Home India Ministry of Health and Family Welfare NSQ ALERT FOR THE MONTH OF JUlY-2024...
Date: 2024-08-22 Category: Not Applicable State: Union Government Country: India

NSQ ALERT FOR THE MONTH OF JUlY-2024

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This gazette notification is a Not of Standard Quality (NSQ) alert for the month of July 2024, issued by CDSCO. It lists specific drugs and products that have failed quality tests conducted by various Central and Regional Drugs Testing Laboratories across India.

Key Changes

  • A total of 57 products are listed as Not of Standard Quality (NSQ).
  • The products include tablets, capsules, injections, suspensions, and syrups.
  • The reasons for being declared NSQ vary and include issues with dissolution, assay, description, particulate matter, sterility, bacterial endotoxins, disintegration, uniformity of content, identification, and labeling.
  • The products were manufactured by various companies located across India, including Maharashtra, Himachal Pradesh, Tamil Nadu, Karnataka, Telangana, Uttarakhand, West Bengal, Gujarat and Singapore.
  • The products were tested by Central Drugs Laboratories in Kolkata, CDTL Mumbai, CDTL Hyderabad, RDTL Guwahati and RDTL Chandighardh.
  • Multiple products manufactured by Bonsai Pharma, Karnataka Antibiotics and Pharmaceuticals Ltd., Manali Petrochemicals Limited, Shell Eastern Chemicals (S), Paschim Banga Pharmaceuticals, Life Max Cancer Laboratories, Martin & Brown Bio-Sciences Pvt. Ltd., Agron Remedies Pvt. Ltd. are listed.
  • Multiple batches of Propylene Glycol IP, Calcium with Vitamin D3 Tablets, Compound Sodium Lactate Injection and Rabeprazole Tablets are listed.

Impact Analysis

Manufacturers

  • Action Item: Immediately review manufacturing processes, quality control procedures, and testing protocols to identify and rectify the issues leading to NSQ results. Engage with CDSCO to demonstrate commitment to quality and compliance.

Distributors and Retailers

  • Action Item: Implement a system for quickly identifying and removing NSQ products from shelves. Communicate with suppliers and manufacturers regarding the NSQ alert and return procedures.

Consumers/Patients

  • Action Item: Healthcare providers should be made aware of the NSQ alert and advise patients accordingly. Promote awareness among the public regarding the importance of purchasing drugs from reputable sources and verifying authenticity.

CDSCO and State Drug Control Authorities

  • Action Item: Enhance collaboration with state drug control authorities to ensure effective monitoring and enforcement. Review and update regulations and guidelines to prevent future occurrences of NSQ products.

