Home India Ministry of Health and Family Welfare Drug Alert for the Month of September 2024...
Date: 2024-10-24 Category: Not Applicable State: Union Government Country: India

Drug Alert for the Month of September 2024

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • This is a monthly notification issued by CDSCO listing drugs identified as Not of Standard Quality (NSQ) based on regulatory surveillance and analysis of drug samples.
  • The purpose is to inform stakeholders about NSQ batches found in the market.

Key Changes

  • A total of 49 drugs/products have been declared as Not of Standard Quality (NSQ) for the month of September 2024.
  • The NSQ drugs are listed with details including Product/Drug Name, Batch No., Manufacturing Date, Expiry Date, Manufactured By, NSQ Result, and Reported by CDSCO Laboratory.
  • The NSQ results vary and include issues such as Dissolution, Assay, Description, Particulate matter, Clarity of Solution, Microbial Limit Test, Identification, Related Substances, Uniformity of Weight, Bacterial Endotoxins Test and pH.
  • The drugs were tested by CDSCO laboratories including CDL Kolkata, RDTL Guwahati, CDTL Mumbai, CDTL Hyderabad and RDTL Chandigarh.
  • Manufacturers of the NSQ drugs are located across India, including Haryana, Maharashtra, Himachal Pradesh, Gujarat, Telangana, Uttarakhand, Sikkim, West Bengal, and Jammu & Kashmir.

Impact Analysis

Manufacturers

  • Re-evaluate and strengthen supplier qualification processes for raw materials and excipients.

Distributors/Retailers

  • Maintain proper storage conditions to prevent degradation of drug quality.

Consumers/Patients

  • Increased awareness among consumers about checking drug quality parameters like manufacturing date, expiry date, and batch number before consumption is needed.

Regulatory Authorities (CDSCO)

