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Date: 2024-05-17 Category: Not Applicable State: Union Government Country: India

SPURIOUS ALERT FOR THE MONTH OF APRIL 2024

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 is a Spurious Alert notification for the month of April 2024, issued by the drug authorities for the National Capital Territory (NCT) of Delhi and Jharkhand. It identifies specific drugs found to be spurious, along with details of the manufacturer (as per label), expiry date, sales outlets involved, and methods to differentiate the spurious product from the original, as provided by the original manufacturer.

Key Changes

  • Five products have been identified as spurious in Delhi and Jharkhand.
  • The spurious products identified are: Instgra Tablets (Dolutegravir Tablets IP 50 mg), Telmisartan 40mg and Amlodipine 5mg Tablets I.P. (Telma-AM), Domperidone and Naproxen Sodium Tablets (Naxdom 500), Rifaximin Tablets (Rifagut 400), and Cefixime Trihydrate with Lactic Acid Bacillus Tablets LP (Presef 200 LB Tablets).
  • Multiple sales outlets in Delhi, Rajasthan, Maharashtra, and Jaipur are listed as being involved in the distribution of spurious Instgra Tablets.
  • Sales outlets in Delhi are listed as being involved in the distribution of spurious Telmisartan and Amlodipine Tablets.
  • Sales outlets in Delhi and Patna are listed as being involved in the distribution of spurious Domperidone and Naproxen Sodium Tablets.
  • Sales outlets in Delhi and Patna are listed as being involved in the distribution of spurious Rifaximin Tablets.
  • Sales outlets in Assam, Jharkhand and West Bengal are listed as being involved in the distribution of spurious Cefixime Trihydrate with Lactic Acid Bacillus Tablets.
  • The notification mentions that Uttar Pradesh did not submit spurious alert data in the required format for April 2024.
  • Mizoram, Tripura and Pondicherry reported 'NIL' spurious data for April 2024.
  • Several states and union territories including Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep did not submit any data regarding spurious alerts for April 2024.

Impact Analysis

Regulatory Authorities (NCT of Delhi, Jharkhand, CDSCO, State Drugs Licensing Authorities)

  • Action Item: Regulatory authorities should strengthen their surveillance and enforcement capabilities, including increased inspections, intelligence gathering, and collaboration with other agencies. They should also streamline the process for reporting and investigating suspected spurious drugs and impose strict penalties on offenders. Harmonization of data reporting formats across states is crucial.

Patients/Consumers

  • Action Item: Public awareness campaigns should be initiated to educate consumers on how to identify genuine medicines and report suspected spurious drugs. Consumers should always purchase medicines from licensed pharmacies and verify the authenticity of the product before consumption.

Pharmaceutical Manufacturers (Emcure, Glenmark, Pure and Cure Healthcare, Sun Pharma, Pragti Remedies)

  • Action Item: Manufacturers should enhance their anti-counterfeiting measures, including advanced packaging technologies, track and trace systems, and collaboration with law enforcement agencies. They should also actively participate in public awareness campaigns to educate consumers about identifying genuine products.

Pharmacies and Retailers

  • Action Item: Pharmacies and retailers should implement strict quality control measures to ensure the authenticity of the medicines they stock. This includes purchasing from authorized distributors, verifying product documentation, and training staff to identify suspected spurious drugs. Regular audits and inspections should be conducted to maintain compliance.

Distributors and Supply Chain

  • Action Item: Distributors should implement robust traceability systems to track the movement of pharmaceutical products throughout the supply chain. They should also conduct thorough due diligence on their suppliers and customers to ensure they are not involved in the distribution of spurious drugs. Regular training should be provided to staff on identifying and reporting suspected counterfeit products.

