13 Formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert
New Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), in its latest drug safety alert, has flagged 13 medicine batches for failing to qualify for a random sample test for July 2024.
The list of drugs declared not of standard quality includes Cephalexin Oral Suspension manufactured by Nestor Pharmaceuticals, Salbutamol Nebuliser Solution manufactured by Cotec Healthcare, Sodium Valproate Gastro Resistant Tablets manufactured by Unicare India, Cilader - 10 manufactured by Alventa Pharma, Bioglip 1Tablets manufactured IBN Herbals, Ciprofloxacin Hydrochloride manufactured by Wings Biotech, New improved Gentle Daily care Natural protein Shampoo manufactured by Himalaya Wellness, Irinotecan Inj.IP 100 mg vial Supplied by Kerala Medical Services Corporation, Vitamin B Complex tablet supplied by Kerala Medical Services Corporation Ltd, Chlorpromazine Tab Supplied by Kerala Medical Services Corporation, Fluorometholone eye drops IP manufactured by Cotec Healthcare, and Iron and Folic Acid Syrup manufactured by Jackson Laboratories.
Many factors contributed to the drug samples' failure in the test, such as non-compliance with the IP requirements for the particular drug, failure of the dissolution test, pH, and some assays of the drug test, among others.
Furthermore, the alert noted that NSQ data was not received as per format and in EXCEL SHEET from State Drugs Licensing Authorities of Karnataka (PDF format), and Jharkhand (PDF format), for the month of July 2024.
In addition to the above, the alert mentioned, "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 and 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 dated09.02.2024."
B. State Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Cephalexin Oral Suspension IP 125/500 | CHDA-01 | 04/23 | 09/24 | Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad | It fails the test ‘Assay’ and Descriptive part as per IP | Drugs Testing Laboratory Thiruvananthapuram |
2. | Salbutamol Nebuliser Solution BP 5 mg/ml | CHS-3085 | 06/23 | 05/25 | Cotec Healthcare Pvt.Ltd, N.H.No. 74, Roorkee , Dehradun , Highway, Kishanpur, Roorkee Uttarakhand | It fails the test ‘pH’ as per BP | Drugs Testing Laboratory Thiruvananthapuram |
3. | Sodium Valporate Gastro Resistant Tablets IP 200 mg | SVT1140 | 09/23 | 08/26 | Unicure India Ltd., C-21,22 &23, Sector-3, Noida-201301, Distt. Gautam Budh Nagar (UP) | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
4. | Cilader - 10 | AGT30720 | 07/23 | 06/25 | Alventa Pharma Ltd, Vill, Kishanpura, Baddi- Nalagarh Road, tehsil, baddi, Dist, Solan (HP) | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
5. | Bioglip 1 Tablets | BEL23021 | 09/23 | 08/25 | IBN Herbals, Khasra No. 63, Vill, Juddi Kalan, Baddi- 173205, Distt. Solan (HP) | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
6. | Ciprofloxacin Hydrochloride | CPXT- 1016 | 10/23 | 09/26 | Wings Biotech LLP, 43&44, HPSIDC, | It fails the test ‘Dissolution’ | Drugs Testing Laboratory |
Tablets IP 500 mg | Ind.Area, Baddi- 173205 HP | as per IP | Thiruvananthapuram | ||||
7. | New improved Gentle Daily care Natural protein Shampoo | B20240005 2 | 01/24 | 12/26 | Himalaya Wellness Company, No- 182, Village Guru Majra, Tehsil, Baddi- 174101 Dist Solan (HP) | It fails the test for “heavy metals as lead (Pb)” as per IS 7884:2023 | Drugs Testing Laboratory Thiruvananthapuram |
8. | Irinotecan Inj.IP 100 mg vial | D0368/23- 24 | Supplied by Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram - 14 | It fails the tests particulate matter and assay as per IP | Drugs Testing Laboratory Thiruvananthapuram | ||
9. | Vitamin B Complex tablet N.F.I.1 | S0004/24- 25 | Supplied by Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram - 14 | The sample does not conform to IP standard with respect to the ‘Descriptive part’ for tablets | Drugs Testing Laboratory Thiruvananthapuram | ||
10. | Vitamin B Complex tablet N.F.I.1 | S0003/24- 25 | Supplied by Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram - 14 | The sample does not conform to IP standard with respect to the ‘Descriptive part’ for tablets | Drugs Testing Laboratory Thiruvananthapuram | ||
11. | Chlorpromazine Tab IP 50 mg | D 0644/24- 25 | Supplied by Kerala Medical Services Corporation Ltd, | The sample does not conform to IP | Drugs Testing Laboratory Thiruvananthapuram |
Thycaud P.O, Thiruvananthapuram - 14 | standards. It fails the ‘Descriptive part’ | ||||||
12. | Fluorometholone Eye drops IP | CHE 3044 | 05/23 | 04/25 | Cotec Healthcare Pvt.Ltd, K.H.No. 593/1 Roorkee , Dehradun , Highway, Kishanpur, Roorkee- 247667 Uttarakhand | It fails the test ‘Assay’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
13. | Iron & Folic Acid Syrup IP (JKMSCL Hospital Supply) | SY- 1641 | 01-08-2023 | 01-07-2025 | Jackson Laboratories Pvt. Ltd 22-24, Majitha Road Bye Pass Amritsar 143001 , India | The sample fails in the test for pH w.r.t the sample portion received. | CFDL Jammu (J&K) |
To View the official notice, click the below link:
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