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Date: 2022-06-10 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of May 2022

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 lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for May 2022.
  • A total of 1233 samples were tested.
  • 1192 samples were declared to be of Standard Quality.
  • 41 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 0 samples were declared as Misbranded.

Key Changes

  • 41 samples failed to meet the standard quality parameters.
  • The reasons for failure include Uniformity of Dispersion & Disintegration, Dissolution, Water Content, Description & Particulate Matter, Sterility, Identification & Assay, Assay, Moisture Content, and Disintegration.
  • The list specifies the name of the drug/medical device/cosmetic, batch number, date of manufacture, date of expiry, manufacturer, reason for failure, the authority that drew the sample, and the zone from which it was drawn.
  • Manufacturers listed are from various states including West Bengal, Punjab, Uttarakhand, Chandigarh, Daman, Puducherry, Himachal Pradesh, Jammu & Kashmir, Telangana, Jharkhand, Assam, Mizoram, Madhya Pradesh, Delhi and Haryana.

Impact Analysis

Manufacturers

  • Action Item: Review manufacturing processes and quality control measures to prevent future occurrences. Engage with regulatory authorities to address concerns and implement corrective actions.

Consumers

  • Action Item: Raise awareness among consumers about the listed products and encourage them to report any adverse effects. Strengthen pharmacovigilance programs to monitor and address safety concerns.

Regulatory Authorities (CDSCO, State Drug Control)

  • Action Item: Enhance surveillance and testing of drugs and medical devices. Strengthen collaboration between central and state drug control authorities. Implement stricter penalties for manufacturers of substandard products.

Supply Chain (Distributors, Retailers)

