New drug, import and manufacturing applications through CDSCO and the DCGI, filed on SUGAM and defended through Subject Expert Committee review.
The Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India, is the gate every new drug, import and manufacturing approval passes through. Applications are filed on the SUGAM portal, and technical questions are usually routed to a Subject Expert Committee for the relevant therapeutic area.
The scientific case is rarely what holds a file up. Incomplete dossiers, inconsistent evidence between sections and slow or partial query responses are what add months.
Dossier compilation and gap assessment, SUGAM filing, tracking, SEC preparation and query response, and the coordination between your manufacturing, clinical and quality teams that the file depends on.
For a drug approved elsewhere, whether local data is expected, and whether a waiver is realistic, changes the timeline and budget more than any other single factor. It is worth resolving before the programme is committed rather than discovering it in a Subject Expert Committee meeting.
Often substantially, but not wholesale. We assess what transfers, what needs rewriting for Indian expectations, and what has to be generated fresh, so nobody budgets for a formatting exercise and finds a data-generation project.
Tell us the molecule, the indication and where you are in the process. We will tell you what the realistic path and timeline look like.
Talk to our regulatory team