Drug Alert: 50 Drug Samples including Macleods' THYROX75 Fail To Qualify CDSCO Test
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 50 medicine batches for failing to qualify for a random drug sample test for April– 2024, which were tested in both Central and State drug laboratories.
Out of the 50 Not of Standard Quality samples published for April– 2024, 33 were tested in Central Laboratories including CDL Kolkata, RDTL Chandigarh, RDTL Guwahati, and CDTL Indore, while 17 samples were examined in state laboratories, including State Drugs Testing Laboratory Srinagar (Jammu and Kashmir), State Food and Drugs Laboratory Bambolim Goa, State Drugs Testing Laboratory Thiruvananth apuram Kerala, and MP State lab.
The list of drug samples tested in the central drug laboratory declared Not of Standard Quality includes Human Growth Hormone Inj. (Norditropin Nordiflex 15mg / 1.5ml) imported by Novo Nordisk India, Cilnidipine Tablets IP (Cinatab -10) manufactured by Mascot Health Series, Thyroxine Sodium Tablets I.P. (THYROX75) manufactured by Macleods Pharmaceuticals, Amoxycillin Oral Suspension IP manufactured by Ridley Life Science and others.
The drug samples tested in state laboratories that failed to qualify for drug sample tests include Ceftriaxone Injection IP 250 mg (JKMSCL Hospital Supply) manufactured by Himalaya Meditek, Rabeprazole Sodium Tablets IP (CYRA) manufactured by Mepro Pharmaceuticals, Metronidazole Tablets IP 200 mg manufactured by Arco Pharma, Salbutamol Nebuliser Solution BP manufactured by Kerala Medical Services Corporation, Paracetamol Paediatric Oral Suspension IP 125 mg/ml manufactured by Quest laboratories and others.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the disintegration test, failure of pH and identification test, failure of clarity test, failure of specific assay of drug test, and others.
The alert added, " Sate Drugs Licensing Authorities of Mizoram, Tripura, Pondicherry have stated that the NSQ data as “NIL” for the Month of April, 2024."
Furthermore, it stated, "State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttarakhand, West Bengal, Andaman and Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data- in respect of the Not of Standard Quality (NSQ) Alert for the Month of April 2024 as per DCG(I) Circular dated 09.02.2024."
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF APRIL – 2024.
A. CDSCO/Central Laboratories | |||||||
S. N. | Product/Drug Name | Batch No. | Manufa cturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1 | PemolateSuspension (Paracetamol, Phenylephrine Hydrochloride& Chlorpheniramine Maleate Suspension) | 407 | 10/2023 | 09/2025 | M/s. Pulse Pharma MFG. Co., S. No. 553, Lala Estate, Idar Highway Road, Savgadh, Himatnagar, Gujarat, India | Assay of Paracetamol& Phenylephrine Hydrochloride | CDL, Kolkata |
2 | Senocartine (Levocarnitine Injection USP 1g / 5ml) | RS23049 | 08/2023 | 01/2026 | M/s. Ratnatris Pharmaceuticals Pvt. Ltd., Survey No. 416, At Indrad, Tal- Kadi, Dist. Mehsana 382715 Gujarat, India | Description & Particulate Matterin Injections | CDL, Kolkata |
