56 Formulations declared Not of standard quality as per data provided by states: CDSCO Drug Alert
New Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), in its latest drug safety alert, has flagged 56 medicine batches for failing to qualify for a random sample test for February 2025.
The list of drugs declared not of standard quality includes Calcium & Vitamin D3 Tablets manufactured by Affy Parenterals Vill, Para 500 manufactured by Laborate Pharmaceuticals, Phenytoin Tablets manufactured by Jackson Labratories, Telfine -CT manufactured by Cosmas Pharmacls, Xorcid-O Suspension manufactured by Spen Formulations, Cloprostenol Injection IP (Vet) (M Promate Injection) manufactured by Monatt Biotech and others.
This came as part of the continuous regulatory surveillance, where 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.
The alert mentioned that NSQ data received in EXCEL SHEET from State Drugs Licensing Authorities of Puducherry, Kerala, West Bengal, Tripura, Telangana, Jammu Kashmir and Goa (PDF Format), Ladakh (PDF Format), Jharkhand (PDF Format), Himachal Pradesh (PDF Format), Assam(PDF Format), Karnataka (PDF Format), Rajasthan (PDF Format)for the month of February, 2025 as per DCG(I) Circular dated 09.02.2024.
Further, it added that State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Chandigarh, Gujarat, Haryana, Manipur, Madhya Pradesh, Maharashtra, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Delhi, Uttarakhand, Uttar Pradesh, 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 February, 2025 as per DCG(I) Circular dated 09.02.2024.
The alert furter highlighted that 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.
Explaining Misbranded Drugs, the alert noted that drugs shall be deemed to be misbranded:
a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or
b) if it is not labelled in the prescribed manner; or
c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
The term “Misbranded Drug” has been defined under Section 17 of the Drugs and Cosmetics Act, 1940.
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF FEBRUARY– 2025
B. State Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufact uring Date | Expiry Date | Manufactured By | NSQ Result | Reported by State Laboratory |
1. | Calcium & Vitamin D3 Tablets IP | PGT246 72 | 09/24 | 08/26 | Affy Parenterals Vill. Gullawala P.O Baddi Distt. Solan 173205 (HP) | The sample does not conform to the IP 2022 requirement with respect to uniformity of weights | Drug Testing Laboratory Srinagar (J&K) |
2. | Para 500 | NBRT- 018 | 05/23 | 04/26 | Laborate Pharmaceuticals India Ltd (Unit II) 31, Rajban Road Nariwala Paota Sahib (HP) Mfg For : GPP Axalade 101, Kohand –Assandh Road V.P.O Salwan Haryana -132046 | The sample does not conforms to the IP 2022 requirement w.r.t dissolution test | Drug Testing Laboratory Srinagar (J&K) |
3. | Phenytoin Tablets IP 100 mg | T-1150 | 04/24 | 03/26 | Jackson Laboratories Pvt Ltd 22-24, Majitha Road Bye Pass Amritsar – 143001 (India) | The sample does not conforms w.r.t the test for description | Modern Drug Testing Laboratory Kathua (J&K) |
4. | Telfine -CT | T-1150 | 01/24 | 12/25 | Cosmas Pharmacls Ltd. Buranwala Road Village Kotla P.O Barotiwala Solan (H.P) 174103 Mrk. By: NemaSis kabee Vakil Sahab Haveli Near Ansal Mall Bamba Mohalla Jodhpur India - 342001 | The sample does not conform w.r.t the Assay contents of Telmisartan and Chlorthalidone | Modern Drug Testing Laboratory Kathua (J&K) |
5. | Xorcid-O Suspension | LSF- B0656 | 07/23 | 06/25 | Spen Formulations Pvt Ltd Plot No. 123, Industrial Area , Mehatpur, Distt. Una-174315 (H.P) | Under Investigation / The sample is found spurious as the Assay contents of Sucralfate and Oxetacaine are found to be NIL and also fails in the test for Description | Modern Drug Testing Laboratory Kathua (J&K) |
