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Centre to amend Rules to mandate PAC submission to licensing authority
Chronicle Pharmabiz
|March 19, 2026
THE Union Health Ministry has issued a draft amendment to various rules under the D&C Rules, 1945, to include requirement of the manufacturing and loan licenses for drugs, biopharmaceuticals, and those under the Indian Systems of Medicine, among others, mandating submission of information related to post approval changes (PACs) with the licensing authority.
Amendments have been proposed in rule 74 related to conditions for manufacturing license in Form 25, for drugs other than those specified in Schedules C and C(1) and X, rule 74B related to conditions of loan licence in Form 25A for the same drugs, rule 74A related to conditions for license in Form 25B to repack for sale or distribution of drugs other than those specified in Schedules C and C (1), rule 78 related to conditions of
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