3 | Frusemide Injection IP 10mg / ml (Senfuro) | RS23037 | 08/2023 | 07/2025 | M/s. Ratnatris Pharmaceuticals Pvt. Ltd., Survey No. 416, At Indrad, Tal- Kadi, Dist. Mehsana 382715 Gujarat, India | Particulate Matter | CDL, Kolkata |
4 | Dextromethorphan HBr, Phenylephrine HCl & Chlorpheniramine Maleate Syrup (DEX HS Syrup) | S24B045 | 02/2024 | 01/2026 | M/s. Shri hari Pharmaceuticals, Vasdsar-Motibhoyan Road, Village: Vadsar - 382 721, Kalol District, Gandhinagar, Gujarat | Assay of Dextromethorph an Hydrobromide | CDL, Kolkata |
5 | Ofloxacin and Ornidazole Tablets IP | 6001523 | 06/2023 | 05/2026 | M/s. Karnataka Antibiotics and Pharmaceuticals Limited, Plot No-14, Peenya-II, Phase, Bengalluru- 560058, Karnataka. | Description | CDL, Kolkata |
6 | Ambroxol, Guaiphenesin, Terbutalineand Menthol (Bromodex - T) | BDT-1257 | 12/2023 | 05/2025 | M/s. Aurio Pharma Laboratories Pvt. Ltd., Rabindra Sarani, Namita, Kolkata-700049 | Assay of Menthol | CDL, Kolkata |
7 | Human Growth HormoneInj. (Norditropin Nordiflex 15mg / 1.5ml) | MC76638 | 05/2022 | 04/2024 | M/s. Novo Nordisk A/S Novo Alle, DK-2880 Bagsvaerd, Denmark, Imported by: Novo Nordisk India Prtivate Limited, Plot No. 32, 47-50, EPIP Area, Whitefield, Bangalore- 560066, | Description | CDL, Kolkata |
8 | Cilnidipine Tablets IP (Cinatab -10) | MT223472A | 07/2022 | 06/2024 | M/s. Mascot Health Series Private Limited, Plot No. 79, 80, Sector-6A, IIE, SIDCUL, Haridwar 249 403. | Dissolution | CDL, Kolkata |
9 | Atropine Sulphate Injection IP | 23UJ85 | 10/2023 | 09/2025 | M/s. SVP Life Sciences, C/10/1, Sara Industrial Estate, Selaqui, Dehradun, Uttarakhand | pH, Particulate Matter & Assay | CDL, Kolkata |
10 | Metoclopramide Injection IP 10mg / 2ml | 23DQE20 | 05/2023 | 04/2025 | M/s. SVP Life Sciences, C/10/1, Sara Industrial Estate, Selaqui, Dehradun, Uttarakhand | Assay | CDL, Kolkata |
11 | Ambroxol Hydrochloride, TerbutalineSulphate, Guaiphenesin Menthol Syrup (Luzicough-T) | JL-231248 | 12/2023 | 11/2025 | M/s. Jineka Healthcare Private Limited, Khasra No. 507-525, Bedpur Crossing Bhagwanpur Bypass, Roorkee, Distt. Haridwar (U.K.) 247 667 | Identification & Assay of Menthol and Assay of Terbutaline Sulphate | CDL, Kolkata |
12 | Gabapentin Tablets IP (Gabon-300) | MT225040 | 11/2022 | 10/2024 | M/s. Mascot Health Series Private Limited, Plot No. 79, 80, Sector-6A, IIE, SIDCUL, Haridwar 249 403. | Related Substances | CDL, Kolkata |
13 | Promethazine Hydrochloride Syrup IP (Phena Kid Syrup) | DEML- 304269 | 02/2023 | 01/2025 | M/s. Dr. Edwin Medilabs Pvt. Ltd., Plot No. B-29, Industrial Area, Focal Point Chanalon, Kurali, SAS Nagar - 140 103 (pb) | Assay | CDL, Kolkata |
14 | ★Cefixime Trihydrate with Lactic Acid Bacillus Tablets I.P. (Presef-200 LB Tablets) | BHCJ-009 | 11/2022 | 10/2024 | M/s. Pragti Remedies, Plot No. 143, G. S. Road Link, Ulubari Guwahati, Assam-781008 | Identification & Assay of Cefixime and GramPositive endospore bearingrod shaped bacterium. The sample deemed to be Spurious. | CDL, Kolkata Refer Sr No 05of spurious alertApril 2024 |
15 | Telmisartan Tables IP (Telwide 80 Tablets) | GT3F32 | 06/2023 | 05/2025 | M/s. Ritual Drugs Pvt. Ltd., Plot No. 271-272, Phase-I, HSIIDC, Barhi Industrial Area, Sonepat (HR) - 131 101 | Description & Dissolution | CDL, Kolkata |
