Drug alert: 51 drug samples fail to qualify CDSCO test, 3 declared spurious
New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 51 medicine batches for failing to qualify for a random drug sample test for the month of July, while three drug samples have been declared spurious.
The list of Drugs declared as Not of Standard Quality includes Stadmed's Paracin Plus Suspension (Ibuprofen and Paracetamol Suspension), Hindustan Antibiotics' Ornidazole and Ofloxacin Tablets IP, Alves Healthcare's Rabeprazole Gastro-Resistant Tablets IP 20 mg, Zee Laboratories' Amoxycillin and Potassium Clavulanate Tablets I.P. 625 mg, Zenith Drugs' Cyproheptadine Hydrochloride Syrup IP (Hungree Syrup), and others.
Apart from the above, popular medicines such as Rosuvastatin Tablets IP (Rosuvas 10 Tablets) manufactured by Sun Pharma Laboratories, drug combination Tamsulosin Hydrochloride, and Dutasteride Tablets (Urimax D) manufactured by Cipla are also on the list of drugs declared as Not of Standard Quality.
Responding to the news, Sun Pharma spokesperson informed the Medical Dialogue Team, "We have investigated the matter and found that Rosuvas 10 (Rosuvastatin Tablets I.P. 10 mg) having batch number SID3056A are spurious. This batch is not manufactured by Sun Pharma. We have requested CDSCO, Delhi to take action on this and also made an appeal for removal of these products from the Drug Alert list."Pantoprazole
Furthermore, the alert pointed out that Pantoprazole GastroResistant and Domperidone Prolonged Release Capsules IP (PAN-D), Pantoprazole Gastro-resistant Tablets IP (PAN 40), and Amoxycillin and Potassium Clavulanate Tablets IP (CLAVAM 625) are declared as spurious as the actual manufacturer, Alkem Health Science, has informed that the impugned batches of the product have not been manufactured by them and that it is a spurious drug.
"Thus, the product is purported to be spurious, however, the same is subject to the outcome of the investigation." the alert added regarding the spurious drug samples.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1306 samples. Out of these, 1252 samples were found to be of standard quality, while 51 of them were declared as not of standard quality (NSQ), and 3 drugs were declared Spurious.
A few of the reasons why the drug samples tested failed were the failure of the assay, the failure of the dissolution test, the failure of disintegration, and the failure of the identification test, and others.
The samples collected were tested in six laboratories, namely CDL Kolkata, CDTL Chennai, CDTL Mumbai, RDTL Chandigarh, RDTL Guwahati, and CDTL Hyderabad.
List of Drugs, Medical Devices, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of JULY – 2023: | ||||||||
Total number of samples tested | 1306 | |||||||
Total number of samples declared as of Standard Quality | 1252 | |||||||
The total number of samples declared as Not of Standard Quality | 51 | |||||||
The total number of samples declared as Spurious | 3 | |||||||
Total number of samples declared as Misbranded | 0 | |||||||
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 | Folic Acid Tablets IP 5mg | T112005 | 05/2022 | 04/2024 | ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan 173205 H.P. | Description & Hydrolysis Products | CDSCO East Zone Kolkata | CDL Kolkata |
