Veterinary Regulatory Services

At Regalliance, we understand the complexities of navigating regulatory approvals for animal health assets. Our expert advisors provide end-to-end, tailored support to propel growth and guide veterinary manufacturers and global brand owners through compliance, licensing, and legal practice in India.

Vaccine & Biological Regulatory Services

Regalliance serves as your integrated regulatory partner, leveraging extensive regulatory affairs expertise to streamline compliance, mitigate administrative queries, and accelerate market access for domestic biological manufacturers and global brand owners.

Introduction

Vaccines and biologicals play a crucial role in preventing and controlling infectious diseases in livestock, poultry, and companion animals, thereby safeguarding national bio-security, animal welfare, and agricultural productivity. In India, these products are subject to multi-tiered regulatory governance to guarantee their safety, efficacy, purity, and potency.

The registration, import, manufacturing, testing, and commercialization of veterinary vaccines and biologicals in India are regulated under the framework of:

The Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Rules, 1945

The regulatory framework is jointly overseen by:

Central Drugs Standard Control Organization (CDSCO), headed by the Drugs Controller General of India (DCGI)
Department of Animal Husbandry and Dairying (DAHD), under the Ministry of Fisheries, Animal Husbandry and Dairying
Ministry of Health and Family Welfare (MoHFW)

Definition of Veterinary Vaccines & Biologicals

Statutory Classification under "New Drug" Parameters

Under the Indian regulatory framework, all biological products, veterinary vaccines, immunoglobulins, diagnostics, and rDNA-derived veterinary entities are legally categorized as “New Drugs”.

Lifecycle Status: Unlike conventional chemical drugs—which transition out of “New Drug” status four years after initial approval—veterinary vaccines and biologicals permanently maintain their New Drug classification.

CLAA Oversight: Every new veterinary strain, modified live platform, inactivated emulsion, or recombinant product requires explicit central authorization from the Central Licensing Approving Authority (CLAA) / DCGI prior to local manufacturing or import.

Regulatory Requirements & Pathways

A. Domestic Manufacturer Pathway

1. Manufacturing & Local Distribution Compliance

Facility Setup & GMP Compliance

Manufacturing plants must comply with Schedule M guidelines and WHO-GMP standards. Establishments must maintain detailed Plant Master Files (PMF) and Drug Master Files (DMF).

Competent Technical Supervision

Domestic manufacturing operations must be supervised full-time by approved technical personnel holding qualifications in Pharmacy, Pharmaceutical Chemistry, or Microbiology.

Stability Testing Protocols

Real-time and accelerated stability evaluation data must be generated and maintained for both the Drug Substance (bulk active antigen) and the Drug Product (final formulated dosage form) across specific climatic zones.

Post-Approval Variations

Any post-market modification in manufacturing site, strain update, fermentation scale-up, or analytical methodology must follow CDSCO biological variation guidelines.

2. Involved Regulatory Bodies

Central Drugs Standard Control Organization (CDSCO)

Headed by the Drugs Controller General of India (DCGI), CDSCO acts as the central licensing authority responsible for clinical trial approvals, marketing authorizations, and biological manufacturing licenses.

State Licensing Authority (SLA)

Works jointly with CDSCO to evaluate manufacturing infrastructure, grant state manufacturing licenses, and participate in facility inspections.

Central Licensing Approving Authority (CLAA)

Provides the central statutory approval required for biological manufacturing licenses after regulatory review.

Subject Expert Committees (SEC)

Independent scientific and clinical expert panels that review preclinical data, clinical trial protocols, and safety & efficacy dossiers before regulatory approvals.

rDNA Oversight Committees (IBSC / RCGM)

Recombinant, gene therapy, and genetically modified vaccine platforms require prior approval from the Institutional Biosafety Committee (IBSC) and the Review Committee on Genetic Manipulation (RCGM) under the Department of Biotechnology (DBT) before initiating human clinical trials.

3. Required Forms & Overview

Stage / Purpose	Statutory Form Applied	Official Approval / License Received	Regulatory Overview
R&D / Trial Manufacturing	Form CT-10 / Form CT-11	Permission to Manufacture	Permission to manufacture new drug or vaccine batches for clinical trials, BA/BE studies, and laboratory testing.
New API Development	Form CT-12 / Form CT-13	Form CT-15	Approval to manufacture unapproved Active Pharmaceutical Ingredients (APIs) for formulation development and clinical trial use.
Commercial Manufacturing Approval	Form CT-21	Form CT-22 (API) Form CT-23 (Formulation)	Permission to manufacture pharmaceutical biological formulations for commercial sale and distribution.
Biological Plant Licensing	Form 27	Form 28-D	License to manufacture biological products (including vaccines and blood products) with explicit CLAA endorsement.