16 | Quinine Sulphate Tablets IP 300 mg (REZ-Q* 300) | R22417106 | 09/2022 | 08/2024 | M/s. Shreya Life Sciences Pvt. Ltd., 13, 14, 15, Raipur, PO Bhagwanpur, Roorkee- 247 661, Uttarakhand. | Description | CDL, Kolkata |
17 | Cefixime Dispersible Tablets IP (Vixif-100 Tablets) | SBT136B | 02/2023 | 01/2025 | M/s. Amster Labs, Unit-II Hilltop, Ind. Estate, Vill. Bhatauli Kalan, Baddi, Dist. Solan (H.P.) | Disintegration | CDL, Kolkata |
18 | Amoxycillin and Pottasium Clavulanate with Lactic Acid Bacillus Tablets (Yamox-CL) | SEB-23122 | 09/2022 | 02/2025 | M/s. Supermax Laboratories, Plot No. 40, Pharmacity, Selaqui Industrial Area, Dehradun - 248 011 | Assay / Content of Gram Positive endospore bearingrod shaped bacterium | CDL, Kolkata |
19 | Thyroxine Sodium Tablets I.P. (THYROX- 75) | MTC2338A | 04/2023 | 03/2025 | M/s. Macleods Pharmaceuticals Ltd., Plot No. 2209, GIDC, Sarigam, Dist. Valsad 396 155 | Dissolution | CDL, Kolkata |
20 | Cyclosporine Capsules IP 25 mg (Cycloclean- 25) | RDCPH230 02 | 10/2023 | 09/2025 | M/s. Johnlee Pharmaceuticals Pvt. Ltd., Plot No. 10, 11, Sector 6B, IIE, SIDCUL, Haridwar, 249403 | Water | CDL, Kolkata |
21 | Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorphenamine Maleate & Menthol Syrup (Tuspress) | 23CH0250 | 12/2023 | 11/2026 | M/s. Enicar Pharmaceuticals Pvt. Ltd., Plot No. J-214, 215, 216, MIDC, Tarapur, Boisar, Dist. Palghar- 401506 | Assay of Menthol | CDL, Kolkata |
22 | Tranexamic Acid Injection IP (GYNAEPIL Injection) | ANO43004 R | 08/2023 | 07/2025 | M/s. Psychotropics India Ltd., Plot No. 12, 12A, Industrial Park-2, Phase-1, Salempur, Mehdood-2, Haridwar-249403 (Uttarakhand) | Description, Related Substances& Particulate Matter | CDL, Kolkata |
23 | Carvedilol Tablets IP 6.25 mg (Carviv-6.5 TABLETS) | VDT-23931 | Oct- 2023 | Sep- 2025 | M/s. Vidhyasha Pharmaceuticals, 28, Industrial Area, Johron Trilokpur Road, Kala Amb, Distt. Sirmour, H.P.- 173030 | Dissolution | RDTL, Chandigarh |
24 | TerbutalineSulphate, Ambroxol, Guaiphenesinand Menthol Syrup (Cufrish EXPECTORANT) | S-2245 | Nov- 2023 | Oct- 2025 | M/s. Northern India Chemical Works Pvt.Ltd., V.Dantal, MRT-250001 | pH | RDTL, Chandigarh |
25 | Clindamycin and Adapalene Gel (CLON- A Gel) | YEX-463 | Jan- 2024 | Dec- 2025 | M/s. Yaxon Biocare Pvt.Ltd., Plot No. 6, HSIIDC, Industrial Area Rai, Sonipat-131029 (HR). | Assay of Clindamycin Phosphate calculatedas Clindamycin | RDTL, Chandigarh |
26 | Neostigmine Mehtysulphate Injection IP(N-MINE Injection) | HINM23002 B | Feb- 2023 | Jan- 2025 | M/s. Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt.Solan (H.P.) India-173205 | Identification (A) | RDTL, Chandigarh |
27 | Diphenhydramine Hydrochloride Capsules IP (XL Dryl-D Capsules) | CPD240100 6 | Jan- 2024 | Dec- 2025 | M/s. Caspian Pharmaceuticals, Mauza Ogli, Suketi Road, Kala-Amb, Sirmaur-173030 | Dissolution and Assay of Diphenhydramin e Hydrochloride | RDTL, Chandigarh |
28 | Cloxacillin Sodium Oral SuspensionUSP 125mg/5ml | RD220020 | Jul-2022 | Jun- 2024 | M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC Indl.Complex, Narela, Delhi-110040 | Assay of Cloxacillin Sodium calculated as Cloxacillin | RDTL, Chandigarh |
