Drug Alert: CDSCO declares 49 drug samples as Not of Standard Quality; Details

New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) recently flagged 49 medicine batches for failing to qualify a random drug sample test for the month of December. These drug samples including Lorvas SR Tablets manufactured by Torrent Pharma, Udiliv 300 Tablets by Abbott and others are declared as 'Not of Standard Quality' while 1 out of the 47 drug samples has been declared as 'Spurious'.

This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 1336 drug samples. Out of this, 1286 samples were found of Standard quality while 49 of them were declared as Not of Standard Quality (NSQ).

Notable drugmakers including Torrent Pharma, Abbott, Akums Drugs and Pharmaceuticals Ltd., Zee Labs and others are involved in manufacturing the drugs.

The drug samples tested failed due to the presence of Assay, Description, Particulate Matter & pH, Uniformity of Content & Dissolution, Dissolution, Related Substances, Description, pH, water content & Assay, Assay of Neomycin Sulphate, Polymixin-B Sulphate and others.

The samples collected were tested in four laboratories namely CDTL Mumbai, RDTL Chandigarh, CDL Kolkata, RDTL Guwahati., CDL Chennai.

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

S.No.	Name of Drugs/medical device/cosmetics	Batch No./Date of Manufacture/Date of Expiry/Manufactured By	Reason for failure	Drawn By	From
1.	Zobra Eye Ointment– 5g (Tobramycin Ophthalmic Ointment U.S.P. 0.3% w/w)	B. No.: ZH17, Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Selvok Pharmaceutical Co., 147, G.I.D.C., Antalia, Bilimora- 396321(Gujarat).	Assay	CDSCO, South Zone, Chennai	CDL, Kolkata
2.	Diclofenac Sodium Injection I.P.	B. No.: I-18165, Mfg date: 11/2018, Exp date: 10/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar 143 001 (India) Punjab.	Description, Particulate Matter & pH	, CDSCO, North Zone, Ghaziabad	CDL, Kolkata
3.	Amoxycillin & Potassium Clavulanate Tablets I.P. 1000 mg	B. No.: BT 180322, Mfg date: 05/2018, Exp date: 04/2020, Mfd by: M/s. Theon Pharmaceuticals Ltd., Village Saini Majra, Tehsil Nalagarh, Distt. Solan (H.P.).	Uniformity of Content & Dissolution	CDSCO, North Zone, Ghaziabad	CDL, Kolkata
4.	Delisprin 75 (Aspirin Delayed-Release Tablets U.S.P. 75 mg)	B. No.: M107M018, Mfg date: 12/2018, Exp date: 05/2020, Mfd by: M/s. Aristo Pharmaceuticals Pvt. Ltd., #Plot No. 208, New Industrial Area No.-2, Mandideep, Dist. Raisen (M.P.).	Dissolution	CDSCO, East Zone, Kolkata	CDL, Kolkata
5.	Amlor - 2.5 (Amlodipine Besylate Tablets I.P.)	B. No.: KN19001, Mfg date: 01/2019, Exp date: 12/2020, Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (Part) I.D.A, Pashamilaram-502307, Sanga Reddy Dist, T.S., India. (Telangana).	Related Substances	CDSCO, East Zone, Kolkata	CDL, Kolkata
