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.

The list of drugs declared not of standard quality includes Paziva -40 manufactured by Gnosis Pharmaceuticals, Pantomed -40 manufactured by Digital Vision, Cefixime Oral Suspension IP (Dry Syrup) manufactured by Nestor Pharmaceuticals, Moxymed CV manufactured by Alexa Pharmaceuticals, Frusemide Injection manufactured by Nestor Pharmaceuticals and others.

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.

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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To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/state-august-2024-253703.pdf

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