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