Drug Alert: CDSCO declares 31 samples as sub-standard in quality in random sampling; Details

Written by Meghna A Singhania Published On 21 May 2019 11:14 AM | Updated On 16 Aug 2021 11:48 AM

New Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared more than a dozen drugs as sub-standard in quality, counterfeited and misbranded/ adulterated. These include Paracetamol tablets, Ciprofloxacin tablets, Gentamicin injections and Oxytocin Injections.

The move comes following analysis and test conducted by the CDSCO on 1064 drug samples as a part of the random sampling. The test found that 31 out of the total drug samples did not meet quality and therefore they were affirmed as not of standard quality (NSQ), spurious and misbranded under Form-13, Form-34 and Form- MD-32.

The drug samples were tested at four laboratories namely CDL, Kolkata, CDTL, Mumbai, RDTL, Guwahati and RDTL, Chandigarh.

The set of these 31 drugs in various dosage forms failed the quality test over the presence of foreign matter, description, particulate matter, extractable volume & assay, sterility, disintegration, dissolution and others parameters. The manufacturers of the drugs are based in states like Rajasthan, Punjab, Chandigarh, Gujarat, Maharashtra, Himachal Pradesh, Uttarakhand and Goa.

The medications included in the list are indicative of treating pain, cold or flu symptoms; antibacterial drug to treat and prevent several infections; induce labour, strengthen labour contractions childbirth, control bleeding after childbirth, or to induce an abortion.

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of April 2019 reads;

