48 Drug Samples Including Alkem's PAN 40, Cadila's ACILOC 150 Fail To Qualify CDSCO Test, 1 Declared spurious
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), flagged 48 medicine batches for failing to qualify for a random drug sample test for the month of June, while one drug sample has been declared spurious.The list of Drugs declared as Not of Standard Quality includes Rosuvastatin and Vitamin D3 Tablets manufactured...
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), flagged 48 medicine batches for failing to qualify for a random drug sample test for the month of June, while one drug sample has been declared spurious.
The list of Drugs declared as Not of Standard Quality includes Rosuvastatin and Vitamin D3 Tablets manufactured by Synokem Pharmaceuticals (Batch No.22S1GTA576), Prednisolone Tablets manufactured by Unicure India (Batch No.PDT1009), Paracetamol Tablets I.P. 650 mg manufactured by Hindustan Antibiotics(Batch No.0019), Acenomac 1 (Nicoumalone Tablets IP) manufactured by Macleods Pharmaceuticals(Batch No.FNU02202A), Aciclovir Tablets IP 400 mg manufactured by Nestor pharmaceuticals(Batch No.YCTZ-01), Cetirizine tablets manufactured by Hindustan Antibiotics (Batch No.0051) and others.
Apart from the above, popular medicines such as PAN 40 (Pantoprazole Gastro-Resistant Tablets I.P.) manufactured by Alkem health science (Batch No.22441073), and ACILOC 150 (Ranitidine tablets I.P. 150mg) manufactured by Cadila Pharmaceuticals (Batch No.LD21512) are also on the list of drugs declared as Not of Standard Quality.
Furthermore, FLAGORIN, Heparin Inj. I.P. 1000 IU/ml manufactured by Divine Laboratories has been declared as Spurious.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1273 samples. Out of these, 1225 samples were found to be of standard quality, while 48 of them were declared as not of standard quality (NSQ), and 1 drug was 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.
The samples collected were tested in five laboratories, namely CDL Kolkata, 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 June– 2023:
Total number of samples tested: 1273 |
Total number of samples declared as of Standard Quality: 1225 |
Total number of samples declared as Not of Standard Quality: 48 |
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 Manufa cture | Date of Expiry | Manufactured By | Reason for failure | Drawn By | From |
1 | Clorin Capsules (Aspirin & Clopidogrel Capsules) | SPC221847 | Aug-22 | Jul-24 | Salus Pharmaceuticals, 480/211, Harraipur, P.O. Gurumajra, Teh. Baddi, Dist. Solan (H.P.) – 173205 | Assay of Aspirin & Dissolution of Aspirin | CDSCO Hyderabad | CDL Kolkata |
2 | Astrifos 2 gm (Ifosfamide Injection IP with Mesna Injection) | OL220037A | Aug-22 | Jul-24 | Astrica Healthcare Pvt. Ltd., First Floor, Plot No. 9-18/5, Bharathi Nagar, Temple Alwal, Medchal Hyderabad - 10, Works At: Vill: Gaunspura, P.O. Noorpur Bet, Hambran, Ludhiana – 141 008 Punjab . | Assay of Ifosfamide | CDSCO Hyderabad | CDL Kolkata |
3 | Rosuvastatin & Vitamin D3 Tablets | 22S1GTA576 | May-22 | Apr-24 | Synokem Phramaceuticals Ltd., Plot No. 35-36, Sector - 6A, I.I.E. (SIDCUL), Ranipur (BHEL), Haridwar - 249 403, (Uttarakhand). | Assay of Rosuvastatin | CDSCO Bangalore | CDL Kolkata |
4 | CGTROM-1 (Nicoumalone Tablets IP) | CT22231818 | Mar-23 | Feb-25 | CMG Biotech Pvt. Ltd., 58, Industrial Area, Phase-III, Sansarpur Terrace, HP - 176 501. | Related substances | CDSCO Bangalore | CDL Kolkata |
