CDSCO Drug Alert: 27 Drug Samples flagged
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 27 medicine batches for failing to qualify for a random drug sample test for the month of May– 2023, while one drug sample has been declared Spurious.
These drug samples which are declared not of standard quality include Jackson Laboratories' Bupivacaine Heavy (Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml), Alves Healthcare's Doxycycline Capsules IP, Terrace Pharmaceuticals' Teripil -80 (Telmisartan Tablets I.P.), Bengal Chemical and Pharmaceuticals' Ofloxacin and Ornidazole Tablets IP, Zee Laboratories' MONAMOX-CL 625 (Amoxycillin& Potassium Clavulanate Tablets I.P.) and others.
Apart from this, the list further includes the Popular marketed drug CLAVAM 625 (Amoxicillin And Potassium Clavulanate Tablets I.P.) manufactured by Alkem Health Sciences, a unit of Alkem Laboratories, and Tinvista 300 (Tinidazole Tablets I.P. 300 mg) manufactured by Cadila Pharmaceuticals.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1302 samples. Out of these, 1274 samples were found to be of standard quality while 27 of them were declared as Not of Standard Quality (NSQ) and 1 drug was declared Spurious.
A drug shall be deemed to be spurious if it is manufactured under a name that belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug, or if it wrongly claims to be the product of another manufacturer.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of Disintegration test, failure of the sterility test, etc.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Hyderabad, RDTL Guwahati, CDTL Mumbai, and RDTL Chandigarh.
List of Drugs, Medical Devices, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of May – 2023:
Total number of samples tested | 1302 |
Total number of samples declared as of Standard Quality | 1274 |
Total number of samples declared as Not of Standard Quality | 27 |
Total number of samples declared as Spurious | 1 |
Total number of samples declared as Misbranded | NIL |
S.No | Name of Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
1. | Heparin Injection I.P. 25000 IU / 5ml | B. No.: 22HE17 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Sai Parenterals Ltd., D1 & D4, Survey No. 280, Phase-V, IDA, Jeedimetla, Hyderabad 500055, Telangana. | Assay | CDSCO Zonal Office Hyderabad | CDL Kolkata |
2. | Bupivacaine Heavy (Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml), | B. No.: I-5319 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar – 143 001 (India). Punjab. | Description Foreign and Particulate matter | Drug Control Department Jammu & Kashmir | CDL Kolkata |
3. | Doxycycline Hydrochloride Capsules IP 100 mg | B. No.: DEC2215 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Modern Laboratories, 45-47, Sector D-2, Sanwer Road, Indore, Madhya Pradesh – 452 015, India, | Assay | CDSCO Ahmedabad | CDL Kolkata |
4. | Gentamicin (Gentamicin Injection I.P.) – 2 ml | B. No.: GM22242 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi | Description and Particulate Matter | CDSCO South Zone Chennai | CDL Kolkata |
Hapsi, Kanadia Road, Indore. | |||||
5. | Misoprostol | B. No.: 22HT303 | Assay | CDSCO | CDL |
Tablets I.P. | Mfg dt: 11/2022 | South Zone | Kolkata | ||
200 mcg | Exp dt: 10/2024 | Chennai | |||
Mfd by: M/s. Accent | |||||
Pharmaceuticals & | |||||
Diagnostics, Village | |||||
Bhalon (Seri), Forest | |||||
Road, Solan – 173 | |||||
212, Himachal | |||||
Pradesh. | |||||
6. | Doxycycline | B. No.: AC22031 | Assay | CDSCO | CDL |
Capsules IP | Mfg dt: 10/2022 | South Zone | Kolkata | ||
Exp dt: 09/2024 | Chennai | ||||