Our Organization

  • Action Item: Cross-reference the list of NSQ products with our procurement records and supplier list. Conduct a thorough audit of our quality control processes and vendor management system.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. Central Drugs Laboratory, Kolkata: A central drug testing laboratory that tests drug samples and reports findings to CDSCO. Bonsai Pharma: Pharmaceutical manufacturer with multiple products listed in the NSQ alert. Karnataka Antibiotics and Pharmaceuticals Ltd.: Pharmaceutical manufacturer with multiple products listed in the NSQ alert. Manali Petrochemicals Limited: Chemical manufacturer with multiple products listed in the NSQ alert. Shell Eastern Chemicals (S): Chemical manufacturer with multiple products listed in the NSQ alert. Paschim Banga Pharmaceuticals: Pharmaceutical manufacturer with multiple products listed in the NSQ alert. Life Max Cancer Laboratories: Pharmaceutical manufacturer with multiple products listed in the NSQ alert. Martin & Brown Bio-Sciences Pvt. Ltd.: Pharmaceutical manufacturer with multiple products listed in the NSQ alert. Agron Remedies Pvt. Ltd.: Pharmaceutical manufacturer with multiple products listed in the NSQ alert. CDTL Mumbai: Central Drugs Testing Laboratory located in Mumbai. CDTL Hyderabad: Central Drugs Testing Laboratory located in Hyderabad. RDTL Guwahati: Regional Drugs Testing Laboratory located in Guwahati. RDTL Chandighardh: Regional Drugs Testing Laboratory located in Chandighardh.
Official Source Record View Original Source →
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NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JULY – 2024. A. CDSCO/Central Laboratories S.No Product/Dru Batch No. Manufactu Expiry Manufactured By NSQ Reported by g Name ring Date Date Result CDSCO Laboratory 1. Ivermectin JDJS403 04/2024 03/2026 M/s. J. DUNCAN Dissolution Central Drugs Tablets I.P. 6 HEALTH CARE Laboratory, Kolkata mg PVT.LTD., Plot No. 65, 66, 67, Phase-II, Atgaon, Industrial Complex, Atgaon, Tal- Shahapur, Dist-Thane- 421601, Maharashtra State, India. 2. Itraconazole MAR-24154 03/2024 02/2026 M/s. Bonsai Pharma, Dissolution Central Drugs 100mg Kishanpura, Baddi- Laboratory, Kolkata Capsules Nalagarh Road, P.O. (FUNGOBEE Gurumajra, Distt-Solan Capsules) (H.P.). 3. Compound F31823 10/2023 09/2026 M/s. Higgs Healthcare, Assay of Central Drugs Sodium Khasra No. 480/1, Potassium Laboratory, Kolkata Lactate Bhatolikalan, Baddi, Injection I.P. H.P. (Ringer Lactate Solution for Injection) (Hi- Ring-RL) 4. Pantoprazole FEB24144 02/2024 01/2026 M/s. Bonsai Pharma, Dissolution Central Drugs Tablets 40 mg Kishanpura, Baddi- Laboratory, Kolkata I.P. Nalagarh Road, P.O. (MEDIPANTO- Gurumajra, Distt-Solan40 Tablets) (H.P.). 5. Propylene PG-IP/2023- 01/2024 12/2028 M/s. Manali Relative Central Drugs Glycol IP 24/2435 Petrochemicals Density and Laboratory, Kolkata Limited, Plant II Water Sathangadu Village, Manali, Chennai- 600068 6. Itraconazole UC-23240A 10/2023 09/2025 M/s. Ultra Drugs Pvt. Dissolution Central Drugs Capsules BP Ltd., (Unit-II) H Laboratory, Kolkata 100 mg S No. 211, K. No. 77/1, 78/1, Vill. Katha, Baddi, Distt. Solan, (H.P.) 173205. 