Drug Alert: CDSCO Flags 19 formulations As Not Of Standard Quality
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 19 medicine batches for failing to qualify for a random drug sample test for the month of March.
These drug samples including Paracetamol Tablets IP 650 mg (Febrex -650), Ondansetron Tablets IP 4 mg, MOXEL-250 (Amoxycillin Capsules IP 250 mg), HAVLOC INSTANT HAND SANITIZER GEL, I Clean Hand Sanitizer (Isopropyl Alcohol), and others are declared as 'Not of Standard Quality'.
Apart from drugs, a few medical devices that are declared not of standard quality are Operation Theatre Gauzee (Gauze Swabs B.P. 80) manufactured by M/s. Anand, Surgicom (Cotton Gauze Pad) (Absorbent Gauze – BP Type 13 Absorbent Cotton Wool IP) manufactured by M/s. The Ramaraju Surgical Cotton Mills Ltd, Combine Dressing Pad B.P. 1980 manufactured by M/s. Modern Healthcare.
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1572 samples. Out of this, 1553 samples were found of standard quality while 19 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 sterility test.
The samples collected were tested in four laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, CDTL Chennai.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of March-2021
Total number of samples tested | 1572 |
Total number of samples declared as of Standard Quality | 1553 |
Total number of samples declared as Not of Standard Quality | 18+1 (Survey) |
Total number of samples declared as Spurious | 0 |
Total number of samples declared as Misbranded | 0 |
Sl. No. | Name of Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
1. | Operation Theatre Gauze (Gauze Swabs B.P. 80) | B. No.: 08 Mfg dt: 08/2020 Exp dt: 07/2023 Mfd by: M/s. Anand Product, 8/162, J – 17, Vanniyampatti Road, Sankarapandiyapuram, Chatrapatti – 626 102, Tamil Nadu. | (Warp) Threads per 10 cm | CDSCO, South Zone Chennai | CDL, Kolkata |
2. | Surgicom (Cotton Gauze Pad) (Absorbent Gauze – BP Type 13 Absorbent Cotton Wool IP) | B. No.: 1023/20 Mfg dt: 03/2020 Exp dt: 02/2023 Mfd by: M/s. The Ramaraju Surgical Cotton Mills Ltd., 2/318-2/321, Sankarankovil Road, Perumalpatti- 627 753, Tamil Nadu. | Threads per stated length for the absorbent cotton gauze (13 light) | CDSCO, South Zone Chennai | CDL, Kolkata |
3. | Combine Dressing Pad B.P. 1980 | B. No.: CD012 Mfg dt: 11/2018 Exp dt: 10/2021 Mfd by: M/s. Modern Healthcare, 782/15, North Street, Chatrapatti -626102 (Via) Rajapalayam, TamilNaudu. | Sterility | CDSCO, South Zone, Chennai | CDL, Kolkata |
4. | CORSAVE-10 (Rosuvastatin Calcium Tablets I.P. 10 mg) | B. No.: 19SGLT011 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Synokem Pharmaceuticals Limited, Plot No. 35-36, Sector-6A, I.I.E. (SIDCUL), Ranipur | Related Substances | CDSCO East Zone | CDL, Kolkata |
(BHEL), Haridwar -249 403, (Uttarakhand). | ||||||
5. | XTER-250 (Terbinafine Tablets I.P. 250 mg) | B. No.: 419-1282 Mfg dt: 09/2019 Exp dt: 08/2021 Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib – 173 025, Himachal Pradesh. | Dissolution | CDSCO East Zone | CDL, Kolkata | |
6. | CHYMOCIP (Trypsin & Chymotrypsin Tablets) | B. No.: G19CHP004 Mfg dt: 06/2019 Exp dt: 05/2022 Mfd by: M/s. Acme Generics LLP, Plot No. 115, HPSIDC, Industrial Area, Davni, P.O. Gurumajra, Tehsil, Nalagarh, Distt. Solan Himachal Pradesh - 174101. | Assay of Trypsin and Chymotrypsin | CDSCO East Zone | CDL, Kolkata | |
