CDSCO Drug Alert: 48 Drug Samples Flagged
New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 48 medicine batches for failing to qualify for a random drug sample test for the month of August.
These drug samples which are declared not of standard quality include Misoprostol Tablets I.P. 200 mcg manufactured by Synokem Pharmaceuticals, Cefotaxime for Injection IP 500 mg manufactured by Maan Pharmaceuticals, Telmisartan, and Chlorthalidone Tablets manufactured by Pure & Cure Healthcare, Paracetamol 120 mg plus Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT) manufactured by Fourrts (India) Laboratories and others.
Apart from this, the list further includes popular diabetes drug combination Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (GLIMESTAR M2 FORTE) manufactured by Mankind Pharma and AMTAS PRP (Amlodipine and Perindopril Tablets) manufactured by Intas Pharmaceuticals.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1166 samples. Out of these, 1118 samples were found to be of standard quality while 48 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the disintegration test, failure of the sterility test, etc.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Chennai, CDTL Mumbai, RDTL Chandigarh, and RDTL Guwahati.
List of Drugs, Medical Devices, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of AUGUST – 2023
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of AUGUST – 2023 | ||||||||
Total number of samples tested | 1166 | |||||||
Total number of samples declared as of Standard Quality | 1118 | |||||||
Total number of samples declared as Not of Standard Quality | 48 | |||||||
Total number of samples declared as Spurious | 00 | |||||||
Total number of samples declared as Misbranded | 00 | |||||||
S.No | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufa cture | Date of Expiry | Manufactured By | Reason for failure | Drawn By | From |
1 | MOL-PCB Syrup (Paracetamol, Bromhexine Hydrobromide Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Menthol Syrup) – 60 ml | L22541 | 03/2023 | 02/202 5 | Aan Pharma Private Limited, 816/1, Pramukh Ind. Estate, Rakanpur 382 721, Ta. Kalol Dist. Gandhinagar (Guj.) India | pH, Assay of Bromhexine Hydrobromide and Phenylephrine Hydrochloride | CDSCO, Ahmedaba d | CDL Kolkata |
2 | Nifedipine Sustain Release Tablets I.P. 20 mg | T230307 | 03/2023 | 02/202 5 | Medisky Pharmaceuticals Pvt. Ltd., Plot No. 260, GIDC, Talod – 383 215, Sabarkantha, Gujarat | Dissolution | CDSCO, Ahmedaba d | CDL Kolkata |
3 | DICLOGLOBE 50 (Diclofenac Sodium Tablets I.P. 50 mg) | GT23026 | 01/2023 | 12/202 5 | Globela Pharma Pvt. Ltd., 357, 358, G.I.D.C. Sachin, Surat- 394 230, Gujarat, India | Disintegration | CDSCO, Ahmedaba d | CDL Kolkata |
4 | Trimax Expectorant (Terbutaline Sulphate with BromhexineHCl& Guaiphenesin), | 23009 | 01/2023 | 10/202 4 | Norris Medicines Limited, Plot No. 901/3-5, G.I.D.C. Estate, Ankleshwar – 393 002 (Gujarat). | Assay of Bromhexine Hydrochloride &Menthol.This sample is found to contain 0.118% w/v of Ethylene Glycol and this sample does not give positive test for Diethylene Glycol | CDSCO, Ahmedaba d | CDL Kolkata |
