solopose Plus | Mankind Pharma Ltd | ||
117 | Stalopam 5 mg, 10 mg, 20 mg, Stalopam Lite Tablet | Lupin Laboratories Ltd. | ||
118 | Stalowil Plus | Lifecare Pharmaceuticals Pvt. Ltd. | ||
119 | SSRI PLUS 10MG/0.5MG TAB | Pharmakraft Therapeutics Pvt Ltd | ||
120 | Suprabenz Plus | Alkem Laboratories Ltd | ||
121 | Szetalo 5 mg, 10 mg, 20 mg | Piramal Healthcare | ||
122 | S-Zetalo 5 mg, 10 mg, 20 mg Film Coated Tablet, Szetalo LS Tablet | Abbott Healthcare P. Ltd | ||
123 | Talo 10 mg, 20 mg | Rishab Healthcare Pvt. Ltd. | ||
124 | Tralo 10 mg, 20 mg Tablet | Elikem Pharmaceuticals Private Limited | ||
125 | Truzap 5 mg, 10 mg | Intas Pharmaceuticals Ltd | ||
126 | Wqulok C 0.25 mg/5 mg Tablet | Kanad Labs | ||
127 | Zoly Plus | Grownbury Pharmaceuticals Pvt. Ltd. | ||
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