Drug Controller General (India) Circular The DCGI has issued a circular regarding the implementation of revised Schedule M and WHO Technical Report Series (TRS) guidelines. All vaccine and sterile product manufacturers are requested to comply with the requirements outlined in these guidelines after conducting a gap analysis. This circular aims to ensure adherence to good manufacturing practices for sterile pharmaceutical products.
DCGI Mandates Compliance with Revised Schedule M and WHO TRS Guidelines for Vaccine and Sterile Product Manufacturers. The Drug Controller General of India (DCGI) has issued a circular on August 7, 2024, mandating the implementation of revised Schedule M and WHO Technical Report Series (TRS) guidelines for vaccine and sterile product manufacturers. The circular references GSR No. 922(E) dated December 28, 2023, and various WHO TRS guidelines, including WHO TRS 1044 Annexure 2, "WHO good manufacturing practices for sterile pharmaceutical products." Manufacturers are required to conduct a gap analysis and take necessary steps to comply with the requirements outlined in these guidelines. This circular aims to ensure the quality and safety of vaccines and sterile products in India by aligning manufacturing practices with international standards. The DCGI has directed all vaccine and sterile product manufacturers, as well as state drug controllers, zonal/sub-zonal offices of CDSCO, and the CDSCO website, to comply with the provisions of this circular.