CDSCO flags 34 drugs for failing quality test; Details

Published On 2020-02-15 06:10 GMT   |   Update On 2020-02-15 06:10 GMT

New Delhi: The apex drug regulator, Central Drugs Standard Control Organization (CDSCO) has flagged 34 batches of medicines for failing quality tests in January, including Sun Pharmaceutical Ltd's Valaciclovir Hydrochloride, Hydrated Ph. Eur; Zydus Healthcare Ltd's Depotex 16 mg (Methylprednisolone Tablets IP) and others.

The CDSCO recently issued an alert, stating that the regulator tested 1177 drug samples in January. Out of this, 1143 samples were declared as of Standard Quality while 34 drug samples failed to clear the test. The drug samples failed the quality test due to lack of assay content, dissolution, uniformity of volume and presence of particulate matter in the injection.

The samples were tested in various laboratories in Kolkata, Chandigarh, Guwahati and Mumbai. The samples were drawn by CDSCO in Mumbai, Kerala, Assam, Indore, Arunanchal Pradesh, Ghaziabad, Ahmedabad, Bangalore, Mizoram and Jammu.

The formulations mentioned in the list include drugs indicated for treating obesity, mental illness, bacterial infection, arthritis and others. The details read;

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.

Absorbent Cotton Wool I.P.,

B. No.: A/1812,

Mfg dt: 12/2018, Exp dt: 11/2021, Mfd by: M/s. Altus

Surgical Pvt. Ltd., 21/D, Mahagujarat Ind. Estate, Sarkhej-Bavla Road, Moraiya, Ahmedabad.

Water Soluble Substances and Sulphated Ash Content

CDSCO,

Ahmedabad

CDL,

Kolkata

2.

Ranitidine Injection I.P.

B. No.: RI-138,

Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Rathi Laboratories (Hindustan) Pvt. Ltd.

Industrial Area, Patna- 800013.

Particulate matter

CDSCO,

North Zone, Ghaziabad

CDL,

Kolkata

3.

REGUNAC – 50

(Diclofenac Gastro- Resistant Tablets I.P. 50 mg)

B. No.: FZ57F801,

Mfg dt: 06/2018, Exp dt: 05/2021, Mfd by: M/s. Zim

Laboratories Limited, B- 21/22, MIDC Area,

Kalmeshwar -441 501, Dist. Nagpur, Maharashtra.

Description

CDSCO,

East Zone, Kolkata

CDL,

Kolkata

4.

Diclofenac Sodium Tablets I.P.

B. No.: DF-R008, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Bengal Chemicals &

Pharmaceuticals Ltd., 115-C, Industrial Estate, Pologround, Indore – 452 015.

Disintegration

CDSCO,

East Zone, Kolkata

CDL,

Kolkata

5.

Fluconazole Tablets

B. No.: TOH-02, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Om

Biomedic Pvt. Ltd., Plot No. 68,69, 82 & 83,

Sector -6A, Sidcul, Haridwar – 249403 (Uttarakhand).

Uniformity of Dispersion

CDSCO,

East Zone, Kolkata

CDL,

Kolkata

6.

THEOIMMUNE

(Pro-Biotic Capsules)

B. No.: GC190060,

Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Theon

Pharmaceuticals Ltd., Vill: Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh -174

101.

Assay of Streptococus faecalis, Clostridium butyricum, Bacillus mesentericus, and Lactic Acid bacillus

CDSCO,

East Zone, Kolkata

CDL,

Kolkata

7.

Pantoprazole Gastro- resistant Tablets I.P.

B. No.: T-6988,

Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Kwality

Pharmaceuticals Ltd.,

Nagkalan, Majitha Road, Amritsar Punjab.

Description

CDSCO,

Sub-Zone, Guwahati

CDL,

Kolkata

8.

Amloclav 625 (Amoxycillin & Potassium Clavulanate Tablets I.P.)

B. No.: BT136026,

Mfg dt: 04/2018, Exp dt: 03/2020, Mfd by: M/s. Shashi

Pharma, S.N. 77/P, At Vill. Dhanot, Chhatral - 382729, Ta. Kalol. Dist. Gandhinagar (Guj.)

Water, Dissolution and Assay

CDSCO,

Bangalore

CDL,

Kolkata

9.

Gabapentin Tablets IP 300 Mg

B. No.: STN-181861,

Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Terrace Pharmaceuticals (P)

Description and Related substances

Drug Control Office District-

Bilaspur

RDTL,

Chandigarh


Ltd. 3-B (a), Phase-III, Industrial Area Sansarpur Terrace,

Distt. Kangra ( H.P)-176501

(H.P.)