29 | Enteric Coated RabeprazoleSodium andDomperidone (SustainedRelease) Capsules (STOMCOOLDSR CAPSULES) | SCDSR240 01 | Feb- 2024 | Jan- 2026 | M/s. VIP Pharmaceuticals Pvt. Ltd., Village, Manpura, Tehsil Nalagarh, Distt. Solan-174101 (H.P.) | Dissolutionof Domperidone (8th hours) and Dissolutionof Domperidone (12th hours) | RDTL, Chandigarh |
30 | AMOXYCILLIN TRIHYDRATEI.P. (MARKMOXORAL SUSPENSION I.P.) | OD-598 | Apr-2023 | Mar- 2025 | M/s. J.R.S. ORYX PHARMACEUTICALS (P) LTD., 217- 218, Sector-3, H.S.I.I.D.C., KARNAL- 132001 (India) | Assay | RDTL, Guwahati |
31 | Amoxycillin Oral Suspension IP | RD220034 | Oct-2022 | Sep- 2024 | M/s. Ridley Life Science Pvt. Ltd., D- 1651, DSIDC, Indl. Complex, Narela, Delhi- 110040 | Assay/Content of Amoxycillin | RDTL, Guwahati |
32 | Telmisartan Tablets IP 40 mg. (Tzil 40) | 189TTF002 | Jan-2023 | Dec- 2024 | M/s. Swiss Garniers Biotech Pvt. Ltd., 21, Industrial Area, Mehatpur, District- Una, Himachal Pradesh-174 315, INDIA. | Dissolution | RDTL, Guwahati |
33 | Amlodipine Besylate Tablets IP 5 mg | 1125 | Nov- 2023 | Oct- 2026 | M/s.Brilliant Lifesciences Pvt Ltd., At Chuval Dangarwa, Ta : Detroj Dist: Ahmedabad (Guj) India | Dissolution | CDTL, Indore |
B. STATE LABORATORIES | |||||||
S.N o | Product / Drug Name | Batch No. | Mfg Dt | Exp Dt | Manufactured By | NSQ Results | Reported By CDSCO / State Lab |
1 | Ceftriaxone Injection IP 250 mg (JKMSCLHospital Supply) | HD1607F | June, 2023 | May-25 | M/s. Himalaya Meditek Pvt Ltd Plot No. 35 & 36 Pharmacity Selaqui Ind. Area Dehradun - 248197 | The samplefails in Uniformaity of weights & Assay/Contents are found less than the label claim | State Drugs Testing Laboratory Srinagar (Jammu& Kashmir) |
2 | Exudase DP | 03023118 | Sep-23 | Aug-25 | M/s. Ravenbhel Healthcare Pvt Ltd . 16-17, EPIP, SIDCO Kartholi Bari Brahmana Jammu -1881133 Mrk. By: Ravenbhel Pharmaceuticals (P) Ltd 7-A, Baba Budha Avenue G.T Road Amritsar- 143001 | The sample fails in the test, “Description of tablets”. | State Drugs Testing Laboratory Srinagar (Jammu& Kashmir) |
3 | Rabeprazole Sodium Tablets IP 20mg (RAB 20mg) | UTGRBB3 04 | Aug-23 | Jul-26 | M/s. Khandelwal Laboratories Pvt. Ltd., Plot No. 20, Sector-6, IIE, Sidcul, Pantnagar, U. S. Nagar- Uttarakhand, 263153 | does not comply to IP Standardswith respect to dissolution test | State Food & Drugs Laboratory, Bambolim, Goa |
4 | Rabeprazole Sodium Tablets IP (CYRA) | CA21880 | Aug-23 | Jul-25 | M/s. Mepro Pharmaceuticals Pvt. Ltd.; (Unit II), Q Road, Phase IV, GIDC, hwan- 363035, Dist. Surendranagar, Gujarat. | does not conform to IP Standards with respect to the test for dissolution | State Food & Drugs Laboratory, Bambolim, Goa |
5 | Metronidazole Tablets IP 200 mg | 2869A | 07/23 | 06/25 | M/s. Arco Pharma Pvt Ltd, 1,2,3, Akshay Industrial Estate, Vasai, Palghar (M.S) | It fails thetest ‘Dissolution’ as per IP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
6 | Ciprofloxacin Tablets IP 500 mg | CPT 23022 | 09/23 | 08/26 | M/s. Vivek Pharmachem (India) Ltd, NH-8, Chimanpura, Amer, Jaipur- 303102 | It fails thetest ‘Dissolution’ as per IP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
