Home India Ministry of Health and Family Welfare STATE NSQ ALERT FOR THE MONTH OF JANUARY-2025...
Date: 2025-02-28 Category: Not Applicable State: Union Government Country: India

STATE NSQ ALERT FOR THE MONTH OF JANUARY-2025

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This gazette notification is a monthly alert issued by the Central Drugs Standard Control Organization (CDSCO) regarding drugs found to be Not of Standard Quality (NSQ) in January 2025.
  • The purpose is to inform stakeholders about NSQ batches identified in the market through continuous regulatory surveillance involving sample analysis from sales/distribution points.
  • NSQ drugs are those that do not meet the quality standards or specifications as defined under Section 16 (1) (a) of the Drugs & Cosmetics Act, 1940, and the standards set out in the Second Schedule of the said Act.

Key Changes

  • The notification lists 93 drugs that were found to be Not of Standard Quality (NSQ) by various state laboratories.
  • The listed NSQ drugs include various pharmaceutical products such as tablets, injections, ointments, syrups and creams.
  • The reasons for being declared NSQ vary, including failing dissolution tests, identification tests, assay tests, sterility tests, bacterial endotoxin tests, content of active ingredients, uniformity of dispersion, disintegration, presence of spots/discoloration, rough surface, picking defects, and labeling issues.
  • Specific examples include PC-WIN-650 failing dissolution tests, several Compound Sodium Lactate Injections failing sterility and bacterial endotoxin tests, and multiple products from various manufacturers exhibiting issues such as discoloration, labeling discrepancies, and failing content assays.
  • Some samples were deemed spurious due to failing identification and assay tests.
  • The data was compiled from State Drugs Licensing Authorities of Jammu Kashmir, Chennai, West Bengal, Puducherry, Telangana, Thiruvananthapuram (Kerala), and Bangalore. NIL data was received from Tripura, Ladakh and Himachal Pradesh.
  • Data was not received in the specified format from Jharkhand, Delhi, Goa and Maharashtra.
  • Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Madhya Pradesh, Manipur, Meghalaya, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Uttar Pradesh, Uttarakhand, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep did not submit any data for January 2025.

Impact Analysis

Manufacturers

  • Suggested action: Review manufacturing processes, quality control procedures, and supplier qualifications to identify and rectify deficiencies. Implement robust testing protocols and ensure compliance with regulatory requirements.

Distributors/Retailers

  • Suggested action: Implement a system for tracking and managing drug recalls. Train staff to identify and handle NSQ products appropriately. Verify the authenticity and quality of drugs from suppliers.

Consumers

  • Suggested action: Check the batch numbers of medications against the NSQ list. Consult a healthcare professional if concerned about potential adverse effects or if medications are on the NSQ list. Report any adverse events to the appropriate authorities.

Regulatory Authorities

  • Suggested action: Conduct thorough investigations of NSQ cases. Impose penalties on non-compliant manufacturers. Enhance collaboration between central and state regulatory bodies. Increase the frequency and scope of drug testing.

