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Date: 2024-08-22 Category: Not Applicable State: Union Government Country: India

STATE 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 State Laboratories and reported to the Central Drugs Standard Control Organisation (CDSCO).
  • The alert identifies specific drugs and products that have failed quality tests conducted by Drugs Testing Laboratories, Thiruvananthapuram and CFDL Jammu (J&K).

Key Changes

  • Thirteen products/drugs have been identified as Not of Standard Quality (NSQ).
  • The products include Cephalexin Oral Suspension IP 125/500, Salbutamol Nebuliser Solution BP 5 mg/ml, Sodium Valporate Gastro Resistant Tablets IP 200 mg, Cilader -10, Bioglip 1 Tablets, Ciprofloxacin Hydrochloride Tablets IP 500 mg, New improved Gentle Daily care Natural protein Shampoo, Irinotecan Inj.IP 100 mg vial, Vitamin B Complex tablet N.F.I.1, Chlorpromazine Tab IP 50 mg, Fluorometholone Eye drops IP and Iron & Folic Acid Syrup IP (JKMSCL Hospital Supply).
  • The reasons for failure include failing the test for ‘Assay’ and Descriptive part as per IP, ‘pH’ as per BP, ‘Dissolution’ as per IP, “heavy metals as lead (Pb)” as per IS 7884:2023, particulate matter and assay as per IP, and not conforming to IP standard with respect to the ‘Descriptive part’ for tablets.
  • Nestor Pharmaceuticals Ltd, Cotec Healthcare Pvt.Ltd, Unicure India Ltd., Alventa Pharma Ltd, IBN Herbals, Wings Biotech LLP, Himalaya Wellness Company, Kerala Medical Services Corporation Ltd and Jackson Laboratories Pvt. Ltd are listed as manufacturers of the NSQ products.
  • State Drugs Licensing Authorities of Karnataka and Jharkhand did not submit NSQ data in the required EXCEL SHEET format.
  • State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, Telangana,Delhi,Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of July, 2024 as per DCG(I) Circular dated 09.02.2024.

Impact Analysis

Manufacturers

  • Impact: Financial losses, reputational damage, and potential suspension or cancellation of licenses.

Consumers/Patients

  • Impact: Potential health risks, anxiety, and reduced trust in healthcare products.

Kerala Medical Services Corporation Ltd

  • Impact: Reputational damage, financial losses due to recalls, and potential legal liabilities.

Regulatory Authorities (CDSCO & State Licensing Authorities)

  • Impact: Enhanced regulatory oversight, stricter enforcement actions, and improved data collection and analysis.

Action Items

  • Conduct training programs for employees on quality control and good manufacturing practices (GMP).

