Several State Drugs Licensing Authorities did not submit any data for June 2024.
A total of 30 products are listed as Not of Standard Quality (NSQ).
Failures were reported by Drugs Testing Laboratories in Thiruvananthapuram and Maharashtra.
Common reasons for failure include not meeting requirements for Dissolution, Assay, pH, Alcohol soluble extractive, Descriptive part of hard gelatin capsules, Total Aerobic Viable Count, Content of Montelukast and Levocetirizine, Related Substances – Rosuvastatin.
The alert notes that NSQ data was not received in the correct format from Rajasthan and Orissa.
What it means
This is a Not of Standard Quality (NSQ) alert issued for the month of June 2024, identifying drugs and pharmaceutical products that failed quality tests conducted by various state laboratories and CDSCO laboratories.
The alert lists the name of the drug/product, batch number, manufacturing and expiry dates, manufacturer, the reason for failure, and the reporting laboratory.
Impact Analysis
Manufacturers
A review of manufacturing processes, quality control procedures, and raw material sourcing is recommended.
Distributors and Retailers
Coordination with manufacturers and regulatory authorities is crucial for the smooth execution of recall procedures.
Consumers/Patients
Increased awareness among consumers about drug quality and reporting mechanisms is necessary.
Regulatory Authorities (State and Central)
The DCG(I) should address the issue of non-reporting of NSQ data by some states to ensure comprehensive monitoring.
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India.
State Drugs Licensing Authorities: State-level regulatory bodies responsible for licensing and monitoring pharmaceutical manufacturing and sales within their respective states.
IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India.
USP: United States Pharmacopeia
BP: British Pharmacopoeia
Drugs and Cosmetics Act 1940: Indian law that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Drugs and Cosmetics Rules 1945: Rules framed under the Drugs and Cosmetics Act 1940 to regulate the import, manufacture, distribution, and sale of drugs and cosmetics.
DCG(I) Circular dated 09.02.2024: Circular issued by the Drugs Controller General of India regarding the reporting of Not of Standard Quality (NSQ) data.
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JUNE – 2024.
B. State Laboratories
S.No Product/Drug Batch No. Manufacturing Expiry Manufactured By NSQ Result Reported by
Name Date Date CDSCO
Laboratory
1. Liquid Paraffin IP EP4032 01/24 12/26 Repacked by :- Kerala State It fails the test Drugs Testing
Drugs & Pharmaceuticals light absorption Laboratory
Ltd, Kalavoor.P.O, as per IP Thiruvananthapura
Alappuzha m
2. Losartan HLOA06 11/23 10/25 Hindustan Antibiotics It fails the test Drugs Testing
Potassium Tablets Ltd, at II, W.E.A, ‘Dissolution’ as Laboratory
IP 50 mg Faridabad- 121 per IP Thiruvananthapura
001(Haryana) R.O, m
Pimpri, Pune -411 018
3. Amloheart-AT LE223030 03/23 02/25 Lividus Pharmaceuticals Drugs Testing
[Amlodipine pvt.Ltd, ikeva, Level2, It fails the test Laboratory
Besylate and Agnito Tech park,141 ‘Assay’ of Thiruvananthapura
Atenolol Tablets] Kandachavadi, Near, Amlodipine m
Perungudi, OMR, Besylate
Chennai-600096
4. Bacotil-200 ZTB-148 03/24 02/26 Zenith Healthcare Ltd It fails the test Drugs Testing
[Cefpodoxime works: 388/34, ‘Dissolution’ as Laboratory
Proxetil Tablets Changodarlnd. Estate, per USP Thiruvananthapura
USP ] Sarkhej Bavla Highway, m
Changodar- 382213
(Gujarat)
5. Oseltamivir Cap D 0444/24- Supplied by Kerala The sample does Drugs Testing
IP 75 mg 25 Medical Services not conform to IP LaboratoryCorporation Ltd, standard with Thiruvananthapura
Thycaud P.O, respect to the m
Thiruvananthapuram-14 ‘Descriptive part’
of hard gelatin
capsules
6. Haridrakhandam 207/23 03/24 02/26 Bhaskaravilasam It fails the test Drugs Testing
Vaidyasala, ‘pH’ as per API Laboratory
Panayamuttom, Thiruvananthapura
Nedumangadu m
Thiruvananthapuram 695
561
7. Yogarajaguggulu 209/21 03/22 3 yrs from Bhaskaravilasam It fails the test Drugs Testing
the date of Vaidyasala, ‘Alcohol soluble Laboratory
mfg Panayamuttom, Extractive and Thiruvananthapura
Nedumangadu, pH’ as per API m
Thiruvananthapuram 695
561
8. CANDITRAL 100 5230123 Jan-23 Jun-25 GLENMARK THE SAMPLE Maharashtra
(ITRACONAZOLE PHARMACEUTICALS LTD. DOES NOT
CAPSULE B.P. 100 COMPLY WITH B P
MG) REQUIREMENTS
FOR
DISSOLUTION
TEST
9. Lytraco 200 SLP-22445 Feb-23 Jan-25 STERLIFE PHARMA PVT. THE SAMPLE Maharashtra
Itraconazole LTD. DOES NOT
Capsules 200 mg COMPLY WITH B P
REQUIREMENTS
FOR
DISSOLUTION
TEST THE
SAMPLE IS
OFFICIAL IN B P
2021 THEREFORE
THE SAMPLE ISMISBRANDED
VIDE SECTION
17(b) AND RULE
96 OF THE DRUGS
AND COSMETICS
ACT 1940 AND
RULES 1945.