7 | Bimatoprost Eye Drops 3 ml | CHE-3036 | 04/23 | 03/25 | M/s. Cotec Healthcare Pvt.Ltd, K.H.No. 593/1 Roorkee , Dehradun , High way, Kishanpur, Roorkee- 247667 Uttarakhand | It fails thetest ‘Sterility’ as per IP | StateDrugs Testing Laboratory Thiruvananth apuram, Kerala |
8 | Frusemide Injection IP 20 mg | FRIA-11 | 11/23 | 10/25 | M/s. Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad -121001 | It fails thetest ‘Sterility’ as per IP | StateDrugs Testing Laboratory Thiruvananth apuram, Kerala |
9 | Salbutamol NebuliserSolution BP | D 2259/23- 24 | 06/23 | 05/25 | Supplied by M/s. Kerala Medical services Corporation Limited, Thycaud P.O, Thiruvananthapuram | It fails the test Acidity pH as per BP | StateDrugs Testing Laboratory Thiruvananth apuram, Kerala |
10 | Warfarin sodium Tablet IP 5 mg | TW250004 | 07/23 | 06/26 | M/s. Centurion Remedies pvt.Ltd, G/5, G/6, Idl.Estate, Gorwa, Vadodara 390016 | It fails the ‘Description’. | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
11 | Amloheart-AT [Amlodipine Besylateand Atenolol Tablets] | LE 223030 | 03/23 | 02/25 | M/s. Lividus Pharmaceuticals pvt.Ltd, ikeva level 2, Agnito Tech Park, 141, Kandanchavadi, Near Perungudi, OMR, Chennai- 600096 | It fails the test ‘Assay’ as per IP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
12 | Bupivacaine Hydrochloridein Dextrose Inj. USP 0.50% 4 ml Amp | D2258/23- 24 | 09/23 | 08/25 | Supplied by M/s. Kerala Medical services Corporation Limited, Thycaud P.O, Thiruvananthapuram | It fails the test Sterility as per USP | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
13 | Mucoid-A [Acetyl Cysteine & Ambroxol HCL Tablets ] | MTT-6856 | 12/23 | 11/25 | M/s. MDC Pharmaceuticals Ltd, Unit-II, sai Road, Baddi- 173 205 | The content of active ingredients is not within the limits of Schedule V of Drugs and cosmetic act and rules there under | State Drugs Testing Laboratory Thiruvananth apuram, Kerala |
14 | Sallaki Tablets | AB 23055 | 11/23 | 10/26 | M/s. Gufic Biosciences Limited, 703, Udayambag, Belgaum, Karnataka | The sample fails the test Disintegration as per API | StateDrugs Testing Laboratory Thiruvananth apuram, Kerala |
15 | Panion Tablets | 7964 | 04/23 | 03/27 | M/s. Win Trust Pharmaceuticals Ltd. Dugri, Dhandra Road, Ludhiana | The sample is an Ayurvedic preparation It gives positive result for the presenceof Diclofenac Sodium (Allopathic drug) and hence declaredas Not of Standard Quality. The sample is a spurious drug. | StateDrugs Testing Laboratory Thiruvananth apuram, Kerala |
16 | Paracetamo Paediatric Oral Suspension IP 125 mg/ml | L-0475 | Oct-22 | Sep-24 | Quest laboratories Pvt. Ltd., Plot No. 45, Sector III, Pithampur, Dist. Dhar- 454 775 | The Sample failed in description | MP State lab reported on 19.04.2024 |
17 | Paracetamol Paediatric Oral Suspension IP 250 mg/ml | 21350 | Sep-22 | Aug-24 | Zenith Drugs Pvt. Ltd. , 75/5, Muradpura(Orangepura), Dhar Road , Near Kalaria, Indore 453 001 | The Sample failed in description | MP State lab reported on 19.04.2024 |
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