CDSCO flags 39 drug samples including Aspirin, Remdesivir as not of standard quality
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has flagged 39 medicine batches as 'Not of Standard Quality' after the samples failed to qualify a random drug sample test for the month of June, 2021.These drug samples which have been declared as not of standard quality include Skymap Pharmaceutical's...
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has flagged 39 medicine batches as 'Not of Standard Quality' after the samples failed to qualify a random drug sample test for the month of June, 2021.
These drug samples which have been declared as not of standard quality include Skymap Pharmaceutical's Omeprazole Gastro-Resistant Capsules, Bharat Parenteral's Folic acid tablets, and Jackson Laboratorie's Aspirin tablets.
In addition to this , the list also includes some popular medicines such as Diclofenac Sodium manufactured by Hindustan Antibiotics, Goodvit (Folic Acid Tablets I.P) manufactured by Overseas Health Care, Amikef-500-2 ml (Amikacin Sulphate Injection I.P.) manufactured by Lupin, lverpil-12 (lvermectin Dispersible Tablets 12 mg manufactured by Psychotropics India Ltd., Coldbest- PC SYRUP (Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup, 60 ml) manufactured by Digital Vision.
Remdesivir for Injection 100 mg/vial (COVIPRI INJECTION), a popular covid medication manufactured by Pristine Life Sciences, is also on the list of "Not of Standard Quality" drugs..
Further, two veterinary medications, Cypermethrin Dip Concentrate Liquid IP Vet. manufactured by Saibliss Drugs & Pharmaceuticals and Amitraz Dip Concentrate Liquid manufactured by Ambrosia Pharma, are on the list of "Not of Standard Quality."
This came after analysis and testing were conducted by the CDSCO, Drugs Control Department, on 681 drug samples. Out of these, 642 samples were found to be of standard quality while 39 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the Vitamin D3 assay, failure of Phenylephrine Hydrochloride assay, and the Assay of Methylcobalamine & Dissolution of Pregabalin.
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 June - 2021
| Total number of samples tested | 681 |
| Total number of samples declared as of Standard Quality | 642 |
| Total number of samples declared as Not of Standard Quality | 39 |
| Total number of samples declared as Spurious | Nil |
| Total number of samples declared as Misbranded | Nil |
| S. No | Name of Drugs/medical devices/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured by | Reason for failure | Drawn By | From |
| 1 | SESTIL –AD (Loperamide Hydrochloride Dispersible Tablets) | B. No: CST-75 Mfg dt: 07/2020 Exp dt: 06/2023 Mfd by: M/s Coastal Medicare Pvt Ltd. RS No. 9/2,5,Ramachandrapuram, Surampalli, Krisha Dist, Andhra Pradesh | Assay | CDSCO Hyderabad | CDL, Kolkata |
| 2 | Alusil (Aliuminium, Magnesium and Simethicone Chewable Tablet I.P.) | B. No.: AC80 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: Mls. Unicure India Ltd., C-21, 22 & 23,Sector-3, Noida - 201 301, Distt. Gautam Budh Nagar, Uttar Pradesh. | Assay of Polydimethylsiloxane (Simethicone) | CDSCO Hyderabad
| CDL, Kolkata |
| 3 | Belitra - 200 (Itraconazole Capsules 200 mg) | B. No.. AC20084 Mfg dt: 08/2020 Exp dt. 07/2022 Mfd by: Mls. Cian Healthcare Ltd., Khasra No. 248 Vill Sisona, Bhagwan pur, Roorkee, Uttarakhand | Dissolution | CDSCO Hyderabad
| CDL, Kolkata |
