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Date: 2018-12-12 Category: Not Applicable State: Union Government Country: India

Drug Alert list for November 2018

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

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Executive Summary & Key Takeaways

Key Changes

  • The listed products include drugs, medical devices (absorbent cotton wool), and injections.
  • A total of 27 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • Reasons for failure include: Related Substances, Particulate Matter, Description, Sulphated Ash, Dissolution, Sinking Time, Disintegration Test, Sterility, Assay of Dexamethasone, Total Viable Bacterial Count, Uniformity of Weight, Physical Parameter, Assay of Terbutaline Sulphate & Assay of Bromhexine HCL.
  • Multiple batches of Amoxycillin Oral Suspension I.P. manufactured by Zee Laboratories are listed due to Physical Parameter issues.
  • Several products failed due to dissolution issues, including Paracetamol Tablets, Telmisartan Tablets, Glimepiride Tablets, and Levocetirizine Hydrochloride Tablets.
  • Several CDSCO Zonal offices and RDTLs were involved in the testing of the failed products.

What it means

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of November 2018.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer details, reason for failure, and the source from which the sample was drawn.

Impact Analysis

Manufacturers

  • There will be a financial impact due to the recall of affected batches and potential damage to brand reputation.

Consumers/Patients

  • The notification creates a loss of confidence in the quality of pharmaceutical products and the regulatory oversight.

Regulatory Authorities

  • Regulatory authorities should conduct regular audits of manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP).

Pharmacies/Distributors

  • Pharmacies and distributors should implement stricter quality control measures to ensure the authenticity and quality of the products they sell.