7. Sterile KP247236 07/2023 06/2025 M/s. NEON Description & Central Drugs Noradrenaline LABORATORIES Particulate Laboratory, Kolkata Concentrate LTD., At: Shatisthal, Matter I.P. Plot No. 1-5, At & Post: Shirgaon, Tal. Palghar, Dist. Thane - 401 407, M.S. 8. Paracetamol 2600823 02/2023 01/2026 M/s. Karnataka Description Central Drugs Tablets IP 650 Antibiotics and Laboratory, Kolkata mg Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bengaluru- 560058 9. Ofloxacin and 6001723 06/2023 05/2026 M/s. Karnataka Description Central Drugs Ornidazole Antibiotics and Laboratory, Kolkata Tablets I.P. Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya Industrial Area, Bengaluru- 560058 10. Carbamazepin TCRN-004 10/2023 09/2025 M/s. J.P. Industries, Dissolution Central Drugs e Extended- Bhud, Baddi, Dist- Laboratory, KolkataRelease Solan, HP, India. Tablets IP 200 mg 11. Teneligliptin & ST23-2897 10/2023 09/2025 M/s. Salud Care (I) Description & Central Drugs Metformin Pvt. Ltd., 435, Assay of Laboratory, Kolkata Hydrochloride Kishanpur, Roorkee- Teneligliptin Extended 247661 Hydrobromid Release e Hydrate Tablets IP (20 mg / 500 mg) 12. Calcium EZF-1873 01/2024 06/2026 M/s. Overseas Health Assay of Central Drugs Aspartate, Care Pvt. Ltd., 335 Clacitriol Laboratory, Kolkata Calcium Km. Milestone, Orotate, National Highway No. Calcitriol, 1, P.O. Box No. 25, Minerals and Phillaur-144 410 (Pb). Vitamins Tablets (Ezorb Forte Tablets) 13. Budesonide SN30395 04/2023 03/2025 M/s. Cipla Ltd. (Unit-II), Assay of Central Drugs Nebuliser Taza Block, Budesonide Laboratory, Kolkata Suspension Rorathang, Sikkim BP (Budecort 737133, India. Respules) 14. Propylene PG-IP/2023- 11/2023 10/2028 M/s. Manali Relative Central Drugs Glycol IP 24/2339 Petrochemicals Density Laboratory, Kolkata Limited, Plant II Sathangadu Village, Manali, Chennai- 600068 15. Ceftriaxone S24015 02/2024 01/2026 M/s. Sai Parenterals Clarity of Central Drugs Sodium for Limited, Plot No.: 45A solution, Laboratory, Kolkata Injection IP & B, Anrich Industrial Particulate 1gm / 10 ml Estate, IDA Bollaram, Matter &Sangareddy (Dist)- Appearance 502325, Telangana of solution 16. Calcium DBIS-8889B 01/2024 12/2025 M/s. Broad Injectables Disintegration Central Drugs Carbonate, Plot No. 51-52, Ind. & Assay of Laboratory, Kolkata Calcitriol, Area, Tahliwal, Distt. Calcitriol, Methylcobalam Una-174301 (H.P.) Vitamin B6 & in, Folic Acid & Methylcobala Vitamin B6 min Soft Gelatin Capsules (CAMED-CM) 17. Monopropylen 9815216014 01/2024 01/2026 M/s. Shell Eastern Specific Central Drugs e Glycol USP Chemicals (S) Seraya Gravity Laboratory, Kolkata Manufacturing Site, Singapore 18. Monopropylen 9815617014 01/2024 01/2026 M/s. Shell Eastern Water & Central Drugs e Glycol USP Chemicals (S) Seraya Specific Laboratory, Kolkata Manufacturing Site, Gravity Singapore 19. Monopropylen 9814815014 