The Ministry of Health and Family Welfare on September 03, 2026, has proposed amendments to the New Drugs and Clinical Trials Rules, 2019 to modify the requirements relating to prior intimation, approval and permissions, particularly in relation to the existing provisions under Rule 31, Rule 34, Rule 35 and Rule 36.
The following has been proposed:
The words “(for export purpose only)” in the proviso to Rule 31(2) are proposed to be omitted, thereby removing this specific export-purpose limitation.
Rule 34(1) is proposed to clarify that the requirement relating to Form CT-05 will exclude cases where prior intimation under the proviso to Rule 31(2) is applicable.
Rule 35 is proposed to recognise, in addition to the existing reference to Rule 34, the acknowledgement of prior intimation under Rule 31(2) and deemed approval under Rule 34(2A), as applicable. Further, clause (xiii) of Rule 35 is proposed to be deleted.
Rule 36(1) is proposed to similarly recognise the acknowledgement of prior intimation under Rule 31(2) and deemed approval under Rule 34(2A), in addition to Form CT-07.
The proposed rules will come into force from the date specified by the Government at the time of their final publication in the Official Gazette.
