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Date: 2015-02-04 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of January 2015

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

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Executive Summary & Key Takeaways

What it means

  • The gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for January 2015.
  • The listed items failed quality tests conducted by various CDSCO zones and Regional Drug Testing Laboratories (RDTL).

Key Changes

  • Ten items are listed as non-standard quality, spurious, adulterated, or misbranded.
  • Failures are attributed to various reasons including particulate matter, clarity of solution, assay, dissolution, and not conforming to IP standards.
  • Affected products include antibiotics (Amoxycillin & Potassium Clavulanate, Ciprofloxacin), anti-TB drugs (Rifampicin, Isoniazid, Ethambutol, Pyrazinamide), anti-malarial drugs (Primaquine Phosphate), and other medications (Serratiopeptidase, Razocid).
  • Manufacturers of the listed products are located across India, including Himachal Pradesh, Gujarat, Daman, Uttarakhand, and Rajasthan.
  • Testing was conducted by CDSCO zones in Kolkata, Mumbai, Chandigarh, and by RDTLs in Guwahati, Chandigarh, and Ghaziabad.

Impact Analysis

Manufacturers

  • Suggested action: Immediately review manufacturing processes, quality control procedures, and testing protocols to identify and rectify deficiencies. Cooperate fully with regulatory investigations.

Distributors/Retailers

  • Suggested action: Verify inventory against the listed batch numbers and quarantine any affected products. Follow manufacturer's instructions for returns and refunds.

Consumers/Patients

  • Suggested action: Patients who have consumed products from the listed batches should consult their healthcare provider for advice and alternative treatment options.

Regulatory Authorities (CDSCO/State FDA)

  • Suggested action: Continue to strengthen surveillance and testing programs to identify and prevent the distribution of substandard drugs. Enhance collaboration between central and state regulatory bodies.