  • Regularly update and improve testing protocols to detect a wide range of quality defects.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. Drugs & Cosmetics Act, 1940: The primary legislation governing the quality, safety, and efficacy of drugs and cosmetics in India. Not of Standard Quality (NSQ) drugs: Drugs that fail to meet the quality standards or specifications as defined under Section 16 (1) (a) of the Drugs & Cosmetics Act, 1940. CDL Kolkata: Central Drugs Laboratory, Kolkata, a CDSCO laboratory. RDTL Guwahati: Regional Drugs Testing Laboratory, Guwahati, a CDSCO laboratory. CDTL Mumbai: Central Drugs Testing Laboratory, Mumbai, a CDSCO laboratory. CDTL Hyderabad: Central Drugs Testing Laboratory, Hyderabad, a CDSCO laboratory. RDTL Chandigarh: Regional Drugs Testing Laboratory, Chandigarh, a CDSCO laboratory.
Official Source Record View Original Source →
See Full Document Text
NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF SEPT – 2024. 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. A. CDSCO/Central Laboratories S.No Product/Drug Batch No. Manufacturin Expiry Manufactured By NSQ Result Reported by Name g Date Date CDSCO Laboratory 1. Metronidazole HMAA04 07/2023 06/2025 M/s. Hindustan Dissolution CDL, Kolkata Tablets I.P. 400 Antibiotics Ltd., At: 11 mg W.E.A. Faridabad - 121001 (Haryana) R.O. Pimpri, Pune - 411 018, India 2. Domperidon U587F2401 06/2024 05/2026 M/s. Rainbow Life Assay CDL, Kolkata Suspension Sciences Pvt. Ltd., (Vomitel) C/o. Unijules Life Sciences Ltd., B-35, 36, MIDC Kalmeshwar, Nagpur 441 501. 3. Oxytocin OTC-382A 04/2023 03/2025 M/s. Pushkar Pharma, Description, CDL, Kolkata Injection I.P. 5 Kheri, Kala Amb - Particulate IU/1 ml 173030 (H.P.). matter & Assay of Oxytocin 4. Metformin TF147A 02/2024 01/2026 M/s. Swiss Biotech Dissolution of CDL, Kolkata Hydrochloride Parenterals , Kewat Glimepiride 500 mg SR & No. 1138, VPO - Glimepiride 2 Kachhwa, Karnal- mg Tablets IP 132001, Haryana (SPAMET GM 2 Tablets) 5. Diclofenac HDFA02 11/2023 10/2025 M/s. Hindustan Dissolution CDL, Kolkata Sodium Tablets Antibiotics Ltd., At: 11 IP 50 mg W.E.A. Faridabad - 121001 (Haryana)R.O. Pimpri, Pune - 411 018, India 6. Calcium MA24E55 05/2024 04/2026 M/s. Martin & Brown Description & CDL, Kolkata Gluconate Biosciences Pvt. Ltd., Particulate Injection I.P. 10 K. No. 918/419, matter ml Malkumajra, Nalagarth Road, Baddi, Dist. Solan (H.P.) 173205 7. Oxytocin 22X23002 07/2023 06/2027 M/s. Radiant Assay CDL, Kolkata Injection I.P. 1 Parenterals Ltd., ml 242/4, 5 & 6, G.I.D.C. Estate at & Post Waghodia, Dist. Vadodara, Gujarat 391 760. 8. Ceftriiaxone 324476 04/2024 03/2026 M/s. Zee Laboratories Particulate CDL, Kolkata Injection I.P. 1g Ltd., Behind 47, Matter & Clarity Industrial Area, Paonta of Solution Sahib-173025 9. Gentamycin 324-564 05/2024 04/2026 M/s. Zee Laboratories Description & CDL, Kolkata Sulphate Ltd., Behind 47, Particulate Injection I.P. 40 Industrial Area, Paonta matter mg/ml Sahib-173025 10. Glycopyrrolate GNI2406AC 07/2024 06/2026 M/s. Celon Description & CDL, Kolkata 0.5 mg / 5ml + Laboratories Pvt. Ltd., Clarity of Neostigmine Plot No. 2, ALEAP Solution methysulfate Industrial Estate, Injection 2.5 mg Gajularamaram, / 5ml) (Stimin) Medchal District - 500 090, Telangana State, India. 