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Date: 2014-09-08 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of August 2014

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This gazette notification lists drugs, medical devices, and cosmetics declared as not of standard quality, spurious, adulterated, or misbranded by various Regional Drugs Testing Laboratories (RDTL) and Central Drugs Testing Laboratories (CDTL) across India for the month of August 2014.
  • The products listed failed quality tests for reasons such as disintegration, dissolution, description, physical appearance, assay content, uniformity of weight, clarity of solution, and loss on drying.

Key Changes

  • A total of 22 products are listed as not of standard quality/spurious/adulterated/misbranded.
  • The products include tablets, suspensions, capsules, gels, and injections.
  • The reasons for failure include disintegration (3 products), dissolution (3 products), description/physical appearance (2 products), assay content (7 products), uniformity of weight (2 products), clarity of solution (4 products), and loss on drying (1 product).
  • The listed products were manufactured by various companies located in Assam, Uttarakhand, Sikkim, Daman, Gujarat, Himachal Pradesh, Tamil Nadu, Delhi, Haryana, and Karnataka.
  • Testing was conducted by Regional Drugs Testing Laboratories (RDTL) in Guwahati, Chandigarh and Central Drugs Testing Laboratories (CDTL) in Mumbai, Chennai and Kolkata.

Impact Analysis

Manufacturers

  • Action Item: Review manufacturing processes and quality control procedures to prevent future occurrences. Implement corrective and preventive actions (CAPA) immediately.

Consumers

  • Action Item: Public awareness campaigns should be initiated to inform consumers about the affected products and potential risks. Provide guidance on reporting adverse events.

Retailers and Distributors

  • Action Item: Establish a system for quickly identifying and removing substandard products from the supply chain. Enhance supplier quality audits.

Regulatory Agencies (CDSCO, State FDAs)

  • Action Item: Increase the frequency and scope of inspections of manufacturing facilities. Strengthen collaboration between central and state drug regulatory authorities. Improve testing infrastructure and capacity.