  • Action Item: Implement robust systems for tracking and tracing pharmaceutical products. Ensure compliance with storage and handling requirements to maintain product quality. Conduct regular audits of suppliers to verify compliance with regulatory standards.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. CDL: Central Drugs Laboratory RDTL: Regional Drugs Testing Laboratory IP: Indian Pharmacopoeia State Drug Control Department: State-level regulatory bodies responsible for enforcing drug regulations within their respective states.
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of May – 2022. Total number of samples tested 1233 Total number of samples declared as of Standard Quality 1192 Total number of samples declared as Not of Standard Quality 41 Total number of samples declared as Spurious 0 Total number of samples declared as Misbranded 0 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. Zinc Sulphate B. No.: ZST21050 Uniformity of CDSCO CDL Dispersible Tablets Mfg dt: 10/2021 Dispersion East Zone Kolkata I.P. Exp dt: 09/2023 & Kolkata Mfd by: M/s. La- Disintegration Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24 Parganas , Kolkata - 700125, West Bengal. 2. Zinc Sulphate B. No.: ZST21048 Uniformity of CDSCO CDL Dispersible Tablets Mfg dt: 10/2021 Dispersion East Zone Kolkata I.P. Exp dt: 09/2023 & Kolkata Mfd by: M/s. La- Disintegration Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24 Parganas , Kolkata - 700125, West Bengal. 3. Metfovan -500 SR B. No.: APT/04215 Dissolution CDSCO CDL Tablets (Metformin Mfg dt: 03/2021 & East Zone Kolkata Hydrochloride (SR) Exp dt: 02/2023 Assay Kolkata Tablets) Mfd by: M/s. Amkon Pharmaceuticals, Plot No. 242, Ind. Area, Phase-IX, S.A.S. Nagar, Mohali – 160 062, Punjab. Page 1 of 104. Acebrophylline B. No.: PF8AA04 Water Content CDSCO CDL Capsules 100 mg Mfg dt: 11/2020 East Zone Kolkata Exp dt: 10/2022 Kolkata Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27- 30, Sector-8A, I.I.E, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand. 5. Geragen – 2 ml B. No.: V2111674 Description CDSCO CDL (Gentamicin Mfg dt: 08/2021 & East Zone Kolkata Injection IP) Exp dt: 07/2023 Particulate Matter Kolkata Mfd by: M/s. B.M. Pharmaceuticals, 47- 48, Ind. Area, Phase II, Chandigarh - 160002. 6. DYNAPAR AQ B. No.: D23S363 Sterility CDSCO CDL (Diclofenac Sodium Mfg dt: 11/2021 East Zone Kolkata Injection I.P. 75 Exp dt: 10/2023 Kolkata mg/ml) Mfd by: M/s. Troikaa Pharmaceuticals Ltd., At: Survey No: 46/1-4, Kadaiya Village, Nani Daman-396210. 7. (Afedol- SP) B. No.: PBT-238 Identification & CDSCO, CDL Aceclofenac, Mfg dt: 06/2021 Assay of South Zone Kolkata Paracetamol & Exp dt: 05/2023 Serratiopeptidase Chennai Serratiopeptidase Mfd by: M/s. Bonn Tablets Schtering Bio Sciences, Plot No. 64 & 65, 1st Floor, Electronic Park, Thirubuvanai, Mannadipet Commune, Puducherry 605 107. 8. Agrophylline - 2ml B. No.: AGP-20 Description CDSCO CDL (Etophylline & Mfg dt: 11/2021 & South Zone Kolkata Theophyline for Exp dt: 10/2023 Particulate Matter Chennai Injection) Mfd by: M/s. Agron Remedies Pvt. Ltd. Sarverkhera , Page 2 of 10Moradabad Road, Kashipur -244713, Uttarakhand. 9. SPYCLAV 625 LB B. No.: TACLB1011A Assay CDSCO CDL (Amoxycillin and Mfg dt: 03/2021 South Zone Kolkata Potassium Exp dt: 08/2022 Chennai Clavulanate with Mfd by: M/s. Lactic Acid Bacillus Associated Biotech, Tablets) Kishanpura, Guru Majra Road, Baddi, Teh. Nalagarh, Distt. Solan, Himachal Pradesh - 174101. 10. Metsodoz - 8 B. No.: GFM622101 Identification CDSCO CDL Tablets Mfg dt: 07/2021 & South Zone Kolkata (Methylprednisolone Exp dt: 06/2023 Assay Chennai Tablets IP 8 mg) Mfd by: M/s. Progressive Lifesciences Pvt. Ltd., Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar -247 665, Uttarakhand. 11. CALNIF RETARD B. No.: JKEG21006 Dissolution CDSCO CDL (Nifedipine Mfg dt: 07/2021 Ahmedabad Kolkata Prolonged Release Exp dt: 06/2024 Tablets I.P. 20 mg) Mfd by: M/s. Cadila Pharmaceuticals Limited, Industrial Growth Centre, SIDCO, Samba-184 121, Jammu & Kashmir. 