S. N.	Name of Drugs/medical device/cosmetics	Batch No./Date of Manufacture/Date of Expiry/Manufactured By	Reason for failure	Drawn By	From
1.	IBUPROFEN TABLETS IP 200 MG	B. No.: 5922, Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Vikram Laboratories (P) Ltd., Behind Tubewell Colony, Meerut Road, Muzaffarnagar-251002.	Test for Dissolution	CDSCO, South Zone, Chennai	CDTL, Chennai
2.	PANCURE TABLETS (PANTOPRAZOLE TABLETS IP 40 MG)	B. No.: SLP-18123, Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Sterlife Pharma Pvt Ltd., Plot No. 90 R.S No.3/P1, Vardhman Industrial Park, Nh-27, Bhojpara-360311, Rajkot, Gujarat.	Test for Dissolution	CDSCO, Zonal Office, Ahmedabad	CDTL, Chennai
3.	Thyrocure - 100 (Thyroxine Tablets I.P. 100 mcg)	B. No.: THDT605, Mfg dt: 07/2018, Exp dt: 12/2019, Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23,Sector- 3, Noida-201301, Distt. Gautam Budh Nagar (U.P.).	Assay	CDSCO, East Zone, Kolkata	CDL, Kolkata
4.	DIASET 2 (Glimepiride Tablets I.P. 2 mg)	B. No.: L35C15, Mfg dt: 06/2018, Exp dt: 05/2021, Mfd by: M/s. Stadmed Private Limited, C-18, Sarojini Nagar Industrial Estate, Lucknow – 226 008.	Dissolution	CDSCO, East Zone, Kolkata	CDL, Kolkata
5.	OCONA-CT Scalp Solution (Coal Tar & Ketoconazole Solution) – 50 ml	B. No.: COAK89, Mfg dt: 12/2017, Exp dt: 11/2019, Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd. 47, 48, Sector - 6A, I.I.E., SIDCUL, Haridwar – 249 403, Uttarakhand.	Foreign Matter	CDSCO, East Zone, Kolkata	CDL, Kolkata
6.	Tranexamic Acid Injection I.P. 500mg /5 ml	B. No.: TA-024, Mfg dt: 01/2018, Exp dt: 12/2019, Mfd by: M/s. Redico Remedies, 123, Mandhala, Barotiwala, Distt. Solan (H.P.) - 174103	Description & Particulate Matter	CDSCO, Hyderabad	CDL, Kolkata
7.	Gentamicin Injection I.P. 80 mg / 2ml	B. No.: 1794, Mfg dt: 12/2017, Exp dt: 11/2020, Mfd by: M/s. Sai Parenterals Pvt. Ltd., D4, Phase V, IDA Jeedimetla, Hyderabad - 500 055.	Description & Particulate Matter	CDSCO, Hyderabad	CDL, Kolkata
8.	Climox 1.2g (Amoxycillin & Potassium Clavulanate Injection I.P.),	B. No.: I-16813, Mfg dt: 04/2018, Exp dt: 03/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22- 24, Majitha Road, Bye Pass, Amritsar -143001 (India).	Particulate Matter & Clarity of Solution	CDSCO, Sub Zone Goa	CDL, Kolkata
9.	Oxytocin Injection I.P.	B. No.: I-16999, Mfg dt: 05/2018, Exp dt: 04/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22- 24, Majitha Road, Bye Pass, Amritsar 143001 (India)	Description, Particulate Matter, Extractable Volume & Assay	CDSCO, Sub Zone, Baddi	CDL, Kolkata
10.	Hemosponge (Absorbable Gelatin Sponge U.S.P.)	B. No.: 20180601, Mfg dt: 06/2018, Exp dt: 05/2022, Mfd by: M/s. Goodwill Lifesciences, 157-158, RJD Integrated Textile Park, Paal-Hazira Road, Ichhapore, Surat - 394510	Sterility	CDSCO, Ahmedabad	CDL, Kolkata
11.	Vomiros-4MD (Ondansetron Orally Disintegrating Tablets IP)	B. No.: ST-457, Mfg dt: 11/2018, Exp dt: 10/2020, Mfd by: M/s. Sridhara Life Science Pvt. Ltd., Khasra No.285, 290, Village- Sisona, Bhagwanpur, Roorkee, Haridwar (Uttarakhand) 247661.	Disintegration	CDSCO, West Zone, Mumbai	CDTL, Mumbai
12.	Carbamazepine Tablets I.P. 200 mg	B. No.: CRB801, Mfg dt: 02/2018, Exp dt: 01/2021, Mfd by: M/s. Medico Remedies Limited, (A WHO GMP & ISO 9001- 2015 Certified Company) 50, Juhu Supreme Shopping Center, Gulmohar Cross Road No.9, Juhu, Mumbai-400 049. Factory at 8 & 9 Dewan & Sons Udyog Nagar, Palghar 401 404 Maharashtra.	Disintegration	CDSCO, West Zone, Mumbai	CDTL, Mumbai
13.	Fusigen Ointment (Sodium Fusidate Ointment BP)	B. No.: GF568003, Mfg dt: 11/2018, Exp dt: 04/2021, Mfd by: M/s. Geno Pharmaceuticals Private Limited., situated at Thivim Industrial Estate, Karaswada, Mapusa, Goa- 403526.	Assay	CDSCO, Sub Zone/ Port Office, Goa	CDTL, Mumbai
14.	Ciprofloxacin Tablets I.P. 500mg	B. No.: CT70140, Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega	Dissolution	Drugs Control Department Assam	RDTL, Guwahati
		Biotech Ltd. 7th Mile Stone,
		Dehradun Road, Roorkee,
		Uttarakhand- 247667.
15.	Cefpodoxime Proxetil Dispersible Tablets (Eziprod 200)	B. No.: MHV-100, Mfg dt: 12/2017, Exp dt: 11/2019, Mfd by: M/s. Vee Laboratories Village Kaller,	Assay & Disintegration	Drugs Control Department Mizoram	RDTL, Guwahati
		Subathu Road, Saproon
		(Post) Solan- 173211
		(H.P.).
16.	Paracetamol Tablets I.P 650 mg (Pelmol-650)	B. No.: MST-17528, Mfg dt: 07/2017, Exp dt: 06/2019, Mfd by: M/s. M Sea Pharmaceuticals Pvt. Ltd. Surajpur, Paonta Sahib, Dist- Sirmour (H.P.)- 173025.	Dissolution	Drugs Control Department Assam	RDTL, Guwahati
