Last Updated on October 7, 2024 by The Health Master
Drug alert
Drug alert: Download the list of NSQ samples for May 2024, the link is given below: 52 drug samples declared as not of standard quality (NSQ), nationwide.
NSQ Lists are given below the article
Out of these 52 samples, 39 were declared NSQ by CDSCO and 13 were declared NSQ by various STATES across India.
Out of these 13 samples were declared NSQ by various STATES across India, 5 were declared as Misbranded.
Details of the NSQ samples declared by STATES is as under:
Sr. | Name of STATES | Number of NSQ samples declared |
1 | Telangana | 13 |
Total | 13 |
NOTE:
1. NSQ data was not received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Jharkhand, Jammu &
Kashmir (MD and ED not appropriate), Kerala (Expiry date not specified). for the Month of May, 2024 as per DCG(I) Circular dated
09.02.2024.
2. Sate Drugs Licensing Authorities of Goa have stated that the NSQ data as “NIL” for the Month of M ay, 2024.
3. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal
Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, 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 May, 2024 as per DCG(I) Circular dated 09.02.2024.
Drug alert: Previous months
April 2024: 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.
During the month of September 2023, the authorities tested 1188 samples, out of which 1126 were of standard quality. The number of samples declared as not of standard quality was 62, with none being misbranded and none being spurious.
During the month of August 2023, the authorities tested 1166 samples, out of which 1118 were of standard quality. The number of samples declared as not of standard quality was 48, with none being misbranded and none being spurious.
During the month of July 2023, the authorities tested 1306 samples, out of which 1252 were of standard quality. The number of samples declared as not of standard quality was 51, with none being misbranded and 3 being spurious.
During the month of June 2023, the authorities tested 1273 samples, out of which 1225 were of standard quality. The number of samples declared as not of standard quality was 48, with none being misbranded and one being spurious.
During the month of May 2023, the authorities tested 1302 samples, out of which 1274 were of standard quality. The number of samples declared as not of standard quality was 27, with none being misbranded and one 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: 50 drug samples declared as NSQ in April 2024
Drug alert: 66 out of 931 samples declared as NSQ in March 2024
Drug alert: 58 out of 1167 samples declared as NSQ in February 2024
Drug alert: 46 out of 932 samples declared as NSQ in January 2024
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List of Drugs declared as NSQ by CDSCO for the Month of May– 2024.
A. CDSCO/Central Laboratories | |||||||
S.No | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufactur e | Date of Expiry | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Terbutaline Sulfate,Bromhexin e Hydrochloride with Guaiphenesin Syrup | VS16010 | 01-01-2024 | 01-12-2026 | Priya Life Science,174-A, 175, Siddhi Industrial Infrastructure Park, Opp. Waghodia GIDC, Waghodia | The sample does not conform to Manufacturer’s Specification with respect to the Assay of Bromhexine Hydrochloride and Terbutaline Sulphate. | Central Drugs Laboratory, Kolkata |
