REGULATORY REQUIREMENTS FOR THE APPROVAL
OF VETERINARY MEDICINAL PRODUCTS
Regulatory approval of veterinary medicinal products is a mandate and rigorous process to
ensure the quality, efficacy and safety of the new drug to both animals and humans which plays
an important role in food chain. One of the well established approval processes is the USA New
Animal Drug Application (NADA) which comes under US FDA Center for Veterinary
Medicine (CVM). The following five major technical sections of the drug approval process will
be discussed, they are; Target Animal Safety, Effectiveness, Human Food Safety, CMC
(Chemistry, Manufacturing, and Controls) and Environmental impact.
The International Co-operation on Harmonisation of Technical Requirements for
Registration of Veterinary Medicinal Products (VICH) guidance documents are referred for the
conduct of studies to meet the requirement of the above said major technical sections. VICH is
an ongoing programme to harmonise technical requirements for marketing of veterinary
medicinal products in three regions viz., USA, Japan and Europe.
In India, the regulatory requirements for the approval of Veterinary medicinal products are
mentioned in the Drugs and Cosmetics Act and Rules 1945 and revised on 2003. The standards
like strength, quality and purity of veterinary drugs are specified in Schedule F(1) of the Drugs
and Cosmetics Act and Rules and for no such standards specified in Schedule F(1), the current
edition of British Pharmacopoeia (Veterinary) should be referred for the standards required for
the marketing approval of Veterinary medicinal products in India.
It is essential for the Veterinary Pharmacologists and Toxicologists to understand the process of
veterinary drug approval process to explore the opportunities and contribute their expertise in the
development of new veterinary drugs.