Regulatory Affairs Consulting Services in India
Artixio helps life sciences companies with regulatory affairs services in India—understanding what needs to be done, preparing the right documentation, and managing the approval steps from start to finish.
Services We Offer
India’s Leading Regulatory Affairs Consulting Partner
India’s healthcare industry has grown into one of the world’s major hubs, driven by government incentives, rising R&D investments, and a strong demand for affordable therapies. As the domestic pharmaceutical sector—currently valued at over $50 billion—heads toward a projected $130 billion by 2030, and the need for reliable regulatory affairs consultancy and compliant market-entry strategies has never been higher.
Although the scale and opportunity are growing, product registration in India remains complex. It involves coordination between central and state authorities, multiple legislations, and alignment with global standards like ICH, WHO GMP, and ISO. As a regulatory affairs company in India, Artixio helps simplify this process with clear guidance and hands-on support.
Regulatory Authorities in India
| Authority | Scope |
|---|---|
| Central Drugs Standard Control Organization (CDSCO) | Central authority for new drug approvals, clinical trials, import licenses, and post-market surveillance. |
| Drug Controller General of India (DCGI) | Heads CDSCO and leads national policy for drugs and medical devices. |
| State Drug Licensing Authorities (SLAs) | Approve manufacturing and sales licenses at state level. |
| FSSAI (Food Safety & Standards Authority of India) | Regulates food supplements and nutraceuticals. |
Regulatory Affairs Process in India
Step 1 - Product Classification
- New drug: Not previously approved in India
- Generic drug: Same active ingredient as before
- Biosimilar or Vaccine
- Medical Devices: Class A to D, based on the risk
- Cosmetics/Nutraceuticals
Step 2 - Appointment of Authorized Indian Agent (For Imports)
Step 3 - Documentation and Dossier Preparation
- Common Technical Document (CTD/eCTD) format for drugs
- Device Master File (DMF) for medical devices
- Product composition and specifications
- Stability and toxicity studies
- Clinical trial data (if applicable)
- Manufacturing site GMP certification
- Product labels and package inserts
- Free Sale Certificate (for imported products)
- Product testing data (for cosmetics or food products)
Step 4 - Clinical Trial Authorization
- Submit the approval application via the SUGAM online portal
- Trials must be in compliance with Schedule Y of the Drugs and Cosmetics Rules
- Register the trials in the Clinical Trials Registry India (CTRI)
- Ethics committee clearance and GCP compliance are required
Step 5 - Submission of Application for Product Approval
Step 6 - Review and Evaluation by Regulatory Authorities
- Technical validity
- Indian pharmacopoeial standards compliant
- Manufacturing facility inspection report
- Clinical trial data or literature evidence
- Labelling and packaging compliance
Step 7 - Product Approval & Post-Market Obligations
Once approved, the company must:
- Submit adverse event and PSUR reports
- Batch testing release and documentation
- Undergo audits, when required
Artixio offers complete regulatory affairs consulting services in India, helping global healthcare companies launch products with confidence and full regulatory clarity.
Complete Regulatory Services for Market Entry in India
Why Choose Artixio for CDSCO Regulatory Affairs Services?
Are You Launching Your Product in India?
Artixio helps with the end-to-end seamless product registration process.We help with local insight, regulatory accuracy, and full-cycle support and ensure that your products enter the market without delays or compliance risks. Connect with our regulatory affairs consultant in India today for expert guidance and swift market entry.
FAQs
Are CTD/eCTD formats accepted in India?
Is a separate license needed for each state in India?
What is the validity period of product registrations in India?
Is prior approval in US/EU markets sufficient for Indian registration?
Still Have Questions ?
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