2 | Tamsulosin Hydrochloride & Dutasteride Tablets (Urimax D) | GH20067 | 01/2022 | 12/2024 | Cipla Ltd., Verna Indl. Estate, Goa 403722, India | Identification and Assay of Dutasteride and Assay of Tamsulosin Hydrochloride | CDSCO East Zone Kolkata | CDL Kolkata |
3 | Paracin Plus Suspension (Ibuprofen and Paracetamol Suspension) | KCC24A0 02A1A | 04/2023 | 03/2025 | Stadmed Private Limited, 15, Jawpore Road, Kolkata- 700074 | Assay of Ibuprofen and Paracetmol | CDSCO East Zone Kolkata | CDL Kolkata |
4 | Paracin Plus Suspension (Ibuprofen and Paracetamol Suspension) | KCC24A0 01A1A | 04/2023 | 03/2025 | Stadmed Private Limited, 15, Jawpore Road, Kolkata- 700074 | Assay of Ibuprofen and Paracetmol | CDSCO East Zone Kolkata | CDL Kolkata |
5 | Ornidazole & Ofloxacin Tablets IP | HOOZ01 | 07/2022 | 06/2024 | Hindustan Antibiotics Ltd., (A Govt. of India Enterprise) At: 11, W.E.A., Faridabad – 121 001 (Haryana). | Description | CDSCO East Zone Kolkata | CDL Kolkata |
6 | MONZET (Montelukast Sodium and Levocetrizine Hydrochloride Tablets IP) | DMZT- 2205 | 12/2022 | 11/2024 | Kniss Laboratories Pvt. Ltd., No.9, Multe Industrial Estate, Gerugambakkam, Chennai- 600128. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
7 | Lonapam® MD 0.5 (Clonazepam Mouth Dissolving Tablets 0.5 mg) | 43L22T01 | 03/2022 | 02/2025 | Shine Pharmaceuticals Limited, Plot No. 132, Karjan- Vemardi Road, Juni Jitherdi, | Related Substances | CDSCO East Zone Kolkata | CDL Kolkata |
Ta. Karjan-391240, Dist.: Vadodara (Gujarat) | ||||||||
8 | Lonapam® MD 0.5 (Clonazepam Mouth Dissolving Tablets 0.5 mg) | 43L23T01 | 02/2023 | 01/2026 | Shine Pharmaceuticals Limited, Plot No. 132, Karjan- Vemardi Road, Juni Jitherdi, Ta. Karjan-391240, Dist.: Vadodara (Gujarat) | Related Substances | CDSCO East Zone Kolkata | CDL Kolkata |
9 | Lonapam® MD 0.5 (Clonazepam Mouth Dissolving Tablets 0.5 mg) | 43L22T03 | 09/2022 | 08/2025 | Shine Pharmaceuticals Limited, Plot No. 132, Karjan- Vemardi Road, Juni Jitherdi, Ta. Karjan-391240, Dist.: Vadodara (Gujarat) | Related Substances | CDSCO East Zone Kolkata | CDL Kolkata |
10 | Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml) | M481005 | 07/2021 | 06/2023 | Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C. Satpur, Nashik, Maharashtra 422 007 | Assay of Flucloxacillin | CDSCO West Zone Mumbai | CDL Kolkata |
11 | Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml) | M481006 | 07/2021 | 06/2023 | Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C. Satpur, Nashik, Maharashtra 422 007 | Assay of Flucloxacillin | CDSCO West Zone Mumbai | CDL Kolkata |
12 | Neomycin Sulphate Ointment USP 20 gm | 023 | 03/2023 | 02/2025 | Deep Pharma, Unit-2, Survey No. 293/3, Behind Jalaram Mandir, Kalikund Kheda Road, Dholka, Ahmedabad- 382225, Gujarat | Assay of Neomycin | CDSCO Ahmedabad | CDL Kolkata |
13 | PYRITOL (Paracetamol Injection) 2ml | HIPM220 08B | 12/2022 | 11/2024 | Health Biotech Ltd., Village: Sandoli, Nalagarh Road, Baddi, Dist. Solan (HP) India 173205 | Particulate Matter | CDSCO Ahmedabad | CDL Kolkata |
14 | Rabeprazole Gastro-Resistant Tablets IP 20 mg | AT23029 | 02/2023 | 01/2025 | Alves Healthcare Private Limited, Village Nangal Uperla, Swarghat Road, Tehsil, Nalagarh, Dist. Solan - 174101 (H.P.), India | Dissolution | CDSCO Ahmedabad | CDL Kolkata |
15 | SN-15 Plus (Serratiopeptidase & Diclofenac Potassium Tablets) | DS-407 | 10/2022 | 09/2024 | Ruby Organics Pvt. Ltd., D- 79, T.T.C, M.I.D.C, Turbhe, Navi Mumbai-400705. | Disintegration | CDSCO Hyderabad | CDL Kolkata |