2. | METOPROLOL SUCCINATE EXTENDED RELEASE TABLETS IP | GT3J026 | 01-10-2023 | 30-09-2025 | Scott-Edil Pharmacia Ltd.,56, EPIP., Phase-I, Jharmajri, Baddi, Distt. Solan-173 205, (H.P.), INDIA | The sample does not conforms to claim as per I.P.2022inrespectto the Test of Dissolution (1Hr), Dissolution (4 Hours) | Central Drugs Laboratory, Kolkata |
3. | Cuftin COUGH LINCTUS | ECT- 2421 | 01-09-2023 | 31-08-2025 | ELFOS LABORATORIES at : F-54, M.I. Area, JAIPUR- 17 | The sample does not conforms to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate | RDTL, Chandigarh |
4. | CefuroximeAxetil Tablets IP | DB23030 4 | 01-12-2023 | 30-11-2025 | Daxin Pharmaceuticals Pvt. Ltd., PlotNo 121-122 EPIP, Jharmajri Phase 1, Teh. Baddi, Distt. Solan (H.P.) – 174103 | The sample does not conforms to claim as per IP 2022in respect to the Test of Dissolution of Cefuroxime Axetil equivalent to Cefuroxime | Central Drugs Laboratory, Kolkata |
5. | LevosalbutamolSul phate,AmbroxolHC L,Guaiphenesin Syrup | 5346 | 07-03-2024 | 04-02-2026 | Esquire Drug House,138, GIDC, Estate, Wadhwan City, District | The sample does not conform to claim as per Schedule V of Drugs & Cosmetics Act with respect | Central Drugs Laboratory, Kolkata |
Surendranagar 363035 (Gujarat) | To Assay of Levosalbutamol Sulphate Equivalent to Levosalbutamol. NB:The sample does not give positive test for Diethylene glycol and is found to contain 0.0071 % w/v Ethylene glycol; (Limit NMT 0.1% w/v, Method: GC, Ref: USP under the monograph of Propylene glycol,) | ||||||
6. | Acetylsalicylic Acid Tablets 75 mg | JTN23- 211 | 05-07-2023 | 03-06-2026 | AK Krishna Pharma Pvt.Ltd., Plot No. 68, 69 &82,83, Sector-6A, Sidcul, IIE, Dist. Haridwar, Uttarakhand, India. | Sample does not conforms to IP with respect to test for Dissolution. | Central Drugs Laboratory, Kolkata |
7. | LactuloseSolution U.S.P. | GA2312 7 | 02-11-2023 | 07-10-2025 | Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, PuhanaIqbalpur Road, Roorkee-247667 | The sample does not conforms to claim as per U.S.P.in respect to the Assay. | Central Drugs Laboratory, Kolkata |
8. | Terbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesinand Menthol Syrup | 23D-20 | 01-04-2023 | 31-03-2025 | RADICALS PHARMA PVT. LTD.,194, Mile Stone, Ambala-Delhi Highway Shahpur, Ambala Cantt- 133004 (Hry.) | The sample does not conforms to claim as per Patent and Proprietary (RDTL/MS/3286) in respect to the Assay of Terbutaline Sulphate, Bromhexine Hydrochloride | RDTL, Chandigarh |
9. | Prednisolone TabletsIP10mg | PRDT- 1007 | 01-11-2022 | 31-10-2024 | WINGSBIOTECH LLP,43 & 44, HPSIDC, Industrial Area, Baddi – 173205 (H.P.) | The sample does not conforms to claim as per IP 2018 and Addendum 2021 in respect to the Assay of Prednisolone | RDTL, Chandigarh |
10. | Mecobalamin, AlphaLipoicAcid, Pyridoxine Hydrochlorideand Folic Acid Soft Gelatin Capsules | DBIS- 8591 | 02-11-2023 | 08-10-2025 | Broad Injectables,PlotNo. 51-52, Ind. Area TahliwalDistt. Una 174301 (H.P.) | The sample does not conforms to claim as per Schedule V of Drugs and Cosmetics Act with respect to the Assay/content of Mecobalamin and PyridoxineHydrochloride | Central Drugs Laboratory, Kolkata |