5 | Erythromycin Stearate Tablets IP 250 mg | AT22356 | Dec-22 | Nov-24 | Alves Healthcare Private Limited, Village: Nangal Uperla, Swarghat Road, Tehsil: Nalagarh, Distt. Solan – 174 101 H.P., India | Dissolution | CDSCO South Zone Chennai | CDL Kolkata |
6 | Keraboost (Tablets of D-Biotin, N- Acetyl L-Cysteine, Vitamins & Minerals) | GT200998 | Sep-22 | Aug-24 | Gnosis Pharmaceuticals Pvt. Ltd., Nahan Road, Village: Moginand, Kala Amb, Distt. Sirmour , H.P. 173030. | Description and Assay of Calcium Pantothenate | CDSCO South Zone Chennai | CDL Kolkata |
7 | NUHENZ (Methylcobalamin, Alpha Lipoic acid, Myo-Inositol, Folic Acid, Chromium Polynicotinate, Selenium Dioxide Monohydrate & Benfotaimine Capsules) | D222427 | Oct-22 | Sep-24 | Stanford Laboratories Private Limited, 8, Industrial Area, Mehatpur, Distt. Una, (H.P.) – 174 315, India | Assay of Alpha Lipoic acid | CDSCO South Zone Chennai | CDL Kolkata |
8 | NUHENZ (Methylcobalamin, Alpha Lipoic acid, Myo-Inositol, Folic Acid, Chromium Polynicotinate, Selenium Dioxide Monohydrate & Benfotaimine Capsules) | D222376 | Aug-22 | Jul-24 | Stanford Laboratories Private Limited, 8, Industrial Area, Mehatpur, Distt. Una, (H.P.) – 174 315, India | Assay of Alpha Lipoic acid | CDSCO South Zone Chennai | CDL Kolkata |
9 | Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml | M481001 | Jul-21 | Jun-23 | Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C. Satpur, Nashik, Maharashtra 422 007. | Assay of Flucloxacillin | CDSCO West Zone Mumbai | CDL Kolkata |
10 | Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml | M481002 | Jul-21 | Jun-23 | 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 | M481003 | Jul-21 | Jun-23 | 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 | Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml | M481004 | Jul-21 | Jun-23 | Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C. Satpur, Nashik, Maharashtra 422 007. | Assay of Flucloxacillin | CDSCO West Zone Mumbai | CDL Kolkata |
13 | Anabol Syrup (Cyproheptadine Hydrochloride Syrup IP) | L22556 | Mar-23 | Feb-25 | Aan Pharma Private Limited, 816/1, Rakanpur, Ta. Kalol Dist. Gandhinagar – 380 060, Gujarat (India). | Assay of Cyproheptadine Hydrochloride | CDSCO Ahmedabad | CDL Kolkata |
14 | Glipizide Tablets I.P. 5 mg | T3180 | Mar-23 | Feb-25 | Stallion Laboratories Pvt. Ltd., C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad - 382220, Gujarat, India | Dissolution | CDSCO Ahmedabad | CDL Kolkata |
15 | IO-Pred-S Eye Drops (Prednisolone Acetate Ophthalmic Suspension USP) | N22L17 | Dec-22 | Nov-24 | Indiana Ophthalmics LLP, 135,136,137, G.I.D.C. Estate, Phase-II, Wadhwan City - 363035, Dist. Surendranagar, Gujarat, India | Assay of Prednisolone Acetate | CDSCO Ahmedabad | CDL Kolkata |
16 | IO-Pred-S Eye Drops (Prednisolone Acetate Ophthalmic Suspension USP) | N22L18 | Dec-22 | Nov-24 | Indiana Ophthalmics LLP, 135,136,137, G.I.D.C. Estate, Phase-II, Wadhwan City - 363035, Dist. Surendranagar, Gujarat, India | Assay of Prednisolone Acetate | CDSCO Ahmedabad | CDL Kolkata |
17 | Manokast 5 (Montelukast Tablets IP) | CT22230271A | May-22 | Apr-24 | CMG Biotech Pvt. Ltd., 58, Industrial Area, Phase- III, Sansarpur Terrace – 176501 (H.P.). | Assay of Montelukast | CDSCO East Zone Kolkata | CDL Kolkata |
18 | Ofloxacin and Ornidazole Tablets IP | 6001022 | Jun-22 | May-25 | Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase Peenya, Bengaluru – 560 058 | Description | CDSCO East Zone Kolkata | CDL Kolkata |
19 | Prednisolone Tablets I.P. 5 mg | PDT1009 | Oct-22 | Sep-24 | Unicure India Ltd., C-21, 22 & 23, Sector -3 Noida 201301, Distt. Gautam Budha Nagar (U.P.) | Related Substances | CDSCO East Zone Kolkata | CDL Kolkata |
