How to get manufacturing license for Schedules C & C(1) drugs, excluding those in Part XB and Schedule X

The manufacture of pharmaceuticals in India is governed by a robust regulatory framework designed to ensure the safety, efficacy, and quality of drugs available in the market. Among the various regulatory pathways, obtaining a manufacturing license for drugs listed under Schedules C and C(1)—excluding those specified in Part XB and Schedule X—is critical for manufacturers dealing with biologicals and sterile products.
This blog presents a comprehensive overview of the legal provisions, procedural requirements, documentation, and compliance obligations involved in the grant of such a license under the Drugs and Cosmetics Act, 1940, and Rules, 1945.

Understanding Schedules C and C (1)

Schedules C and C (1) pertain to a special category of drugs that require stringent manufacturing controls due to their sensitive nature and direct application routes (e.g., injections, ophthalmic use, etc.).

Schedule C includes:

• Sera and vaccines
• Toxins and antigens
• Hormones
• Antibiotics for parenteral use
• Other biological products

 Schedule C (1) includes:

• Ophthalmic preparations
• Injectable antibiotics
• Sterile formulations not covered under Schedule C

Excluded Categories:

• Part XB: Drugs like blood products, r-DNA products, and stem cell-based formulations
• Schedule X: Narcotic and psychotropic substances (requiring a separate, more stringent licensing procedure)

Eligibility Criteria for Applicants

Entities eligible to apply for this manufacturing license must meet the following regulatory and operational prerequisites:
•    Legal Status: The applicant must be a registered business entity in India (proprietorship, partnership, LLP, or private/public Company).
•    Infrastructure: The premises must be appropriately designed, equipped, and maintained as per GMP norms for sterile and biological manufacturing. Cleanroom classifications and air handling systems are critical.
•    Technical Manpower: Employment of technically qualified personnel such as:
                                           a)    Competent Technical Staff (B. Pharm/M. Pharm with experience)
                                           b)    Qualified Manufacturing Chemists
                                           c)    Quality Control and Quality Assurance professionals
•    Quality Systems: Comprehensive SOPs, in-process checks, documentation systems, and validated processes must be in place.

Application Process: Step-by-Step Guide

Step 1: Preparation and Compliance Readiness

• Prepare the manufacturing premises as per Schedule M standards.
• Install and validate necessary equipment (autoclaves, laminar flow hoods, sterilizers, etc.).
• Document the Site Master File (SMF), layout plans, and HVAC specifications.

Step 2: Submission of Application

• Submit Form 27 (Application for license to manufacture Schedule C and C(1) drugs) to the competent licensing authority.
• Pay the applicable fees via challan or online payment portal as notified by the authority.

Step 3: Documentation Checklist

The application must be supported by:

• Duly filled Form 27
• Ownership or rental agreement for the premises
• Manufacturing and testing equipment list
• Details and certificates of technical staff
• Product-wise formulation and manufacturing processes
• Stability data, method of analysis, and specifications
• Environmental clearance or pollution NOC (if applicable)
• GMP compliance declaration and Site Master File (SMF)
• Quality Assurance protocols and batch manufacturing records templates

Step 4:  Inspection and Verification

A joint inspection is conducted by Drug Inspectors from the State and/or Central Licensing Authorities to assess:

• GMP compliance of the facility
• Qualification and training of staff
• Suitability of manufacturing processes and quality control systems
• Validation and calibration records

Step 5:  Issuance of License

Upon satisfactory inspection and document verification, the Manufacturing License is granted in Form 28, authorizing the applicant to manufacture and sell/distribute the approved formulations.

Post-License Regulatory Compliances

After obtaining the manufacturing license, the licensee must continuously comply with:

• Batch manufacturing and quality control documentation
• Periodic validation of equipment and processes
• Stability testing and product shelf-life monitoring
• Pharmacovigilance and Adverse Drug Reaction (ADR) reporting
• Annual license retention
• Submission of Periodic Safety Update Reports (PSURs) for applicable products

Conclusion

Obtaining a license to manufacture drugs under Schedules C and C (1) is a technically and legally intensive process, reflecting the sensitivity and complexity of these pharmaceutical products. It is vital for applicants to adopt a meticulous approach—right from infrastructure planning to documentation, and from technical staffing to GMP implementation.
The authorities emphasize quality-by-design, documentation integrity, and patient safety, making it essential for manufacturers to integrate regulatory compliance into every stage of production and quality assurance.
Engaging with regulatory consultants, validation experts, and GMP auditors can significantly streamline the application and post-license compliance journey, ensuring sustained market access and regulatory trust.
 

For more details, please click HERE