Nepal is soon graduating to a middle-income developing nation by 2026 from its current category of least developed country. This gain must be consistent with the rules
While an effective regulatory authority is a necessity to ensure people's access to safe, effective and quality assured pharmaceutical products, an ineffective regulatory authority hinders people's access to such medicines. The National Drug Policy of 1995 that envisioned making Nepal self-reliant in the production of essential medicines has led to a growth of pharmaceutical industries, with more than 100 of them registered with the Department of Drug Administration (DDA) – the national medicines regulatory authority of Nepal.
Thanks to these industries, Nepal is able to produce almost half of its requirement.
Though almost all the raw and packaging materials required for such industries are imported, the subsequent value addition has helped create massive numbers of jobs in the pharmaceutical sector. A combined total of more than 25,000 retail and wholesale pharmacies and 150 importers operating in Nepal's pharmaceutical market have a share of the pie.
Likewise, the pharmaceutical market is ever ex-panding with a consumption worth about Rs 53 billion a year. However, the capacity to regulate the sector is not widening, which is generally blamed on the limited human resources of the DDA and not having its branch offices in all the seven provinces.
This has continuously stymied the regulatory supervision potential.
The regulators are further challenged through the continuous innovation in the pharmaceutical sector, to keep up with which they need continuous capacity building and diversified human resources, such as pharmacists, doctors, biomedical engineers, statisticians and scientists. As the threat to public health grows with frequent outbreaks of diseases and poorly regulated medicines, it's urgent that the regulatory capacity be strengthened to tame the threat.
The World Health Organisation (WHO) categorises countries at different levels of maturity: 1, 2, 3 or 4 using the Global Benchmarking Tool to assess the regulatory authorities across different functions, such as registration and inspection of products and establishments, laboratory testingand clinical trial. The higher the level, the better the regulatory authority is, with level 3 deemed optimum for a stable well-functioning regulatory authority.
Such universally accepted classifications facilitate countries to harmonise the regulatory practices and recognise each other for regulatory decisions on pharmaceutical productsthrough information sharing, convergence and collaboration.
Particularly, resource-constrained countriescan benefit from such arrangements.
For instance, if the Republic of Korea – currently operating at maturity level 4 – registers a product manufactured by a company based in India, Nepal can adopt the decision for registration if the company applies for marketing here, thus, saving precious time of the evaluators of the regulatory authority and help-ing them with appropriate decision-making.
Similarly, if manufacturers based in Nepal want to export their products abroad or participate in the global tender process for supply of pharmaceutical products, the imminent prerequisite is the maturity of its regulatory authority – the DDA – to at least level 3.
WHO has stated it would soon introduce the conceptof "WHO Listed Authority" with the provision of listing the countries operating at maturity level 3 and 4. Nepal is sure to miss out on the list as it currently operates at maturity level 1.
Nepal is soon graduating to a middle-income developing nation by 2026 from its current category of least developed country. This achievement must be consistent across other major determinants, such as the stringent regulation of medicines and medical devices, which is possiblethrough graduation to a higher maturity level for medicines regulation.
To ensure that it happens, a host of regulatory revamps are required across regulatory functions, such as registration, inspection, vigilance of pharmaceutical products, clinical trial and laboratory testing, among others. The current act regulating the pharmaceutical sector The Drugs Act, 1978 (2035) and the regulations framed there under shall have to be revised to match the new WHO mandates.
The incumbent government, through a common programme, has set out a plan to establish the Food and Drug Authority to strengthen the supervision of health service delivery.
The idea seems to stem from the practices seen elsewhere with stronger regulatory authority, such as the Indonesian Food and Drug Authoritythat has financial and administrative autonomy.
A stronger regulatory authority with enough diverse human resources will help in prompt decision making that will facilitate the stakeholders involved in the pharmaceutical business.
This will also help implement the objective of the National Drug Policy, 1995 and sustainable development goals linked to availability of safe, effective, quality and affordable essential medicines and vaccines.
A stronger regulatory authority also has the tendency to attract international investors thereby helping the country with the badly needed foreign direct investment (FDI).
The recent incidents of deaths linked to consumption of syrup contaminated with toxic compounds in Gambia, Uzbekistan and Indonesia make it all the more urgent to strengthen the regulatory supervision of pharmaceutical products.
In the aftermath of the COVID-19 pandemic, Nepal have seen a growing number of clinical trials, a function that is to be regulated by the medicines regulatory authority. Whether to authorise or not to of such trials based on inappropriate evaluation can become a massive threat to the trial participants or avoidance of opportunity for innovation. So, it is critically important that our regulatory authority beat par with the regulatory authorities seen anywhere in the world.
Baral is a pharmacist
A version of this article appears in the print on March 29, 2023, of The Himalayan Times.
