Last Updated on December 7, 2024 by The Health Master
Drug alert
Drug alert: Download the list of NSQ samples for October 2024, the link is given below: 90 drug samples declared as not of standard quality (NSQ), nationwide.
NSQ Lists are given below the article
Out of these 90 samples, 56 were declared NSQ by CDSCO and 34 were declared NSQ by various STATES across India.
Details of the NSQ samples declared by STATES is as under:
Sr. | Name of STATES | Number of NSQ samples declared |
1 | Kerala | 14 |
2 | Telangana | 10 |
3 | Tripura | 5 |
4 | Puducherry | 2 |
5 | RDTL Chandigarh | 2 |
6 | J&K | 1 |
Total | 34 |
Not of Standard Quality (NSQ) drugs:
The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs.
(Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’
mean that the drug complies with the standards set out in the Second Schedule of the said Act.)
NOTE:
NOTE:
- NSQ data was received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Himachal Pradesh ,Jammu
Kashmir, Puducherry, Telangana,Kerala, Tripura , Goa(PDF format Nil), Jharkhand (PDF Format) , Karnataka (PDF Format), Ladakh
(PDF format Nil), Maharashtra (PDF format), Rajasthan (PDF format), for the Month of October, 2024 as per DCG(I) Circular dated
09.02.2024. - State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Manipur,
Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, 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 October, 2024 as per DCG(I) Circular dated 09.02.2024.
Drug alert: Previous months
September 2024: 67 drug samples declared as NSQ, out of these 67 samples, 49 were declared NSQ by CDSCO and 18 were declared NSQ by various STATES across India.
August 2024: 59 drug samples declared as NSQ, out of these 59 samples, 48 were declared NSQ by CDSCO and 11 were declared NSQ by various STATES across India.
July 2024: 70 drug samples declared as NSQ, out of these 70 samples, 57 were declared NSQ by CDSCO and 13 were declared NSQ by various STATES across India.
June 2024: 61 drug samples declared as NSQ, out of these 61 samples, 31 were declared NSQ by CDSCO and 30 were declared NSQ by various STATES across India.
May 2024: 52 drug samples declared as NSQ, out of these 52 samples, 39 were declared NSQ by CDSCO and 13 were declared NSQ by various STATES across India.
April 2024: 50 drug samples declared as NSQ, out of these 50 samples, 33 were declared NSQ by CDSCO and 17 were declared NSQ by various STATES across India.
During the month of March 2024, the authorities tested 931 samples, out of which 864 were of standard quality. The number of samples declared as not of standard quality was 66, with one being misbranded and none being spurious.
During the month of February 2024, the authorities tested 1167 samples, out of which 1018 were of standard quality. The number of samples declared as not of standard quality was 58, with none being misbranded and two being spurious.
During the month of January 2024, the authorities tested 932 samples, out of which 886 were of standard quality. The number of samples declared as not of standard quality was 46, with none being misbranded and none being spurious.
During the month of December 2023, the authorities tested 1008 samples, out of which 930 were of standard quality. The number of samples declared as not of standard quality was 78, with none being misbranded and none being spurious.
During the month of November 2023, the authorities tested 1197 samples, out of which 1133 were of standard quality. The number of samples declared as not of standard quality was 62, with one being misbranded and one being spurious.
During the month of October 2023, the authorities tested 1105 samples, out of which 1044 were of standard quality. The number of samples declared as not of standard quality was 61, with none being misbranded and none being spurious.
The test samples were drawn by the zonal and sub-zonal offices of CDSCO, and tested in the drug testing laboratories, i.e CDLs, CDTLs, and RDTLs, in Kolkata, Mumbai, Hyderabad, Chandigarh, Indore, and Guwahati.
Drug alert: 67 drug samples declared as NSQ in September 2024
Drug alert: 59 drug samples declared as NSQ in August 2024
Drug alert: 70 drug samples declared as NSQ in July 2024
Drug alert: 61 drug samples declared as NSQ in June 2024
Drug alert: 52 drug samples declared as NSQ in May 2024
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Commercial Testing Laboratories
Latest Notifications: Testing Laboratories
Commercial Testing Laboratories
Commercial Testing Laboratories: Procedure
Updated list of Medical Device Testing Laboratories (MDTLs)
List of Laboratory Instruments for Pharma & Cosmetics Industry
Calibration of Laboratory Instruments
NABL: List of NABL Accredited Testing Laboratories
NABL 164 released : Guidelines for Inter-laboratory comparison
NABL releases NABL 136: specific criteria for X-Ray equipment
NABL 126: Specific criteria for calibration of Medical Devices
Laboratory Waste Management, Types and Its Disposal
NABL certification procedure for Laboratories
Quality Assurance Vs Quality Control in the Pharma Industry
NABL certification for Laboratories: Let’s understand
Major FDA audit findings about Equipment and Instruments
Equipment and Instruments: Maintenance, difference and importance in the Pharma Industry
Upcoming events: Pharma, Cosmetics, Homoeopathy & Medical Devices
Cosmetics Testing in India: A Comprehensive Guide
Difference between Validation and Calibration in the Pharma Industry
Calibration of Laboratory Instruments
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Duties and responsibilities of QA person in Pharma Industry
Dissolution test: Importance in Pharma Industry
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Blood Centre (Blood Bank)
Procedure to obtain license for Commercial Testing Laboratories
Govt rejects review applications from 5 Pharma Companies on pricing of Metoprolol
USFDA declines to approve this Hormone Disorder Drug
DTAB recommends Stricter Qualifications for Wholesale Drug Licenses
Price fixation of Wysolone DT Tablets: Review application rejected
Two new Drug Testing Laboratories open: Gujarat FDCA
Streamlining Pharma Exports: DGFT Introduces Electronic Submission system
DTAB agrees with proposal to amend New Drugs and Clinical Trials Rules
Drug recall: Gilead recalled this drug after failed trial
List of Drugs declared as NSQ by CDSCO for the Month of October– 2024.
