Drug Alert: 41 Drug samples including Cipla's TOFAJAK tablets fail To Qualify CDSCO Test
New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 41 medicine batches for failing to qualify for a random drug sample test for November– 2024.
These include Calcium And Vitamin D3 Tablets IP manufactured by Bengal Chemicals and Pharmaceuticals, Paracetamol Tablets IP 500mg manufactured by Karnataka Antibiotics and Pharmaceuticals, Pantoprazole Tablets IP (Opipan-40) manufactured by Orison Pharma International, Telmisartan Tablets IP 40 mg manufactured by Life Max Cancer Laboratories and others.
Furthermore, the list includes popular medicines Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS) manufactured by Cipla, Itraconazole Capsules BP 200 mg (Itrotus-200) manufactured by Synokem Pharmaceuticals, and IsosorbideMononitrate Sustained Release Tablets 30 mg (Monit30-SR) manufactured by Intas Pharmaceuticals.
The alert further mentioned that as part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market.
Not of Standard Quality (NSQ) drugs are the drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. (Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.)
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of disintegration test, clarity of solution and particulate matter, failure of pH, particulate matter, and description.
The samples collected were tested in five laboratories: RDTL Chandigarh, CDL Kolkata, CDTL Mumbai,CDTL Indore and RDTL-Guwahati.
NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF NOVEMBER – 2024
A. CDSCO/Central Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Glimepride, Pioglitazone Hydrochloride & Metformin Hydrochloride (Extended Release) Tablets (OZOMET-PG 2 ) | BE32456 | 05/2024 | 04/2026 | M/s. Ozone Pharmaceuticals, Village: Katha, Baddi, Distt. Solan (H.P.) 173 205 | Assay of Pioglitazone | Central Drugs Laboratory, Kolkata |
2. | Sucralfate USP | SCF/24/004 9 | 05/2024 | 04/2029 | M/s. Par Drugs & Chemicals Limited, 333/1, 333/2, 334, 335, 336/A&B, 337, 338, GIDC Ind. Estate Phase-2, Chitra, Bhavnagar- 364004, Gujarat | Spurious Identification & Assay | Central Drugs Laboratory, Kolkata |
3. | Sucralfate USP | LSU240401 5 | 04/2024 | 03/2029 | M/s. Legend Industries (Unit-II), C1/200, 201/4, Phase-II, GIDC, Opp. Encore Ltd., Naroda, Ahmedabad 382 330, | Spurious Identification & Assay | Central Drugs Laboratory, Kolkata |
Gujarat | |||||||
4. | Compound Sodium Lactate Injection I.P. (Ringers Lactate I.P. ) (RL 500ml) | 03BF2443 | 03/2024 | 02/2027 | M/s. PaschimBanga Pharmaceuticals, NH- 31, Tin Mile Hat, Sonapur Hat, PS- Chopra, Dist-Uttar Dinajpur - 733214 (WB) | Sterility | Central Drugs Laboratory, Kolkata |
5. | Promethazine Injection IP 25 mg / ml | 4A04070 | 08/2024 | 07/2026 | M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., N-118, 119, 113, 119/1, 119/2 & 118/1, MIDC, Tarapur, Boisar, Dist-Palghar- 401506 Maharashtra | Assay | Central Drugs Laboratory, Kolkata |