12 Saccharomyces B. No.: SBC/C/002 Moisture Content CDSCO CDL boulardii Capsules Mfg dt: 09/2021 Hyderabad Kolkata (250 mg) Exp dt: 08/2023 Mfd by: M/s. Unique Biotech Limited, Plot No.-2, Phase- II, MN Park, Kolthur Village, Shameerpet Mandal, Medchal Malkajgiri District, Hyderabad - 560 078, Telangana, Page 3 of 10India. 13. Enoxaparin Sodium B. No.: SENXB2118 Sterility CDSCO CDL Injection I.P. Mfg dt: 12/2021 Jammu Kolkata 60mg/0.6ml Exp dt: 11/2023 Mfd by: M/s. Samarth Lifescience Pvt. Ltd., Unit - II, Plot No. 2, Industrial Area, Lodhimajra, Baddi, Himachal Pradesh - 173205. 14. Pantoprazole B. No.: TF1037A Dissolution CDSCO CDTL Gastro-Resistant Mfg dt: 06/2021 Sub Zone Chennai Tablets IP Exp dt: 11/2022 Bangalore Mfd by: M/s. Navkar Lifesciences, Plot No.76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan , Himachal Pradesh. 15. Ciprofloxacin B. No.: 0702620 Dissolution CDSCO CDTL Hydrochloride Mfg dt: 06/2020 Sub Zone Chennai Tablets IP Exp dt: 05/2023 Bangalore 500 mg Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase, Peenya, Bangalore -560058. 16. Telmisartan Tablets B. No.: CT-10408 Dissolution Drug Control RDTL IP Mfg dt: 08/2020 Department Guwahati Exp dt: 07/2023 Jharkhand Mfd by: M/s Cosmas Pharmacls Ltd., Buranwala Road, Village: Kotta, P.O.: Baratiwala, Solan, Himachal Pradesh – 174103. 17. Amoxycillin and B. No.: PT-0681A Dissolution of Drug Control RDTL Potassium Mfg dt: 01/2021 Amoxycillin and Department Guwahati Clavulanate Exp dt: 12/2022 Clavulanic Acid Jharkhand Tablets IP Mfd by: M/s Saitech Page 4 of 10Medicare Pvt. Ltd., Village Kheri, Trilokpur Road, Kala- Amb, Dist. Sirmour, Himachal Pradesh – 173030. 18. Omeprazole B. No.: E2100419 Assay of Drug Control RDTL (Delayed- Release) Mfg dt: 01/2021 Omeprazole and Department Guwahati and Domperidone Exp dt: 12/2022 Domperidone Assam (Sustained- Mfd by: M/s Dr. Release) Capsules Reddys Laboratories Ltd. Village Mauja Thana, Baddi- 173205, Dist. Solan, Himachal Pradesh. 19. Misoprostol Tablets B. No.: UHT21298 Assay Drug Control RDTL IP 200mcg Mfg dt: 09/2021 Department Guwahati Exp dt: 08/2023 Assam Mfd by: M/s Unimarck Healthcare Ltd. WHO- GMP Certified Company Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar- 249403, Uttarakhand. 20. ATENOLOL Tablets B. No.: ATTJ21001 Disintegration Drug Control RDTL IP 50mg Mfg dt: 01/2021 and Department Guwahati Exp dt: 12/2022 Assay Assam Mfd by: M/s Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu- 181133. 21. Telmisartan Tablets B. No.: TETY-01 Dissolution Drug Control RDTL IP 40mg Mfg dt: 04/2021 Department Guwahati Exp dt: 03/2023 Jharkhand Mfd by: M/s Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad-121001, Haryana, INDIA. 22. Telmisartan Tablets B. No.: MT212218 Dissolution Drug Control RDTL IP 80mg Mfg dt: 06/2021 Department Guwahati Page 5 of 10Exp dt: 05/2023 Assam Mfd by: M/s Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sec. -6A, IIE, Sidcul, Haridwar – 249403, Uttarakhand. 23. Dexamethasone B. No.: DXMT-1003 Assay Drug Control RDTL Tablets I.P. 0.5mg Mfg dt: 05/2020 Department Guwahati Exp dt: 04/2023 Jharkhand Mfd by: M/s Wings Biotech, 43 & 44, HPSIDC, Industrial Area, Baddi - 173205, Himachal Pradesh. 24. METRONIDAZOLE B. No.: MT-21D20 Dissolution Drug Control RDTL TABLETS I.P. Mfg dt: 04/2021 Department Guwahati Exp dt: 03/2023 Jharkhand Mfd by: M/s Martin & Brown Bio-sciences K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan, Himachal Pradesh. 25. Metronidazole B. No.: DMRT-02 Dissolution Drug Control RDTL Tablets IP Mfg dt: 04/2021 Department Guwahati Exp dt: 03/2024 Jharkhand Mfd by: M/s SGS PHARMACEUTICALS (P) LTD, E-13/1, Sector - 17, Kavi Nagar Indl. Area, Ghaziabad-201002, Uttar Pradesh. 26. Enteric Coated B. No.: JC-20726 Assay of Drug Control RDTL Rabeprazole Mfg dt: 07/2020 Rabeprazole Department Guwahati Sodium & Exp dt: 06/2022 Sodium Mizoram Domperidone SR Mfd by: M/s Jineka Capsules Healthcare Pvt. Ltd., 15, Sector 6-B, IIE, Ranipur, Haridwar- Page 6 of 10249403, Uttarakhand. 27. Rosuvastatin B. No.: 21S1GTA035 Dissolution Drug Control RDTL Calcium Tablets IP Mfg dt: 01/2021 Department Guwahati 10mg Exp dt: 12/2022 Assam Mfd by: M/s SYNOKEM PHARMACEUTICALS LTD. Plot No.: 35-36, Sector-6A, I.I.E.