Drug Alert: CDSCO flags 26 formulations as not of standard quality
New Delhi: In the latest drug safety alert, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO) has flagged 26 medicine batches for failing to qualify for random drug sample tests for the month of June.
These drugs samples which are declared not standard quality include Hindustan Antibiotics' Ibuprofen Tablets, Swiss Garnier Biotech's Cyfolac Forte (Prebiotic & Probiotics Capsules), Oxalis Labs's Salmeterol and Fluticasone Propionate, Shine Pharmaceuticals's Atorvastatin Calcium, Healer's Lab's Albendazole and others.
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1096 samples. Out of this, 1070 samples were found of standard quality while 26 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, and Identification and Assay of Streptococcus faecalis.
The samples collected were tested in five laboratories, namely CDL Kolkata, RDTL Chandigarh, and RDTL Guwahati.
List of Drugs, Medical Devices, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of June – 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. | Rolled Bandage | B. No.: A104 Mfg dt: 10/2019 Exp dt: 09/2022 Mfd by: M/s. Anamika Udyog 127, Multan Nagar, Meerut, Uttar Pradesh (India). | Test for Threads per dm, Length, Width, Weight in gm/m2, Foreign Matter & Fluorescence | CDSCO Sub-Zone Guwahati | CDL Kolkata |
2. | Ibuprofen Tablets I.P. 400 mg | B. No.: IDTY-04 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Hindustan Antibiotics Ltd., At-11, W.E.A. Faridabad 121001, Haryana. | Assay & Dissolution | CDSCO North Zone Ghaziabad | CDL Kolkata |
3. | Cyfolac* Forte (Prebiotic & Probiotics Capsules) | B. No.: 23CCF050 Mfg dt: 06/2021 Exp dt: 11/2022 Mfd by: M/s. Swiss Garnier Biotech Pvt. Ltd., 21, Industrial Area, Mehatpur, Dist. UNA, Himachal Pradesh – 174 315. | Assay | CDSCO South Zone Chennai | CDL Kolkata |
4. | Salmeterol 25 mcg and Fluticasone Propionate 250 mcg Inhalation IP | B. No.: NSB2201C Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Oxalis Labs, Village- Theda, P.O. Lodhimajra, Tehsil- Baddi, Dist. Solan, Himachal Pradesh - 174 101 | Assay | CDSCO, Ahmedabad | CDL Kolkata |
5. | Salmeterol 25 mcg and Fluticasone Propionate 250 mcg Inhalation IP | B. No.: NSB2201B Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Oxalis Labs, Village- Theda, P.O. Lodhimajra, Tehsil- Baddi, Dist. Solan, Himachal Pradesh - 174 101. | Assay | CDSCO, Ahmedabad | CDL Kolkata |
6. | Atorvastatin Calcium Tablets I.P. 40 mg | B. No.: 17T20T07 Mfg dt: 10/2020 Exp dt: 09/2023 Mfd by: M/s. Shine Pharmaceuticals Limited, Plot No. 132, Karjan- Vemardi Road, Juni Jitherdi, Ta. Karjan 391 240, Distt. Vadodara (Gujarat). | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
7. | Albendazole Tablets I.P. | B. No.: ALO-522 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Healer's Lab Unit II, Plot No. 33, H.P.S.I.D.C. Extn. Baddi, Dist. Solan, Himachal Pradesh. | Description | CDSCO East Zone Kolkata | CDL Kolkata |
8. | Amoxycillin and Potassium Clavulanate Tablets IP | B. No.: 20A1430 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Astam Healthcare Pvt. Ltd. Vill. Theda, Teh. Nalagarh, Distt. Solan - 174101, Himachal Pradesh. | Assay of Clavulanic Acid | Drug Control Department Jharkhand | RDTL Guwahati |
9 | Atorvastatin Tablets IP 20 mg. | B. No.: AVAT21001 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Galpha Laboratories Ltd., Village: Thane, Baddi, Himachal Pradesh 173205. | Dissolution | CDSCO Sub Zone Guwahati Assam | RDTL Guwahati |
10 | Ciprofloxacin Tablets IP | B. No.: OCFG5-20-229 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur- 842005, Bihar | Assay & Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
11 | Rabeprazole Gastro Resistant Tablets I.P. 20mg. | B. No.: RRZT-009 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Kurnool Road, Pernamitta Ongole- 523002, Andhra Pradesh. | Description | Drug Control Department Bihar | RDTL Guwahati |