As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market.
A. CDSCO/Central Laboratories | |||||||
S. No | Product/Drug Name | Batch No. | Manufacturin g Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Absorbent Cotton Wool IP | 2013 | 02/2024 | 01/2027 | M/s. Jind Surgicals 24- 27, HSIIDC Industrial Area, New Hansi Road, Jind-126 102, Haryana | Surface active Substances, Sulphated ash, Fluorescence, Water Soluble Substances | Central Drugs Laboratory, Kolkata |
2. | Trypsin & Chymotrypsin Tablets (Lysoflam Forte) | LFTF24002C | 06/2024 | 05/2026 | M/s. Cachet Pharmaceuticals Private Limited, Village – Thana, Baddi, Distt. Solan, Himachal Pradesh 173205 | Assay of Trypsin & Chymotrypsin | Central Drugs Laboratory, Kolkata |
3. | Chlorhexidine Gluconate Solution 4% w/v | 012 | 07/2024 | 06/2026 | M/s. OVERSEAS CHEMICALS, Vill. Bonderbill (Sukanta Pally), Hooghly 712 247, W.B. | Assay | Central Drugs Laboratory, Kolkata |
4. | Diclofenac Sodium, Paracetamol & Chlorzoxazone Tablets | DCPT3310 | 09/2023 | 08/2025 | M/s. MODERN LABORATORIES, 45-47, Sector D-2, Industrial Area, Sanwar Road, Indore (M.P.) – 452 015. | Disintegration | Central Drugs Laboratory, Kolkata |
5. | Hydroquinone, Tretinoin & Allantoin Cream (Lumadip) | LD-18 | 12/2023 | 11/2025 | M/s. Tosc International Pvt. Ltd., (Pharmaceutical Division), Plot No. 47, Sector-3, SIDCUL, Pantnagar-263153 (Rudrapur), Distt. Udham Singh Nagar, (Uttarakhand) | Description & pH | Central Drugs Laboratory, Kolkata |
6. | Liposomal Amphotericinn B Injection 50mg (Ambilip) | ALLC4A1 | 03/2024 | 02/2026 | M/s. UNITED BIOTECH (P) LIMITED, Bagbania, Baddi-Nalagarh Road, Distt. Solan (HP) 174 101. | Bacterial endotoxins and Assay of Amphotericin B | Central Drugs Laboratory, Kolkata |
7. | Ornidazole & Ofloxacin Tablets IP | HOOA07 | 08/2023 | 07/2025 | M/s. Hindustan Antibiotics Ltd., At 11, W.E.A. Faridabad 121 001 (Haryana). | Description | Central Drugs Laboratory, Kolkata |
8. | Amlodipine and Perindopril Tablets (Amtas PRP) | K2201310 | 06/2022 | 05/2025 | M/s. Intas Pharmaceuticals Ltd., Bhagey Khola Rangpo, East Sikkim 737 132, India. | Assay of Perindopril Erbumine | Central Drugs Laboratory, Kolkata |
9. | Decitabine for Injection 50 mg / vial | H230266 | 03/2023 | 02/2025 | M/s. Dr. Reddys Laboratories, Formulation Unit-7, Plot Nos. P1 to P9, Phase-III, VSEZ, Duvvada visakhapatnam | Water Content | Central Drugs Laboratory, Kolkata |
10. | Natamycin Ophthalmic Suspension IP (Nataprime Eye Drops) | PE062308 | 06/2023 | 05/2025 | M/s. Primus Pharmaceuticals, Sadhoura Road, Mouza Ogli Khari, Vill. Asgarpur Majra, Kala Amb. Dist, Sirmour (H.P.)- 173030. | Sterility | Central Drugs Laboratory, Kolkata |
11. | Iron Sucrose Injection USP 5 ml | IRA12320 | 08/2023 | 07/2025 | M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore, M.P. | Specific Gravity, Particulate matter, Assay of Sucrose & Assay of Ferric Hydroxide with sucrose calculated as elemental Iron | Central Drugs Laboratory, Kolkata |
12. | Paclitaxel Injection IP | OI220089A | 11/2022 | 10/2024 | M/s. Cosmas Research Lab Ltd., Village: Gaunspura, P.O. Noorpur Bet, Hambram, Ludhiana-141008 | Description & Particulate Matter | Central Drugs Laboratory, Kolkata |
13. | Glucosamine Sulfate Potassium Chloride MSM and Diacerein Tablets (Orcerin GM ) | KOO2207A | 05/2022 | 04/2025 | M/s. MACLEODS PHARMACEUTICAL LTD., Khasra No. 21, 22, 66, 67 & 68, Aho- Yangtam, Namchepung, PO: Ranipool, Sikkim – 737 135. | Description | Central Drugs Laboratory, Kolkata |