6.	Enbilol (Nebivolol Hydrochloride Tablets I.P. 5 mg)	B. No.: MT190877, Mfg date: 06/2019, Exp date: 05/2021, Mfd by: M/s. Mascot Health Series (P) Ltd., Plot No. 79, 80, Sec-6A, IIE, SIDCUL Haridwar- 249403 (Uttarakhand).	Dissolution	CDSCO, East Zone, Kolkata	CDL, Kolkata
7.	Regunac-50 (Diclofenac Gastro Resistant Tablets I.P. 50 mg)	B. No.: FZ57B801, Mfg date: 02/2018, Exp date: 01/2021, Mfd by: M/s. Zim Laboratories Limited, B - 21/22, MIDC, Kalmeshwar – 441 501, District - Nagpur, Maharashtra.	Description	CDSCO, East Zone, Kolkata	CDL, Kolkata
8.	CEFIXIME IP (COMPACTED)	B. No.: CFEC190215, Mfg date: 06/2019, Exp date: 05/2022, Mfd by: M/s.Covalent Laboratories Pvt Ltd, Survey No. 374, Gundla Machnoor Village, Hathnoor Mandal, Sanga Reddy, (Dist)- 502296, Telangana.	pH, water content & Assay	CDSCO, Zonal Office, Hyderabad	CDL, Chennai
9.	CLOXACILLIN CAPSULES IP 250 mg	B. No.: MBC-18017, Mfg date: 04/2018, Exp date: 03/2020, Mfd by: M/s.Maxmed Lifesciences Pvt. Ltd, Plot No. 54, Sector IIDC, SIDCUL, Rudrapur (Uttarakhand).	DESCRIPTION AND IDENTIFICATION	CDSCO, South Zone Chennai	CDL, Chennai
10.	Ursodeoxycholic Acid Tablets IP 300 mg ( UDILIV 300 TABLETS)	B. No.: 010924D7, Mfg date: 01/2019, Exp date: 01/2021, Mfd by: M/s. Abbott India Limited, L 18/19, Verna Industrial Area, Verna, Salcette, Goa- 403722.	Identification	Drugs Control Office	RDTL, Chandigarh
11.	Dabigatran Etexilate Mesilate Capsules ( DABROUTE 110 MG CAPSULES)	B. No.: SC-3115, Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Sunvet Healthcare Village Shambhuwala, Nahan, Paonta Road, Distt.Sirmour (H.P).	Assay	CDSCO, Sub-Zone, Baddi, Himachal Pradesh.	RDTL, Chandigarh
12.	Azithromycin Tablets IP (RZITH-250 TABLETS)	B. No.: NT-18899, Mfg date: 02/2019, Exp date: 01/2021, Mfd by: M/s. H.L.Healthcare Pvt. Ltd. Plot No.25, Ind. Area, Phase-II, Gagret- 177201 (H.P.).	Assay	CDSCO, Sub-Zone, Baddi, Himachal Pradesh.	RDTL, Chandigarh
13.	Indapamide SR Tablets 1.5 mg (LORVAS SR TABLETS)	B. No.: CX23F011, Mfg date: 06/2019, Exp date: 05/2024, Mfd by: M/s. TORRENT PHARMACEUTICALS LTD. Baddi 173205, Dist.Solan (H.P), INDIA.	Dissolution	CDSCO, Sub-Zone, Baddi, Himachal Pradesh.	RDTL, Chandigarh
14.	Domperidone Tablets IP 10 mg (DOMIDON- 10 TABLETS)	B. No.: T-19066, Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye Pass, Amritsar- 143001 (Punjab) India.	Identification A.	CDSCO North Zone Ghaziabad	RDTL, Chandigarh
15.	PRE AND PROBIOTIC CAPSULES-DS	B. No.: UPPC-1808, Mfg date: 11/2018, Exp date: 04/2020, Mfd by: M/s. Heal (India) Laboratories Pvt. Ltd. No. 197/1, Periyapalayam Road, Manjankaranai-601102, Tamilnadu.	Identification and Assay of Streptococcus faecalis T-110 JPC, Clostridium butyricum TO-A, Bacillus mesentericus TO- A JPC, Lactobacillus sporogenes.	CDSCO North Zone, Ghaziabad	RDTL, Chandigarh
16.	PRE AND PROBIOTIC CAPSULES-DS	B. No.: UPPC-1907, Mfg date: 03/2019, Exp date: 08/2020, Mfd by: M/s. Heal (India) Laboratories Pvt. Ltd. No. 197/1, Periyapalayam Road, Manjankaranai-601102, Tamilnadu.	Identification and Assay of Streptococcus faecalis T-110 JPC, Clostridium butyricum TO-A, Bacillus mesentericus TO- A JPC, Lactobacillus sporogenes.	CDSCO North Zone Ghaziabad	RDTL, Chandigarh