10.

(Amoxycillin Dispersible Tablets IP 250 mg )

B. No.: LBT-1578,

Mfg dt: 03/2019, Exp dt: 09/2020, Mfd by: M/s. Legen

Healthcare, Plot No.20, Sector -5, Parwanoo,

Distt.Solan.(H.P.) 173

220

Uniformity of Dispersion

Drug Control Office District - Mandi (H.P.)

RDTL,

Chandigarh

11.

Albendazole Tablets IP 400MG

B. No.: 8600219,

Mfg dt: 01/2019, Exp dt: 12/2021,

Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot no.14, II Phase, Peenya, Bangalore- 560058.

Dissolution

Drug Control Office Ghaziabad (UP)

RDTL,

Chandigarh

12.

Albendazole Tablets IP 400 MG

B. No.: ABTW-05, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Nestor

Pharmaceuticals Limited 11, Western Extension Area, Faridabad-121001 (Haryana).

Dissolution

Drug Control Office Ghaziabad (UP)

RDTL,

Chandigarh

13.

Albendazole Tablets IP 400 MG

B. No.: 8600119,

Mfg dt: 01/2019, Exp dt: 12/2021,

Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot No.14, II Phase, Peenya, Bangalore- 560058.

Dissolution

CDSCO,

Sub-Zone, Jammu

RDTL,

Chandigarh

14.

Dom-H (Domperidone Suspension)

B. No.: 1801,

Mfg dt: 03/2018, Exp dt: 02/2020, Mfd by: M/s. Harsh Healthcare 100-101, Industrial Area Rau- 453331 Madhya Pradesh.

Assay

Drugs Control Department, Arunachal Pradesh

RDTL,

Guwahati

15.

Albendazole Tablets I.P.

B. No.: 8491015,

Dissolution

Drugs

RDTL,

400mg

Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Bengal Chemicals &

Pharmaceuticlas Ltd. 164, Maniktala Main Road, Kolkata-700054.

Control Department, Arunachal Pradesh

Guwahati

16.

Albendazole Tablets I.P. 400mg

B. No.: 9622,

Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Orissa

Drugs & Chemicals Ltd. 1, Mancheswar Industrial Estate,

Bhubaneswar Odisha.

Dissolution

Drugs Control Department, Arunachal Pradesh

RDTL,

Guwahati

17.

Frusemide Tablets I.P. 40 mg. (Rasix)

B. No.: 7127,

Mfg dt: 06/2017, Exp dt: 05/2020, Mfd by: M/s.Ramson Remedies 186-187,

Insustrial Focal Point, Amritsar, A.O. 2G Floor, Baktawar, Malabar Hill,

Mumbai-6.

Dissolution

Drugs Control Department, Arunachal Pradesh

RDTL,

Guwahati

18.

Nimesulide Tablets 100mg

B. No.: NP17016,

Mfg dt: 09/2017, Exp dt: 08/2020,

Mfd by: M/s. Navketan Pharma Pvt. Ltd., F-106, MIDC, Waluj, Aurangabad-431136 Maharashtra.

Dissolution

Drugs Control Department, Arunachal Pradesh

RDTL,

Guwahati

19.

Telmisartan Tablets I.P. 40mg

B. No.: TMA1001, Mfg dt: 02/2019, Exp dt: 01/2021,

Mfd by: M/s. Sai Mirra Innopharm Pvt. Ltd. 288 & 299, SIDCUL Estate, Ambattur, Chennai- 600098 Tamilnadu.

Dissolution

Drugs Control Department, Arunachal Pradesh

RDTL,

Guwahati

20.

Ferrous Sulphate and Folic Acid Tablets I.P.

B. No.: IFTJ18028, Mfg dt: 09/2018, Exp dt: 08/2020, Mfd by: M/s. Vivek Pharmachem (India) Ltd. EPIP, Bari Brahmana, Jammu- 181133.

Disintegration

Drugs Control Department, Assam

RDTL,

Guwahati

21.

Preginate (Doxylamine

B. No.: ZD18715,

Adulterated

Drugs

RDTL,

Succinate and Pyridoxine Hydrochloride Tablets)

Mfg dt: 07/2018, Exp dt: 06/2020,

Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd. B-3, Dev Bhoomi Industrial Estate Puhana, Iqbalpur Road,

Roorkee- 247667Uttarakhand.

Control Department, Nagaland

Guwahati

22.

