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Drug Alert: CDSCO declares 26 drug samples as sub-standard in quality in random sampling; Details


Drug Alert: CDSCO declares 26 drug samples as sub-standard in quality in random sampling; Details

New Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared more than a dozen drugs as sub-standard in quality, counterfeited and misbranded/ adulterated. These include Aspirin Gastroresistant tablets IP, Ofloxacin Tablets I.P. 400 mg,  Ciprofloxacin Tablets IP (P-CIP 500 TABLETS), Glimepiride Tablets IP 3mg and others.

The move comes following analysis and test conducted by the CDSCO on a total of 843 drug samples as a part of the random sampling. The test found that 26 out of the total drug samples did not meet quality and therefore they were affirmed as not of standard quality (NSQ), spurious and misbranded under Form-13, Form-34 and Form- MD-32.

The drug samples were tested at CDSCO, South Zone, Chennai; Drug Control Department at Meghalaya, Mizoram and Assam. CDSCO, Sub Zone/Port Office, Goa; CDSCO, North Zone, Ghaziabad; Office of Drugs Inspector, Sirmour (H.P) and Drugs Control Department Delhi and Jhajjar also named from where the drug samples were drawn.

The set of these 26 drugs in various dosage forms failed the quality test over Particulate Contamination, pH, Test for Salicylic Acid and assay of Aspirin, Test for Dissolution, Identification & Assay,  Identification, Uniformity of weight & Assay, Description & Particulate Matter.

The medications included in the list are indicative of preventing blood clots forming following a heart attack or stroke; drug to treat a variety of bacterial infections; medication for the treatment of severe bacterial infections; drug to control high blood sugar in people with type 2 diabetes and others.

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of April 2019 read;

S.

N.

Name of Drugs/Medical

device/cosmetics

Batch No./Date of Manufacture/Date of

Expiry/Manufactured By.

Reason for failure Drawn By From
1. TELMISARTAN TABLETS IP 40 MG (TELMIRAL 40) B. No.:78TML18002,

Mfg dt: 11/2018, Exp dt: 06/2020,

Mfd by: M/s. Crescent Therapeutics Limited Khasra No. 587/588, Beside Jharmajri, Village: Kunjhal, Baddi, Tehsil: Nalagarh, Dist. Solan(H.P)

173205.

Test for Dissolution CDSCO,

South Zone, Chennai.

CDTL,

Chennai

2. Compound Sodium Lactate Injections I.P. B. No.: R-1/18/145,

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

Mfd by: M/s. Sanctus Drugs & Pharmaceutical Pvt. Ltd, Plot No. 251, Sector-1, Pithampur, Dist. Dhar (M.P.).

BET Drug Control Department, Meghalaya RDTL,

Guwahati

3. Compound Sodium Lactate Injections I.P. B. No.: R-1/18/140,

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

Mfd by: M/s. Sanctus Drugs & Pharmaceutical Pvt. Ltd, Plot No. 251, Sector-1,

Pithampur, Dist. Dhar, Madhya Pardesh.

BET Drug Control Department, Meghalaya RDTL,

Guwahati

4. Amoxycillin And Potassium Clavulanate Tablets

I.P. (Clavage-1000)

B. No.: SBPT- 4321, Mfg dt: 02/2018, Exp dt: 07/2019, Mfd by: M/s. Saitech

Medicare Pvt. Ltd. Trilokpur Road, Kala Amb (H.P.)- 173030.

Test for Dissolution Drug Control Department, Mizoram RDTL,

Guwahati

5. Pantoprazole For Injection (Panzel) B. No.: 318-7,

Mfg dt: 01/2018, Exp dt: 06/2019, Mfd by: M/s. Zee

Laboratories, 47, Industrial Areas, Paonta Sahib- 173025.