Our Company

  • Communicate with our supply chain partners to ensure that they are aware of the gazette notification and are taking steps to avoid using the blacklisted manufacturers.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, responsible for testing and analyzing drug samples. CDTL: Central Drugs Testing Laboratory, another type of laboratory responsible for testing and analyzing drug samples. M/s Hecatomb Laboratories Pvt. Ltd.: Manufacturer of ERYTHROMYCIN ESTOLATE TABLETS, Batch No. EE009, which failed disintegration test. M/s Regent Ajanta Biotech: Manufacturer of R-ZONE 20 TABLETS, Batch No. RAB-113, which failed dissolution test and ERYRAB SUSPENSION, Batch No. RAB-068, which failed description and physical tests. M/s Bee Dee Pharmaceuticals: Manufacturer of TINIDAZOLE WITH NORFLOXACIN DT TABLETS, Batch No. NT-193, which failed disintegration test. M/s. Indchemie Health Specialities Pvt. Ltd.: Manufacturer of Metron (Metronidazole Tablets IP), Batch No. MRT-13003S, which failed dissolution test. M/s. Anchor Pharma Pvt. Ltd.: Manufacturer of Chloroquine Phosphate Tablets I.P., Batch No. A2/190, which failed Assay of Chloroquine Phosphate test. M/s. Globela Pharma Pvt. Ltd.: Manufacturer of Doxycycline Hydrochloride Capsules IP 100mg, Batch No. GC73405, which failed Uniformity of Weight test. Biogenetic Drugs Pvt.Ltd: Manufacturer of Ibuprofen Tablets IP 400 mg, Batch No:15033-BG137, which failed Dissolution test. Alkem Laboratories Ltd: Manufacturer of Sumol Plus Suspension of Mefenamic Acid, Batch No : SULS3010IB, which failed Assay Content test. M/s. Tanmed Pharmaceuticals: Manufacturer of Dinac-50 Tablets (Diclofenac Sodium Tablets IP), Batch No.: TNT-010, which failed Disintegration test. M/s. Kairav Chemicals Ltd.: Manufacturer of Diclofenac Sodium IP, Batch No.: DS/01/13/085, which failed Loss on Drying test. M/s. Sara Pharmaceuticals: Manufacturer of Lignocaine Hydrochloride and Adrenaline Injection IP, Batch No.: LA 2106A, which failed Description, Particulate Matter & Assay tests. M/s. Mankind Pharma Limited & M/s. R.K Laboratories (P) Ltd.: Manufacturers of MAHACEF-500 (Ceftriaxone Injection IP & Sterile Water for Injection IP 5 ml), Batch No: C3AAM003, R120076, which failed Clarity of Solution test. M/s. Biomed Life Sciences: Manufacturer of Rabfess Injection (Rabeprazole Sodium 20 mg Lyophillized Powder for Injection & Sterile Water for Injection BP), Batch No: VI0201, DEE01, which failed Clarity of Solution & Particulate Matter tests. Karnataka Antibiotics & Pharmaceuticals Ltd. & M/s. Nirma Ltd.: Manufacturers of Cetriax – 1gram (Ceftriaxone for Injection USP & Sterilised Water for Injection BP 10 ml), Batch No: 4404913, 3502272, which failed Clarity of Solution, Completeness & Particulate Matter tests. M/s. Kanha Biogenetic Laboratories: Manufacturer of Ramipril Tablets IP 2.5mg (Eldapril 2.5), Batch No.: ARKB 3054, which failed Assay test. M/s. ARBRO PHARMACEUTICAL LTD.: Manufacturer of SALBUTAMOL TABLETS – I.P. 2 mg, Batch No – AT-13121, which failed Assay test. M/s. WINGS PHARMACEUTICAL LTD: Manufacturer of SALBUTAMOL TABLETS – I.P. 4 mg, Batch No – SSMT-1004, which failed Assay test. M/s. MAIDEN PHARMACEUTICALS LIMITED: Manufacturer of Ranitidine Hydrochloride – Tablets B.P. (MANTEK-150), Batch No – MT13-011, which failed Uniformity of weight and Assay tests. M/s. Caplin Laboratories Ltd.: Manufacturer of Diclofenac Sodium Gel 1% (SPORT GEL), Batch No – BO-2, which failed Assay of Diclofenac Diethylamine test. M/s. Santo Formulation: Manufacturer of Serratiopeptidase, DIclofenac Sodium and Paracetamol Tablets (Sendic Plus), Batch No – 7030, which failed Assay of Serratiopeptidase test. M/s. Dallas Formulations P Ltd.: Manufacturer of Rabeprazole and Domperidone Sustained Release Caps (Rabela DSR Caps), Batch No – DMC-81, which failed Assay of Rabeprazole Sodium test.
