Words by Sadhana Dahal
In the realm of healthcare, medicine wields an immense power to diagnose, treat, and prevent ailments. Its influence on human well-being spans pain management, early disease detection, mental health support, and disease outbreak control. The relentless march of global drug innovations across centuries has significantly elevated life expectancy, underscoring medicine’s paramount role in enhancing human existence.
Many diseases that were once fatal are now manageable or preventable, leading to longer and healthier lives for many individuals. Medicine thus has a great impact on overall well-being. So far, a wave of global drug and chemical innovations has continuously increased life expectancy by 2.5 years per decade from 1840 to 2002 (Boudoulas, KD 2017). Behind the scenes of every effective pharmaceutical, however, stand the watchful protectors – drug testing laboratories.
This article embarks on an exploration of the hurdles encountered by Nepalese drug testing laboratories and unveils strategic pathways for augmenting their prowess. This journey is aimed at fortifying the safety and quality of medicines, contributing to the betterment of the nation’s health.
Drug Safety & Drug laboratories
Drug safety has earned a lot of attention in daily medical practice and is given a greater priority due to its major role in patients’ health. With regard to approving new medication or questioning the possibility of withdrawing a drug from the market, a comprehensive concept of drug safety is significant. It is really hard to figure out the loss that people and the country have to bear with counterfeit and substandard drugs.
That is where the importance of a good drug laboratory comes into play. It is through a good laboratory that the safety and quality of the drug are ensured. Drug testing laboratories analyze and evaluate the safety, efficacy, and potential risks associated with pharmaceuticals. While assuring quality, laboratories ensure that the composition, purity, and strength of active ingredients do meet quality standards. Quality personnel involved confirm the absence of impurities through various tests so that health risks related to medicine are minimized.
Every pharmaceutical product that reaches the market is pre-analyzed in the quality control laboratory of the pharmaceutical industry. Nevertheless, laboratories continue to monitor the quality and safety of pharmaceutical products even after they are released to market so that any deviations from quality standards can be detected and rectified. It is always essential to regularly monitor such labs, which have a direct effect on the public’s health, by regulatory bodies.
Continuous or regular monitoring is considered vital for reproducibility, integrity, and quality control. Regulatory oversight will help ensure accountability and maintain the integrity of the drug testing process in the pharmaceutical industry. But again, the one who has the authority to monitor, i.e., the laboratory of the regulatory body of the government, must be strong enough to reproduce accurate data.
It is through these data and test results that come from the laboratory that can make informed decisions about the safety and quality of drugs, which are directly related to public health. In Nepal, the only drug testing laboratory under the government is the National Medicinal Laboratory (NML), which is responsible for quality control and regulation of medicines and pharmaceutical products in the country.
It has the primary role of testing, analyzing, and ensuring the quality, efficacy, and safety of medicines in the Nepalese market. Current Landscape of Drug Testing Laboratories in Nepal Central to Nepal’s healthcare landscape, the National Medicinal Laboratory (NML) shoulders the responsibility of ensuring the quality and regulation of medicines and pharmaceuticals. Yet, the panorama of drug laboratories in Nepal is marred by a slew of challenges impeding their optimal functionality. This section sheds light on the precise challenges and gaps confronting Nepalese drug testing laboratories.
Challenges and Gaps in Nepalese Drug Testing Laboratories
1. Outdated Regulations and the Call for Reevaluation Nepal’s burgeoning pharmaceutical sector, boasting over 128 private allopathic drug entities, operates in the shadow of outdated and inadequate regulations. The absence of revised regulations forms a significant hurdle in guaranteeing the quality and safety of medicines within the market.
2. Inadequate Infrastructure and Resource Constraints Laboratories, ill-equipped and constrained by limited resources, grapple with the challenge of conducting accurate and dependable tests. Scarce budgets further hinder the procurement of advanced equipment, upkeep of essential facilities, and training for staff members.