14. | Iron Sucrose Injection USP 5 ml | MA24B129 | 02/2024 | 01/2026 | M/s. MARTIN & BROWN BIO-SCIENCES PVT. LTD., K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist-Solan (H.P) -173205 | Particulate Matter | Central Drugs Laboratory, Kolkata |
15. | SUCRALFATE USP | LSU2404015 | 04/2024 | 03/2029 | M/s. Legend Industries, (Unit-II) C1/200, 201/4, Phase-II, GIDC, Opp. Encore Ltd., Naroda, Ahmedabad-382330, Gujarat | Spurious, Identification & Assay | Central Drugs Laboratory, Kolkata |
16. | SUCRALFATE USP | SCF/24/0049 | 05/2024 | 04/2029 | M/s. Par Drugs & Chemicals Limited, 333/1, 333/2, 334, 335, 336/A & B, 337, 338 GIDC Ind. Estate, Phase-2, Chitra, Bhavnagar-364004, Gujarat | Spurious, Identification & Assay | Central Drugs Laboratory, Kolkata |
17. | Betamethasone Sodium Phosphate Injection I.P. (Betalone ) | IBT-11189 | 06/2024 | 05/2026 | M/s. E.G. Pharmaceuticals, Vill. Mandhala, Teh. Baddi, Dist. Solan, H.P. | Description & Particulate matter | Central Drugs Laboratory, Kolkata |
18. | Amoxycillin and Potassium Clavulanate for Injection IP 1.2 gm | 23AP10 | 10/2023 | 09/2025 | M/s. SAI Parenterals Limited, D1 & D4, Survey No. 280, Phase-V, IDA, Jeedimetla, Hyderabad – 500 055, Telangana, India | Particulate matter & Clarity of Solution | Central Drugs Laboratory, Kolkata |
19. | Ciprofloxacin Injection IP 100 ml | 09AF0061 | 12/2022 | 11/2025 | M/s. Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd), NH-31, Tin Mile Hat, P.S. Chopra, Dist- Uttar Dinajpur-733214 (WB) | Extractable Volume | Central Drugs Laboratory, Kolkata |
20. | Rosuvastatin Tablets IP (ROZUTIN- 10) | VDT-23531 | 06/2023 | 05/2025 | M/s.Vidhyasha Pharmaceuticals, 28, Industrial Area, Johron, Trilokpur Road, Kala Amb, Distt-Sirmour, H.P. 173 030. | Related Substances | Central Drugs Laboratory, Kolkata |
21. | Rabeprazole Sodium & Domperidone SR Capsules (RABALKEM- DSR) | RKBC22064 S | 12/2022 | 11/2024 | M/s. Shiva Biogenetic Laboratories Pvt. Ltd., Vill-Manpura, Baddi, Dist. Solan, (H.P.) -174 101. | Assay of Rabeprazole | Central Drugs Laboratory, Kolkata |
22. | Aceclofenac, Paracetamol and Serratiopeptidase Tablets (Megaceclo SP) | AMT2302037 | 02/2023 | 01/2025 | M/s. MARINE MEDICARE PVT. LTD., Village – Kulhariwala & P.O. Mandhala, Tehsil Baddi, Distt-Solan (H.P.), Pin-174103, India. | Description and Assay of Serratiopeptidase | Central Drugs Laboratory, Kolkata |
23. | Enrofloxacin Injection I.P. (Vet.) (ENROXACIN VET Injection) | LV326 | 01/2023 | 12/2024 | M/s. Lavista Ideal Pharmacy Pvt. Ltd., Lavista Ideal Pharmacy Pvt. Ltd., Back side of Tata Motor Vill-Nalka, PO – Manpura, Tehsil Baddi, Dist. Solan (HP) – 173205 | pH | Central Drugs Laboratory, Kolkata |
24. | Rabeprazole Sodium (Enteric Coated) And Domperidone (Sustained Release) Capsules (ZABIL- DSR) | UD2C- 23469E | 06/2023 | 05/2025 | M/s. Ultra Drugs Pvt. Ltd., (Unit-II), HS No. 211, K. No. 77/1, 78/1, Vill. Katha, Baddi, Distt. Solan (H.P.) – 173 205. | Dissolution of Rabeprazole & Domperidone, Assay of Domperidone | Central Drugs Laboratory, Kolkata |
25. | Calcium 500 mg with Vitamin D3 250 IU Tablets IP | LMT240377 | 03/2024 | 02/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar- 249403 (U.K) | Dissolution of Calcium and Assay of Vitamin D3 | RDTL, Guwahati |
26. | Glimepiride Tablets IP 2 mg | LMT240333 | 03/2024 | 02/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector-6A, IIE, SIDCUL, Haridwar- 249403 (U.K) | Dissolution | RDTL, Guwahati |
27. | Adrenaline Injection IP 1.8mg/ml (Adrenascot) | GA3A020 | 01/2023 | 12/2024 | M/s. Scott-Edil Pharmacia Ltd., 56, EPIP., Phase-I, Jharmajri, Baddi, Distt. Solan – 173 205, (H.P.),INDIA | Appearance of Solution and Description | RDTL, Guwahati |