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Annexure List of Drugs, Medical Devices and Cosmetics declared as not of standard quality/spurious/adulterated/misbranded by Regional Drugs Testing Laboratory, Guwahati-37 For the Month of August, 2014 Sl. Name of Batch No./Date of Reason for Drawn By From No Drugs/medical Manufacture/Date of failure with . device/cosmeti Expiry/Manufactured By Report No. cs (in Form- 13)& Date 1 ERYTHROMY B. No. EE009, Disintegration C D S C O , R D T L, CIN D/Mfg. Jul, 2013 , 09494/2014-15 East Zone Guwahati D/Exp. Jun, 2015, Dated ESTOLATE Mfg. By. 04-08-2014 TABLETS M/s Hecatomb Laboratories Pvt. Ltd., Bagharbori, Panjabari, Guwahati- 37, Assam. 2 R-ZONE 20 B. No. RAB-113, Dissolution CDSCO, RDTL, TABLETS D/Mfg. Apr, 2014, 09534/2014-15 East Zone. Guwahati D/Exp. Mar, 2016, Dated Mfg. By. 13-08-2014 M/s Regent Ajanta Biotech, Indl Site:86-87,Village- Makhiyali Dundi, Peerpura Road, Roorkeee, Uttarakhand. 3 ERYRAB B. No. RAB-068, Description, CDSCO, RDTL, SUSPENSION D/Mfg. Jun, 2013, Physical East Zone Guwahati D/Exp. May, 2015, 09555/2014-15 S Mfg. By. Dated M/s Regent Ajanta Biotech, 19-08-2014 86-87, Village-Makhiyali Dundi, Peerpura Road, Roorkeee, Uttarakhand. 4 TINIDAZOLE B. No. NT-193, Disintegration CDSCO, RDTL, WITH D/Mfg. Feb, 2012, 09571/2014-15 East Zone Guwahati D/Exp. Jan, 2015, Dated NORFLOXACI Mfg. By. 26-08-2014 N DT M/s Bee Dee Pharmaceuticals,, TABLETS Kalapahar Industrial Area, Guwahati-781026, Assam. 5 Metron B.No. MRT-13003S, Dissolution CDSCO, CDTL, Mumbai (Metronidazole D/Mfg. Feb, 2013, West Zone D/Exp. Jan, 2016 Tablets IP) Mfg. By. M/s. Indchemie Health Specialities Pvt. Ltd., Village- Kumrek, Rangpo, East Sikkim- 7371326 Chloroquine B.No. A2/190, Assay of CDSCO, CDTL, Mumbai Phosphate D/Mfg. Jan, 2014, Chloroquine West Zone D/Exp. Dec, 2016 Phosphate Tablets I.P. Mfg. By. M/s. Anchor Pharma Pvt. Ltd., B-6, O.I.D.C., Ringanwada, Daman-396210 7 Doxycycline B.No. GC73405, Uniformity of CDSCO, CDTL, Mumbai Hydrochloride D/Mfg. Aug, 2013, Weight West Zone D/Exp. July, 2016 Capsules IP Mfg. By. 100mg M/s. Globela Pharma Pvt. Ltd., 357, G.I.D.C., Sachin Surat- 394230, Gujarat 8 Ibuprofen B.No:15033-BG137 Dissolution CDSCO, CDTL, Chennai Tablets IP 400 18/11/330/14- Hyderabad D/Mfg. Mar, 2013 mg 15/ D/Exp. Feb, 2016/ Mfg. By. Biogenetic Drugs Pvt.Ltd, Jharmazri Baddi-174 103, Dist- Solan 9 Sumol Plus B.No : SULS3010IB, D/Mfg. Assay Content CDSCO, CDTL, Chennai Suspension of Mefenamic South Zone 08.2013, D/Exp. 07.2015 Acid Mfg. By.-Alkem Laboratories 18/D/201/14- Ltd, At.Village Thana, Baddi, 15 Himachal Pradesh-173 205. 10 Dinac-50 B. No.: TNT-010, Mfg dt: Disintegration CDSCO, CDL, Kolkata Tablets 05/2013, Exp dt: 04/2016, Mfd South Zone. 32-10/2014- (Diclofenac by: M/s. Tanmed SS/ Sodium Tablets Pharmaceuticals, New No.1/429, IP) Multi Industrial Nagar, DCA(S)- Gerugambakkam, Chennai 02/1078 600122 Dt. 12.08.2014 11 Diclofenac B. No.: DS/01/13/085, Mfg dt: Loss on CDSCO, CDL, Kolkata Sodium IP, 29/07/13, Exp dt: 27/07/2018, Drying West Zone, Mfd by: M/s. Kairav Chemicals 32-9/2014-SS/ Ltd., Block No 2221, Vill: Santej, Tal: Kalol, Distt. DCA(W)- Gandhinagar, Gujarat 78/1118 Dt. 19.08.201412 Lignocaine B. No.: LA 2106A, Mfg dt: Description, CDSCO, CDL, Kolkata Hydrochloride 09/2012, Exp dt: 08/2014, Mfd Particulate Subzone, and Adrenaline by: M/s. Sara