10. MONTOR -LC B18523001 Jan-23 Dec-24 TORQUE THE SAMPLE Maharashtra
TABLET PHARMACEUTICALS DOES NOT
(MONTELUKAST PVT. LTD. COMPLY WITH I P
SODIUM & REQUIREMENTS
LEVOCETRIZINE FOR
DIHYDROCHLORI DISSOLUTION
DE TABLET I.P.) TEST
11. MONTICET-L TP-7581 Sep-22 Aug-24 TICOMA PHARMACIA THE SAMPLE Maharashtra
Tablets DOES NOT
( Montelukast & COMPLY WITH IP
Levocetirizine REQUIREMENTS
Hydrochloride FOR
Tablets) DISSOLUTION
TEST FOR
MONTELUKAST.
THE SAMPLE IS
OFFICIAL IN 1 P
2018 THEREFORE
THE SAMPLE IS
MISBRANDED
VIDE SECTION
17(b) AND RULE
96 OF THE DRUGS
AND COSMETICS
ACT 1940 AND
RULES 1945.
12. Levocetrizine T22H370C Aug-22 Jul-24 Bajaj Formulations THE SAMPLE Maharashtra
Dihydrochloride & DOES NOT
Montelukast COMPLY WITH IP
Sodium Tablets I.P. REQUIREMENTS
Zeemont FOR
DISSOLUTIONTEST FOR
MONTELUKAST.
13. VolKast Kid Syrup ABS- Jan-23 Dec-24 Amentis Biotech Pvt. Ltd. CONTENT OF Maharashtra
60 ml. 2301022 MONTELUKAST
AND
LEVOCETIRIZINE
GYDROCHLORIDE
IN THE SAMPLE IS
LESS (i.e.
MONTELUKAST IS
10.50% AND
LEVOCETIRIZINE
HYDROCHLORIDE
IS 71.88% OF THE
STATED AMOUNT)
THAN THE
PERMISSIBLE
LIMITS.
14. Levetiracetam T23D050A Apr-23 Mar-25 BAJAJ FORMULATIONS THE SAMPLE Maharashtra
Tablets U.S.P.500 DOES NOT
Mg COMPLY WITH
(LEVEEG-500) USP
REQUIREMENTS
FOR
DISSOLUTION.
15. M2 Pan-DSR CWHC-283 Oct-22 Sep-24 COSWAY THE SAMPLE Maharashtra
(Pantoprazole PHARMACEUTICALS DOES NOT
Gastro-resistant & COMPLY WITH IP
Domperidone REQUIREMENTS
Prolonged-release FOR
Capsules IP) DISSOLUTION OF
PANTOPRAZOLE
AT ACID STAGE
16. Omeford - 40 SNT-220421 Sep-22 Aug-24 SVR HEALTHCARE (A THE CONTENT OF Maharashtra
GMP Certified Company) OMEPRAZOLE IN
THE SAMPLE IS
LESS (l.e. 40.84%
OF LABELLEDAMOUNT) THAN
THE SCHEDULE V
LIMITS
17. COZOL- AC1952 Jul-23 Jun-25 ALICON THE SAMPLE Maharashtra
D(Omeprazole with PHARMACEUTICAL PVT DOES NOT
Domperidone LTD COMPLY WITH IP
Capsules) REQUIREMENTS
FOR
OMEPRAZOLE
AND
DOMPERIDONE
CAPSULES FOR
THE
DISSOLUTION
TEST
(OMEPRAZOLE).
THE SAMPLE IS
OFFICIAL IN IP.
18. DRPLAN-DSR AC2209003A Sep-22 Aug-24 ADDII BIOTECH PVT. LTD. THE SAMPLE Maharashtra
(Pantoprazole DOES NOT
Gasto-resistant & COMPLY WITH IP
Domperidone REQUIREMENTS
Prolonged-release FOR
Capsules IP) PANTOPRAZOLE
AND
DOMPERIDONE
CAPSULES FOR
THE
DISSOLUTION
TEST
(PANTOPRAZOLE)
.
19. SOFTOM-D UD2C- Apr-23 Mar-25 ULTRA DRUGS PVT. LTD. THE SAMPLE Maharashtra
Omeprazole and 23252B (UNIT-II) DOES NOT
Domperidone COMPLY WITH IP
Capsules IP REQUIREMENTS
FOR
OMEPRAZOLE
ANDDOMPERIDONE
CAPSULES FOR
THE
DISSOLUTION
TEST
(OMEPRAZOLE).