Hospitals and Healthcare Providers

  • Suggested action: Regularly update drug formularies with the latest NSQ alerts. Train healthcare professionals to identify and report suspected NSQ drugs. Implement a system for tracking and managing drug recalls within the healthcare facility.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. State Drugs Licensing Authorities: State-level regulatory bodies responsible for licensing and monitoring pharmaceutical manufacturers and distributors within their respective states. Drugs & Cosmetics Act, 1940: The primary legislation governing the regulation of drugs and cosmetics in India. Indian Pharmacopoeia (IP): The official book of standards for drugs manufactured and/or marketed in India.
Official Source Record View Original Source →
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NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JANUARY– 2025 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/Dr Batch Manufa Expiry Manufactured By NSQ Result Reported by State ug Name No. cturing Date Laboratory Date 1. PC-WIN- VGT2316 09/23 08/25 Mfg By: Vrindavan Global Plot The sample does not Drug Testing Laboratory 650 99C No. 23-B & C , Ind. Area conform to IP 2022 Srinagar (J&K) - Report Lodhimajra Baddi Distt. Solan with respect to the test attached as Annexure A (HP) 173205 for Dissolution Mrk. By: In Med Therepeutics Plot No. 286, Basement Part-I, Industrial Area , Phase I , Panchkula -134113 2. Aceclofenac PRT2401 01/2024 45992 M/s. Regent Ajanta Biotech, Description Karnataka & -01 86-87, Village Makhiyali Dundi, Drotaverine Peerpura Road, Roorkee- Hydrochlori 247667 (U.K) de Tablets (100 mg/ 80 mg) 3. Compound 03BF231 Dec/202 46327 M/s. Paschim Banga Bacterial Endotoxins Karnataka Sodium 9 3 Pharmaceuticals, (A Unit of Test Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 4. Compound 03BF224 45200 09/2026 M/s. Paschim Banga Test for Sterility Karnataka Sodium 1 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH-Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 5. Compound 03BF226 Oct/202 46266 M/s. Paschim Banga Test for Sterility Karnataka Sodium 0 3 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 6. Compound 03BF231 45261 46327 M/s. Paschim Banga Bacterial Endotoxins Karnataka Sodium 8 Pharmaceuticals, (A Unit of Test” and “Test for Lactate Farista Vanijya Pvt. Ltd), NH- Sterility Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 7. Compound 03BF225 45200 46266 M/s. Paschim Banga Test for Sterility Karnataka Sodium 6 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 8. Compound 03BF238 45323 46388 M/s. Paschim Banga Test for Sterility Karnataka Sodium 9 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 9. Compound 03BP005 Sep/202 46235 M/s. Paschim Banga Test for Sterility Karnataka Sodium 7 3 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 10. Compound 03BF232 45261 46327 M/s. Paschim Banga Bacterial Endotoxin Karnataka Sodium 8 Pharmaceuticals, (A Unit of Test” and “Test for Lactate Farista Vanijya Pvt. Ltd), NH- Sterility Injection I.P 31, TIN MILE HAT, Sonapur(Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 11. Compound 03BP006 09/2023 46235 M/s. Paschim Banga Test for Sterility Karnataka Sodium 0 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 12. Compound 03BF232 45261 46327 M/s. Paschim Banga Bacterial Endotoxin Karnataka Sodium 9 Pharmaceuticals, (A Unit of Test” and “Test for Lactate Farista Vanijya Pvt. Ltd), NH- Sterility Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 13. Compound 03BF221 Sep/202 46235 M/s. Paschim Banga Test for Sterility Karnataka Sodium 0 3 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 14. Compound 03BP012 Jan/202 46357 M/s. Paschim Banga Test for Sterility Karnataka Sodium 0 4 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 15. Compound 03BF234 45261 46327 M/s. Paschim Banga Sterility Test” Karnataka Sodium 2 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 16. Compound 03BF225 45200 46266 M/s. Paschim Banga Sterility Test Karnataka Sodium 4 Pharmaceuticals, (A Unit of Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B)17. Compound 03BF236 Dec/202 46327 M/s. Paschim Banga Bacterial Endotoxin Karnataka Sodium 9 3 Pharmaceuticals, (A Unit of Test Lactate Farista Vanijya Pvt. Ltd), NH- Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 18. Compound 03BP011 45261 46327 M/s. Paschim Banga Test for Sterility and Karnataka Sodium 