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**Executive Summary:**
This document from the Central Drugs Standard Control Organization (CDSCO) addresses the manufacturing and marketing of Fixed Dose Combinations (FDCs) containing Tolperisone HCl 150mg and Paracetamol 500mg tablets. It refers to previous communications and directs State/UT Drugs Controllers to ensure compliance with regulatory requirements. The document emphasizes the need for manufacturers to update their product monographs in line with current knowledge and regulations.
**Key Points / Main Content:**
* **Subject:** Manufacturing and marketing of FDCs containing Tolperisone HCl 150mg and Paracetamol 500mg tablets.
* **Reference:** The document refers to previous communications and directives regarding FDCs.
* **Directives to State/UT Drugs Controllers:**
* Ensure that the manufacturing and marketing of the specified FDC are in compliance with current regulatory requirements.
* Take necessary action to adhere to the directions issued by the Government.
* **Responsibilities of Manufacturers:**
* Update the product monograph for the FDC in light of recent knowledge and regulatory changes.
* Comply with labeling requirements.
**Impact Analysis**
* **State/UT Drugs Controllers**
* *Impact:* Responsible for enforcing the directives related to the manufacturing and marketing of the specified FDC within their jurisdiction.
* *Action Required:* Ensure compliance with the guidelines, and take necessary actions.
* **Manufacturers of Tolperisone HCl 150mg and Paracetamol 500mg FDC**
* *Impact:* Must ensure their products comply with current regulations and update product monographs accordingly.
* *Action Required:* Review and update product monographs, implement necessary changes to manufacturing and marketing practices, and ensure compliance with labeling requirements.
Key Entities Referenced
Directorate General of Health Services: An organization, likely the sender's department.
Central Drugs Standard Control Organization: A central drug control organization; the sender of the notification.
All State/UTs Drugs Controller: Addressee of the notification.
Tolperisone HCI 150mg Paracetamol 500mg tablet: The Fixed Dose Combination (FDC) drug which is the subject of the notification.
Drugs Controller General India: Recipient of the notification copy.
All Zonal/Sub Zonal offices of CDSCO: Recipient of the notification copy.
Indian Drug Pharmaceuticals Association Forum: Recipient of the notification copy.
Dr. V. G. Somani: The sender of the notification.
Nil
File No. 4-213/2008-Dc
Tele. No.: | i 011-23236965 |
Government of India
Fax No. af 011-23236973 3
Directorate General of Health Services
Central Drugs Standard Control Organization
ro, (FDC Division)
Pated 91 SEP ot
All State/UTs Drugs Controller
Subject: Manufacturing and marketing of FDC of Tolperisone HCI 150mg +
Paracetamol |P 500mg tablet-regarding.
Sir,
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Yours faithfully,
Yur
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(Dr. V. G. Somani)
Copy to:- Drugs Controller General (India)
1. All Zonal/Sub Zonal offices of CDSCO.
2. Indian Drug/Pharmaceuticals
Association Forum
3. Website of COSCO