**Executive Summary**
The Government of India has notified amendments to the Drugs Rules, 1945, to expand the veterinary vaccine testing functions of the Central Drugs Laboratory (CDL) at CCS-NIAH, Baghpat. Effective via Gazette Notification G.S.R. 65(E) dated January 28, 2026, the institute's testing scope has increased from two to 42 veterinary vaccines. This initiative aims to strengthen the national regulatory framework, reduce testing timelines, and ensure the quality and safety of veterinary biologicals.
**Key Points / Main Content**
* **Regulatory Amendments**
* The expansion is authorized under the provisions of the Drugs and Cosmetics Act, 1940, through amendments to the Drugs Rules, 1945.
* The changes were officially notified via Gazette Notification G.S.R. 65(E) on January 28, 2026.
* **Expansion of Testing Capacity**
* The mandate for the Chaudhary Charan Singh–National Institute of Animal Health (CCS-NIAH) has grown from testing two vaccines to 42.
* Newly included vaccines cover diseases such as Canine Distemper, Canine Coronavirus, Duck Plague, Fowl Pox, Salmonella, and Tetanus.
* The testing facilities support vaccines for a wide range of animals, including dogs, horses, poultry, and general livestock.
* **Strategic Objectives**
* To augment the country's vaccine and biological testing capacity.
* To facilitate "ease of import" and accelerate regulatory clearance for veterinary biologicals.
* To improve the turnaround time for manufacturers by reducing testing timelines.
* To safeguard animal health and livestock productivity through the timely availability of quality-assured vaccines.
**Impact Analysis**
**Veterinary Vaccine Manufacturers**
* **Impact**: Manufacturers will experience improved turnaround times for product testing and more efficient regulatory clearance processes.
* **Action Required**: Align manufacturing and submission schedules with the expanded testing capabilities at CCS-NIAH for the 42 specified vaccine types.
**Regulatory and Health Authorities**
* **Impact**: The national quality assurance system is strengthened, providing a more robust framework for ensuring vaccine efficacy and safety.
* **Action Required**: Oversee the implementation of the expanded testing functions and ensure compliance with the amended Drugs Rules.
**Livestock and Poultry Owners**
* **Impact**: Increased availability of quality-assured vaccines contributes to better animal health and protection against various infectious diseases.
* **Action Required**: No direct action required; stakeholders benefit from a more reliable supply of tested veterinary biologicals.
Key Entities Referenced
Chaudhary Charan Singh–National Institute of Animal Health (CCS-NIAH), Baghpat: The primary institute where Central Drugs Laboratory (CDL) functions have been expanded to enable testing of 42 different veterinary vaccines.
Central Drugs Laboratory (CDL): The national regulatory laboratory whose functions for veterinary vaccine testing have been expanded at a specific regional institute.
Drugs Rules, 1945: The regulatory framework amended to officially expand the scope of veterinary biological testing and improve turnaround times for manufacturers.
Drugs and Cosmetics Act, 1940: The parent legislation under which the government issued the notification to strengthen the national quality assurance system for veterinary vaccines.
Ministry of Health and Family Welfare
Government Notifies Expansion of Central Drugs
Laboratory Functions at CCS-NIAH, Baghpat for
Veterinary Vaccine Testing
Government Strengthens Veterinary Vaccine Regulatory
Ecosystem Through Enhanced Testing Infrastructure
प्रव तथ: 20 JUN 2026 5:28PM by PIB Delhi
In a notable step towards strengthening the country's veterinary biological testing infrastructure, the
Government of India has notified amendments to the Drugs Rules, 1945, expanding the functions of the
Central Drugs Laboratory (CDL) at the Chaudhary Charan Singh–National Institute of Animal Health
(CCS-NIAH), Baghpat, Uttar Pradesh, for veterinary vaccine testing. The amendments have been notified
vide Gazette Notification G.S.R. 65(E), dated the 28th January, 2026 in the Gazette of India,
Extraordinary, Part II, section 3, sub-section (i) under the provisions of the Drugs and Cosmetics Act,
1940.
The notification is in line with the Government's ongoing efforts to augment vaccine and biological testing
capacity in the country and further strengthen the regulatory framework for ensuring the quality, safety
and efficacy of veterinary vaccines.
Prior to this amendment, CCS-NIAH was notified for testing only two veterinary vaccines. With the latest
notification, the scope of testing at the institute has been substantially expanded, enabling it to test 42
veterinary vaccines. These include vaccines used for the prevention and control of diseases such as Canine
Distemper, Canine Coronavirus, Duck Plague, Fowl Pox, Salmonella and Tetanus, among others, affecting
dogs, horses, poultry and other livestock.
The enhanced testing capacity at CCS-NIAH is expected to facilitate improved ease of import and
regulatory clearance of veterinary biologicals, while significantly strengthening the national quality
assurance system for veterinary vaccines. The expanded mandate will also help reduce testing timelines
and improve turnaround time for manufacturers.
India is among the leading producers of veterinary vaccines globally. The expansion of testing facilities at
CCS-NIAH will support the growth of the veterinary vaccine sector, promote timely availability of
quality-assured vaccines, and contribute to safeguarding animal health and livestock productivity across
the country.
The e-Gazette notification can be accessed at: https://egazette.gov.in/WriteReadData/2026/273682.pdf
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HFW/ Union Health Ministry Notifies expansion of CDL /20 June 2026/2(रलीज़ आईडी: 2275694) आगंतुक पटल : 291
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