20. OMEPRAZOLE & SPC230578 Mar-23 Feb-25 SALUS THE SAMPLE Maharashtra
DOMPERIDONE C PHARMACEUTICALS DOES NOT
CAPSULES COMPLY WITH IP
(REMIZOLE-D) REQUIREMENTS
FOR
OMEPRAZOLE
AND
DOMPERIDONE
CAPSULES FOR
THE
DISSOLUTION
TEST
(OMEPRAZOLE).
21. PANTOPRAZOLE PTRC-149 Feb-23 Jan-25 IOSIS REMEDIES PVT. THE SAMPLE Maharashtra
(EC) & LTD. DOES NOT
DOMPERIDONE COMPLY WITH IP
(SR) CAPSULES REQUIREMENTS
IP FOR
(PANTIAC-DSR) PANTOPRAZOLE
AND
DOMPERIDONE
CAPSULES FOR
THE
DISSOLUTION
TEST
(PANTOPRAZOLE)
.
22. DYNACID BULH23008 Apr-23 Mar-25 Leeford Healthcare Ltd. 1) THE SAMPLE Maharashtra
SUSPENSION DOES NOT
(aluminium, COMPLY WITH I.P.
magnesium & REQUIREMENTS
simethicone oral FOR TOTAL
suspension IP.) AEROBIC VIABLECOUNT IN TEST
FOR MICROBIAL
CONTAMINATION.
2) TOTAL
AEROBIC VIABLE
COUNT OF THE
SAMPLE IS
20993128 CFU/GM.
(1.P. LIMIT-TOTAL
AEROBIC VIABLE
COUNT OF THE
SAMPLE - NOT
MORE THAN 100
CFU/GM
23. ELTHROM-200 G-042/5045 May-23 Apr-25 ELFIN DRUGS PVT. LTD. CONTENT OF Maharashtra
(Azithromycin oral AZITHROMYCIN IN
suspension IP) THE SAMPLE IS
15ML LESS (72.96% OF
LABELLED
AMOUNT) THAN
THE IP LIMIT WITH
RESPECT TO
ABOVE
PROTOCOL. (IP
LIMIT-90.0%-
110.0%)
24. Alpracan 0.5 T2455 Oct-22 Sep-25 Evolet Pharmaceutical Pvt. THE SAMPLE Maharashtra
Tablets Ltd. DOES NOT
(Alprazolam COMPLY WITH IP
Tablets) REQUIREMENTS
FOR
ALPRAZOLAM
TABLETS FOR
THE
DISSOLUTION
TEST WITH
RESPECT TO
ABOVE
PROTOCOL.25. RABEPP TABLETS ATG2K135 Nov-22 Oct-24 ANROSE PHARMA CONTENT OF Maharashtra
(Rabeprazole RABEPRAZOLE
Sodium Tablets IP) SODIUM IM THE
SAMPLE IS LESS
(65.04% OF THE
LABELLED
AMOUNT) THAN
THE IP LIMIT WITH
RESPECT TO
ABOVE
PROTOCOL. (IP
LIMIT 90.0% -
110.0%)
26. INFI-650 TABLETS AT-100008 Dec-22 Nov-25 ABARIS HEALTHCARE THE SAMPLE Maharashtra
(PARACETAMOL DOES NOT
TABLETS I.P. 650 COMPLY WITH IP
mg) REQUIREMENTS
FOR
DISSOLUTION
TEST.
27. CUCID-DM CDMC501 May-23 Apr-25 TULBROS THE SAMPLE Maharashtra
FORMULATIONS DOES NOT
COMPLY WITH IP
REQUIREMENTS
FOR
DISSOLUTION
TEST FOR
OMEPRAZOLE IN
ACID STAGE.
28. Virpan-40 T-2306031A Jun-23 May-25 WHITE ENGLE THE SAMPLE Maharashtra
LABORATORIES DOES NOT
COMPLY WITH IP
REQUIREMENTS
FOR
DISSOLUTION IN
BUFFER STAGE.
29. Pantakos-40 CCT231092 Sep-23 Aug-25 Cent Cure Pvt Ltd. THE SAMPLE Maharashtra
(Pantoprazole B DOES NOTGastro-resistant COMPLY WITH IP
Tablets IP ) REQUIREMENTS
FOR
DISSOLUTION IN
BUFFER STAGE.
30. Rosumep ASP PBWGM04 Sep-23 Aug-25 Pure & Care Healthcare THE SAMPLE Maharashtra
10/75mg Capsules Pvt. Ltd. DOES NOT
COMPLY WITH IP
FOR THE TEST
“RELATED
SUBSTANCES –
ROSUVASTATIN”.
NOTE:
1. NSQ data was not received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Rajasthan (PDF format) and
Orissa (PDF Format). for the Month of June, 2024 as per DCG(I) Circular dated 09.02.2024.
2. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh,Goa,Gujarat, Haryana, Himachal
Pradesh, Manipur, 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 June, 2024 as per DCG(I) Circular dated 09.02.2024.