New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 44 medicine batches for failing to qualify a random drug sample test for the month of July, while 1 drug sample has been declared misbranded.These drugs samples which are declared not of standard quality include Piramal Enterprises Ltd's Supradyn...
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 44 medicine batches for failing to qualify a random drug sample test for the month of July, while 1 drug sample has been declared misbranded.
These drugs samples which are declared not of standard quality include Piramal Enterprises Ltd's Supradyn tablet, Syncom Healthcare's Albendazole tablets IP 400 mg (ZEEBEE-Tablet), Quest Laboratories' Domperidone Suspension I.P., Bharat Parenteral's Quinine Sulphate Tablets IP 300 mg, Swiss Garnier Biotech's STATIX-20 (Atorvastatin Tablets IP 20 mg) etc.
In addition, other popular drug samples that are declared not of standard quality include Paracetamol Tablets I.P. 500 mg (Biocin) manufactured by Danish Healthcare, Levofloxacin (Levoziv-500) Tablets I.P. 500 mg manufactured by Zee Laboratories, Brutab-400 (Ibuprofen Tablets IP 400 mg) manufactured by Neutec Healthcare, and Norfloxacin Tablets IP 400 mg manufactured by Unicure.
Apart from this, the popular covid drug Remdesivir for Injection 100 mg/vial (CIPREMI) manufactured by Cipla and Remdesivir for injection manufactured by Teena Labs Ltd. are on the list. Additionally, Bharat Serums and Vaccines' Liposomal Amphotericin B Injection 50 mg (ABHOPE INJ.) and Amphotericin B Lipid Complex Injection I.V. (AMPHOLIP 50 MG/10 ML) are also on the list.
Further, the list includes popular diabetes drugs DRMET FORTE G1 (Glimepiride & Metformin Hydrochloride SR Tablets) manufactured by Neptune Life Science Pvt. Ltd. and Glimepiride Tablets IP 1 mg manufactured by Trugen Pharmaceuticals Pvt. Ltd.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1028 samples. Out of these, 983 samples were found to be of standard quality while 44 of them were declared as Not of Standard Quality (NSQ) and 1 drug was declared misbranded.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of disintegration, failure of the Vitamin D3 assay etc.
The samples collected were tested in four laboratories, namely CDL Kolkata, CDTL Mumbai, 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 July – 2021
Total number of samples tested
Total number of samples declared as of Standard Quality
Total number of samples declared as Not of Standard Quality
Total number of samples declared as Spurious
Total number of samples declared as Misbranded
Name of Drugs/medical device/cosmetic
Batch No./Date of Manufacture/Date of Expiry/Manufactured By
Calcium Carbonate, Magnesium Oxide, Manganese Sulphate, Zinc & Vitamin D3
Mfd by: M/s. Mascot Health Series Pvt. Ltd. Plot No. 79, 80, Sector - 6A, IIE, Sidcul, Haridwar- Uttarakhand -249403.
Supradyn (Multivitamin Tablets with Minerals and Trace Elements)
B. No.: MH3388 Mfg dt: 10/2019 Exp dt: 09/2021
Mfd by: M/s. Piramal Enterprises Ltd., K-1, Addl., MIDC area, Mahad Maharashtra, 402302.
Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Ortin
Laboratories Ltd. 275 & 278 (part) I.D.A.
Pashamailaram Medak Distt. Telangana -502307.
Drug Control Department N.F. Railway Lumding
Albendazole tablets IP 400 mg (ZEEBEE -
B. No.: JDT0047 Mfg dt: 08/2018 Exp dt: 07/2021
Mfd by: M/s. Syncom Healthcare Ltd., Dehradun, Uttarakhand-
Drug Control Department Tezpur, Sonitpur
G1 (Glimepiride & Metformin Hydrochloride SR Tablets)
Mfd by: M/s. Neptune Life Science Pvt. Ltd., 100-B, EPIP, Phase-II, Thana, Baddi-173205, Himachal Pradesh.
Assay & Dissolution of Glimepiride
Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Quest
Laboratories Pvt. Ltd., Plot No. 45, Sector –III, Pithampur, Dist. - Dhar,
Calcium & Vitamin D3 Tablets I.P. (CALGIO-D3)
B. No.: LTA-6957 Mfg dt: 03/2020 Exp dt: 08/2021
Mfd by: M/s. Lifevision Healthcare, Plot No. 140- 141, E.P.I.P., Phase-1,
Jharmajri, Baddi, Dist.- Solan, Himachal Pradesh - 174103.
Brutab-400 (Ibuprofen Tablets IP 400 mg)
B. No.: BRU18007 Mfg dt: 03/2019 Exp dt: 02/2022 Mfd by: M/s. Neutec
E-698, DSIIDC Industrial Area, Narela, Delhi- 110040.
(Levoziv -500) Levofloxacin Tablets I.P.