5 Pharmaceuticals, (A Unit of Bacterial Endotoxins Lactate Farista Vanijya Pvt. Ltd), NH- Test Injection I.P 31, TIN MILE HAT, Sonapur (Ringer’s HAT, PS. Chopra Dist. Uttar Lactate I.P) Dinajpur-733214 (W.B) 19. Aceclofenac AMT2407 45474 46174 M/s. Marine Medicare Pvt. Ltd., On the received puducherry , 160 Vill. Kulhariwala & P.O. sample presence of Paracetamo Mandhala, Tehsil-baddi, Distt. spots observed which l and Solan (H.P) 174 103 should not be present Chlorzoxazo As per DCC ne Tablets Guidelines on Not Of (Megaceclo Standard Quality MR) (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration- NSQ 20. Paracetamo WNZT- 45231 46296 M/s Wings Biotech LLP., 43 & On the received puducherry l, Cetirizine 3240 44, HPSIDC, Industrial Area, sample presence of Hydrochlori Baddi-173 205 (H.P) spots were observed de & which should not be Phenylephri present As per DCC ne Guidelines on Not Of Hydrochlori Standard Quality de Tablets (NSQ) Drugs (WINCOLD Approved in 1993 Z) (Annexure A) Tablets vide serial No.(i) Presence ofSpot/discoloration - NSQ 21. Cefpodoxim VCT/129 45139 45839 M/s Vats Biotech Pvt Ltd,(An On the received puducherry e Proxetil ISO 9001:2015 GMP,GLP sample Tablets IP Certified co) Vill.Kailar, P.O. Discoloration,rough 200 MG Saproon, Teh & Distt Solan- s u r f a c e a n d picking (RIZDOX- 173 211 (H.P) defects were observed 200) 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/discoloration (iv)Picking and (vii)Rough surface. - NSQ 22. Calcium MDP - 45536 46235 M/s. MEDINOK HEALTHCARE The sample received puducherry Carbonate 746 PVT LTD., R.S.No. 2/1, Plot is labelled as & Vitamin No. 87,88,89, Vazhudhavur CALCIUM D3 Tablets Main Road, Kurumbapet, CARBONATE & (VICTOCAL Puducherry – 605 009. VITAMIN D3 – D3) TABLETS, however CALCIUM CARBONATE & VITAMIN D3 TABLETS is an official IP monograph (2022) hence should be labelled as CALCIUM AND VITAMIN D3 TABLETS IP. - Label issue 23. Pregabalin MP - 45566 46266 M/s. Medistark Biotech Pvt. The label of the puducherry (SR) & 240724 Ltd., R.S. container in the drug isMethylcobal No. 68/4, 68/10, Sri mentioned as amin Tablet Srinivasapuram, Agasampattu, 'Approved colour used' (Mecoben – Vanur Tk, Tamilnadu – 605 but the common name PG) 111. of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. - Misbranded 24. Thiamine ZRST- 45505 46023 M/s. ZRS (i) On the received puducherry Hydrochlori 1361 PHARMACEUTICALS INDIA sample, Presence of de Tablets PVT LTD., Khasra No 48, Spot defect was IP 100mg 490/3,562/489/1, Opposite observed which should (KTHAMINE Sector-6, Tehsil Kasauli, not be present as per -100) Parwanoo, Solan, HP-173220 DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. (iii) The label claim of the drug states 'Thiamin hydrochloride IP 100mg' instead of 'Thiamine Hydrochoride IP 100mg' but the proper name of the drug should be written as prescribed under 96(1),(i)(A) of The Drugs and Cosmetics Act. (iv) The label claim of the received sample states Thiamin Hydrochloride IP 100mg whereas in the IP monograph, The usual strength of the thiamine tablet is stated as 5mg, 10mg, 50mg. Hence,the Strength of the sample received does not match the usual strength as mentioned in the IP monograph. - NSQ 25. Paracetamo SG034B0 44958 45658 M/s. Sharun Pharmaceuticals NOTE:(i) On the puducherry l, 3 Pvt Ltd.,R.S. NO: 195/9 & received sample, Phenylephri 197/4, Pangoor, Ariyur Presence of Spot ne HCl, Revenue Village, Villianur, defect was observed Caffeine & Puducherry-605102 which should not be Diphenhydr present as per DCC amine HCl Guidelines on Not Of Tablets Standard Quality (CINKOLD) (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence ofSpot/discoloration. (ii)The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. vel - NSQ 26. BETAHISTI T-18946 44958 45658 M/s Jackson Laboratories Pvt On the received puducherry NE Ltd., Plot No . 56 & 61, sample presence of DIHYDROC Industrial Area, Phase- III, spots were observed HLORIDE Sansarpur Terrace, Distt. which should not be TABLETS Kangra (H.P)-176501 present As per DCC IP (Betahox- Guidelines on Not Of 8) Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discolouration. - NSQ 27. Aceclofenac P240502 45413 46113 M/s.