20 | Flutrol 250 (Salmeterol and Fluticasone Propionate Inhalation I.P.) | NSB2206A | Apr-22 | Mar-25 | Oxalis Labs, Village: Theda, P.O. Lodhimajra, Tehsil: Baddi Distt. Solan, Himachal Pradesh - 174101 | Assay of Salmeterol Xinafoate and Fluticasone Propionate | CDSCO East Zone Kolkata | CDL Kolkata |
21 | Aceclofenac Tablets I.P. (100 mg) | MT224501 | Oct-22 | Sep-24 | Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector-6A, IIE, Sidcul, Haridwar- 249 403, Uttarakhand. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
22 | Paracetamol Tablets I.P. 650 mg | 0019 | Jan-23 | Dec-24 | Hindustan Antibiotics Ltd., Pimpri, Pune - 411 018, India | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
23 | Glimkar-4 (Glimepiride Tablets 4 mg) | GKR-2210 | Apr-22 | Mar-24 | Apple Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – 247 667 (U.K.). | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
24 | Acenomac 1 (Nicoumalone Tablets IP) | FNU02202A | Nov-22 | Oct-24 | Macleods Pharmaceuticals Ltd., Plot No. 1, 2 & 3, Mahim Road, Near Kuldeep Nagar, Palghar (W) – 401 404, Dist. Thane, Maharashtra. | Related substances | CDSCO East Zone Kolkata | CDL Kolkata |
25 | Mupirocin Ointment IP 2% w/w | 002 | Mar-22 | Feb-24 | Saar Biotech, NH-21 A, Bhud, Baddi, Distt. Solan (HP) - 173205. | Assay | CDSCO East Zone Kolkata | CDL Kolkata |
26 | FLAGORIN (Heparin Inj. I.P. 1000 IU/ml) | DP2127 | Jul-22 | Jun-25 | Divine Laboratories Pvt. Ltd., Block No. 471, Dabhasan, Tal - Padra, Distt. Vadodara – 391 440, India. | Identification (A) and Potency of Heparin The sample is deemed to be Spurious | CDSCO East Zone Kolkata | CDL Kolkata |
27 | Telmisartan Tablets IP 40 mg (TLS-40 TABLETS) | DT0862B | Jul-22 | Jun-24 | DM PHARMA PRIVATE LIMITED, Vill. Bhud, NH- 21A, Baddi, Distt. Solan (H.P.)-173205. | Dissolution | CDSCO SubZone Bangalore | RDTL Chandigarh |
28 | Aciclovir Tablets IP 400 mg | YCTZ-01 | Jun-22 | May-24 | Nestor pharmaceuticals LIMITED, 11, Western Extension Area, Faridabad-121001, INDIA | Assay of Aciclovir | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
29 | Telmisartan Tablets IP 40 mg (Telwin-40 Tablets) | TT230416 | Mar-23 | Feb-25 | Trugen Pharmaceuticals Pvt. Ltd., Vill. Tejjupur, Near Chodiala Rly. Station, Roorkee, Distt. Haridwar, Uttarakhand- 247661 | Dissolution | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
30 | Zinc Sulphate Dispersible Tablets IP | ZST22015 | Feb-22 | Jan-24 | LA-CHEMICO PRIVATE LIMITED, Taki Road, Kadambagachi, Barasat, North 24-Paraganas, Kolkata-700125, W.B. | Disintegration Test | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
31 | Aluminium Hydroxide (0.291 gm), Magnesium Hydroxide (98 mg) and Oxetacaine (10 mg ) Gel | ML220582 | Oct-22 | Sep-24 | Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector-6A, IIE, Sidcul, Haridwar-249403 | Assay of Oxetacaine | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
32 | Acetazolamide Tablets IP 250 mg | 423-27 | Jan-23 | Dec-25 | ZEE LABORATORIES LTD., Behind 47, Industrial Area, Paonta Sahib- 173025 | Uniformity of weight | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
33 | Cetirizine tablets IP 10 mg | 0051 | May-22 | Apr-24 | Hindustan Antibiotics Ltd., (A Govt. Of India Enterpriese), Pimpri, Pune - 411018. | Related substances | CDSCO West Zone Mumbai | CDTL Mumbai |
34 | NOOPHIN (BUPRENORPHIN E INJECTION I.P. 2ml) | LM18920 | Aug-21 | Jul-27 | Cooper Pharma Ltd.C3 Industrial area Selaque,Dehradun – 248197 | Related Substances | Drug Control Department Bihar | RDTL Guwahati |