Mfd by: M/s. Alves | |||||
Healthcare Private | |||||
Limited, Nangal | |||||
Uperla, Swarghat | |||||
Road, Tehsil: | |||||
Nalagarh, Distt. Solan | |||||
-174101, Himachal | |||||
Pradesh. India. | |||||
7. | Teripil -80 | B. No.: STN-221142 | Dissolution | CDSCO | CDL |
(Telmisartan | Mfg dt: 11/2022 | East Zone | Kolkata | ||
Tablets I.P.) | Exp dt: 10/2024 | Kolkata | |||
Mfd by: M/s. Terrace | |||||
Pharmaceuticals (P) | |||||
Ltd., 3-B(a) Phase - III, | |||||
Industrial Area, | |||||
Sansarpur Terrace, | |||||
Distt. Kangra, | |||||
Himachal Pradesh- | |||||
176501. | |||||
8. | Ofloxacin | B. No.: 2618015 | Description | CDSCO | CDL |
& | Mfg dt: 01/2023 | East Zone | Kolkata | ||
Ornidazole | Exp dt: 12/2024 | Kolkata | |||
Tablets IP | Mfd by: M/s. Bengal | ||||
Chemical and | |||||
Pharmaceuticals Ltd, | |||||
164, Maniktala Main | |||||
Road, Kolkata - | |||||
700 054. |
9. | Tinvista 300 (Tinidazole Tablets I.P. 300 mg) | B. No.: JKGJ20001 Mfg dt: 03/2020 Exp dt: 02/2024 Mfd by: M/s. Cadila Pharmaceuticals Limited, Industrial Growth Centre, SIDCO, Samba - 184 121, State of Jammu & K.ashmir. | Disintegration | CDSCO East Zone Kolkata | CDL Kolkata |
10. | Heparin Sodium Injection IP 5000 IU / 5ml | B. No.: AIG-9415 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Alliaance Biotech, 440/3, Vill. Katha, Baddi, Distt. Solan, Himachal Pradesh - 173205. | Description, Identification & Particulate Matter, Assay (Sample is deemed to be Spurious) | Drug Control Department Odisha | CDL Kolkata |
11. | AMOXICILLIN CAPSULES IP (ALMOX-500) | B. No.: 22281692 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Alkem laboratories Ltd., At. Village-Thana, Tehsil- Baddi, Dist. Solan, Himachal Pradesh- 173205. | Assay | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
12. | ENALAPRIL MALEATE TABLETS IP 2.5mg (LAPRIL) | B. No.: GB21113 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. ORTIN LABORATORIES LTD, 275 & 278, (part)/I.D.A. Pashamylaram- 502307, Sanga Reddy, Dist. T.S. Telangana India. | Assay | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
13. | Rabeprazole Sodium and Domperidone Tablets | B. No.: RT220468 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC, Indl. Complex, Narela, Delhi-110040. | Description | Drug Control Department Meghalaya | RDTL Guwahati |
14. | LECET M Tablets (Levocetirizine Dihydrochloride, Montelukast Sodium Tablets I.P.) | B. No.: INT-3551B Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Instant Remedies Pvt. Ltd. An ISO 9001: 2015 & GMP Certified Company) V.P.O. Gholu, Majra, Dappar- 140507, Punjab. | Dissolution of Montelukast Levocetirizine Dihydrochloride | Drug Control Department Jharkhand | RDTL Guwahati |
15. | CLAVAM 625 (Amoxicillin And Potassium Clavulanate Tablets I.P.) | B. No.: 22442372 Mfg dt: 08/2022 Exp dt: 01/2024 Mfd by: M/s. ALKEM HEALTH SCIENCE, A unit of Alkem Laboratories Limited, Unit-2, Samardung Karek Block, P.O.: Namthang, South Sikkim- 737137. | Identification of Clavulanic Acid and Assay of Amoxicillin and Clavulanic Acid | Drug Control Department Bihar | RDTL Guwahati |
16. | Paracetamol Tablets IP 500 mg (Galpara) | B. No.: GPT22002 Mfg dt: 07/2022 Exp dt: 06/2025 Mfd by: M/s. Galpha Laboratories Limited, Village – Thana, Baddi, Himachal Pradesh – 173205. | Dissolution | Drug Control Department Meghalaya | RDTL Guwahati |
17. | Paracetamol Tablets I.P. 500 mg | B. No.: DGT22-270 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. ORNATE LABS PVT. LTD. Bela Industrial Area, Muzaffarpur – 842005, Bihar. | Dissolution | Drug Control Department Bihar | RDTL Guwahati |
