Key January 2026 regulatory updates

▸ The New Drugs and Clinical Trials (Amendment) Rules, 2026 were notified via Gazette G.S.R. 46(E) dated 20 January 2026, amending the New Drugs and Clinical Trials Rules, 2019.
▸ These amendments introduce a “prior intimation” mechanism, alongside “permission”, for manufacture of new drugs or investigational new drugs meant for analytical and non clinical (pre clinical) testing.
▸ The change applies to manufacture for analytical and non clinical testing only and explicitly excludes certain high risk categories (sex hormones, cytotoxic drugs, beta lactams, biologics with live microorganisms, and narcotic/psychotropic substances).
▸ Applicants must still file online in Form CT 10 to the Central Licensing Authority, but for eligible products they can proceed with manufacture once prior intimation is acknowledged, rather than waiting for a formal permission letter, thereby shortening timelines.
▸ Related forms in the Eighth Schedule, including CT 10, CT 12 and CT 13, have been revised to incorporate the “prior intimation” construct.
▸ As per Gazette G.S.R. 50 (dated 21 January 2026): The New Drugs and Clinical Trials (Second Amendment) Rules, 2026 introduce a “prior intimation” mechanism (instead of prior permission) for certain bioavailability (BA) / bioequivalence (BE) studies, making the approval process faster and simpler in specific cases. The rules come into force 90 days after publication in the Official Gazette CDSCO’s Gazette Notifications page for January 2026 lists, in addition to G.S.R.
▸ 46(E), a separate draft notification G.S.R. 45(E) on possible exemption of animal toxicity studies under certain conditions; this is a draft at this stage and, if finalized, could impact pre-clinical CRO toxicology workloads and study designs.
▸ CDSCO’s public facing sections (e.g., Public Notices, Daily Dispatch Reports, SEC recommendations) list routine operational documents around January 2026,

Implications for CROs – clinical, bioanalytical, pre‑clinical

▸ Veeda and sponsor companies manufacturing or procuring new drugs/INDs for bioanalytical method development, stability work, and routine analytical testing can expect reduced lead time once the rules come into force (45 days from publication in the Gazette).
▸ Veeda’s Pre Clinical division conducting non clinical toxicology or pharmacology studies will benefit from faster access to test articles manufactured under the prior intimation route, except for the excluded high risk categories.
▸ Veeda’s Clinical Trials division will not see a change in core trial authorization requirements, but upstream simplification of manufacturing for analytical/non clinical purposes may ease study start up logistics (e.g., reference standards, stability batches).