6. | Heparin Sodium Injection IP 25000 IU / 5 ml | GV3H001 | 08/2023 | 07/2026 | M/s. Scott-Edil Pharmacia Ltd., 56, EPIP, Phase-I, Jharmajri, Baddi, Distt. Solan 173205 H.P. (India) | pH, Particulate Matter, Description | Central Drugs Laboratory, Kolkata |
7. | Heparin Sodium Injection IP 25000 IU / 5 ml | GV3E001 | 05/2023 | 04/2026 | M/s. Scott-Edil Pharmacia Ltd., 56, EPIP, Phase-I, Jharmajri, Baddi, Distt. Solan 173205 H.P. (India) | pH, Particulate Matter, Assay of Heparin (Anti- factor Iia activity), Description | Central Drugs Laboratory, Kolkata |
8. | Glimepiride Tablets IP 2 mg | GTF5005 | 09/2023 | 08/2025 | M/s. SaiMirraInnopharmPv t,Ltd., No-288 & 289, SIDCO Estate, Ambattur, Chennai- 600 098 | Dissolution of Glimepiride | Central Drugs Laboratory, Kolkata |
9. | Aspirin Gastro- resistant Tablets IP 75 mg | ANET1107 | 07/2023 | 12/2024 | M/s. Unicure India Ltd., C-21, 22 & 23 Sector-3, Noida- 201301, Distt. | Test for Salicylic Acid | Central Drugs Laboratory, Kolkata |
GautamBudh Nagar (U.P.) | |||||||
10. | Calcium And Vitamin D3 Tablets IP | BCV-X01 | 04/2024 | 09/2025 | M/s. Bengal Chemicals & Pharmaceuticals Ltd., At 115 C, Industrial Estate, Pologround, Indore 452 015. | Uniformity of Content of Vitamin D3 | Central Drugs Laboratory, Kolkata |
11. | Paracetamol Tablets IP 500mg | 2555322 | 12/2022 | 11/2025 | M/s. Karnataka Antibiotics and Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bengaluru 560 058 | Description | Central Drugs Laboratory, Kolkata |
12. | Clarithromycin Tablets IP 500 mg | TCRM-010 | 11/2023 | 10/2025 | M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, BaddiDistt. Solan, H.P., India. | Dissolution | Central Drugs Laboratory, Kolkata |
13. | Methylcobalami n Injection (Rejoice) | SLA593 | 12/2023 | 05/2025 | M/s. Amster Labs, Unit-II, Hilltop, Ind. Estate, Vill. BhatauliKalan, Baddi, Distt. Solan, H.P | pH, Particulate Matter, Assay & Description | Central Drugs Laboratory, Kolkata |
14. | Enteric Coated Rabeprazole Sodium &Domperidone Sustained Release Capsules (R LONG-D) | 23101006A | 10/2023 | 09/2025 | M/s. Resonant Pharmaceuticals Pvt. Ltd., Survey No. 430- 1-A, Nr. Saffro Mellow Color Factory, Village: Navagam 387540, Dist-Kheda, Gujarat, India. | Dissolution and Assay of Rabeprazole Sodium | Central Drugs Laboratory, Kolkata |
15. | Carbimazole Tablets IP 10 mg | TC-3270005 | 02/2024 | 01/2026 | M/s. Centurion Remedies Pvt. Ltd., G/5, 6 B.I.D.C, Gorwa, Vadoddara- 390016 | Thiamazole& other Related Substances | Central Drugs Laboratory, Kolkata |
16. | Clopidogrel Tablets IP (Clopirel-75) | T-2401753 | 01/2024 | 12/2025 | M/s. Oscar Remedies Pvt. Ltd., Oscar House, BadiMajra, Yamuna Nagar - 135 001 (HR) | Dissolution | Central Drugs Laboratory, Kolkata |