Radin Syrup (Ranitidine Oral Solution I.P.)

B. No.: S18J025,

Mfg dt: 10/2018, Exp dt: 09/2020,

Mfd by: M/s. Shri Hari Pharmaceuticals Plot No. 767/1, Vadsar- Motibhoyan Road, Vill- Vadsar- 382721,

Taluka, Kalol, Dist- Gandhinagar, Gujarat.

Assay

Drugs Control Department, Mizoram

RDTL,

Guwahati

23.

Paracetamol Tablets

I.P. 650 (Cule 650)

B. No.: TPT-190266,

Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Talwar

Pharma Jhabrera Road, Kurdi, Manglour-

247656, Roorkee, Dist- Haridwar Uttarakhand.

Dissolution

Drugs Control Department, Assam

RDTL,

Guwahati

24.

Dressipad (1 Surgical Dressing 10cm. X 10cm.)

B. No.: KSCD-29, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s.K.S.

Surgical Pvt. Ltd. Vill- Begmabad, Budhana, Unchi Sadak, Modi

Nagar, U.P.

Sterility test

Drugs Control Department, Kerala

RDTL,

Guwahati

25.

Dressipad (1 Surgical Dressing 10cm. X 10cm.)

B. No.: KSCD-12, Mfg dt: 11/2017, Exp dt: 10/2020, Mfd by: M/s. K.S.

Surgical Pvt. Ltd. Vill- Begmabad, Budhana, Unchi Sadak, Modi Nagar, U.P.

Sterility test

Drugs Control Department, Kerala

RDTL,

Guwahati

26.

Vitamin B-complex Tablet (Prophylactic) NFI (III)

B. No.: T8605,

Mfg dt: 12/2018, Exp dt: 05/2020, Mfd by: M/s. Zest

Pharma, Plot No.275, Sector F, Sanwer Road,

Assay of Vitamin B1

Drugs Inspector, CDSCO,

Sub Zone, Indore

CDTL,

Mumbai



Indore (M.P.) 452015.

27.

Depotex 16 mg (Methylprednisolone Tablets IP)

B. No.: AFV1010, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Zydus Healthcare Ltd., Manufatured at : Vill.

Saini Majra, Nalagarh- Ropar Road, Nalagarh, Distt.: Solan-HP.

Dissolution

CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

28.

Olmemark-40 (Olmesartan Medoxomil Tablet IP 40 mg)

B. No.: TPT8689, Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Trugen

Pharmaceuticals Pvt. Ltd., Village-Tejjupur, Near Chodiala Rly.

Station Roorkey, Dist- Haridwar (UK)- 247661.

Dissolution

CDSCO,

Sub Zone, Indore.

CDTL,

Mumbai

29.

Decodil Expectorant

B. No.: LF19008,

Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Ortin

Laboratories Ltd., 275 & 278 (part) I.D.A.

Pashamilaram 502307, Sanga Reddy Dist.

Telangana.

pH

CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

30.

Ampicillin Capsules I.P. 250 mg

B. No.: CB181217,

Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Micron

Pharmaceuticals, 2117, A-2, Phase III, G.I.D.C,

Vapi-396195, Gujarat.

Assay

CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

31.

Valaciclovir Hydrochloride, Hydrated Ph. Eur.

B. No.: AA41927,

Mfg dt: 05/2019, Exp dt: 04/2022, Mfd by: M/s. Sun Pharmaceutical Industries Limited, Industrial Area No.3,

Dewas 455001 Madhya Pradesh.

Related Substances

CDSCO,

Sub Zone, Indore.

CDTL,

Mumbai

32.

Valaciclovir Hydrochloride, Hydrated Ph. Eur.

B. No.: AA41926,

Mfg dt: 04/2019, Exp dt: 03/2022, Mfd by: M/s. Sun Pharmaceutical

Related Substances

CDSCO,

Sub Zone, Indore.

CDTL,

Mumbai


Industries Limited, Industrial Area No.3, Dewas 455001 M.P.

33.

Oral Rehydration Salts IP

B. No.: GP19127,

Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Globela

Pharma Pvt. Ltd., 357,

358 GIDC, Sachin, Surat-394230, Gujarat.

Assay for Potassium

CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

34.

Oral Rehydration Salts IP

B. No.: GP19128,

Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Globela

Pharma Pvt. Ltd., 357, 358 GIDC, Sachin, Surat-394230, Gujarat.

Assay for Potassium

CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

Also Read: Drug Alert: CDSCO Declares 49 Drug Samples As Not Of Standard Quality; Details

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