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Date: 2023-06-14 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of May 2023

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

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Executive Summary & Key Takeaways

Gazette Notification Overview

  • This gazette notification, issued in May 2023, lists drugs, medical devices, and cosmetics that have been declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded.
  • A total of 1302 samples were tested.
  • 1274 samples were declared to be of Standard Quality.
  • 27 samples were declared as Not of Standard Quality.
  • 1 sample was declared as Spurious.
  • No samples were declared as Misbranded.

Key Changes - List of Substandard/Spurious Drugs

  • Heparin Injection I.P. 25000 IU / 5ml (Batch No.: 22HE17) failed assay testing. Manufactured by M/s. Sai Parenterals Ltd., Hyderabad, Telangana.
  • Bupivacaine Heavy (Bupivacaine Hydrochloride & Dextrose Injection USP 4 ml), (Batch No.: I-5319) showed foreign and particulate matter. Manufactured by M/s. Jackson Laboratories Pvt. Ltd., Amritsar, Punjab.
  • Doxycycline Hydrochloride Capsules IP 100 mg (Batch No.: DEC2215) failed assay testing. Manufactured by M/s. Modern Laboratories, Indore, Madhya Pradesh.
  • Gentamicin (Gentamicin Injection I.P.) – 2 ml (Batch No.: GM22242) showed description and particulate matter issues. Manufactured by M/s. Nandani Medical Laboratories Pvt. Ltd., Indore.
  • Misoprostol Tablets I.P. 200 mcg (Batch No.: 22HT303) failed assay testing. Manufactured by M/s. Accent Pharmaceuticals & Diagnostics, Solan, Himachal Pradesh.
  • Doxycycline Capsules IP (Batch No.: AC22031) failed assay testing. Manufactured by M/s. Alves Healthcare Private Limited, Solan, Himachal Pradesh.
  • Teripil -80 (Telmisartan Tablets I.P.) (Batch No.: STN-221142) failed dissolution testing. Manufactured by M/s. Terrace Pharmaceuticals (P) Ltd., Kangra, Himachal Pradesh.
  • Ofloxacin & Ornidazole Tablets IP (Batch No.: 2618015) showed description issues. Manufactured by M/s. Bengal Chemical and Pharmaceuticals Ltd, Kolkata.
  • Tinvista 300 (Tinidazole Tablets I.P. 300 mg) (Batch No.: JKGJ20001) failed disintegration testing. Manufactured by M/s. Cadila Pharmaceuticals Limited, Samba, Jammu & Kashmir.
  • Heparin Sodium Injection IP 5000 IU / 5ml (Batch No.: AIG-9415) failed description, identification & particulate matter, and assay testing and is deemed spurious. Manufactured by M/s. Alliaance Biotech, Baddi, Himachal Pradesh.
  • AMOXICILLIN CAPSULES IP (ALMOX-500) (Batch No.: 22281692) failed assay testing. Manufactured by M/s. Alkem laboratories Ltd., Baddi, Himachal Pradesh.
  • ENALAPRIL MALEATE TABLETS IP 2.5mg (LAPRIL) (Batch No.: GB21113) failed assay testing. Manufactured by M/s. ORTIN LABORATORIES LTD, Sanga Reddy, Telangana.
  • Rabeprazole Sodium and Domperidone Tablets (Batch No.: RT220468) failed description testing. Manufactured by M/s. RIDLEY LIFE SCIENCE PVT. LTD., Delhi.
