New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 41 medicine batches for failing to qualify for a random drug sample test for the month of May.
These drugs samples which are declared not of standard quality include Dr. Reddys Laboratories’ Omeprazole (Delayed- Release) and Domperidone (SustainedRelease) Capsules, Cadila Pharmaceuticals’ CALNIF RETARD (Nifedipine Prolonged Release Tablets I.P. 20 mg), Troikaa Pharmaceuticals’ DYNAPAR AQ (Diclofenac Sodium Injection I.P. 75 mg/ml) and others.
The list further includes Synokem pharmaceuticals’ Rosuvastatin Calcium Tablets IP 10mg, Symbiosis Pharmaceuticals’ Methylcobalamin, Alpha Lipoic Acid, Pyridoxine HCI and Folic Acid Capsules (VEMIFOL PLUS CAPSULES).
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1233 samples. Out of this, 1192 samples were found of standard quality while 41 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 disintegration test, failure of moisture content test failure of the sterility test.
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 – 2022.
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.
Zinc Sulphate Dispersible Tablets I.P.
B. No.: ZST21050 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24
Parganas , Kolkata –
700125, West Bengal.
Uniformity of Dispersion &
Disintegration
CDSCO
East Zone Kolkata
CDL
Kolkata
2.
Zinc Sulphate Dispersible Tablets I.P.
B. No.: ZST21048 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24
Parganas , Kolkata –
700125, West Bengal.
Uniformity of Dispersion &
Disintegration
CDSCO
East Zone Kolkata
CDL
Kolkata
3.
Metfovan -500 SR Tablets (Metformin Hydrochloride (SR) Tablets)
B. No.: APT/04215
Mfg dt: 03/2021 Exp dt: 02/2023 Mfd by: M/s. Amkon
Pharmaceuticals, Plot No. 242, Ind. Area, Phase-IX, S.A.S.
Nagar, Mohali – 160 062, Punjab.
Dissolution &
Assay
CDSCO
East Zone Kolkata
CDL
Kolkata
4.
Acebrophylline Capsules 100 mg
B. No.: PF8AA04 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Pure &
Cure Healthcare Pvt. Ltd., Plot No. 26A, 27- 30, Sector-8A, I.I.E,
SIDCUL, Ranipur,
Haridwar-249403, Uttarakhand.
Water Content
CDSCO
East Zone Kolkata
CDL
Kolkata
5.
Geragen – 2 ml (Gentamicin Injection IP)
B. No.: V2111674
Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. B.M.
Pharmaceuticals, 47- 48, Ind. Area, Phase II, Chandigarh –
160002.
Description &
Particulate Matter
CDSCO
East Zone Kolkata
CDL
Kolkata
6.
DYNAPAR AQ
(Diclofenac Sodium Injection I.P. 75 mg/ml)
B. No.: D23S363
Mfg dt: 11/2021 Exp dt: 10/2023
Mfd by: M/s. Troikaa Pharmaceuticals Ltd., At: Survey No: 46/1-4, Kadaiya Village, Nani
Daman-396210.
Sterility
CDSCO
East Zone Kolkata
CDL
Kolkata
7.
(Afedol- SP) Aceclofenac, Paracetamol & Serratiopeptidase Tablets
B. No.: PBT-238 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Bonn Schtering Bio
Sciences, Plot No. 64 & 65, 1st Floor, Electronic Park, Thirubuvanai, Mannadipet Commune,
Puducherry 605 107.
Identification & Assay of Serratiopeptidase
CDSCO,
South Zone Chennai
CDL
Kolkata
8.
Agrophylline – 2ml (Etophylline & Theophyline for Injection)
B. No.: AGP-20 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Agron Remedies Pvt. Ltd.
Sarverkhera ,
Description &
Particulate Matter
CDSCO
South Zone Chennai
CDL
Kolkata
Moradabad Road,
Kashipur -244713, Uttarakhand.
9.
SPYCLAV 625 LB
(Amoxycillin and Potassium Clavulanate with Lactic Acid Bacillus Tablets)
B. No.: TACLB1011A Mfg dt: 03/2021
Exp dt: 08/2022 Mfd by: M/s.
Associated Biotech, Kishanpura, Guru Majra Road, Baddi, Teh. Nalagarh, Distt. Solan, Himachal
Pradesh – 174101.
