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Vaccines and biologicals play a crucial role in preventing and controlling infectious diseases in animals, thereby safeguarding animal health and productivity. In India, the registration and regulation of veterinary vaccines and biologicals are governed by specific laws and regulatory bodies to ensure their safety, efficacy, and quality. This guide aims to provide a comprehensive understanding of the registration process for manufacturers and importers of veterinary vaccines and biologicals in India.
The registration of veterinary vaccines and biologicals in India is primarily regulated by the Drugs Controller General of India (DCGI) along with the Department of Animal Husbandry and Dairy under the Ministry of Health and Family Welfare. The DCGI enforces the provisions of the Drugs and Cosmetics Act, of 1940, and the Drugs and Cosmetics Rules, of 1945.
Manufacturers/importers of veterinary vaccines and biologicals in India must obtain a license from the respective State Drug Control Authority after obtaining NOC from CDSCO & DADF where their manufacturing facility is located. The process involves the following licenses:
Any new drug or vaccine for use in veterinary purposes needs to be tested at government-approved labs prior to issuance of form 45/form 46.
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Application category |
Permission in following Forms |
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License to manufacture |
Form 28 D for manufacturer only |
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Import permission |
Form 45 or form 46 |
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Test license |
Form 11 |
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Registration Certificate |
Form 41 |
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Import License |
Form 10 |
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NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