28. | Buprenorphine Injection I.P. (LUPIGESIC) | 1470 ASG | 01/2024 | 12/2025 | M/s. S.M.G. PHARMACEUTICALS (Pvt) Ltd., Plot No-K.B Complex Opp. Mahavir Nagar, N.H. No-I, Vitpl- 306185 Gujarat | Assay” of Buprenorphine | RDTL, Guwahati |
29. | Telmisartan Tablets I.P. (Telesky-40 Tablet) | CMT23-1658 | 03/2024 | 02/2026 | M/s. Cortex Medical Inc., Plot No. -3F, Apperal Park, Katha, Industrial Area Baddi, Distt.- Solan (H.P.) | Dissolution | RDTL, Guwahati |
30. | Telmisartan Tablets I.P. 40 mg | LMT240611 | 05/2024 | 04/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Description | RDTL, Guwahati |
31. | Telmisartan Tablets IP 40 mg | LMT240536 | 05/2024 | 04/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) | Description | RDTL, Guwahati |
32. | Buprenorphine Injection I.P. (LUPIGESIC) | 1470 ASG | 09/2023 | 08/2025 | M/s. S.M.G. PHARMACEUTICALS (Pvt) Ltd., Plot No-K.B Complex Opp. Mahavir Nagar, N.H. No-I, Vitpl- 306185. AT-75/1GI.DC Vipl-306185 | Assay/Content of Buprenorphine | RDTL, Guwahati |
33. | Ciprofloxcin Tablets IP 250 mg | CT23241818 | 02/2024 | 01/2026 | M/s. CMG BIOTECH PVT.LTD. ( A WHO- GMP Certified Co.), 58, Industrial Area, Phase- III, Sansarpur Terrace, Jaswan Dist. Kangra H.P. 176501 | Dissolution of Ciprofloxcin | RDTL, Guwahati |
34. | Esomeprazole Tablets IP 40 mg (Essokynt-40) | TT23-505 | 07/2023 | 06/2025 | Tanishka Pharmaceuticals Pvt. Ltd., Vill. Nandpur, Kharuni-Lodhi Majra Road, Baddi Teh. Nalagarh (H.P.) | Dissolution (Buffer Stage) | RDTL, Guwahati |
35. | Fexofenadine Hydrochloride Tablets I.P. | T-2403971 | 03/2023 | 02/2026 | M/s. Oscar Remedies Pvt. Ltd., OSCAR HOUSE, BADI MAJRA, YAMUNA NAGAR- 135001 (HR) | Dissolution of Fexofenadine Hydrochloride. | RDTL, Guwahati |
36. | Paracetamol Tablets IP 500 mg (Pararex-500 | CT-7129 | 09/2023 | 08/2026 | CHEMETAC PHARMACEUTICALS 42, MAINA PUR, MEERUT ROAD, GHAZIABAD-201003 | Dissolution | RDTL, Guwahati |
37. | Ciprofloxacin Tablets U.S.P. 500 mg | T-2401066 | 01/2024 | 12/2025 | M/s. Rivpra Formulation Pvt. Ltd. ., Plot No.8, Sector-6A, IIE SIDCUL, Haridwar-249 403 (U.K.).. | Dissolution | RDTL, Guwahati |
38. | Metronidazole 400 mg Tablets (Metagyl – 400) | B22-275 | 12/2022 | 05/2025 | Saint Michael Biotech, Plot No. 130, Village Kurdi, Manglore, Jharbrera Road, Roorkee- 247656 (Haridwar) (U.K.) | Dissolution of Metronidazole. | RDTL, Guwahati |
39. | Aceclofenac & Paracetamol Tablets (Eldigesic-P) | AGT305144 | 05/2023 | 04/2026 | Alventa Pharma Limited., Vill. Kishanpura, Baddi- Nalagarh Road, Tehsil Baddi, Distt. Solan (H.P.) -174101. | Assay of Aceclofenac | CDTL-Mumbai |
40. | Sodium Fusidate Cream 2 % | 344 | 11/2023 | 10/2025 | Bharat Parenterals Limited., Survey No. 144-A, Jarod- Samlaya Road, Vill. Haripura, Tal. Savli, Dist. Vadodara – 391250, Gujarat, India | Assay | CDTL-Mumbai |
41. | Enalapril Maleate Tablets IP 5 mg (Opioril- 5) | 23HT1771 | 11/2023 | 10/2025 | Orison Pharma International, Vill. Khari, Mauza Ogli, Kala Amb, Distt. Sirmour – 173030 (H.P.) | Dissolution and Assay of Enalapril Maleate | CDTL-Mumbai |
42. | Bupropion Hydrochloride Extended Release Tablets U.S.P. 150 mg (Brudel SR-150) | T23169 | 09/2023 | 08/2026 | Rebase Lifescience Pvt. Ltd., Block No.6, Plot No. 11 & 12, Nr. Amrut Dairy, Lalpur, Daskroi, Ahmedabad, Gujarat – 382 430 | Assay of Bupropion Hydrochloride | CDTL-Mumbai |
43. | Propylene Glycol USP / IP | BT1205B251 22023 | 12/2023 | 12/2025 | Balaji Amines Limited., Unit IV, F – 104, Chincholi, MIDC, Tq. Mohol Dist. Solapur – 413255 Maharashtra | Water | CDTL-Mumbai |