11. | TELMISARTAN ANDAMLODIPINE TABLETS IP | TE3016A | 01-05-2023 | 30-04-2025 | M/s. NavkarLifesciences,Plot No. 76, LodhiMajra, Industrial Area, Baddi, Distt. Solan (H.P.) | The sample received DOES NOT CONFORM toI.P.2022Specification with respect to the test parameters Dissolution and Assay of Amlodipine Besylate equivalent to Amlodipinecontentonly. CDTLHREPORTNO.: CDTLH/1510/F- 1068/2023-24 | CDTL, Hyderabad |
12. | Cefoperazone& Sulbactam for Injection | B- 22680D | 01-01-2023 | 02-12-2024 | Pace Biotech, Surajpur, Paonta Sahib, Dist- Sirmour (H.P)- 173001 | The sample does not conforms to claim as per The Schedule V of The Drugs and Cosmetics Act,1940withrespectto the Test for ‘Clarity of solution’ and’ Particulate matter’ | Central Drugs Laboratory, Kolkata |
13. | Cefotaxime InjectionIP500mg | CTI2308 1 | 08-08-2023 | 07-01-2025 | M/s. Vivek Pharmachem (India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303 102 INDIA | The sample does not conforms to I.P. with respect to the Test for ‘Related Substances’, ‘Particulate matter’ and ‘Clarity of solution’ | Central Drugs Laboratory, Kolkata |
14. | Dexamethasone SodiumPhosphate Injection I.P | DSA123 13 | 06-07-2023 | 04-06-2025 | M/s Nandani Medical Laboratories Pvt. Ltd.,,221/5,Bicholi Hapsi, Kanadia Road, Indore | The sample does not conforms to IP with respect to Assay/ content of Dexamethasone Phosphate | Central Drugs Laboratory, Kolkata |
15. | Amoxycillin&Potas sium Clavulanate InjectionIP1.2gm | 23AP04 | 03-05-2023 | 02-04-2025 | SAI Parenterals Limited, D1&D4, Survey No.280,Phase-V, IDA, Jeedimetla, Hyderabad, 500055, TS | The sample does not conforms to claim as per I.P. 2022 in respect to the Test of Clarity of solution and Assay of Potassium Clavulanate calculated as Clavulanic Acid | Central Drugs Laboratory, Kolkata |
16. | TELMISARTAN AND METOPROLOL SUCCINATE (EXTENDED RELEASE) TABLETS | BD23178 0H | 01-12-2023 | 30-11-2025 | BIOALTUS PHARMACEUTICA LS PRIVATE LIMITED, (A WHO GMP CERTIFIED COMPANY) At: 19- 20, DIC, Ind. Area, Baddi, Distt. Solan, (H.P.) 173205 | NOTE: THE SAMPLE RECEIVED DOES NOT CONFORM TO MANUFACTURERS SPECIFICATION WITH RESPECT TO THE TEST FOR DISSOLUTION FOR THE CONTENT OF METOPROLOL SUCCINATE EQUIVALENT TO METOPROLOL TARTRATE (EXTENDED RELEASE) AT THE FINAL TEST TIME (20th HOUR) OF L1+L2+L3 LEVEL ONLY. CDTLHREPORTNO.: CDTLH/1527/F- | CDTL, Hyderabad |
17. | Pantoprazole Tablets I.P.. | PAA-507 | 01-06-2023 | 31-05-2025 | Healers Lab, Unit II, Plot No. 33, HPSIDC, Extn., Baddi, Distt.Solan, (H.P.) | The sample Does not complies conforms to Manufacturer Specification with respect to the above tests only. | RDTL, Guwahati |
18. | Pantoprazole Tablets I.P.. | PAA-507 | 01-06-2023 | 31-05-2025 | Healers Lab, Unit II,Plot No. 33, H.P.S.I.D.C., Extn., Baddi,Distt.Solan (H.P.) | The sample Does not complies conforms to Manufacturer Specification with respect to the above tests only. | RDTL, Guwahati |
19. | Ambroxol HCl, Levosalbutamoland Guaiphenesin Syrup | VDL- 1240 | 01-07-2022 | 30-06-2024 | VVPB Pharmaceuticals Pvt. Ltd., Kh. No. 114, Vill. Damowala, P.O. Barotiwala, Baddi, Distt. Solan (H.P.) | The sample does not conforms to claim as per Patent and Proprietary in respect to the Test of Diethylene Glycol (DEG) and Assay of Ambroxol Hydrochloride | RDTL, Chandigarh |