Particulate Contamination Drug Control Department, Assam RDTL,

Guwahati

6. Finzest (Terbinafine Hydrochloride Cream 1% w/w) B. No.: FZ0417,

Mfg dt: 11/2017, Exp dt: 10/2019,

Mfd by: M/s. Medizest Pharmaceuticals Pvt. Ltd., Plot No. L-40, Verna

Industrial Estate, Verna, Goa-403722.

pH CDSCO, Sub

Zone/Port Office, Goa

CDTL,

Mumbai

7. LEVOCETIRIZINE HYDROCHLORIDE TABLETS IP 5 MG B. No.: SHT8957, Mfg dt: 09/2018, Exp dt: 08/2021,

Mfd by: M/s. SYNCOM Health care Limited,D- 42,IIE SIDCUL,

Selaqui, (Dehradun) 248197 Uttarakhand.

Test of Dissolution CDSCO,

North Zone, Ghaziabad

RDTL,

Chandigarh

8. ASPIRIN GASTRO- RESISTANT TABLETS IP B. No.: HAGT18004, Mfg dt: 09/2018, Exp dt: 08/2020,

Mfd by: M/s. RAVIAN LIFE SCIENCE PVT.LTD

Plot No 34 Sector -8 A IIE SIDCUL

Haridwar-249403, Uttarakhand India.

Test for Salicylic Acid and assay of Aspirin CDSCO,

North Zone, Ghaziabad

RDTL,

Chandigarh

9. Cefixime Tablets IP (MICRA-200

Tablets)

B. No.: R-132,

Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Escape

Lifesciences Pvt. Ltd. Chudiala Station Road, Village Khelpur Bhagwanpur, Roorkee, UK.

Identification & Assay Office of Drugs Inspector, Sirmour (H.P) RDTL,

Chandigarh

10. Ciprofloxacin Tablets IP (P-CIP 500 TABLETS ) B. No.: R-124,

Mfg dt: 02/2018, Exp dt: 01/2020,

Mfd by: M/s. Pansun, Pharmaceuticals,Plot No. 183, Sector 6A, IIE,Sidhgual, Haridwar

(U.K).

Identification, Uniformity of weight & Assay Office of Drugs Inspector, Sirmour (H.P) RDTL,

Chandigarh

11. Amoxycillin and Potassium Clavulanate Tablets IP 625 mg

(ANAXIM-CV 625 TABLETS)

B. No.: R-20219,

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

Pharmaceuticals Plot No.183, Sector 6A, IIE, Sidhgual Haridwar (U.K).

Identification & Assay Office of Drugs Inspector, Sirmour (H.P) RDTL,

Chandigarh

12. Cefixime Tablets IP (GECEFF-200

Tablets)

B. No.: R-129,

Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. GEFEX

PHARMA Pvt. Ltd. IGC,

Phase-I, Samba- 184121(J&K).

Identification & Assay Office of Drugs Inspector, Sirmour (H.P) RDTL,

Chandigarh

13. Neomycin Sulphate, Polymixin-B Sulphate and Bacitracin Zinc Powder B. No.: GLEP-181020,

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

Mfd by: M/s. Grampus Laboratories Vill. Johron,

Industrial Area,Kala Amb, Distt. Sirmour (H.P).

Identification CDSCO,

North Zone, Ghaziabad

RDTL,

Chandigarh

14. Neomycin Sulphate, Polymixin-B Sulphate and Bacitracin Zinc Powder B. No.: GLEP-181006,

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

Mfd by: M/s. Grampus Laboratories Vill. Johron, Industrial Area,Kala Amb, Distt. Sirmour (H.P).

Identification CDSCO,

North Zone, Ghaziabad

RDTL,

Chandigarh

15. Cefixime and Ofloxacin Tablets (P-XIME-O TABLETS ) B. No.: R-110,

Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Pansun

Pharmaceuticals, Plot No. 22&23, Station Road,Bala Industrial Area, Sikkim.

