All Escitalopram formulations to carry boxed warning: CDSCO tells 102 pharma firms

Written by Farhat Nasim Published On 2021-02-05T15:28:41+05:30 | Updated On 23 Aug 2021 4:36 PM IST

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, 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

The notification further mentioned the following companies and many others, marketing the subject drug under the corresponding brand names :

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 Pvt.Ltd.)
35	Elcit 5 mg, 10 mg, 20 mg	Elite Pharmac Pvt. Ltd
36	Elpram S 10 mg	Kabir Lifesciences & Research Private Limited (Mfg. by. LIVEWELL HEALTHCARE)
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.

Central Drugs Standard Control OrganizationcdscoEscitalopramantidepressantIntas PharmaLupinTorrent PharmaLundbeckRexipraStalopamFeliz SCipralexNexitoClonazepambox warningsun pharma

Farhat Nasim

Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751