CDSCO flags 22 drugs as not of standard quality
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 22 samples including drugs and a medical device as Not of Standard Quality for failing to qualify for a random sample test for the month of April-2021.
These drugs samples which are declared Not of Standard Quality include Aksum's PANTOWEL-40, Synokem's L-CETAM 500, Unimark Healthcare's MISOPROSTOL Tablets I.P. 200 mcg, Bharat Parenteral's OLANZAPINE Tablets I.P. 5 mg.
In addition, other popular drug samples that are declared Not of Standard Quality include Paracetamol Tablets IP 650 manufactured by Sotac Pharmaceuticals, GLUCORID (Metformin Hydrochloride Sustained-Release Tablets I.P. 500 mg) manufactured by Ridley Life Science, ZINC SULPHATE DISPERSIBLE TABLETS IP 20 mg manufactured by Hindustan Laboratories and others.
Apart from drugs, a medical device manufactured by Ramaraju Surgical Cotton Mills, an instant sterile mopping pad (Absorbent Gauze-BP Type 13 with X-Ray Detectable Thread) has been declared non-standard quality.
This came after analysis and tests were conducted by the CDSCO, Drugs Control Departments on 931 samples. Out of this, 908 samples were found of standard quality while 22 (legal) +1 (survey) 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 Serratiopeptidase assay.
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 April -2021
| Total number of samples tested | 931 |
| Total number of samples declared as of Standard Quality | 908 |
| Total number of samples declared as Not of Standard Quality | 22(Legal)+01(Survey) |
| Total number of samples declared as Spurious | 0 |
| Total number of samples declared as Misbranded | 0 |
| S.No. | Name of Drugs/medical device/cosmetic s | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
| 1. | INSTANT STERILE MOPPING PAD (Absorbent Gauze- BP Type 13 with X-Ray Detectable Thread) | B. No.:1017/20 Mfg dt: 03/2020 Exp dt: 02/2023 Mfd by: M/s.The Ramaraju Surgical Cotton Mills Ltd., 2/318 - 2/321, Sankarankovil Road, Perumalpatti - 627 753 Tamil Nadu. | Threads per stated length | CDSCO, South Zone, Chennai | CDL, Kolkata |
| 2. | RUTIN (RutosideTrihydra te 95%) (as per F.M) | B. No.:20181126 (as per F.M) Mfg dt: 11/2018 (as per F.M) Exp dt: 11/2021 (as per F.M) Mfd by: M/s.Ningbo Hi- Tech Biochemicals Co., Ltd, China (as per F.M). | Water, Related Substances and Assay | CDSCO, Sub Zone Baddi | CDL, Kolkata |
| 3. | REALHIM-10 (Tadalafil Tablets I.P. 10 mg) | B. No.:LC9L225 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s.LifecareNeuro Products Limited, 70/1, Dharampur, Nr. EPIP Phase-II, Baddi-173 205, Himachal Pradesh. | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 4. | SPINOBAK-10 (Baclofen Tablets I.P. 10 mg) | B. No.:K3ALT001 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Sirmour Remedies (P) Ltd., Village - Layarda, P.O. | Assay | CDSCO, East Zone, Kolkata | CDL,
Kolkata |
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| Missarwala, Paonta Sahib, Distt . Sirmour (HP) -173 205. |
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| 5. | PANTOWEL - 40 (Pantoprazole Sodium Tablets | B. No.:OBYA01 Mfg dt: 02/2020 Exp dt: 07/2022 Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd., 19, 20, 21 Sector-6A, I.I.E, SIDCUL, Ranipur, Haridwar-249403 Uttarakhand. | Dissolution | CDSCO East Zone Kolkata | CDL, Kolkata |
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| I.P. 40 mg) |
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| 6. | L-CETAM 500 (Levetiracetam Tablets I.P. 500 mg) | B. No.:20S1GTA508 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s.Synokem Pharmaceuticals Ltd., Plot No: 35-36, Sector-6A, I.I.E. (SIDCUL). Ranipur (BHEL), Haridwar -249403 Uttarakhand. | Dissolution | CDSCO East Zone Kolkata | CDL, Kolkata |
| 7. | MISOPROSTOL Tablets I.P. 200 mcg | B. No.:UHT20096 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s.Unimark Healthcare Ltd., Plot No. 24, 25 & 37 Sector 6A, SIDCUL, Haridwar 249 403 Uttarakhand. | Assay | CDSCO Hyderabad Zone | CDL, Kolkata |
| 8. | GLUCORID (Metformin | B. No.:GLU-2009 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s. Ridley Life Science Pvt. Ltd., D-1651, DSIDC Indl. Complex, Narela, New Delhi-110 040. | Dissolution | CDSCO Hyderabad | CDL, Kolkata |
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| Hydrochloride |
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| Sustained |