17.	ERYTHROMYCIN STEARATE TABLETS IP 250 MG	B. No.: GPT004, Mfg date: 10/2018, Exp date: 09/2020, Mfd by: M/s. OMEGA PHARMA Khasra No. 482, Village Saliyar, Roorkee-247667, Distt. Haridwar, Uttrakhand.	Dissolution	CDSCO North Zone, Ghaziabad.	RDTL, Chandigarh
18.	Calcitriol, Methylcobalamin, Folic Acid, Boron, Calcium Carbonate, Omega-3- Fatty Acids (EPA+DHA) Softgel Capsules ( 3G MAX SOFTGEL CAPSULES).	B. No.: ALD9075A, Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Amster Labs Vill. Saraj Majra Gujjran, Near Toll-Tax, Baddi-173205 (HP).	Assay of Folic Acid.	Drugs Control Office, H.P.	RDTL, Chandigarh
19.	PANTOPRAZOLE SODIUM STERILE	B. No.: APSS18004, Mfg date: 09/2018, Exp date: 08/2021, Mfd by: M/s. Rajasthan Antibiotics Limited, A- 619 & 630, Indl. Area. Bhiwadi-301019 (Rajasthan)-India	Assay	CDSCO, Sub-Zone, Baddi.	RDTL, Chandigarh
20.	Fexofenadine Hydrochloride Tablets IP 180 mg (MEDROFEX-180 TABLETS)	B. No.: SPT190012A, Mfg date: 01/2019, Exp date: 12/2020, Mfd by: M/s. SALUS PHARMACEUTICALS 480/211, Harraipur, PO Gurumajra, Teh. Baddi, Distt. Solan (H.P.)- 173205.	Dissolution	CDSCO, Sub-Zone, Baddi.	RDTL, Chandigarh
21.	NEOMYCIN SULPHATE, POLYMIXIN-B SULPHATE AND BACITRACIN ZINC POWDER	B. No.: GLEP-181020, Mfg date: 10/2018, Exp date:,09/2020, Mfd by: M/s. Grampus Laboratories Johron, Industrial. Area, Kala Amb.Distt.Sirmour (H.P.). 173030.	Assay of Neomycin Sulphate, Polymixin-B Sulphate.	CDSCO North Zone, Ghaziabad	RDTL, Chandigarh
22.	Lactulose Oral Solution USP (LACTOLOOK SOLUTION)	B. No.: S-11366, Mfg date: 04/2019, Exp date: 03/2021, Mfd by: M/s. Montek Biopharma 45, Himuda Ind. Area Bhatolikalan, Baddi Dist. Solan (H.P.).	Assay	CDSCO North Zone, Ghaziabad	RDTL, Chandigarh
23.	Ferrous Ascorbate, Folic Acid and Mecobalamin Suspension (FERIKIND-M SUSPENSION	B. No.: A6APS006, Mfg date: 03/2019, Exp date: 08/2020, Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd. 22, Sector-6A, I.I.E., SIDCUL, Haridwar- 249403 (Uttarakhand).	Assay of Folic Acid	CDSCO North Zone, Ghaziabad	RDTL, Chandigarh
24.	Diclofenac Gel IP	B. No.: 266, Mfg date: 01/2019, Exp date: 12/2020, Mfd by: M/s. Maxchem Pharmaceuticals (P) Ltd. Plot No.22, Sec-3, IIE, Pantnagar, Rudrapur, Distt. US Nagar-263153 (Uttarakhand).	Related Substances	CDSCO North Zone, Ghaziabad	RDTL, Chandigarh
25.	Dried Aluminium Hydroxide, Magnesium Hydroxide and Simethicone Suspension ( DIZER MPS)	B. No.: SL-383, Mfg date: 04/2019, Exp date: 03/2021, Mfd by: M/s. Sridhara Lifesciences Pvt. Ltd.Khasra No. 285, Sisona, Bhagwanpur, Roorkee, Distt. Haridwar (Uttarakhand).	pH	CDSCO, Sub-Zone, Baddi.	RDTL, Chandigarh