– Prosilio Pharmaceuticals On the received puducherry and Pvt. Ltd., R.S.No. 35/6, sample presence of Thiocolchico Uruvaiyar Main Road, spots were observed side Tablets Uruvaiyar, Villianur Commune, which should not be (Speronac - Puducherry – 605 110. present As per DCC MR) Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence ofSpot/discoloration. - NSQ 28. Clopidogrel MDP - 45444 46143 M/s. Medinok Healthcare Pvt. (i) On the received puducherry Tablet I.P 309 Ltd., (A GMP & ISO 9001:2015 sample, Presence of 75 mg Certified Company) S p o t a n d discoloration (Maxgrel - R.S.No. 2/1, Plot No. 87,88,89, defects were observed 75) Vazhudhavur Main Road, which should not be Kurumbapet, Puducherry – 605 present as per DCC 009 Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. (iii) On the received sample, The name of the manufacturer and the address of the premises of the manufacturer appears in an inconspicuous manner on the label whereas they should appear in a conspicuous manneras prescribed under 96 (1) (iv) of the Drugs and Cosmetics Act. (iv) On the received sample,the label details of the primary packing does not match with that of the secondary packing (Excipients …q.s is not mentioned in primary packing)- NSQ 29. Mecobalami D240601 45444 46143 M/s LINUX LIFE SCIENCES On the received puducherry n Sublingual 9 PVT LTD., R.S. No.241/1 & sample, Presence of Tablets 241/5, Kalitheerthalkuppam, Spot defect was 1500 mcg Madagadipet Post, Mannadipet observed which should (Re- Xite commune,Puducherry- 605 not be present as per BTX) 107, India. DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration.- NSQ 30. Amoxycillin RIX-040 45292 45992 M/s RIPPON LABORATORIES The sample received puducherry Trihydrate No.44,45, Pazaniyappa Nagar, is labelled as Capsules Othiyampet, Villianur, AMOXYCILLIN (RIMOXIN) Puducherry-605 110 TRIHYDRATE CAPSULES , however AMOXYCILLIN TRIHYDRATE CAPSULES is an official IP monograph (2022) hence should be labelled as AMOXYCILLINTRIHYDRATE CAPSULES IP.- Label issue 31. Metoprolol MP - 45352 46054 M/s. Medistark Biotech Pvt. The label of the puducherry Succinate 231584 Ltd., R.S.No. 68/4, 68/10, Sri container in the drug is Extended Srinivasapuram, Agasampattu, mentioned as Release & Vanur (TK), Tamilnadu – 605 'Approved colour used' Telmisartan 111 but the common name Tablets of the permitted colour (Leaftel used in the formulation Beta – 25) as prescribed under rule 127 (2) of the drug rule was not mentioned. - Misbranded 32. Lucos-LM AMS2341 12/2023 11/2025 Alop Med-Sciences Pvt Ltd, Sample does not Drugs Testing kid 6 Shamti, Solan-173212.H.P conform to Label claim Laboratory, suspension with respect to the Chennai - 6 content of Levocetirizine Hydrochloride and Montelukast in Montelukast Sodium. 33. Spironolacto T- 03/2024 02/2026 Oscar Remedies Pvt. Ltd, Sample does not Drugs Testing ne Tablets 2403993 Oscar House, Badi Majra, conform to IP Laboratory, IP Yamuna Nagar(HR) - 135001 specification for Chennai - 6 Spironolactone Tablets with respect to Dissolution 34. Nozal 3447 03/2024 02/2026 Olcare Laboratories, 505/A, Sample does not Drugs Testing Cream G.I,D.C, Estate, Wadhwancity- conform to BP Laboratory, 363035. Dist. Surendranagar- Specification for Chennai - 6 (GUJ) Ketoconazole Cream with respect to the content of Ketoconazole.35. Gentamicin 24BUE74 05/2024 04/2026 SVP Life Sciences, C/10-1, Sample does not King Institute of Injection IP- Sara Industrial Estate, Selequi, conform to the Preventive Medicine & 2ml Dehradun requirement for PH. Research, Guindy, Chennai-32 36. Sucralfate SEL2401 01/2024 12/2025 CU-V-Kar Genetic Medicines Sample does not Drugs Testing and Pvt Ltd, 14, Pharmacity, conform to Label claim Laboratory, Oxetacain Selaqui, Distt. Dehradun, with respect to content Madurai -19. Suspension Uttarakhand-248011. of Oxetacaine. 37. Aspirin TAS2301 10/2023 09/2025 Hindustan Laboratories Sample does not Drugs Testing Tablets 0AL Limited, Plot No, 5-9, Survey conform to IP Laboratory, NO.38/2, Aliyali, Palghar (W), Specification for Madurai -19. Dist. Palghar 4041404(MS) Aspirin Tablets with respect to the content of Aspirin. 