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| |
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| Release Tablets |
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| I.P. 500 mg) |
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| 9. | TLM-80 (Telmisartan Tablets I.P. 80 mg) | B. No.:31T20T02 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s. Shine Pharmaceuticals Ltd., Plot No. 132, Karjan- Vemardi Road, JuniJitherdi, Ta. Karjan – 391 240, Dist.: Vadodara (Gujarat). | Dissolution | CDSCO Hyderabad | CDL, Kolkata |
| 10. | OLANZAPINE Tablets I.P. 5 mg | B. No.:T0434 Mfg dt: 08/2020 Exp dt: 07/2023 Mfd by: M/s. Bharat Parenterals Ltd., Vill. Haripura Ltd, Ta. Savli, Dist. Vadodara - 391520, Gujrat. | Dissolution | CDSCO Hyderabad | CDL, Kolkata |
| 11. | ULTRAFLOX-500 (Ciprofloxacin Tablets I.P.) | B. No.:190112A Mfg dt: 01/2019 Exp dt: 12/2021 Mfd by: M/s. Bal Pharma Limited, Plot No. 1, 2, 3 & 69, Sector-4, IIE, SIDCUL, Pantnagar, Rudrapur, Distt.-Udham Singh Nagar, Uttarakhand. | Dissolution | CDSCO Hyderabad | CDL, Kolkata |
| 12. | ORVASTIN-20 (Atorvastatin Tablets IP 20 mg) | B. No.: P-0H0440 Mfg dt: 08/2020 Exp dt: 01/2023 Mfd by: M/s.Morepen Laboratories Ltd., Plot No.12-B, Sector-2, Parwanoo, Dist. Solan, Himachal Pradesh - 173220. | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 13. | REVOL-CC (Calcium Carbonate, Magnesium Oxide, Manganese Sulphate, Zinc & Vitamin D3 Tablets) | B. No.:MT191326 Mfg dt: 08/2019 Exp dt: 07/2021 Mfd by: M/s.Mascot Health Series Pvt Ltd., Plot No. 79, 80, Sector 6A, IIE, Sidcul, Haridwar 249 403, Uttarakhand. | Assay of Vitamin D3 | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 14. | Aceclofenac, Paracetamol and Serratiopeptidase Tablets (ACEPRO-SP TABLETS) | B. No.:SST-0657 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. SHRI SAI BALAJI PHARMATECH PVT. LTD. Plot No.20, Ext. HPSIDC Industrial Area, Baddi, Distt. Solan Himachal Pradesh 173205. | Assay of Serratiopeptidase | CDSCO, Sub Zone, Baddi | RDTL, Chandigarh |
| 15. | Paracetamol Tablets IP 650 mg (MECIPAR 650 TABLETS) | B. No.:SP20641 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Sotac Pharmaceuticals Pvt. Ltd. Plot No. PF/21 Nr. Acme Pharma Opp. Teva Pharma, GIDC-II, Sanad, Ahmedabad, Gujarat. | Dissolution | CDSCO, Sub-Zone, Jammu | RDTL, Chandigarh |
| 16. | TELMISARTAN TABLETS IP 40 MG | B. No.:CLT-14747 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. CAREMAX FORMULATIONS Plot No.56 & 61, Industrial Area, Phase-III, Sansarpur Terrace, Distt. Kangra Himachal Pradesh - 176501. | Uniformity of weight & Dissolution | CDSCO NorthZone | RDTL, Chandigarh |
| 17. | Chlorhexidine Gluconate and Ethyl Alcohol Antiseptic Solution (CORUB) | B. No.:G-215 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Gag Pharmaceuticals V.P.O. Mubarkpur-Shaikhan- 144025 Punjab. | Identification | Drug Control Department Himachal Pradesh | RDTL, Chandigarh |
| 18. | TRANEXAMIC ACID TABLETS IP | B. No.:T2002047 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s.Rhydburg Pharmaceuticals Ltd., C-2 & 3, S.I.E.L, Selaqui, Dehradun, Uttarakhand. | Related Substances | CDSCO North Zone | RDTL, Chandigarh |
| 19. | Progesterone Sustained- Release Tablets (FULGEST SR 200 TABLETS) | B. No.:GFSM008 Mfg dt: 06/2019 Exp dt: 05/2021 Mfd by: M/s. Synokem Pharmaceuticals LTD. Plot No. 56-57, Sector-6A, IIE, (SIDCUL), Ranipur (BHEL), Haridwar-249403, Uttarakhand. | Dissolution | CDSCO, Sub-Zone, Baddi | RDTL, Chandigarh |
| 20. | Tranexamic Acid Tablets IP 250 mg (TYRODIN TABLETS ) | B. No.:T0164 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s.Canixa Life Sciences Pvt. Ltd. K.No.313, Raipur Industrial Area, Bhagwanpur, Roorkee, Dist. Haridwar, Uttarakhand-247667. | Related Susbtances | CDSCO, North Zone | RDTL, Chandigarh |
| 21. | 70% Isopropyl Alcohol Hand Rub (ICANDY) | B. No.: I010520 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by:*RGG COSMETICS PVT. LTD. (Complete address of the manufacturer not mentioned on the label). | Identification | Drug Control Department Himachal Pradesh | RDTL, Chandigarh |
| 22. | ZINC SULPHATE DISPERSIBLE TABLETS IP 20 mg | B. No.: TAC0006AL Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Hindustan Laboratories, Plot No.5-9, Survey No. 38/2, Aliyali, Palghar-(W), Dist-Palghar- 401404 Maharashtra. | Disintegration Test | CDSCO Sub- Zone, Guwahati | RDTL, Guwahati |
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