How to get License to Manufacture LVPs, Sera, Vaccines & r-DNA Derived Drugs

India has emerged as a pharmaceutical powerhouse, not only meeting domestic healthcare needs but also supplying affordable, high-quality medicines across the globe. Among the wide range of medicinal products manufactured in the country, certain categories—such as Large Volume Parenterals (LVPs), Sera, Vaccines, and recombinant DNA (r-DNA) derived drugs—hold a unique position because of their direct role in critical care, disease prevention, and advanced therapies.
Given their complexity and sensitivity, the production of these drugs requires state-of-the-art facilities, skilled professionals, and stringent regulatory oversight. To ensure safety, efficacy, and compliance with global standards, manufacturers must obtain a licensee from the Central Licensing Authority (CLA) or the State Licensing Authority (SLA), depending on the product type. This licensing framework forms the backbone of India’s regulatory ecosystem for high-risk biological and biotech-based medicines.

Understanding the Product Categories

1.    Large Volume Parenterals (LVPs):

• Sterile preparations administered intravenously, typically in volumes above 100 ml.
• Used for fluid replacement, electrolyte balance, nutrition support, and drug dilution.
• Examples: Dextrose Injection, Ringer’s Lactate, Sodium Chloride Injection.

2.    Sera:

• Biological products derived from animal or human blood, used to neutralize toxins or provide passive immunity.
• Commonly used in treatment of snake bites, diphtheria, or tetanus.

3.    Vaccines:

• Biological preparations that stimulate immunity against specific diseases.
• Includes inactivated, live attenuated, and modern mRNA or vector-based vaccines.

4.    Recombinant DNA (r-DNA) Derived Drugs:

• Produced using biotechnology and genetic engineering.
• Includes monoclonal antibodies, recombinant insulin, growth hormones, and cancer biologics.

Due to their direct impact on critical human systems, these drugs require state-of-the-art sterile facilities and rigorous quality control.

Legal Provisions for License

• Governed under Part VII of the Drugs and Cosmetics Rules, 1945.
• Application is made in Form 27-D.
• License is issued in Form 28-D.
• Inspections and approvals are conducted by the CLA (for vaccines and r-DNA products) or SLA (for certain categories of parenterals and sera).

Eligibility & Documentation for License to Manufacture LVPs, Sera, Vaccines, and r-DNA Drugs

Applicants must fulfill the following requirements to obtain a license for manufacturing Large Volume Parenterals, Sera, Vaccines, or r-DNA derived drugs:

A. Core Eligibility Requirements

• Legal Entity: The applicant must be a registered pharmaceutical company, LLP, or partnership firm with valid incorporation documents.
• Manufacturing Premises: A sterile facility designed as per Schedule M GMP norms, with validated HVAC, WFI systems, cleanroom classifications, and effluent treatment.
• Qualified Technical Staff: Presence of competent professionals (pharmacists, microbiologists, biotechnologists) with requisite qualifications and experience in sterile and biotech manufacturing.
• Quality Systems: Independent Quality Control (QC) laboratory and robust Quality Assurance (QA) framework to ensure sterility, safety, and efficacy of products.
• Biosafety & Cold Chain: Adequate biosafety level compliance, biomedical waste disposal systems, and validated cold chain infrastructure for safe handling and distribution.

B. Top 10 Must-Have Documents

1. Form 27-D Application with Challan of Fees Paid.
2. Covering Letter and Specific Power of Attorney authorizing the signatory.
3. Site Plan & Layout of the building, with measurements and Schedule M compliance.
4. Proof of Premises – ownership/lease/rent documents registered with competent authority.
5. Consent to Establish from the State Pollution Control Board.
6. List of Directors/Partners/Trustees with ROC/Deed copies.
7. List of Competent Technical Staff (with qualifications, experience, prior FDA approvals).
8. Appointment/Acceptance Letters of staff for manufacturing and testing sections.
9. Section-wise List of Plant & Machinery.
10.Site Master File (as per WHO TRS) with SOPs, STPs, and validation reports.

Additional Mandatory Documentation

• HVAC & Water System Validation Certificates – proof of sterile utility readiness.
• Self-Declarations from technical staff and directors on compliance.
• Valid Test License in Form 29/CT-11 (if applicable).
• Source of Drug Substance with regulatory status (Form 46A/45A/CT-19/CT-22) and Certificate of Analysis.
• Master Manufacturing Formula (MMF) and Batch Manufacturing Record (BMR) draft.
• Process Validation Reports for three consecutive batches.
• Finished Product Documentation – specifications, method of analysis, validation reports, stability study (tabular format).
• Comparative Evaluation with approved Indian or international brands.
• Draft Labels, Cartons, and Package Inserts complying with labeling rules.
• New Drug Approval Status (Form 46/CT-23) if applicable.
• NOC from Department of Industrial Safety & Health.
• Bio-waste Disposal Agreement & Container Closure System Compliance (mandatory for LVPs).

Step-by-Step Application Process

1. Preparation of Documents

Compile the required documents, including site master file, list of machinery, floor plan, environmental safety approvals, and staff qualifications.

2. Filing of Application

• Submit Form 27-D to the appropriate licensing authority.
• Attach prescribed fees as per the Drugs and Cosmetics Rules.

3. Scrutiny of Application

The authority examines completeness of documentation, legal status, and technical capability of the applicant.

4. Inspection of Manufacturing Facility

• A joint inspection team visits the site to verify:
• Layout and design of the plant.
• Validation of sterile areas and cleanroom standards.
• Availability of water systems, HVAC systems, and effluent treatment facilities.
• Implementation of quality assurance and quality control systems.

5. Grant of License

Upon successful verification, the license is issued in Form 28-D, permitting the manufacture of specified products.

Validity and Renewal of manufacturing License 

• License validity: 5 years from the date of issue.
• Renewal: Must be filed before expiry using the prescribed form and fee.

Importance of Compliances

The manufacture of LVPs, sera, vaccines, and r-DNA derived drugs involves high risk and global scrutiny. Compliance ensures:

• Patient Safety: Avoids contamination, pyrogenicity, and adverse reactions.
• Regulatory Credibility: Builds trust with the Drug Regulatory Authority, WHO, and foreign regulatory agencies.
• Market Access: Enables export opportunities to stringent markets like US, EU, and Japan.
• Sustainability: Ensures adherence to environmental and biosafety standards.

Conclusion

Securing a license to manufacture Large Volume Parenterals, Sera, Vaccines, and recombinant DNA (r-DNA) derived drugs is a rigorous but essential process that safeguards patient health and ensures product reliability. The stringent eligibility requirements, exhaustive documentation, and multi-stage inspections reflect the critical nature of these products and their role in modern healthcare.
For pharmaceutical companies, compliance is not just a regulatory obligation but also a pathway to building trust, credibility, and global competitiveness. By adhering to Good Manufacturing Practices, maintaining high-quality infrastructure, and implementing robust quality and biosafety systems, manufacturers can meet domestic healthcare needs while also expanding into international markets.
Ultimately, the licensing framework strengthens India’s position as a global hub for safe, effective, and innovative pharmaceutical solutions.

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