20. | Dexamethasone Sodium Phosphate Injection I.P. (8mg/2ml) | 323-885 | 03-08-2023 | 09-07-2025 | ZEE LABORATORIES LTD., Behind 47, Industrial Area, Paonta Sahib- 173025 | The sample does not conforms to IP with respect to test for “Free Dexamethasone”, “Particulate matter,”, “Extractable volume” ,”Assay of Dexamethasone Sodium Phosphate calculated as Dexamethasone Phosphate” and is also not of standard quality for the reason stated under “Description”. | Central Drugs Laboratory, Kolkata |
21. | Dexamethasone Sodiumphosphate Injection IP | DX-2305 | 05-05-2023 | 04-04-2025 | M/s. Konis Pharmaceuticals, Krishna Nagar – 522502 (A.P.) | The sample does not conforms to claim as per IP2022 in respect to the Test of Description and Particulate matter | Central Drugs Laboratory, Kolkata |
22. | Paracetamol 500 mg. Tablets | PAR-31 | 01-08-2023 | 31-07-2026 | ASKON HEALTH CARE,11-B, INDUSTRIAL AREA, MAXI ROAD, UJJAIN- 456010 (M.P.) | The sample Does not Complies conforms to I.P. with respect to the above tests only. | RDTL, Guwahati |
23. | Ofloxacin Ornidazole Tablets IP | AD24059 | 01-04-2024 | 31-03-2026 | Skymap Pharmaceuticals Pvt. Ltd., (A WHO- GMP Certified Company) B-3, Dev Bhoomi Industrial Estate, PuhanaIqbalpur Road, Roorkee-247667 | Note: the sample received does not conformtoi.p.2022 specification with respect to the test for dissolution for the content of ofloxacin and ornidazole ( s1, s2 and s3 level) only. Cdtlh report no.: cdtlh/0131/f – | CDTL, Hyderabad |
24. | Vildagliptinand Metformin Hydrochloride Tablets IP 50mg/1000mg | VMC04G 23A | 01-10-2023 | 30-09-2025 | Bajaj Healthcare Ltd., R.S. No.1818, Manjusar – Savli Road, At & Post- Manjusar, Tal. Savli, Dist. Vadodara- 391775. | The sample does not conform to IP with respect to the test for Dissolution and Assay of Vildagliptin. | Central Drugs Laboratory, Kolkata |
25. | Amoxycillin & Potassium Clavulanate Tablets I.P.. | TCV- 2303003 | 01-03-2023 | 28-02-2025 | Rivpra Formulation Pvt. Ltd.,Plot No.8, Sector-6A, I.I.E. SIDCUL, Haridwar- 249403, (U.K.) | The sample does not conform to I.P. with respect to the test for Assay. | RDTL, Guwahati |
26. | Clonazepam TabletsI.P.0.5mg | 04L23T0 3 | 06-12-2023 | 04-11-2026 | M/s. Shine Pharmaceuticals Limited, PlotNo. 132, Karjan- Vermardi Road, Juni Jitherdi, Ta. Karjan-391240, Distt. Vadodara, (Gujarat). | The sample does not conforms to claim as per IP in respect to The Test of Related Substances | Central Drugs Laboratory, Kolkata |
27. | Metronidazole Extended Release Tablets USP 600 MG | TC- 060323 | 03-03-2023 | 04-02-2025 | Technica Lab & Pharma Pvt. Limited, Plot No. 100, Sector- 7, IIE, SIDCUL, Haridwar, Uttarakhand | The sample does not conform to U.S.P with respect to the test of Dissolution. | Central Drugs Laboratory, Kolkata |
28. | Diclofenac Sodium and Paracetamol Tablets IP | RCT230 50 | 09-06-2023 | 04-02-2026 | Galpha Laboratories Limited..,Village – Thana, Baddi, Himachal Pradesh- 173 205. | The sample does not conforms to claim as per IP in respect to the Test of Description | Central Drugs Laboratory, Kolkata |
29. | Atropine Sulphate Injection IP | 23UG18 | 01-07-2023 | 30-062025 | SVP LIFE SCIENCES, C/10-1 Sara Industrial Estate, Selaqui, Dehradun | The sample does not conforms to claim as per IP2022in respect to the Test of pH and Assay of Atropine Sulphate | RDTL , Chandigarh |