44. | Racecadotril & Oflozacin Suspension (Combact-O + Suspension) | L23J003A | 10/2023 | 09/2025 | Bajaj Formulations, Khasra No. 161, Village- Lakeshwary, Bhagwanpur, Roorkee, Distt. Haridwar- 247661 (U.K.) | Assay of Racecadotril & Ofloxacin | CDTL-Mumbai |
45. | Pantoprazole Sodium (Enteric Coated and Domperidone (Sustained Release) Capsules (Penstal-DSR) | C582 | 01/2024 | 12/2025 | Stalion Laboratories Pvt. Ltd, c-1B, 305/2,3,4 & 5, G.I.D.C., Kerala (Bavla), Dist. Ahmedabad- 382220, Gujarat | Dissolution of Domperidone | CDTL-Mumbai |
46. | Terbinafine Hydrochloride Tablets IP (TERBONATE- 250) | NT-7900 | 03/2024 | 02/2026 | M/s. Neptune Life Sciences Pvt. Ltd., 100- B, EPIP, Phase-II, Thana, Baddi- 173205 (H.P.) | Test for Dissolution | CDTL, Hyderabad |
47. | Ondansetron Injection IP 2mg/ml | OT-5411 | 08/2024 | 07/2026 | M/s. Alchemist Remedies Pvt. Ltd.,138- 139, Industrial Area 2,AB Road Dewas , Madhya Pradesh | The sample does not Conform to IP Standards with respect to TEST FOR STERILITY | CDTL,Chennai |
48. | Single use Syringe (EDGEX) | 5DSB27 | 11/2023 | 10/2028 | NOBLE PHARMACARE LTD., A/24, C.I.N. Complex, Patia, Bhubaneswar, Odhisa- 751024 | Cleanliness and Design of Piston/Plunger assembly | RDTL, Chandigarh |
49. | Rabeprazole Sodium (EC) and Levosulpiride (SR) Capsules (RPL LS CAPSULES) | CGC-24020 | 08/2024 | 07/2026 | Calrax Healthcare Pvt.Ltd., Plot No. 45, EPIP, Phase-I, Jharmajri, Baddi, Distt. Solan (H.P.)-173205 | Dissolution of Levosulpiride | RDTL, Chandigarh |
50. | Amoxycillin and Potassium Clavulanate Tablets IP (Moxileb-CV 625 Tablets) | MBT23068 | 10/2023 | 09/2025 | Mediwell Biotech, Plot No. 21-22, Phase-IV, Himuda Industrial Township, Bhatoli Kalan, Baddi, Distt. Solan, (HP) 173205 | Assay of Amoxycillin Trihydrate calculated as Amoxycillin | RDTL, Chandigarh |
51. | Pantoprazole Tablets IP | MT-23J13 | 10/2023 | 03/2025 | MARTIN & BROWN BIO- SCIENCES PVT. LTD., K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)-173205 | Dissolution (Buffer Stage) | RDTL, Chandigarh |
52. | Aciclovir Intravenous Infusion IP 250 mg (Acyclotech Injection) | D0072406B | 06/2024 | 05/2026 | M/s. Protech Telelinks, Mauza Ogli, Suketi Road, Kala Amb, District Sirmour (H.P.) 173030 | Assay of Aciclovir | RDTL, Chandigarh |
53. | Ceftriaxone and Sulbactam for Injection (Tykone- S Injection) | UNI-240013 | 06/2024 | 05/2027 | Unital Formulations, 114- B, EPIP, Phase-1, Jharmajri, Baddi, Solan (H.P.) | Particulate matter | RDTL, Chandigarh |
54. | Ampicillin 1G Powder for Injection 1000 mg | EXPN-24004 | 04/2024 | 03/2026 | Unital Formulations, 114- B, EPIP, Phase-1, Jharmajri, Baddi, Solan,H.P.-1732025, under neutral code no. HP/DRUGS/MB/08/712 | Particulate matter and Assay of Ampicillin Sodium calculated as Ampicillin | RDTL, Chandigarh |
55. | Amoxycillin and Potassium Clavulanate Injection (Manclav 300 mg) | HIAP23001A | 01/2023 | 12/2024 | Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt. Solan (H.P.) India-173205 | Particulate matter and Assay of Potassium Clavulanate calculated as Clavulanic Acid | RDTL, Chandigarh |
56. | Meropenem Injection IP (ZENEM 1 g INJECTION) | B240720D | 07/2024 | 06/2026 | OSCAR REMEDIES PVT.LTD., Oscar House, Badi Majra, Yamuna Nagar-135001 (HR) | Particulate matter and Content of Sodium | RDTL, Chandigarh |
Not of Standard Quality (NSQ) drugs:
The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs.
(Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.)
ay’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.)
List of Drugs declared as NSQ by STATES for the Month of October– 2024.
As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market.
