Pharmaceutical Development in Nepal and a Comparative Critical Review of the Nepal Pharmacy Council Act (2000)

1. Introduction

The Nepal pharmacy council Act, 2057BS (2000 AD) was established to manage a statutory body Nepal Pharmacy Council (NPC) with the aim of regulating the pharmacy profession, education and setting of quality standards for pharmacists in Nepal. The Nepal Pharmacy Council Regulations 2059 (2002) were framed in 2002. The NPC Act led to the formation of NPC, responsible for the registration of pharmacists and Assistant pharmacists in Nepal [1].

The council is entrusted with ensuring ethical pharmacy practice, maintaining professional standards, and upholding public health by guaranteeing the competency of pharmacy professionals throughout the country. There are currently 7430 pharmacists and 14507 Assistant pharmacists registered in Nepal Pharmacy Council, as of Sept. 9, 2025 [1].

Before critically analyzing act, it is important to first discuss the background that led to the establishment of the NPC. This includes the history of pharmacy education in Nepal, the progress of pharmaceutical development, and the role of different pharmacy-related organizations. With the increasing number of pharmacy graduates, the need for a regulatory body like the Pharmacy Council became essential. Therefore, outlining this background is crucial to framing any act amendments in line with both the national context and global practices.

1.1. History of Pharmacy Education in Nepal

Pharmacy education in Nepal formally began in 1972 with the introduction of a two-and-a-half-year Proficiency Certificate Level (PCL) program at the Institute of Medicine (IOM) under Tribhuvan University. Designed for students who had completed school-level education, this program laid the foundation for professional pharmacy training in the country. At the time, many students joined the PCL program as a stepping stone to medical studies, particularly MBBS, as it provided eligibility to sit for medical entrance examinations [2,3,4].

To address the widespread shortage of pharmacists in 1980s and to regulate the informal sale of medicines, a Drug Retailer’s Training initiative was launched in 1981. This 45-hour course provided essential practical and theoretical instruction on pharmacology, ethics, storage practices, and relevant legal frameworks. By 1989, a total of 4,096 participants had completed the training, helping to fill the gap in pharmaceutical services across the country [2,5].

A significant milestone in pharmacy education came in 1994 with the launch of the Bachelor of Pharmacy (B. Pharm) program at Kathmandu University (KU). This marked the beginning of degree-level pharmaceutical education in Nepal. The university later expanded its academic offerings to include the Master of Pharmacy (M. Pharm) program in 2000, followed by the Ph.D. in Pharmaceutical Sciences in 2004. Additionally, KU introduced a Post-Baccalaureate Doctor of Pharmacy (Pharm D) program in 2010 [6], contributing to the diversification of advanced pharmacy education in the country [2].

The role of pharmacists has evolved globally from being primarily involved in compounding and dispensing to taking on broader responsibilities within multidisciplinary healthcare teams [7,8]. In many developing countries, pharmacies serve as critical points of access for healthcare information and services. Pharmacists, with their expertise in medicines and therapeutics, are well-positioned to contribute to areas such as clinical management and basic diagnostics. However, in the context of Nepal, pharmacists are still largely concentrated in the pharmaceutical manufacturing sector, with limited integration into clinical [9] and public health teams. This has led to low public awareness of the pharmacist's role and underutilization of pharmacy services in patient care [2].

By 2004, institutions affiliated with the Council for Technical Education and Vocational Training (CTEVT) began offering the Diploma in Pharmacy, a three-year program considered equivalent in structure and purpose to the earlier PCL [2,3]. As of 2025, a total of 116 institutions under CTEVT offer the Diploma in Pharmacy program, with an annual enrollment capacity of 4,640 students [10].

The B. Pharm program has also expanded significantly; as of the 2024/25 academic year, a total of 27 colleges affiliated with four federal universities (TU, PU, KU & Purbanchal U.), two provincial universities (GU & MTU), and two health science academies (KAHS & MBAHS) are offering the course, with a collective enrollment capacity of 755 students, as per MEC allocated quota. Out of 27 colleges only 7 are public. For details about each institution allocation of B. Pharm quota for year 2024 and 2025 see Table 1 below [2,11].