5 | Frusemide Injection IP (2ml) | AI22236 | 08/2022 | 07/202 4 | Alves Healthcare Private Limited, NangalUperla, Swarghat Road, Nalagarh, Dist. Solan, Himachal Pradesh - 174101 | pH | CDSCO, Ahmedaba d | CDL Kolkata |
6 | Refined Glycerin CP Grade | 21100637 | 10/2021 | 09/202 5 | Adani Wilmar, Pitampura, New Delhi – 110 034 | Assay of Glycerin.Thi sample is found to contain 0.025% w/w of Ethylene Glycol and does not give positive result for Diethylene Glycol | CDSCO, Ahmedaba d | CDL Kolkata |
7 | Sterile Noradrenaline Concentrate IP (2mg /1ml) | INABB23 01 | 04/2023 | 03/202 5 | Samarth Life Sciences Pvt. Ltd., Unit II: Plot No.2, Industrial Area, Lodhimajra, Baddi, H.P. 173205, India | Description & Particulate Matter | CDSCO, Ahmedaba d | CDL Kolkata |
8 | CyproheptadineHCl with Tricholine Citrate Syrup (Sylpro Plus Syrup) | 33002 | 05/2023 | 04/202 5 | Norris Medicines Limited, Plot No. 801/P, 901/4-5, G.I.D.C. Estate, Ankleshwar – 393 002 (Gujarat). | Assay of TricholineCitrate.This sample is found to contain Diethylene Glycol 0.243%w/v and Ethylene Glycol 0.171%w/v | CDSCO, Ahmedaba d | CDL Kolkata |
9 | Sibolone (Tibolone Tablets IP) | PLSB230 1 | 02/2023 | 09/202 5 | Phaarmasia Ltd., Unit – II, Plot No. 145, Phase V, IDA, Jeedimetla (V), Qutubullapur (M), MedchalMalkajgiri (Dist.) 500 055 | Dissolution | CDSCO, Hyderabad | CDL Kolkata |
10 | Methylprednisolone Sodium Succinate for Injection USP 40mg | 22MS03 | 11/2022 | 10/202 4 | SAI Parenterals Limited, D1 & D4, Survey No.280, Phase- V, IDA, Jeedimetla, Hyderabad- 500055, Telangana, India. | Uniformity of Dosage Units, Loss on Drying & Assay of Methylprednisolone Sodium Succinate | CDSCO, Hyderabad | CDL Kolkata |
11 | Misoprostol Tablets I.P. 200 mcg | 22S1GTA 026 | 01/2022 | 12/202 3 | Synokem Pharmaceuticals Ltd., Plot No.35-36, Sector- 6A, I.I.E (SIDCUL), Ranipur (BHEL), Haridwar- 249403, Uttarakhand. | Assay | CDSCO Bangalore | CDL Kolkata |
12 | Cefotaxime for Injection IP 500 mg | CD22002 | 03/2022 | 02/202 4 | Maan Pharmaceuticals Ltd., Plot-1, G.I.D.C., Phase II, Modhera Road, Mehsana – 384 002, Gujarat, India | Particulate Matter & Clarity of Solution | CDSCO Bangalore | CDL Kolkata |
13 | Bacillus Clausii Spores Suspension (EbaniproSuspension) | AFL2258 8 | 08/2022 | 07/202 4 | Aarmed Formulation Pvt. Ltd., Survey No. 431/2, Plot No.1, Steel Town, Moraiya, Tal. Sanand, Distt. Ahmedabad (Gujarat) | Purity & Specified Pathogen (Pseudomonas aeruginosa) | Drug Control Departmen t Jammu & Kashmir | CDL Kolkata |
14 | (Absorbable Surgical Suture U.S.P (synthetic) 70 cm), (Monofilament Poliglecaprone 25) (STERGIC) | TV22212 7 | 09/2022 | 08/202 5 | Sugii Surgical India Pvt. Ltd., No.3, Old No. 49/51, 8th Main, Peenya 2nd Stage, Bengaluru – 560058 | Diameter | CDSCO Bangalore | CDL Kolkata |
