22 drug samples including Sun Pharma Rosuvas fail to qualify CDSCO test
Sun Pharma clarified that two batches of Rosuvas 20 were found spurious
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 22 drug samples as Not of Standard Quality.
The drug samples failed to qualify random drug sample test for the month of May.
Rosuvas 20, Rosuvas F-5 manufactured by Sun Pharma Laboratories, Paracetamol Tablets manufactured by Hindustan Antibiotics, Telmisartan 40 mg and Amlodipine 5 mg Tablets manufactured by Glenmark Pharmaceuticals are popular drug samples that are declared not of standard quality among others.
Responding to the alerts, Sun Pharma Spokesperson told the Medical Dialogues team in an official statement," "We have investigated the matter and found that both the batches (EMX0174 & EMX0685) of Rosuvas 20 (Rosuvastatin Tablets I.P. 20 mg) are spurious medicines. These batches are not manufactured by Sun Pharma. We have requested CDSCO East Zone to take action on this and also made an appeal for removal of these products from the Drug Alert list."
Regarding Rosuvas F-5, the statement said," "We have tested the control sample of Rosuvas F-5 (Rosuvastatin and Fenofibrate Tablets I.P.) [batch no EMU2687]. Our test report shows that the product is complying as per the specifications of dissolution test. We will be submitting our detailed investigation report to DCGI in the coming days."
The list also includes Amlodipine and Aspirin Tablets manufactured by Medipol Pharmaceutical, Diclofenac Sodium Tablets manufactured by Quest Laboratories, Amlodipine Tablets manufactured by Terrace Pharmaceuticals, Primaquine Phosphate manufactured by Jackson Laboratories, Nofloxacin Tablets manufactured by Unicure India.
An analysis and tests were conducted by the CDSCO, Drugs Control Department, on 627 drug samples. Out of this, 625 samples were found of standard quality, while 22 (21 Legal + 01 Survey) 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 to meet the Clarity of Solution & Appearance of Solution, failure of the Diameter, Thickness and Hardness test and others.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, CDTL Chennai, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of May - 2021
| Total number of samples tested | 627 |
| Total number of samples declared as of Standard Quality | 625 |
| Total number of samples declared as Not of Standard Quality | 22 (21 Legal + 01 Survey) |
| 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. | Ramipril Tablets I.P. 2.5 mg | B. No.: RMP-23 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s. C.I. Laboratories, 24-B, B.L. Shah Road, Kolkata - 700053. | Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 2. | Rosuvas 20 (Rosuvastatin Tablets I.P.) | B. No.: EMX0685 Mfg dt: 03/2020 Exp dt: 08/2023 Mfd by: M/s. Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East-Sikkim- 737135. | Dissolution & Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 3. | CARDINOL-50 (Atenolol Tablets I.P. 50 mg) | B. No.: 1091-05 Mfg dt: 02/2020 Exp dt: 01/2023 Mfd by: M/s. Hab Pharmaceuticals & Research Limited, 10, Pharmacity SIDCUL, Selaqui, Dehradun, Uttarakhand. – 248011. | Disintegration | CDSCO, Hyderabad | CDL, Kolkata |
| 4. | Pantoprazole Tablets I.P. 40 mg | B. No.: PP22 Mfg dt: 09/2020 Exp dt: 02/2022 Mfd by: M/s. Suzikem Drugs Pvt. Ltd., Plot No. 205/2A, IDA Cherlapally Phase II, Medchal - | Dissolution | CDSCO, Hyderabad | CDL,
Kolkata |
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| Malkajgiri District, T.S. TELANGANA - 500051. |
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| 5. | Inmecin R (Indomethacin Sustained Release Capsules U.S.P.) | B. No.: PC-111958 Mfg dt: 11/2019 Exp dt: 04/2022 Mfd by: M/s. Primus Pharmaceuticals, Sadhoura Road, Mouza Ogli Khari, Vill Asgarpur Majra, Kala Amb, Distt. Sirmour, Himachal Pradesh -173030. | Dissolution | CDSCO, Hyderabad | CDL, Kolkata |