  • LECET M Tablets (Levocetirizine Dihydrochloride, Montelukast Sodium Tablets I.P.) (Batch No.: INT-3551B) failed dissolution of Montelukast Levocetirizine Dihydrochloride testing. Manufactured by M/s. Instant Remedies Pvt. Ltd., Punjab.
  • CLAVAM 625 (Amoxicillin And Potassium Clavulanate Tablets I.P.) (Batch No.: 22442372) failed identification of Clavulanic Acid and Assay of Amoxicillin and Clavulanic Acid testing. Manufactured by M/s. ALKEM HEALTH SCIENCE, Sikkim.
  • Paracetamol Tablets IP 500 mg (Galpara) (Batch No.: GPT22002) failed dissolution testing. Manufactured by M/s. Galpha Laboratories Limited, Baddi, Himachal Pradesh.
  • Paracetamol Tablets I.P. 500 mg (Batch No.: DGT22-270) failed dissolution testing. Manufactured by M/s. ORNATE LABS PVT. LTD. Muzaffarpur, Bihar.
  • Spasom-40 Capsules (Omeprazole Capsules I. P.) (Batch No.: SRGC-22051) failed assay of Omeprazole testing. Manufactured by M/s. SPAS Remedies, Baddi, Himachal Pradesh.
  • MONAMOX-CL 625 (Amoxycillin& Potassium Clavulanate Tablets I.P.) (Batch No.: 422-1199) failed Assay and Dissolution testing. Manufactured by M/s. Zee Laboratories Ltd., Paonta Sahib, Himachal Pradesh.
  • Probiotic Capsules (Batch No.: PTC/C/003) failed Identification and Assay of Streptococcus faecalis testing. Manufactured by M/s. UNIQUE BIOTECH LTD., Hyderabad, Telangana.
  • Paracetamol, Phenylphrine Hydrochloride, Diphenhydramine Hydrochloride and Caffeine Tablets (Syscold Tablets) (Batch No.: SPT-192) failed Disintegration test and Assay of Phenylephrine Hydrochloride testing. Manufactured by M/s. Signoret Pharmaceuticals Pvt. Ltd., Punjab.
  • Nimesulide and Paracetamol Tablets (Nimfed Tablets) (Batch No.: CMT22-666) failed Disintegration test. Manufactured by M/s. Cortex Medical Inc., Baddi, Himachal Pradesh.
  • Paracetamol Oral Suspension IP (Paragus 250 Suspension) (Batch No.: CL30476) failed Assay of Paracetamol testing. Manufactured by M/s. Cosmas Pharmacls Ltd., Solan, Himachal Pradesh.
  • Loperamide Hydrochloride Tablets IP (DYRIA STOP TABLETS) (Batch No.: DY-2214) failed Dissolution of Loperamide Hydrochloride testing. Manufactured by M/s. Cyper Pharma, Baddi, Himachal Pradesh.
  • Chlorpheniramine Maleate Tablets IP 4 mg (Batch No.: CPM2205) failed Assay of Chlorpheniramine Maleate testing. Manufactured by M/s. CYPER PHARMA, Baddi, Himachal Pradesh.
  • Glimepiride Tablets IP 2 mg (Batch No.: T192009) failed Dissolution of Glimepiride testing. Manufactured by M/s. ANG Lifesciences India Ltd., Baddi, Himachal Pradesh.
  • Doxycycline and Lactic Acid Bacillus Capsules (DOXYFIL-LB CAPSULES) (Batch No.: DXF-2103) failed Identification and Assay of Lactic Acid Bacillus testing. Manufactured by M/s. CYPER PHARMA, Baddi, Himachal Pradesh.
  • Cefixime and Ofloxacin Tablets (ZENCEF-O TABLETS) (Batch No.: ZFO-2101) failed Assay of Cefixime Trihydrate Calculated as anhydrous Cefixime testing. Manufactured by M/s. CYPER PHARMA, Baddi, Himachal Pradesh.

