India · Central Drugs Standard Control Organisation · Biosimilars
Review target
90 working days
official guidance
Legal time limit
-
Not published
Steps
6
5 requirements
Application fee
-
A similar biologic is shown to be similar in quality, safety and efficacy to an approved reference biologic through a step by step comparison. The Review Committee on Genetic Manipulation oversees development up to preclinical data, and the drug regulator handles clinical trials and marketing approval. Quality data cannot be shortened. Recombinant biological products that claim similarity to an innovator reference biologic approved in India or in ICH countries.
The official review target is 90 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Preclinical review by the Review Committee on Genetic Manipulation; 2. Clinical trial permission for comparative studies (90 days); 3. Comparative clinical trial; 4. Marketing authorization review; 5. Marketing permission; 6. Post marketing Phase IV study.
Outcome: Marketing permission for the similar biologic, usually with a post marketing Phase IV study.
Legal basis: New Drugs and Clinical Trials Rules, 2019 (rDNA products are new drugs); Guidelines on Similar Biologics, 2016
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 90 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 targetofficial guidance. General target for clinical trial applications in official answers to common questions. 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. 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.