Despite this progress, there remains a persistent shortage of pharmacists, especially in the public healthcare system. Many District Hospitals, District Public Health Offices, and even some provincial hospitals lack trained pharmacy professionals, which continues to hamper the delivery of quality pharmaceutical services. In the private sector, the growth has been more robust; the number of registered drug retail outlets increased from 16,640 in 2014 to 30,185 by 2025[12]. Registration data from the Nepal Pharmacy Council shows a steady increase in qualified personnel, with 3,761 pharmacists and 7,162 pharmacy assistants registered in 2010, rising to 7,430 pharmacists and 14,507 pharmacy assistants by 2025 [1,2].

In line with global efforts to advance pharmacy education, the International Pharmaceutical Federation (FIP) in October 2021 convened stakeholders from across all six WHO regions to co-develop roadmaps aimed at enhancing the quality and scope of pharmacy and pharmaceutical sciences education worldwide [13]. These initiatives serve as a guiding framework for countries like Nepal in strengthening their pharmacy workforce and integrating pharmacists more fully into national health systems [2].

1.2. History of Pharmaceutical development in Nepal

The roots of pharmaceutical practices in Nepal can be traced back to the Licchavis era, particularly during the reign of King Amshuverma (605–621 CE), when an ancient Ayurvedic hospital, referred to as "Aarogyashala," is believed to have existed. Although historical evidence is limited, it indicates the early presence of organized healthcare rooted in traditional medicine. During King Pratap Malla’s rule (1641–1674 AD), an Ayurvedic medicine production unit was initiated in Hanuman Dhoka, which was later relocated to Thapathali by Prime Minister Jung Bahadur Rana in 1846. This facility eventually became known as the Singh Durbar Vaidyakhana. Initially reserved for the royal family, the medicines were later made available to the general public under King Tribhuvan’s reign [14].

The introduction of modern (allopathic) medicine began after the Sugauli Treaty in 1816 AD with the establishment of the British Residency in Nepal. A small clinic set up within the residency compound marked the beginning of western medical practice, later followed by the establishment of Bir Hospital in 1889. As the popularity of modern medicine grew, the pharmaceutical trade expanded, leading to the formation of wholesale and retail drug businesses [14,15,16,17].

In 1964, the Royal Drug Research Laboratory (RDRL) was founded to initiate drug research and production. This laboratory evolved into Royal Drug Limited (RDL) in 1972, under the Nepalese government, marking the start of institutionalized allopathic drug manufacturing. Around the same time, Chemidrug Industries Pvt. Ltd. became the first private pharmaceutical company in Nepal, beginning operations in Kathmandu in 1970 [14].

The formal regulation of pharmaceuticals began with the enactment of the Drug Act in 1978, followed by the establishment of the Department of Drug Administration (DDA) in 1979 under the Ministry of Forest and Soil Conservation. This act was designed to prevent the misuse and misrepresentation of pharmaceuticals, ensure safety and efficacy, and regulate production, marketing, distribution, and use [3,14]. Several regulatory instruments followed, including:

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Drug Consultative Council and Advisory Committee Regulation (2037 BS),

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Drug Registration Regulation (2038 BS),

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Interrogation and Inspection Regulation (2040 BS),

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Drug Manufacturing Code (2041 BS), and

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Drug Standard Regulation (2043 BS).

The National Medicines Laboratory, formerly RDRL, now serves as the national body for drug testing and quality control. Two key advisory bodies under the Ministry of Health and Population-Drugs Advisory Council and Drugs Advisory Committee-were also established to guide policy and ensure scientific development and regulation of pharmaceuticals [14].

The National Drug Policy was introduced in 1995 with the objective of promoting the availability of safe, effective, and quality medicines [18]. It also aimed to strengthen coordination among governmental, non-governmental, and private sectors engaged in drug-related activities, including production, regulation, distribution, and information dissemination [14].