15 | Erythromycin Stearate Tablets IP 250 mg | AT23118 | 04/2023 | 03/202 5 | Alves Healthcare Private Limited, Village: NangalUperla, Swarghat Road, Tehsil, Nalagarh, Distt. Solan - 174101 (H.P.), India | Dissolution | CDSCO, South Zone Chennai | CDL Kolkata |
16 | Selamer-400 Tablets (Sevelamer Carbonate Tablets 400 mg) | MT22612 4B | 12/2022 | 11/202 4 | Mascot Health Series Pvt. Ltd, Plot No.79, 80, Sec-6A, IIE, Sidcul, Haridwar – 249 403, Uttarakhand, India. | Description | CDSCO, South Zone Chennai | CDL Kolkata |
17 | Telmisartan and Chlorthalidone Tablets | PF8C006 | 09/2022 | 08/202 4 | Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, I.I.E., SIDCUL, Ranipur Haridwar – 249 403, Uttarakhand | Dissolution of Chlorthalidone | CDSCO East Zone Kolkata | CDL Kolkata |
18 | AMTAS PRP (Amlodipine and Perindopril Tablets) | K2200008 2 | 01/2022 | 12/202 4 | Intas Pharmaceuticals Ltd., Bhageykhola, Rangpo, East Sikkim -737132, India. | Assay of Perindopril Erbumine | CDSCO East Zone Kolkata | CDL Kolkata |
19 | Esylate (Etamsylate Injection 250 mg) | I-2359 | 12/2021 | 11/202 3 | Jackson Laboratories Pvt. Ltd., Majitha Road, Amritsar 143001 (India). | Description, Particulate Matter & Extractable Volume | CDSCO East Zone Kolkata | CDL Kolkata |
20 | Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Montzer-C) | MTZ2200 3 | 12/2022 | 11/202 4 | Tirupati Medicare Limited, Nahan Road, Paonta Sahib, Distt. Sirmour (H.P.) 173 205. | Dissolution of Montelukast | CDSCO East Zone Kolkata | CDL Kolkata |
21 | Nicomode-2 (Nicoumalone Tablets IP 2 mg) | T222932 | 02/2023 | 01/202 5 | United Bioceuticals Pvt. Ltd., Plot No. 33C, Industrial Park IV, Begumpur, Haridwar - 249402, Uttarakhand | Related Substances | CDSCO East Zone Kolkata | CDL Kolkata |
22 | Erythromycin Stearate Tablets (Enthrocin-500) | ATG3A04 8 | 01/2023 | 12/202 4 | Anrose Pharma, 147, Mauza Sansiwala, P.O. Barotiwala, Tehsil Kasauli, Distt. Solan (H.P.). | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
23 | Cefoperazone & Sulbactam for injection | S3A099 | 01/2023 | 12/202 4 | Arion Healthcare, GMP Certified Company Vill. Kishanpura, Baddi, Distt. Solan 174 101 (H.P). | Assay of Sulbactam | CDSCO Hyderabad | CDL Kolkata |
24 | Doxycycline and Lactic Acid Bacillus Capsules(DOXORIA-L) | SOC- 2062A | 11/2022 | 10/202 4 | Symbiosis Pharmaceuticals Pvt. Ltd., At C/o Ovation Remedies, Behind IITT Engg. College, Trilokpur Road, Kala Amb- 173030 (Sirmour), HP | Assay /Content of Gram positive rod shaped spore forming bacteria | CDSCO East Zone Kolkata | CDL Kolkata |
25 | Amoxycillin Capsules IP 500 MG (AMOXYCILLIN 500) | C-5076 | Oct- 2022 | Sep- 2024 | Jackson Laboratories Pvt.Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143 001 | TEST FOR DISSOLUTION | CDSCO Subzone Bangalore | CDTL Chennai |
26 | Ciprofloxacin Hydrochloride Tablets IP 500 mg | 0700323 | Feb- 2023 | Jan- 2025 | Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase, Peenya, Bangalore-560058. | TEST FOR DISSOLUTION | CDSCO South Zone Chennai | CDTL Chennai |
