The Step-by-Step Guide to Getting a Manufacturing License in India
Introduction
Obtaining a manufacturing license in India is a crucial step for any pharmaceutical company planning to produce Active Pharmaceutical Ingredients (APIs) or formulations. Governed under the Drugs and Cosmetics Act, 1940 and its associated rules, the licensing process can be complex, time-consuming, and heavily documentation-driven. This guide simplifies the key stages involved and outlines how you can approach them efficiently.
Types of Manufacturing Licenses
Pharmaceutical manufacturers must apply for specific licenses depending on the type of drugs, category, and business model. These include:
Form 24/25 for general API/Formulation manufacturing
Form 27/28 for Schedule C & C1 (e.g., injectables)
Form 25B for repacking drugs
Form 24A/25A for loan licenses
Form 27D for large volume parenterals
Step-by-Step Process
1. Company Setup & Premises Readiness
Ensure your company is legally registered and your manufacturing facility complies with required infrastructure, GMP norms, equipment, and environmental standards.
2. Registration on Online Portals
Register on ODLS/ONDLS or NSWS/IPDMS portals to initiate your license application digitally.
3. Application Filing
Submit the application in the appropriate Form with details of technical staff, layout plans, product list, manufacturing capabilities, and necessary supporting documents.
4. Documentation and Attachments
Include Site Master File, stability data, water system validation, HVAC design, quality control SOPs, and proof of ownership or lease of the premises.
5. Inspection and Verification
State DCA or CDSCO authorities will conduct a physical inspection of the premises. Any gaps must be addressed for final approval.
6. License Grant & Renewal
If all conditions are met, the license is granted. Note that licenses require periodic renewal and may need amendments for product additions or changes in company structure.
How AAHVI PHARMA Can Help
At AAHVI, we specialize in end-to-end support for obtaining manufacturing licenses across India. From portal registrations and document preparation to facility readiness and authority liaison, we ensure your application is error-free and meets all regulatory standards. Our strong success rate is built on deep compliance expertise and proactive follow-ups with drug authorities.
Conclusion
Securing a manufacturing license is a critical compliance milestone for any pharmaceutical venture. With expert assistance and proper documentation, this process can be made smoother and faster — allowing you to begin manufacturing with confidence and full legal clearance.
