In pursuance of Gazette Notification G.S.R. 50(E) dated January 21, 2026, amendments were made to the New Drugs and Clinical Trials Rules, 2019 introducing a system of prior intimation to come into force after ninety (90) days from the date of publication in the Official Gazette. The period of ninety (90) days from the date of publication is completed on April 21, 2026, and the provisions of the said notification come into force with effect from April 21, 2026.

All stakeholders are required to submit online applications (for export purpose only) as prior intimation in Form CT-05 on the Sugam portal, in compliance with the requirements and provisions specified in the Gazette Notification.

The Prior Intimation System shall be applicable to single-dose, two-period, two-sequence, two-treatment bioavailability or bioequivalence studies in normal healthy adult human volunteers (for export purpose only), oral dosage forms of drugs excluding drugs of Cytotoxic, Hormone, Narcotic and psychotropic substances categories and drugs with narrow therapeutic index or highly variable pharmacokinetics, and drugs already approved in India or any one of the countries namely United States of America, European Union, Japan, Australia, Canada and United Kingdom. The application of prior intimation shall be accompanied with approval of the Ethics Committee registered with the Central Licensing Authority under Rule 8 of the New Drugs and Clinical Trials Rules, 2019. The sample size shall be more than or equal to eighteen (18). Ethics Committees are required to maintain a separate record of review and approval of such studies conducted on the basis of acknowledgement of prior intimation, which shall be reviewed by the Central Licensing Authority at the time of renewal of registration, inspection, or as required.

Once the application in Form CT-05 is submitted online on the Sugam portal, the acknowledgement of application submission received from the portal may be treated as “prior intimation” and may be used accordingly. For all other purposes or categories not covered under the amended rules, the existing system of prior approval shall remain applicable.

“Single-dose, two-period, two-sequence, two-treatment, bioavailability or bioequivalence studies in normal healthy adult human volunteers (for export purpose only).

Oral dosage form of a drug, other than drugs of Cytotoxic, Hormone, Narcotic and psychotropic substances categories and Drugs with narrow therapeutic index or Drugs having highly variable pharmacokinetics.

Already approved in India or any one of the countries, namely, United States of America, European Union, Japan, Australia, Canada and United Kingdom.

The application of the prior intimation shall be accompanied with approval of the Ethics Committee registered with the Central Licensing Authority under rule 8 under New Drugs and Clinical Trials Rules, 2019.

The samples size shall be more than or equal to eighteen (18).

Ethics Committee shall maintain a separate record of review and approval of such bioavailability or bioequivalence studies being conducted on the basis of the acknowledgement of prior intimation, which shall be reviewed by the Central Licensing Authority at the time of renewal of the Registration of the Ethics Committee or any inspection or whenever required by the Central Licensing Authority.”