Pharmaceutical Regulatory Services in India

Your Strategic Partner for End to End Pharmaceutical Services in India, from Concept to Market

Pharmaceuticals

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 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

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.

Artixio’s Services in India for Pharmaceuticals

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?

FAQS

1. What are the forms applicable for pharmaceutical registration and import in India?

Following are few forms provided by pharmaceutical registration, import, clinical trials and other requirements in India by CDSCO:

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?

Foreign manufacturers need to appoint an Indian Authorized Representative who applies for Form 40 on behalf of the foreign manufacturer to obtain the Form 41 Registration Certificate.

3. What is the procedure for conducting clinical trials in India?

To conduct clinical trial in India, manufacturers require Clinical Trial Permission by applying Form CT04, obtain Ethics Committee Approval, Submit Protocol, Investigators Details, Insurance and Informed Consent Forms.

4. What are the documents required for import of pharmaceuticals in India?

Foreign manufacturers and domestic importers require import license to import pharmaceuticals in India. The documents required include, Power of Attorney, GMP certificate, Certificate of Pharmaceutical Product (CoPP), product labels, site master file and product dossier. In addition, administrative documents including IEC codes as applicable.

5. What are the reference countries accepted by CDSCO?

Typically, CDSCO recognizes following health authorities from reference countries, US FDA, MHRA (UK), Health Canada, TGA (Australia), EMA (European Union), Swissmedic, HSA (Singapore). Acceptance may vary on case basis, consultation with CDSCO is recommended.

Pharmaceutical Regulatory Services in India

Pharmaceuticals

Services We Offer

Solution by Countries

Our Industries

Regulatory Affairs

Product Registration

IND (Investigational New Drug)

NDA (New Drug Application)

Technical Writing

Regulatory Strategy

Digital Marketing

Market Access

Regulatory Operations

Regulatory Authorities in India

Classification of Pharmaceuticals in India