38. Nozal 4246 10/2024 09/2026 Olcare Laboratories, 505/A, Sample does not Drugs Testing G.I,D.C, Estate, Wadhwancity- conform to BP Laboratory, 363035. Dist. Surendranagar- Specification for chennai - 6 (GUJ) Ketoconazole cream with respect to the content of Ketoconazole 39. Amoxycillin PGA24- 01/2024 12/2025 Pondchy Pharmaceuticals, Sample does not Drugs Testing Dispersible 001 R.S.No.218/4, 218/5, conform to IP Laboratory, Tablets IP Odiaampet, Manaveli Road, Specification for chennai - 6 125 mg Villianur Commune, Dispersible Tablets Puducherry, 605110. with respect to uniformity of Dispersion and Disintegration 40. Povinanz ES40030 03/2024 02/2026 Nanz med Science Pharma Pvt sample does not Drugs Testing Gargle Ltd, Rampur Ghat, Paonta conform to label with Laboratory, Sahib, District Sirmour (H.P) respect to the content chennai - 6 India - 173 025 of available iodine in povidone-iodine 41. Amoxycillin PGA24- 08/2024 07/2026 Pondchy Pharmaceuticals, Sample does not Drugs Testing Dispersible 006 R.S.No.218/4, 218/5, conform to IP Laboratory, Tablets IP Odiaampet, Manaveli Road, Specification for chennai - 6 125 mg Dispersible TabletsVillianur Commune, with respect to Puducherry, 605110. uniformity of Dispersion and Disintegration 42. Ttocin MVO-070 10/2024 09/2026 Bonn Schetering Bio Sciences, Sample does not Drugs Testing Ointment, Plot No.64 & 65, 1st Floor, conform to label claim Laboratory, Mupirocin Electronic park, Thirubuvanai, with respect to the chennai - 6 with Tea Mannadipet Commune, content of mupirocin. Tree Oil Puducherry, 605107. Ointment 43. Flumethrin EE- 09/2024 08/2026 Ethicare Laboratories, 15, Sample does not Drugs Testing 1% Porur- 240906 Industrial Estate, Digiana, conform to Lablel Laboratory, On Solution Jammu-180010 Claim with respect to Madurai -19. the content of Flumethrin. 44. Sucnol-O SCI-2305 11/2023 10/2025 Apple Formulations Pvt Ltd, Sample does not Drugs Testing Suspension Plot No.208, Kidhsnpur, conform to Label Laboratory, Roorkee-247667(U.K) Claim with respect to Madurai -19. the content of Oxetacaine 45. Betamethas B76 08/2024 07/2026 Syndicate Pharma, 185/B, Sample does not Drugs Testing one 185/B-1, 187/A & 188, sector - conform to IP Laboratory, Valerate F, Sanwer Road, Indore- Specification for chennai - 6 Ointment IP 452015. Betamethasone 0.1% w/w Valerate Ointment with respect to the content of Betamethasone in Betamethasone Valerate. 46. Co- MT402 01/2024 12/2026 Maxwell Lifescience Pvt Ltd, T- Sample does not Drugs Testing Trimoxazole 53 & T-81, M.I.D.C, Tarapur, conform to IP Laboratory, Tablets IP Boisar, Dist, Palghar, 401506. Specification for Co- chennai - 6 480mg Trimoxazole Tablets with respect to Dissolution for Trimethoprim and Sulphamethoxazole47. N-Clin Gel M030 07/2024 06/2026 Elegant Cosmed Pvt Ltd, Plot Sample does not Drugs Testing No.32&33, G.I.D.C, Rajkot, conform to label claim Laboratory, Gujarat, Kuvadva - 360023 with respect to the chennai - 6 content Clindamycin in Clindamycin Phosphate 48. Gentamicin 24BUF83 06/2024 05/2026 SVP Life science, C/10-1, Sara sample does not King Institute of Injection IP- industrial Estate, Selequri, Conform to the Preventive Medicine & 2ml Dehradun requirement for PH Research, Guindy, Chennai-32 49. Gentamicin HLI620F 06/2024 05/2026 Himalaya Meditek Private Ltd, sample does not King Institute of Injection IP- Plot.No 35&36 Pharmacity, Conform to the Preventive Medicine & 2ml Selaquri Industrial Ara, requirement for PH Research, Guindy, Dehradun - 248 197 Chennai-32 50. Gentamicin HLI615F 06/2024 05/2026 Himalaya Meditek Private Ltd, sample does not King Institute of Injection IP- Plot.No 35&36 Pharmacity, Conform to the Preventive Medicine & 2ml Selaquri Industrial Ara, requirement for PH Research, Guindy, Dehradun - 248 197 Chennai-32 51. Gentamicin HLI623F 06/2024 05/2026 Himalaya Meditek Private Ltd, sample does not King Institute of Injection IP- Plot.No 35&36 Pharmacity, Conform to the Preventive Medicine & 2ml Selaquri Industrial Ara, requirement for PH Research, Guindy, Dehradun - 248 197 Chennai-32 52. Gentamicin 23BUH50 08/2023 07/2025 SVP Life science, C/10-1, Sara sample does not King Institute of Injection IP- industrial Estate, Selequri, Conform to the Preventive Medicine & 2ml Dehradun requirement for PH Research, Guindy, Chennai-32 53. Gentamicin HLI628F 06/2024 05/2026 Himalaya Meditek Private Ltd, sample does not King Institute of Injection IP- Plot.No 35&36 Pharmacity, Conform to the Preventive Medicine & 2ml Selaquri Industrial Ara, requirement for PH Research, Guindy, Dehradun - 248 197 Chennai-32 54. Ketoya MO26 08/2024 07/2026 Elegant Cosmed Pvt Ltd, Plot sample does not Drugs Testing Soap No.32&33, G.I.D.C, Rajkot, conform to label claim Laboratory, Kuvadva - 360023,Gujarat, with respect to the chennai - 6 content of Ketoconazole 55. Betamethas BO6 05/2024 04/2026 Syndicate Pharma, 185/B, Sample does not Drugs Testing one 185/B-1, 187/A & 188, sector - conform to IP Laboratory, Valerate specification for chennai - 6Oilment IP F, Sanwer Road, Indore- Betamethasone 0.1% w/w 452015. Valerate Ointment with respect to the content of Betamethasone in Betamethasone Valerate. 