16 | Ondansetron Injection IP | L3003 | 11/2022 | 10/2024 | Captab Biotic, Unit-II, Plot No.125, EPIP Road, Mauja Jharmajri, Baddi, Distt. Solan H.P. 173205. | Description and Particulate Matter | Drug Control Department Himachal Pradesh | CDL Kolkata |
17 | Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) RL 500 ml | ODF 221292 | 12/2022 | 11/2024 | Haseeb Pharmaceuticals Pvt. Ltd., Plot No. F 9/14, 15, 16, MIDC, Nagpur-440016. | Particulate Contamination | Drug Control Department Odisha | CDL Kolkata |
18 | Diclofenac Sodium, Paracetamol and Serratiopeptidase Tablets | F23018 | 02/2023 | 01/2026 | Brussels Laboratories Pvt. Ltd., 33, Changodar Ind. Estate, Sarkhej Bavla Road, Changodar - 382210, Ahmedabad, Gujarat. | Assay of Serratiopeptidase | CDSCO Ahmedabad | CDL Kolkata |
19 | Carbamazepine Tablets IP 200 mg | GCB5 | 12/2022 | 11/2024 | Super Formulations Pvt. Ltd., 16-B & 15-F, Industrial Area, Maxi Road, Ujjain (M.P.)-456010. | DISSOLUTION | CDSCO Zonal Office Chennai | CDTL Chennai |
20 | Norfloxacin Tablets IP 400 mg | NRT2300 9 | 01/2023 | 12/2024 | Vivek Pharmachem (India) Ltd.,NH-8, Chimanpura, Amer, Jaipur-303 102. | DISSOLUTION | CDSCO Subzonal Office Bangalore | CDTL Chennai |
21 | Chymovit Forte (Trypsin- Chymotrypsin Tablets) | DMT0027 J | 01/2023 | 12/2024 | DM PHARMA PRIVATE LIMITED., Vill. Bhud, NH- 21A, Baddi, Distt. Solan (H.P.) 173 205 | Uniformity of Weight, Average Weight & Disintegration test (Acid stage) | CDSCO West-Zone Mumbai | CDTL Mumbai |
22 | Trypsin-Chymotrypsin Tablets (Chymnetra-Forte) | DT1624H | 12/2022 | 11/2024 | DM PHARMA PRIVATE LIMITED., Vill. Bhud, NH- 21A, Baddi, Distt. Solan (H.P.) 173 205 | Uniformity of Weight, & Average Weight | CDSCO West-Zone Mumbai | CDTL Mumbai |
23 | Amoxycillin & Potassium Clavulanate Tablets I.P. 625 mg | 422-494A | 03/2022 | 02/2024 | Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib- 173 025 | Assay | CDSCO West-Zone Mumbai | CDTL Mumbai |
24 | Tropicamide Eye Drops IP 1 % w/v | GTC002 | 05/2022 | 04/2024 | Vivimed Labs Limited., Plot No.8, Phase V, IDA, Jeedimetla, Medchal- Malkajgiri, Dist. Telangana State – 500 055 | Sterility & Assay | CDSCO West-Zone Mumbai | CDTL Mumbai |
25 | Cyproheptadine Hydrochloride Syrup IP (Hungree Syrup) | 30489 | 03/2023 | 02/2025 | Zenith Drugs Pvt. Ltd., 72/5, Muradpura (Orangpura) Dhar Road, Near Kalaria, Indore 453001 (MP) India | pH | CDSCO Indore | CDTL Mumbai |
26 | AMLODIPINE AND ATENOLOL TABLETS IP (ALAMO -AT) | MDG281 K | 11/2022 | 10/2024 | M.R. HEALTHCARE PVT. LTD. Village : Tanda Mallu, Kashipur Road, Ramnagar - 244715, Dist. Nainital, Uttarakhand( INDIA) | Assay of Amlodipine Besilate equivalent to Amlodipine Only | CDSCO Zonal Office Hyderabad | CDTL, HYDERABAD |
27 | ONDANSETRON ORALLY DISINTEGRATING TABLETS IP (ONDAPLUS-MD 4) | GT23030 56B | 03/2023 | 02/2025 | Roseate Medicare., Vill. Anji, Bypass Road, P.O. Barog, Tehsil & Distt. Solan, 173211 (H.P.) INDIA. | Test for Disintegration | CDSCO Zonal Office Hyderabad | CDTL, HYDERABAD |
28 | AMOXYCILLIN AND POTASSIUM CLAVULANATE ORAL SUSPENSION I.P. (TRUECLAM DS) | PM-16064 | 09/2022 | 02/2024 | PERENNIAL MEDICARE, Shamti, Solan-173212 (H.P.) | pH and Assay | CDSCO Zonal Office Hyderabad | CDTL, HYDERABAD |