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. State Drugs Licensing Authorities: State government agencies responsible for licensing and regulating the manufacture, sale, and distribution of drugs within their respective states. Drugs Testing Laboratory Thiruvananthapuram: A state government laboratory responsible for testing drugs and pharmaceuticals to ensure quality and compliance with standards. CFDL Jammu (J&K): Central Drugs Testing Laboratory in Jammu & Kashmir. IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India. BP: British Pharmacopoeia, the official collection of standards for medicinal products in the United Kingdom. IS 7884:2023: Indian Standard for Shampoo DCG(I) Circular dated 09.02.2024: Circular issued by the Drugs Controller General (India) regarding the format for submitting NSQ data.
Official Source Record View Original Source →
See Full Document Text
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF July – 2024. B. State Laboratories S.No Product/Drug Batch No. Manufacturing Expiry Manufactured By NSQ Result Reported by Name Date Date CDSCO Laboratory 1. Cephalexin Oral CHDA-01 04/23 09/24 Nestor Pharmaceuticals It fails the test Drugs Testing Suspension IP Ltd, 11, Western ‘Assay’ and Laboratory 125/500 Extension Area, Descriptive Thiruvananthapuram Faridabad part as per IP 2. Salbutamol CHS-3085 06/23 05/25 Cotec Healthcare It fails the test Drugs Testing Nebuliser Pvt.Ltd, N.H.No. 74, ‘pH’ as per Laboratory Solution BP 5 Roorkee , Dehradun , BP Thiruvananthapuram mg/ml High way, Kishanpur, Roorkee Uttarakhand 3. Sodium Valporate SVT1140 09/23 08/26 Unicure India Ltd., It fails the test Drugs Testing Gastro Resistant C-21,22 &23, Sector-3, ‘Dissolution’ Laboratory Tablets IP 200 mg Noida-201301, Distt. as per IP Thiruvananthapuram Gautam Budh Nagar (UP) 4. Cilader -10 AGT30720 07/23 06/25 Alventa Pharma Ltd, It fails the test Drugs Testing Vill, Kishanpura, Baddi- ‘Dissolution’ Laboratory Nalagarh Road, tehsil, as per IP Thiruvananthapuram baddi, Dist, Solan (HP) 5. Bioglip 1 BEL23021 09/23 08/25 IBN Herbals, Khasra No. It fails the test Drugs Testing Tablets 63, Vill, Juddi Kalan, ‘Dissolution’ Laboratory Baddi-173205, Distt. as per IP Thiruvananthapuram Solan (HP) 6. Ciprofloxacin CPXT-1016 10/23 09/26 Wings Biotech LLP, It fails the test Drugs Testing Hydrochloride 43&44, HPSIDC, ‘Dissolution’ LaboratoryTablets IP 500 Ind.Area, Baddi-173205 as per IP Thiruvananthapuram mg HP 7. New improved B20240005 01/24 12/26 Himalaya Wellness It fails the test Drugs Testing Gentle Daily 2 Company, No-182, for “heavy Laboratory care Natural Village Guru Majra, metals as lead Thiruvananthapuram Tehsil, Baddi-174101 (Pb)” as per IS protein Dist Solan (HP) 7884:2023 Shampoo 8. Irinotecan Inj.IP D0368/23- Supplied by Kerala It fails the Drugs Testing 100 mg vial 24 Medical Services tests Laboratory Corporation Ltd, particulate Thiruvananthapuram Thycaud P.O, matter and Thiruvananthapuram -14 assay as per IP 9. Vitamin B S0004/24- Supplied by Kerala The sample Drugs Testing Complex tablet 25 Medical Services does not Laboratory N.F.I.1 Corporation Ltd, conform to IP Thiruvananthapuram standard with Thycaud P.O, respect to the Thiruvananthapuram - ‘Descriptive 14 part’ for tablets 10. Vitamin B S0003/24- Supplied by Kerala The sample Drugs Testing Complex tablet 25 Medical Services does not Laboratory N.F.I.1 Corporation Ltd, conform to IP Thiruvananthapuram standard with Thycaud P.O, respect to the Thiruvananthapuram - ‘Descriptive 14 part’ for tablets 11. Chlorpromazine D 0644/24- Supplied by Kerala The sample Drugs Testing Tab IP 50 mg 25 Medical Services does not Laboratory Corporation Ltd, conform to IP ThiruvananthapuramThycaud P.O, standards. It Thiruvananthapuram - fails the 14 ‘Descriptive part’ 12. Fluorometholone CHE 3044 05/23 04/25 Cotec Healthcare It fails the test Drugs Testing Eye drops IP Pvt.Ltd, K.H.No. 593/1 ‘Assay’ as per Laboratory Roorkee , Dehradun , IP Thiruvananthapuram High way, Kishanpur, Roorkee- 247667 Uttarakhand 13. Iron & Folic Acid SY-1641 01-08-2023 01-07-2025 Jackson Laboratories Pvt. The sample CFDL Jammu (J&K) Syrup IP (JKMSCL Ltd 22-24, Majitha Road fails in the test Hospital Supply) Bye Pass Amritsar for pH w.r.t 143001 , India the sample portion received. NOTE: 1. NSQ data was not received as per the format of DCG(I) Circular dated 09.02.2024 in EXCEL SHEET from State Drugs Licensing Authorities of Karnataka (PDF format), and Jharkhand (PDF format), for the Month of July, 2024. 2. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, Telangana,Delhi,Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of July, 2024 as per DCG(I) Circular dated 09.02.2024.

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