Pharmaceutical Company Registration in India: A Complete Guide
The pharmaceutical industry in India is one of the largest and most regulated sectors, governed by the Drugs and Cosmetics Act, 1940, and the rules framed thereunder. Setting up a pharmaceutical company requires navigating a complex regulatory landscape involving multiple approvals from the Central Drugs Standard Control Organization (CDSCO), State Drug Control Departments, and various other authorities.
This comprehensive guide covers everything you need to know about pharmaceutical company registration, from initial business incorporation to obtaining manufacturing licenses, GMP certification, and product approvals. Whether you're establishing a formulation unit, API manufacturing facility, or a pharmaceutical trading company, this guide provides the roadmap for regulatory compliance.
Industry Overview: The Indian Pharmaceutical Sector
India is known as the "Pharmacy of the World," supplying over 50% of global vaccine demand, 40% of generic demand in the US, and 25% of all medicines in the UK. The Indian pharmaceutical industry is valued at over $50 billion and is expected to reach $130 billion by 2030.
Key Statistics
- • 3rd largest by volume globally
- • 14th largest by value worldwide
- • Over 10,500 manufacturing units
- • 3,000+ pharmaceutical companies
- • Export to 200+ countries
Business Opportunities
- • Generic drug manufacturing
- • API (Bulk Drug) production
- • Biosimilars and biologics
- • Contract manufacturing
- • OTC and wellness products
CDSCO and Drug Regulatory Framework
The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body for pharmaceuticals in India, operating under the Ministry of Health & Family Welfare. It regulates the import, manufacture, distribution, and sale of drugs and cosmetics through various zonal offices across the country.
Central Level (CDSCO)
- • New drug approvals
- • Import registration
- • Clinical trial permissions
- • Blood bank licenses
- • Vaccine manufacturing
State Level
- • Manufacturing licenses
- • Sale licenses (wholesale/retail)
- • Testing laboratory licenses
- • Drug inspectorate
- • Enforcement actions
Key Legislations
- • Drugs & Cosmetics Act, 1940
- • Drugs & Cosmetics Rules, 1945
- • Pharmacy Act, 1948
- • Narcotic Drugs Act, 1985
- • NDPS Act provisions
Drug Manufacturing Licenses: Types and Requirements
Manufacturing pharmaceutical products in India requires obtaining appropriate licenses from the State Drug Control Department. The type of license depends on the nature of products being manufactured and the scale of operations.
| License Type | Form No. | Products Covered |
|---|---|---|
| Allopathic Drugs | Form 25, 25-B, 25-F | Tablets, capsules, injections, syrups |
| Cosmetics | Form 32, 32-B | Skin care, hair care, beauty products |
| Ayurvedic Drugs | Form 25-D | Herbal medicines, Ayurvedic preparations |
| Homeopathic Medicines | Form 25-C | Homeopathic dilutions, mother tinctures |
| Blood Bank | Form 26-G, 28-G | Blood collection, processing, storage |
| Medical Devices | Form 41, 42 | Class A, B, C, D medical devices |
Schedule M Compliance: Good Manufacturing Practices
Schedule M of the Drugs and Cosmetics Rules specifies the Good Manufacturing Practices (GMP) requirements for pharmaceutical manufacturing units. Compliance with Schedule M is mandatory for obtaining and retaining manufacturing licenses.
Premises Requirements
- • Location away from pollution sources
- • Adequate space for operations
- • Smooth, washable floors and walls
- • Proper ventilation and lighting
- • Separate areas for different operations
- • Temperature and humidity control
Personnel Requirements
- • Qualified Production Manager
- • Approved Analytical Chemist
- • Microbiologist (for sterile products)
- • Trained manufacturing staff
- • Health monitoring protocols
- • Regular training programs
Equipment Standards
- • Validated manufacturing equipment
- • Calibration protocols
- • Maintenance schedules
- • Cleaning validation
- • Preventive maintenance records
Documentation System
- • Master Formula Records
- • Batch Manufacturing Records
- • Standard Operating Procedures
- • Quality Control records
- • Distribution records
GMP Certification: WHO-GMP and EU-GMP
Good Manufacturing Practice (GMP) certification is essential for pharmaceutical companies, especially those planning to export their products. Different markets require different GMP standards.
WHO-GMP
World Health Organization GMP standards accepted by most developing countries.
- • Required for exports to Africa, Asia, Latin America
- • Issued by State Drug Control
- • Valid for 3 years
- • Re-inspection required for renewal
EU-GMP
European Union GMP certification required for exports to EU member states.
- • Required for EU exports
- • Inspection by EU authorities
- • Stringent quality standards
- • Mutual recognition with PIC/S countries
US FDA
US Food and Drug Administration inspection for exports to the United States.