56. Mupirocin SO-033 03/2024 02/2026 SB Lifesciences pvt ltd, At.Plot Sample does not Drugs Testing Ointment IP No.45, EPIP, Phase-I, conform to IP Laboratory, Jharmajri Baddi, Dist Solan specification for Madurai -19. (HP)-173205 Mupirocin Ointment with respect to the content of Mupirocin 57. Mupirocin ME-41 02/2024 01/2026 Maxwell pharma, Plot No.6&7, Sample does not Drugs Testing Ointment IP Sector-5, Parwanoo, Solan, conform to IP Laboratory, H.P PIN-173220, India specification for Madurai -19. Mupirocin Ointment with respect to identification and content of mupirocin 58. Lukus G198 06/2024 05/2026 INDKUS Biotech India, Vill Sample does not Drugs Testing manuja rampur jattan, conform to IP Laboratory, Moginand, Kala amb, specification for Madurai -19. Sist.sirmour (HP) - 173001 Luliconazole Cream with respect to the content of Luliconazole 59. Coscopin CSP2300 06/2023 05/2025 Windlas Biotech Limited (Plant- Sample does not Drugs Testing Cold Plus 1 2) Khasra No.141 to 143 & conform to Label claim Laboratory, 145, Mohabewala, Indl. Area, with respect to the Madurai -19. Dehradun-248110. content of Uttarakhand. Phenylephrine Hydrochloride 60. Mobicool RL- 02/2024 01/2026 Rednex pharmaceuticals,LS Sample does not Drugs Testing TM-S 231203 No-142, NR, HBS, conform to Label claim Laboratory, Suspenion Chancharvadi Vasna, Ta: with respect to content Madurai -19. sanand Di: Ahmedabad Oxetacaine61. Mupirocin NO33015 11/2023 10/2025 Nanz med Science Pharma Pvt Sample does not Drugs Testing Ointment IP 6 Ltd, Rampur Ghat, Paonta conform to IP Laboratory, 2% w/w Sahib, District Sirmour (H.P) specification for Madurai -19. India - 173 025 Mupirocin Ointment with respect to the content of mupirocin 62. Luliconazole 2946 05/2024 04/2026 Regent Ajanta Biotech, 86-87, sample does not Drugs Testing Cream IP Village Makhiyali Dundi, Conform to IP Laboratory, 1% w/w Peerpura Road, Roorkee - Specification for Madurai -19. 247667 (UK) Luliconazole Cream with respect to the PH of 10% w/v solution. 63. Cefixime & MLS- 07/2024 06/2026 Maskon Life sciences pvt ltd, Sample does not Drugs Testing Lactic Acid 24506 Kh.No.69/70, Khatakheri, conform to label claim Laboratory, Bacillus Bhagwanpur, Roorkee 247667 with respect to the Madurai -19. Dispersible (UK) India content of Anhydrous Tablets Cefixime in Cefixime Trihydrate 64. VIP Hair B107C 06/2024 05/2026 VIMAC, #18/C. Noombal Sample does not Drugs Testing Colour Village, SF.No.125/1A, 1B, conform to BIS Laboratory, Shampoo Ambattur, Taluk, Tiruvallur specification for Chennai - 6 District, Chennai-600077. oxidation hair dye with respect to the content of phenyl methyl pyrazolone and Resorcinol 65. B&B Beaute 2201202 22.01.2 21.01.2 Gabt Co Ltd, Guanzhou, The sample is found to Drugs Testing Blanc Hair 4 024 027 China. contain m- Laboratory, Colour phenylenediamine Chennai - 6 Conditioner which must not form Natural part of the conposition Black of cosmetics products as per BIS specification 4707 (Part 2): 2017, under Annex A (clauses 1,2 and 3.1), serial No.1198.66. Nyomi Fruit 2024071 12.07.2 11.07.2 Guangzhou Aocai Bio- Sample does not Drugs Testing Vinegar 2 024 027 Technology Co. Ltd, Address. conform to BIS Laboratory, Black Hair Building D.No.10, Shi Specification for Chennai - 6 Gel Colour Longgang Industry, Chang Oxidation Hair dye Yaoling Village, Zhong Luotan with respect to the Town, Guangzhou, China. content of Phenyl Methyl Pyrazole. 67. Xputum-LS 24-XLS- 02/2024 07/2025 Stedman Pharmaceuticals Pvt Sample does not Drugs Testing Syrup 010 Ltd, C-4, SIDCO conform to Label Laboratory, Pharmaceuticals Complex, Claim With respect to Madurai -19. Alathur, Thiruporur-603 110, content of Tamilnadu. Levosalbutamol in Levosalbutamol Sulphate. 68. Podine-M PM 04 04/2024 03/2026 Karlin Pharmaceuticals & sample does not Drugs Testing Exports Private Limited, conform to label claim Laboratory, No.2/140, Indira Nagar, with respect to the Chennai - 6 Valasaravakkam, Chennai - content of available 600087 iodine in povidone iodine 69. Mupirocin DC2437 03/2024 08/2025 Arius Formulation Private Sample does not Drugs Testing Ointment IP Limited, R.S.No.141/1, Groud conform to IP Laboratory, floor, Navarkulam Main Road, Specification for Madurai-19 Pattanur, Tamilnadu - 605101 Mupirocin Ointment with respect to the content of Mupirocin 70. Cumox 500 FDCX- 10/2024 09/2026 Firstmed Therapeuticals pvt ltd, Sample does not Drugs Testing 076 R.S.No.31/1, Pondy- conform to IP Laboratory, Tindivanam Main Road, specification for Chennai - 6 Auroville (PO), Amoxycillin capsules Thiruchitrambalam, Tamilnadu with respect to - 605 101 Uniformity of Weight and to the content of Amoxycillin in Amoxycillin Trihydrate. 