Okay, here is the summary of the provided policy text, following your specified structure:
**Executive Summary:**
This circular from the Central Drugs Standard Control Organization (CDSCO) addresses the implementation of Schedule M (revised vide GSR No. 922E dated 28.12.2023) and various WHO Technical Report Series (TRS) guidelines. It requests that all manufacturers conduct a gap analysis and take the necessary steps to comply with the requirements outlined in these guidelines. This is for information and necessary compliance.
**Key Points / Main Content:**
* **Subject:** Implementation of revised Schedule M and WHO TRS guidelines.
* **Reference Documents:**
* Schedule M revision (GSR No. 922E dated 28.12.2023).
* Various WHO TRS guidelines, including WHO TRS 1044 Annexure 2 (GMP for sterile products).
* **Compliance Requirement:** Manufacturers must perform a gap analysis.
* **Required Action:** Manufacturers must take necessary steps to comply with the guidelines.
**Impact Analysis**
* **Vaccine Manufacturers/Sterile Product Manufacturers:**
* *Impact:* Required to comply with revised Schedule M and WHO TRS guidelines, potentially necessitating changes to manufacturing processes.
* *Action Required:* Conduct a gap analysis and implement changes to ensure compliance.
* **State Drugs Controllers:**
* *Impact:* Responsible for overseeing and ensuring manufacturer compliance within their jurisdiction.
* *Action Required:* Ensure manufacturers within their state are aware of and comply with the guidelines.
* **CDSCO Zonal/Sub-Zonal Offices:**
* *Impact:* Responsible for monitoring and enforcing compliance with the guidelines.
* *Action Required:* Monitor manufacturers within their zones for compliance.
Key Entities Referenced
Directorate General of Health Services: An attached office of the Ministry of Health & Family Welfare.
Central Drugs Standard Control Organization: National Regulatory Authority in India for Pharmaceuticals and Medical Devices.
Schedule M: Good Manufacturing Practices (GMP) requirements for pharmaceutical products in India.
WHO Technical Report Series: A series of technical reports published by the World Health Organization (WHO) on various aspects of pharmaceuticals and healthcare.
GSR No. 922E: A Gazette of India notification number related to the revision of Schedule M.
WHO TRS 1044 Annexure 2: Specific guidance within the WHO Technical Report Series focusing on good manufacturing practices for sterile pharmaceutical products.
Dr. Rajeev Singh Raghuvanshi: Drugs Controller General of India (DCGI)
All State Drugs Controllers: Regulatory authorities responsible for drug control within individual states of India.
File No. QMS/38/Misc/2024
Directorate General of Health Services
Central Drugs Standard Control Organization
(QMS Monitoring Division)
Dated:
Circular 07 AUb 2094
Subject: Implementation of Schedule M and WHO Technical Report Series (TRS)
- regarding.
This is with reference to revision of Schedule M vide GSR No. 922(E) dated
28.12.2023 and various WHO TRS guidelines including WHO TRS 1044 Annexure-
2 “WHO good manufacturing practices for sterile pharmaceutical products” which
are published by WHO from time to time.
In this regard, it is requested that all manufacturers should take necessary steps for
compliance with respect to various requirements as per above guidelines after due
gap analysis.
This is for information and necessary compliance.
(Dr. Rajeev Singh Kaghuvanshi)
Drugs Controller General (India)
To
1. All vaccine manufacturers/Sterile product manufacturers.
2. All State Drugs Controllers.
3. All Zonal / Sub Zonal offices of CDSCO.
4. CDSCO website.
5. DCG(I) guard file.