Drug Alert: CDSCO flags 56 formulations as Not of Standard Quality
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has declared 56 drug samples as “Not of Standard Quality” (NSQ) in its latest alert for October 2024. Among these, Trypsin & Chymotrypsin Tablets (Lysoflam Forte), Chlorhexidine Gluconate Solution 4% w/v, Diclofenac Sodium, Paracetamol & Chlorzoxazone Tablets, Hydroquinone, Tretinoin & Allantoin Cream (Lumadip), Liposomal Amphotericin B Injection 50mg (Ambilip) are some of the most widely used drugs listed.
As part of its ongoing regulatory oversight, the CDSCO collects drug samples from various sales and distribution points across the country. These samples are then analyzed to identify any batches that fail to meet the required quality standards.
The list of Not of Standard Quality (NSQ) drugs is published monthly on the CDSCO portal. The goal of this initiative is to inform stakeholders, including healthcare professionals, distributors, and consumers, about the presence of substandard or counterfeit drugs in the market, thereby enhancing public safety and promoting greater transparency.
Lately, the drugs samples collected in the month of October failed to meet the prescribed regulatory standards and were found in various tests to have deficiencies like dissolution, assay, disintegration, bacterial endotoxins, and particulate matter.
The tests on the collected drug samples were conducted at different CDSCO drug laboratories including Central Drugs Laboratory, Kolkata; RDTL, Guwahati; CDTL-Mumba; CDTL, Hyderabad; CDTL, Chennai and RDTL, Chandigarh.
Below is the detailed list of drugs flagged as NSQ:
|
A. CDSCO/Central Laboratories |
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|
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, |
Description & pH |
Central Drugs Laboratory, Kolkata |
|
(Uttarakhand) |
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|
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, |
Description & Particulate Matter |
Central Drugs Laboratory, Kolkata |
|
Ludhiana-141008 |
|||||||
|
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, DistUttar 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 (RABALKEMDSR) |
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- |
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 |
|
DSR) |
|||||||
|
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. |
1470 ASG |
09/2023 |
08/2025 |
M/s. S.M.G. PHARMACEUTICALS |
Assay/Content of Buprenorphine |
RDTL, Guwahati |
|
(LUPIGESIC) |
(Pvt) Ltd., Plot No-K.B Complex Opp. Mahavir Nagar, N.H. No-I, Vitpl- 306185. AT-75/1GI.DC Vipl-306185 |
||||||
|
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, PhaseIII, 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 |
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 |
|
(Penstal-DSR) |
|||||||
|
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.,138139, 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 BIOSCIENCES 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 |
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 |
|
Injection) |
|||||||
|
53. |
Ceftriaxone and Sulbactam for Injection (TykoneS 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, 114B, 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 |
Under Section 16(1)(a) of the Drugs & Cosmetics Act, 1940, drugs are considered NSQ if they fail to comply with the standards of quality as prescribed in the Second Schedule of the Act. These standards ensure that drugs meet the necessary specifications for safety, potency, and efficacy.