6. | Cloprostenol Injection IP (Vet) (M Promate Injection) | I241020 | 10/24 | 09/26 | Monatt Biotech E-31, New Focal Point Bathinda - 151005 | Sheep Husbandry Supply / The sample is found spurious as the Assay contents of Cloprostenol Sodium I.P is found to be | Modern Drug Testing Laboratory Kathua (J&K) |
Nil and also fails in the Test for Sterility | |||||||
7. | MIDAZOLAM Injection IP | 24257 | 08/2024. | 07/2026. | M/s. T Walkers Pharmaceuticals Pvt Ltd, Gta No 285-B, Viii-Kasaramboli, Po Ambedvet, Tal- Mulshi, Dist Pune 411004 Maharashtra | NOT OF STANDARD QUALITY The sample Midazolam Injection I.P does not comply for Assay and pH parameters as per IP 2022. | State Lab, Drugs Control Laboratory,Telangana. |
8. | Zinc Sulphate 20mg Dispersible Tablets IP | T-15192 | 03/2023. | 02-2025. | Karnal Pharmaceuticals Pvt Ltd 38, Pharmacity, Selaqui, Dehradun,Uttarakhand-248 011 Uttarakhand | NOT OF STANDARD QUALITY The sample Zinc Sulphate 20 mg Dispersible Tablets IP does not comply disintegration test as per I.P 2022. | State Lab, Drugs Control Laboratory,Telangana. |
9. | Cefdoxi-CV-50 dry syrup Cefpodoxime & Potassium Clavulanate for Oral Suspension | CD0724 002F | 02/2024. | 07/2025. | Alencure Biotech Pvt Ltd Village: Nagal, Suketi road, P.O. Moginand, Kala Amb, Distt. Sirmour-173030 (HP) HIMACHAL PRADESH | NOT OF STANDARD QUALITY
| State Lab, Drugs Control Laboratory,Telangana. |
10. | Amoxyheal-CV tablets Amoxycillin & Potassium Clavulanate Tablets I.P | TB2403 78A | 10/2024. | 09/2026. | Polestar power industries(Pharma division) Damuwala, Haripur road, Barotiwala, Baddi, Distt: Solan (H.P.)- 174 103 HIMACHAL PRADESH | NOT OF STANDARD QUALITY The sample failed with respect to the test for Unifarmity of Weight for tablets, as 6 out of twenty tablets fall outside the prescribed limit of 5 percent. | State Lab, Drugs Control Laboratory,Telangana. |
11. | Diclofenac Sodium tablets IP 50mg. | DT23- 38 | 12/2023. | 11/2025. | Leostar Healthcare Pvt. Ltd Sy No. 321, Plot No. 10, Biotect park phase- III, Genome valley, Karlapatla (V), Markook(M), Siddipet(Sist)502281, | NOT OF STANDARD QUALITY
parameter. | State Lab, Drugs Control Laboratory,Telangana. |
12. | RABISAP tablets Rabeprazole Gastro Resistant Tablets IP 20 mg | AST 24524 | 10/2024. | 09/2026. | AASSK Pharmaceuticals Pvt Ltd Plot NO.9 Dr .Ambedkar Street, Kozhumanivakkam, Mangadu,Chennai-600122. TAMIL NADU | NOT OF STANDARD QUALITY Sample does not complies in respect of Dissolution test as per IP | State Lab, Drugs Control Laboratory,Telangana. |
13. | Rabicy-20 Tablets Rabeprazole Tablets IP 20 mg | AT2403 4149 | 03/2024. | 02/2026. | Accura Care Pharmaceuticals Pvt Ltd ( A Venture of Biochemix grop (Agmp& ISO Certified Co) Vill. Mogin and Nahan Road Kala Amb.Dist Sirmour (H.P)173030 HIMACHAL PRADESH | NOT OF STANDARD QUALITY &MISBRADED
is not labeled in the prescribed manner | State Lab, Drugs Control Laboratory,Telangana. |
14. | ACEGLO tablets Aceclofenac and | ATG4I7 87 | 09/2024. | 08/2026. | Anrose pharma 147,Mauza Sansiwala ,Post :Barotiwala ,Tehsil - | MISBRANDED DRUG The drug product Aceclofenac and | State Lab, Drugs Control Laboratory,Telangana. |
Paracetamol Tablets | Kasauli ,Dist .Solan(H.P.)-173205 HIMACHAL PRADESH | Paracetamol Tablets is official i.e. included in the Addendum 2024 to Indian Pharmacopoeia 2022 effective from 1st July, 2024-current edition of IP and as required as per Second Schesule 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 conjunction with the official title Aceclofenac and Paracetamol tablets on the label of the drug product was not menttioned as an indication that the drug product purports to comply with IP standards. Hence the drug product shall be deemed to be Misbranded Drug as per Secton 17 of Drugs and Cosmetics Act, as it is not labeled in the prescribed manner. | |||||
