Biologicals · Vaccines · Biosimilars
Biologics Registration in India, From Clinical Trial to Marketing Authorisation
Shen Clinical Services provides biologics registration services in India for vaccines, monoclonal antibodies, recombinant proteins, blood products, cell-based products and biosimilars. We plan the regulatory pathway, build the CTD dossier, file with CDSCO’s Biological Division, handle Subject Expert Committee reviews and support licensing, lot release and post-approval changes, from our regulatory team in Gurugram, Delhi NCR.
CDSCO Biological DivisionThe approving authority
NDCT Rules, 2019Trials and marketing authorisation
Similar Biologics GuidelinesBiosimilar pathway
CTD DossiersQuality, non-clinical, clinical
On this page
Product Types
Biological Products We Register in India
Each class of biological product follows its own route through CDSCO:
| Product | Key approvals | What to know |
|---|---|---|
| Vaccines | Clinical trial, marketing authorisation, Form 28-D manufacturing licence | Batches undergo lot release testing at CDL Kasauli |
| Recombinant proteins and monoclonal antibodies | Marketing authorisation as a new drug, Form 28-D licence | RCGM approval for research with genetically engineered organisms, where needed |
| Biosimilars | Marketing authorisation via the similar biologics pathway | Stepwise comparability against an innovator reference product |
| Blood and blood products | Form 28-E licence under the CLAA scheme | Plasma sourcing and testing requirements apply |
| Stem cell and cell-based products | Regulated as new drugs under the NDCT Rules, 2019 | Product-specific clinical and quality data |
| Imported biologicals | Registration certificate (Form 41) and import licence (Form 10) | Overseas site and product registered before import |
Regulatory Pathway
How Biologics Approval Works in India
Key steps and CDSCO target timelines our biologics product registration services cover:
| Step | Rule / timeline |
|---|---|
| Manufacture for test or analysis | Form 29 NOC or test licence; live-organism biologics still need prior permission (45 working days) after the 2026 amendment |
| Clinical trial permission | Form CT-04 to CT-06; 90 working days target |
| Marketing authorisation for a new biological | Form CT-18 (import) or CT-21 (manufacture); 90 working days target with expert committee |
| Import registration certificate | Form 40 to Form 41; 270 working days target |
| Import licence | Form 8 to Form 10; 45 working days target |
| Manufacturing licence | Form 28-D (vaccines, r-DNA) or 28-E (blood products), granted jointly by central and state authorities |
| Vaccine lot release | Testing by the Central Drugs Laboratory, Kasauli |
| After approval | Pharmacovigilance system and PSURs for new drugs, plus post-approval change approvals |
Biosimilars
The Biosimilar Approval Pathway in India
Biosimilars, called similar biologics in India, follow an abbreviated pathway built on comparability with an innovator product:
- Reference product: an innovator biologic licensed in India or an ICH country, used throughout the programme
- Quality first: detailed analytical similarity, the foundation of the whole exercise
- Non-clinical: in vitro studies, with animal studies only where they are truly needed
- Clinical: comparative PK and PD studies, with efficacy trials only if residual uncertainty remains
- Guidelines: the 2016 Guidelines on Similar Biologics, with a revised draft published by CDSCO and DBT in May 2025
Developing the product itself? See our biosimilar development and biosimilar regulatory services.
Our Process
How Our Biologics Registration Process Works
STEP 01
Classify and Plan
We confirm the product category, pathway and approvals, including any local trial waiver.
STEP 02
Build the Dossier
We prepare the CTD, with particular care on Module 3 quality and manufacturing data.
STEP 03
File and Defend
We file with CDSCO, answer queries and prepare you for Subject Expert Committee review.
STEP 04
License and Maintain
We support licensing, lot release, post-approval changes and safety reporting.
Why Shen
Why Choose Shen for Biologics Registration Services in India
Quality and CMC Focus
Most biologics queries are about manufacturing and quality data, so that is where we start.
Physician-Led Clinical Strategy
Clinicians plan the trials and comparability arguments that support your dossier.
Trials Under One Roof
We can run the clinical trials in India your approval needs, designed with our protocol design team.
Full Lifecycle Support
From first filing to pharmacovigilance and post-approval changes.
What We Cover
Our Biologics Product Registration Services
Biologics regulatory strategy
Vaccine registration
Monoclonal antibody registration
Recombinant protein approvals
Biosimilar marketing authorisation
Blood product licensing
CTD dossier and Module 3 CMC
Clinical trial applications
Import registration and licences
Test licences and NOCs
Expert committee preparation
Post-approval changes
FAQs
Biologics Registration in India: Frequently Asked Questions
Which authority approves biologics in India?
Biologics are approved by the Biological Division of the Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India. Vaccines and sera are also tested by the Central Drugs Laboratory, Kasauli, and research involving genetically engineered organisms may need approval from DBT’s Review Committee on Genetic Manipulation.
Are biologics treated as new drugs in India?
Generally, yes. Under India’s pharmacovigilance guidance, vaccines and biologicals are always considered new drugs unless the licensing authority specifies otherwise, so they follow the New Drugs and Clinical Trials Rules, 2019 for trials and marketing authorisation.
What is the regulatory pathway for biosimilars in India?
Biosimilars, called similar biologics in India, are approved through a stepwise comparability exercise against an innovator reference product licensed in India or an ICH country: quality first, then non-clinical and clinical data. The 2016 Guidelines on Similar Biologics apply, and CDSCO and DBT published a revised draft in May 2025.
Do vaccines need lot release before sale in India?
Yes. Vaccines are subject to lot release testing by the Central Drugs Laboratory, Kasauli, so every batch is checked before it reaches the market.
How long does biologics registration take in India?
CDSCO’s Citizen Charter (2025) targets 90 working days for new drug and clinical trial applications reviewed by the Subject Expert Committee, 270 working days for an import registration certificate and 45 working days for an import licence. The clock pauses while queries are open.
Is a local clinical trial needed for an imported biological?
Not always. Rule 101 of the NDCT Rules, 2019 lets CDSCO consider waiving local trials for products approved in notified countries, decided case by case. For biosimilars, the comparability data and the Similar Biologics guidelines decide what clinical data India needs.
Resource Spotlight
Need wider support? Our medical writing services prepare the clinical and CMC summaries for your CTD. See our regulatory affairs services for drugs and devices, or appoint us as your Indian Authorized Agent if you have no Indian entity.
Bring Your Biological Product to India
Planning a filing? Ask for a biologics pathway assessment and timeline.
Developing a biosimilar? We can plan the comparability exercise with you.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: CDSCO Biologicals; Draft Guidelines on Similar Biologics, 2025 (CDSCO and DBT); CDSCO Citizen Charter (2025); NDCT Rules, 2019 and Amendment Rules, 2026. General regulatory information, not legal advice.