Assay
CDSCO
South Zone Chennai
CDL
Kolkata
10.
Metsodoz – 8 Tablets (Methylprednisolone Tablets IP 8 mg)
B. No.: GFM622101
Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s.
Progressive Lifesciences Pvt. Ltd., Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar -247
665, Uttarakhand.
Identification &
Assay
CDSCO
South Zone Chennai
CDL
Kolkata
11.
CALNIF RETARD
B. No.: JKEG21006
Dissolution
CDSCO
CDL
(Nifedipine
Mfg dt: 07/2021
Ahmedabad
Kolkata
Prolonged Release
Exp dt: 06/2024
Tablets I.P. 20 mg)
Mfd by: M/s. Cadila
Pharmaceuticals
Limited, Industrial
Growth Centre,
SIDCO, Samba-184
121, Jammu &
Kashmir.
12
Saccharomyces
B. No.: SBC/C/002
Moisture Content
CDSCO
CDL
boulardii Capsules
Mfg dt: 09/2021
Hyderabad
Kolkata
(250 mg)
Exp dt: 08/2023
Mfd by: M/s. Unique
Biotech Limited, Plot
No.-2, Phase- II, MN
Park, Kolthur Village,
Shameerpet Mandal,
Medchal Malkajgiri
District, Hyderabad –
560 078, Telangana,
India.
13.
Enoxaparin Sodium Injection I.P.
60mg/0.6ml
B. No.: SENXB2118 Mfg dt: 12/2021 Exp dt: 11/2023
Mfd by: M/s. Samarth Lifescience Pvt. Ltd., Unit – II, Plot No. 2, Industrial Area, Lodhimajra, Baddi, Himachal Pradesh –
173205.
Sterility
CDSCO
Jammu
CDL
Kolkata
14.
Pantoprazole Gastro-Resistant Tablets IP
B. No.: TF1037A Mfg dt: 06/2021 Exp dt: 11/2022 Mfd by: M/s. Navkar Lifesciences, Plot
No.76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan ,
Himachal Pradesh.
Dissolution
CDSCO
Sub Zone Bangalore
CDTL
Chennai
15.
Ciprofloxacin Hydrochloride Tablets IP 500 mg
B. No.: 0702620
Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s.
Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase, Peenya,
Bangalore -560058.
Dissolution
CDSCO
Sub Zone Bangalore
CDTL
Chennai
16.
Telmisartan Tablets IP
B. No.: CT-10408
Mfg dt: 08/2020 Exp dt: 07/2023
Mfd by: M/s Cosmas Pharmacls Ltd., Buranwala Road, Village: Kotta, P.O.: Baratiwala, Solan, Himachal Pradesh –
174103.
Dissolution
Drug Control Department Jharkhand
RDTL
Guwahati
17.
Amoxycillin and Potassium Clavulanate
Tablets IP
B. No.: PT-0681A Mfg dt: 01/2021 Exp dt: 12/2022
Mfd by: M/s Saitech
Dissolution of Amoxycillin and Clavulanic Acid
Drug Control Department Jharkhand
RDTL
Guwahati
Medicare Pvt. Ltd., Village Kheri, Trilokpur Road, Kala- Amb, Dist. Sirmour, Himachal Pradesh –
173030.
18.
Omeprazole (Delayed- Release) and Domperidone (Sustained- Release) Capsules
B. No.: E2100419
Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s Dr.
Reddys Laboratories Ltd. Village Mauja Thana, Baddi- 173205, Dist. Solan,
Himachal Pradesh.
Assay of Omeprazole and Domperidone
Drug Control Department Assam
RDTL
Guwahati
19.
Misoprostol Tablets IP 200mcg
B. No.: UHT21298 Mfg dt: 09/2021 Exp dt: 08/2023
Mfd by: M/s Unimarck Healthcare Ltd. WHO- GMP Certified Company Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar-
249403, Uttarakhand.
Assay
Drug Control Department Assam
RDTL
Guwahati
20.
ATENOLOL Tablets IP 50mg
B. No.: ATTJ21001 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s Vivek
Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu-
181133.
Disintegration and Assay
Drug Control Department Assam
RDTL
Guwahati
21.
