Life Sciences Product Registration in India

Artixio offers complete product registration support in India across life sciences sectors—Pharmaceuticals, MedTech, Cosmetics, Nutrition, Biologics, and Veterinary. We manage end-to-end compliance to help you launch faster.

Services We Offer

Solution by Countries

Our Industries

Getting a product approved in India involves working with multiple regulatory bodies, managing strict documentation formats, and following category-specific rules. Artixio helps life sciences companies launch their products in India confidently—with clarity, speed, and compliance at every stage.

Regulatory Bodies We Work With

Industry	Regulatory Authority
Pharmaceuticals	CDSCO (Central Drugs Standard Control Organization), DCGI
Medical Devices	CDSCO – Medical Device Division
Cosmetics	State Licensing Authorities (SLAs), CDSCO
Nutritionals	FSSAI (Food Safety and Standards Authority of India)
Biologics	CDSCO, Review Committees (e.g., SECs, Apex Committee)
Veterinary Products	CDSCO, Department of Animal Husbandry & Dairying

Product Registration Lifecycle in India

Step 1: Product Classification & Regulatory Pathway

Step 2: Data Gap Analysis & Requirements Mapping

Step 3: Dossier Preparation & Internal QA Review

Step 4: Application Submission & Authority Liaison

Step 5: License / Approval Granting

Step 6: Post-Approval Compliance & Maintenance

Why Partner with Artixio for Product Registration in India

Experts in CDSCO, FSSAI, and SLA pathways
Support for new, renewal, and import registrations
India-based team with multilingual documentation skills
Deep knowledge of India-specific templates and formats
Hands-on coordination with local regulatory officers
End-to-end support across all 6 life sciences categories

FAQs

What is required to register a pharmaceutical or medical product in India?

It depends on the product type. Common requirements include dossier submission, local testing data, product labels, Free Sale Certificate, and regulatory fees. For drugs and devices, CDSCO is the primary authority.

Is a local authorized agent needed for product registration?

Yes. For foreign manufacturers, appointing an India-based authorized agent is mandatory for regulatory submissions and communications.

Can Artixio help with both registration and post-market compliance?

Absolutely. We handle everything from dossier filing to label compliance, renewals, and change notifications across all life sciences product types.

Can registration be done without a local presence in India?

No. A local Indian entity or authorized representative is required to file the application and communicate with authorities on behalf of the foreign manufacturer.

Is prior international approval mandatory for Indian registration?

In most cases, proof of approval or sale in the country of origin is needed, along with a Free Sale Certificate. Some categories may require additional international compliance evidence.

Are site inspections or audits mandatory?

Yes, for certain product types or risk categories, Indian regulatory authorities may conduct site inspections or request audit reports as part of the registration process.

Can one registration cover multiple product variants or sizes?

Not always. Registrations are generally granted per product or per formulation. Each variant may need a separate approval, depending on regulatory classification.