Pharmaceuticals, # Matter & Goa Injection IP 4 & 15, Industrial Estate, Assay Nagercoil, Tamil Nadu. 32-21/2014- SS/ DCA(G)- 06/1007 Dt. 04.08.2014 13 MAHACEF- B.No: C3AAM003, R120076, Clarity of CDSCO, CDL, Kolkata 500 Mfg dt: 12/2013, 11/2012, Exp Solution Chandigarh (Ceftriaxone dt: 11/2015, 10/2016, Mfd by: 32-18/2014- Injection IP & M/s. Mankind Pharma Limited, SS/ Sterile Water Kishanpura, Jamniwala, Teh: for Injection IP Paonta Sahib, Distt. Sirmour DCA(C)- 5 ml) 173025, H.P & M/s. R.K 40/1079 Laboratories (P) Ltd., Village – Manpura, Nalagarh, Distt. Solan Dt. 12.08.2014 (H.P.) – 174 101. 14 Rabfess B.No: VI0201, DEE01, Mfg dt: Clarity of CDSCO, CDL, Kolkata Injection 06/2013, 05/2012, Exp dt: Solution & Chandigarh (Rabeprazole 06/2015, 04/2018, Mfd by: M/s. Particulate Sodium 20 mg Biomed Life Sciences, 5 Dewan Matter Lyophillized & Sons, Lokmanya Nagar, 32-18/2014- Powder for Palghar (W), Thane – 401 404, SS/ Injection & India. Sterile Water DCA(C)- for Injection 02/1031 BP), Dt. 08.08.2014 15 Cetriax – 1gram B.No: 4404913, 3502272 Mfg dt: Clarity of CDSCO, CDL, Kolkata (Ceftriaxone for 10/2013, 02/2013 Exp dt: Solution, SubZone Injection USP 09/2016, 01/2018, Mfd by: M/s. Compleateness Bangalore & Sterilised Karnataka Antibiotics & & Particulate Water for Pharmaceuticals Ltd., Plot No. Matter Injection BP 10 14, II Phase, Peenya, Bangalore 32-13/2014- ml), 560058 & M/s. Nirma Ltd., SS/ Sachana, Gujrat – 382150 DCA(B)- 74/1080 Dt. 12.08.201416 Ramipril B. No.: ARKB 3054, Mfg dt: Assay CDSCO, CDL, Kolkata Tablets IP 04/2013, Exp dt: 03/2015, Mfd East Zone 32-8/2014-SS/ 2.5mg (Eldapril by: M/s. Kanha Biogenetic 2.5), Laboratories, Pl.No. 1-B, EPIP, DCA(E)- Phase-I, Jharmajri, Baddi, Solan 327/1088 (HP). Dt. 14.08.2014 17 SALBUTAMO Batch No – AT-13121, D/Mfg. Assay CDSCO,, RDTL, L TABLETS – SEP./2013, D/Exp. – North Zone CHandigarh RDTL/757/13- I.P. 2 mg AUG./2015, Mfd. By- M/s. 14 ARBRO PHARMACEUTICAL LTD., 6/14, Kirti Nagar, Date:- 08-08- Industrial Area, New Delhi- 14 110015. 18 SALBUTAMO Batch No – SSMT-1004, D/Mfg. Assay CDSCO, RDTL, L TABLETS – JUL./2013, D/Exp. – North Zone Chandigarh RDTL/768/13- I.P. 4 mg JUN./2015, Mfd. By- M/s. 14 WINGS PHARMACEUTICAL LTD, 35, HPSIDC, Industrial Date:- 08-08- Area, Baddi-173205. 14 19 Ranitidine Batch No – MT13-011, D/Mfg. Uniformity of CDSCO, RDTL, Hydrochloride – APR./2013, D/Exp. – weight and North Zone Chandigarh Tablets B.P. MAR./2016, Mfd. By- M/s. Assay (MANTEK- MAIDEN RDTL/893/13- 150) PHARMACEUTICALS 14 LIMITED, 81, H.S.I.D.C, Industrial Area, Kundli, 131 028 Date:- 08-08- (HR) 14 20 Diclofenac Batch No – BO-2, D/Mfg. – Assay of CDSCO, RDTL, Sodium Gel 1% MAR./2014, D/Exp. – Diclofenac Sub Zone, Chandigarh FEB./2017, Mfd. By- M/s. Diethylamine Chandigarh. (SPORT GEL) Caplin Laboratories Ltd., LSD/RDTL/00 At.Argus Salud Pharma LLP, 17/14-15 Khasra No.380, Village Suraj Majra, NH-21A, Baddi, H.P. Date:- 27-08- 1421 Serratiopeptidas Batch No – 7030 Assay of CDSCO, J& RDTL, e, DIclofenac D/Mfg. – AUG./2013 Serratiopeptida K, Chandigarh Sodium and D/Exp. – JUL./2015 se Paracetamol Mfd. By- LSD/RDTL/00 Tablets (Sendic M/s. Santo Formulation, 38/14-15 Plus) Deonghat, P.O. Saproon, Date:- 27-08- Distt.Solan-173211(H.P.) 14 22 Rabeprazole Batch No – DMC-81 Assay of CDSCO, RDTL, and D/Mfg. – MAR./2014 Rabeprazole Sub Zone, Chandigarh Domperidone D/Exp. – AUG./2015 Sodium Chandigarh. Sustained Mfd. By- LSD/RDTL/00 Release Caps M/s. Dallas Formulations P Ltd., 1/14-15 (Rabela DSR 144, DIC, Industrial Area, Sai Date:- 29-08- Caps) Road, Baddi. (HP) 14

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