Amendment to Rule 89 of the Drugs Rules, 1945 for obtaining licence under Form 29 for additional manufacturing licence categories

Through G.S.R. 713(E), the Central Government has notified the Drugs (Twelfth Amendment) Rules, 2026 after considering stakeholder comments received on the draft amendment issued under G.S.R. 299(E) dated 21 April 2026. The amendment modifies Rule 89 of the Drugs Rules, 1945 by replacing the earlier reference to “Form 25 or Form 28” with a broader list of manufacturing licence categories, namely Form 25, Form 25A, Form 25F, Form 28, Form 28A, Form 28B, Form 28D, Form 28DA, Form 28E and Form 28F. This change expands eligibility for obtaining licences in Form 29 for testing, examination and analysis purposes across additional categories of drug manufacturing licences. The amendment comes into force from the date of its publication in the Official Gazette.