11. Ketoconazole 4129 01/07/2024 30/06/20 M/s. Olcare Assay CDL, Kolkata Cream BP 26 Laboratories 505/A, (Nozal Cream) GIDC Estate, Wadhwan City - 363035, Dist.Surendranagar, Gujarat 12. Heparin Sodium L1192317G 08/2023 07/2025 M/s. Protech Telelinks, Description & CDL, Kolkata Injection IP Mauza Ogli, Suketi Particulate 5000 IU / 5ml Road, Kala Amb, Dist- matter (Hepathin 5000 Sirmour (H.P.) 173030 Injection 5 ml / vial) 13. Heparin Sodium L1192317C 08/2023 07/2025 M/s. Protech Telelinks, Description, CDL, Kolkata Injection IP Mauza Ogli, Suketi Particulate 5000 IU / 5ml Road, Kala Amb, Dist- matter and (Hepathin 5000 Sirmour (H.P.) 173030 Assay of Injection 5 ml / Heparin (Anti- vial) factor IIa activity) 14. Gentamicin IGMJ330 10/2023 09/2025 M/s. Regain Description & CDL, Kolkata Injection I.P. Laboratories 134/5, Particulate (Gentagain ) HTM Road, Raipur matter Lane, Hisar-125001 15. Glipizide Z24-187 02/2024 01/2026 M/s. Zee Laboratories Dissolution CDL, Kolkata Tablets I.P. 5 Ltd., Behind 47, mg Industrial Area, Paonta Sahib-173205 16. Omeprazole & RC-331223 12/2023 11/2025 M/s. Renowed Life Dissolution of CDL, Kolkata Domperidone Sciences, Plot No-12, Omeprazole Capsules IP Sector-6B, SIDCUL,, (Omerin-D Haridwar, Uttarakhand Capsules) (India) 249403 17. Dried Aluminium DNS- 10/2022 09/2024 M/s. Devout Nord (I) Description, CDL, Kolkata Hydroxide, 2210001 Ltd., Plot No. 28B, Microbial Limit Magnesium Sector-8B, IIE, Sidcul, Test, Hydroxide & Haridwar-249 403 Identification Activated (U.K). and Assay of Dimethicone Activated Suspension Dimethicone (Chill Acid MPS)18. Nimesulide & GD332005 04/2022 03/2025 M/s. Innova Captab Description CDL, Kolkata Paracetamol Limited, 1281/1, Hilltop Tablets Industrial Estate, Near (Nimuvent-P EPIP, Phase-I, Tablets) Jharmajri, Baddi, Dist. Solan (H.P.) 19. Cipronir 500 CCF212003 12/2022 11/2025 M/s. Celebrity Dissolution CDL, Kolkata (Ciprofloxacin Biopharma Ltd., Vill. Tablets IP 500 Panga, Via - Jharmajri, mg) Hill Top Estate, Barotiwala, Distt. Solan, H.P. 174103 20. Ofloxacin & B22-114 08/2022 07/2025 M/s. Saint Michael Dissolution of RDTL, Guwahati Ornidazole Biotech, No. 130, Ofloxacin & Tablets I.P. Village Kurdi, Ornidazole (SMB OZ Manglore, Jharbrera TABLETS) Road, Roorkee- 247656 (Haridwar) (U.K.) 21. Calcium 500 mg LMT240025 01/2024 12/2025 M/s. Life Max Cancer Assay of RDTL, Guwahati and Vitamin D3 Laboratories, Plot No. Calcium and 250 IU Tablets 106 & 106 A, Sector Vitamin D3 and IP 6A, IIE, SIDCUL, Dissolution of Haridwar249403 (U.K) Calcium 22. Loperamide L-2401 01/2024 12/2025 M/s.Arya Dissolution and RDTL, Guwahati Hydrochloride Pharmaceuticals, 111- Assay/ Content Tablets I.P. 2 c, Industrial Estate, of Loperamide mg (LOMJAN) Indore-15. Hydrochloride and Description 23. Glimepiride LMT240339 03/2024 02/2026 M/s. Life Max Cancer Dissolution RDTL, Guwahati Tablets IP 1 mg Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K)24. Fexofenadine 658-021 11/2023 10/2025 M/s. Signature Dissolution RDTL, Guwahati Hydrochloride Phytochemical Tablets I.P. Industries, 122, MI, Selaqui Industrial Area, Dehradun - 248 011. 