71. Norfloxacin RNFT- 10/2024 09/2026 Mfg By: Revat Laboratories NOT OF STANDARD State Lab, Tablets IP 017 . . Pvt.Ltd., 12-321, Opp. I.D.A, QUALITY D r u g s C o n t r o l 400mg Kurnool Road, Pernamitta, Dissolution test doesOngole - 523 002 Andhra not complies for Laboratory, Pradesh. Norfloxacin Tablets IP Telangana. at S2 Level as per IP 2022. 72. Cefpodoxim BPT- 02/2024 01/2026 Mfg By: Geenac Pharma Plot NOT OF STANDARD State Lab, e & 3003 . . No: 582, Raipur, Bhagwanpur, QUALITY D r u g s C o n t r o l Potassium Roorkee, Uttarakhand-247667. The sample does not Laboratory, Clavulanate Uttarakhand. m e e t s t h e T e la n g a na. Tablets . S p e c if i c a t i o n s w r t . Mrkt: Wellnow Healthcare Identification test - Kanal Industrial Estate, Road and Assay - for No. 6, Borivali East, Mumbai - Cefpodoxime and 400 066. Clavulanic Acid as per STP. U/S. 17 B of Drugs and Cosmetics Act 1940. The Sample is deemed to be Spurious Drug. 73. Norfloxacin RNFT- 12/2023 11/2025 Mfg By: Revat Laboratories NOT OF STANDARD State Lab, Tablets IP 014 . . Pvt.Ltd., 12-321, Opp. I.D.A, QUALITY D r u g s C o n t r o l 400mg Kurnool Road, Pernamitta, Dissolution test does Laboratory, Ongole - 523 002 Andhra not complies for Telangana. Pradesh. Norfloxacin Tablets IP at S2 level as per IP 2022. 74. Parenteral 24PT41 11/2024 10/2026 Mfg By: Sai parenterals limited NOT OF STANDARD State Lab, preparations . . D1&D4, Survey no. 280, Phase QUALITY D r u g s C o n t r o l , Piperacillin - V Survey No. 280, Phase - V, Test for sterility does Laboratory, & IDA, Jeedimetla, Hyderabad - not complies as per IP Telangana. Tazobactam 500055, Telangana, India for the sample Injection I.P. Telangana. Piperacillin and 4.5 gm Tazobactam injection IP 4.5 gm 75. Retibak AHO2400 23-07- 06/2026 Mfg By: M/s. Aarohee NOT OF STANDARD State Lab, (0.2% 48 2024. . healthcare Private Ltd, Sy.No. QUALITY D r u g s C o n t r o l Retinol) 751 & 757 Burgula (V), Farooq Sample does not Laboratory, Face Serum Nagar (M), Rangareddy meets the Telangana. District. s p e c if i c a t i o n s w r t . toManufactured for : M/s. Origo identification test for cosmeceuticals Pvt.Ltd., R e t i n o l a s p e r S T P . . Marketed By: Cosmonova Medicare Pvt. Ltd., No. 18/5(A), 1st main S.R. Nagar, Richmond Road, Bangalore - 560 027. 76. Pantoprazol P03524 09/2024 08/2026 Mfg By: Spansules NOT OF STANDARD State Lab, e tablets IP . . formulations India Pvt.Ltd, Sy QUALITY D r u g s C o n t r o l NO.172, Plot No. 154/A4, IDA Assay and Dissolution Laboratory, bollaram village Jinnaram test does not complies Telangana. mandal, Sangareddy dist, for Pantoprazole Hyderabad - 502 325, tablets as per IP Telangana. 2022. 77. Kaltfer EHL- 07/2024 12/2025 Mfg By: M/s. Exotic Healthcare NOT OF STANDARD State Lab, Drops 3532 . . Plot No. 1305, Sector - 82, QUALITY D r u g s C o n t r o l Iron(III)- JLPL, Mohali, SAS Nagar, The sample Does not Laboratory, Hydroxide Punjab. m e e t s t h e Telangana. Polymaltose . S p e c if i c a t i o n s w r t . Complex Mrkt: M/s. Curezen Pharma Identification Test - Drops. Pvt. Ltd, Pharmaceuticals No. Negative, Assay - Nil 2/A/GF/FF/SF, Ground floor, as per STP. U/S. 17 B Vijaynagar colony, of Drugs and Secunderabad, Hyd - 500025. Cosmetics Act 1940. The Sample deemed to be Spurious Drug. 78. Ondansetro T-15842 12/2023 11/2025 Mfg By: Karnani NOT OF STANDARD State Lab, n orally . . Pharmaceuticals Pvt.Ltd, QUALITY D r u g s C o n t r o l disintegratin fact:38 Pharma city, Selaqui While opening the Laboratory, g tablets IP Dehradun - 248 011. s t r i p , i t i s f o u n d t h a t T e l a n g a n a . 4 mg Uttarakhand. the tablets are not in intact condition. Received 50 tablets, out of 50 tablets, 40 tablets are not in intact condition. Hence sample is of Not ofStandard Quality with respect to Description test parameter. 79. TELMA AM 5240367 45352 46419 M/s. Glenmark Does not confirm to State Drugs Testing Pharmaceuticals Ltd., Solan I.P. Laboratory, Kolkata, H.P. West Bengal. 