Nepal is soon going for Bio equivalence study for generic medicine. Department of Drug Administration (DDA) have signed a MOU with Tribhuwan University Teaching hospital for conducting Bio equivalence but we haven't seen any progress on this area: We have tried to list out few of the minimum criteria that has to be fulfilled for Bio-equivalence.
1. Reference Drug : To prove any generic drug as equivalent, there should be reference drug. So far, there is no as such reference drugs mentioned for any category by the regulatory body. For reference drug, the regulatory body has to announce the reference drugs with all the pharmacokinetic features.
2. Guideline: The regulatory body should have proper astringent guideline for conducting such study. Guideline for the institution (research center/hospital), for ethical board, consent, guideline for pilot and pivotal study, guideline for validation batch and In-vitro study in multimedia before clinical study. Is the regulatory body is well equipped with all the necessary guideline? Its always better to follow established guideline from USFDA, EMA, or ICH for reference for a developing countries like Nepal.
3. Skilled manpower : Multi-disciplinary, skilled man power is necessary to manage the complete project. Single study need, Pharmaco kinetics expert (PhD in Pharmacokinetics or experienced), Bio analytical experts (M.Pharm with bio analysis experience), Bio statistician, Doctors and nurses for clinical purpose, Project Manager, Quality assurance experts. Nepal lacks skilled manpower in its own country. Majority of skilled manpower are working abroad in same domain.
4. Equipment: Basic analytics equipment is necessary for Bio analysis. Apart from analytical equipment, other equipment additional equipment with high degree of accuracy is must.
5. Management System: The whole bio equivalence is not possible without proper management. The regulatory body should have collaboration with different department and sectors that actually have experience on Bio equivalence.