18. | Spasom-40 Capsules (Omeprazole Capsules I. P. | B. No.: SRGC-22051 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. SPAS Remedies (An ISO 9001, GMP & WHO-GMP Certified Unit),Vill- Bersan, P.o.- Lodhi Majra, Teh. Baddi, Distt. Solan, Himachal Pradesh- | Assay of Omeprazole | Drug Control Department Bihar | RDTL Guwahati |
173205 | |||||
19. | MONAMOX-CL 625 (Amoxycillin& Potassium Clavulanate Tablets I.P.) | B. No.: 422-1199 Mfg dt: 08/2022 Exp dt: 01/2024 Mfd by: M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib- 173 025. Himachal Pradesh . | Assay and Dissolution | CDSCO West-Zone Mumbai. | CDTL, Mumbai |
20. | Probiotic Capsules | B. No.: PTC/C/003 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. UNIQUE BIOTECH LTD., Plot No.2, Phase-II, MN Park, Kolthur Village, Shameerpet Mandal, Medchal Malkajgiri Dist. Hyderabad- 500101, Telangana, India. | Identification and Assay of Streptococcus faecalis | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
21.. | Paracetamol, Phenylphrine Hydrochloride, Diphenhydramine Hydrochloride and Caffeine Tablets (Syscold Tablets) | B. No.: SPT-192 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Signoret Pharmaceuticals Pvt. Ltd., Plot No-556, Industrial Area, Phase IX, SAS Nagar-160059 Punjab. | Disintegration test and Assay of Phenylephrine Hydrochloride | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
22. | Nimesulide and Paracetamol Tablets (Nimfed Tablets) | B. No.: CMT22-666 Mfg dt: 09/2022 Exp dt: 08/2024 Mfd by: M/s. Cortex Medical Inc., Plot No.- 3F, Apperal Park, Katha, Industrial Area Baddi-173205, Distt. Solan, Himachal Pradesh. | Disintegration test | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
23. | Paracetamol Oral Suspension IP (Paragus 250 Suspension) | B. No.: CL30476 Mfg dt: 02/2023 Exp dt: 01/2025 Mfd by: M/s. Cosmas | Assay of Paracetamol | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
Pharmacls Ltd., Buranwala Road, Village: Kotla, P.O.: Barotiwala, Solan (H.P.)-1741003. | |||||
24. | Loperamide Hydrochloride Tablets IP (DYRIA STOP TABLETS) | B. No.: DY-2214 Mfg dt: 02/2023 Exp dt: 01/2025 Mfd by: M/s. Cyper Pharma, K.No. 825- 827, Village Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh- India. | Dissolution of Loperamide Hydrochloride | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
25. | Chlorpheniramine Maleate Tablets IP 4 mg | B. No.: CPM2205 Mfg dt: 12/2022 Exp dt: 11/2024 Mfd by: M/s. CYPER PHARMA, K.No. 825- 827, Village Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.)-173205 INDIA. | Assay of Chlorpheniramine Maleate | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
26. | Glimepiride Tablets IP 2 mg | B. No.: T192009 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan-173205, Himachal Pradesh. | Dissolution of Glimepiride | CDSCO Sub-Zone Jammu | RDTL Chandigarh |
27. | Doxycycline and Lactic Acid Bacillus Capsules (DOXYFIL-LB CAPSULES) | B. No.: DXF-2103 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. CYPER PHARMA, K.No. 825- 827, Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - | Identification and Assay of Lactic Acid Bacillus. | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
173205 INDIA. | |||||
28. | Cefixime and Ofloxacin Tablets (ZENCEF-O TABLETS) | B. No.: ZFO-2101 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. CYPER PHARMA, K.No. 825-827, Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 173205 INDIA. | Assay of Cefixime Trihydrate Calculated as anhydrous Cefixime | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
Also Read:Drug alert: 35 drug samples fail to clear CDSCO test, 1 declared spurious