From an industrial perspective, the pharmaceutical sector saw significant growth in the 1980s and 1990s, with the establishment of major domestic companies such as Manoj, Everest, Lomus, and NPL. However, several large-volume parenteral manufacturers-including Pashupati Chemical and BHK Pharma-eventually ceased operations. The adoption of Good Manufacturing Practice (GMP) guidelines, including certification by the World Health Organization (WHO), has improved the quality standards of domestic pharmaceutical products. As of Sept. 9, 2025 there total 194 pharmaceutical companies among which 114 are allopathic, 66 are ayurvedic and 14 are veterinary company [12]. And of them only 58 are GMP certified companies running in Nepal [19].

The Association of Pharmaceutical Producers of Nepal (APPON), founded in 1990, plays a crucial role in advocating for the pharmaceutical industry. It represents approximately 45% of the domestic market share and supports technical and regulatory advancement to enhance the competitiveness of Nepalese pharmaceuticals in both local and international markets. Several companies have already received Certificates of Pharmaceutical Products (CoPP) to facilitate exports [20].

Hospital pharmacy services in Nepal began with the establishment of Patan Hospital (formerly Santabhavan) in 1956, followed by Tansen Mission Hospital in 1959. In the 1970s and 1980s, government hospitals commonly prepared basic medicinal formulations such as cough mixtures, ointments, and antiseptic solutions. However, there was a lack of trained pharmacy professionals, with most dispensing duties carried out by assistant health workers. In 1979, the Ministry of Health created the first posts for assistant pharmacists at Mechi Zonal Hospital and Bharatpur Hospital. Despite these early efforts, by 2007, fewer than 8% of registered pharmacists and 37% of pharmacy assistants were employed in hospital or community settings. Even today, many hospitals lack proper pharmacy services, although a few institutions-such as Manipal Hospital (Pokhara), Dhulikhel Community Hospital, and Model Hospital-have established exemplary systems [14].

The Nepal Pharmacy Council, established through an act passed in 2000, serves as the regulatory and professional body for pharmacists in Nepal, ensuring academic standards and professional conduct [21]. The MEC currently oversees quota allocation for pharmacy colleges and conducts regular annual inspections.

The Nepal Chemists and Druggists Association (NCDA, https://ncda.org.np/), founded in 1973, represents the interests of pharmaceutical retailers and wholesalers. Its primary aim has been to enforce uniform pricing and represent the trade profession in national forums.

The Nepal Pharmaceutical Association (NPA) is a professional body established in 1972 to promote the development, regulation, and quality advancement of the pharmacy profession in Nepal (https://npa.org.np/).

Recently, Dr. Dirgha Raj Joshi founded the Association of Faculties of Pharmacy of Nepal (AFPN) on 1^st Baishakh 2082 BS with the vision of uniting pharmacy educators across the country. (https://dirghajoshi.com.np/afpn/).

In Nepal, pharmacists are predominantly engaged in roles within pharmaceutical industries, whereas globally, pharmacists are increasingly involved in community-based services and direct clinical care to patients. However, there is a growing recognition and advocacy for expanding the role of clinical pharmacy in Nepal [22,23,24,25].

Given this historical and contextual background, the objective of this article is to critically analyze the Pharmacy Council Act of Nepal (2000) in light of the nation’s evolving pharmaceutical education, professional practice, and regulatory needs. While the Act was a landmark step in establishing a statutory body to regulate pharmacy practice and education, its provisions now appear limited when compared to the dynamic global role of pharmacists, the rapid expansion of pharmacy education, and the growing pharmaceutical industry in Nepal. This article seeks to assess whether the Act adequately addresses the challenges of uneven professional distribution, limited integration of pharmacists into clinical and community health systems, and the need for stronger alignment with international standards such as those promoted by the International Pharmaceutical Federation (FIP). By situating Nepal’s Pharmacy Council Act within both its historical context and a comparative global framework, this analysis aims to identify gaps, highlight opportunities for reform, and propose ways to strengthen the role of pharmacists in safeguarding public health and advancing the nation’s healthcare system.