17. | Clobazam Tablets IP 5 mg (ZAMBA 5) | 16672 | 07/2023 | 07/2026 | M/s. ELIKEM Pharmaceuticals Pvt. Ltd., 816/1, Rakanpur, Ta-Kalol, Dist. Gandhinagar, Gujrat 382721 | Uniformity of Content & Dissolution of Clobazam | Central Drugs Laboratory, Kolkata |
18. | Pantoprazole Tablets IP (Opipan-40) | 23D-T812A | 07/2023 | 06/2025 | M/s. Orison Pharma International, Vill. Khari, MauzaOgli, Kala Amb, Distt. Sirmour - 173030 (H.P.) | Description | RDTL, Guwahati |
19. | Ciprofloxacin Tablets U.S.P. 500 mg | T-2401066 | 01/2024 | 12/2025 | M/s. Rivpra Formulation Pvt. Ltd.., Plot No.8, Sector-6A, I. I.E. SIDCUL, Haridwar- 249 403 (U.K.). INDIA. | "Dissolution" of Ciprofloxacin | RDTL, Guwahati |
20. | RABEPRAZOL E TABLETS IP | MT-24B25 | 02/2024 | 07/2025 | M/s.MARTIN& BROWN BIOSCIENCES PVT. LTD., K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)-173205 | Assay of Rabeprazole Sodium | RDTL, Guwahati |
21. | RABEPRAZOL E TABLETS IP | MT-24B21 | 02/2024 | 07/2025 | M/s.MARTIN& BROWN BIOSCIENCES PVT. LTD., K.No. 918/419, Malkumajra, | Assay of Rabeprazole Sodium | RDTL, Guwahati |
Nalagarh Road, Baddi, Dist. Solan (H.P.)-173205 | |||||||
22. | Itraconazole Capsules BP 200 mg (Itrotus- 200) | 24S2GCA2 82 | 04/2024 | 03/2026 | M/s. Synokem Pharmaceuticals Ltd., Plot No.56-57, Sector 6A, I.I.E (SIDCUL), Ranipur (BHEL), Haridwar-249 403 (Uttarakhand) | Dissolution | RDTL, Guwahati |
23. | Itraconazole Capsules BP 200 mg (Itradila 200) | IG23038 | 05/2023 | 04/2025 | M/s. InnovaCaptab Limited, 1281/1, Hilltop Industrial Estate, Near EPIP, Phase-I, Jharmajri, Baddi, Dist. Solan (H.P.) India | Dissolution | RDTL, Guwahati |
24. | Itraconazole Capsules B.P. 200 mg (It-Bert 200) | WC819C | 11/2023 | 10/2025 | M/s. Saphnix Life Sciences, Village- Barotiwala, Paonta Sahib, Distt. Sirmour, Himachal Pradesh- 173025 | Dissolution | RDTL, Guwahati |
25. | Zinc Sulphate Tablets IP 20 mg (Tonzee 20) | ZS-2314 | 11/2023 | 10/2025 | M/s. Torino Laboratories Pvt. Ltd.,, R.O. 210, Adamji Building, 413, NarsiNatha Street, Masjid Bunder, MUMBAI- 400 009. | Disintegration | RDTL, Guwahati |
26. | INFUSION SET | 50FC670 | 03/2024 | 02/2027 | M/s.Omex Medical Technology, At Kotadi, Plot No.1, Shivalik Industrial Park, Mehsana Highway, Ta Vijapur, Gujarat, India | Sterility | RDTL, Guwahati |
27. | Itraconazole Capsules BP 200 mg (Itropi- 200) | 23K-C354 | 02/2024 | 01/2026 | M/s. Orison Pharma International, Vill. Khari, MauzaOgli, Kala Amb, Distt. Sirmour - 173030 (H.P.) | Dissolution | RDTL, Guwahati |
28. | RABEPRAZOL E TABLETS IP | MT-24B30 | 02/2024 | 07/2025 | M/s.MARTIN& BROWN BIOSCIENCES PVT. LTD., K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)-173205 | Assay /Content of Rabeprazole Sodium | RDTL, Guwahati |
29. | Primaqine Phosphate Tablets IP 2.5 mg (PQUIN- 2.5) | CN2301 | 04/2023 | 09/2025 | M/s.CENTURY DRUGS PVT. LTD., Plot No. 38, Sector - 3, Pithampur, Dist. Dhar Madhya Pradesh | Description | RDTL, Guwahati |
