On April 12, Kathmandu, there was a discussion on “Strategies for Improving Quality of Medicines and Research in Pharmaceutical sector” on the occasion of 8th National Summit of Health & Population Scientist in Nepal.
This is a very commendable work by NHRC to bring major pharmaceutical stakeholders in one platform to discus on pharmaceutical development. Research and its goal and road maps.
During the panel discussion, everyone seems to be much aware about the problem of pharmaceuticals in Nepal. I have tried to summarised as:
1. Substandard pharmaceutical products do exist in Nepali market
2. Lack of collaboration between academic and industrial institution on research and development
3. Poor R and D investment out of total revenue generated by a pharmaceutical industry, which have directly impacted in R and D (Less than 10% )
4. Lack of collaboration on orthodox medicinal practices and ayurvedic practice with modern practice
5. Good Pharmacy practice and Good distribution practice is yet to be implemented to ensure the quality of pharmaceutical products
6. Less the 0.5% of total National budget is allocated in pharmaceutical sector.
7. Institutional reform need to be done and organizational structure need to be restructured.
8. Significant policy reform necessary
9. Nepal can exploit TRIPS agreement of WTO on patented product and Nepal don’t have to go through para 4 filling
10. BA BE study
Everyone seems to be much aware about the problem and the solution but the discussion couldn’t give proper direction for next steps. The question were collected ( not sure how it was being collected) but no questions has been taken from the floor.
Following are the few things that hasn’t be addressed:
1. Bio equivalence need to be done, no doubt but basics like, RLD products not yet identified, what is the reference while doing Bioequivalence study?
2. What is the strategy for Multimedia and invitro comparative study of generic drugs with RLD drugs
3. Why pharmaceutical industry is still reluctant to invest its revenue share to improve the quality of its products and for F R and D?
4. Why pharma industry cannot exploit the TRIPS agreement in Nepal?
5. Why the academic and industrial collaboration is not yet done?
6. There are huge chunk of pharmaceutical products which too includes biologicals but seems like it is not under the regulation of DDA, why?
7. The discussion couldn't bring the issue of medicinal products or Health technology product?
8. The discussion was not able to discuss on FDA, which was already under the process of implementation by Nepal government.
9. There are other simpler pathway for innovation and research but no one seems to be interested in those areas
10. What is the condition of educational system and syllabus designed, are they still relevant to current pharmaceutical market?
Wish such events will be conducted on regular interval and pharmaceutical industry will be driven by science and technology.
Tags:
Pharmacist voice