01/2024 01/2026 M/s. Shell Eastern Water Central Drugs e Glycol USP Chemicals , Metropolis Laboratory, Kolkata Tower, 1, 9 North Buona Vista Drive 07 01, Singapore-138588 20. Monopropylen 9729323113 11/2023 11/2025 M/s. Shell Eastern Water & Central Drugs e Glycol USP Chemicals (S) Seraya Specific Laboratory, Kolkata Manufacturing Site, Gravity Singapore 21. Sterile DP4095 03/2024 02/2026 M/s. Divine Description & Central Drugs Noradrenaline Laboratories Pvt. Ltd., Particulate Laboratory, Kolkata Concentrate IP Block No. 471, Matter (ADRAID) Dabhasa, Tal. Padra, Dist. Vadodara- 391440, India22. Compound 03BF2450 03/2024 02/2027 M/s. Paschim Banga Sterility Central Drugs Sodium Pharmaceuticals (A Laboratory, Kolkata Lactate Unit of Farista Vanijya Injection I.P. Pvt. Ltd), NH-31, Tin (Ringers Mile Hat, Sonapur Hat, Lactate I.P.) P.S. Chopra, Dist. RL Uttar Dinajpur-733214 (W.B.). 23. Oxalobacter, RHCE23001 05/2023 10/2024 M/s. Swift Life Assay of Central Drugs Lactobacillus & Sciences Pvt. Ltd., D- Oxalobacter Laboratory, Kolkata Bifidobacteriu 1, Sara Industrial Species & m with FOS Estate, Rampur, Bifidobacteriu Capsules Dehradun (UK) m Bifidum (OXASPUR) 248197 24. Tamsulosin GH30334 05/2023 04/2025 M/s. Cipla Ltd., Verna Identification Central Drugs and Indl. State, Goa- and Assay of Laboratory, Kolkata Dutasteride 403722 Tamsulosin Tablets Hydrochloride (Urimax-D) , Dutasteride and Description. 25. Azithromycin NZYMT-223 09/2023 08/2025 M/s. M Sea Dissolution Central Drugs Tablets IP 500 Pharmaceuticals (P) Laboratory, Kolkata mg (Aziley-500 Ltd., Surajpur, Paonta Tablets) Sahib, Sirmour, Himachal Pradesh - 173001. 26. Azithromycin NZKT-013 08/2023 07/2025 M/s. M Sea Dissolution Central Drugs Tablets IP 500 Pharmaceuticals (P) Laboratory, Kolkata mg (ZIK 500 Ltd., Surajpur, Paonta Tablets) Sahib, Sirmour, Himachal Pradesh - 173025.27. Compound 03BF1734 08/2022 07/2025 M/s. Paschim Banga Bacterial Central Drugs Sodium Pharmaceuticals (A endotoxins Laboratory, Kolkata Lactate Unit of Farista Vanijya Injection I.P. Pvt. Ltd), NH-31, Tin (RL FFS 500 Mile Hat, Sonapur Hat, ML) P.S. Chopra, Dist. Uttar Dinajpur-733214 (W.B.). 28. Calcium CLG-4148 12/2022 11/2024 M/s. Priya Assay of Central Drugs Gluconate Pharmaceuticals, Calcium Laboratory, Kolkata Injection I.P. 109/397, Nehru Nagar, 10 ml Kanpur-12 29. Ceflxime MBT-03023 05/2023 04/2025 M/s. Mestra Pharma Water & Central Drugs Tablets IP Pvt. Ltd., AT: 44-45, Uniformity of Laboratory, Kolkata (Zimspor-200) Shiv Ganga Industrial Dispersion Estate, Lakeshwari, Bhagwanpur Roorkee, Haridwar (UK) 30. Dextrose and VZ224015 04/2024 03/2026 M/s. Styrun Water Central Drugs Ascorbic Acid Healthcare, Survey Laboratory, Kolkata with Zinc No.89, Pirana Road, At Powder (Vz- & Post: ODD, Ta, Plus) Daskroi, Ahmedabad- 382425, Gujrat, India. 31. Ciprofloxacin OCF5-23-222 07/2023 06/2025 M/s. Ornate Labs Pvt. Dissolution Central Drugs Tablets I.P. Ltd., Bela Industrial Laboratory, Kolkata 500 mg (Ocif- Estate, Muzaffarpur - 500 Tablets) 842 005. 