30. | Montelukast Sodium & Levocetirizine Hydrochloride Tablets | ATA-176 | 01-02-2023 | 31-01-2025 | Alliaance Biotech, 440/3, Village Katha, Baddi, Distt.Solan (HP) – 173205 | The sample does not conform to I.P. with respect to the above tests only. | RDTL, Guwahati |
31. | Fluconazole Tablets IP (150 mg).. | UGT233 38 | 01-03-2023 | 28-02-2025 | Unimark Healthcare Ltd., Plot No.: 24, 25 & 37 Sector 6 A, SIDCUL, Haridwar – 249403 (Uttarakhand) | The sample received does not conform to the I.P.2022 standard with respect to the test for Related substances. | CDTL, Mumbai |
32. | Ceftriaxone Injection I.P | 324-166 | 02-02-2024 | 07-07-2026 | Zee Laboratories Limited, Behind47, Industrial Area, Paonta Sahib- 173205. | The sample does not complies to claim as per IP 2022in respect of test for appearance of solution, clarity of solution, particulate matter and sterility (Powder for Injection). | Central Drugs Laboratory, Kolkata |
33. | Ramipril & Hydrochlorthiazide Tablets IP | PT- 31954 | 01-07-2023 | 01-06-2025 | Pharmaroots Healthcare, Khasra No. 411, Village Tipra, P.O. Barotiwala, Tehsil Baddi, Distt. Solan, H.P. | The sample received does not conform to the I.P.2022standardwith respect to the test for assay of Ramipril. Note:-Other test could not be done due to technical reason | CDTL, Mumbai |
34. | GLIPIZIDEAND METFORMIN TABLETS IP | 4010026 | 08-11-2023 | 03-04-2025 | USV Private Limited, At : B- 249/B-250, IInd Stage, Peenya Industrial Estate, Bangalore-560 058 | The sample does not conform to claim I.P. with respect to the test for Dissolution of Glipizide | CDL, Kolkata |
35. | Ceftriaxone for InjectionI.P.1gm | DC3011 9 | 05-10-2023 | 09-09-2025 | Captab Biotec, Unit- II, Plot No.125, E.P.I.P., Road, Mauja, Jharmajri, Baddi, Distt. Solan, H.P. | The sample does not conforms to I.P. with respect to test for “Particulate Matter | CDL, Kolkata |
36. | Gentamicin Sulphate Injection I.P. 2ml | 323-216 | 03-03-2023 | 05-02-2025 | ZEE LABORATORIES LTD., Behind 47, Indl. Area, Paonta Sahib- 173025 | The sample does not conforms to I.P. with respect to the test for “Particulate matter” and is also not of standard quality for the reason stated under “Description” | CDL, Kolkata |
37. | Calcium 500 mg withVitaminD3250 IU Tablets IP | LMT240 263 | 01-03-2023 | 28-02-2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector-6A, IIE, SIDCUL, Haridwar- 249403 (U.K) | The sample Does not Complies conforms to I.P. with respect to the above tests only. | RDTL, Guwahati |
38. | Cefixime & Ofloxacin Tablets | DB23005 7 | 02-02-2023 | 01-01-2025 | Daxin Pharmaceuticals Pvt.Ltd., Plot No 121-122 EPIP, Jharmajri Phase1, Teh. Baddi, Distt. Solan (H.P.) -174103 | The sample does not conforms to claim as per Schedule V of Drugs & Cosmetics Act with respect to the Assay of Cefixime Trihydrate eq. to anhydrous Cefixime and Assay of Ofloxacin | CDL, Kolkata |
39. | Ceftriaxone Injection IP | C2402- 02F | 02-02-2024 | 05-01-2026 | Integrated Laboratories Pvt. Ltd., Nahan Road, Vill. Moginand, Kala Amb, Distt. Sirmour (H.P.)- 173030 | The sample does not conform to IP with respect to the Particulate matter, Clarity of Solution and for the reason stated under Description | Central Drugs Laboratory, Kolkata |
List of Drugs declared as NSQ by STATES for the Month of May– 2024.