Telmisartan Tablets IP 40mg
B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s Nestor Pharmaceuticals
Limited, 11, Western Extension Area, Faridabad-121001,
Haryana, INDIA.
Dissolution
Drug Control Department Jharkhand
RDTL
Guwahati
22.
Telmisartan Tablets
IP 80mg
B. No.: MT212218
Mfg dt: 06/2021
Dissolution
Drug Control
Department
RDTL
Guwahati
Exp dt: 05/2023 Mfd by: M/s Mascot Health Series Pvt.
Ltd., Plot No. 79, 80, Sec. -6A, IIE, Sidcul, Haridwar – 249403,
Uttarakhand.
Assam
23.
Dexamethasone Tablets I.P. 0.5mg
B. No.: DXMT-1003 Mfg dt: 05/2020 Exp dt: 04/2023 Mfd by: M/s Wings Biotech, 43 & 44, HPSIDC, Industrial
Area, Baddi – 173205, Himachal Pradesh.
Assay
Drug Control Department Jharkhand
RDTL
Guwahati
24.
METRONIDAZOLE TABLETS I.P.
B. No.: MT-21D20 Mfg dt: 04/2021 Exp dt: 03/2023
Mfd by: M/s Martin & Brown Bio-sciences K. No. 918/419,
Malkumajra, Nalagarh Road, Baddi, Distt.
Solan, Himachal
Pradesh.
Dissolution
Drug Control Department Jharkhand
RDTL
Guwahati
25.
Metronidazole Tablets IP
B. No.: DMRT-02 Mfg dt: 04/2021 Exp dt: 03/2024 Mfd by: M/s SGS
PHARMACEUTICALS
(P) LTD, E-13/1, Sector – 17, Kavi Nagar Indl. Area, Ghaziabad-201002,
Uttar Pradesh.
Dissolution
Drug Control Department Jharkhand
RDTL
Guwahati
26.
Enteric Coated Rabeprazole Sodium & Domperidone SR Capsules
B. No.: JC-20726
Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s Jineka
Healthcare Pvt. Ltd., 15, Sector 6-B, IIE,
Ranipur, Haridwar-
Assay of Rabeprazole Sodium
Drug Control Department Mizoram
RDTL
Guwahati
249403, Uttarakhand.
27.
Rosuvastatin Calcium Tablets IP 10mg
B. No.: 21S1GTA035 Mfg dt: 01/2021
Exp dt: 12/2022 Mfd by: M/s SYNOKEM
PHARMACEUTICALS LTD. Plot No.: 35-36,
Sector-6A, I.I.E.(SIDCUL),
Ranipur (BHEL),
Haridwar-249403, Uttarakhand.
Dissolution
Drug Control Department Assam
RDTL
Guwahati
28.
Omeprazole Gastro-resistant Capsules I.P.
B. No.: 520-170
Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s ZEE
LABORATORIES, 47,
Industrial Area, Paonta Sahib – 173025, Himachal
Pradesh.
Dissolution
Drug Control Department Assam
RDTL
Guwahati
29.
Doxofylline Tablets IP 400mg
B. No.: SPTG-20390 Mfg dt: 08/2020
Exp dt: 07/2022 Mfd by: M/s SPECTRUM
FORMULATION PVT.
LTD, Khasra No. 12, Makhanpur, Bhagwanpur, Roorkee, Haridwar –
Uttarakhand.
Dissolution
CDSCO
Sub-Zone Guwahati
RDTL
Guwahati
30.
Dexamethasone Tablets I.P. 0.5mg
B. No.: DPO2004 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s Danish Health Care (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain – 456010, Madhya Pradesh,
INDIA.
Assay
Drug Control Department Jharkhand
RDTL
Guwahati
31.
BUPRENORPHINE INJECTION I.P.
B. No.: LM 18870
Mfg dt: 012/2020 Exp dt: 011/2026 Mfd by: M/s Cooper pharma Ltd.
C-3, Industrial Area,
Selaqui, Dehradun- 248197, Uttarakhand.
Assay
Drug Control Department Bihar
RDTL
Guwahati
32.
BUPRENORPHINE INJECTION I.P.
B. No.: LM 18730
Mfg dt: 08/2018 Exp dt: 07/2024 Mfd by: M/s Cooper pharma Ltd., C-3, Industrial Area, Selaqui, Dehradun-
248197, Uttarakhand.