3. Feeble Data Management and Environmental Concerns Laboratories wrestle with subpar data management practices, resulting in potential inaccuracies and the incapacity to maintain accurate records. Additionally, the dearth of guidelines for pharmaceutical waste disposal harbors the potential for environmental pollution and public health hazards.
Strategies for Enhancing Drug Testing Laboratories in Nepal
Navigating these challenges necessitates a multi-faceted approach for rejuvenating drug testing laboratories in Nepal. This segment outlines a comprehensive set of strategies, poised to elevate the overall efficacy and impact of these indispensable institutions.
1. Regulatory Reforms and Augmented Financial Backing
Overhauling regulations stands imperative to harmonize practices with contemporary pharmaceutical trends. Adequate financial support enabling the upgrade of infrastructure, acquisition of cutting-edge equipment, and the execution of requisite training programs.
2. Collaboration Among Regulatory Agencies, Industry, Academia, and International Entities
Forging alliances and knowledge exchange among key stakeholders fosters the dissemination of best practices, insights, and resources. Collaborative endeavors usher in a holistic approach to bolstering drug testing laboratories.
3. Nurturing Personnel and Leadership via Capacity-Building Programs
Continuous training and skill development programs for lab staff act as strong defenses against becoming outdated. Teaching leadership skills to management teams also greatly enhances overall efficiency and effectiveness.
4. Instituting a Digital Data Management System
A digital data management system serves to refine record-keeping and enhance access to vital information, promoting precision and traceability within drug testing processes.
5. Training for Equipment Maintenance and Troubleshooting
Equipping staff with troubleshooting expertise and the know-how for routine equipment maintenance extends machinery longevity, diminishes repair expenses, and minimizes operational interruptions.
6. Advocating Green Practices and Prudent Pharmaceutical Waste Management
Framing guidelines for pharmaceutical waste disposal and fostering eco-conscious practices safeguards both the environment and public health, in alignment with global sustainability aspirations.
Success Stories From Around The Globe
Catalysts for Nepal’s ascent Th ere are several countries that have made significant improvements in their drug laboratories. Historically, like Nepal, the Medicines Control Authority of Zimbabwe (MCAZ), the Central Drugs Standard Control Organization (CDSCO) of India (MCAZ), and many laboratories in south-east Asia faced challenges related to regulatory inefficiency, inadequate resources, a lack of transparency, delay in drug approval, and many others.
Now MCAZ is an ISO/IEC 17025-accredited and WHO-prequalified laboratory, which is the Regional Centre of Regulatory Excellence (RCoRE) of the New Partnership for Africa’s Development (NEPAD). WHO prequalifi cation combined with ISO 17025 accreditation has placed its chemistry laboratory in a strategic position to contribute its best in local and global level by providing excellent medicine quality control services.(Sithot.T et.al 2021) Likewise, the reforms taken by CDSCO are exemplary (George, B. 2017).
We can see the Indian pharmaceutical market expanding rapidly, and has been involved in vaccine production and many other biotechnological and pharmaceutical products. Th e reforms undertaken by CDSCO, MCAZ, and many others are examples behind us that the drug testing laboratory can address its shortcomings and transform into a more effective and responsive body, thereby ensuring the safety and quality of medicines.
Paving the path to a Healthier Future Nepal’s voyage towards a healthier populace underscores the urgency of transforming drug testing laboratories. Sourced from tales of global achievement, these laboratories can transcend their present limitations.
Regulatory reforms, harmonized stakeholder cooperation, inventive capacity enhancement schemes, and reimagined waste management methodologies collectively possess the potential to revolutionize Nepal’s drug testing arena. However, the journey demands a concerted orchestra of government, industry, academia, and international cohorts. By embracing transformation, aligning with universal benchmarks, and unflinchingly prioritizing safety, Nepal’s drug testing laboratories can etch their legacy as sentinels of public health, ushering in a brighter and healthier future for all