Drugs Manufacturing License
A Drugs Manufacturing License is a mandatory regulatory approval granted under the Drugs and Cosmetics Act, 1940 for companies engaged in the production of pharmaceutical products, Ayurvedic or Unani medicines, cosmetics, and medical devices. Whether you manufacture tablets, capsules, syrups, ointments, or herbal products, obtaining this license is essential to legally operate and ensure public health safety.
- Saved 20,00,000+ Hours of entrepreneurs PAN India
- Experience zero delays in registering your dream business
10000+
Happy Clients
3500+
Expert Advisors
50+
Branch Offices
Free Consultation by Expert
Benefits
Legal Authorization to Manufacture Drugs
Legitimizes your manufacturing unit for domestic and international markets.Brand Credibility
Boosts trust among healthcare professionals, vendors, and consumers.Eligibility for Government and Institutional Tenders
Enables participation in health department procurements.Market Expansion
Facilitates distribution in retail and wholesale pharma channels.Avoidance of Regulatory Penalties
Ensures full compliance with health ministry regulations.
🛠️ Process of Registration
Initial Consultation & Category Identification
Determining your product type and appropriate license form (25, 28, etc.).Document Compilation & Verification
Assisting in preparation of technical documents and staff compliance.Application Filing
Submission of application with the State/Central Licensing Authority.Inspection & Verification
Coordination with Drug Inspectors for facility inspection and staff interviews.License Approval & Grant
Issuance of the license post successful inspection and documentation.
Documents Required
Company Incorporation Certificate / Partnership Deed
Manufacturing Premises Address Proof and Rent/Lease Agreement
Site Layout Plan and Plant Design
Details of Manufacturing Equipment & Machinery
List of Technical Staff with Qualifications and Experience Certificates
Proof of Qualification and Registration of Competent Technical Staff (CTO)
Affidavit of Non-Conviction under Drugs Act
Environmental Clearance and Pollution NOC (if applicable)
GMP (Good Manufacturing Practices) Compliance Details
Product List and Formulation Details
What You’ll Get
Industry-Specific Regulatory Knowledge
CDSCO and State Drug Control Expertise
Strong Coordination with Drug Inspectors
GMP Compliance Guidance
Transparent & Timely Process Execution
Post-License Regulatory Support
Frequently Asked Questions
Any entity involved in the production of allopathic, ayurvedic, or cosmetic drugs must obtain this license.
Licenses are granted based on the product type — allopathic (Form 25/28), ayurvedic, or cosmetic manufacturing.
Yes, Good Manufacturing Practice (GMP) compliance is mandatory for the grant of a manufacturing license.
Generally valid for 5 years, subject to renewal and ongoing compliance.
Yes, a manufacturing license can include multiple formulations and dosage forms, as long as they’re approved.
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