7. | Paracetamol Tablets IP 650 mg (Febrex -650) | B. No.: FAP1D07 Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Indoco Remedies Ltd. Mumbai – 400 098. | Dissolution | CDSCO, Visakhap atnam | CDL, Kolkata | |
8. | Ondansetron Tablets IP 4 mg | B. No.: T13104 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Quest Laboratories Pvt. Ltd., Plot No.45, Sector-III, Pithampur, Dist. Dhar- 454775, Madhya Pradesh. | Dissolution | CDSCO, Sub-Zone Indore | CDTL, Mumbai | |
9. | MOXEL-250 (Amoxycillin Capsules IP 250 mg) | B. No.: VBC-19I25 Mfg dt: 09/2019 Exp dt: 08/2022 Mfd by: M/s. Venus Biosciences P. Ltd., 116, Export Promotion Industrial Park, Phase I, Jharmajri, Baddi, Dist: Solan- 173205 Himachal Pradesh. | Assay | CDSCO, West Zone | CDTL, Mumbai | |
10. | ERA CARE HAND SANITIZER | B. No.: LTLAP035 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Nature's Boon Ayurvedic Pharmacy | Identification | Drug Control Department Himachal Pradesh | RDTL, Chandigarh | |
Punjab-141012. | |||||
11. | VEL-SAFE HAND SANITIZER | B. No.: VH-1505 Mfg dt: 11/2020 Exp dt: 11/2022 Mfd by: M/s. VELNEX MEDICARE 344-A, HSIIDC, SAHA (AMBALA) Haryana-133104. | Assay of Glycerol and Hydrogen Peroxide | Drug Control Department Himachal Pradesh | RDTL, Chandigarh |
12. | Ofloxacin and Ornidazole Suspension (INTRACARE R.T.U. SUSPENSION) | B. No.: UIU-22120 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Senate Laboratories, 252, 252, Sisona, Bhagwanpur, Roorkee-247661 Uttarakhand. | Assay of Ofloxacin and Ornidazole | Drug Control Department Jammu & Kashmir | RDTL, Chandigarh |
13. | LEEGRA 120 Tablets (Fexofenndine Hydrochloride Tablets IP 120 mg) | B. No.: OLST – 035 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Oaksun Life Sciences, Plot No. 36, 37, 38, 46 & 47, Chengicherla (V), Medipally (M), Medchal-Malkjigiri (Dist.) T.S.500 092 Telangana. | Dissolution | CDSCO Hyderabad Zone | CDTL, Chennai |
14. | HAVLOC INSTANT HAND SANITIZER GEL | B. No.: BR0402 Mfg dt: 04/2020 Exp dt: 18 months from the date of Mfg Mfd by: M/s. BRP Industry Pvt. Ltd., No. 42/2, First Floor, Govindan Street, Ayyavoo Colony, Aminjikarai, Chennai, TamilNadu – 600029. | Assay of Ethyl Alcohol | CDSCO, South Zone, | CDTL, Chennai |
15. | HAVLOC INSTANT HAND SANITIZER LIQUID | B. No.: BR0401 Mfg dt: 04/2020 Exp dt: 18 months from the date of Mfg Mfd by: M/s. BRP Industry Pvt. Ltd., No. 42/2, First Floor, Govindan Street, Ayyavoo Colony, Aminjikarai, Chennai, TamilNadu – 600029. | Assay of Ethyl Alcohol | CDSCO, South Zone, | CDTL, Chennai |
16. | HAVLOC INSTANT HAND SANITIZER GEL | B. No.: BR0412 Mfg dt: 04/2020 Exp dt: 18 months from the date of Mfg Mfd by: M/s. BRP Industry Pvt. Ltd., No. 42/2, first Floor, Govindan Street, Ayyavoo Colony, Aminjikarai, Chennai, TamilNadu – 600029. | Assay of Ethyl Alcohol | CDSCO, South Zone, | CDTL, Chennai |
17. | i Clean Hand Sanitizer (Isopropyl Alcohol) | B. No.: IC328 Mfg dt: 03/2020 Exp dt: 24 Months. from Date of Mfg Mfd by: Not Stated on the lable. | Assay of Isopropyl Alcohol | CDSCO, South Zone, | CDTL, Chennai |
18. | i Clean Hand Sanitizer (Isopropyl Alcohol) | B. No.: 1220 Mfg dt: 12/2020 Exp dt: 24 Months from Date of Mfg Mfd by: Not Stated on the lable. | Assay of Isopropyl Alcohol | CDSCO, South Zone, | CDTL, Chennai |
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