| 4 | Dicloenac Sodium lnj. I.P. 75 mg / 3ml | B. No.. DSIX-109 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by Mls. Hindustan Antibiotics Ltd., At: 11, W.E.A. F aridabad -121001 Haryana. | Particulate Matter | CDSCO South Zone | CDL, Kolkata |
| 5 | Bupivacaine Hydrochloride in Dextrose lnjection USP 4 ml. | GB No : TBD-2003 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: Mls. Systochem Laboratories Ltd., B-75, Roop Nagar, Indl. Area Loni 201102, Uttar Pradesh. | pH | CDSCO South Zone | CDL, Kolkata |
| 6 | FEN PIL – 120 (Fexofenadine Hydrochloride Tablets I.P 120 mg | B. No.: AWX29002 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: Mls. Psychotropics India Limited, Plot No. 46 & 49, Sector - 6A, I IE, SIDC UL, Ranipur, Haridwar - 249 403 Uttarakhand. | Dissolution | CDSCO East Zone Kolkata | CDL, Kolkata |
| 7 | Asonac-100 (Aceclofenac Tablets I.P.) | B. No.: 420-576 , Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib- 173025 Himachal Pradesh | Dissolution | CDSCO, East Zone Kolkata | CDL, Kolkata |
| 8 | Omeprazole Gastro-Resistant Capsules IP 20 mg | B. No.: GM20033 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: Mls. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana lqbalpur Road, Roorkee - 247667, Uttarakhand. | Dissolution & Assay | CDSCO, East Zone Kolkata | CDL, Kolkata |
| 9 | Goodvit (Folic Acid Tablets I.P) | B. No.: GVT-76 Mfg dt: 07/2020 Exp dt: 12/2021 Mfd by: Mls. Overseas Health Care Pvt. Ltd., 335 K.M. Milestone, National Highway No. 1, P.O. Box No. 25, Phillaur — 144 410 Punjab. | Hydrolysis Products | CDSCO, East Zone Kolkata | CDL, Kolkata |
| 10 | Amikef-500-2 ml (Amikacin Sulphate Injection I.P.) | B. N—o. A20332VP Mfg dt: 07/2020 Exp dt 06/2022 Mfd by: Mls. Lupin Ltd., 116, 1st Floor, K. B. Complex, Opp. Mahavir Nagar, Vapi - 396195, India, At: 75/1, G.I.D. C., | Description & Particulate Matter | CDSCO, East Zone Kolkata | CDL, Kolkata |
| 11 | lverpil-12 (lvermectin Dispersible Tablets 12 mg | B. No.: AFM20018 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Psychotropics India Ltd., Plot No. 46 & 49, Sector -6A, IIE, SIDCUL, Ranipur, Haridwar -249 403 Uttarakhand | Total Aerobic Microbial Count | CDSCO, East Zone Kolkata | CDL, Kolkata |
| 12 | Amikacin Sulphate Injection I.P. 500 mg/2 ml | B. No.: 7901719. Mfg dt: 09/2019 Exp cit: 08/2021 Mfd by: M/s. Karnataka Antiblotics & Phamaceuticals Ltd., Plot No. 14,II Phase, Peenya Bangaluru-560058 | Description & Particulate Matter | CDSCO, East Zone Kolkata | CDL, Kolkata |
| 13 | Bupivacaine Hydrochloride in Dextrose Injection USP 4ml | B. No: 1320328 Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Swiss Parentrals Ltd., 808, 809 & :810, Kerela Industrial Estate, G.1.O.C., Nr. Bavla, Dist. Ahmedabad -382220, Gujarat | Assay/Content of Dextrose | Drug Control Department Madhya Pradesh | CDL, Kolkata |
| 14 | SANGENTA INJECTION (Gentamicin Injection IP, 30 ml) | B. No.: JDLl-169 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: Mis. Jpee Drugs Plot No. 53, Sector 6-A, SIDCUL, Haridwar, : Uttarakhand | Description & Particulate Matter | Drug Control Department Andhra Pradesh | CDL, Kolkata |
| 15 | SANDEXA INJECTION 30 ml (Dexamethasone Sodium Phosphate Injection IP 2.0 mg/ml) | B. No.: JDLl-167 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Jpee Drugs, Plot No. 53, Sector 6-A, SIDCUL, Haridwar, Uttarakhand. | Description, Assay & Particulate Matter | Drug Control Department Andhra Pradesh | CDL, Kolkata |