Impact Analysis

Manufacturers

  • Suggested Action: Conduct a thorough investigation of manufacturing processes to identify the root cause of the quality failures. Implement corrective and preventive actions (CAPA) to address the issues. Strengthen quality control measures and ensure compliance with GMP standards.

Consumers/Patients

  • Suggested Action: Healthcare providers should be informed about the list of substandard drugs and advise patients accordingly. Strengthen pharmacovigilance programs to monitor and report adverse drug reactions.

Regulatory Authorities (CDSCO, State Drug Controllers)

  • Suggested Action: Intensify market surveillance and drug testing activities. Strengthen regulatory oversight of pharmaceutical manufacturing facilities. Enhance collaboration between central and state drug regulatory authorities.

Pharmacies and Distributors

  • Suggested Action: Implement a system to verify the quality and authenticity of drugs before stocking and selling them. Train staff to identify and report suspected substandard drugs.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. State Drug Control Department: State-level regulatory bodies responsible for enforcing drug regulations within their respective states. GMP: Good Manufacturing Practices, a set of guidelines for ensuring that pharmaceutical products are consistently produced and controlled according to quality standards. IP: Indian Pharmacopoeia USP: United States Pharmacopeia
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of May – 2023. Total number of samples tested 1302 Total number of samples declared as of Standard Quality 1274 Total number of samples declared as Not of Standard Quality 27 Total number of samples declared as Spurious 1 Total number of samples declared as Misbranded NIL S.No Name of Batch No./Date of Reason for Drawn By From Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1. Heparin Injection B. No.: 22HE17 Assay CDSCO CDL I.P. 25000 IU / 5ml Mfg dt: 10/2022 Zonal Office Kolkata Exp dt: 09/2024 Hyderabad Mfd by: M/s. Sai Parenterals Ltd., D1 & D4, Survey No. 280, Phase-V, IDA, Jeedimetla, Hyderabad 500055, Telangana. 2. Bupivacaine B. No.: I-5319 Description Drug Control CDL Heavy Mfg dt: 10/2022 Foreign and Department Kolkata Jammu (Bupivacaine Exp dt: 09/2024 Particulate matter & Hydrochloride in Mfd by: M/s. Jackson Kashmir Dextrose Injection Laboratories Pvt. Ltd., USP 4 ml), 22-24, Majitha Road, Bye Pass, Amritsar – 143 001 (India). Punjab. 3. Doxycycline B. No.: DEC2215 Assay CDSCO CDL Hydrochloride Mfg dt: 10/2022 Ahmedabad Kolkata Capsules IP Exp dt: 09/2024 100 mg Mfd by: M/s. Modern Laboratories, 45-47, Sector D-2, Sanwer Road, Indore, Madhya Pradesh – 452 015, India, 4. Gentamicin B. No.: GM22242 Description CDSCO CDL (Gentamicin Mfg dt: 07/2022 and South Zone Kolkata Injection I.P.) – Exp dt: 06/2024 Particulate Matter Chennai 2 ml Mfd by: M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Page 1 of 7Hapsi, Kanadia Road, Indore. 5. Misoprostol B. No.: 22HT303 Assay CDSCO CDL Tablets I.P. Mfg dt: 11/2022 South Zone Kolkata 200 mcg Exp dt: 10/2024 Chennai Mfd by: M/s. Accent Pharmaceuticals & Diagnostics, Village Bhalon (Seri), Forest Road, Solan – 173 212, Himachal Pradesh. 6. Doxycycline B. No.: AC22031 Assay CDSCO CDL Capsules IP Mfg dt: 10/2022 South Zone Kolkata Exp dt: 09/2024 Chennai Mfd by: M/s. Alves Healthcare Private Limited, Nangal Uperla, Swarghat Road, Tehsil: Nalagarh, Distt. Solan -174101, Himachal Pradesh. India. 