Mfg dt: 07/2020 Exp dt: 06/2023 Mfd by: M/s. Zee Laboratories Ltd.
Behind 47, Industrial Area, Paonta Sahib, Himachal Pradesh - 173025.
B. No.: BCN2002 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: M/s. Danish
76/27-28, Industrial Estate, Maxi Road, Ujjain, Madhya Pradesh – 456010.
Amlodipine Besilate Tablets IP 5 mg (AMLORACE-5)
B. No.: GLL19018 Mfg dt: 03/2019 Exp dt: 02/2022
Mfd by: M/s. IBN Herbals, Khasra No 63, Vill- Juddi Kalan, Baddi-173205, Dist- Solan, Himachal Pradesh.
Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Hab Pharmaceuticals &
Research Limited, 10, Pharmacity, SIDCUL, Selaqui, Dehradun- 248011, Uttarakhand.
Cefixime Dispersible Tablets IP (Cefimax-100 DT)
Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Orison
Pharma International, Khari, Mauza-Ogli, Kala
Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Theon
Pharmaceuticals Ltd. Vill. Saini Majra, Teh. Nalagarh, Dist. Solan, Himachal Pradesh - 174101.
Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Medox Lifesciences,
Plot No- 222-223, Phase- III, Ind. Area, Sansarpur- Terrace, Distt. Kangra, Himachal Pradesh -
B. No.: NT-802 Mfg dt: 10/2020 Exp dt: 09/2022
Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23, Sector- 3, Noida, Uttar Pradesh - 201301.
Quinine Sulphate Tablets I.P. 300 mg
Mfg dt: 10/2018 Exp dt: 09/2021 Mfd by: M/s. Bharat Parenterals Ltd. Vill Haripura, Ta. Savil,
Dist.- Vadodara - 391520, Gujarat.
Sanitizer (100ml) Chlorhexidine Gluconate Solution IP 2.5% Ethnol IP70%
Exp dt: Best before 24 months
Mfd by: M/s. SHREE ENTERPRISES Plot No 1,
Near Star Talkies, Burmamines, Jamshedpur, Jharkhand -831007.
Assay of Ethanol (Misbranded) 'Mfg. Lic No.'' is not mentioned on the Label.
B. No.: YAT91042 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Yoluri
Formulation Pvt. Ltd. Sy No.: 296/7/6, I.D.A.,
B. No.: RID-1925 Mfg dt: 02/2020 Exp dt: 01/2023
Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD. D- 1651, DSIDC, Indl.
Mfd by: M/s. Nuclotec
Remedies Pvt. Ltd. 14, Milestone, Rudrapur- Kashipur Road, Gadarpur, Distt.-U.S. Nagar, Uttarakhand – 263152..
Rabeprazole Sodium Gastro Resistant Tablets IP
B. No.: LTA-7123 Mfg dt: 04/2020 Exp dt: 03/2022
Mfd by: M/s. Lifevision Healthcare (a WHO-GMP Certified Company) Plot no.140-141, E.P.I.P.
dist. Solan, Himachal Pradesh -174103.
Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Trugen
Pharmaceuticals Pvt. Ltd. Vill-Tejjupur, Near Chodiala Rly Station, Roorkee, Distt. Haridwar, Uttarakhand -247661.
Cefixime Dispersible Tablets I.P. (Cefexi-100)
B. No.: BIG -137 Mfg dt: 03/2019 Exp dt: 02/2022
Mfd by: M/s. Indo-Gulf Pharmaceuticals
(unit of I.G. Pharma Ltd.),
12.4 km, Meerut Road, Roorkee, Distt- Haridwar, Uttarakhand.
Uniformity of dispersion and Water content
B. No.: BPSB20093 Mfg dt: 08/2020 Exp dt: 07/2022
Mfd by: M/s. Swiss Garnier Biotech Pvt. Ltd., 21, Industrial Area, Mehatpur, Dist. Una, Himachal
Sea Port Office Visakhapatnam Andhra Pradesh
Calastravit -500 (Calcium with Vitamin D3 Tablets IP)
Mfd by: M/s. Maa Pharma Tech, Survey No. 915/2,
Sea Port Office Visakhapatnam Andhra Pradesh
Block Part B, Jetalpur Pirana Road, At & Post. Girmatha Village, Tal- Daskroi, Dist. Ahmedabad
Cefoperazone for Injection I.P.
Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Sunvet
Pharma Private Limited, Village: Upper Moginand, Nahan Road, Kala Amb, Distt. Sirmour 173030,
Description, Identification, pH, Water, Particulate Matter, Clarity of Solution, Assay
Doxycycline Hydrochloride Capsules I.P.
Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Super
Formulations Pvt. Ltd., 16 B & 15 F, Industrial Area, Maxi Road, Ujjain, Madhya Pradesh - 456 010.