29 | ALBENDAZOLE TABLETS I.P. 400 mg (FOZY) | RD09- 2202 | 10/2022 | 09/2024 | Vance & Health Pharmaceuticals Pvt. Ltd., Khasra No. 410, Karondi, Roorkee-247 667, Uttarakhand | Test for Dissolution | CDSCO Port Office Visakhapatnam | CDTL, HYDERABAD |
30 | Olmesartan Medoxomil Tablets IP 40 mg | GT22183 1 | 10/2022 | 09/2024 | Theon Pharmaceuticals Ltd., Vill.Saini Majra, Tehsil Nalagarh, Distt. Solan (H.P.) 174101 | Dissolution | CDSCO North Zone | RDTL Chandigarh |
31 | Aluminium Hydroxide (0.291 gm), Magnesium Hydroxide (98 mg) and Oxetacaine (10 mg )Gel | ML22076 1 | 11/2022 | 10/2024 | Mascot Health Series Pvt. Ltd, Plot No. 79,80, Sec-6A, IIE, Sidcul, Haridwar 249403 | Assay of Oxetacaine | CDSCO North Zone | RDTL Chandigarh |
32 | Sodium Valproate and Valproic Acid Controlled Release Tablets 500 mg | 422-2202 | 12/2022 | 11/2024 | ZEE LABORATORIES LTD., Behind 47, Industrial Area, Paonta Sahib-173025 | Identification of Valproic Acid and Assay of Valproic | CDSCO North Zone | RDTL Chandigarh |
Acid and Sodium Valproate | ||||||||
33 | Rabeprazole Sodium (Enteric Coated) and Domperidone (Sustained Release) Capsules (20 mg/30 mg) | RPE-2258 | 07/2022 | 06/2024 | Apple Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee-247667 (U.K.) | Assay of Rabeprazole Sodium | CDSCO North Zone | RDTL Chandigarh |
34 | Itraconazole Capsules 100 mg | Z22-293 | 03/2022 | 02/2024 | Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025 | Dissolution | CDSCO North Zone | RDTL Chandigarh |
35 | Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (Glimipulse M1 Tablets) | SGT- 0624A | 12/2022 | 11/2024 | Saitech Medicare Pvt. Ltd., Village-Kheri, Trilokpur Road, Kala-Amb, Distt. Sirmour, (H.P.) 173030 | Assay of Glimepiride | CDSCO Sub- Zone Baddi | RDTL Chandigarh |
36 | Rosuvastatin Tablets IP (Rosuvas 10 Tablets) | SID3056A | 11/2022 | 04/2025 | Sun pharma laboratories ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East- Skkim-737135 | Description and Assay of Rosuvastatin Calcium calculated as Rosuvastatin | Drug Control Department Delhi | RDTL Chandigarh |
37 | Nimesulide and Paracetamol Tablets (CDNIM-P TABLETS) | SMP- 2205 | 01/2023 | 12/2024 | Cyper Pharma, K.No. 825- 827, Vill.Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.) 173205 INDIA | Uniformity of weight and Assay of Nimesulide and Paracetamol | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
38 | Calcium Carbonate with Vitamin D3 Tablets (CYPCAL-FORTE TABLETS) | CLF- 22013 | 11/2022 | 10/2024 | CYPER PHARMA, K.No. 825-827, Vill.Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.) 173205 INDIA | Assay of Vitamin D3 | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
39 | Albendazole Tablets IP 400 mg | ABD-2206 | 01/2023 | 12/2024 | CYPER PHARMA, K.No. 825-827, Vill.Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.) 173205 | Dissolution | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
40 | Indomethacin Capsules IP (INDOMETHACIN CAPSULES) | IND-2202 | 02/2023 | 01/2026 | CYPER PHARMA, K.No. 825-827, Vill.Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.) 173205 INDIA | Uniformity of weight and Assay of Indomethacin | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
41 | Griseofulvin Tablets IP 250 mg (Grisowin-250 Tablets) | GSP- 22B08 | 01/2023 | 12/2024 | CYPER PHARMA, K.No. 825-827, Vill.Gullarwala, Sai Road, Baddi, Tehsil Nalagarh, Distt. Solan (H.P.) 173205 (India) | Uniformity of weight and Assay of Griseofulvin | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