15. | Amrox-LS syrup Levosalbutamol Sulphate, Amborxol Hydrochloride & Guaipenesin syrup | AJLH24 051 | 06/2024. | 05/2026. | M/s. Leeford Healthcare Ltd. Plot No. 88-B, EPIP, Phase – II, Village- Thana, Baddi, Distt. Solan (H.P) 173205 HIMACHAL PRADESH | MISBRANDED DRUG In the composition the label should be mentioned as Levosalbutamol Sulphate IP equivalent to Levosalbutamol. But the label is mentioned as only Levosalbutamol Sulphate IP, equivalent to Levosalbutamol as not mentioned. Hence it is a Misbranded drug as per section 17 of Drugs and Cosmetics Act, as it is not labeled in the prescribed manner. | State Lab, Drugs Control Laboratory,Telangana. |
16. | Cefixime Dispersible Tablets IP 100 mg | oo84 | 10/2024. | 03/2026. | Stride Organics Private Limited SY.No.265/P,Kondapur(Vill.),Ghatkes ar,Medchal District(T.S.) Telangana | MISBRANDED DRUG
manner. | State Lab, Drugs Control Laboratory,Telangana. |
17. | Moovrun tablets Diclofenac Sodium and Paracetamol tablets | DFP- 2403 | 01/2024. | 12/2025. | Concord Drugs Ltd . Sy no.249 ,Brahmanapally ,R.R.(DT),T.S.501505 Telangana | MISBRANDED DRUG The drug product Diclofenac sodium and Paracetamol tablets is offcially included in the current edition of Indian Pharmacopoeia IP 2022 and as required as per second schedule of the Drugs and Cosmetics Act, 1940 the said Product shall comply with the standards set out in the Indian Pharmacopoeia. But the designation IP in conjunction with the offcial title Diclofenac sodium and Paracetamol tablets on the label of the drug product was not mentioned as an indication that the drug | State Lab, Drugs Control Laboratory,Telangana. |
product purports to comply with the IP satadards. Hence the drug product shall deemed to be MISBRANDED DRUG as per section 17 of Drugs and Cosmetics Act, 1940 as it is not labelled in the prescribed Manner. | |||||||
18. | Sodium Hypochlorite 5% (NaOCL) | NSSH1 0 | 01/2024. | 12/2025. | Neucleus Scientific, Azara, Guwahati – 781017 (Assam) | The Sample does not conform to standard in respect of the test “Assay” performed. | State Drugs Testing Laboratory, Agartala, Tripura. |
19. | URINIF-SR (Nitrofurantoin Sustained Release Tablets I.P. 100 mg | USR- 186 | 11/2024. | 10/2026. | Overseas Health Care Pvt. Ltd., 335 km, Milestone, National Highway No. 1, P.O. Box No. 25, Philaur – 144410, Punjab. | The sample does not conform to standard in respect of the test for “Dissolution” test performed. | State Drugs Testing Laboratory, Agartala, Tripura. |
20. | Glitel M1 (Glimepride & Metformin Hydrochloride Prolonged Releasre Tablets IP) | LGN05/ 186/08 | 05/2024. | 04/2026. | Logos Pharma, Village MaissaTibba, Tehsil Nalagarh, Dist. Solan (H.P) - 174101. | The sample does not conform to Standard in respect of the tests for “Assay, Dissolution & Uniformity of content for Glimepiride” performed. | State Drugs Testing Laboratory, Agartala, Tripura. |
21. | Glitel M2 (Glimepride & Metformin Hydrochloride Prolonged Releasre Tablets IP) | LGM09/ 237/11 | 09/2024. | 08/2025. | Logos Pharma, Village MaissaTibba, Tehsil Nalagarh, Dist. Solan (H.P) - 174101. | The sample does not conform to Standard in respect of the tests for “Assay, Dissolution & Uniformity of content for Glimepiride” performed. | State Drugs Testing Laboratory, Agartala, Tripura. |
22. | Amoxycillin & Potassium Clavulanate Tab I.P. | APTD- 002 | 12/2024. | 05/2026. | M/s. Standard Pharmaceuticals Ltd., Serampore-712203, West Bengal | Does not conform to I.P. | State Drugs Testing Laboratory, Kolkata, West Bengal. |
23. | Telmisartan Tab IP 40 mg [Telmasil-40] | TBS 034 | 45352 | 02/26 | RTN Pharma, Sy. No. 675/2, Plot No.15, 17, 18 & 19 Bharathiyar Nagar, Avalapalli Road, Hosur- 635 109 , Tamil Nadu | It fails the test ‘Dissolution’ Specified in the laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
