CDSCO Declares 15 Drug Samples Including Levofloxacin, Paracetamol As Not Of Standard Quality
New Delhi: The apex drug regulatory body, Central Drugs Standard Organization (CDSCO) has flagged 15 drug samples as "Not of Standard Quality" after they failed to qualify a random drug sample test for the month of December 2020.
These drug samples included popular formulations and brands like Paracetamol Tablets IP 650 mg, Levofloxacin Tablets IP L-FOX-500 TABLETS, Fluconazole Tablets IP 150 mg FLUCOL TABLETS, and others. The list also included samples of DOCTORS CARE HAND SANITIZER, Calamine, Tramadol Prolonged Release Tablets (CORLIVIDOL-100 SR TABLETS), Rosuvastain Tablets IP 20 mg, and others.
This came after the analysis and test conducted by the CDSCO on 943 drug samples. Out of this, 928 samples were found of Standard quality while 15 of them were declared as Not of Standard Quality (NSQ).
Drugmakers including Bharat Parenterals Ltd., Nanz Med Science Pharma Pvt. Ltd. (A unit of Med Science Canada Inc.), Perk Pharmaceuticals Ltd., Unicure India Ltd., and others are involved in manufacturing the formulations collected by the authorities for random testing.
A few of the causes why the drug samples tested failed were due to Dissolution, Assay of Isopropyl Alcohol, Hydrogen Peroxide, Glycerol, Related Substances, Uniformity of weight, and others.
The samples collected were tested in three laboratories namely CDL Kolkata, RDTL Chandigarh, CDTL Mumbai.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of December-2020
Total number of samples tested | 943 |
Total number of samples declared as of Standard Quality | 928 |
Total number of samples declared as Not of Standard Quality | 015 |
Total number of samples declared as Spurious | 0 |
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. | Alora 0.25 (Alprazolam Tablets I.P. 0.25 mg) | B. No.: 03A19T02 Mfg dt: 11/2019 Exp dt: 10/2022 Mfd by: M/s. Shine Pharmaceuticals Limited, Plot No. 132, Karjan – Vemardi Road, Juni Jitherdi, Te. Karjan – 391 240, Dist. Vadodara, Gujarat. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
2. | Telmicept – 40 (Telmisartan Tablets I.P. 40 mg) | B. No.: C21T479003 Mfg dt: 09/2019 Exp dt: 08/2022 Mfd by: M/s. Concept Pharmaceuticals Ltd., A- 28/3, MIDC, Chikalthana, Aurangabad – 431 006 Maharashtra. | Dissolution | CDSCO Sub-Zone Guwahati | CDL Kolkata |
3. | HAND SANITIZER | B. No.: V20EL011 Mfg dt: 04/2020 Exp dt: 08/2022 Mfd by: M/s. VOWCARE PRODUCTS Plot No. 77, Zone 4th, I.G.C., SIDCO Lassipora, Dist. Pulwama Jammu & Kashmir - 192305. | Assay of Isopropyl Alcohol, Hydrogen Peroxide, Glycerol | Drugs Control Department Srinagar | RDTL Chandigarh |
4. | PANTOPRAZOLE SODIUM TABLETS IP 40 MG | B. No.: ATPP-2011 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. ANG Lifesciences India Ltd. At Kh No. 139/2, Village | Dissolution | CDSCO Sub-Zone Jammu | RDTL Chandigarh |
Jodhapur, Barotiwala, Dist. Solan, (HP). | |||||
5. | DOCTORS CARE HAND SANITIZER | B. No.: 114D Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Beaubelle'Z Health & beauty Care, NH8, Gujarat. | Assay of Ethyl Alcohol | CDSCO North-Zone | RDTL Chandigarh |
6. | Paracetamol Tablets IP 650 mg PARLIN- 650 TABLETS | B. No.: CD505598 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Unisafe Bioscience Pvt. Ltd., At 3726/27, GIDC, Vatwa, Ahmedabad Gujarat. | Dissolution | CDSCO North-Zone | RDTL Chandigarh |
7. | SULFASALAZINE TABLETS B.P. 500 mg | B. No.: SSZT718 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Unicure India Ltd.C-21, 22 & 23, Sector- 3, Noida-201301 Distt. Gautam Budh Nagar Uttar Pradesh. | Related Substances | CDSCO North-Zone | RDTL Chandigarh |
8. | Fluconazole Tablets IP 150 mg FLUCOL TABLETS | B. No.: BY20002 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Ortin Laboratories Ltd. 275 & 278 (Part), I.D.A. Pashamilaram-502307, Sanga Reddy Dist. Telangana. | Dissolution and Related Substances | CDSCO North-Zone | RDTL Chandigarh |
9. | CIPROFLOXACIN TABLETS I.P. 500 mg | B. No.: DT-281 Mfg dt: 01/2020 Exp dt: 06/2021 Mfd by: M/s. Daffodills Pharmaceuticals Ltd. Jawahar Nagar, Rohta Road, Meerut-250001, Uttar Pradesh. | Uniformity of weight | CDSCO Sub-Zone Jammu | RDTL Chandigarh |
10. | Levofloxacin Tablets IP L-FOX-500 TABLETS | B. No.: SPTG-20639 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. SPECTRUM FORMULATION PVT. | Uniformity of weight | CDSCO North-Zone | RDTL Chandigarh |
LTD. Khasra No.12, Makhanpur, Bhagwanpur, Roorkee, Haridwar- Uttarakhand. | |||||
11. | Tramadol Prolonged Release Tablets (CORLIVIDOL-100 SR TABLETS) | B. No.: PTN-026 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Perk Pharmaceuticals Ltd. A-7, Industrial Estate,Partapur- 250103 Uttar Pradesh. | Dissolution and Related Substances | Drugs Control Department Govt. of N.C.T. of Delhi | RDTL Chandigarh |
12. | Calamine, Diphenhydramine Hydrochloride and Camphor Lotion NANZIDRYL LOTION | B. No.: NYL-002 Mfg dt: 09/2019 Exp dt: 08/2022 Mfd by: M/s. Nanz Med Science Pharma Pvt.Ltd. (A unit of Med Science Canada Inc.) Rampur Ghat, Paonta Sahib- 173205.District-Sirmour Himachal Pradesh. | Assay of Camphor | Drugs Control Department Himachal Pradesh | RDTL Chandigarh |
13. | Rosuvastain Tablets IP 20 mg | B. No.: T9329 Mfg dt: 09/2019 Exp dt: 08/2022 Mfd by: M/s. Bharat Parenterals Ltd., Vill Haripura, Tal Savli, Vadodara-391520, Gujarat. | Dissolution | CDSCO West Zone Mumbai | CDTL Mumbai |
14. | Cystecot-600 (N - Acetylcysteine Tablets) | B. No.: MT191313 Mfg dt: 08/2019 Exp dt: 07/2021 Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector 6 A, IIE, SIDCUL, Haridwar- 249403, Uttarakhand. | Assay | CDSCO West Zone Mumbai | CDTL Mumbai |
15. | Pantoprazole Tablets IP 40 mg | B. No.: T9356 Mfg dt: 09/2019 Exp dt: 08/2022 Mfd by: M/s. Bharat Parenterals Ltd., Vill Haripura, Tal Savli, Vadodara-391520, Gujarat. | Dissolution | CDSCO West Zone Mumbai | CDTL Mumbai |
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