11 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 11 medicine batches for failing to qualify for a random sample test for August 2024.
In addition to the above, the alert mentioned that the Not of Standard Quality (NSQ) data was not received as per Format and in EXCEL SHEET from State Drugs Licensing Authorities of Karnataka (PDF format), Thiruvanthapuram (Excel format), and Jammu Kashmir (Excel Format) for the Month of August 2024 as per DCG(I) Circular dated 09.02.2024.
Furthermore, the alert noted that the 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 August, 2024 as per DCG(I) Circular dated 09.02.2024.
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF AUGUST - 2024.
B. State Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Paziva -40 | GT300234 | 05/23 | 04-25 | M/s.Gnosis Pharmaceuticals Pvt.Ltd, Nahan Road , Village Moginand , Kala-Amb Dist. Sirmour, HP- 173 030 | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapura m |
2. | Pantomed -40 | GTEO230 C | 01/24 | 12-25 | Digital Vision 176, Mauza ogli, Nahan Road, Kala -Amb, Dist Sirmour - 173 030 | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapura m |
3. | Cefixime Oral Suspension IP (Dry Syrup) | CADA-02 | 09 /23 | 08/25 | Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad - 121001 | It fails the test ‘Assay’ and ‘water’ as per IP | Drugs Testing Laboratory Thiruvananthapura m |
4. | Moxymed CV | ABT 23316 | 11/23 | 04/25 | Alexa Pharmaceuticals , Plot No. 20, Ext HPSIDC, Indl.Area, Baddi, Solan – 173 205 | The content of Amoxycillin and Clavulanic acid is not with in the limits of schedule ‘V’ of Drugs and Cosmetics Act & Rules as mentioned | Drugs Testing Laboratory Thiruvananthapura m |
in the Laboratory protocol | |||||||
5. | Frusemide Injection IP 20 mg | FRIB-03 | 01/24 | 12/25 | Nestor Pharmaceuticals Ltd, Faridabad- 121 001 | It fails the test ‘Sterility’ as per IP | Drugs Testing Laboratory Thiruvananthapura m |
6. | Kudajarishtam | 0110 | 01/24 | Nil | Bala Herbals, Industrial Estate, Edakkulangara, Kollam | It fails the tests ‘Total Solids’ and ‘Specific gravity’ as per API. | Drugs Testing Laboratory Thiruvananthapura m |
7. | Tab Nodosis | SMST- 24151 | 02/24 | 01/26 | Steadfast Medishield pvt.Ltd, At khasra,No.322, Nanhera , Anantpur, Bhgwanpur, Roorkee, Dist. Haridwar | It fails the test ‘Assay’ as per IP | Drugs Testing Laboratory Thiruvananthapura m |
8. | Haridrakhanda m | 207/23 | 03/24 | 02/26 | Bhaskara Vilasam Vaidyasala, Panayamuttom, Nedumangadu, Thiruvananthapuram - 695 561 | It fails the test ‘pH’ as per API. | Drugs Testing Laboratory Thiruvananthapura m |
9. | Pantoprazole Inj. BP 40 mg | D0726/24- 25 | Kerala Medical Services Corporation Ltd, Thycaud.P.O, Thiruvananthapuram | The sample does not comply with BP. It fails the test Particulate contaminatio n clarity and colour of solution. | Drugs Testing Laboratory Thiruvananthapura m |
10. | Yogaraja Guggulu | 209/21 | 03/22 | 3 yrs from mfg date | Bhaskara Vilasam Vaidyasala, Panayamuttom, Nedumangadu, Thiruvananthapuram - 695 561 | It fails the test Alcohol Soluble Extractive and pH as per API | Drugs Testing Laboratory Thiruvananthapura m |
11. | PANCEF-OF | T442401 | Jan-24 | Dec-25 | Aglomed Ltd. 51, Raipur , Roorkee - 247661 . H.O : 702-A, Poonam Chambers , Dr. A.B Road , Worli , Mumbai - 400018, India | The sample does not comply with respect to the test parameters at S.No II d (Disintegratio n Test) | Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/978 Dated: 07.08.2024 |
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