32. Ofloxacin & UGT23J14A 01/2023 12/2024 M/s. Unigrow Dissolution & Central Drugs Ornidazole Pharmaceuticals, Vill. Assay Laboratory, Kolkata Tablets IP Katha, Baddi, Distt. (Samri-OZ) Solan, HP 33. Synetivit LSG-2890 07/2023 12/2024 M/s. Lifevision Disintegration Central Drugs Capsules Healthcare, Plot No. , Assay of Laboratory, Kolkata (Omega-3 140-141, EPIP, Phase- Lactic AcidFatty Acid, 1, Jharmajri, Baddi, Bacillus, Green Tea Distt. Solan (H.P.) Vitamin B6, Extract, 174103 Folic Acid & Ginkgo Biloba, Niacinamide Ginseng, Grape Seeds Extract, Vitamins, Minerals & Trace Elements Soft Gelatin Capsules) 34. Lingocaine & 305 12/2023 11/2025 Carewin Assay of CDTL-Mumbai Adrenaline Pharmaceuticals (Guj) Adrenaline Injection IP Pvt. Ltd., 38, Saket (Lignocop- Ind. Estate-II Sarkhej- ADR) Bavla NH-8A, PO. Moraiya, Ahmedabad, (Guj.) Pin-382210 35. Acetylsalicylic JTN23-211 07/2023 06/2026 AK Krishna Pharma Test for CDTL-Mumbai Acid 75mg Ltd. Ltd., Plot No. 68, Salicylic acid, (Kardiorin AK) 69 & 82, 83 Sector-6A, Assay of SIDCUL, IIE, Dist. Aspirin and Haridwar, Uttarakhand, Description india. 36. Levetiracetam GAG0628 08/2023 07/2025 Agron Remedies Pvt. Dissolution CDTL-Mumbai Tablets IP Ltd., Sarverkhera, (Levodil-500) Moradabad Road, Kashipur-244713, Uttarakhand 37. Diclofenac T24B008 02/2024 01/2027 Snehal Pharma & Misbranded CDTL-Mumbai Tablets IP Surgicals Pvt. Ltd., (Improper 50mg (Snedic- B1/11, MIDC Butibori, labeling) 50) Nagpur-44110838. Amoxycillin CT5023001A 09/2023 08/2025 Aurobindo Pharma Description CDTL-Mumbai and Potassium Limited, Unit XII, Clavulanate Survey No. 314, Tablets IP Bachupally, (Pressclav- Bachupally Mandal, 625) Medchal-Malkajgiri District. Telangana State, india - 500090. 39. M/s. KARNANI ONDANSETR PHARMACEUTICALS Description ON ORALLY PVT. LTD. and DISINTEGRAT T-15842 12/2023 11/2025 CDTL, Hyderabad Fact : 38, Pharma City, Uniformity of ING TABLETS Selaqui, Dehradun- Content IP 4mg 248011 (Uttarakhand) 40. M/s. KARNANI ONDANSETR PHARMACEUTICALS Description ON ORALLY PVT. LTD. and DISINTEGRAT T-15961 01/2024 12/2025 CDTL, Hyderabad Fact : 38, Pharma City, Uniformity of ING TABLETS Selaqui, Dehradun- Content IP 4mg 248011 (Uttarakhand) 41. Calcium 500 LMT240376 03/2024 02/2026 Life Max Cancer Dissolution of RDTL, Guwahati mg with Laboratories, Plot No. Calcium & Vitamin D3 106 & 106 A, Sector- Assay of 250 IU Tablets 6A, IIE, SIDCUL, Vitamin D3 IP Haridwar 249403 (U.K) 42. Albendazole VGT230119 05/2023 04/2026 VAPI CARE PHARMA Dissolution of RDTL, Guwahati Tablets IP 400 PVT. LTD., PLOT Albendazole mg (Zento NO.225/3, NEAR 400) MORARJI CIRCLE, GIDC VAPI, DIST.VALSAD-396195 GUJARAT 43. COMPOUND 03BF2462 03/2024 02/2027 PASCHIM BANGA Sterility RDTL, Guwahati SODIUM PHARMACEUTICAL, LACTATE NH-31, TIN MILE HAT,INJECTION SONAPUR HAT, P.S.- I.P. (RL) CHOPRA, DIST : UTTAR DINAJPUR, PIN - 733214 (W.B.) 44. Calcium 500 LMT240412 04/2024 03/2026 Life Max Cancer Dissolution RDTL, Guwahati mg. with Laboratories, Plot No. (Calcium) Vitamin D3 106 & 106 A, Sector- and Assay of 250 IU Tablets 6A, IIE, SIDCUL, Vitamin D3 IP Haridwar249403 (U.K) 45. Paracetamol CT-5063 12/2022 11/2025 CHEMETAC "Dissolution" RDTL, Guwahati Tablets IP 500 PHARMACEUTICALS of mg (Pararex- 42, MAINA PUR, Paracetamol. 