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1 min read
India remains one of the world’s most strategic pharmaceutical markets—offering scale, manufacturing strength, and growing innovation. However, navigating drug registration in India has become increasingly complex, particularly for global manufacturers unfamiliar with evolving local regulations.
A clear indicator of this rising complexity is the approval trend itself. In 2024, only 19 new drugs were approved, compared to 27 in 2023. This slowdown reflects stricter regulatory scrutiny, higher data expectations, and greater procedural rigor—making expert regulatory planning more critical than ever.
Understanding India’s Regulatory Landscape
Drug approvals in India are governed by the Central Drugs Standard Control Organization (CDSCO). From clinical trial permissions and import registrations to marketing authorization and post-approval compliance, CDSCO oversight spans the entire product lifecycle.
For sponsors, common challenges include:
- Interpreting frequently updated CDSCO guidelines
- Managing complex submission pathways
- Ensuring dossier completeness and accuracy
- Coordinating with local authorities
- Maintaining compliance after approval
Without the right regulatory partner, these hurdles can lead to delays, multiple queries, or even rejection.
End-to-End Drug Registration: Why It Matters
End-to-end regulatory support means more than just filing an application. It ensures continuity, compliance, and clarity at every stage—from early strategy to post-market maintenance.
This holistic approach minimizes regulatory risk, accelerates timelines, and allows sponsors to focus on innovation rather than administrative complexity.
How Freyr Supports Drug Registration in India
At Freyr Solutions, we provide comprehensive, end-to-end Drug Registration services for India, designed to support both first-time entrants and established market players.
Our India-focused regulatory services include:
- Regulatory Strategy & Guidance
We develop customized regulatory pathways aligned with CDSCO requirements, product classification, and approval routes. - Dossier Preparation, Review & Submission
Our experts ensure dossiers are accurate, complete, and compliant—reducing review cycles and authority queries. - Local Representation & Authority Liaison
We act as your local regulatory interface, managing all communication with CDSCO and other relevant authorities. - Post-Approval & Lifecycle Management
From variations and renewals to safety updates and compliance maintenance, we support your product throughout its lifecycle.
One Partner. Complete Coverage.
Whether you are planning your first submission in India or seeking long-term regulatory support, Freyr brings together local expertise, global regulatory intelligence, and proven execution capabilities.
With a presence across 120+ countries and a global team of 2,400+ regulatory professionals, we help sponsors:
- Reduce approval timelines
- Maintain regulatory consistency
- Stay compliant in a rapidly evolving environment
The Takeaway
India’s drug approval process is no longer just about submission—it’s about strategy, precision, and sustained compliance. With the right partner, complexity becomes manageable and market access becomes achievable.
Let Freyr simplify your India drug registrations and help you bring products to market with confidence. Contact us to learn more about our end-to-end Regulatory services.