24. | Paracetamol Tab IP 500 mg | PAK 551 | 06/23 | 05/26 | Healer’s Lab Unit II, Plot No. 33, H.P.S.I.D.C, Extn. Baddi, Distt-Solan (H.P) | It fails the test ‘Dissolution’ Specified in the laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
25. | Paracetamol Tab IP [Parayes -500 ) | 423- 1582 | 09/23 | 08/26 | Zee Laboratories Ltd, behind 47, Industrial Area, Paonta Sahib- 173 025 | It fails the test ‘Dissolution’ Specified in the laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
26. | Fevanex Rapid - 650[ Paracetamol Tab IP 650 mg] | SRGT- 24471 | 08/24 | 07/26 | SPAS REMEDISE Vill, bersan P.O, Lodhi Majra, Tehsil Baddi, Dist.Solan (HP) 173 205 | It fails the test ‘Dissolution’ Specified in the laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
27. | Vitamin B Complex Tablets N.F.I | VBT241 6 | 03/24 | 02/26 | Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015 | The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. | Drugs Testing Laboratory Thiruvananthapuram |
28. | Liquid Paraffin IP | 163 | 03/24 | 08/26 | Medi smith Pharma Lab, #20A 1 st phase, KIADB, Mysore Road Kumbalagodu, Bangalore- 560074 | It fails the test ‘Light Absorption’ specified in the laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
29. | Vitamin B Complex Tablets N.F.I | VBT 2468 | 05/24 | 04/26 | Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015 | The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. | Drugs Testing Laboratory Thiruvananthapuram |
30. | Isosorbide Dinitrate Tablets IP [ISOMIC 10] | PT- 42968 | 08/24 | 07/26 | Pharmaroots Healthcare, Khasra No. 411, Village Tipra.P.O, Barotiwala, Tehsil ,dist. Soaln (HP) | The sample does not conform to identification test for Isosorbide Dinitrate as per IP. Hence the sample is spurious and | Drugs Testing Laboratory Thiruvananthapuram |
declared as Not of Standard Quality | |||||||
31. | Vitamin B Complex Tablets N.F.I | VBT 2415 | 03/24 | 02/26 | Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015 | The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. | Drugs Testing Laboratory Thiruvananthapuram |
32. | Vitamin B Complex Tablets N.F.I | VBT 2417 | 03/24 | 02/26 | Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015 | The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. | Drugs Testing Laboratory Thiruvananthapuram |
33. | Vitamin B Complex Tablets N.F.I | VBT 2414 | 03/24 | 02/26 | Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015 | The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for | Drugs Testing Laboratory Thiruvananthapuram |
the reason specified in the laboratory protocol. | |||||||
34. | Folic Acid Tablets IP 5 mg [Foldivit] | FTV240 04 | 06/24 | 05/26 | Danish Healthcare (p) Ltd, 76/27-28, Industrial Estate, Maxi Road, Ujjain, 456010, MP | It fails the test ‘Dissolution’ Specified in the laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
35. | Mydew Ultra Syndet Bar | 2387 | 01/24 | Best before 36 months from the date of Mfg. | Jain Soap, 39/A, Devam Estate, Gandhi Nagar, Gujarat | The sample does not conform to the test pH as per manufacturer’s specification for Mydew Ultra Syndet Bar as specified in the Laboratory Protocol | Drugs Testing Laboratory Thiruvananthapuram |
36. | Acetazolamide Tablets IP 250 mg | T 240840 | 08/24 | 07/27 | Micron Pharmaceuticals, 2117, A-2, PhaseIII, GIDC, Vapi- 396 195 | It fails the test ‘Dissolution’ Specified in the laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
37. | Clopidogrel Tab IP 75 mg | D 2720/24 -25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram-14 | It fails the test ‘Dissolution’, ‘Assay’ and descriptive part for tablets specified above as per IP | Drugs Testing Laboratory Thiruvananthapuram | ||