7. Teripil -80 B. No.: STN-221142 Dissolution CDSCO CDL (Telmisartan Mfg dt: 11/2022 East Zone Kolkata Tablets I.P.) Exp dt: 10/2024 Kolkata Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd., 3-B(a) Phase - III, Industrial Area, Sansarpur Terrace, Distt. Kangra, Himachal Pradesh- 176501. 8. Ofloxacin B. No.: 2618015 Description CDSCO CDL & Mfg dt: 01/2023 East Zone Kolkata Ornidazole Exp dt: 12/2024 Kolkata Tablets IP Mfd by: M/s. Bengal Chemical and Pharmaceuticals Ltd, 164, Maniktala Main Road, Kolkata - 700 054. Page 2 of 79. Tinvista 300 B. No.: JKGJ20001 Disintegration CDSCO CDL (Tinidazole Tablets Mfg dt: 03/2020 East Zone Kolkata I.P. 300 mg) Exp dt: 02/2024 Kolkata Mfd by: M/s. Cadila Pharmaceuticals Limited, Industrial Growth Centre, SIDCO, Samba - 184 121, State of Jammu & K.ashmir. 10. Heparin Sodium B. No.: AIG-9415 Description, Drug Control CDL Injection IP 5000 Mfg dt: 05/2022 Identification & Department Kolkata Particulate IU / 5ml Exp dt: 04/2024 Odisha Matter, Assay Mfd by: M/s. Alliaance (Sample is Biotech, 440/3, Vill. deemed to be Katha, Baddi, Distt. Spurious) Solan, Himachal Pradesh - 173205. 11. AMOXICILLIN B. No.: 22281692 Assay CDSCO CDTL CAPSULES IP Mfg dt: 07/2022 Zonal Office Hyderabad (ALMOX-500) Exp dt: 06/2024 Hyderabad Mfd by: M/s. Alkem laboratories Ltd., At. Village-Thana, Tehsil- Baddi, Dist. Solan, Himachal Pradesh- 173205. 12. ENALAPRIL B. No.: GB21113 Assay CDSCO CDTL MALEATE Mfg dt: 12/2021 Zonal Office Hyderabad TABLETS IP Exp dt: 11/2023 Hyderabad 2.5mg (LAPRIL) Mfd by: M/s. ORTIN LABORATORIES LTD, 275 & 278, (part)/I.D.A. Pashamylaram- 502307, Sanga Reddy, Dist. T.S. Telangana India. 13. Rabeprazole B. No.: RT220468 Description Drug Control RDTL Sodium and Mfg dt: 05/2022 Department Guwahati Domperidone Exp dt: 04/2024 Meghalaya Tablets Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC, Indl. Complex, Narela, Delhi-110040. Page 3 of 714. LECET M Tablets B. No.: INT-3551B Dissolution of Drug Control RDTL (Levocetirizine Mfg dt: 05/2022 Montelukast Department Guwahati Dihydrochloride, Exp dt: 04/2024 Levocetirizine Jharkhand Montelukast Mfd by: M/s. Instant Dihydrochloride Sodium Tablets Remedies Pvt. Ltd. An ISO 9001: 2015 & I.P.) GMP Certified Company) V.P.O. Gholu, Majra, Dappar- 140507, Punjab. 15. CLAVAM 625 B. No.: 22442372 Identification of Drug Control RDTL (Amoxicillin And Mfg dt: 08/2022 Clavulanic Acid Department Guwahati Potassium Exp dt: 01/2024 and Assay of Bihar Clavulanate Mfd by: M/s. ALKEM Amoxicillin and Tablets I.P.) HEALTH SCIENCE, Clavulanic Acid A unit of Alkem Laboratories Limited, Unit-2, Samardung Karek Block, P.O.: Namthang, South Sikkim- 737137. 16. Paracetamol B. No.: GPT22002 Dissolution Drug Control RDTL Tablets IP 500 mg Mfg dt: 07/2022 Department Guwahati (Galpara) Exp dt: 06/2025 Meghalaya Mfd by: M/s. Galpha Laboratories Limited, Village – Thana, Baddi, Himachal Pradesh – 173205. 17. Paracetamol B. No.: DGT22-270 Dissolution Drug Control RDTL Tablets I.P. Mfg dt: 06/2022 Department Guwahati 500 mg Exp dt: 05/2024 Bihar Mfd by: M/s. ORNATE LABS PVT. LTD. Bela Industrial Area, Muzaffarpur – 842005, Bihar. 18. Spasom-40 B. No.: SRGC-22051 Assay of Drug Control RDTL Capsules Mfg dt: 02/2022 Omeprazole Department Guwahati (Omeprazole Exp dt: 01/2024 Bihar Capsules I. P. Mfd by: M/s. SPAS Remedies (An ISO 9001, GMP & WHO-GMP Certified Unit),Vill- Bersan, P.o.