B. State Laboratories | |||||||
S. No | Product/Drug Name | Batch No. | Manufact uring Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Fer-XT Tablets, Ferrous Ascorbate & Folic Acid Tablets | FXT.2309 | 09-2023. | 02-2025. | M/s. Alfansa Bio Pvt.Ltd #5-5-35/23, 2nd Floor, Murthy Building, Prasanth Nagar, Hyderabad- 500072 Telangana | NOT OF STANDARD QUALITY & MISBRANDED The drug product ferrous Ascorbate and Folic Acid Tables is official in Indian Pharamacopoeia 2022. But the letters IP is not mentioned on the strip after the product name Ferrous Ascorbate and Folic Acid tablets. Hence it is a Misbranded Drug under section 17 of Drugs and Cosmetics Act 1940. So the drug product Ferrous Ascorbate & Folic Acid Tablets is Not of Standard Quality and Misbranded. | State Lab, Drugs Control Laboratory, Telangana. |
2. | Zyfer-XT Tablets, Ferrous Ascorbate, Folic Acid Tablets | WW-2405 | 05-2024. | 10-2025. | M/s. Hindustan Nutraceuticals INC Plot No.14, Sai Nagar, Boduppal, Hyderabad-039 Telangana | NOT OF STANDARD QUALITY Sample Does not meets the Specifications wrt. Assay of Folic Acid as per STP. | State Lab, Drugs Control Laboratory, Telangana. |
3. | Tablets, Cefixime Tablets IP 400 mg | CTTB-01 | 06-2024. | 05-2026. | M/s. Nestor Pharmaceticals Limited 11, Wetern Extension area, Faridabad-121 001, India HARYANA | NOT OF STANDARD QUALITY Tablets does not complies in respect of Description. | State Lab, Drugs Control Laboratory, Telangana. |
4. | Cefem -200 Tablets, Cefixime with Lactic Acid Bacillus tablets | DB240126 | 2024-04 | 2026-03 | Daxin Pharmaceuticals Pvt Ltd.,. Plot No. 121- 122 EPIP, Jharmajri Phase 1, The. Baddi, Distt. Solan (H.P.) – 174 103 HIMACHAL PRADESH | NOT OF STANDARD QUALITY 1. Thirteen Individual weights deviated from the average weight 636.0 mg i.e 6 tablets deviated by less than 5 percent and 7 tablets deviated by more than 5 percent . Hence the sample does not complies the test Uniformity of weight. 2. Assay of Cefixime does not complies. Hence the sample is of NOT OF STANDARD QUALITY | State Lab, Drugs Control Laboratory, Telangana. |
5. | Myoplus Tablets, Paracetamol & Chlorzoxazone Tabletes | MT24-1 | 04-2024. | 03-2026. | M/s. LEOSTAR Healthcare Pvt.Ltd Plot no.10, Biotech Park, Phase-III, Genome Valley, Karkapatla, Telangana-502281 Telangana | NOT OF STANDARD QUALITY 18 Tablets were tested. All the 18 tablets did not Disintigrate within the time limit (i.e 15 Minutes) specified as per IP. | State Lab, Drugs Control Laboratory, Telangana. |
6. | VRIZAROX- 100DT Tablets Cefpodoxime Proxetil Dispersible Tablets | CABQ4001 | 01-2024. | 12-2025, | Chiros Pharma Vill: Loharon , P.O.: Ghatti, Solan- 173211(H.P) HIMACHAL PRADESH | MISBRANDED The monograph of Cefpodoxime Tablets in the current edition of Indian Pharamacopoeia i.e. IP-2022. is also applicable for Cefpodoxime Dispersible Tablets as indicated under labelling section of the monograph. However the firm failed to indicate the latters IP after the product name Cefpodoxime Dispersible Tablets. Hence, the drug is deemed to be Misbranded as per section 17 of the Drugs and Cosmetics Act, 1940, since it is not labeled in the prescribed mannar. | State Lab, Drugs Control Laboratory, Telangana. |
7. | Dulhan Special Kharachi Mehandi Cone | Nil | Nil | Nil | Mohsin Idustries, Hyderabad Telangana State | MISBRANDED: As the Cautions ‘DO NOT USE FOR COLOURING EYELASHES OR EYEBROWS. DO NOT USE ON CUT, IRRITATED OR ABRADED SKIN’ as per BIS standard IS 17318:2020 is not mentioned on the label of the cosmetic sample. | State Lab, Drugs Control Laboratory, Telangana. |
8. | Tablets, Divalproex Sodium SR Tablets 500 mg | TMT-0211 | 06-2024 | 05-2026 | Tas Med (Indi) Pvt. Ltd., Plot No. -8, Phase IV. Industrial Area HIMUDA, Bhatoli Kalan, Baddi, Distt. Solan (H.P.) 173205 HIMACHAL PRADESH | MISBRANDED The drug product Divalproex Sodium SR Tablets is official in the currect edition of IP 2022. and as required as per second schedule of the Drugs and cosmetics Act, 1940, the said drug product shall comply with the standards set out in the Indian Pharmacopoeia. But the designation IP in conjunctin with the official title Divalproex Sodium SR Tablets on the label of the drug product was not mentioned as an indication that the drug product purports to comply with IP standrds. Hence the drug product shall be deemed to be MISBRANDED DRUG as per Section 17 of the drug and Cosmetics Act 1940 as it not labeled in the prescribed manner | State Lab, Drugs Control Laboratory, Telangana. |