4. Forms & Statutory Government Fees (Manufacturer)

Application	Government Fee
Form CT-10 (Trial Manufacturing Application)	₹5,000 / Product
Form CT-12 / CT-13 (Unapproved API Manufacturing)	₹5,000 / Product
Form CT-04 (Clinical Trial Permission – Phase I)	₹3,00,000
Form CT-04 (Clinical Trial Permission – Phase II, III & IV)	₹2,00,000
Form CT-21 (Commercial Manufacturing Permission)	₹5,00,000

How Regalliance Assists Manufacturers

Plant Master File (PMF) & DMF Compilation

Preparation and structuring of Plant Master Files (PMF) and Drug Master Files (DMF) in compliance with Schedule M requirements and international Common Technical Document (CTD) standards.

Multi-Agency Clearance

End-to-end coordination of approvals between State Licensing Authorities (SLA), CDSCO, and CLAA to streamline regulatory submissions and inspections.

Clinical Dossier Defendability

Preparation of clinical trial protocols, Subject Expert Committee (SEC) presentation dossiers, and comprehensive responses to regulatory technical queries for faster approvals.

B. Importer Pathway

Role of Authorized Indian Agent (IAA)

Foreign Representation

Overseas vaccine manufacturers and foreign brand owners cannot directly submit registration or import applications on Indian regulatory portals.

Mandatory Appointment

A legally appointed Authorized Indian Agent (IAA) is required through a notarized and apostilled Power of Attorney (POA).

Required License

The IAA must possess valid wholesale licenses Form 20B and Form 21B to manage SUGAM portal submissions and assume regulatory responsibility.

Involved Regulatory Bodies

Central Drugs Standard Control Organization (CDSCO)

Reviews overseas manufacturing facilities, Plant Master Files, global clinical data, and grants site registrations along with commercial import permissions.

National Control Laboratories (NCL / NIB Noida / NCTL Kasauli)

Government-authorized laboratories that perform analytical, immunological, and safety testing on imported sample batches released under test licenses.

Subject Expert Committees (SEC)

Evaluate global Phase I–III clinical data and determine whether India-specific bridging studies or local clinical trials are required before approval.

3. Required Forms & Overview

Purpose	Statutory Form Applied	Official Approval / License Received	Regulatory Overview
Import Test License	Form 11 / Form CT-16	Form CT-17 / Form 11 Clearance	Authorizes the import of limited quantities of vaccines or biological products for analytical testing, clinical trials, research, or BA/BE studies.
Overseas Site & Product Registration	Form 40	Form 41 Registration Certificate	Registration of the foreign manufacturing facility together with the specific vaccine or biological product intended for import into India.
Commercial Import Approval	Form CT-18	Form CT-19 (API) Form CT-20 (Formulation)	New Drug import authorization permitting the commercial sale and distribution of approved biological products in India.
Commercial Import License	Form 8 / Form 8A	Form 10 / Form 10A	Final commercial import license for standard biological formulations (Form 10) or Schedule X substances (Form 10A), allowing lawful import and marketing in India.

4. Forms & Statutory Government Fees (Importer)

Application	Government Fee
Form 40 (Site & Product Registration)	$10,000 (Manufacturing Plant) $5,000 per Product
Form 8 / Form 10 (Commercial Import License)	₹10,000 (First Product) ₹1,000 per Additional Product
Form CT-16 (Import Test License)	₹5,000 per Product
Form CT-18 (Permission to Import New Drug for Sale)	₹5,00,000
Form 40 Renewal / Re-Registration	$10,000 (Plant) $5,000 per Product
Shelf-Life Extension / Reduction Amendment	$1,800

How Regalliance Assists Importers

🏢 Turnkey IAA Representation

Regalliance holds active Form 20B and Form 21B wholesale licenses, enabling us to legally serve as your nominated Authorized Indian Agent (IAA) for regulatory filings and ongoing compliance.

💻 SUGAM Portal Management

Complete management of digital submissions, dossier uploads, application tracking, deficiency responses, and regulatory communications through the CDSCO SUGAM Portal.

🧪 Sample Testing Coordination

Coordination of import sample logistics, routing of batches to NIB Noida or NCTL Kasauli, laboratory liaison, and clearance of batch release protocols.

Digital Regulatory Transformation

NANDI Portal

The NANDI (NOC Approval for New Drug and Inoculation System) portal is a digital platform introduced by the Government of India to streamline regulatory approvals for veterinary medicines and vaccines. It replaces manual paperwork with an end-to-end online workflow for application submission, review, approval, and tracking of No Objection Certificates (NOCs).