17.	Paracetamol Tablets I.P 500 mg	B. No.: CT70153, Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee, Uttarakhand- 247667.	Dissolution	Drugs Control Department Assam	RDTL, Guwahati
18.	Paracetamol Tablets I.P 500 mg	B. No.: BT70106, Mfg dt: 05/2017, Exp dt: 04/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee, Uttarakhand- 247667.	Dissolution	Drugs Control Department Assam	RDTL, Guwahati
19.	Paracetamol Tablets I.P 500 mg	B. No. : CT70154, Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee, Uttarakhand- 247667.	Dissolution	Drugs Control Department Assam	RDTL, Guwahati
20.	Ciprofloxacin HCL Tablets I.P 500mg	B. No.: CT70140, Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee, Uttarakhand- 247667.	Dissolution	Drugs Control Department Assam	RDTL, Guwahati
21.	PANTOPRAZOLE GASTRO- RESISTANT TABLETS IP 40 MG	B. No.: TJPE802, Mfg dt: 03/2018, Exp dt: 02/2020, Mfd by: M/s. Unicure (India) Ltd. (Unit - II) 46(B)/49/B, Village Raipur, Bhagwanpur, Roorkee - 247661 (U.K.).	Dissolution	CDSCO, S.Z., Jammu.	RDTL, Chandigarh
22.	B-COMPLEX TABLETS NFI	B. No.: T-17313, Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22- 24, Majitha Road, Bye Pass, Amritsar- 143001(India).	Identification B and the Assay of Calcium Pantothenate	H.Q. State Jammu	RDTL, Chandigarh
23.	B-COMPLEX TABLETS NFI	B. No.: T-17377, Mfg dt: 07./2018, Exp dt: 06./2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22- 24, Majitha Road, Bye Pass, Amritsar- 143001(India).	Identification B and the Assay of Calcium Pantothenate.	H.Q. State Jammu	RDTL, Chandigarh
24.	Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets ( AMOXRAG-625 TABLETS )	B. No.: SLB-759, Mfg dt: 08/2018, Exp dt: 01/2020, Mfd by: M/s. SKOHIND LABS 20, Ext HPSIDC, Ind. Area, Baddi (H.P.) 173205.	Identification B and the Assay of Potassium Clavulanate Diluted calculated as Clavulanic Acid, Lactic Acid Bacillus.	H.P State	RDTL, Chandigarh
25.	Hydroxy Propyl Methyl Cellulose Ophthalmic Solution ( HYPROMELLOSE OPHTHALMIC SOLUTION USP )	B. No.: 8B05170, Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt Ltd. N-118, 119, 113, 119/1, 119/2, & 118/1, M.I.D.C., Tarapur, Boisar, Dist.Palghar - 401506.	Sterility	FDA, Haryana	RDTL, Chandigarh
26.	Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP along with sterile Pricon Angular Cannula 23G. ( APPAVISC PFS SOLUTION )	B. No.: PFB-701, OPCP-195, Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Appasamy Ocular Devices (P) Ltd., Plot No. 74-D, Katha Baddi, Distt.Solan (H.P.)- 173205 Mfd. By: Iscon Surgicals Limited 22/4 Heavy Industrial Area Jodhpur-342003, Rajasthan, India.	Sterility B.	Drug Controller officer, Haryana Karnal	RDTL, Chandigarh
27.	(DEXAMETHASON E SODIUM PHOSPHATE INJECTION IP)	B. No.: 317-936, Mfg dt: 09/2017, Exp dt: 08/2019, Mfd by: M/s. Zee Laboratories Ltd Behind 47, Industrial Area, Paonta Sahib -173025. INDIA.	Assay of Dexamethasone Sodium Phosphate Calculated as Dexamethasone Phosphate	Drugs Controller officer, Jhajjar	RDTL, Chandigarh
28.	Amoxycillin Trihydrate, Clavulanate Potassium Tablets (AMOXCV-625 TABLETS)	B. No.: VRBT-1863, Mfg dt: 09/2018, Exp dt: 02/2020, Mfd by: M/s. Vaishnav Remedies Khasra No. 524, Village - Sailyar Shalapur, Madhopur Road, Roorkee, Distt- Haridwar Uttrakhand - 247667.	Identification and the Assay of Amoxycillin Trihydrate calculated as Amoxycillin, Clavulanate Potassium calculated as Clavulanic Acid.	Drugs Controller officer, Haryana Karnal	RDTL, Chandigarh
29.	Heparin Injection IP 25000 units (AZZIRIN INJECTION )	B. No.: MCP19388, Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Health Biotech Ltd. Unit-II, Sandholl-173205.	Assay of Heparin Sodium	Drugs Controller officer, Panchkula	RDTL, Chandigarh

Also Read: Red Flag: CDSCO warns against Medtronic pacemaker for battery-related malfunction

analysisCarbamazepine TabletsCDSCOCefpodoxime Proxetil Dispersible TabletsCentral Drugs Standard Control OrganisationclimoxDCGIdrug samplesDrugs Controller General of IndiaEziprodFusigen OintmentGentamicin injectionGlimepiride TabletsHemospongeIbuprofen tabletsLaghu Udyog BharatiNot of Standard QualityNSQoxytocin injectionpancure tabletsParacetamolParacetamol TabletsSpuriousSQstandard qualityThyrocureTranexamic Acid Injection

Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

Meghna A Singhania

Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751