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, a network of laboratories responsible for testing and analyzing drug samples. IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India. M/s. Affy Parenterals: One of the manufacturers listed in the gazette notification for producing substandard drugs. M/s. Lupin Ltd.: One of the manufacturers listed in the gazette notification for producing substandard drugs. M/s. Macleods Pharmaceuticals Ltd.: One of the manufacturers listed in the gazette notification for producing substandard drugs. M/s. Endolabs Healthcare Pvt. Ltd.: One of the manufacturers listed in the gazette notification for producing substandard drugs. M/s Syncom Healthcare Ltd.: One of the manufacturers listed in the gazette notification for producing substandard drugs. Comed Chemicals Ltd.: One of the manufacturers listed in the gazette notification for producing substandard drugs. Elanco Healthcare Pvt. Ltd.: One of the manufacturers listed in the gazette notification for producing substandard drugs.
Official Source Record View Original Source →
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Annexure List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of January, 2015 Sl. Name of Batch No./Date of Reason for failure Drawn By From No. Drugs/medical Manufacture/Date of with Report No. device/cosmetics Expiry/Manufactured By (in Form-13)& Date 1. Elmox CV 1.2 g B. No.: AP3029 Particulate Matter & CDSCO, East CDL, (Amoxycillin & Mfg dt: 03/2013, Clarity of Solution Zone, Kolkata Kolkata Potassium Exp dt: 02/2015 32-8/2014-SS/ Clavulanate Mfd by: M/s. Affy Parenterals, Vill: DCA(E)-261/2082 injection IP 1.2g) Gullerwala, P.O. Baddi, Distt. Solan, Dt. 29.01.2015 HP 2. Akuri T-3 Tablets B. No.: A2004RP Assay & Dissolution CDSCO, East CDL, (Rifampicin, Mfg dt: 12/2012, of Rifampicin Zone, Kolkata Kolkata Isoniazid & Exp dt: 11/2014 32-8/2014-SS/ Ethambutol Mfd by: M/s. Lupin Ltd., 116 K.B. DCA(E)-107/1927 Hydrochloride Complex, Opp. Mahavir Nagar, Dt. 06.01.2015 Tablets) Vapi, Distt. Valsad, Gujarat, India 3. Forecox Tablets B. No.: HRJ3202A Assay of Rifampicin CDSCO, West CDL, (Rifampicin, Mfg dt: 12/2013, 32-9/2014-SS/ Zone, Mumbai Kolkata Isoniazid, Exp dt: 09/2016 DCA(W)-137/2053 Pyrazinamide & Mfd by: M/s. Macleods Dt. 20.01.2015 Ethambutol Pharmaceuticals Ltd., Survey No. Hydrochloride 363/1 (8-9), Plot No 8-9, Ganesh Tablets IP) Industrial Estate, Kachigam, Daman 396 210 4. Macox-ZH B. No.: HRG319A Assay & Dissolution CDSCO, West CDL, Tablets Mfg dt: 11/2013, of Rifampicin Zone, Mumbai Kolkata (Rifampicin, Exp dt: 10/2015 32-9/2014-SS/ Isoniazid, Mfd by: M/s. Macleods DCA(W)-129/2045 Pyrazinamide Pharmaceuticals Ltd., Survey No. Dt. 20.01.2015 Tablets IP), 363/1 (8-9), Plot No 8-9, Ganesh Industrial Estate, Kachigam, Daman 396 210 5. P-Quine 7.5mg B. No.: KT-13025 Does not conform to CDSCO, West CDTL, (Primaquine Mfg dt: 02/2013, IP 2010 standard Zone, Mumbai Mumbai Phosphate Exp dt: 07/2015 with respect to the Tablets I.P.) Mfd by: M/s Endolabs Healthcare test for Assay Pvt. Ltd., Khasra No. 68, 69,71, Village-Sikandarpur Bhaiswal, Near Bhagwanpur, Roorkee, Dist. Haridwar-247661 (UK).6. Razocid 20 B. No. PGT-2508, Dissolution, Drugs Control RDTL, Tablets D/Mfg. 02/2014, Report No. Department, Guwahati D/Exp. 01/2016, 10100/2014-15 Arunachal Mfg. By. Dated Pradesh M/s Affy Parenterals, 02-01-2015 Vill-Gullarwala, P.O.-Baddi, Dist.- Solan, Himachal Pradesh. 7. Ciprobiotic-Forte B. No. GHB13007, Dissolution Drugs Control RDTL, Tablets D/Mfg. 05/2013, Report No. Department, Guwahati D/Exp. 04/2016, 10122/2014-15 Nagaland Mfg. By. Dated M/s Syncom Healthcare Ltd., 08-01-2015 D-42, UPSIDC Industrial Area, Selaqui, Dehradun, Uttarakhand- 248197. 8. Serratiopeptidas B. No. B142405, Assay of CDSCO- RDTL, e Tablets IP D/Mfg. 06/2014, Serratiopeptidase Subzone, Chandigarh D/Exp. 05/2016, (81.7% against the Chandigarh (LYSER Mfg. By. Comed Chemicals Ltd., limit NLT-90% - FORTE) Solan (H.P), Village Dassomajra, 110%) P.O. Bhud, Baddi, Tehsil- Nalagarh, Report No. Solan (H.P.) LSD/RDTL/0111/14- 15, Dated: 06-01-2015 9. Ciprofloxacin B. No. EEN-020, Dissolution CDSCO, RDTL, Tablets IP D/Mfg. 05/2014, Report No. North Zone, Chandigarh D/Exp. 04/2016, RDTL/0354/14-15, Ghaziabad 500mg (ELCIP- Mfg. By. Elanco Healthcare Pvt. Dated: 30-01-2015 500) Ltd., H-1139, RIICO, Industrial Area, Phase IIIrd, Sitapura-Jaipur-302022 10. Ciprofloxacin B. No. 13004AA-SC, Dissolution CDSCO, RDTL, Hydrochloride D/Mfg. 02/2013, Report No. North Zone, Chandigarh D/Exp. 01/2016, LSD/RDTL/0395/15- Ghaziabad Tablets Mfg. By. Synocom Healthcare Ltd., 16, IP(CIPROLUP D-42, UPSIDC, Industrial Area, Dated: 30-01-2015 250) Selaqui (Dehradun) 248197, Uttarakhand

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