27 | Ofloxacin & Metronidazole Benzoate Suspension (VIVFLOX-MZ Suspension) (For Paediatric USE ONLY) | PFS-1204 | Nov- 2022 | Oct- 2024 | Proceed Formulations, 17, Ind. Area, Morthikri, Ramgarh-Derabassi Road,, Derabassi – 140 201. | ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACIN | CDSCO South Zone Chennai | CDTL Chennai |
28 | Metronidazole & Ofloxacin Suspension (nor-metrogyl o Suspension) | XSWN22 006 | April- 2022 | Mar- 2024 | Hema Laboratories Pvt. Ltd. Plot No.29, Pharma City, Selaqui Industrial Area, Dehradun – 248 011 (State Uttarakhand) | ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACIN | CDSCO South Zone Chennai | CDTL Chennai |
29 | Ibuprofen and Paracetamol Dispersible Tablets (Ibucon Plus Kid) | C211143 003 | March- 2023 | Feb- 2026 | Concept Pharmaceuticals Ltd., A-28/3, MIDC, Chikalthana, Aurangabad – 431 006 | Diameter & Uniformity of Dispersion | CDSCO West Zone Mumbai | CDTL Mumbai |
30 | Calamine, Zinc Oxide, Aloe vera & Light Liquid Paraffin (Calmin Lotion) | C-012 | Apr- 2022 | March- 2025 | Gladios Products Pvt Ltd., 31, Virat Industiral Estate, Dhanot, Gandhinagar, Gujarat – 382721 | Specific gravity | CDSCO Zonal Office Ahmedaba d | CDTL Mumbai |
31 | Lorazepam Tablets I.P. 2 mg | LZMT100 6 | Feb- 2023 | Jan- 2025 | Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida- 201301, Distt. : Gautam Budh Nagar (U.P.) | Dissolution and Assay | CDSCO West Zone Mumbai | CDTL Mumbai |
32 | Calcium and Vitamin D3 Tablets I.P. | KTB2176 AL | Nov - 2022 | Apr- 2024 | Karnataka Antibiotics & Pharmaceuticals Limited., Plot No.37, Site No.34/4, NTTF Main Road, 2nd Phase, Peenya Industrial Area, Bengluru- 560058. At: Plot No. 5-9, Survey No.38/2, | Uniformity of content for Vitamin D3 | CDSCO West Zone Mumbai | CDTL Mumbai |
Aliyali Palghar (W), Dist. Palghar- 401404 (M.S). | ||||||||
33 | Levocetirizine and Amrboxol Syrup (C & C Syrup) | BL23015 | Feb- 2023 | Jan- 2025 | Baxil Pharma Pvt. Ltd., 10km, Nainital Highway, Shyampur, Haridwar 249408, Uttarakhand. | Assay of Ambroxol Hydrochloride | CDSCO Ghaziabad | RDTL Chandigarh |
34 | Povidone-Iodine Ointment USP 5% w/w | P1040 | Aug- 2022 | Jul- 2025 | Babu Ram Om Prakash (BROP), Trilokpur Road, Ogli Village, Kala Amb, | Assay of Povidon Iodine calculated asAvailable Iodine | CDSCO Ghaziabad | RDTL Chandigarh |
35 | Cefpodoxime Proxetil for Oral Suspension IP | UCST- 2310 | Mar- 2023 | Feb- 2025 | Ultra Drugs Pvt. Ltd., Manpura, Nalagarh, Distt.Solan-174101 (H.P.) | pH | CDSCO Sub-Zone Jammu | RDTL Chandigarh |
36 | Diclofenac Prolonged- Release Tablets IP 100 mg | CHT- 3037 | Jan- 2023 | Dec- 2024 | Cotec Healthcare Pvt. Ltd., NH.No. 74, Roorkee- Dehradun Highway, Kishanpur, Roorkee-247667 (Uttarakhand) | Dissolution | CDSCO Ghaziabad | RDTL Chandigarh |
37 | Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg) | 54CAT09 6 | Sep- 2022 | Aug- 2024 | Swiss Garnier Life sciences, 21-23, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh- 174315.INDIA | Dissolution (buffer stage) of Aspirin and The Assay of Atrovastatin Calcium calculated as Atorvastatin | CDSCO Ghaziabad | RDTL Chandigarh |