26.	Isosorbide Mononitrate Tablets IP (ISO-10 TABLETS)	B. No.: STN-181818, Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd. 3.B (a), Phase-III, Industrial Area, Sansarpur Terrace, Distt. Kangra (H.P)- 176501.	Description	Drugs Control Office H.P.	RDTL, Chandigarh
27.	Nitroglycerin Controlled-Release Tablets ( NITROMED- CR 2.6 TABLETS)	B. No.: CRT-190409, Mfg date: 04/2019, Exp date: 03/2021, Mfd by: M/s. Civron Pharmaceuticals 13, Industrial Area, Phase- III, Sansarpur-Terrace, Distt. Kangra (H.P).	Assay	CDSCO, Sub-Zone, Baddi.	RDTL, Chandigarh
28.	Nitroglycerin Controlled-Release Tablet (NITROMED- CR 6.4 TABLETS)	B. No.: CRT-190618, Mfg date: 06/2019, Exp date: 05/2021, Mfd by: M/s. Civron Pharmaceuticals 13, Industrial Area, Phase- III, Sansarpur-Terrace, Distt. Kangra (H.P).	Assay	CDSCO, Sub-Zone, Baddi	RDTL, Chandigarh
29.	Ciprofloxacin Tablets I.P. 500mg. (CIPJOHN-500)	B. No.: HTN813D, Mfg date: 04/2018, Exp date: 03/2021, Mfd by: M/s. Himalaya Meditek Pvt. Ltd. Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun-248197 (Uttarakhand).	Dissolution	Drugs Controller Department Arunachal Pradesh	RDTL, Guwahati
30.	Cefadroxil Tablets I.P. 500mg. (Cedoxil-500)	B. No.: T-16549, Mfg date: 03/2018, Exp date: 02/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar-143004 (Punjab).	Dissolution	Drugs Controller Department Arunachal Pradesh	RDTL, Guwahati
31.	Cefuroxime Axetil Tablets I.P. 500mg. (Amytum-500)	B. No.: C903701T, Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Nikvin Healthcare (I) Pvt. Ltd. Baddi, Barotiwala Road, Behind Govt. Timber Depot, Vill-Katha, H.P.- 173205.	Dissolution	Drugs Controller Department Tripura	RDTL, Guwahati
32.	Zinc Sulphate Dispersible Tablets I.P.	B. No.: ZN-S003, Mfg date: 04/2019, Exp date: 03/2021, Mfd by: M/s.Cyano Pharma (P) Ltd. 115-C, Indl. Estate, Plolo ground Indore-452015.	Disintegration	Drugs Controller Department Arunachal Pradesh	RDTL, Guwahati
33.	Ondansetron Hydrochloride Tablets I.P. 4 mg. (Emigo 4)	B. No.: ZLC1AQ8004, Mfg date: 08/2018, Exp date: 07/2021, Mfd by: M/s. Zuventus Healthcare Ltd., 5119, Oberoi Garden Estate, D-wing, Candivali, Andheri(E), Mumbai- 400072.	Dissolution	Drugs Controller Department Meghalaya	RDTL, Guwahati
34.	Calcium with Vitamin D3 Tablets	B. No.: TAK8048AL, Mfg date: 04/2018, Exp date: 03/2020, Mfd by: M/s. Hindustan Laboratories Plot No. 5- 9, Survey No.-38/2, Aliyali, Palghar (W), Maharashtra-401404.	Assay of Vitamin D3	Drugs Controller Department Assam	RDTL, Guwahati
35.	Calcium with Vitamin D3 Tablets	B. No.: TAK8162AL, Mfg date: 06/2018, Exp date: 05/2020, Mfd by: M/s. Hindustan Laboratories Plot No. 5- 9, Survey No.-38/2, Aliyali, Palghar (W), Maharashtra-401404.	Assay of Vitamin D3	Drugs Controller Department Assam	RDTL, Guwahati
36.	Calcium with Vitamin D3 Tablets	B. No.: TAK8137AL, Mfg date: 06/2018, Exp date: 05/2020, Mfd by: M/s. Hindustan Laboratories Plot No. 5- 9, Survey No.- 38/2, Aliyali, Palghar (W), Maharashtra -401404.	Assay of Vitamin D3	Drugs Controller Department Assam	RDTL, Guwahati
