The Indian Pharmacopoeia Commission (IPC) has released draft monographs and general chapters for feedback, offering the industry a chance to provide feedback on planned changes to vaccine rules.
IPC released amendments to four biological documents – two on vaccines – for consultation. In one document, IPC proposed changes to a general chapter on cell substrates to produce vaccines for human use. The changes cover the need to source trypsin and recombinant dissociating enzymes that are approved by the national regulatory authority for the intended use.
In the second document, IPC discusses how to test for extraneous agents in viral vaccines for human use. The other two draft documents cover blood and blood related products, as well as vaccines and immunosera for human use.
The comment periods close on 15 and 16 January. IPC plans to bring the changes into effect in 2026.
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