Improving Healthcare through Quality Medicines produced in Nepal
A Nepali-German development cooperation success story
Following the earthquake in 2015, pressure on Nepal increased to locally produce essential medicines. Currently 55 pharmaceutical manufacturers are operating in Nepal and 28 new pharmaceutical companies are planned. The production focuses on generics, including antibiotics, painkillers and medicines against hypertension gastro-intestinal diseases. The pharmaceutical sector is growing strongly (20% annual growth rate as per Nepali Marketing Circle) and governmental policies successfully promote the sector. This is largely due to the experiences after the earthquake in 2015 and the blockade on imports from India which have resulted in tremendous stockouts and severe healthcare implications.
‘Our company had to shut down for 1-2 months after the earthquake. Also, immediately after the earthquake, there was the blockade from India. Nepal experienced severe stockouts and shortages of medicines. It was a very difficult situation.’
Ms Prashansa Shrestha, Ohm Pharmaceuticals.
One way to improve health care is to make good quality essential medicines readily available by producing them locally. Local production of medicines can decrease dependence on foreign suppliers, provide local jobs, increase expertise, cut transport costs and generally improve health care. Local production can also give better control to Nepali regulators, which are fighting against low quality drugs, sometimes produced in remote factories that are difficult to monitor. To be competitive, quality upgrade of the Nepali pharmaceutical sector is needed. In order to be in line with international requirements and to be competitive to international imports, Nepali companies need to further upgrade their quality and production standards. At the moment, qualified technical staff is limited, the quality dossiers of Nepali firms do not correspond to international requirements and there is a lack of quality infrastructure services such as bioequivalence testing (facilities), amongst others.
APPON’s quality circle and PTB join hands to strengthen local pharmaceutical production and value-added in Nepal. The association of pharmaceutical producers of Nepal, APPON, and the German National Metrology Institute (Physikalisch-Technische Bundesanstalt PTB), have been cooperating since 2013 to address the quality challenges of the pharmaceutical sector. Every year, PTB supports several tailor-made technical seminars. So far, the areas of Quality
Risk Management, Bioequivalence Testing, quality dossier preparation, reference standards, Good Manufacturing Practices (GMP) and GMP inspections
and vendor validation have been covered – all being priority topics in Nepal.
‘The cooperation with PTB was a turning point for our company. When we had the first audit by a German expert, we were still in a bad condition, quality-wise. It was a wake-up call for us and since then we have worked step by step to improve on quality requirements. This year, we had an audit by a qualified person from France and we did so much better. The first audit by PTB and the subsequent technical seminars have been like a roadmap to quality improvement for our company.’
Ms Prashansa Shrestha, Ohm Pharmaceuticals.
The APPON-PTB cooperation is a success story of German development cooperation. Regular seminars are specifically designed to meet the needs of the
pharmaceutical industry in Ne
pal and it shows. The technical seminars are attended by a large and constantly growing number of participants from all over the country. They are highly valued by the participants and their employing companies, who cover seminar fees and travel costs. Participants reported that the knowledge they acquired had expanded their scope
of work, improved their daily work processes and increased their responsibilities within their company. As one of the tangible results of the APPON-PTB training, two Nepali companies have already
submitted quality dossiers in an international format to Department of Drug Administration (DDA), and ten more are currently preparing and planning to submit them within 2020. The seminars also serve as a platform for technical
exchange with other companies and with regulatory institutions – on neutral grounds enabling open discussions.
‘As a result of the A PPON-PTB trainings, our company was able to develop several product dossiers in international format. This helps us a lot to export to foreign countries.’
Sabhiyata Khanal, Asian Pharmaceuticals Pvt.Ltd
In future, the seminars shall include more on-site demonstrations. There is potential for future technical seminars in the areas of product development and qualification / validation along the pharmaceutical value chain, as well as on strengthening of external testing and measurement services. Even considering confidentiality issues, Nepali companies are ready to open their doors for on-site trainings and exchange.