35 | Diclofenac Sodium Injection IP DOLOMAX 25mg/ml | FDF1-098 | Sep-21 | Aug-23 | BITECH LABORATORY INDORE-452015 (M.P.) | Assay | Drug Controller Department Gaya | RDTL Guwahati |
36 | Ranitidine tablets ip 150mg (ACILOC 150) | LD21512 | OCT.20 21 | MAR.2 024 | Cadila pharmaceuticals LIMITED, 1389, DHOLKA – 382225, Dist.: Ahmedabad | Description | Drug Controller Department Sikkim | RDTL Guwahati |
37 | Chlorpheniramine Maleate & Codeine Phosphate Syrup ONEREX™ COUGH SYRUP | ONCS 1713 | MAR.2 022 | FEB.20 24 | Wings biotech LLP 43 & 44, HPSIDC Industrial Area, Baddi- 17205 (H.P.) | Identification and Assay of Codeine phosphate | Drug Controller Department Bihar | RDTL Guwahati |
38 | Pantoprazole Gastro- Resistant Tablets IP (PAN*40) | 22440483 | Feb-22 | Jul-24 | ALKEM HEALTH SCIENCE, A unit of Alkem Laboratories Limited, Unit- 2, Samardung Karek Block, P.O.: Namthang, South Sikkim- 737137 | Assay of Pantoprazole | Drug Controller Department Bhagalpur | RDTL Guwahati |
39 | Panqub™ DSR Capsules (Pantoprazole Sodium (GR) & Domperidone (PR) Capsules I.P.) | PHC-21252 | Jan-22 | Dec-23 | Phytochem Healthcare, Vill- Theda, Lodhimajra Road, PO- Manpura, Kharuni, The- Nalagarh, Dist. Solan (H.P.) - 174101 | Dissolution of Domperidone | Drug Controller Department Assam | RDTL Guwahati |
40 | PAN 40 (Pantoprazole Gastro- Resistant Tablets I.P.) | 22441073 | Apr-22 | Sep-24 | Alkem health science, A unit of Alkem Laboratories Limited, Unit- 2, Samardung Karek Block, P.O.: Namthang, South Sikkim- 737137 | Assay of Pantoprazole | Drug Controller Depertment Goalpara | RDTL Guwahati |
41 | Ceeti-LM (Levocetirizine & Montelukast Sodium Tablets I.P.) | ALT-0432 | Dec-22 | Nov-24 | Anant Pharmaceuticals G.T. Road, Uchani, Karnal - 132001 | Dissolution of Montelukast and Levocetirizine Hydrochloride | Drug Controller Depertment Mizoram | RDTL Guwahati |
42 | DICLOFENAC SODIUM TABLETS I.P.50 mg | TS7464 | Nov-22 | Oct-24 | ADROIT PHARMACEUTICALS Pvt. Ltd at: 46 , Garoba Maidan, Nagpur -8 (M.S) | Test for Disintegration (Acid Stage) | CDSCO Zonal office Hyderabad | CDTL Hyderabad |
43 | ALUMINIUM HYDROXIDE ,MAGNESIUM HYDROXIDE & ACTIVATED DIMETHICONE SUSPENSION (HICID-MPS SUSPENSION) | HCD 2201 | Feb-22 | Jan-24 | HIPPO LABS PVT. LTD. Plot no. 17 ,R.G. Nagar, IDA, Prashanthi Nagar, Kukatpally,Hyderabad-72 | Weight per ml | CDSCO Visakhapatna m | CDTL Hyderabad |
44 | CLOZAPINE TABLETS I.P. 100 MG | CZPT1006 | Nov-22 | Apr-24 | UNICURE INDIA LTD, C- 21, 22 &23 Sector-3, Noida -201301, Distt. Gautam Budh Nagar (U.P.) | Assay | CDSCO Zonal office Hyderabad | CDTL Hyderabad |
45 | ALBENDAZOLE TABLETS I.P. 400 MG (FOZY) | RD09-2202 | Oct-22 | Sep-24 | VANCE & HEALTH PHARMACEUTICALS PVT. LTD, KHASRA No.410 Karondi, Roorkee- 247667, Uttarakhand. | Test for Dissolution | CDSCO Visakhapatna m | CDTL Hyderabad |
46 | PANTOPRAZOLE GASTRO RESISTANT TABLETS IP 40 MG | JDT-7092 | Feb-23 | Jan-25 | JPEE DRUGS, Plot no. - 53, Sector 6-A,SIDCUL Haridwar (Uttarakhand). | Test for Dissolution (Buffer Stage) | CDSCO Zonal office Hyderabad | CDTL Hyderabad |
47 | TELMISARTAN TABLETS IP 20 MG (TELTAN 20) | HCL2317 | Nov-22 | Oct-24 | HANUCHEM LABORATORIES, Plot no. 16-17 , Sector-5, Indl. Area , Parwanoo, Dist. Solan -173 220 (H.P.) | Test for Dissolution | CDSCO Zonal office Hyderabad | CDTL Hyderabad |
48 | PANTOPRAZOLE GASTRO RESISTANT TABLETS IP 40 MG | JDT-7132 | Feb-23 | Jan-25 | JPEE DRUGS, Plot no. - 53, Sector 6-A,SIDCUL Haridwar (Uttarakhand). | Test for Dissolution (Buffer Stage) | CDSCO Zonal office Hyderabad | CDTL Hyderabad |
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