B. STATE LABORATORIES | |||||||
S. No | Name of Drugs/medical device/cosmeti cs | Batch No. | Date of Manufactur e | Date of Expiry | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Cyra Tablets, Rabeprazole Sodium Tablets IP | CA21868 | 07/2023. | 06/2025. | Mfg By: Mepro Pharmaceuticals Pvt.Ltd, Unit-II, Q Road, Phase – IV, G.I.D.C. Wadhwan – 363035, Dist. Surendranagar, Gujrat. | NOT OF STANDARD QUALITY The tablets does not complies in buffer stage for the dissolution test parameter, hence it is NOT OF STANDARD QUALITY. | State Lab Drugs Control Laboratory, Telangana. |
2. | Rabedin tablet Tablets, Rabeprazole Sodium Gastro- Resistant Tabelts IP, | LV23HT- 034B | 08/2023. | 01/2025. | Mfg By: LV life Sciences VPO Gurumajra, BaddiDistt. Solan(H.P)- 174101. Himachal Pradesh. Mrkt: Odin Healthcare Pvt.Ltd, Plot No. 1, Industrial Area, ChambaghatSolan, H.P. – 173 213. | NOT OF STANDARD QUALITY The sample does not meet the acid stage acceptance criteria as per IP specifications, hence it is declared as NOT OF STANDARD QUALITY. | State Lab Drugs Control Laboratory, Telangana. |
3. | Moxtas Distab 250 Tablets, Amoxycillin trihydrate dispersible tablets IP. | MALT- 2019 | 10/2023. | 09/2025. | Mfg By: Wings Novitas Healthcare LLP 43 & 44, HPSIDC, Industrial area, Baddi – 173 205. (H.P). Himachal Pradesh. | NOT OF STANDARD QUALITY Tablets are with uneven surface and are crumbling while taking out of the strip. Hence failed with respect to the test Description of Tablets. | State Lab Drugs Control Laboratory, Telangana. |
4. | Tolcenta-P Tablets, | ZT22806 | 12/2022. | 11/2024. | Mfg By: Zenomed Health Care Pvt.Ltd. (ISO & | NOT OF STANDARD QUALITY | State Lab Drugs Control |
Tolperisone Hydrochloride and Paracetamol tablets, | GMP) Certificed NO. 70- 73, First Cross, Rainbow Nagar, Vazthuthavuran Pattai, Navamlkapper, Villupuram (Dt), Tamil Nadu – 605102 Tamil nadu. Mrkt: Elinova Pharma Pvt.Ltd, D.No. 5-74/301, Panchavati Colony, Hyderabad, Telangana. | While Opening the strip, the tablets are sticky in nature and adhering to the foil, hence the sample does not complies with respect to description. The assay content of Tolperisone Hydrochloride is not within the prescribed limit, hence the sample does not complies as per manufacturing method of analysis. | Laboratory, Telangana. | ||||
5. | Nagris Pakeezah Art Henna (3 Henna Cones) | – | Nil | Nil | Mfg By: Nagris Herbs, LN Nagar, Jiyaguda, Hyderabad. | NOT OF STANDARD QUALITY The sample does not conform to the test for determination of absence of Picramic Acid as per BIS standard IS 17318:2020 as required as per rule 39 (Standard of Cosmetics) 2020.As the cautions do not use for coluring eyelashes or eyebrows. Do not use on cut, Irritated or abranded skin as per Bis Standard IS 17318: 2020 is not mentioned on the label of the cosmetic sample. Hence, the sample not labeled in the prescribed manner and deemed to be Misbranded Cosmetics as | State Lab Drugs Control Laboratory, Telangana. |
per Section 17Cof Drugs and Cosmetics ACT, 1940. | |||||||
6. | Oxifer-XT Tablets, Ferrous ascorbate elemental iron, Folic acid & Zinc sulphate Tablets, | EOX 2306 | 12/2023. | 05/2025. | Mfg By: Eminent Remedies Plot No. 9/1/A, Road, NO.14 Near Telangana Foods IDA, Nacharam, Hyderabad – 500076 (TS), Telangana. Mrkt: Organic Pharma, H.No. 7-67/G3, Hyderabad. | NOT OF STANDARD QUALITY Sample does not meets the Specifications wrt Assay of elemental Iron (Ferrous Ascorbate). | State Lab Drugs Control Laboratory, Telangana. |
7. | Levolets- M Kid Syrups, Montelukast Sodium & Levocetrizine Dihydrochloride syrup | RC24BL- 521 | 02/2024. | 01/2026. | Mfg By: Rikencare Life sciences villmessaTibba, Pharmaceuticals O Manjholi, Tehsil- Nalagarh, DistSolan, HP- 174101 Himachal Pradesh. Mrkt: Manvi Life Sciences, 1-1-289, Ashoknagar, Hyderabad – 500020. | NOT OF STANDARD QUALITY Sample does not comply Description of syrup and Assay of Montelukast. | State Lab Drugs Control Laboratory, Telangana. |