| 16 | Coldbest- PC SYRUP (Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup, 60 ml) | B.No.: DL5872 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: Mis. Digital Vision, The sample 176, Mauza Ogli, Nahan Road, Kala-Amb, Dist- Sirmour, Himachal Pradesh- 173030 | Assay of Phenylephrine Hydrochloride. The sample shows the presence of Diethylene Glycol (DEG) and content of Diethylene Glycol in the sample has been found to be 1.27 % w/w | Drug Control Department Andhra Pradesh | CDL, Kolkata |
| 17 | Coldbest- PC SYRUP (Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup, 60 ml) | B. No.: DL5201 Mfg dt: 09/2019 Exp dt: 08/2021 Mfd by: Mis. Digital Vision, 176, Mauza Ogli, Nahan Road, Kala-Amb, Dist Sirmour, Himchcal Pradesh- 173030. | Assay of Phenylephrine Hydrochloride. The sample shows the presence of Diethylene Glycol (DEG) content of which is found to be 7.71 % w/w | Drug Control Department Andhra Pradesh | CDL, Kolkata |
| 18 | Folic Acid Tablets IP | B. No.: T9122 Mfg dt: 05/2019 Exp dt: 04/2022 ' Mfd by: M/s. Bharat Parenterals Ltd. V11l Haripura, Ta. Savli, Dist. Vadodara-391520, Gujarat | Assay | CDSCO Sub-zone Guwahati | RDTL, Guwahati |
| 19 | ASPIRIN TABLET I.P. (Dilsprin 75) | B. No.: T-20902 Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s Jackson Laboratories Pvt. Ltd. Majitha Road, Bye Pass, Amritsar , B.O-32-33, CBD Belapur, New Mumbai. | Description | Drug Control Depertment Nagaland | RDTL, Guwahati |
| 20 | OYSCAL | B. No.: BPT-6611 Mfg dt: 01/2020 Exp dt: 06/2021 Mfd by: Mis. Banson Pharmaceutical Pvt Ltd. C- g &10 Focal Point, Nabha(Pb) 147201. | Assay of Vitamine D3 | Drug Control Depertment Nagaland | RDTL, Guwahati |
| 21 | AMPICILLIN CAPSULES LP. 500 mg | B. No.: AMP-19B03 Mfg dt: 08/2019 Exp dt: 07/20 22 Mfd by: Mis Cyper Pharma, K.No. 825-827, Gullarwala Saj Road, Baddi, Dist-Solan, Himachal Pradesh | Assay | Drug Control Depertment Nagaland | RDTL, Guwahati |
| 22 | Calcium Carbonate & Vitamine D3 Tablets (oyscal) | B. No.: BPT-6617 Mfg dt: 01/2020 Exp dt: 06/2021 Mfd by: M/s. Banson Pharmaceutical Pvt Ltd. C-/ 9 &10 Focal Point, Nabha Punjab-147201 | Assay of Vitamine D3 | Drug Control Depertment Nagaland | RDTL, Guwahati |
| 23 | CHLORCIM-500 (Chloramphenicol Capsules I.P. 500 MG) | B. No.: OC-1809006 Mfg dt: 09/2018 Exp dt: 08/2021 Mfd by: M/s. Oshin Laboratories Pvt ltd. Aggarwal Industrial Area, Piou Maniyari, Narela Road, Kundli-131028, Haryana
| Dissolution | Drug Control Depertment Mizoram | RDTL, Guwahati |
| 24 | Atorvastatin Tablets IP 20 mg | B. No.: AVBT802 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Unicure India Ltd, C-21, 22 & 23, Sector- 3, Noida-201301, Distt Gautam Budh Nagar Uttar Pradesh. | Dissolution | CDSCO Sub-zone Guwahati | RDTL, Guwahati |
| 25 | MERICOBAL-PG | B.No.: TLC-262 Mfg dt: 09/2019 Exp dt: 08/2021 Mfd by: M/s. Taksa Lifescience, E-47, Industrial Area, Focal Point : D erabassi , Distt.-Mohali, Punjab | Assay of Methylcobalamine & Dissolution of Pregabalin | Drug Control Depertment Mizoram | RDTL, Guwahati |
| 26 | Omeprazole Capsules IP | B. No.: OMl-2001 Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Ridley Life Science Pvt. Ltd., D-1651, DSIDC lndl. Complex, Narela, Delhi-110040. | Dissolution & LOD test | CDSCO Sub-zone Guwahati | RDTL, Guwahati |
| 27 | Amoxycillin Oral Suspension I.P. 60 ml Dry Syrup 125mg/5 ml | B. No.: 9903620 Mfg dt: 03/2020 Exp dt: 08/2021 ' Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, (A Govt. of India Enterprises), Plot No. 14, II Phase, Peenya, Bangaluru-560058 | Assay | CDSCO West Zone Mumbai | CDTL, Mumbai |
