The Ministry of Health and Family Welfare on January 18, 2022 has issued the draft New Drugs and Clinical Trials (2nd Amendment) Rules, 2022 to further amend the New Drugs and Clinical Trials Rules, 2019.
The following amendment has been made:
•In rule 2, under sub-rule (1), in clause (I), the following clause shall be inserted, namely: ─
“(la) “Designated Registration Authority” means the authority designated under sub-rule (1) of rule 17;”
•In the principal rules, in Eighth Schedule, in Form CT-03,─
(a)In para1,─ (i) for the words, “The designated authority”, the words “The Designated Registration Authority” shall be substituted; (ii) the words, “Regulation of”, shall be omitted;
(b) For the words, “Central Licensing Authority”, the words “Designated Registration Authority” shall be substituted.
(Notification No. G.S.R.21(E))
