27 Formulations Declared Not of Standard Quality, 7 Misbranded: CDSCO Alert Based on State Data
New Delhi: The State Drugs Control Laboratories, under the Central Drugs Standard Control Organisation (CDSCO), have issued a detailed alert for October 2024, identifying 34 drug samples as "Not of Standard Quality" (NSQ). Out of these, 7 drugs were flagged as misbranded due to non-compliance with the labeling requirements as per Section 17 of the Drugs and Cosmetics Act, 1940.
"The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market," the apex drug regulatory body said.
Drug samples were collected from various sales and distribution points across multiple states, including Telangana, Himachal Pradesh, Kerala, and others. These samples underwent testing for compliance with the standards outlined in the Drugs and Cosmetics Act, 1940. The alert includes both pharmaceutical drugs and a cosmetic product, with reasons for failure ranging from dissolution, disintegration, and sterility issues to labeling and weight uniformity violations.
Key Highlights of the Alert:
1. Misbranded Drugs
Several drugs failed to meet the labeling requirements as per Section 17 of the Drugs and Cosmetics Act, 1940. For instance, Fer-XT Tablets (Ferrous Ascorbate & Folic Acid Tablets), manufactured by Alfansa Bio Pvt. Ltd. (Hyderabad), was flagged as misbranded because the designation "IP" (Indian Pharmacopoeia) was missing on the product label. Another, Divalproex Sodium SR Tablets 500 mg, produced by Tas Med (India) Pvt. Ltd. (Himachal Pradesh), also lacked the "IP" designation, rendering it misbranded.
2. Quality Failures
Many drugs did not conform to pharmacopoeial standards for critical parameters like assay and dissolution. Zyfer-XT Tablets (Ferrous Ascorbate, Folic Acid Tablets) failed the assay of folic acid, while, Myoplus Tablets (Paracetamol & Chlorzoxazone Tablets) did not disintegrate within the prescribed time.
3. Sterility Concerns
Certain injectable products were flagged for failing sterility tests. Emitil Injection (Prochlorperazine Mesylate), produced by Martin & Brown Bio Science Pvt. Ltd. (Himachal Pradesh), was deemed unfit for medical use due to pH non-compliance.
Below is a detailed table of all 34 drugs:
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. 121122 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 CefpodoximeDispersible 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 | Nil | Nil | Nil | Mohsin Idustries, | MISBRANDED | State Lab, Drugs Control |
Kharachi Mehandi Cone | 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. | 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 | State Lab, Drugs Control Laboratory, Telangana. |
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 | |||||||
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 Pradesh176501 | 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 mplex Tablets N.F.I | VBT2442 | 04-2024 | 03-2026 | Modern Laboratories, 45-47, Sector D-2, Industrial Area, Sanwer Road, Indore (M.P.)-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 (M.P.)-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 (M.P.)-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 (M.P.)-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, CPV/1092, XL Garden Palachira (P.O), Varkala, PIN – 695 | The sample does not conform to IS 2888:2004 for the test ‘matter insoluble in alcohol , percent by Mass, Max ’ as per the | Drugs Testing Laboratory Thiruvananthapuram |
143 | specifications of toilet soap for Grade III | ||||||
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 | S0010/2425 | 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 | S0008/2425 | 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 | S0009/2425 | 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 | S0007/2425 | 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 |