38. | Cefixime Oral Suspension IP 100 mg/5ml | D2852/2 4-25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram-14 | It fails the test ‘Assay’ and ‘Descriptive part’ for oral powders specified above as per IP | Drugs Testing Laboratory Thiruvananthapuram | ||
39. | Vitamin B Complex Tablets N.F.I | S0018/2 4-25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram-14 | The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. | Drugs Testing Laboratory Thiruvananthapuram | ||
40. | Vitamin B Complex Tablets N.F.I | S0017/2 4-25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram-14 | The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets | Drugs Testing Laboratory ThiruvananthapuramH20 |
are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. | |||||||
41. | Asokarishtam | 56 | 09/24 | Within 3 Yrs from the date of Mfg. | Sakthi Ayurveda Pharmaceuticals, Ottasekharamangalam, Neyyattinkara, Thiruvananthapuram | It fails the test ‘Total Solids’ , ‘Specific Gravity’, ‘Reducing Sugar’ and ‘Alcohol Content’ as specified in the Laboratory protocol as per API | Drugs Testing Laboratory Thiruvananthapuram |
42. | Amrutharishtam | 58 | 09/24 | 3 Yrs from the date of Mfg. | Sakthi Ayurveda Pharmaceuticals, Ottasekharamangalam, Neyyattinkara, Thiruvananthapuram | It fails the test ‘Total Solids’ , ‘Specific Gravity’, ‘Reducing Sugar’ and ‘Alcohol Content’ as specified in the Laboratory protocol as per API | Drugs Testing Laboratory Thiruvananthapuram |
43. | Balarishtam | 57 | 09/24 | NO EXPIRY | Sakthi Ayurveda Pharmaceuticals, Ottasekharamangalam, Neyyattinkara, Thiruvananthapuram | It fails the test ‘Total Solids’ , ‘Specific Gravity’, ‘Reducing Sugar’ and ‘Alcohol Content’ as specified in the Laboratory protocol as per API | Drugs Testing Laboratory Thiruvananthapuram |
44. | CEFIXIME & LACTIC ACID BACILLUS TABLETS (AFIX- L 200) | MDP - 785 | Oct-24 | Sep-26 | M/s. MEDINOK HEALTHCARE PVT. LTD., R.S.No. 2/1, Plot No. 87,88,89, Vazhudhavur Main Road, Kurumbapet, Puducherry – 605 009. | For the received sample Cefixime & Lactic Acid Bacillus tablets (AFIX- L 200),
,whereas the primary packaging label specifies 'Red oxide of Iron' as the colour. This discrepancy indicates a mismatch between the primary and secondary packaging labels.
Iron' but physical verification of the tablet | Puducherry |
observed as pale yellow colour. - NSQ | |||||||
45. | PREGABALIN AND METHYLCOBALA MIN CAPSULES (Amalin Plus ) | MDP- 774 | Oct-24 | Sep-26 | M/s. MEDINOK HEALTHCARE PVT. LTD., R.S.No. 2/1, Plot No. 87,88,89, Vazhudhavur Main Road, Kurumbapet, Puducherry – 605 009. | The sample received is labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES, however PREGABALIN AND METHYLCOBALAMIN CAPSULES is an official IP monograph (2022) hence should be labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES IP- Misbranded | Puducherry |
46. | CALCIUM WITH VITAMIN D3 TABLETS IP (S- CAL) | ST2406 09 | Jun-24 | Nov-25 | M/s. Spycaa Life care Sciences Private Limited, No. 253/4C, Thiruvandavar Village, Sirupinayur Panchayat, Uthiramerur Taluk, Kancheepuram District, Pin-603 308 | For the received sample, label is mentioned as "Approved colour used" but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drug Rule,1945 was not mentioned.-Misbranded | Puducherry |
47. | RABEPRAZOLE ENTERIC COATED TABLETS IP 20mg (Rabelanz-20) | SP/T/76 2 | Jun-24 | May-26 | M/s Signoret Pharmaceuticals Pvt.Ltd., Plot No. 556, Industrial area, Phase IX, SAS Nagar-160059 | For the received sample Rabeprazole Enteric Coated Tablets IP 20mg,
surface.
| Puducherry |
of the Drugs Rules ,1945.
,1945 was not mentioned.
NSQ | |||||||
48. | PANTOPROZOL E SODIUM (EC) & DOMPERIDONE (SR) CAPSULES (Tonixpro DSR) | MDP- 345 | Jul-24 | Jun-26 | M/s. Medinok Healthcare Pvt. Ltd., R.S.No. 2/1, Plot No. 87, 88, 89, Vazhudhavur Main Road, Kurumbapet, Puducherry – 605 009. |
Capsules'.
