India · Central Drugs Standard Control Organisation · Vaccines
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
Vaccines are always new drugs in India, so each vaccine needs permission from the Central Licencing Authority. Domestic makers also need a manufacturing licence from the State Licensing Authority with approval of the Central Licence Approving Authority. Each lot is released by the Central Drugs Laboratory in Kasauli before sale. Human vaccines imported or made in India.
The official review target is 90 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Clinical trial permission (90 days); 2. Marketing permission for the vaccine (90 days); 3. Manufacturing licence with central approval; 4. Lot release by the Central Drugs Laboratory.
Outcome: Marketing permission, manufacturing or import licence, and lot release for each lot.
Legal basis: New Drugs and Clinical Trials Rules, 2019, rule 2(w)(v); Drugs Rules, 1945, rules 3A and 68A
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 180 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. General decision limit for new drug permissions. This is the time limit written in the rules. It is an official target, not a measured review time. | 90 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in India: Registration certificate and import licence for imported drugs, Accelerated approval, Expedited review, Import of an unapproved new drug by a government hospital. See all routes on the India page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.