Folic Acid Tablets IP 5 mg
Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Trugen
Pharmaceuticals Pvt. Ltd., Vill. Tejjupur, Near Chodiala Rly Station, Roorkee, Distt. Haridwar, Uttarakhand – 247 661.
Sodium Valproate Gastro Resistant Tablets IP 200 mg
B. No.: SVT871 Mfg dt: 12/2020 Exp dt: 05/2022
Mfd by: M/s. Unicure India Ltd., Noida – 201301, Uttar Pradesh.
(Oral Rehydration Salts I.P.)
B. No.: KL2001 Mfg dt: 01/2020 Exp dt: 12/2021
Mfd by: M/s. Danish Healthcare (P) Ltd., 76/27- 28 Industrial Estate, Maxi Road, Ujjain – 456 010, Madhya Pradesh.
Sodium Potassium Total Chlorides and Citrate
Telmicept 40 (Telmisartan Tablets I.P. 40 mg)
Mfd by: M/s. Concept Pharmaceuticals Ltd., A - 28/3, MIDC, Chikalthana, Aurangabad – 431 006, Maharashtra.
B. No.: DGTA12266 Mfg dt: 12/2020 Exp dt: 11/2022
Mfd by: M/s. Digital Vision, 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt.
500 ml (Compound Sodium Lactate Inj. I.P. 500 ml (Ringer Lactate Solution for
Mfd by: M/s. Denis Chem Lab Limited, 457, Chhatral, Ta. Kalol, Dist.
Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Clevus
Lifesciences, Near Apple Terminal Market, Sector - 6, Parwanoo, Himachal
Exp dt: 3 Yrs from Mfg. Date
Mfd by: M/s. Sri Sanjeevi Natchiyar Surgicals, 2/181- D, Vayakattu Street, Samusigapuram – 626 102
Weight in gm / m2, Length, Width, Foreign Matter and Flourescence
FloxidinTM VET – 100 ml (Enrofloxacin Injection I.P. 10% VET)
Mfd by: M/s. Samrudh Pharmaceuticals Pvt. Ltd., Plot No. J-174, J-168 & J-
B. No.: BREMD210001 Mfg dt: 04/2021
Mfd by: M/s. Teena Labs Ltd. Plot No. 41,S.V. Co- Operative Industrial Estate, Bachupally (V & M),
Water and Residue on ignition
Ampicillin 500 mg (Ampicillin Capsules I.P.)
Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Super
Pharma Products., 13 A & C, Industrial Area, Maksi Road, Ujjain, Madhya
Orvastin-40 (Atorvastatin Tablets I.P. 40 mg)
Mfd by: M/s. Morepen Laboratories Ltd., Plot No. 12B, Sector-2, Parwanoo, Dist. Solan, Himachal Pradesh – 173220.
Closantel 15% Oral Solution (WORM- GO ORAL SOLUTION)
B. No.: CLP-443 Mfg dt: 03/2020 Exp dt: 02/2022
Mfd by: M/s. Saibliss Drugs & Pharmaceuticals 66-67, Ind.Area, Ponta
Sahib, Distt. Sirmour, Himachal Pradesh.
Identification (Negative for Closantel Sodium Dihydrate)
B Injection 50 mg (ABHOPE INJ.)
Mfg dt: 02/2021 Exp dt: 01/2024 Mfd by: M/s. Bharat
Serums and Vaccines Ltd. Plot No. K-27, Anand Nagar, Add.MIDC, (E) Ambernath-421501, Taluka: Ambernath City, District: Thane-Zone 6, Maharashtra.
Identification (Negative for Amphotericin B)
Remdesivir for Injection 100 mg/vial (CIPREMI)
Mfd by: M/s. CIPLA LTD. Plot No. G-84/1, Tarapur, M.I.D.C., Boisar, Dist, Palghar, Maharashtra- 401506.
B Lipid Complex Injection I.V. (AMPHOLIP 50 MG/10 ML)
Mfd by: M/s. BHARAT SERUMS AND VACCINS LIMITED Plot No. K-27,
Additional M.I.D.C., Ambernath (E) 421501, Maharashtra.
Identification (Negative for Amphotericin B)
Enalapril Maleate Tablets IP (GNAP-2.5 TABLETS)
Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. CMG BIOTECH PVT. LTD 58,
Industrial Area, Phase III, Sansarpur Terrace, Himachal Pradesh - 176501.
Drug Control Department Himachal Pradesh
Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.
Allergic rhinitis-an overview on treatment recommendations and current guidelines
A quick review on flu and the growing role of Oseltamivir
Opinion: New "Drugs, Medical Devices and Cosmetics Bill 2022" Can Be Made Robust
Infographic: Allergic Rhinitis-Quick Overview of Treatment Algorithm
Challenges in Rural Child Health: Experiences of a pediatrician in Rural Haryana- Dr Preeti Joon
Association of prior head injury with sense of smell in older adults