Details
“Raju Vernekar
Vernekar.raj@gmail.com
The Drug Controller General (India) has declared the following 20 medicines as of sub-standard quality, spurious and misbranded and the manufacturers of these medicines have been asked to withdraw the stocks about respective batches from the market. Nearly 790 samples, were tested by different units of DCGI across the country in June and a list of substandard drugs was released under “drug alert” on 8 July by DCGI.
The manufacturers located in different states, whose drugs have been disapproved are:
Maharashtra: Cefotaxime Sodium Injection, Mfg date 07/2019, expiry date 06/2021, Mfd by M/s.Hindustan Antibiotics Ltd, Pimpri, Pune, Maharashtra (the reason for failure-water), the sample was drawn by CDSCO, East Zone, Kolkata from CDL, Kolkata and Sustained-release capsules (Folron Capsules), Mfg date:10/2019, Exp date: 09/2021, Mfd by M/s. Zim Laboratories Ltd, Nagpur,(reason for failure-.Assay of folic acid) sample drawn by CDSCO, Himachal Pradesh from RDTL, Chandigarh.
Goa: Ocupol Dx. (Chloramphenicol & Dexamethasone Eye/Ear Drops), Mfg date: 07/2019,Exp date: 12/2020,Mfd by: M/s.Centaur Pharmaceuticals Pvt. Ltd., Margao(the reason for failure-Assay of Chloramphenicol), sample drawn by CDSCO, Hyderabad from CDL, Kolkata.
Himachal Pradesh: The title of the medicine-Nitrobact-100 (Nitrofurantoin capsules), Mfg date 09/2019, Expiry date 08/2021, Mfd by M/s.Swiss Garnier Biotech Pvt. Ltd, Una, (the reason for failure-Dissolution) sample is drawn by CDSCO, East Zone, Kolkata from CDL, Kolkata. Auditon-MD tablets( orally disintegrating tablets 8 mg), Mfg date:10/2018, Exp date: 09/2020, Mfd by: M/s. Rachel Pharma, Kangra, (the reason for failure-Description & Disintegration), (Sample drawn by CDSCO, North Zone, Ghaziabad from CDL, Kolkata, Thyroxine Sodium Tablets (Thyroute 50 Tablets), Mfg date:11/2019, Exp date: 10/2021, Mfd by M/s.Life Vision Healthcare, Solan, (the reason for failure-uniformity of content), sample drawn by CDSCO, Himachal Pradesh from RDTL, Chandigarh, Amoxycillin, and Potassium Clavulanate tablets, Mfg date: 09/2018, Exp date: 08/2020, Mfd by M/s.Astam Healthcare Pvt. Ltd, Solan,(the reason for failure-.identification of Potassium Clavulanate and assay of Amoxycillin Trihydrate), the sample is drawn by Drug Controller, Himachal Pradesh from RDTL, Chandigarh, Calcium and vitamin D3 tablets (batch CVDT, 1384) Mfg date: 04/2019, Exp date: 03/2021, Mfd by M/s. Wings Biotech, Baddi, (the reason for failure- the dissolution of calcium carbonate), the sample is drawn by CDSCO, Himachal Pradesh from RDTL, Chandigarh and Calcium and vitamin D3 Tablets (batch CVDT 1653), Mfg date:07/2019, Exp date: 06/2021, Mfd by M/s. Wings Biotech, Baddi, (the reason for failure- the dissolution of calcium carbonate), sample drawn by CDSCO (North-Zone), Ghaziabad from RDTL, Chandigarh.
Uttarakhand: Mometran Cream (Mometasone Furoate Cream), Mfg. date 06/2019, Expiry date: 07/2021, Manufactured by M/s. Mascot Health Series Pvt. Ltd, Haridwar, (the reason for failure-assay), the sample is drawn by Central Drugs Standard Control Organisation(CDSCO), Mumbai from the Central Drug Testing Laboratory(CDTL), Mumbai, Glicot-60 (Gliclazide tablets 60 mg), Mfg date:07/2019, Expiry date: 06/2021, Mfd by M/s. Mascot Health Series Pvt. Ltd, Haridwar,(the reason for failure-Dissolution), the sample is drawn by CDSCO, East Zone, Kolkata from CDL, Kolkata, Fexcor-120 (Fexofenadine Hydrochloride tablets 120 mg), Mfg date: 08/2019, Expiry date 07/2021, Mfd by M/s. Akums Drugs & Pharmaceuticals Ltd, Haridwar,(the reason for failure-Description), sample drawn by CDSCO, East Zone, Kolkata from CDL, Kolkata, and Pioglitazone & Metformin Hydrochloride tablets, Mfg date:08/2019, Exp date: 01/2022, Mfd by M/s.Cian Healthcare Ltd, Haridwar, (the reason for failure-Dissolution of Metformin Hydrochloride), sample drawn by CDSCO, Ahmedabad from CDL, Kolkata.
Uttar Pradesh: Telmisartan Tablets 20 mg, Mfg date:07/2019,Exp date: 06/2021,Mfd by: M/s.Unicure India Ltd., NOIDA, (the reason for failure-Dissolution), the sample is drawn by CDSCO, North Zone, Ghaziabad from CDL, Kolkata, and Setnorm–4 (Ondansetron tablets 4 mg), Mfg date:02/2019, Exp date: 01/2021, Mfd by M/s. Unicure India Ltd., NOIDA (the reason for failure-Description), sample drawn by CDSCO, Goa from CDL, Kolkata.
Haryana: Bhringraj Hair oil 200 ml. (vegetable oil including sesame oil), Mfg date 05/2019, Expiry date: 04/2022, Mfd by M/s. Ananya Herbal Pvt. Ltd, Sonepat, (the reason for failure-Acid value (Type 1 & Type 3), the sample is drawn by Drugs Control Department, Bihar from RDTL, Guwahati and Dextromethorphan hydrobromide and Chlorpheniramine Maleate syrup (Heel-DXSyrup), Mfg date:08/2019, Exp date: 07/2021, Mfd by M/s.Yashwant Healthcare, Sonepat, (the reason for failure-Assay of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate), sample drawn by Drug Controller, Haryana from RDTL, Chandigarh.
Punjab: Eudox-100 (Doxycycline Capsules), Mfg date 03/2019, Expiry date: 02/2021, Mfd by M/s.Ultra-Chiron Pharmaceuticals Pvt. Ltd, Mohali (the reason for failure- Uniformity of weight), the sample is drawn by CDSCO), Mumbai from CDTL, Mumbai, and Doxyrap-100 (Doxycycline and lactic acid bacillus tablets), Mfg date 01/2019, Expiry date 12/2020, Mfd by M/s.Dr. Edwin Lab, Mohali (the reason for failure-uniformity of weight, Assay), sample drawn by Drugs Control Department, Mizoram from RDTL, Guwahati.
Tamil Nadu: Absorbent gauze cloth, Mfg date 01/2019, Expiry date 12/2021, Mfd by M/s. Balu Surgicals, Samusigapuram,(the reason for failure-length), sample drawn by Drugs Control Department, Kerala from the Regional Drugs Testing Laboratory(RDTL), Guwahati.
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