The Ministry of Health and Family Welfare (MoH&FW) on June 23, 2026, issued the Draft Drugs (...... Amendment) Rules, 2026, further to amend the Drugs Rules, 1945.
The following has been amended, namely:
• Rule 34 has been amended to permit importers of eligible drugs (excluding sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic drugs) to submit an online prior intimation in Form 12 to the Central Licensing Authority and import the drugs based on the acknowledgement received, instead of obtaining an import licence.
• Consequential amendments have been made to Rules 33 and 35 to recognise the acknowledgement of prior intimation on par with an import licence for matters relating to import conditions, inspection, compliance, cancellation and appeals.
• Further, Form 12 in Schedule A has been revised by replacing references to "Licence" with "Licence or Prior Intimation", thereby aligning the prescribed form with the new regulatory framework.
Comments/Suggestions are invited till July 27, 2026.
[Notification no. - G.S.R. 509(E)]