Identification, & Assay Office of Drugs Inspector, Sirmour (H.P) RDTL,

Chandigarh

16. Ciprofloxacin HCl Tablets IP (PENCIP- 500 TABLETS) B. No.: R-21719,

Mfg dt: 12/2018, Exp dt: 11/2020,

Mfd by: M/s. Pansun, Pharmaceuticals,Plot No. 183, Sector 6A, IIE,

Sidhgual, Haridwar (U.K).

Identification, & Assay Office of Drugs Inspector, Sirmour (H.P) RDTL,

Chandigarh

17. Glimepiride Tablets IP 3mg B. No.: GPDT18005, Mfg dt: 10/2018, Exp dt: 09/2020,

Mfd by: M/s. RAVIAN LIFESCIENCE PVT. LTD.,

Plot No. 34, Sector- 8A, IIE, SIDCUL, Haridwar-249403,

(Uttarakhand).

Test for Dissolution Drugs Control Department, Delhi RDTL,

Chandigarh

18. Lignocaine and Adrenaline Injection IP B. No.: V-7079,

Mfg dt: 11/2017, Exp dt: 10/2019, Mfd by: M/s. ALPA

LABORATORIES LTD, 33/2, A.B.Road,

Pigdamber-453446, Indore (M.P.).

Test for Assay Drugs Control Officer, Jhajjar RDTL,

Chandigarh

19. PRE AND PROBIOTIC CAPSULES-DS B. No.: UPPC-1801 Mfg dt: 08/2018, Exp dt: 01/2020,

Mfd by: M/s. Heal (India) Laboratories Pvt. Ltd.,No. 197/1,Periyapalayam Road, Manjankaranai- 601102,Tamilnadu.

Identification & Assay CDSCO,

North Zone, Ghaziabad

RDTL,

Chandigarh

20. METRONIDAZOLE BENZOATE ORAL SUSPENSION B. No.: MNSG18-255,

Mfg dt: 11/2018, Exp dt: 10/2020,

Mfd by: M/s. ORNATE LABS PVT. LTD. Bela

Industrial Estate, Muzaffarpur-842005, Bihar

Test for Metronidazole CDSCO,

North Zone, Ghaziabad

RDTL,

Chandigarh

21. Drotaverine Hydrochloride Injection B. No.: DTB-003, Mfg dt: 10/2017, Exp dt: 09/2019, Mfd by: M/s. Radico

Remedies, 123, Mandhala, Barotiwala, Distt. Solan (H.P.) 174103.

Description & Particulate Matter CDSCO,

Hyderabad Zone

CDL,

Kolkata

22. Ofloxacin Tablets

I.P. 400 mg

B. No.: BT8291,

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

Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee-247667, Uttarakhand.

Uniformity of weight CDSCO,

North Zone, Ghaziabad

CDL,

Kolkata

23. Alprazolam Tablets I.P. B. No.: TAZP-002, Mfg dt:  11/2018, Exp dt:  10/2020, Mfd by: M/s. Medipol

Pharmaceuticals India Pvt.

Ltd., 1199/3, Bhud, Baddi, Distt. Solan, H.P., India.

Test for Dissolution CDSCO,

North Zone, Ghaziabad

CDL,

Kolkata

24. M-BETASONE

(Betamethasone Tablets I.P. 0.5 mg)

B. No.: OPT7531, Mfg dt: 01/2018, Exp dt: 06/2020, Mfd by: M/s. Omega

Pharma, Khasra No. 482, Village Saliyar, Roorkee, Dist. Haridwar, Uttarakhand

Assay & Related substances CDSCO,

Ahmedabad Zone.

CDL,

Kolkata

25. Domperidone Tablets I.P. 10 mg B. No.: DMP-18, Mfg dt: 02/2017, Exp dt: 01/2020,

Mfd by: M/s. Bewell Labs Pvt. Ltd., Rabindranagar,

P.O. Laskarpur,

Dist. 24 Parganas (S) West Bengal 700 153.

Assay & Dissolution CDSCO,

East Zone, Kolkata

CDL,

Kolkata

Also Read: Drug Alert: CDSCO declares 31 samples as sub-standard in quality in random sampling; Details


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