Action Items

  • Enhance employee training on quality control and GMP requirements.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory authority for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, a network of laboratories responsible for testing and analyzing drug samples. Drug Controller: State Drug Controller, the regulatory authority responsible for the enforcement of drug regulations at the state level. GMP: Good Manufacturing Practices, a set of guidelines and regulations that ensure the quality and safety of pharmaceutical products. IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India. USP: United States Pharmacopeia
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 November, 2018 Sl. Name of Batch No./Date of Reason for failure Drawn By From No Drugs/medical Manufacture/Date of . device/cosmetics Expiry/Manufactured By 1. LC-5 B. No.: LC042, Related Substances CDSCO, CDL, (Levocetirizine Mfg dt: 01/2017, South Zone Kolkata Dihydrochloride Exp dt: 12/2018, Chennai Tablets I.P.) Mfd by: M/s.The Madras Pharmaceuticals, 137-B, Old Mahabalipuram Road, Karapakkam, Chennai 600 096. 2. Numbcaine Heavy B. No.: IBPVA2706, Particulate Matter CDSCO, Sub CDL, (Bupivacaine Mfg dt: 12/2017, Zone, Baddi Kolkata Hydrochloride in Exp dt: 11/2019, Dextrose Injection Mfd by: M/s. Samarth Life U.S.P.), Sciences, Unit-II, Plot No 2, Industrial Area, Lodhimajra, Baddi. 3. Doxylamine B. No.: 710-12, Description CDSCO, CDL, Succinate & Mfg dt: 03/2017, East Zone, Kolkata Pyridoxine Exp dt: 02/2019, Kolkata Hydrochloride Mfd by: M/s. HAB Tablets Pharmaceuticals & Research Limited 10, Pharmacity, SIDCUL, Selaqui, Dehradun 248197. 4. AARMOL B. No.: 2491134, Description CDSCO, CDTL INJECTION Mfg dt: 04/2017, Ahmedabad Chennai (PARACETAMOL Exp dt: 03/2019, Zonal Office, INFUSION IP Mfd by: M/s. Shree Ahmedabad 1000 mg/100 ml) Krishnakeshav Laboratories Ltd. Amraiwadi Road Ahmedabad-380008. 5. Absorbent Cotton B. No.: 1992, Sulphated Ash CDSCO, Sub CDTL, Wool I.P. Mfg dt: 05/2017, Zone, Indore Mumbai Exp dt: 04/2020, Mfd by: M/s. Venkatesh Surgical Cotton Industries, Village-Ajania, Dist. Chhindwara M.P.6. DRUPARA-500 B. No.: RT1756, Dissolution CDSCO, CDTL, (Paracetamol Tablets Mfg dt: 03/2018, West Zone, Mumbai Exp dt: 02/2020 IP) Mumbai Mfd by: M/s. Rachil Pharma, 18-19, Phase-1, Ind. Area, Sansarpur Terrace, Dist. Kangra (H.P.) 176501. 7. Absorbent Cotton B. No.: 1666, CDSCO RDTL, Wool IP Mfg dt: 05/2018, Sinking time North Zone., Chandigarh Exp dt: 04/2021, Mfd by: M/s. JIND SURGICALS 24-27, HSIDC Industrial Estate, New Hansi Road, Jind-126102 (Haryana). 8. Diclofenac B. No.: T7457, Dissolution Drug Control RDTL, Prolonged Release Mfg dt: 11/2017, Department Chandigarh Tablets IP Exp dt: 10/2019, Delhi Mfd by: M/s. Zest Pharma, Plot No. 275, Sector F, Sanwar Road, Indore-452015. 9. METOCLOPRAMIDE B . No.: MEI1801, Related Substances CDSCO RDTL, INJECTION IP Mfg dt: 01/2018, North Zone Chandigarh Exp dt:,12/2019, Mfd by: M/s. modern laboratories 45-47, Sector D- 2, Sanwer Road, Indore (M.P.) 452015. 10. Paracetamol, B. No.:ULT-2118, Disintegration Test Drug RDTL, Phenylephrine Mfg dt: 05/2018, Controller Chandigarh Hydrochloride and Exp dt:,04/2020, H.P. Chlorpheniramine Mfd by: M/s. Ultratech Maleate Tablets Pharmaceuticals, Vill. Tipra, (COLDOX-FORTE P.O. Barotiwala, Distt. TABLETS) Solan(H.P). 11. Telmisartan Tablets B. No.: AT70264, Dissolution CDSCO RDTL, IP 80 mg (TELXER Mfg dt: 06/2017, S.Z., Baddi Chandigarh 80 MG TABLETS) Exp dt: 05/2019, Mfd by: M/s.CIAN HEALTH CARE PVT. LTD., Kh. No.:248, Village Sisona, Bhagwanpur, Roorkee, Haridwar, Uttarakhand.12. SODIUM B. No.: ST-207, Sterility CDSCO, RDTL, BICARBONATE Mfg dt: 01/2018, S.Z., Baddi. Chandigarh INJECTION I.P Exp dt: 12/2019, 7.5% W/V Mfd by: M/s. Rathi Laboratories (Hindustan) Pvt.Ltd., Industrial Area, Patna-800013 13. Injection of B. No.: I-13914, The Particulate CDSCO, RDTL, Etophylline and Mfg dt: 04//2017, matter Sub.Zone, Chandigarh Theophylline Exp dt: 03/2019, Baddi (THEOJACK Mfd by: M/s. Jackson INJECTION) Laboratories Pvt.Ltd., Bye Pass, Majitha Road, Amritsar-143001. 