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.
Also Read:CDSCO Flags 14 Drug Samples Including Aspirin, Rosuvastatin As Not Of Standard Quality
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
For more details click on the link below;
https://.in/pdf_upload/drugalertmarch21-151433.pdf
Also Read:CDSCO Extends Licence Validity For 8 Medical Devices By Additional 6 Months