2. Methods

This study used a qualitative, document-based, and analytical approach to critically examine the Nepal Pharmacy Council (NPC) Act, 2000 (2057 BS). The primary source was the official text of the Act from the Nepal Law Commission, supplemented by secondary sources including scholarly articles, government reports, regulatory websites, and pharmacy acts from other countries. The analysis was guided by a SWOT (Strengths, Weaknesses, Opportunities, Threats) framework, with emphasis on the Act’s administrative, legal, and educational provisions, their relevance to contemporary pharmacy practice (hospital, community, and clinical), and their implications for professional development, academic institutions, and public health in Nepal.

3. NPC act and Amendment Suggested

Table 2 shows chapters and sections of NPC act 2000. Table 3 shows analysis of the NPC Act in SWOT form.

Preamble of NPC act: “Whereas, it is expedient to manage the Nepal Pharmacy Council to make effective the Pharmacy Profession through systematic and scientific operation” [1].

Amendment suggested: Whereas, it is expedient to regulate and strengthen the pharmacy profession in Nepal by ensuring the competency, ethical conduct, and continuous development of pharmacy professionals; to safeguard public health through the promotion of safe, effective, and quality use of medicines; to advance pharmacy education and practice in alignment with international standards; and to integrate pharmacists as vital members of the healthcare system for the service of society.

Current Functions, Duties, and Powers of NPC [1]

NPC Act (2000) currently assigns the Council the following core responsibilities:

• Policy and Program Management: Prepare and implement plans for systematic and scientific management of the pharmacy profession.
• Education Recognition: Grant recognition to institutions offering pharmacy education and validate their certificates and degrees.
• Curriculum and Standards: Determine curricula, admission requirements, and examination systems; ensure compliance and revoke recognition if standards are not maintained.
• Registration of Professionals: Determine qualifications to practice pharmacy and maintain a register of pharmacists and pharmacy assistants.
• Disciplinary Actions: Remove names from the register for professional misconduct or violation of the prescribed code of conduct.

While these provisions establish the foundation of professional regulation, they primarily focus on administrative, educational, and disciplinary functions. Moreover number 1 and 2 are mostly taken now by MEC this limits the role of NPC. The current Act does not explicitly address public health integration, continuing professional development, research promotion, or equitable access to pharmacy services, which are emphasized in global pharmacy council practices.

So, here are some suggested amendment for functions, duties, and powers of the Council:

(a) Policy and Planning: To formulate, implement, and periodically review policies, plans, and programs for the advancement of the pharmacy profession, ensuring alignment with national health priorities, public health needs, and international standards.

(b) Education Recognition and Accreditation: To recognize, accredit, and periodically inspect educational institutions providing pharmacy education, ensuring that the certificates and degrees awarded meet internationally accepted standards of competence, quality, and ethical training. [For this council may need to discuss with MEC to share authorities]

(c) Curriculum and Examination Standards: To prescribe and periodically review curricula, admission criteria, training requirements, and examination systems for pharmacy education. To ensure compliance with these standards through inspections, audits, and evaluation, and to suspend or revoke recognition of institutions or programs failing to meet established standards after due process. [For this council may need to discuss with MEC to share authorities]

(d) Registration and Licensing: To determine qualifications and competencies required to practice as a pharmacist or pharmacy assistant. To maintain and update a National Register of pharmacists and pharmacy assistants, granting licenses only to those meeting prescribed standards.

(e) Professional Conduct and Disciplinary Actions: To establish, publish, and enforce a code of professional and ethical conduct for pharmacists and pharmacy assistants. To initiate investigations and disciplinary actions, including suspension or removal from the register, in cases of professional misconduct, negligence, or violation of ethical standards, ensuring due process and transparency.

(f) Continuing Professional Development (CPD) [26]: To promote and regulate continuing professional development programs for registered pharmacists and pharmacy assistants to ensure ongoing competency, knowledge update, and alignment with evolving healthcare practices.