80. CLAVPARK CHTJ426 45566 46266 M/s. Park Pharmaceuticals, Does not confirm to State Drugs Testing -LB 625mg 0 Vill. Kalujhanda, Solan, H.P claim Laboratory, Kolkata, (Amoxycillin West Bengal. , Potassium Clavulanate & Lactic Acid Bacillus Tab) 81. Cetirizine CE3010 09/23 08/25 Kerala State Drugs and It fails the test ‘Assay’ Drugs Testing Syrup IP Pharmaceuticals Limited, as per IP Laboratory Kalavoor .P.O, Alappuzha -688 Thiruvananthapuram 522 82. Paradolo AGT4055 05/24 04/27 Alventa Pharma Ltd, Vill, It fails the test Drugs Testing 500 4 Kishanpura, Baddi-Nalagarh ‘Dissolution’ as per IP Laboratory [Paracetam Road, Tehsil, Baddi, Distt. Thiruvananthapuram ol Tab IP Solan (HP) 174 101 500 mg] 83. Cetirizine CE 3008 09/23 08/25 Kerala State Drugs and It fails the test Assay Drugs Testing Syrup IP Pharmaceuticals Limited, and content of Laboratory Kalavoor .P.O, Alappuzha -688 packaged dosage Thiruvananthapuram 522 forms specified in the laboratory protocol as per IP 84. Ondem-4 2444145 04/24 03/26 Alkem Health Science, Unit -2, It fails the test Drugs Testing [Ondansetro 1 Samardung, Karek Block, P.O dissolution specified in Laboratory n Tablets Namthang District Namchi, the Laboratory Thiruvananthapuram IP] Sikkim – 737 137 Protocol as per IP 85. Liquid HP 07/24 06/26 Multicure Pharma Private It fails the tests Drugs Testing Paraffin IP 24002 Limited,Factory 14 A, IAD, ‘Weight per ml and Laboratory 400 ml Yadadri Bhongir- 508 116, ‘Light Absortion’ as per Thiruvananthapuram Hyderabad IP86. Cetirizine CE4019 05/24 04/26 Kerala State Drugs and It fails the tests Drugs Testing Syrup IP Pharmaceuticals Limited, Microbial Laboratory Kalavoor .P.O, Alappuzha -688 contamination in non- Thiruvananthapuram 522 sterile products as per IP 87. Tuclav -CV MYRTAB 08/24 01/26 Mayer Lab, Chambaghat, It fails the test Drugs Testing 625[ -618 Adjacent to Railway Crossing, Dissolution and Assay Laboratory Amoxycillin District Solan (HP)- 173 213 as per IP Thiruvananthapuram and Potassium Clavulanate Tab IP 88. Losartan D Kerala Medical Services It fails the ‘Descriptive Drugs Testing Potassium 2615/24- Corporation Ltd, Thycaud P.O, Part’ for the tablets as Laboratory Tab IP 25 25 Thiruvananthapuram-14 per IP , tablets should Thiruvananthapuram mg have sufficient hardness for handling without crumbling and breaking 89. Fexofenadin T 3105 10/24 09/26 Jackson Laboratories Pvt Ltd, It fails the test Drugs Testing e 22-24, Majitha Road, Byepass, ‘Dissolution’ as per IP Laboratory Hydrochlori Amritsar -143 001 Thiruvananthapuram de Tab IP 180 mg [Fexodil- 180] 90. Glimepiride D2505/24 Kerala Medical Services It fails the test Drugs Testing Tablet IP 1 -25 Corporation Ltd, Thycaud P.O, dissolution and Laboratory mg Thiruvananthapuram-14 ‘Descriptive Part’ Thiruvananthapuram specified in the Laboratory Protocol as per IP 91. Vitamin B S0016/24 Kerala Medical Services The sample does not Drugs Testing Complex -25 Corporation Ltd, Thycaud P.O, conform to IP Laboratory Tablets NFI Thiruvananthapuram-14 standards with respect Thiruvananthapuram to ‘Descriptive Part’ for tablets.92. Glimepiride D2721/24 Kerala Medical Services The sample does not Drugs Testing Tablet IP 1 -25 Corporation Ltd, Thycaud P.O, conform to IP Laboratory mg Thiruvananthapuram-14 standards with respect Thiruvananthapuram to ‘Descriptive Part’ for tablets. 93. Glimepiride D2854/24 Kerala Medical Services The sample does not Drugs Testing Tablet IP -25 Corporation Ltd, Thycaud P.O, conform to IP Laboratory Thiruvananthapuram-14 standards with respect Thiruvananthapuram to ‘Descriptive Part’ for tablets. 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: 1. NSQ data was received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Jammu Kashmir, Chennai, West Bengal, Puducherry, Telangana, Thiruvananthapuram (Kerala), Bangalore. Further NSQ data was received from Tripura, Ladakh and Himachal Pradesh as NIL. However, data was not received as per format in Excel Sheet from Jharkhand (PDF Format), Delhi (PDF Format) Goa (PDF format) and Maharashtra (PDF Format) for the Month of January, 2025 as per DCG (I) Circular dated 09.02.2024. 2. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Madhya Pradesh, Manipur, Meghalaya, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Uttar Pradesh, Uttarakhand, 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 January, 2025 as per DCG (I) Circular dated 09.02.2024.

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