Assay
Drug Control Department Bihar
RDTL
Guwahati
33.
ODIMONT-AL
(Montelukast, Levocetirizine HCl & Ambroxol HCl (SR) Tablets)
B. No.: GZOA21003 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s GKM New Pharma. Plot
No.5, 6, 7 & 8, Pipdic Electronic Park, Thirubuvanai,
Puducherry- 605 107.
Dissolution
CDSCO
Sub-Zone Goa
CDTL
Mumbai
34.
Fluconazole Capsules I.P.
150 mg
B. No.: 4700821
Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s
Karnataka Antibiotics & Pharmaceutical Pvt. Ltd., Plot No.14, II Phase, Peenya,
Bengaluru – 560 058.
Uniformity of weight
CDSCO
Zonal Office Ahmedabad
CDTL
Mumbai
35.
Methylcobalamin, Alpha Lipoic Acid, Pyridoxine HCI and Folic Acid Capsules (VEMIFOL PLUS CAPSULES)
B. No.: SOC-1911A Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s Symbiosis
Pharmaceuticals Pvt. Ltd. (Plant-3) Plant at: Trilokpur Road, Kala Amb-173030,
Himachal Pradesh.
Assay of Alpha Lipoic Acid
CDSCO
Sub-Zone Baddi
RDTL
Chandigarh
Marketed by: VIVEX PHARMACEUTICALS PVT. LTD. SCO 131,
Sector-110, TDI City,
Mohali, SAS Nagar- 140307.
36.
Iron (III) Hydroxide Polymaltose Complex with Folic Acid Syrup (POLY- FORTE SYRUP)
B. No.: DLK-071C Mfg dt: 11/2021 Exp dt: 04/2023 Mfd by: M/s Digital Vision 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour, Himachal Pradesh -173030. Marketed by: ORISON
PHARMACEUTICALS
51, Industrial Estate, Ambala Cantt-
133006.
Assay of Folic Acid
CDSCO
Sub-Zone Baddi
RDTL
Chandigarh
37.
Diclofenac Diethylamine, Methyl Salicylate, Linseed Oil and Menthol Gel (ARMNAC GEL)
B. No.: 017
Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s GMH
Laboratories Plot No. 13, Industrial Township, Bhatoli Kalan, Baddi, Distt.
Solan, Himachal
Pradesh -173205.
Assay of Linseed Oil
CDSCO
Sub-Zone Baddi
RDTL
Chandigarh
38.
Doxofylline Tablets IP 400 mg (DOXOSIGN TABLETS)
B. No.: 994-09
Mfg dt: 06/2021 Exp dt: 05/2024 Mfd by: M/s HAB
PHARMACEUTICALS & RESEARCH LIMITED 10,
Pharmacity, SIDCUL, Selaqui, Dehradun –
248011, Uttrakhand.
Dissolution
CDSCO
North-Zone
RDTL
Chandigarh
39.
Ondansetron Injection IP (ONET
INJECTION)
B. No.: EA11107
Mfg dt: 11/2021 Exp dt: 10/2023
Sterility
CDSCO
Sub-Zone Baddi
RDTL
Chandigarh
Mfd by: M/s Elder Labs Limited Vill: Kishanpura, Baddi- Nalagarh Road, Baddi, Distt.-Solan, Himachal Pradesh –
174101.
40.
Cloxacillin Sodium Capsules IP 500 mg (CLOXRID-500 CAPSULES)
B. No.: CLO-2003 Mfg dt: 07/2020 Exp dt: 06/2022
Mfd by: M/s RIDLEY LIFE SCIENCE PVT . LTD. D-1651, DSIDC
Indl. Complex,
Narela, Delhi-110040.
Identification
CDSCO
North-Zone
RDTL
Chandigarh
41.
Amlodipine Tablets IP (AMLOTIS-10 TABLETS)
B. No.: 2113452T001
Mfg dt: 06/2021 Exp dt: 05/2023
Mfd by: M/s Scott-Edil Pharmacia Ltd. Unit- II, Plot No. 21-22, E.P.I.P., Phase-1,
Jharmajri, Baddi, Distt. Solan-173205, Himachal Pradesh,
INDIA.
Assay
CDSCO
Sub-Zone Baddi
RDTL
Chandigarh