| 6. | LEDOVANC (Vancomycin Hydrochloride for Intravenous Infusion I.P. 500 mg) | B. No.: VNI20335AC Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Celon Laboratories Pvt. Ltd., Plot No: 2, Alep Industrial Estate, Gajularamaram, Medchal, District, State Telangana, 500090. | Clarity of Solution & Appearance of Solution | CDSCO, Hyderabad | CDL, Kolkata |
| 7. | Nitrazepam Tablets I.P. 5 mg | B. No.: DNIT2001 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Sunrise International Labs Ltd., Plot No. 100, Lane- 5, Sector - II, Phase - II, IDA, Cherlapally, Hyderabad, 500051. | Dissolution | CDSCO, South Zone, Chennai | CDL, Kolkata |
| 8. | Rosuvas® F-5 (Rosuvastatin and Fenofibrate Tablets I.P.) | B. No.: EMU2687 Mfg dt: 09/2019 Exp dt: 02/2022 Mfd by: M/s. Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East Sikkim – 737 135. | Dissolution of Fenofibrate | CDSCO, Ahmedabad | CDL, Kolkata |
| 9. | Paracetamol Tablets IP 500 mg | B. No.: 0999 Mfg dt: 03/2019 Exp dt: 02/2022 Mfd by: M/s. Hindustan Antibiotics Ltd., Pimpri, Pune – 411018 Maharashtra. | Dissolution | CDSCO, Subzone, Bangalore | CDTL Chennai |
| 10. | Clopidogrel & Aspirin Tablets | B. No.: TACB-011 Mfg dt: 07/2019 Exp dt: 06/2021 Mfd by: M/s. Medipol Pharmaceutical India Pvt Ltd., 1199/3, Bhud, Baddi, Dist. Solan, Himachal Pradesh. | Disintegration, free salicylic acid & Assay of Aspirin | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 11. | Piclin (Sodium Picosulfate Tablets 10 mg) | B. No.: NT00061 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Medicamen Biotech Ltd., SP-1192, A & B, Phase IV, Industrial Area, Bhiwadi- 301019, Distt. Alwar, Rajasthan. | Diameter, Thickness and Hardness | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 12. | Sertraline Tablets IP 50 mg | B. No.: GM19030 Mfg dt: 09/2019 Exp dt: 08/2021 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee- 247667 Uttarakhand. | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 13. | Diclofenac Sodium Tablets IP 50 mg | B. No.: T2224 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Quest Laboratories Pvt. Ltd., Plot No. 45, Sector-III, Pithampur, Dist. Dhar- 454775 Madhya Pradesh. | Disintegration | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 14. | Amlodipine Tablets IP (LOPIN-5 TABLETS) | B. No.: STN-200968 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd. 3-B (a), Phase-III, Industrial Area, Sansarpur Terrace, Distt. Kangra, Himachal Pradesh -176501. | Dissolution | CDSCO, North-Zone | RDTL, Chandigarh |
| 15. | Telmisartan 40 mg and Amlodipine 5 mg Tablets IP (TELMA-AM TABLETS) | B. No.: 05201874 Mfg dt: 10/2020 Exp dt: 09/2023 Mfd by: M/s. Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi-Nalagarh Road, Tehsil Baddi, Distt.Solan, Himachal Pradesh -173205. | Dissolution of Amlodipine | Drug Control Department Delhi | RDTL, Chandigarh |
| 16. | DIPHENHYDRAMINE HYDROCHLORIDE, AMMONIUM CHLORIDE, SODIUM CITRATE AND MENTHOL SRYUP | B. No.: LX-5435 Mfg dt: 01/2021 Exp dt: 06/2022 Mfd by: M/s. LEGEN HEALTHCARE, Plot No.20, Sector-5, Parwanoo, Distt. Solan. Himachal Pradesh- 173220. | Assay of Menthol | CDSCO, North-Zone | RDTL, Chandigarh |
| 17. | FEXOFENADINE HYDROCHLORIDE TABLETS IP | B. No.: FXNT-1009 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. WINGS BIOTECH 43 & 44 HPSIDC, Industrial Area, Baddi -173205 Himachal Pradesh. | Dissolution | CDSCO, North-Zone | RDTL, Chandigarh |
| 18. | Primaquine Phosphate I.P. 2.5 mg | B. No.: T-22109 Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Majitha Road, Bye Pass, Amritsar-143001 Punjab. | Dissolution and Assay Test | CDSCO Sub-zone, Guwahati | RDTL, Guwahati |
| 19. | Nofloxacin Tablets I.P. 400 mg | B. No.: NT801 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Unicure India Ltd, C-21,22 & 23, Sector-3, Noida-201301, Distt. Gautam Budh Nagar Uttar Pradesh. | Dissolution | CDSCO Sub-zone, Guwahati | RDTL, Guwahati |