Key Entities Referenced

Emcure Pharmaceuticals Ltd.: Manufacturer (as per label) of Instgra Tablets (Dolutegravir Tablets IP 50 mg). Glenmark Pharmaceuticals Ltd.: Manufacturer (as per label) of Telmisartan 40mg and Amlodipine 5mg Tablets I.P. (Telma-AM). Pure and Cure Healthcare Pvt. Ltd.: Manufacturer (as per label) of Domperidone and Naproxen Sodium Tablets (Naxdom 500). Sun Pharma Laboratories Ltd.: Manufacturer (as per label) of Rifaximin Tablets (Rifagut 400). Pragti Remedies: Manufacturer (as per label) of Cefixime Trihydrate with Lactic Acid Bacillus Tablets LP (Presef 200 LB Tablets). NCT of Delhi: National Capital Territory of Delhi, one of the regions where spurious drugs were identified. Jharkhand: State in India, one of the regions where spurious drugs were identified. CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals in India. State Drugs Licensing Authorities: State-level regulatory bodies responsible for licensing and monitoring pharmaceutical activities within their respective states. DCG(I): Drugs Controller General (India); reference made to circular dated 09.02.2024 regarding data submission.
Official Source Record View Original Source →
See Full Document Text
SPURIOUS ALERT FOR THE MONTH OF APRIL – 2024. NCT of DELHI S. No. Product/Drug B. No. Manufactur Expiry Manufactured Sales Outlets Response of Reported Name ing Date Date By as per label Involved in Original by Distribution of Manufacturer CDSCO/ Spurious Drugs stating how to State/Ma (Name and address identify the nufactur of outlet with pin original er code and product from pharmacist name reported with registration spurious number) product 1 Instgra E16DV23 Feb.2023 Sep.2026 Emcure 1) M/s. Harsh Based on NCT of Tablets 001 Pharmaceutical Pharma Capital Delhi p h y s i c a l D e l h i (Dolutegravir s Ltd., Lane No. verification Tablets IP 50 3, Phase II, 2) M/s. Vedas with original mg) SIDCO, Bari- Healthcare Delhi p r o d u c t o n s p o t Brahmana, and SLA email Jammu – 181 3) M/s. Mili dt. May 10, 133, India Healthcare Mumbai 2 0 2 4 4) M/s. Khushi Enterprises Jaipur 5) M/s. V. K. Enterprises Jaipur 2 Telmisartan 18230073 Feb.23 Jan.26 Glenmark 1) M/s. Dass Medical As per SLA NCT of 40mg and Pharmaceutical Store Delhi (on email dt. May Delhi Amlodipine s Ltd. Samlik direction of court) 1 0 , 2 0 2 4 5mg Tablets Marchak, Page 1 of 3I.P. (Telma- Industrial 2) M/s. Shree Giriraj Ji AM) Growth Centre, Pharma Delhi East Sikkim, Sikkim-737135 3) M/s Amba Medicose Delhi 3 Domperidone FHA0966 Dec.2023 Nov. 2026 Pure and Cure 1) M/s. Jai Mata Di Based on NCT of and Naproxen Healthcare Pvt. Bhagirath Palace physical Delhi Sodium Ltd. Plot No. Delhi c o m p a r is o n Tablets 26A, 27-30, and analytical (Naxdom 500) Sector-8A, 2) M/s. JMD tests done by I.I.E., Sidcul, Enterprises Patna manufacturer Ranipur, and SLA email Haridwar-249 dt. May 10, 403 2024 (Uttarakhand) 4 Rifaximin GKE0938 June. 2023 May. 2025 Sun pharma 1) M/s. Jai Mata Di Based on NCT of Tablets A laboratories ltd. Bhagirath Palace physical Delhi (Rifagut 400) Plot No. 754, Delhi c o m p a r is o n Setipool, and analytical Nandok Block, 2) M/s. JMD tests done by R.O. Ranipool, Enterprises Patna manufacturer East Sikkim- and SLA email 737 dt. May 10, 2024 JHARKHAND 5 Cefixime BHCJ-009 Nov. 2022 Oct. 2024 Pragti 1. M/s. Pragti Based on SLA SLA, Trihydrate Remedies Plot Remedies Plot No. email dt. May Jharkhan with Lactic No. 143 GS 143 GS Road Link 13, 2024 d Acid Bacillus Road Link Ulubari Guwahathi Tablets LP. Ulubari Assam 781008; (Presef 200 Guwahathi Page 2 of 3LB Tablets) A s s a m 7 8 1 0 0 8 2 . M / s. Pama ★Serial No. 14 (This firm does Pharmaceuticals Devi of NSQ alert not exist at the Mandap Road Ratu of April, 2024 given address Road Ranchi; as per SDC, Assam vide 3. M/s. Sarthak letter no- Agency Kathitand CFDA/2019/05/ Ratu Road Ranchi; PT-1/1073, Dt. 19.03.2024) 4. M/s. Life Saver 11/1 Dewan Gazi Road Kolkata West Bengal NOTE: 1. Spurious Alert data was not received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Uttar Pradesh for the Month of April, 2024 as per DCG(I) Circular dated 09.02.2024. 2. Sate Drugs Licensing Authorities of Mizoram, Tripura, Pondicherry have stated that the Spurious data as “NIL” for the Month of April, 2024. 3. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Spurious Alert for the Month of April, 2024 as per DCG(I) Circular dated 09.02.2024. Page 3 of 3

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