CAPSULES', however Pantoprazole Gastro- resistant and Domperidone Prolonged-release Capsules is an official IP monograph (2022) hence should be labelled as PANTOPRAZOLE SODIUM (EC) & DOMPERIDONE (SR) CAPSULES IP.
should be written as | Puducherry |
prescribed under 96(1), (i)(A) of the Drugs & Cosmetics Act.- Misbranded | |||||||
49. | TELMISARTAN & HYDROCHLORO THIAZIDE TABLETS IP (Lanztel-H) | RHT24- 401 | Jul-24 | Jun-26 | M/s Revantis Healthcare, Plot No. 124, HPSIDC, Industrial Area, Baddi, Distt. Solan (H.P)-173205 | For the received sample Telmisartan & Hydrochlorothiazide Tablets IP, Presence of Spot and Rough Surface was observed which should not be present as per Drugs & Cosmetics (Amendment) Act, 2008 of DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No. (i) Presence of Spot/discoloration (vii) Rough surface and rule 124B of the Drugs Rules,1945. -NSQ | Puducherry |
50. | ACECLOFENAC & PARACETAMOL TABLETS (ACPON-P) | ACP- 046 | Aug-24 | Jul-27 | M/s Rippon Laboratories No.44-45, Palaniappa Nagar, Othiyampet, Villianur commune, Puducherry-605 110 | The sample received is labelled as ACECLOFENAC & PARACETAMOL TABLETS (ACPON-P), however ACECLOFENAC & PARACETAMOL TABLETS is an official IP monograph (Addendum 2024) hence should be labelled as ACECLOFENAC & PARACETAMOL TABLETS IP.- Misbranded | Puducherry |
51. | TELMISARTAN TABLETS IP 40 mg (Leaftel-40) | 240390 | Mar-24 | Feb-26 | M/s. Sai sarvaa Biotech Pvt. Ltd., Plot No. 8 & 9, Balaji Nagar, Pattanur, Auroville (PO), Vanur(Tk), Villupuram (Dt), Pin – 605 101. | For the received sample Telmisartan Tablets IP 40 mg (Leaftel-40), Capping defect was observed which should not be present as per Drugs & Cosmetics (Amendment) Act, 2008 of DCC | Puducherry |
Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No. (VI) Capping and rule 124B of the Drugs Rules,1945.- NSQ | |||||||
52. | SITAGLIPTIN IP 100mg TABLETS (LanZsita 100) | SP/T/83 8 | Jul-24 | Jun-26 | M/s Signoret Pharmaceuticals Pvt.Ltd., Plot No. 556, Industrial Area, Phase IX, SAS Nagar-160059 | For the received sample Sitagliptin IP 100mg Tablets (LanZsita 100), The label is mentioned as ‘Approved colour used’ but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules ,1945 was not mentioned.- Misbranded | Puducherry |
53. | METHYLCOBALA MIN, FOLIC ACID, ALPHA LIPOIC ACID, VITAMIN B6, CHROMIUM PICOLINATE, SODIUM SELENITE & ZINC SOFT GELATIN CAPSULES (Mi- 6) | SOD- 2470 | May-24 | Apr-26 | M/s. Symbiosis Pharmaceuticals Pvt. Ltd., At C/o Ovation Remedies Behind IITT Engg. College, Trilokpur Road, Kala Amb. Distt. Sirmour, HP - 173030 | Does not comply with respect to test for Disintegration -NSQ | Puducherry |
54. | SITAGLIPTIN PHOSPHATE 50 + METFORMIN 500MG TABLETS (LanZsita-M) | SP/T/76 1 | Jun-24 | May-26 | M/s. SIGNORET PHARMACEUTICALS PVT.LTD., Plot No. 556, Industrial area, Phase IX, SAS nagar,-160059. | For the received sample SITAGLIPTIN PHOSPHATE 50 + METFORMIN 500MG TABLETS (LanZsita-M), The label is mentioned as ‘Approved colour used’ but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules,1945 was not mentioned.-Misbranded | Puducherry |
55. | DICLOFENAC SODIUM AND PARACETAMOL TABLETS I.P (DiCLOWiN PLUS) | DPT- 5765 | Aug-24 | Jul-27 | M/s. Wings Biotech LLP, 43 & 44, HPSIDC, Industrial Area, Baddi – 173 205 (H.P) | Does not comply with respect to Assay for Diclofenac sodium -NSQ | Puducherry |
56. | PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg (Lanzpride- PM2) | SP/T/74 3 | Jun-24 | May-26 | M/s. SIGNORET PHARMACEUTICALS PVT.LTD., Plot No. 556, Industrial area, Phase IX, SAS nagar,-160059. | For the received sample PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg (Lanzpride-PM2),
(Lanzpride-PM2), On visual inspection pink coloured spots were observed on other side (white colour) of the tablets .-Misbranded | Puducherry |
To view the official notice, click the link below:
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.