Pharma Regulatory Affairs Consulting in India
Artixio provides end-to-end regulatory support in India, including strategic consulting, international product registration, regulatory process management, and post-marketing compliance services.
Services We Offer
With over three decades of specialized experience, Artixio has facilitated the market entry of more than 50 global pharmaceutical companies into India. By implementing bold strategies and innovative, results-oriented solutions, Artixio has enabled these companies to successfully navigate Brazil’s intricate regulatory environment and achieve commercial success.
Artixio provides end-to-end regulatory services, guiding clients from initial development through post-approval lifecycle management. By leveraging advanced regulatory intelligence, our expert team offers strategic consulting, regulatory writing, dossier preparation, labelling, promotional material review, and regulatory information management. This comprehensive approach ensures that your product remains compliant and competitive at every stage.
Pharmaceutical Registration in India (CDSCO)
The Central Drugs standard control organization (CDSCO) is under the Directorate general of Health services, Ministry of health and family welfare. CDSCO oversees the pharmaceuticals, food supplements, veterinary products, medical devices and cosmetics. It looks after the quality, efficacy and safety of the drug. The main authority for the approval of manufacturing or import license is the Drug Controller General of India (DCGI).
Classification of Pharmaceuticals in India
The drug products are classified in in India legally by –
Schedule I: these are the medicines having no medical use and which have a greater potential of addiction or misuse.
Schedule II: these are the medicines having psychological or physical use but also have a potential of addiction or misuse.
Schedule III: these are the medicines having psychological use and have low to moderate potential of misuse.
Schedule IV: these are the medicines having good psychological and physical use and have low potential of misuse.
Schedule V: these are the medicines which are used as antitussive, antidiarrheal and analgesic purpose and have great physical use.
CDSCO oversees the regulations, under the drug and cosmetic act for drug registration. The manufacturer and importers have to apply the form 44 and have to pay the applicable fees.
Types of licences under CDSCO
Retail sale drug license
Manufacturing license
Wholesale drug license
Import license
Loan license
Cost for drug license in India-
| License Type | Cost |
|---|---|
| Retail | INR 45,000 |
| Wholesale | INR 40,000 |
| Manufacturing | INR 1,00,000 |
Registration Process
For registering a drug product in India, the below mentioned are the steps-
Preparation phase
- The pharmaceutical product intended for registration must be clearly identified, with a comprehensive understanding of its therapeutic value and regulatory requirements.
- The required documents, formulation and manufacturing details, stability data should be ready for submission.
Application submission to CDSCO
- The dossier should be submitted to CDSCO in the CTD (common technical document) format for a NDA or ANDA application
- Application have to be submitted via online portal and fees have to be paid along with submission of required documents.
Evaluation by the CDSCO
- The application will go through the screening process to make sure its completeness.
- The application will be thoroughly reviewed for its safety, efficacy and quality data.
- The CDSCO will also conduct GMP inspections.
Approval of the application
- Upon thorough evaluation and satisfaction of the Central Drugs Standard Control Organisation (CDSCO), approval is granted for the drug's market entry.
Registration Process for Pharmaceuticals in India
The below mentioned documents are required for the drug product registration
Drug name
Dosage form
Formulation composition
Specifications for active and inactive ingredients
Indications
Pharmacological classification
Raw material manufacturer
Any applicable patents
Timeline
It takes approximately 9 months to get an approval for the import license. It takes 180 days for new drug registration and around approx. 3 months for registration of cosmetic product.
Labelling requirements
The labels must be as per Drug and cosmetic act. The following should be included-
- Drug product name
- Net content (in weight/volume/number of units)
- Active ingredients
- Name and address of the manufacturer
- Batch number
- Any special precaution or remark
Post Marketing Surveillance
The post marketing surveillance of CDSCO includes the following-
- Adverse drug reactions reporting
- Pharmacovigilance programme of India
- Signal detection and analysis
- Periodic safety Update reports (PSUR’s)
- Risk evaluation and mitigation strategies
Artixio offers a range of services to assist pharmaceutical companies with product registration in India:
- Medical & Technical Writing
- Due Diligence and Gap Analysis
- Dossier Preparation and compilation
- Dossier Publishing & Submission
- Product Registration
- Marketing Authorization Holder (MAH/LR)
- Investigation New Drug Application (IND) / Clinical Trial Application (CTA)
- New Drug Application (NDA) / Marketing Authorization Applications (MAA)
- Post Approval Lifecycle Maintenance
- Artwork and Label Review
- Ad Promo Review
- Distributor and Import Assistance
Collaborate with Artixio’s India Expertise with Seamless Global Delivery
- Successful Approvals and Product Lifecycle Maintenance for 300+ products
- Diverse Products Experience across Complex Products Categories and Therapeutic Areas
- Strong Regional Expert with 30+ years of experience
- Proven Experience in End-to-End Product Value Chain from Concept to Commercialization
- Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
- ISO 9001:2015 quality standards governed services
- Customer focused, flexible services and solutions
- Flexible Business Model including project based, managed services and FTE staffing model
- Hybrid-Local-Centralized Support across Regulatory functions
FAQs
1. What is the validity of drug registration?
The validity of the drug registration is of 5 years. The renewal applications should be submitted before the current registration’s expiry.
2. In India, what are the requirements for clinical trial?
The clinical trial must be conducted according with GCP (good clinical practices) guidelines.
3. What are the requirement for importing drugs to India?
For importing drugs in India, Registration certificate in form-41 and import license in Form-10 under the drugs and cosmetic act is required.
4. When is the re-registration or renewal is done?
The renewal application must be submitted at least nine months prior to the expiration date of the registration certificate.
5. What are some of the main responsibilities of CDSCO?
Conducting clinical trial, drug approval, controlling the quality of the drug product, governs the State health authorities.
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Specialized Regulatory Affairs
Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
Regulatory Affairs Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
China
Thailand
Indonesia
Philippines
USA
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