38 | Mupirocin Ointment IP (MUPIJAI OINTMENT) | 008 | Sep- 2022 | Aug- 2024 | Baxil Pharma Pvt. Ltd., 10km, Nainital Highway, Shyampur, Haridwar 249408, | Assay of Mupirocin | Drug Control Departmen t Ghaziabad | RDTL Chandigarh |
39 | The auto disable syringe (KOJAK SELINGE) | 312053KJ M1 | Mar- 2023 | Feb- 2028 | HINDUSTAN SYRINGES & MEDICAL DEVICES LTD., 174, 178/25, BALLABGARH, FARIDABAD, INDIA-121004 | Design (Piston/Plunger Assembly) Fit of piston in barrel | CDSCO Sub Zone Baddi | RDTL Chandigarh |
40 | Rabeprazole Gastro- resistant Tablets IP (RABALKEM-20) | RBL2202 0RH | Oct- 2022 | Sep- 2024 | Ravian Life Science Pvt. Ltd., Plot No.34, Sector-8A, IIE, SIDCUL, Haridwar-249 403, Uttarakhand INDIA. | Dissolution | Drug Control Departmen t Assam | RDTL, Guwahati |
41 | Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5ml syrup (COLD OUT) | SF001A0 1 | Jan- 2022 | Dec- 2024 | Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103. Tamil Nadu, INDIA. | Content of Ethylene Glycol 1.9%w/v & Diethylene Glycol 0.14%w/v | CDSCO, South zone, Chennai | RDTL Guwahati |
42 | Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT) | SF001B0 1 | Feb- 2022 | Jan- 2025 | Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103. Tamil Nadu, INDIA. | Content of Ethylene Glycol 1.22%w/v | CDSCO, South zone, Chennai | RDTL Guwahati |
43 | Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT) | SF001A0 2 | Jan- 2022 | Dec- 2024 | Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103. Tamil Nadu, INDIA. | Content of Ethylene Glycol 2.23%w/v& Diethylene Glycol 0.17%w/v | Drugs Inspector, CDSCO, South zone, Chennai | RDTL Guwahati |
44 | CALCIUM ACETATE TABLETS USP 667 mg., (Lanum) | D222313 | Jul-2022 | Jun- 2025 | STANDFORD LABORATORIES PRIVATE LIMITED, 8, Industrial Area, Mehatpur, Dist. Una, H.P. - 174315 | Assay | Drugs Inspector, Guwahati, Assam | RDTL Guwahati |
45 | GENTAMYCIN INJECTION I.P. (GENTAVIK 2ml.) | TGL0223 0318 | Feb- 2023 | Jan- 2025 | T & G MEDICARE, Village- Kunjahal, P.O. Baddi, Distt. Solan (H.P.) | Sterillity and Bacterial Endotoxins Test | lnspector of Drugs, Arunachal Pradesh | RDTL Guwahati |
46 | Pantoprazole Gastro Resistant Tablets I.P. (PAVE -40) | BBT2217 94 | May - 2022 | Apr- 2024 | Biomax Biotechnics (P) Ltd., 261, HSIIDC, Industrial Estate, Alipur, Barwala- 134118 (Haryana) | Dissolution | Drugs Inspector, RAnchii,Jh arkhand | RDTL Guwahati |
47 | Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (GLIMESTAR® M2 FORTE) | P9IAV007 | Nov- 2022 | Oct 2024 | MANKIND PHARMA LTD. Doring Block, Bermiok Elaka, Dist. Namchi, Sikkim 737126 | Disintegration and Dissoluton | Drugs Inspector, Mizoram | RDTL Guwahati |
48 | COMPOUND SODIUM LACTATE INJECTION I.P. | 03BF173 7 | Aug- 2022 | Jul- 2025 | PASCHIM BANGA PHARMACEUTICAL, NH-31 TIN MILE HAT, SONAPUR HAT, P.S.-CHOPRA, DIST: UTTAR DINAJPUR, PIN- 733214 (W.B.) | Bacterial Endoxtoxins Test | Drugs Inspector, AJZAWL, Mizoram | RDTL Guwahati |