8. | Meazon Plus injection Parentaral Preparations, Mecobalamine, Folic acid & Niacianamideinj 1 ml, | 23MP07 | 10/2023. | 09/2025. | Mfg By: Sai parentrals limited D1&D4, Survey No. 280, Phase-V Hyderabad – 500 055 Telangana. | NOT OF STANDARD QUALITY Sample does not comply Assay of Folic Acid. | State Lab Drugs Control Laboratory, Telangana. |
9. | XERONAC-SP Tablets, Aceclofenac, Paracetamol & | RP- T243/C | 12/2023. | 11/2025. | Mfg By: Roma Pharma Pvt.Ltd, Unit-II, Village Nagali, P.O. Barog, Tehsil &Distt. Solan, (H.P) – 173 211, | MISBRANDED The label of the drug does not indicate the comon name of the colur used as requied as per Rule 127(2) | State Lab Drugs Control Laboratory, Telangana. |
Serratiopeptidas e Tablets | Himachal Pradesh. Mrkt: Fornax Pharmaceuticals, No. 6- Anew no. 17, 2nd Floor, VOC Colony, 3rd Street, Amijikrai, Chennai – 600029. TN. | of Drugs Rules, 1945. Label only bears the words Approved colured used. Hence the drug is not labelled in the prescribed manner and is deemed to be Misbranded drug as per section 17(c) of the Drugs and Cosmetics Act 1940. | |||||
10 | Pedxim-200 Tablets, Cefpodoximepro xetil Tablets 200 mg, | TBL- 2676 | 04/2023. | 03/2025. | Mfg By: Ticomapharmaciae-17 Focal Pont, Derabassi- 140507, Distt. Mohali (Punjab) Punjab. | MISBRANDED The product name (title) indicated on the label is as CefpodoximeProxetil Tablets 200 mg instead of CefpodoximeProxetil Dispersible Tablets 200 mg. The label of the product does not state that the tablets should be dispersed in water immediately before use. Hence the product is not labeled in the prescribed manner and is deemed to be Misbranded drug as per section 17(c) of Drugs and Cosmetics Act. | State Lab Drugs Control Laboratory, Telangana. |
11 | DofloxOZT Tablets, Ofloxacin&Ornid azole Tablets | DDX230 1 | 06/2023. | 05/2026. | MfgBy: Doctor’s Vet- Pharma Pvt.Ltd, P.R. Palem (V), Kovur(M), SPSR Nellore Dist. Andhra Pradesh. Mrkt: Doctor’s Life Sciences (India) Ltd, Survey NO. 263/1, 264/1, P.R. Palem (V), | MISBRANDED The drug product Ofloxacin and Ornidazole Tablets is official in Indian Pharmacopoeia. But the letters IP is not mentioned on the strip after the product name Ofloxacin and Ornidazole Tablets. | State Lab Drugs Control Laboratory, Telangana. |
Kovur (M), SPSR Nellore Dist – 524 137, A.P. India. | Hence it is Misbranded Drugs under Section 17(c) of drugs and cosmetics act. | ||||||
12 | Disinfectants, Surgical Spirit BP | SS- 053011 | 05/2023. | 04/2025. | Mfg By: Transflexjawaharnagar, Raipur, (C.G)- 492001, Chhattisgarh. | MISBRANDED As per rule R.124 the drug is included in the current edition of Indian Pharmacopoiea 2022. Hence standards shall be of those as specified in Indian Pharmacopoiea 2022. But the subject drug Surgical spirit bears the letters B.P after the drug name instead of IP. As per rule 96 and 104 as the drug shall be in accordance with standards set out in Indian Pharmaopoiea, the name of the drug surgical spirit shall be followed by the letters IP. As the subject drug is not confirming to the said labelling requirements the drug shall be deemed to be Misbranded as per section 17. | State Lab Drugs Control Laboratory, Telangana. |
13 | Sif Alben Suspension, Albendazole Oral Suspension 2.5% w/v (Vet) | AL80012 3 | 05/2023. | 04/2025. | Mfg By: Siflon Drugs & Pharmaceuticals Pvt.Ltd., Plot no. 20&21, Aleap IE, Gajularamaram (V), Hyderabad – 55 Telanga. | MISBRANDED The given sample Albendazole oral suspension is official included in the IP and required as per schedule of the Drugs and Cosmetics | State Lab Drugs Control Laboratory, Telangana. |
Act 1940. The given sample shall comply with the standards set out in IP but, the designation IP is conjunction with the official tittle Albendazoleoral suspension on label of the drug product was not mentioned as indication that the drug product purports to comply with IP standards. Hence the Drug product shall be deemed to be Misbranded drug as per section 17 of Drugs and Cosmetics Act. |
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