42 | Ampicillin Capsules IP (ampicillin Capsules IP-250) | AMP- 22A07 | 01/2023 | 12/2024 | Cyper Pharma, K.No. 825- 827, Vill. Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.) 173205 INDIA | Assay of Ampcillin Trihydrate calculated as Ampicillin | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
43 | Furosemide Tablets IP 40mg (Furosemide-40) | T212721 | 03/2022 | 02/2024 | United Bioceuticals Pvt. Ltd. Plot No. 33C, Industrial Part- IV, Begumpur, Haridwar- 249402 Uttarakhand | Dissolution | Drug Control Department Nagaland | RDTL, Guwahati |
44 | MULTIELECTROLYTE WITH 20% w/v DEXTROSE INJECTION (INTALYTE (Veterinary) | IN703401 1 | 03/2023 | 02/2026 | Abaris Healthcare Pvt. Ltd., Survey No. 1407-11, Village Rajpur, Tal. Kadi. Dist. Mehsana-382740 (Gujarat) | Particulate Contamination, Sterility and Description | Drug Control Department Bihar | RDTL, Guwahati |
45 | Telmisartan Tablets I.P. 40mg. | T101004 | 09/2021 | 08/2023 | ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205 (H.P.), India | Description | Drug Control Department Bihar | RDTL, Guwahati |
46 | Paraccetamol Tablets I.P. 500 mg | DGT22- 257 | 06/2022 | 05/2024 | ORNATE LABS PVT. LTD. Bela Industrial Estate, Muzaffarpur- 842005 | Dissolution and Assay | Drug Control Department Bihar | RDTL, Guwahati |
47 | DEXADEC INJECTION (Dexamethasone Sodium Phosphate Injection I.P. 2 ml.) | TGL0223 0317 | 02/2023 | 01/2025 | T & G Medicare, Vill. Kunjhal, P.O. Baddi, Dist. Solan, H.P. | Sterility and BET | Drug Control Department Arunachal Pradesh | RDTL, Guwahati |
48 | OFLOXACIN & ORNIDAZOLE TABLETS I.P. (OFNI-OZ) | AT220708 27 | 07/2022 | 06/2024 | Accura Care Pharmaceuticals pvt. Ltd., Vill. Moginand, Nahan Road, Kala Amb. Distt- Sirmour (H.P.) 173030 | Dissolution of Ofloxacin and Ornidazole | CDSCO Sub Zone, Guwahati | RDTL, Guwahati |
S.No | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufacture | Date of Expiry | Manufactured By | Reason for failure | Drawn By | From | Remarks |
49 | Pantoprazole Gastro- Resistant and Domperidone Prolonged Release Capsules IP (PAN-D) | 23440762 | 03/2023 | 02/2025 | Alkem Health Science, A Unit of Alkem Laboratories Limited, Unit- 2, Samardung, Karek Block, P.O.: Namthang, South Sikkim-737137 | Identification & Assay of Pantoprazole & Domperidone (Sample is deemed to be Spurious) | CDSCO East Zone Kolkata | CDL Kolkata | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is subject to outcome of investigation. |
50 | Amoxycillin and Potassium Clavulanate Tablets IP (CLAVAM 625) | 23440774 | 03/2023 | 08/2024 | Alkem Health Science, A Unit of Alkem Laboratories Limited, Unit- 2, Samardung, Karek Block, P.O.: Namthang, South Sikkim-737137 | Identification & Assay of Amoxycillin and Clavulanic Acid (Sample is deemed to be Spurious) | CDSCO East Zone Kolkata | CDL Kolkata | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is subject to outcome of investigation. |
51 | Pantoprazole Gastro- resistant Tablets IP (PAN 40) | 23440087 | 01/2023 | 06/2025 | Alkem Health Science, A Unit of Alkem Laboratories Limited, Unit- 2, Samardung, Karek Block, P.O.: Namthang, South Sikkim-737137 | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is subject to outcome of investigation. |
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