- Lodhi Majra, Teh. Baddi, Distt. Solan, Himachal Pradesh- Page 4 of 7173205 19. MONAMOX-CL B. No.: 422-1199 Assay CDSCO CDTL, 625 (Amoxycillin& Mfg dt: 08/2022 and West-Zone Mumbai Potassium Exp dt: 01/2024 Dissolution Mumbai. Clavulanate Mfd by: M/s. Zee Tablets I.P.) Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib- 173 025. Himachal Pradesh . 20. Probiotic Capsules B. No.: PTC/C/003 Identification CDSCO RDTL Mfg dt: 01/2022 and Assay of North Zone Chandigarh Exp dt: 12/2023 Streptococcus Ghaziabad Mfd by: M/s. UNIQUE faecalis BIOTECH LTD., Plot No.2, Phase-II, MN Park, Kolthur Village, Shameerpet Mandal, Medchal Malkajgiri Dist. Hyderabad- 500101, Telangana, India. 21.. Paracetamol, B. No.: SPT-192 Disintegration Drug Control RDTL Phenylphrine Mfg dt: 01/2022 test and Assay of Department Chandigarh Hydrochloride, Exp dt: 12/2023 Phenylephrine Himachal Diphenhydramine Mfd by: M/s. Signoret Hydrochloride Pradesh Hydrochloride and Pharmaceuticals Pvt. Ltd., Plot No-556, Caffeine Tablets Industrial Area, Phase (Syscold Tablets) IX, SAS Nagar-160059 Punjab. 22. Nimesulide and B. No.: CMT22-666 Disintegration Drug Control RDTL Paracetamol Mfg dt: 09/2022 test Department Chandigarh Tablets (Nimfed Exp dt: 08/2024 Himachal Tablets) Mfd by: M/s. Cortex Pradesh Medical Inc., Plot No.- 3F, Apperal Park, Katha, Industrial Area Baddi-173205, Distt. Solan, Himachal Pradesh. 23. Paracetamol Oral B. No.: CL30476 Assay of Drug Control RDTL Suspension IP Mfg dt: 02/2023 Paracetamol Department Chandigarh (Paragus 250 Exp dt: 01/2025 Himachal Suspension) Mfd by: M/s. Cosmas Pradesh Page 5 of 7Pharmacls Ltd., Buranwala Road, Village: Kotla, P.O.: Barotiwala, Solan (H.P.)-1741003. 24. Loperamide B. No.: DY-2214 Dissolution of Drug Control RDTL Hydrochloride Mfg dt: 02/2023 Loperamide Department Chandigarh Tablets IP (DYRIA Exp dt: 01/2025 Hydrochloride Himachal STOP TABLETS) Mfd by: M/s. Cyper Pradesh Pharma, K.No. 825- 827, Village Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh- India. 25. Chlorpheniramine B. No.: CPM2205 Assay of Drug Control RDTL Maleate Tablets IP Mfg dt: 12/2022 Chlorpheniramine Department Chandigarh 4 mg Exp dt: 11/2024 Maleate Himachal Mfd by: M/s. CYPER Pradesh PHARMA, K.No. 825- 827, Village Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.)-173205 INDIA. 26. Glimepiride B. No.: T192009 Dissolution of CDSCO RDTL Tablets IP 2 mg Mfg dt: 05/2022 Glimepiride Sub-Zone Chandigarh Exp dt: 04/2024 Jammu Mfd by: M/s. ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan-173205, Himachal Pradesh. 27. Doxycycline and B. No.: DXF-2103 Identification and Drug Control RDTL Lactic Acid Mfg dt: 03/2022 Assay of Lactic Department Chandigarh Bacillus Capsules Exp dt: 02/2024 Acid Bacillus. Himachal (DOXYFIL-LB Mfd by: M/s. CYPER Pradesh CAPSULES) PHARMA, K.No. 825- 827, Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - Page 6 of 7173205 INDIA. 28. Cefixime and B. No.: ZFO-2101 Assay of Drug Control RDTL Ofloxacin Tablets Mfg dt: 03/2022 Cefixime Department Chandigarh (ZENCEF-O Exp dt: 02/2024 Trihydrate Himachal TABLETS) Mfd by: M/s. CYPER Calculated as Pradesh PHARMA, K.No. 825- anhydrous 827, Gullarwala, Sai Cefixime Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 173205 INDIA. Page 7 of 7

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