(g) Integration in Healthcare System: To promote the participation of pharmacists in clinical, community, and public health services, ensuring that pharmacy practice contributes effectively to patient care, rational medicine use, and overall health system strengthening.

(h) Research and Policy Advisory Role: To encourage research and innovation in pharmacy practice, pharmaceutical sciences, and medicine use. To advise the government and stakeholders on pharmaceutical policies, public health programs, and professional standards.

(i) Public Awareness and Advocacy: To increase public awareness of the role of pharmacists, the safe and rational use of medicines, and the availability of pharmacy services, including advocacy for equitable access to pharmacy education and professional services across all regions of Nepal.

Current Constitution of the Council: Mostly government-nominated pharmacists, plus association (NPA) and DDA representative. This lacks fair selection, so proposed new amendment is:

(a) Chairperson: The Chairperson of the NPC shall be selected through an open, transparent, and merit-based process. A public call for applications shall be issued for eligible candidates who are registered pharmacists with a minimum of ten years of professional experience and demonstrated leadership in pharmacy education, practice, or research. Applicants shall submit a detailed action plan and vision statement for advancing the NPC’s mandate. A Selection Committee, comprising representatives from the MEC or UGC, the Ministry of Health & Population, and a public health representative, shall evaluate the applications and shortlist three candidates. These shortlisted candidates shall present their strategic plans and undergo interviews before the committee. Based on the committee’s recommendation, the Government shall appoint one candidate as Chairperson for a fixed term of five years, renewable once, ensuring a merit-based, transparent, and visionary leadership for the NPC. The candidate must hold a minimum of a Master’s degree in Pharmacy (Preferred PhD) and have at least ten years of professional experience in the pharmacy field.

(b) Four senior academic pharmacists nominated by universities (through UGC or MEC) offering pharmacy programs – Member

(e) One senior hospital or clinical pharmacist nominated by the Council – Member

(f) One representative of community pharmacists, nominated by their professional body – Member

(g) One representative of the Department of Drug Administration – Member

(h) One public representative (not being a pharmacist) with experience in public health, patient rights, or consumer advocacy – Member

(i) Registrar: The Registrar of the NPC, serving as the Member-Secretary, shall be selected through a transparent and merit-based process similar to that of the Chairperson.

Note: At least three female members among the above nominees to ensure gender balance. All of the members should hold minimum master’s degree in pharmacy. The Council may, if necessary, invite relevant experts or observers to its meetings.

To understand other relevant things; Table 4 shows global pharmacy regulation- legal frameworks, key features, strengths, and weaknesses. Table 5. Shows comparative overview of pharmacy education, licensing, and renewal requirements across countries (including Nepal) and Table 6. Shows recommendations for modernizing the NPC act based on global practices.

4. Conclusions

The NPC Act 2000 was a landmark initiative that formally recognized pharmacy as a regulated profession in Nepal and established the Council to oversee education, registration, and professional conduct. Over the past two decades, pharmacy education and the pharmaceutical industry have grown substantially, yet gaps in workforce distribution, professional roles, and regulatory enforcement persist. The current Act primarily addresses administrative, educational, and disciplinary functions, with limited focus on clinical integration, public health involvement, CPD, research, or digital modernization. Comparative analysis with global regulatory frameworks highlights the importance of mandatory CPD, clear role differentiation between pharmacists and assistants, telepharmacy integration, periodic legislative review, and inclusion of contemporary pharmacy roles such as clinical, community, and pharmacovigilance practices. Proposed amendments emphasize merit-based leadership, enhanced governance, expanded responsibilities, and alignment with international standards to strengthen the NPC’s capacity. Modernizing the NPC Act will not only ensure competent and ethical pharmacy practice but also enhance pharmacists’ contribution to healthcare delivery, rational medicine use, and patient safety. By bridging historical context, current challenges, and global best practices, Nepal can build a robust, dynamic pharmacy profession capable of meeting national health needs and achieving alignment with international standards.