500 MEERUT ROAD, GHAZIABAD-201003 46. Pantoprazole MT-23K36 11/2023 04/2025 MARTIN & BROWN Dissolution at RDTL, Guwahati Tablets IP BIO-SCIENCES PVT. Buffer Stage LTD., K.NO. 918/419, MALKUMAJRA, NALAGARH ROAD, BADDI, DIST.SOLAN (H.P.)-173205 47. Calcium 500 LMT240335 03/2024 02/2026 Life Max Cancer Dissolution RDTL, Guwahati mg with Laboratories, Plot No. (Calcium) Vitamin D3 106 & 106 A, Sector- and Assay of 250 IU Tablets 6A, IIE, SIDCUL, Vitamin D3 IP Haridwar-249403 (U.K) 48. Calcium 500 LMT240348 03/2024 02/2026 Life Max Cancer Dissolution of RDTL, Guwahati mg and Laboratories, Plot No. Calcium and Vitamin D3 106 & 106 A, Sector- Assay of 250 IU Tablets 6A, IIE, SIDCUL, vitamin D3 IP Haridwar-249403 (U.K) 49. Amoxycillin & MICTAB- 03/2024 08/2025 Micro Formulations,, Dissolution of RDTL, Guwahati Potassium 1602 Chambaghat, Near Clavulanic Claulanate Railway Crossing, Acid and also Tablets I.P. Solan, Distt. Solan Assay of(Zalmoxi-CV (H.P.) 173211 Clavulanic 625) Acid 50. RABEPRAZOL MT-24B23 02/2024 07/2025 MARTIN & BROWN Assay RDTL, Guwahati E TABLETS IP BIO-SCIENCES PVT. LTD., K.NO. 918/419, MALKUMAJRA, NALAGARH ROAD, BADDI, DIST.SOLAN (H.P.)-173205 51. Tranexamic KEI-110C 11/2023 10/2025 Elvia Care Pvt. Ltd., Bacterial RDTL, Guwahati Acid Injection Vill Gullarwala, Near Endotoxins IP (Stopmust Sai Road, Baddi, Distt. Test Injection) Solan (H.P.) 52. RABEPRAZOL MT-24B26 02/2024 07/2025 MARTIN & BROWN Assay/Conte RDTL, Guwahati E TABLETS IP BIO-SCIENCES PVT. nt of LTD., K.NO. 918/419, Rabeprazole MALKUMAJRA, Sodium NALAGARH ROAD, BADDI, DIST.SOLAN (H.P.)-173205 53. Pantoprazole PGR-02 12/2023 11/2025 Agron Remedies Pvt. Dissolution in RDTL, Guwahati Gastro- Ltd., Sarverkhera, Acid Stage Resistant Moradabad Road, for Tablets IP 40 Kashipur-244713 Pantoprazole mg (Uttarakhand) 54. M/s Hetero Labs Limited (Unit-I), Survey Identification No.10, I.D.A., by IR, by Carboplatin 31-Dec- CN24010001 01-Jan-2024 Gaddalotharam, HPLC and RDTL,Chandighardh USP 2028 Village: Jinnaram Loss on Mandal, Sangareddy drying Distt. Telangana, India 55. Pantoprazole Aarge Healthcraft, RDTL ,Chandighardh Particulate for Injection PNDA4C22A Mar-2024 Feb-2026 12A/1, Sector-2, Indl. matter BP (Glanpan Area, Parwanoo-IV Injection) 173220 (H.P.) 56. Bromhexine RDTL ,Chandighardh Hydrochloride, Ultra Drugs Terbutaline Formulations Pvt. Ltd., Sulphate and Assay of Plot No. 338/278, Vill. Guaiphenesin UF2184145C Feb-2024 Jan-2026 Terbutaline Manakpur, Lodhimajra, Syrup (T-KUF Sulphate Tehsil-Baddi, Distt. Expectorant Solan, (H.P.) 173205 COUGH SYRUP) 57. Compound RDTL ,Chandighardh Sodium Lactate M/s. HINDUSTAN Injection IP ANTIBIOTICS LTD., Bacterial 2918 Dec-2022 Nov-2025 (Ringers Pimpri,Pune-411018, Endotoxins Lactate INDIA Solution for Injection)

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