Regulatory Approval Process for Veterinary Drugs

Similar to the human pharmaceutical industry, innovation is essential to the existence of animal health companies. The development of new vet drugs takes 5–15 yrs and more than US$100 million is needed to advance an animal health drug from initial concept to market. The current total Indian animal health market is just 1/100th of world market, even with largest livestock population in the world. All animal health drugs (excluding medical devices) are required to be approved by an appropriate regulatory agency prior to marketing, the goal of which is to ensure quality, safety & effectiveness

Phases in New Veterinary Drug Development

Discovery Phase: Unmet animal health needs & satisfactory return on investments (market assessment)

> Patentability

> Ease of manufacture

> Initial PoC: In-Vitro & In-Vivo studies

> Preliminary ADME

> API Stability

> Target animal safety and Preliminary toxicology studies

Development Phase: Further characterisation of drug substance

> Detailed ADME Studies, plasma & tissue bio-analytical methods, 14C studies

> Manufacture potential; scale-up batches

> Business decision to advance the lead to more expensive registration phase

> Contact regulatory agency & open INAD file

Registration Phase: Fulfil the requirement of NADA application

> All Studies in GLP, and GCP mode

> GMP API material

> Robust validated analytical & bio-analytical methods

> Effectiveness, Target animal safety, CMC, Environmental assessment, Human Food safety, FoI summary, and labelling

Approval Process

> Drugs and Cosmetics Act and Rules 1945 (revised in 2003)

> No separate guidelines for approval of Veterinary medicine

> For Vet Biological follow Schedule F(1) – Purity, Strength & Quality

> For other standards – follow British Pharmacopoeia (Veterinary)

Schedule F(1)

Part I: Vaccines – Bacterial | Viral

Part II: Antisera – Antibacterial sera | Antiviral sera | Antitoxin sera

Part III: Diagnostic Antigens

Recommendations for future Regulatory Reforms

> A Separate Veterinary Drug Control Authority

> Drug Consultative Committee – Vet. Drugs & Formulations (VDFs)

> New Drug Approval Committees – include Vets for VDFs

> Veterinary Pharmacopeia – essential

> Vets as Veterinary Drug Officers/Inspectors for VDFs at State level

> Veterinary Drug Portal & Harmonization of Standards

> Govt. policy: pro-development to attract industry and investment

> A global perspective on regulatory approval process is essential: to change regulatory process in India ‘at par’ globally; to develop expertise in regulatory studies; to attract top R&Ds to India and tap the resources