25. Glimepiride LMT240157 02/2024 01/2026 M/s. Life Max Cancer Dissolution RDTL, Guwahati Tablets I.P. 2 Laboratories, Plot No. mg 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) 26. Pantoprazole 22442076 07/2022 12/2024 M/s. Alkem Health Assay and RDTL, Guwahati Gastro-resistant Science, A Unit Of Dissolution in Tablets IP.. Alkem Laboratories acid stage (PAN 40) Limited, Unit-2, Samardung, Karek Block, P.O.: Namthang, South Sikkim - 737 137. 27. Cefpodoxime BPH232520 08/2023 07/2025 M/s. Aristo Identification RDTL, Guwahati Tablets IP 200 Pharmaceuticals Pvt. and Assay/ mg (Monocef-O Ltd., Village: Content of 200) Makhnumajra. P.O.- Cefpodoxime Bhud, Baddi, Dist: Solan (H.P.)- 173205 28. Cefpodoxime BPD231045 04/2023 03/2025 M/s. Aristo Identification RDTL, Guwahati Tablets IP 200 Pharmaceuticals Pvt. and Assay/ mg (Monocef-O Ltd., Village: Content of 200) Makhnumajra. P.O.- Cefpodoxime Bhud, Baddi, Dist: Solan (H.P.)- 173205 29. Amoxicillin And 23443940 11/2023 04/2025 M/s.Alkem Health Identification, RDTL, Guwahati Potassium Science, A Unit of Dissolution and Clavulanate Alkem Laboratories Assay of Tablets I.P. Limited, Unit-2, Amoxicillin and (CLAVAM 625) Samardung, Karek Clavulanic AcidBlock, P.O. Namthang, South Sikkim - 737 137. 30. Fexofenadine T-2403971 03/2024 02/2026 M/s. Oscar Remedies Uniformity of RDTL, Guwahati Hydrochloride Pvt. Ltd., Oscar Weight and Tablets IP House, Badi Majra, Dissolution Yamuna Nagar - 135 001 (HR) 31. Ciprofloxacin JKBD24009 01/2024 12/2026 M/s.Cadila Dissolution of RDTL, Guwahati Tablets IP 500 Pharmaceuticals Ciprofloxacin mg (CIPRODAC Limited,, Industrial 500) Growth Center, Samba -184 121, State of J & K 32. Ramipril Tablets RT-231084 10/2023 09/2025 M/s.Relief Biotech Pvt. Assay of RDTL, Guwahati I.P. 2.5 mg Ltd., Khasra No. 72, Ramipril Makhyali Dundi, Peerpura Road, Roorkee Bypass, Delhi Road, Manglour, Roorkee - 247656, Haridwar (U.K.). 33. COMPOUND 03BF2475 04/2024 03/2027 M/s.Paschim Banga Bacterial RDTL, Guwahati SODIUM Pharmaceuticals, NH- Endotoxins Test LACTATE 31, TIN MILE HAT, INJECTION I.P. SONAPUR HAT, P. S. (RL) CHOPRA, DISTRICT- UTTAR DINAJPORE, PIN-733214 (W.B.) 34. Promethazine AHH0367 12/2022 11/2025 M/s.Nitin Lifesciences Assay of RDTL, Guwahati Hydrochloride Ltd., Rampur Road, Promethazine Injection I.P. Paonta Sahib, Dist. Hydrochloride (PHENERGAN) Sirmour - 173025 (H.P.), India 35. Paracetamol V0244001 02/2024 01/2026 M/s.Vivimed Labs Related CDTL-Mumbai Paediatric Oral Limited., Plot No. 25, Substances Suspension IP Kundeshwari Village,Kashipur 244713, Uttarakhand. 