9. | Divalproex Sodium SR Tablets | TMT-0165 | 06-2024. | 05-2024. | M/s. Tas Med (India) Pvt.ltd. Plot No. phase IV, Industriael Area Himuda, Bhatoli Kalan, Baddi Distt, solan (H.P) 173205. | MISBRANDED The drug product Divalproex Sodium SR Tablets is official in the currect edition of IP 2022. and as required as per second schedule of the Drugs and cosmetics Act, 1940, the said drug product shall comply with the standards set out in the Indian Pharmacopoeia. But the designation IP in conjunctin with the official title Divalproex Sodium SR Tablets on the label of the drug product was not mentioned as an indication that the drug product purports to comply with IP standrds. Hence the drug product shall be deemed to be MISBRANDED DRUG as per Section 17 of the drug and Cosmetics Act 1940 as it not labeled in the prescribed manner | State Lab, Drugs Control Laboratory, Telangana. |
10. | Divalproex Sodium SR Tablets 500 mg | TMT-0164 | 06-2024. | 05-2024. | M/s. Tas Med (India) Pvt.ltd. Plot No. phase IV, Industriael Area Himuda, Bhatoli Kalan, Baddi Distt, solan (H.P) 173205. | MISBRANDED The drug product Divalproex Sodium SR Tablets is official in the currect edition of IP 2022. and as required as per second schedule of the Drugs and cosmetics Act, 1940, the said drug product shall comply with the standards set out in the Indian Pharmacopoeia. But the designation IP in conjunctin with the official title Divalproex Sodium SR Tablets on the label of the drug product was not mentioned as an indication that the drug product purports to comply with IP standrds. Hence the drug product shall be deemed to be MISBRANDED DRUG as per Section 17 of the drug and Cosmetics Act 1940 as it not labeled in the prescribed manner | State Lab, Drugs Control Laboratory, Telangana. |
11. | CYPROHEPTAD INE HCl & TRICHOLINE CITRATE | WHL- 00623 | 02-2024 | 01-2026 | M/s. Warner Hindusthan Pvt Ltd., 24-85/7, Sy. No. 548 & 551, | The label of the container in the drug is mentioned as ‘Approved colour used’ but the common name of the | State lab (Puducherry) |
SYRUP (Cyproan Syrup) | Laxmi Narayana Nagar Colony, New IDA, Uppal, Hyderabad-39 (T.S) | permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned.- MISBRANDED | |||||
12. | BETAHISTINE DIHYDROCHLO RIDE TABLETS IP(CGHEST-8) | CT2425028 4B | 03-2024 | 04-2026 | M/s CMG BIOTECH PVT LTD.,(Unit-II), Plot No.58,Phase III , Industrial Area, Sansarpur Terrace, Tehsil Jaswan, Distt. Kangra, Himachal Pradesh- 176501 | On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discolouration-NSQ | State lab (Puducherry) |
13. | Vitamin B plex Tablets N.F.I | VBT2442 | 04-2024 | 03-2026 | Modern Laboratories, 45-47, Sector D-2, Industrial Area, Sanwer Road, Indore, MP-452015 | Description | State Drugs Testing Laboratory, Agartala, Tripura. |
14. | Vitamin B Complex Tablets N.F.I | VBT2498 | 06-2024 | 05-2026 | Modern Laboratories, 45-47, Sector D-2, Industrial Area, Sanwer Road, Indore, MP-452015 | Description | State Drugs Testing Laboratory, Agartala, Tripura. |
15. | Itraconazole Capsules USP 100 mg | IZC2401 | 04-2024 | 03-2026 | Modern Laboratories, 45-47, Sector D-2, Industrial Area, Sanwer Road, Indore, MP-452015 | Dissolution | State Drugs Testing Laboratory, Agartala, Tripura. |
16. | Itraconazole Capsules USP 100 mg | IZC2401 | 04-2024 | 03-2026 | Modern Laboratories, 45-47, Sector D-2, Industrial Area, Sanwer Road, Indore, MP-452015 | Dissolution | State Drugs Testing Laboratory, Agartala, Tripura. |
17. | cefixime Dispersible Tablets IP 100mg | CT240783 | 07-2024 | 06-2026 | Theon Pharmaceuticals LTD, Vill. Saini Majra, Tehsil Nalagarh, Distt. Solan (H.P) 174101. | Assay & Disintegration | State Drugs Testing Laboratory, Agartala, Tripura. |
18. | Biocetamol -500 | SPD230078 | 03-2023 | 02-2025 | Mfg. By : Skymap Pharmaceuticals Pvt. Ltd . Khasra No. 63 Village Juddi Kalan , Baddi , Distt. Solan (HP) Mrk. By : German Remedies Pharmaceuticals Pvt. Ltd. PF 61 & 62 , Sanad II Industrial Estate , Tal : Sanand Ahmedabad , Gujarat- 382110, India | The sample does not conform to the IP requirements with respect to the test, Dissolution. | Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024- 25/1593 Dated: 29.10.2024. (Report attached as Annexure A) |
19. | Torsemide Tablets IP (Torverge-10 Tablets) | GT7137A | 03-2023 | 02-2025 | J.M. Laboratories Village Bhanat P.O. Ghatti Subathu Road Solan (H.P.) 173211 | Assay of Torsemide (86.85%) | RDTL Chandigarh |
20. | (COUGH-DM Cough Syrup) | SHL3037 | 11-2023 | 10-2025 | Sunfine Healthcare, Plot no. 63, Ind. Area, Lodhimajra, Tehsil Baddi, Distt. Solan HP | Assay of Phenylephrine Hydrochloride | RDTL Chandigarh |
21. | Paracetamol Tablets IP 650 mg [Nopain-650] | URDT2433 | 10-2023 | 09-2026 | Unicure India Ltd., Plot No. 46(B)/49B Village Raipur, Bhagwanpur ,Roorkee Dist, Haridwar, 247661 Uttarakhand | It fails the test ‘Dissolution’ Specified in the Laboratory Protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
22. | Theophylline & Etophylline Tablets | TE4029 | 04-2024 | 03-2027 | Kerala State Drugs & Pharmaceuticals Ltd, Kalavoor.P.O, Alappuzha | It fails the test ‘Disintegration’ Specified in the Laboratory Protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
