Veterinary Drug License Application Process in India 2026 (Most Updated Guidelines)

Veterinary Drug License Application Process in India 2026 (Most Updated Guidelines)

The veterinary drug license application process in India (2026) is governed by the Central Drugs Standard Control Organization (CDSCO) under the Drugs & Cosmetics Act and Rules, and has seen major updates aimed at digitalization and efficiency. One of the most significant changes is the mandatory online submission of all veterinary drug application forms through the CDSCO SUGAM Portal. This includes applications for new drug permissions, bulk drug (API) approvals, finished formulation approvals, and field trial permissions, replacing the previous offline or e-office submissions.

What Is the Veterinary Drug License

The veterinary drug license in India is a regulatory permission that allows manufacturers, importers, distributors, or test laboratories to make, sell, import, or test veterinary medicines, vaccines, and related products. This process is governed by the Drugs & Cosmetics Act, 1940, and enforced by the Central Drugs Standard Control Organization (CDSCO) along with coordination from the Ministry of Fisheries, Animal Husbandry & Dairying.

Who Needs Veterinary Drug License 

• Manufacturers of veterinary drugs (including vaccines, medicines, and biological products)
• Manufacturers of veterinary bulk drugs / APIs Importers of veterinary drugs or vaccines
• Distributors, wholesalers, and stockists dealing in veterinary medicines
• Retailers / medical stores selling veterinary drugs to animal owners or clinics
• Veterinary hospitals, clinics, and dispensaries that sell or dispense medicines
• Research institutions and laboratories conducting testing, analysis, or field trials of veterinary drugs
• Companies applying for test licenses to examine or analyze veterinary medicines
• Exporters of veterinary drugs (where regulatory approval is required)

Read More What is Form 20 and 21 Drug License?

Revised Testing under Veterinary Drug License

The veterinary drug license in India not only regulates the manufacture, sale, and distribution of veterinary drugs but also includes mandatory testing requirements to ensure safety, efficacy, and quality. In 2026, the testing framework has been updated to streamline compliance, digital reporting, and align with international standards.

Why Veterinary Drug License is Important

Importance of a Veterinary Drug License

• It is mandatory under the Drugs & Cosmetics Act, 1940, for anyone manufacturing, selling, importing, or distributing veterinary drugs.
• Operating without a license is illegal and can lead to fines, penalties, or imprisonment.
• Licensed products undergo strict testing and quality checks, ensuring that medicines, vaccines, and biologicals are safe for animals.
• Veterinary drugs directly impact the food chain, milk, meat, and eggs, so safe and tested drugs prevent public health risks.
• A license increases trust among customers, veterinarians, and distributors.
• Operating without a license risks closure, confiscation of products, and legal action.
• Protects businesses from financial loss and reputational damage.

Documents Required for Veterinary Drug License

1. Basic Application Documents

• Duly filled application form (Form 45 / 45A for finished drugs/bulk drugs, Form 46 / 46A for manufacturing permissions, or Form 11 for test licenses)
• Covering letter on company letterhead
• Proof of payment of fees (as per CDSCO guidelines)

2. Identity & Address Proof

• Photographs of applicant / proprietor / partners / directors
• Identity proof (Aadhaar, PAN card, Passport, Voter ID)
• Address proof of the premises (electricity bill, rental agreement, or property documents)

3. Business / Company Documents

• Certificate of incorporation or registration (for companies/LLPs)
• Partnership deed (for partnerships)
• Memorandum of Association (MOA) & Articles of Association (AOA) for companies
• GST registration certificate (if applicable)

4. Premises & Infrastructure Documents

• Affidavit / undertaking that the premises comply with regulations
• Layout plan of the manufacturing/testing premises
• Details of equipment, machinery, and testing facilities
• Storage arrangements for drugs and vaccines (temperature-controlled storage for sensitive products)

5. Personnel & Qualification Documents

• List of key personnel (Qualified pharmacist, veterinary doctors, microbiologist, etc.)
• Educational and professional certificates of the personnel
• Experience proof for responsible technical staff

6. Product & Manufacturing Details

• List of veterinary drugs / vaccines to be manufactured, sold, or tested
• Manufacturing process details for each product
• Stability and quality control protocols Labels and packaging details

7. Test & Quality Documents

• Test reports from approved labs (for new drugs, vaccines, or field trial products)
• Standard Operating Procedures (SOPs) for testing and quality checks

8. NOC & Regulatory Approvals

• No Objection Certificate (NOC) from the Ministry of Fisheries, Animal Husbandry & Dairying (via Nandi portal)
• Any state-level NOC (if required)
• Undertaking to comply with Drugs & Cosmetics Act, 1940

9. Other Documents

• Affidavit of non-conviction / legal compliance
• Declaration of compliance for handling, storage, and disposal of veterinary drugs
• Agreement / MOUs (if contract manufacturing is involved)

Step-by-Step Procedure for Veterinary Drug License

Step 1: Determine the Type of License

• Identify the category of license required:

Step 2: Prepare Required Documents

• Gather all necessary documents, including:

Step 3: Apply Online via CDSCO SUGAM Portal

• Visit the CDSCO SUGAM portal
• Select the appropriate form (Form 45 / 45A / 46 / 46A / 11)
• Fill the application digitally and attach scanned copies of all documents
• Pay the prescribed fees online

Step 4: Obtain NOC through Nandi Portal

• For manufacturing or import of veterinary drugs/vaccines, apply for a Non-Objection Certificate (NOC) via the Nandi portal
• Link your CDSCO application with the Nandi portal for seamless approval

Step 5: Application Review by Authorities

Step 6: Premises Inspection (If Required)

Step 7: Grant of Veterinary Drug License

Read More How to Apply for a Drug License Wholesale and Retail Online?

Post-License Compliance

• Maintain records of production, testing, and distribution
• Follow labeling, storage, and disposal norms under the Drugs & Cosmetics Act, 1940
• Submit periodic reports if required (e.g., stability, adverse events)
• Apply for renewal online before license expiry

Fees & Timeline 

Conclusion 

Obtaining a Veterinary Drug License in India is a critical step for manufacturers, importers, distributors, and testing laboratories involved in veterinary medicines, vaccines, and related products. The process ensures that all veterinary drugs meet strict quality, safety, and efficacy standards, safeguarding the health of animals and supporting public trust in veterinary care.