| 28 | LORAZEPAM INJECTION IP 2 mg/ml (LOPEZ INJECTION) | B. No.: KLLO0002 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. KILITCH DRUGS !NOIA LTD. Plot C-301/2, MIDC, TTC, Navi / Mumbai, Pawane-400705. | Assay | CDSCO Sub-zone Baddi Himachal Pradesh | RDTL Chandigarh |
| 29 | Methylcobalamin Pyridoxine HCL and Nicotinamide Injection (MAXOBAL INJECTION) | B. No. HL-403A Mfg dt: 07/2020 Exp dt: 1212021 Mfd by: M/s. Havik Pharma Plot No. 9 AB, Phase-1, Ind.Area, Sansarpur Terrace, Distt Kangra, Himachal Pradesh | Particulate Matter | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
| 30 | IBUPROFEN AND PARACETAMOL Tablets | B.No: 21001 Mfg dt: 04/2021 Exp dt: 03/2024 Mfg by: M/s Tulip Formulations Pvt Ltd. Village Surajpur Uparla, Tehsil Indore, Dist Kangra , Himachal Pradesh. | Assay of Ibuprofen and Paracetamol | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
| 31 | CALCIUM MEGNESIUM ZINC AND VIT 03 SUSPENSION ((DECALVIT SUSPENSION ) | B.No. BL-822 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: M/s Biosearch Organics D.I.C. IndI. Estate, Govindsar, Katua 184102, Jammu & Kashmir | Assay of Vitamin D3 | Drug Control Department Jammu & Kashmir | RDTL Chandigarh |
| 32 | TELMISARTAN TABLETS I.P. 40 mg (TELMICEPT 40 Tablets) | B. No.: C21T470002 Mfg dt: 07/2020 Exp dt: 06/2023 Mfd by: Mis. CONCEPT PHARMACEUTICALS LTD. A-28/3, MIDC, Chikalthana, Aurangabad- 43100 , Maharashtra | Dissolution | CDSCO North Zone | RDTL Chandigarh |
| 33 | REMDESIVIR for Injection 100 mg/vial (COVIPRI INJECTION) | B. No.. PR/A-54 Mfg dt: 12/2020 Exp dt: 11/2022 ; Mfd by: M/s. Pristine life sciences A-229, PIPDIC industrial estate,Mettupalayam, Singtam, Sikkim | Identification of Remdesivir, Particulate matter, Sterility | Drug Control Department Delhi | RDTL Chandigarh |
| 34 | CEFIXIME DISPERSIBLE TABLETS IP 200 mg | B. No.: TPT GOV-2231 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd. 3-B (a), Phase-III, Industrial Area,Sansarpur Terrace, Distt. Kangra, HimachalPradesh 176501 | Disintegration | CDSCO North Zone | RDTL Chandigarh |
| 35 | Cypermethrin Dip Concentrate Liquid IP Vet. (CYPER 10 % VETERINARY) | B. No: CP-245 Mfg dt:05/2020 Exp dt: 04/2022 Mfd by:M/s Saibliss Drugs & Pharmaceuticals 66-67, Gondpur, Industrial Area, Pontasahib, Dist. Sirmour Himachal Pradesh | Assay of Cypermethrin | Drug Control Department Srinagar | RDTL Chandigarh |
| 36 | Pegabalinan d Methylcobalam n Capsule (MECNAR-PLUS CAPSULES) | B. No: TLC-441 Mfg dt:03/2020 Exp dt: 02/2022 Mfd by: M/s. Taksa Lifescience E-47, Industrial Area, Focal Point, Derabassi Dist Mohali, Punjab | Uniformity of filled weight | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
| 37 | IVERMECTIN TABLETS USP 6 mg | B. No: lVE/20002 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. MAAN PHARMACEUTICALS LTD. Plot-1,G.I.D.C. Phase II, Modhera Road, Mehsana-384002, Gujarat | Dissolution | CDSCO North-Zone | RDTL Chandigarh |
| 38 | Azilsartan Medoxomil Tablet 80 mg (ABEL-SO TABLETS) | B. No: QZ210101 Mfg dt:01/2021 Exp dt: 12/2022 Mfd by: M/s. Hetero Labs Limited (Unit II) Kalyanpur, (Village), Chakken Road, Baddi (Tehsil), Solan ( Dist), Himachal Pradesh-173205 | Dissolution of Azilsartan | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
| 39 | Amitraz Dip Concentrate Liquid BP Vet. (AMTRAZ) | B. No: AVG-401 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. AMBROSIA PHARMA 91, lndl. Estate, Zainakot Srinagar, Jammu & Kashmir. | Assay of Amitraz | Drug Control Department Srinagar | RDTL Chandigarh |
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