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Pharma Compliance Services & CDSCO Consulting In India
Get expert help with CDSCO pharma consulting, DMF submissions, and India drug registration with our pharma compliance specialists.
Pharmaceuticals
Drug Compliance Support for the Indian Market
Looking to enter the Indian pharma market without delays? Hire a pharmaceutical compliance consultant in India to guide your product through every CDSCO requirement with confidence.
Artixio provides end to end services for our clients to commercialize their Novel Therapies, Generics and APIs in India. We are an integrated commercial and regulatory services company supporting our clients through their journey of pharmaceutical commercialization right from Pre-Registration Consulting, SEC Meetings, Registration, Indian Authorized Representative and post approval maintenance.
Regulatory Affairs
Product Registration
IND (Investigational New Drug)
NDA (New Drug Application)
Technical Writing
Regulatory Strategy
Digital Marketing
Market Access
Regulatory Operations
Pharma Products Regulatory Authorities in India
Central Drugs Standard Control Organization (CDSCO) under Ministry of Health regulates pharmaceutical products in India. CDSCO’s offers streamlined guidelines for regulation of drugs on their website with facility of submission of application online through SUGAM portal. CDSCO ensures the drugs are safe and efficacious for human use.
The CDSCO is structured as
- CDSCO Central Organization
- Zonal CDSCO (Delhi, Mumbai, Kolkata and Chennai)
- State FDAs (every state in India)
Need a CDSCO compliance representative? Our pharma experts work as your in-country partner to keep your product launch on track.
Classification of Pharmaceuticals in India
- Schedule I - High potential of misuse or Addiction with no medical use
- Schedule II - High Potential of misuse but have some physical or psychological use
- Schedule III – Moderate to low potential misuse with psychological use
- Schedule IV – Low potential for dependence with good physical or psychological use
- Schedule V – The drugs used as analgesics, antitussive or antidiarrheal purposes with high physical use.
In India, how a pharma product is classified directly impacts its approval timeline. We offer hands-on market entry consulting to help you navigate this stage with clarity.
Artixio’s compliance Services for Pharmaceuticals in India
Pre-Registration
- Indian Authorized Representative
- Regulatory Intelligence & Strategy
- Dossier Gap Analysis
- SEC Meetings and Consultation with CDSCO / State FDA
- Import Strategy
- Market Research
Registration
- Indian Authorized Representative
- Dossier Preparation
- Submission of Application
- NOC for Export
- Medical Writing
- Clinical Trials / BE Studies Support
- Response to CDSCO Queries
- Import License
- Drug License
- Market Access Pricing & Reimbursement
- Labeling and Artwork
Post Market
- Indian Authorized Representative
- Post Approval Lifecycle Maintenance
- Rule 37 Permissions
- Renewals
- Variations
- Line Extensions
- Import Assistance
- Pharmacovigilance
- Distributor Search and Partnership
- Advertisement & Promotional Material Review
- Ongoing Regulatory Intelligence & Monitoring
Why Artixio For Pharma Compliance Services In India?
FAQS
1. What are the forms applicable for pharmaceutical registration and import in India?
| Form | Objective |
|---|---|
| Form 40 | Application for issue of Registration Certificate for import of drugs (excluding those under NDCT Rules) |
| Form 41 | Registration Certificate issued to foreign manufacturer |
| Form 10 | Application for import license for drugs (non-schedule X) |
| Form 11 | Application for import license of small quantities for personal or testing use |
| Form 45 | Import license granted by CDSCO |
| Form 24 | Application for license to manufacture for sale or distribution of drugs (other than those specified in Schedules C, C(1) and X) |
| Form 25 | License to manufacture drugs (non-schedule C/C1/X) |
2. How can foreign manufacturers register and/or import pharmaceutical products in India?
3. What is the procedure for conducting clinical trials in India?
4. What are the documents required for import of pharmaceuticals in India?
5. What are the reference countries accepted by CDSCO?
Regulatory Expertise Across Multiple Countries
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