Regulatory Support for Biological Products in India

India is rapidly emerging as a key hub for both the development and commercialization of biological products. However, the regulatory pathway for biologicals, be it recombinant proteins, monoclonal antibodies, vaccines, or biosimilars, requires specialized expertise and familiarity with CDSCO protocols, clinical expectations, and post-approval requirements.

At DDReg, we deliver end-to-end CDSCO biologics products services, designed to support local manufacturers and global innovators alike in navigating India's rigorous biologics regulatory framework. Whether you are seeking biological product registration in India, clinical trial clearance, or a CDSCO manufacturing license for biologicals, our team brings scientific depth, regulatory clarity, and proven experience to the table.

Biologicals in India are regulated under the New Drugs and Clinical Trials (NDCT) Rules, 2019, and overseen by the Central Drugs Standard Control Organization (CDSCO), along with expert review committees such as the Subject Expert Committee (SEC) and technical bodies like the Review Committee on Genetic Manipulation (RCGM) and GEAC, where applicable.

The process is detailed and multilayered:

• Preclinical and characterization data must align with CDSCO’s biologics evaluation standards.
• Clinical data is typically required for both novel biologics and biosimilars, even when approved in other regions.
• Guidelines demand comparability studies, safety/efficacy trials, and product-specific CMC documentation.

This makes a knowledgeable regulatory partner essential for success in biologic product licensing in India.

• + Regulatory Strategy & Classification
  • Early-stage evaluation to determine if the product qualifies as a biosimilar or novel biologic
  • Mapping applicable Indian regulatory pathways
  • Scientific gap analysis vs. CDSCO and RCGM expectations
  • Preparation of a tailored registration roadmap
• + Clinical Trial Support
  • Clinical Trial Application (CTA) submissions as per NDCT Rules
  • Protocol development and alignment with Indian clinical trial norms
  • Site identification and investigator coordination
  • SEC meeting preparation and response strategy
• + Dossier Preparation & Biologic Product Registration in India
  • Compilation of Common Technical Documents (CTD) or eCTD for submission
  • CMC, quality, non-clinical, and clinical sections drafted per Indian format
  • Submission via SUGAM portal and regulatory follow-up
  • Support in responding to CDSCO queries and expert panel comments
• + Biological Import License for Drugs
  • Assistance with Form 44 and Form 10 submissions for foreign-origin biologics
  • Preparation of import dossiers and site master files
  • Issuance of Registration Certificates (RC) under Form 41
  • Support in logistics compliance for biological shipments
• + CDSCO Manufacturing License for Biologicals
  • Assistance in acquiring Form 28D (biologicals-specific manufacturing license)
  • Coordination with CDSCO and State FDA for site inspection readiness
  • GMP documentation review and facility preparation
• + Post-Approval Lifecycle Support
  • Labeling review and artwork approval in compliance with Indian labeling norms
  • Handling of safety updates , PSURs , and pharmacovigilance compliance
  • Managing post-approval changes, renewals, and line extensions
  • Biovigilance and risk management plan submissions as per CDSCO expectations

Bringing a biologic to India from overseas involves more than just regulatory submission. At DDReg, we specialize in facilitating market access for foreign manufacturers:

• Biological Authorized Agent Support: We act as your local regulatory representative in India, managing all CDSCO interactions and compliance requirements.
• Preparation and submission of documentation in Indian format
• Coordination for site registration, RC issuance, and clinical data bridging
• End-to-end submission through the SUGAM Portal, including deficiency resolution

We assist across the key milestones:

• Dedicated Biologics Team with CMC, regulatory, and clinical expertise
• Track Record of Approvals across biosimilars, vaccines, and recombinant products
• On-ground Engagement with CDSCO, SECs, RCGM, and GEAC
• Integrated Regulatory Solutions from early development to post-approval lifecycle
• Trusted by Global Clients for biologic product licensing in India and beyond

We don’t just manage submissions—we partner with you to accelerate compliant access to one of the fastest-growing biologics markets in the world.