Core Features & Objectives

🏛️ Developed By

Developed by the Department of Animal Husbandry and Dairying (DAHD) in collaboration with the Central Drugs Standard Control Organization (CDSCO) to modernize veterinary regulatory approvals.

🔗 Integrated Digital Platform

Fully integrated with the CDSCO SUGAM Portal, allowing applicants to submit dossiers online, monitor application progress, and receive regulatory updates through a single-window system.

🧪 Safety & Scientific Evaluation

Accelerates the assessment of veterinary drug and vaccine proposals by evaluating their safety, efficacy, and regulatory necessity before approval.

📊 Transparency & Collaboration

Enables transparent communication and real-time coordination between industry stakeholders, government departments, regulatory authorities, and research institutions throughout the approval lifecycle.

Why Choose Regalliance?

At Regalliance, we specialize in providing premium regulatory consulting services for vaccines, biologicals, biosimilars, recombinant products, blood products, and advanced biologic therapies. Our regulatory experts help manufacturers and importers navigate India's complex regulatory framework while ensuring complete compliance with CDSCO, DCGI, CLAA, WHO-GMP, Schedule M, and other applicable regulatory requirements.

Our Specialized Regulatory Support

📑 Technical Dossier Preparation

Preparation and review of Plant Master Files (PMF), Drug Master Files (DMF), CTD/eCTD dossiers, stability documentation, manufacturing records, and regulatory submissions that comply with Indian and international standards.

🏭 Manufacturing & Import Compliance

End-to-end support for biological manufacturing licenses, import registrations, GMP compliance, SUGAM portal submissions, regulatory inspections, post-approval variations, and lifecycle compliance management.

🔬 Clinical & Laboratory Coordination

Coordination of clinical trial applications, Subject Expert Committee (SEC) submissions, sample testing, batch release procedures, and liaison with accredited national laboratories for biological product evaluation.

🌍 Authorized Indian Agent (IAA) Services

For overseas manufacturers, Regalliance provides complete Authorized Indian Agent (IAA) representation, regulatory correspondence, import approvals, dossier management, and coordination with CDSCO throughout the product lifecycle.

Ready to Accelerate Your Indian Market Entry?

Whether you are manufacturing vaccines in India or importing biological products into the country, Regalliance delivers strategic regulatory guidance from product development through commercial approval, helping you achieve faster approvals with confidence.

📧 Email: info@regalliance.in

Frequently Asked Questions (FAQs)

Frequently Asked Questions

Q1: Why are all vaccines and biological products classified as "New Drugs" in India?

Under Rule 2(1)(w) of the NDCT Rules, 2019, all vaccines and biological products are categorized as "New Drugs" and retain this statutory status indefinitely to ensure continuous regulatory oversight.

Q2: What is the statutory role of an Authorized Indian Agent (IAA)?

Foreign manufacturers cannot directly apply on Indian government portals and must appoint an Authorized Indian Agent (IAA) holding valid Form 20B/21B wholesale licenses to manage registrations and assume regulatory responsibility.

Q3: Which licenses are required for domestic vaccine manufacturing?

Domestic manufacturers require clinical/test permissions under Form CT-11 and CT-15, commercial New Drug permission through Form CT-23, and biological manufacturing approval under Form 28-D from CLAA.

Q4: What is the process for importing commercial vaccines into India?

Importers must obtain a Form 11/CT-16 test license, complete foreign site and product registration through Form 40 and Form 41, and finally secure a commercial import license through Form 10.

Q5: What is the NANDI portal?

NANDI (NOC Approval for New Drug and Inoculation System) is a digital platform developed by DAHD in collaboration with CDSCO to streamline veterinary drug and vaccine NOC approvals.

Q6: How does NANDI integrate with CDSCO systems?

NANDI integrates with the CDSCO SUGAM portal, enabling online dossier submission, application tracking, and single-window regulatory communication.

Q7: What are CDSCO registration fees for overseas biological products?

Under Form 40, the statutory fee is $10,000 for foreign manufacturing site registration plus $5,000 per vaccine product.

Q8: Where are vaccine samples tested in India?

Vaccine test batches undergo quality and safety evaluation at notified laboratories including NIB Noida, NCTL Kasauli, and IVRI for veterinary biological products.

Q9: Are global vaccines exempt from local clinical trials?

Local clinical trials or bridging studies may be required unless CDSCO grants a waiver based on SEC evaluation of global safety and efficacy data.

Q10: How does Regalliance support vaccine and biological compliance?

Regalliance provides Authorized Indian Agent (IAA) services, CTD dossier preparation, SUGAM and NANDI portal management, regulatory submissions, and coordination with government laboratories.