30. | Telmisartan Tablets IP 40 mg | LMT240520 | 05/2024 | 04/2026 | M/s.Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Description | RDTL, Guwahati |
31. | Telmisartan Tablets I.P. 40 mg | LMT240611 | 05/2024 | 04/2026 | M/s.Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Description | RDTL, Guwahati |
32. | Esomeprazole MagnesisumTri hydrate (EC) | CPC-0072 | 08/2023 | 07/2025 | M/s.CycusPharma, Vill. Harraipur, Baddi, Nalagarh Road, Distt. | Dissolution and Assay of Levosulpiride | RDTL, Guwahati |
&Levosulpiride (SR) Capsules (ESODENSE-L Capsules) | Solan (H.P.) - 173 205. | ||||||
33. | Pantoprazole Gastro- Resistant Tablets IP 40 mg (Pantojack- 40) | T-1261 | 04/2024 | 03/2026 | M/s.Jackson Laboratories Pvt.Ltd, 22-24, Majitha Road, Bye Pass, Amritsar- 143 001(India) | Dissolution & Description | RDTL, Guwahati |
34. | Promethazine Hydrochloride Injection I.P. (PHENERGAN) 2ml | AHH0230 | 08/2022 | 07/2025 | M/s. NitinLifesciences Ltd, Rampur Ghat Road, Paonta Sahib, Dist. Sirmour173 025 (H.P.) | pH and Assay/ Content of Promethazine Hydrochloride | RDTL, Guwahati |
35. | Folic Acid Tablets IP 5 mg (FOLITAS) | T-2406004 | 06/2024 | 05/2026 | M/s. Aagya Biotech Pvt. Ltd., 1.5 km, Manglour Saharanpur Road, Manglour- 247656, Roorkee, Distt. Haridwar (U.K), India | "Hydrolysis products (N-(4- aminobenzoyl)- L-Glutamic acid)" | CDTL-Mumbai |
36. | Pantoprazole Tablets IP 40 mg (Mb2pan 40 Tablets) | SD6686A | 08/2023 | 07/2025 | M/s. Sigma Softgel& Formulation, Plot No. 171, HPSIDC, Industrial Area, Baddi-1732025, Distt- Solan (H.P.) | Dissolution (Buffer Stage) | RDTL, Chandigarh |
37. | Paracetamol Tablets IP (Paracent 650 Tablets) | 24GT079 | 03/2024 | 02/2027 | M/s.Accent Pharmaceuticals & Diagnostics, Village Bhalon (Seri), Forest Road, Solan-173212 (H.P.) | Dissolution | RDTL, Chandigarh |
38. | Albendazole and Ivermectin Oral | L-24022 | 06/2024 | 05/2026 | M/s.H.L.HealthcarePv t.Ltd., Plot No.25, Ind.Area, Phase-II, | pH and Assay of Albendazole and Ivermectin | RDTL, Chandigarh |
Suspension (Bot Suspension) | Gagret-177201 (H.P.) | ||||||
39. | IsosorbideMono nitrate Sustained Release Tablets 30 mg (Monit- 30-SR) | K2302484 | 12/2023 | 11/2026 | M/s. INTAS PHARMACEUTICAL S LTD., Bagheykhola, Majhitar, Sikkim- 737136, INDIA | Description | RDTL, Chandigarh |
40. | Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS) | 4F30009 | 05/2024 | 04/2026 | M/s.CIPLA LTD, NO.45, Mangalam Main Rd., Villianur Commune, Puducherry 605110 INDIA | Identification and Assay of Tofacitinib citrate calculated as Tofacitinib | RDTL, Chandigarh |
41. | Budesonide Nebuliser Suspension BP - 0.5 mg (Budecide™ 0.5 mg Nebuliser Solution) | K1090259 | 02/2024 | 01/2026 | M/s. KamlaAmrut Pharmaceutical LLP, Survey No.: 53,56,57, Nr. KamlaAmrut Industrial Park, Indrad, Ta.: Kadi, Dist.: Mehsana, Gujarat - 382715, India | Related substances | CDTL Indore |
To view the official notice, click the link below:
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.