36. Aluminum L22455 12/2022 11/2024 M/s.Aan Pharma Pvt. Assay / Content CDTL-Mumbai Hydroxide, Ltd., 816/1, Rakanpur, of Magnesium Simethicone & Tal. Kalol, Dist. Hydroxide, Magnesium Gandhinagar, 380060, Simethicone Hydroxide Gujarat, (India) and Aluminium Suspension Hydroxide gel (Spisam Gel) 37. Gentamicin PA022415 02/2024 01/2026 M/s.Primus pH CDTL-Mumbai Sulphate Pharmaceuticals, Injection IP (P- Sadhoura Road, Genta Injection) Mouza ogli Khari Vill Asgarpur Majra, Kala Amb. Distt. Sirmour- (H. P.) 173030 38. Fluconazole CHT23621 02/2024 01/2026 M/s.Cureza Healthcare Uniformity of CDTL-Mumbai Tablets IP 150 Pvt. Ltd., A.B. Road, weight mg (Flucse - Girwai- 474001 150) 39. BISACODYL T-14996 12/2022 05/2025 M/s. Karnani Dissolution CDTL-Mumbai TABLETS I.P. Pharmaceutical Pvt. (Buffer stage), (Bisalax Ltd., Fact. 38, Pharma Related Tablets) City, Selaqui substances and Dehradun- 248011 Assay of (Uttarakhand) Bisacodyl 40. Cetirizine 275 06/2024 05/2026 M/s. Arrow Pharma, pH CDTL, Hyderabad Dihydrochloride Palia road, Hatod- Syrup (Citrize- 453111 P) 41. Ifosfamide for OL0492(for 08/2023 (for 07/2025 M/s. Kwality Water and RDTL,Chandigarh Injection IP with Ifosfamide), Ifosfamide) (for Pharmaceuticals Assay of Mesna Injection GN2064(for 08/2023 (for Ifosfamid Limited,1-A,Industrial Ifosfamide (Celofos 1000 Mesna) Mesna) e) Area,Raja Ka Bagh, Injection) 07/2026(f Tehsil Nurpur, Kangra- or 176201(India) Mesna)42. Aceclofenac FND033076 08/2023 01/2026 M/s. Ipca Laboratories Identification RDTL,Chandigarh 100 mg, AS Ltd. .,393/394, Melli and Assay of Serratiopeptidas Jorethang Road, Gom Aceclofenac e 15 mg & Block, Bharikhola, Serratiopeptidas Paracetamol South District, Sikkim- e and 325 mg 737 121 Paracetamol Tablets(ZEROD OL-SP TABLETS) 43. Ofloxacin and V-2727 01/2024 12/2025 M/s. Ramson Assay of RDTL,Chandigarh Ornidazole Intra Remedies,186-187, Ofloxacin and Uterine Solution Industrial Focal Point, Ornidazole (Vet.) Amritsar. (UTROCLEAR- OZ SOLUTION) 44. Bupropion GTD0768 11/2023 10/2025 M/s. Digital Vision, Description and RDTL,Chandigarh Hydrochloride 176, Mauza Ogli, Assay of Extended Nahan road, Kala- Bupropion Release Tablets Amb, Distt. Sirmour Hydrochloride USP (Nopion (H.P.)-17030 150 Tablets) 45. Dextromethorph SHL3037 11/2023 10/2025 M/s.Sunfine Assay of RDTL,Chandigarh an Healthcare,Plot No. Phenylphrine Hydrobromide, 63, Ind. Area Hydrochloride Chlorpheniramin Lodhimajra, Tehsil e Maleate and Baddi, Distt. Solan Phenylephrine (H.P.) 173205 Hydrochloride Syrup (COUGH- DM Cough Syrup) 46. Cefoperazone AB234007C 06/2024 05/2026 M/s.ANG Lifesciences Particulate RDTL,Chandigarh and Sulbactam India Ltd.,Village: Matter for Injection Kishanpura, Nalagarh (KEFZONE-S Road, Tehsil: Baddi, INJECTION) Distt.: Solan, HP- 17410147. Piperacillin and AB154006B 06/2024 05/2026 M/s.ANG Lifesciences Particulate RDTL,Chandigarh Tazobactam India Ltd.,Village: Matter Injection IP Kishanpura, Nalagarh (CASIDTAZ P Road, Tehsil: Baddi, Injection) Distt.: Solan, HP- 174101 48. Methylcobalami SRID24010 04/2024 09/2025 M/s.Systole Remedies Particulate RDTL,Chandigarh n Injection 2500 1 Pvt. Ltd.,Vill. Ogli, Kala matter and mcg Amb, Teh. Nahan, Assay of (NUROFENS- Distt. Sirmour (H.P.) - Methylcobalami 2500 Injection) 173 030 n 49. Torsemide GT7137A 03/2023 02/2025 M/s. Assay of RDTL,Chandigarh Tablets IP 10 J.M.LABORATORIES., Torsemide mg (Torverge- Village- 10 Tablets) Bhanat, PO - Ghatti, Subathu Road, Solan (HP) 173211Himachal Pradesh - 173 205 Not of Standard Quality (NSQ) drugs: 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.)

Continue your research