(SIDCUL), Ranipur (BHEL), Haridwar-249403, Uttarakhand. 28. Omeprazole B. No.: 520-170 Dissolution Drug Control RDTL Gastro-resistant Mfg dt: 07/2020 Department Guwahati Capsules I.P. Exp dt: 06/2022 Assam Mfd by: M/s ZEE LABORATORIES, 47, Industrial Area, Paonta Sahib – 173025, Himachal Pradesh. 29. Doxofylline Tablets B. No.: SPTG-20390 Dissolution CDSCO RDTL IP 400mg Mfg dt: 08/2020 Sub-Zone Guwahati Exp dt: 07/2022 Guwahati Mfd by: M/s SPECTRUM FORMULATION PVT. LTD, Khasra No. 12, Makhanpur, Bhagwanpur, Roorkee, Haridwar – Uttarakhand. 30. Dexamethasone B. No.: DPO2004 Assay Drug Control RDTL Tablets I.P. 0.5mg Mfg dt: 08/2020 Department Guwahati Exp dt: 07/2022 Jharkhand Mfd by: M/s Danish Health Care (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain - 456010, Madhya Pradesh, INDIA. Page 7 of 1031. BUPRENORPHINE B. No.: LM 18870 Assay Drug Control RDTL INJECTION I.P. Mfg dt: 012/2020 Department Guwahati Exp dt: 011/2026 Bihar Mfd by: M/s Cooper pharma Ltd. C-3, Industrial Area, Selaqui, Dehradun- 248197, Uttarakhand. 32. BUPRENORPHINE B. No.: LM 18730 Assay Drug Control RDTL INJECTION I.P. Mfg dt: 08/2018 Department Guwahati Exp dt: 07/2024 Bihar Mfd by: M/s Cooper pharma Ltd., C-3, Industrial Area, Selaqui, Dehradun- 248197, Uttarakhand. 33. ODIMONT-AL B. No.: GZOA21003 Dissolution CDSCO CDTL (Montelukast, Mfg dt: 11/2021 Sub-Zone Mumbai Levocetirizine HCl & Exp dt: 10/2023 Goa Ambroxol HCl (SR) Mfd by: M/s GKM Tablets) New Pharma. Plot No.5, 6, 7 & 8, Pipdic Electronic Park, Thirubuvanai, Puducherry- 605 107. 34. Fluconazole B. No.: 4700821 Uniformity of CDSCO CDTL Capsules I.P. Mfg dt: 11/2021 weight Zonal Office Mumbai 150 mg Exp dt: 10/2023 Ahmedabad Mfd by: M/s Karnataka Antibiotics & Pharmaceutical Pvt. Ltd., Plot No.14, II Phase, Peenya, Bengaluru - 560 058. 35. Methylcobalamin, B. No.: SOC-1911A Assay of Alpha CDSCO RDTL Alpha Lipoic Acid, Mfg dt: 02/2022 Lipoic Acid Sub-Zone Chandigarh Pyridoxine HCI and Exp dt: 01/2024 Baddi Folic Acid Capsules Mfd by: M/s (VEMIFOL PLUS Symbiosis CAPSULES) Pharmaceuticals Pvt. Ltd. (Plant-3) Plant at: Trilokpur Road, Kala Amb-173030, Himachal Pradesh. Page 8 of 10Marketed by: VIVEX PHARMACEUTICALS PVT. LTD. SCO 131, Sector-110, TDI City, Mohali, SAS Nagar- 140307. 36. Iron (III) Hydroxide B. No.: DLK-071C Assay of Folic CDSCO RDTL Polymaltose Mfg dt: 11/2021 Acid Sub-Zone Chandigarh Complex with Folic Exp dt: 04/2023 Baddi Acid Syrup (POLY- Mfd by: M/s Digital FORTE SYRUP) Vision 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour, Himachal Pradesh -173030. Marketed by: ORISON PHARMACEUTICALS 51, Industrial Estate, Ambala Cantt- 133006. 37. Diclofenac B. No.: 017 Assay of Linseed CDSCO RDTL Diethylamine, Mfg dt: 02/2022 Oil Sub-Zone Chandigarh Methyl Salicylate, Exp dt: 01/2024 Baddi Linseed Oil and Mfd by: M/s GMH Menthol Gel Laboratories Plot No. (ARMNAC GEL) 13, Industrial Township, Bhatoli Kalan, Baddi, Distt. Solan, Himachal Pradesh -173205. 38. Doxofylline Tablets B. No.: 994-09 Dissolution CDSCO RDTL IP 400 mg Mfg dt: 06/2021 North-Zone Chandigarh (DOXOSIGN Exp dt: 05/2024 TABLETS) Mfd by: M/s HAB PHARMACEUTICALS & RESEARCH LIMITED 10, Pharmacity, SIDCUL, Selaqui, Dehradun – 248011, Uttrakhand. 39. Ondansetron B. No.: EA11107 Sterility CDSCO RDTL Injection IP (ONET Mfg dt: 11/2021 Sub-Zone Chandigarh INJECTION) Exp dt: 10/2023 Baddi Page 9 of 10Mfd by: M/s Elder Labs Limited Vill: Kishanpura, Baddi- Nalagarh Road, Baddi, Distt.-Solan, Himachal Pradesh - 174101. 40. Cloxacillin Sodium B. No.: CLO-2003 Identification CDSCO RDTL Capsules IP 500 mg Mfg dt: 07/2020 North-Zone Chandigarh (CLOXRID-500 Exp dt: 06/2022 CAPSULES) Mfd by: M/s RIDLEY LIFE SCIENCE PVT . LTD. D-1651, DSIDC Indl. Complex, Narela, Delhi-110040. 41. Amlodipine Tablets B. No.: 2113452T001 Assay CDSCO RDTL IP (AMLOTIS-10 Mfg dt: 06/2021 Sub-Zone Chandigarh TABLETS) Exp dt: 05/2023 Baddi Mfd by: M/s Scott-Edil Pharmacia Ltd. Unit- II, Plot No. 21-22, E.P.I.P., Phase-1, Jharmajri, Baddi, Distt. Solan-173205, Himachal Pradesh, INDIA. Page 10 of 10

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