CDSCO Declares 14 Drug Samples Including BP, dyslipidemia Drug As Not Of Standard Quality
New Delhi: The apex drug regulatory body, Central Drugs Standard Organization (CDSCO) has flagged 14 drug samples as "Not of Standard Quality" after they failed to qualify a random drug sample test for the month of November.
These drug samples include popular formulations and brands like Paracetamol Paediatric oral Suspension IP (Parawin –DS Suspension), Paracetamol Tablets I.P. 500 mg, and others. The list also includes samples of Isopropyl Rubbing Alcohol IP Hand Sanitizer (Pure-hand Zenitizer) and Ranitidine Injection IP 25mg/ml (ACILOC Injection).
This came after the analysis and test conducted by the CDSCO on 746 drug samples. Out of this,731 samples were found of Standard quality while 14 of them were declared as Not of Standard Quality (NSQ).
Prominent drugmakers including Cadila Pharma, Synokem Pharma, Goa Antibiotics & Pharmaceuticals Ltd., Goa, (Subsidiary of HLL Lifecare Ltd. A Government of India Enterprise 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 Hydrolysis Products & Assay, Related Substances, Particulate Matter, Assay of Rosuvastatin, and others.
The samples collected were tested in three laboratories namely CDTL Mumbai, RDTL Chandigarh, CDL Kolkata.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of November-2020
Total number of samples tested | 746 |
Total number of samples declared as of Standard Quality | 731 |
Total number of samples declared as Not of Standard Quality | 14 |
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. | Pheniramine Maleate Tablets I.P. | B. No.: TPNM-003 Mfg dt: 12/2018 Exp dt: 11/2020 Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt, Solan, Himachal Pradesh. | Description | CDSCO, East Zone Kolkata | CDL, Kolkata |
2. | Folic Acid Tablets I.P. | B. No.: FA-1901 Mfg dt: 08/2019, Exp dt: 01/2021 Mfd by: M/s. HLL Lifecare limited, 11A-1 & 12/C-1, Sector-E, Industrial Area, Sanwer road, Indore- 452015. | Hydrolysis Products & Assay | CDSCO East Zone Kolkata | CDL, Kolkata |
3. | Levocetrizine Tablets I.P. 5mg | B. No.: 1911 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Deepin Pharmaceuticals Pvt. Ltd., Village: Dharawara, Post: Kalaria-453001, Tehsil: Depalpur (Madhya.Pradesh). | Description | CDSCO Zonal Office Hyderabad | CDL, Kolkata |
4. | Glimas-1,Glimepiride Tablets I.P. 5mg | B. No.: MT191240 Mfg dt: 08/2019 Exp dt: 07/2021 Mfd by: M/s. Mascot Health Series Pvt. Ltd. Plot no. 79, 80, Sec-6A, IIE, Sidcul, Haridwar- 249403, Uttarakhand. | Dissolution | CDSCO Zonal Office Hyderabad | CDL, Kolkata |
5. | Erythromycin Stearate Tablets I.P. 250 mg | B. No.: ENT1911 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Modern Laboratories 45-47, Sector D- 2, Sanwer Road, Indore (MP) 452015. | Description & Dissolution | CDSCO South Zone | CDL, Kolkata |
6. | Ethyl Alcohol, Isopropyl Alcohol (Xerorub Hand Santizer) | B. No.: S-34520 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Seamac Formulations Pvt. Ltd. Plot No. 35, Phase 3rd, Industrial Area, Sansarpur Terrace, Distt. Kangra (Himachal Pradesh) – 176501. | Assay of Ethyl Alcohol, Isopropyl Alcohol | Drugs Control Department Himachal Pradesh | RDTL, Chandigarh |
7. | Telmisartan Tablets I.P. (Telmimac 40 mg Tablets) | B. No.: TC4T-027 Mfg dt: 05/2020 Exp dt: 10/2022 Mfd by: M/s. IOSIS Remedies, Rajpura road, Village- Khera Nihla, Tehsil-Nalagarh, District- Solan Himachal Pradesh- 174101. | Dissolution | Drugs Control Department Himachal Pradesh | RDTL, Chandigarh |
8. | Isopropyl Rubbing Alcohol IP Hand Sanitizer (Pure-hand Zenitizer) | B. No.: SRI-331 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Shri Ramesth Industry Pvt. Ltd. Baddi Barotiwala Road Vill. Juddi Kalan, P.O. & teh Baddi, Distt. Solan 173205 (Himachal Pradesh). | Specific Gravity, Acidity, Limit of non Volatile residue and Assay of Isopropyl Alcohol | Drugs Control Department Himachal Pradesh | RDTL, Chandigarh |
9. | Paracetamol Paediatric oral Suspension IP (Parawin –DS Suspension) | B. No.: PWS-1905 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Apple Formulations Pvt. Ltd. plot No. 208, Kishanpur, Roorkee- 247667 (U.K.). | Related Substances | CDSCO Sub-Zone Jammu | RDTL, Chandigarh |
10. | Ranitidine Injection IP 25mg/ml (ACILOC Injection) | B. No.: RP20139 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Cadila Pharmaceuticals Ltd. 1389, | Particulate Matter | Office of the Dy. Controller Jammu | RDTL, Chandigarh |
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11. | Pregabalin and Methylcobalamin Capsules I.P. (Mobil-P Capsules) | B. No.: C9090149C Mfg dt: 09/2019 Exp dt: 02/2021 Mfd by: M/s. ION Healthcare Pvt. Ltd. Baddi-Barotiwala Road, Baddi, Distt. Solan (H.P.). 173205. | Description | Drugs Control Department Himachal Pradesh | RDTL, Chandigarh |
12. | Hebose-50 (Acarbose Tablets IP 50 mg) | B. No.: MT190814 Mfg dt: 06/2019 Exp dt: 05/2021 Mfd by: M/s. Mascot health Series Pvt. LTD., Plot No. 79, 80, Sec-6A, IIE, Sidcul, Haridwar-249403 Uttarakhand. | Dissolution & Assay | CDSCO West Zone Mumbai | CDTL, Mumbai |
13. | Paracetamol Tablets I.P. 500 mg | B. No.: 251907 Mfg dt: 06/2019 Exp dt: 05/2022 Mfd by: M/s. Goa Antibiotics & Pharmaceuticals Ltd., Goa, (Subsidiary of HLL Lifecare Ltd. A Government of India Enterprise), Near Tuem Industrial Estate, Tuem, Pernem- Goa- 403512. | Dissolution | CDSCO West Zone Mumbai | CDTL, Mumbai |
14. | Rosloy ASP 10/75 (Rosuvastatin & Aspirin Capsules) | B. No.: 19ISGC040 Mfg dt: 09/2019 Exp dt: 02/2021 Mfd by: M/s. Synokem Pharmaceuticals Ltd, Plot No. 56-57, Sector 6 A. I.I.E. (SIDCUL), Ranipur (BHEL), Haridwar- 249403 Uttarakhand. | Assay of Rosuvastatin | CDSCO West Zone Mumbai | CDTL, Mumbai |
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