14. GLIMEPIRIDE B. No.: GSM-18776, Dissolution South Zone RDTL, TABLETS IP Mfg dt: 06/2018, (Glimepiride) Chennai. Chandigarh Exp dt: 05/2020, Mfd by: M/s. Max Chem Pharmaceuticals Pvt.Ltd., Plot No.22, Sector-3, Sidcul- IIE, Rudrapur, Distt.US Nagar, (Uttarakhand)-263153 15. LEVOCETIRIZINE B. No.: SHT7550, Dissolution CDSCO, RDTL, HYDROCHLORIDE Mfg dt: 12/2017, (Levocetirizine North Zone Chandigarh TABLETS IP 5 MG Exp dt: 11/2020, Hydrochloride). Mfd by: M/s. SYNCOM HEALTHCARE LTD., D-42, IIE, SIDCUL ,Selaqui, Dehradun-248197, Uttarakhand 16. PARACETAMOL B. No.: PTTV-104, Dissolution CDSCO, RDTL, TABLETS I.P. Mfg dt: 03/2018, (Paracetamol) North Zone Chandigarh 500 MG Exp dt: 02/2021, Mfd by: M/s. NESTOR PHARMACEUTICALS LIMITED, 11, Western Extension Area, Faridabad- 121001, India.17. LEVOCETIRIZINE B. No.: SHT7549, Dissolution CDSCO, RDTL, HYDROCHLORIDE Mfg dt: 12/2017, (Levocetirizine North Zone Chandigarh TABLETS IP 5 MG Exp dt: 11/2020, Hydrochloride) Mfd by: M/s. SYNCOM HEALTHCARE LTD., D-42, I.I.E., SIDCUL, Selaqui, Dehradun-248197, Uttarakhand. 18. DEXAMETHASONE B. No.: DU15010, Assay of CDSCO, RDTL, TABLETS IP 0.5 Mfg dt: 12/2015, Dexamethasone South Zone., Chandigarh MG Exp dt: 11/2018, Chennai Mfd by: M/s. Baader Schulz Laboratories, Pharma Division Plot No. J-6, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman- 396210 U.T India. 19. ALUMINIUM B . N o . : A L M -036L, Total Viable CDSCO, RDTL, HYDROXIDE Mfg dt: 01/2017, Bacterial Count and N.Z. GZB. Chandigarh Exp dt: 12/2018, SUSPENSION IP Description Mfd by: M/s. SS Pharmaceuticals (P) Ltd., 357-C/229-A, Lukerganj, Allahabad. 20. CEFUROXIME B. No.: FCAT-104, Uniformity of CDSCO, RDTL, AXETIL TABLETS Mfg dt: 12/2017, Weight N.Z. GZB. Chandigarh Exp dt: 05/2019, IP (CEFTIL-250 Mfd by: M/s. Crystal TABLETS) Pharmaceuticals, 365, Model Town, Ambala City-134003. 21. Zolid 500 Tablets B. No.: RAL-048, Assay & Dissolution Drug RDTL, Mfg dt: 06/2018, Controller Guwahati Exp dt: 05/2020, Department, Mfd by: M/s. Ronak Life Mizoram Care Pvt. Ltd. R.S. No. 41(Part), Vill-Rajpur TA. & Dist-Patan-384265,88, Nilkanth Estate, Sarkhej, Ahmedabad. 22. Amoxycillin 500mg. B. No.: PI7224, Particulate Drug RDTL, & Potassium Mfg dt: 12/2017, Contamination & Controller Guwahati Clavulanate 100mg. Exp dt: 11/2019, Particulate Matter Department, for Injection I.P. Mfd by: M/s. Bharat Arunachal Parenteral Ltd. Vill Haripura, Pradesh TA-Savil, Dist Vadodara, Gujarat-391520.23. Amoxycillin Oral B. No.: 717-110, Physical Parameter Drug RDTL, Suspension I.P. Mfg dt: 07/2017, Controller Guwahati Exp dt: 12/2018, Department, Mfd by: M/s. Zee Assam Laboratories 47, industrial Area, Paonta Sahib-173025. 24. Amoxycillin Oral B. No.: 717-116, Physical Parameter RDTL, Suspension I.P. Mfg dt: 08/2017, Guwahati Exp dt: 01/2019, Mfd by: Zee Laboratories 47, industrial Area, Paonta Sahib- 173025. 25. Methyl Ergometrine B. No.: TMEG-021, Physical Parameter RDTL, Tablets I.P. 0.125 Mfg dt: 12/2016, Guwahati mg. Exp dt: 11/2018, Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd. 1199/3, Bhud, Solan, H.P. 26. Amoxycillin Oral B. No.: 717-113, Physical Parameter Drug RDTL, Suspension I.P. Mfg dt: 08/2017, Controller Guwahati Department, Exp dt: 01/2019, Assam Mfd by: M/s. Zee Laboratories 47, industrial area, Paonta Sahib-173025. 27. Terbutaline Sulphate B. No.: ML170825, Assay of Terbutaline Drug RDTL, 2.5 mg. Bromhexine Mfg dt: 02/2018, Sulphate & Assay of Controller Guwahati Department, HCL 8 mg & Exp dt: 01/2020, Bromhexine HCL Mizoram Guaiphenesin Mfd by: M/s. Mascot Health 100 mg. Syrup Series Pvt. Ltd. Plot No.79, 80, Sector-6A, IIE, SIDCUL, Haridwar-249403.

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