37.	Azithromycin Tablets I.P. 500 mg (Zolid 500)	B. No.: RAL-048, Mfg date: 06/2018, Exp date: 05/2020, Mfd by: M/s.Ronak Life Care Pvt. Ltd. R.S. No. 41 (Part) Vill- Rajpur, TA. & Dist- Patan - 384265, Ahmedabad.	Dissolution	Drugs Controller Department, Mizoram	RDTL, Guwahati
38.	Rabeprazole Sodium Tablets I.P. (Rebz-20)	B. No.: DVTE679B, Mfg date: 06/2018, Exp date: 05/2020, Mfd by: M/s. Digital Vision 176, Mauza Ogli Nahan Road, Kala-Amb, Dist-Sirmour, H.P. – 173030.	Dissolution	Drugs Controller Department Assam	RDTL, Guwahati
39.	Telmisartan Tablets I.P. 40 mg.	B. No.: TMA1001, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Sai Mirra Innopharm Pvt. Ltd. 288 & 299, SIDCO Estate, Ambattur, Chennai- 600098.	Dissolution	Drugs Controller Department Arunachal Pradesh	RDTL, Guwahati
40.	Paracetamol Tablets I.P. 500mg. (Asmol- 500)	B. No.: T-18043, Mfg date: 05/2018, Exp date: 04/2020, Mfd by: M/s. Parth Orgichem Pvt. Ltd., Plot No.-G-365, M.G. Road, Industrial Area, Hapur (U.P).	Dissolution	Drugs Controller Department, Manipur	RDTL, Guwahati
41.	Rebeprazole Sodium Tablets I.P. (YDZOLE 20)	B. No.: TPT-0203, Mfg date: 10/2018, Exp date: 09/2020, Mfd by: M/s. Tanpal Pharmaceuticals D-12- 13, Focal Point Nabha- 147201 (Punjab).	Dissolution	Drugs Controller Department, Nagaland	RDTL, Guwahati
42.	Nimesulide Tablets 100 mg	B. No.: NP17016, Mfg date: 09/2017, Exp date: 08/2020, Mfd by: M/s. Navketan Pharma Pvt. Ltd. F-106, MIDC, Waluj, Aurangabad-431136 (Maharashtra).	Disintegration	Drugs Controller Department Arunachal Pradesh	RDTL, Guwahati
43.	Etofylline & Theophylline Tablets IP	B. No.: BN9002, Mfg date: 04/2019, Exp date:,03/2022, Mfd by: M/s. Halewood Laboratories Pvt. Ltd., 319, Phase-II, G.I.D.C., Vatva, Ahmedabad.	Disintegration	CDSCO, South Zone, Chennai	CDTL, Mumbai
44.	Acetaminophen 500 mg soft gelatin Capsules	B. No.: M19AZ012, Mfg date: 06/2019, Exp date: 05/2021, Mfd by: M/s. Medgel Pvt. Ltd., 19 & 20, Special Economic Zone, Pharma Zone, Phase-II, Sector-III, Pithampur, Dist.-Dhar (M.P)- 454775.	Dissolution	CDSCO, Sub Zone, Indore	CDTL, Mumbai
45.	Montelukast Sudium & Levocetirizine Hydrochloride Tablets I.P.	B. No.: 419-11B, Mfg date: 01/2018, Exp date: 12/2020, Mfd by: M/s. Zee Laboratories Limited, Behind 47, Industrial Area, Poanta Sahib- 173025 (Punjab).	Dissolution of Montelukast Sodium	CDSCO, Sub Zone, Indore	CDTL, Mumbai
46.	Norfloxacin Tablets IP 400 mg	B. No.: T8422, Mfg date: 08/2018, Exp date: 07/2020, Mfd by: M/s. Zest Pharma, Plot No. 275, Sector F, Sanwer Road, Indore (M.P.) 452015.	Dissolution	CDSCO, Sub Zone, Indore	CDTL, Mumbai
47.	Zinco (Zinc Sulphate Dispersible Tablets IP)	B. No.: T-20152, Mfg date: 08/2019, Exp date: 07/2021, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar- 143001.	Disintegration	CDSCO, West Zone, Mumbai	CDTL, Mumbai

Also Read: CDSCO declares 37 drug samples including Ibuprofen, Vitamin B-Complex as Not of Standard Quality