12 | Omeprazole Capsules IP 20mg | B. No.: C-0038 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Zenith Drugs Pvt. Ltd. (A WHO-GMP Certified Company) 72/5, Muradpura (Orangpura) Dhar Road, Near Kalaria, Indore- 453001 Madhya Pradesh, India. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
13 | PARACETAMOL PAEDIATRIC ORAL SUSPENSION IP | B. No.: PFSC081019 Mfg dt: 10/2019 Exp dt: 09/2022 Mfd by: M/s. Strassenburg Pharmaceuticals Ltd. at. 247, D.H. Road, 24Pgs (S), Pin700104, West Bengal. | Assay | Drug Control Department Jharkhand | RDTL Guwahati |
14 | Rabeprazole Gastro Resistant Tablets IP 20mg. | B. No.: RRZT-011 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A.Kumool Road, Pernarmitta Ongole- 523002, Andhra Pradesh. | Description & Assay | Drug Control Department Bihar | RDTL Guwahati |
15 | Omeprazole Capsules IP 20mg | B. No.: 5704620 Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited (A Govt. of India Enterprise) Plot No. 14 II Phase Peenya, Bengaluru560058. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
16 | Paracetamol Tablets IP 650mg. | B. No.: PRT-938 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Alco Formulation (India), 14/5, Mathura Road, Faridabad- 121003, Haryana. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
17 | Rabeprazole Gastro Resistant Tablets IP 20mg. | B. No.: RRZT-021 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Kurnool Rd, Pernamitta Ongole- 523002, Andhra Pradesh. | Description and Assay | Drug Control Department Bihar | RDTL Guwahati |
18 | Salbutamol Tablets IP 4mg. | B. No.: 21112002 Mfg dt: 05/2021 Exp dt: 04/2024 Mfd by: M/s. Mercury Laboratories Limited. Unit No.2, Halol-Baroda Road, Village: Jarod, Tal: Waghodia, DistVadodara-391510, Gujarat | Disintegration | Drug Control Department Assam | RDTL Guwahati |
19 | Omeprazole Capsules IP 20mg. | B. No.: CAG-21014 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. ProLaboratories Private Limited, 140-141, Makkanpur, Bhagwanpur, Roorkee, Dist. Haridwar, Uttarakhand - 247661. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
20 | Rabeprazole Gastro Resistant Tablets I.P. 20mg. | B. No.: RRZT-022 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Kurnool Road, Pernamitta Ongole523002, Andhra Pradesh. | Assay and Description | Drug Control Department Bihar | RDTL Guwahati |
21 | Rabeprazole Gastro Resistant Tablets I.P. 20mg. | B. No.: RRZT-019 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Kurnool Road, Pernamitta Ongole- 523002, Andhra Pradesh. | Description and Assay | Drug Control Department Bihar | RDTL Guwahati |
22 | ISOXSUPRINE HYDROCHLORIDE TABLETS IP | B. No.: ST21-0729 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Salud Care (I) Pvt. Ltd.435, Kashanpur, Roorkee247661, Uttarakhand | Assay | CDSCO North-Zone | RDTL Chandigarh |
23 | MONTELUKAST TABLETS IP 10 MG | B. No.: C-1D0342 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. MOREPEN LABORATORIES LTD. Unit-V, Plot No.12-C, Sector-2, Parwanoo, Distt. Solan, Himachal Pradesh -173220. | Dissolution | CDSCO North-Zone | RDTL Chandigarh |
24 | IRON AND FOLIC ACID TABLETS IP | B. No.: IQTY-312 Mfg dt: 11/2021Exp dt: 10/2023 Mfd by: M/s. NESTOR PHARMACEUTICALS LIMITED 11, Western Extension Area, Faridabad-121001, Haryana, INDIA. | Uniformity of Content (Folic Acid) | CDSCO North-Zone | RDTL Chandigarh |
25 | PRE AND PROBIOTIC CAPSULES | B. No.: SL1CB016 Mfg dt: 11/2021 Exp dt: 04/2023 Mfd by: M/s. Unicure India Ltd. Plot No.46(B), /49/B, Village Raipur, Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand. | Identification and Assay of Streptococcus faecalis | CDSCO North-Zone | RDTL Chandigarh |
26 | Povidone-Iodine Ointment USP 5% w/w (ELDINE OINTMENT) | B. No.: EE11004 Mfg dt: 10/2021 Exp dt: 11/2023 Mfd by: M/s. Elder Labs Limited Vill: Kishanpura, BaddiNalagarh Road, Baddi, Distt.-Solan, Himachal Pradesh - 174101. | Assay | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