- • Required for US exports
- • Unannounced inspections
- • 21 CFR Part 210/211 compliance
- • Establishment registration required
Import and Export Registration
Import Registration (For Importers)
To import drugs and cosmetics into India, companies must obtain Import Registration Certificates (IRC) from CDSCO:
- • Form 10: Registration certificate for imported drugs
- • Form 10-A: Registration for bulk drugs/APIs
- • Import license (Form 11): For commercial import
- • Test license (Form 12): For test and analysis
- • Form 41: Medical device import license
Export Requirements
For pharmaceutical exports, companies need:
- • IEC (Import Export Code) from DGFT
- • Manufacturing License for export
- • Free Sale Certificate from State Authority
- • Country-specific GMP certification
- • Certificate of Pharmaceutical Product (COPP)
- • Registration in destination country
Wholesale and Retail Drug Licenses
Trading pharmaceutical products requires separate licenses based on the nature of the business:
Wholesale License (Form 20/20-B/20-F/20-G)
- • Sale to retailers, hospitals, institutions
- • Minimum space: 10x10 feet
- • Refrigeration facility required
- • Competent person with Pharma degree
- • Valid for 1-5 years (varies by state)
Retail License (Form 21/21-B)
- • Pharmacy/medical store operation
- • Minimum space: 10x10 feet
- • Pharmacist with approved qualification
- • Cold storage for vaccines/insulin
- • Display of license mandatory
Step-by-Step Registration Process
Company Incorporation
Register as Private Limited Company or LLP. Obtain PAN, TAN, and open bank account. This is the foundation for all subsequent pharmaceutical licenses.
Premises Setup
Acquire land/building as per Schedule M requirements. Design layout with separate areas for manufacturing, quality control, and storage. Ensure proper utilities and waste management systems.
Equipment Installation
Install manufacturing equipment, quality control laboratory equipment, and utilities (HVAC, water system, compressed air). Perform Installation Qualification (IQ) and Operational Qualification (OQ).
Staff Recruitment
Appoint technical staff including Production Manager, Quality Control In-charge, and other qualified personnel as per Schedule M. Ensure their qualifications are approved by Drug Control.
License Application
Submit manufacturing license application (Form 27/27-B/27-D) to State Drug Control with required documents, fees, and premises details. Schedule pre-licensing inspection.
Inspection and Approval
Drug Inspector conducts facility inspection. Address any observations/deficiencies. Upon satisfactory compliance, manufacturing license is issued in Form 25/25-B.
Product Approvals
Apply for individual product manufacturing approvals (Form 27-D). Submit formulation details, stability data, bio-equivalence studies (for generics), and method of analysis.
Government Schemes for Pharmaceutical Industry
Production Linked Incentive (PLI) Scheme
Incentives of 5-20% on incremental sales for manufacturing of APIs, drug intermediates, and key starting materials (KSMs). Financial outlay of ₹6,940 crores.
Bulk Drug Parks Scheme
Financial assistance up to ₹1,000 crore per park for creating common infrastructure facilities for bulk drug manufacturing.
Medical Devices Parks
Support for developing dedicated medical device parks with world-class infrastructure. Financial assistance up to ₹100 crore per park.
Pharma Clusters
Scheme for common facilities in existing pharmaceutical clusters including effluent treatment, testing labs, and warehousing.
Cost Breakdown for Setup
| Expense Category | Small Unit | Medium Unit | Large Unit |
|---|---|---|---|
| Company Registration | ₹15,000 - ₹25,000 | ₹20,000 - ₹40,000 | ₹50,000 - ₹2,00,000 |
| Land & Building | ₹50,00,000 - ₹2,00,00,000 | ₹5,00,00,000 - ₹20,00,00,000 | ₹50,00,00,000+ |
| Equipment & Machinery | ₹1,00,00,000 - ₹5,00,00,000 | ₹10,00,00,000 - ₹50,00,00,000 | ₹100,00,00,000+ |
| Licenses & Registrations | ₹5,00,000 - ₹15,00,000 | ₹20,00,000 - ₹50,00,000 | ₹1,00,00,000+ |
| GMP Certification | ₹5,00,000 - ₹10,00,000 | ₹10,00,000 - ₹25,00,000 | ₹50,00,000+ |
| Product Approvals | ₹10,00,000 - ₹50,00,000 | ₹1,00,00,000 - ₹5,00,00,000 | ₹10,00,00,000+ |
| Working Capital | ₹50,00,000 - ₹2,00,00,000 | ₹5,00,00,000 - ₹25,00,00,000 | ₹50,00,00,000+ |
Key Compliance Checklist
Pre-Operational
- ✓ Company incorporation complete
- ✓ Premises designed per Schedule M
- ✓ Equipment qualified (IQ/OQ/PQ)
- ✓ Technical staff appointed
- ✓ SOPs documented
Ongoing Compliance
- ✓ License renewal on time
- ✓ Batch records maintained
- ✓ Pharmacovigilance reporting
- ✓ Annual compliance reporting
- ✓ Mock recalls conducted