23. | Montelukast Tablets IP 10 mg | F4E0425 | 05-2024 | 04-2026 | Morepan Laboratories Ltd, Unit-V, Plot No. 12C, sector-2, | It fails the test ‘Dissolution’ Specified in the Laboratory Protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
Parwanoo, Dist.Solan (HP)- 173 220 | |||||||
24. | Panlib -D [Pantoprazole and Domeperidone Tablets] | HTN253D | 04-2024 | 03-2026 | Himalaya Meditek pvt.Ltd, Plot No. 35 & 36, Pharmacity, Selaqui Industrial Area, Dehradun 248 197 | It fails the test ‘Disintegration’ as per IP and the contents of active ingredients of Pantoprazole and Domeperidone are not with in the limits of ‘Schedule V’ of Drugs and Cosmetics Act & Rules thereunder as specified in the Laboratory Protocol | Drugs Testing Laboratory Thiruvananthapuram |
25. | C Mont LC KID 60 Ml Montelukast and Levocetirizine Dihydrochloride syrup 60 ml ] | AL 23206 | 11-2023 | 10-2025 | Cian Healthcare Ltd, (An ISO 9001: 2015 &WHO GMP certified Co) Kh No. 248, village sisona, Bhagwanpur, Roorkee, Haridwar, Uttarakhand – 247661 | The content of Montelukast sodium is not with in the limits of ‘Schedule V’ of Drugs and Cosmetics Act & Rules thereunder as specified in the Laboratory Protocol | Drugs Testing Laboratory Thiruvananthapuram |
26. | Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP 10 mg/5 mg | MLHT-1022 | 09-2023 | 08-2026 | Wings Biotech LLP, 43&44, HPSIDC, Ind.Area, Baddi-173205 HP | It fails the test ‘Dissolution’ Specified in the Laboratory Protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
27. | EMITIL [Prochlorperazine Mesylate Injection IP] | MA 24E27 | 05-2024 | 04-2026 | Martin & Brown Bio Science Pvt Ltd, K No. 918/419, Malkumajra, Nalgrath Road, Baddi, Dist Solan HP 173 205 | It fails the test ‘pH’ as per IP as specified in the Laboratory Protocol | Drugs Testing Laboratory Thiruvananthapuram |
28. | International dona Beauty Soap Jasmine | DNJN1/24 | 01-2024 | use befoe 36 months from packed | Excel+ Health care products, CP- V/1092, XL Garden Palachira (P.O), Varkala, PIN – 695143 | The sample does not conform to IS 2888:2004 for the test ‘matter insoluble in alcohol , percent by Mass, Max ’ as per the specifications of toilet soap for Grade III | Drugs Testing Laboratory Thiruvananthapuram |
29. | Elcipro 500[Ciprofloxacin Hydrochloride Tab IP 500 mg ] | AGT31256 | 12-2023 | 11-2026 | Alventa Pharma Ltd, Vill, Krishnapura, Baddi, Nalagarh Road, Tehsil Baddi, Distt. Solan, HP 174 101 | It fails the test ‘Dissolution’ as per IP as specified in the Laboratory Protocol | Drugs Testing Laboratory Thiruvananthapuram |
30. | Vitamin B Complex Tablet | S0010/24- 25 | Supplied by Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapura m -14 | The sample does not conform to IP Standards with respect to ‘Descriptive part’ for tablets | Drugs Testing Laboratory Thiruvananthapuram |
31. | Vitamin B Complex Tablet | S0008/24- 25 | Supplied by Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapura m -14 | The sample does not conform to IP Standards with respect to ‘Descriptive part’ for tablets | Drugs Testing Laboratory Thiruvananthapuram | ||
32. | Vitamin B Complex Tablet | S0009/24- 25 | Supplied by Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapura m -14 | The sample does not conform to IP Standards with respect to ‘Descriptive part’ for tablets | Drugs Testing Laboratory Thiruvananthapuram | ||
33. | Trenaxa Inj. [Tranexamic Acid injection I.P] | TNA2407 | 03-2024 | 02-2026 | Sanjivani Paranteral Ltd, R- 40, T.T.C, Industrial Area, Rabale, Thane, Belapur Road, Navi Mumbai -400701 | It fails the test Sterility as per IP | Drugs Testing Laboratory Thiruvananthapuram |
34. | Telmisartan Tab IP 40 mg | S0007/24- 25 | Supplied by Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapura m -14 | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
Not of Standard Quality (NSQ) drugs:
The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs.
(Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’
mean that the drug complies with the standards set out in the Second Schedule of the said Act.)
NOTE:
NOTE:
- NSQ data was received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Himachal Pradesh ,Jammu
Kashmir, Puducherry, Telangana,Kerala, Tripura , Goa(PDF format Nil), Jharkhand (PDF Format) , Karnataka (PDF Format), Ladakh
(PDF format Nil), Maharashtra (PDF format), Rajasthan (PDF format), for the Month of October, 2024 as per DCG(I) Circular dated
09.02.2024. - State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Manipur,
Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, 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 October, 2024 as per DCG(I) Circular dated 09.02.2024.
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: