Department Of Drug Administration Research Articles

Developing Nepal's medicines pricing policy: evidence synthesis and stakeholders' consultation.

The objectives of this paper are to (a) explore stakeholders' opinions regarding Nepal's existing medicines pricing practices/situation and (b) build and present a set of medicines pricing policies for Nepal. A review of the literature and field visits to community retail pharmacies, hospital pharmacies, wholesalers, and distributor outlets in Kathmandu were conducted to assess the medicines pricing situation. Following the literature review, preliminary meetings with stakeholders and field visits were held and a draft interview guide was prepared. Consultative sessions subsequently were undertaken in Kathmandu, Nepal, in January 2023 with representatives from the Department of Drug Administration, Ministry of Health and Population, Association of Pharmaceutical Producers of Nepal, consumer groups, Transparency International, Medicines Importers Association of Nepal/ Pharmaceutical Distributors Association of Nepal, Nepal Chemist and Druggist Association, and Nepal Pharmaceutical Association. Notes were taken during these meetings regarding issues and concerns raised as well as experiences and recommendations for the future, as outlined in the interview guide. The stakeholders in general stated that they do not have any objection to price regulation; however, they believe such regulation should be subject to periodic review. Both the importers and the Ministry of Health and Population have the view that an independent body/authority should be charged with regulating the prices of medicines. A set of policy options to be considered for use in Nepal include cost-plus pricing, external price referencing, internal reference pricing, and mark-up regulations. Key issues related to pricing were identified and suggest that a set of pricing policies and updated regulations need to be considered to establish changes that are transparent, rational, and acceptable to the related stakeholders. Hence, suggestions made in this paper could be useful to inform a rational and fair pricing structure and to improve access to medicines.

Availability of access, watch, and reserve (AWaRe) group of antibiotics in community pharmacies located close to a tertiary care hospital in Lalitpur, Nepal.

The access, watch, and reserve (AWaRe) classification of antibiotics was developed in 2019 by the WHO Expert Committee on the Selection and Use of Essential Medicines as a tool to support antibiotic stewardship efforts at local, national, and global levels. The objectives of this study were to assess the availability of antibiotics as per WHO AWaRe classification at community pharmacies located around a tertiary care hospital in Lalitpur and to compare these antibiotics with the national essential medicine list of Nepal. The cross-sectional study was conducted at community pharmacies located within a two-kilometer radius of a teaching hospital from August to November 2022. A total of 82 community pharmacies registered with the Nepal Chemist and Druggists Association and the Department of Drug Administration were studied. Data was collected using a standard proforma containing the names of the antibiotics classified as per the WHO's AWaRe classification. Access group of antibiotics, Ampicillin, (82;100%), Amoxycillin, (82;100%), Flucloxacillin, (82;100%), and Metronidazole, (82;100%) were available in all community pharmacies. Results from the watch group showed that Azithromycin, (80; 97.6%) was available in all pharmacies followed by Cefixime, (80; 97.6%), Ciprofloxacin, (73; 89%), Levofloxacin, (74; 90.2%)and Ofloxacin, (74; 90.2%). Linezolid, (24; 29.3%) was the most common antibiotics available from the reserve group of antibiotics. Colistin was the second commonly available antibiotic. The most available antibiotic from the not recommended group were Ampicillin/Cloxacillin (82; 100%), followed by Piperacillin/Sulbactam, (39; 47.6%). There were differences in the classification of antibiotics between the WHO AWaRe list and the Essential Medicines list of Nepal in terms of numbers of antibiotics listed. Antibiotics from the not recommended and reserve groups were commonly available in community pharmacies. The implementation of antibiotic guidelines should be emphasized along with strict monitoring of the sale of antibiotics without a prescription in community pharmacy settings.

Evaluation of Quality Parameters of Light Sensitive Drugs Marketed in Nepal.

Photosensitivity is the response of drug or drug product to the exposure of solar, UV and visible light in the solid, semisolid, or liquid state that leads to a physical or chemical change. Exposure to light is a concern with numerous medications due to the potential for photo degradation or other chemical reactions that affect drug stability. Out of all the registered brands in Department of Drug Administration, 9 brands of Rabeprazole tablets, 5 brands of Promethazine tablets and 5 brands of methylcobalamin tablets were selected and were subjected for testing and analysis for various quality parameters as per pharmacopoeia. The labels of the collected medicine were analyzed. The obtained data were entered and analyzed in Microsoft office excel 2019. Eleven products did not comply with the existing regulatory requirement on labeling system of medicine as per Regulation of Standard of drugs. There was no uniformity in mentioning the self-life. Similarly, large variation was seen on price of same generic drugs. Information regarding storage conditions, direction for use and category of the drug were lacking in the label of some brands of medicines.Upon Laboratory analysis, two brands of promethazine tablets and three brands of Rabeprazole tablets were found substandard. Drug content of all the brands of Methylcobalamin was found to contain overage. The result of this study indicates that substandard medicines are abundant in Nepalese market. There is weak regulation monitoring which have resulted in no uniformity in similar pharmaceutical products too. Hence, stringent regulatory monitoring is required to assessthe quality of pharmaceutical products in the Nepalese market.

Trend of Antimicrobial Use in Food-Producing Animals from 2018 to 2020 in Nepal.

Antimicrobial resistance is a global public health problem and is primarily driven by the widespread overuse of antibiotics. However, antimicrobial use data in animals are not readily available due to the absence of a national database in many developing countries, including Nepal. This study was conducted to estimate the quantities of antimicrobials available in Nepal as an indicator of their use in food-producing animals between 2018 and 2020. Data were collected through surveys targeting major stakeholders: (i) the Department of Drug Administration (DDA), the Government of Nepal (GoN) for the authorized antimicrobials for veterinary use in Nepal, (ii) veterinary pharmaceuticals for antimicrobials produced in Nepal, (iii) the DDA and Veterinary Importers Association for antimicrobials bought by veterinary drug importers, and (iv) the Department of Customs, GoN, for antibiotics sourced through customs. Data showed that in the 3 years, a total of 96 trade names, comprising 35 genera of antibiotics representing 10 classes, were either produced or imported in Nepal. In total, 91,088 kg, 47,694 kg, and 45,671 kg of active ingredients of antimicrobials were available in 2018, 2019, and 2020, respectively. None of the antibiotics were intended for growth promotion, but were primarily for therapeutic purposes. Oxytetracycline, tilmicosin, and sulfadimidine were among the most-used antibiotics in Nepal in 2020. Oxytetracycline was primarily intended for parenteral application, whereas tilmicosin was solely for oral use. Sulfadimidine was available for oral use, except for a small proportion for injection purposes. Aminoglycosides, fluroquinolones, nitrofurans, sulfonamides, and tetracyclines were mostly produced locally, whereas cephalosporins, macrolides and "other" classes of antimicrobials were imported. Amphenicols and penicillins were exclusively imported and nitrofurans were produced locally only. In general, except for tetracyclines, the volume of antimicrobials produced locally and/or imported in 2020 was lower than that in 2018, which corresponded to a decreasing trend in total antimicrobials available. Furthermore, the subsequent years have seen a decrease in the use of critically important antibiotics, particularly class I antibiotics. Finally, this study has firstly established a benchmark for future monitoring of antimicrobial usage in food-producing animals in Nepal. These data are useful for risk analysis, planning, interpreting resistance surveillance data, and evaluating the effectiveness of prudent use, efforts, and mitigation strategies.

Drug Act 1978 of Nepal: A Critical Analysis

Background: With the enactment of the Drug Act in 1978, through the establishment of different bodies under the act, drug-related activities have been regulated and controlled in Nepal so as to provide safe and efficacious drugs of standard quality to the general public. However, with the overgrowing use of drugs, cosmetics, biotechnological products, nutraceuticals, and veterinary products in the present market and the present act failing to include these aspects, this paper tries to critically analyze the Drug Act 1978 of Nepal which will comprise strengths, weaknesses, opportunities, and threats faced in current scenario regarding the act. The regulation of drugs in Nepal was started with the enactment of the Drugs Act in 1978 AD, which is being carried out by the Department of Drug Administration as provisioned in the section 5 of the act. To facilitate the proper implementation of the act, various rules, regulations and guidelines are framed. The objective of this study was to explore the areas to improve in the Drugs Act and help foster the use of safe, efficacious and quality drugs. Method: The Drugs Act 1978 was critically analyzed focusing on the strengths, weaknesses, opportunities, and threats of the act as of current scenario. Result: After critically analyzing the drugs act 1978 we found out that there is lack in regulations of use of cosmetics, newer biotechnology products, nutraceuticals, veterinary product, innovative pharmaceutical products as well as the online pharmacy services. Conclusion: A major amendment and periodic revision is required with the consequence of meeting timely needs and promoting the idea of safety and efficacy in drug related activities.

Review of drug recalls and quality of pharmaceutical products in Nepal

ObjectivesTo evaluate the pattern of substandard and falsified pharmaceutical products recall in Nepal.SettingWe analysed drug recall notices issued by the Department of Drug Administration (DDA), Nepal, and systematically reviewed peer-reviewed...

Scope of Pharmacovigilance for Ayurvedic Drugs in Nepal: A Review

Ayurveda along with complementary and alternative medicine (CAM) systems have their own principles, have their own pharmacopeia, but are practiced as over the counter drugs without an authentic prescription. Government of Nepal nominated Department of Drug Administration (DDA) in October 2004 as the focal point (National Pharmacovigilance Centre) to liaison with WHO collaborating centre for International Drug Monitoring (IDM), Sweden and started collecting adverse drug reactions (Nepal became a WHO program member in July 2006). Nepal joined the international pharmacovigilance program as a full member in 2007. This study is to reflect the present status of pharmacovigilance in Nepal and put light on scope of pharmacovigilance on drugs of Ayurveda and other complementary alternative systems in Nepal. For which review and analysis of concerned published literatures in print form and in online database. At present; 12 regional pharmacovigilance centers are there in Nepal. Currently, the clear pattern and scope of adverse drug reactions (ADRs) in Nepal remains unexplored. For Ayurveda drugs the concept of pharmacovigilance is not yet formally introduced in Nepal. No policy has been formulated for the same. The conventional belief that Ayurveda drugs have no ADRs should be transformed.

Situation analysis of the pharmacovigilance system in Nepal using the indicator-based pharmacovigilance assessment tool (IPAT)

Abstract Objectives The aim of this study was to assess the national and regional pharmacovigilance centres in Nepal in terms of their policy frameworks, structure and functioning. Methods A descriptive cross-sectional study was conducted during January 2021 among regional pharmacovigilance centres, and the national pharmacovigilance centre and the Ministry of Health and Population. The indicator-based pharmacovigilance assessment tool (IPAT) consisting of 43 indicators (26 core and 17 supplementary) assessing different aspects of pharmacovigilance was used. Key findings Of a total of 14 candidates representing regional pharmacovigilance centres, 12 agreed to participate. The national pharmacovigilance centre located at the Department of Drug Administration had an acceptable level of infrastructure and manpower but poor functioning and weak collaboration with regional centres. There are no policies and procedures specifically related to pharmacovigilance and no requirement for pharmaceutical companies to report adverse drug reactions (ADRs). The national centre received only 42 ADR reports during the evaluation period. The regional centres are mostly located (10 out of 14) in the Kathmandu Valley and had qualified manpower and basic resources. There were poor process indicators suggesting problems with functioning in terms of ADR reporting, signal generation and drug safety communication. Conclusions Underreporting of ADRs, weak processes and poor coordination among centres limit functioning of the system. Creating more awareness, involving consumers and pharmaceutical companies in the reporting process, and conducting more training programmes are needed for the proper functioning of pharmacovigilance services in Nepal.

Knowledge, Attitude and Practices of Pharmacovigilance among Doctors at a Tertiary Care Teaching Hospital Birgunj, Nepal

Introduction: Pharmacovigilance helps in the detection and prevention of adverse effects of drugs. For the effectiveness of this program, health care professionals should report adverse drug reactions (ADRs) considering it as their moral and professional obligation. The objective of the study was to assess the knowledge, attitude, and practices (KAP) of the doctors towards ADRs and pharmacovigilance in National Medical College Teaching Hospital (NMCTH), a tertiary care teaching hospital situated in the Narayani zone.
 Materials and Methods: A cross-sectional study was carried out using a self-administered questionnaire consisting of four parts; first part included a demographic profile of participants, the second part consisted of ten questions for the assessment of the knowledge about pharmacovigilance, third part comprised of six questions on attitude and fourth part consisted of five questions on practice. The results were depicted in the form of percentages for each KAPs questionnaire. 
 Results: The response rate of participants was 85.16%. Pharmacovigilance was correctly defined by 52%. Department of drug administration was responsible for monitoring ADRs in Nepal was correctly given by 80%. Only 8% had reported ADRs, although 62% had encountered an ADR in their clinical practice.
 Conclusion: The doctors at NMCTH had a poor KAP towards pharmacovigilance and educational intervention is needed for the proper functioning of this program.

Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial.

IntroductionFungal infections of the cornea, fungal keratitis (FK), are challenging to treat. Current topical antifungals are not always effective and are often unavailable, particularly in low-income and middle-income countries where most cases occur. Topical natamycin 5% is usually first-line treatment, however, even when treated intensively, infections may progress to perforation of the eye in around a quarter of cases. Alternative antifungal medications are needed to treat this blinding disease.Chlorhexidine is an antiseptic agent with antibacterial and antifungal properties. Previous pilot studies suggest that topical chlorhexidine 0.2% compares favourably with topical natamycin. Full-scale randomised controlled trials (RCTs) of topical chlorhexidine 0.2% are warranted to answer this question definitively.Methods and analysisWe will test the hypothesis that topical chlorhexidine 0.2% is non-inferior to topical natamycin 5% in a two-arm, single-masked RCT. Participants are adults with FK presenting to a tertiary ophthalmic hospital in Nepal. Baseline assessment includes history, examination, photography, in vivo confocal microscopy and cornea scrapes for microbiology. Participants will be randomised to alternative topical antifungal treatments (topical chlorhexidine 0.2% and topical natamycin 5%; 1:1 ratio, 2–6 random block size). Patients are reviewed at day 2, day 7 (with reculture), day 14, day 21, month 2 and month 3. The primary outcome is the best spectacle corrected visual acuity (BSCVA) at 3 months. Primary analysis (intention to treat) will be by linear regression, with treatment arm and baseline BSCVA prespecified covariates. Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF).Ethics and disseminationThe Nepal Health Research Council, the Nepal Department of Drug Administration and the London School of Hygiene and Tropical Medicine ethics committee have approved the trial. The results will be presented at local and international meetings and submitted to peer-reviewed journals for publication.Trial registration numberISRCTN14332621; pre-results.

Untested natural medicines are big threats to health in China and Africa

In mainland China and Africa, when natural medicines apply for licenses, they do not need to pass the same rigorous toxicity and efficacy tests as those of synthetic medicines. The lack of regulation of untested natural medicines by drug administration departments is a big threat to global health. Studies have shown natural medicines severely threaten the health of human beings although they seem harmless. Over 100 million of the Chinese are suffering from diseases caused by natural medicines. These medicines include aristolochic acid (AA)-containing plants (a worldwide problem) and natural medicine injections (only in mainland China). Clear evidence shows the widespread toxicity of AA-containing plants and natural medicine rejections while not a single rigorous test suggests the efficacy of them. One recent example is that plant soups were widely used to treat patients in mainland China during the coronavirus disease 2019 (COVID-19) outbreak. An ingredient of these plant soups is Xixin, which contains AA.

A national survey of private-sector outpatient care of sick infants and young children in Nepal

BackgroundPrevious research has documented that across South Asia, as well as in some countries in Sub-Saharan Africa, the private sector is the primary source of outpatient care for sick infants and children and, in many settings, informal providers play a bigger role than credentialed health professionals (particularly for the poorer segments of the population). This is the case in Nepal. This study sought to characterize medicine shop-based service providers in rural areas and small urban centers in Nepal, their role in the care and treatment of sick infants and children (with a particular focus on infants aged < 2 months), and the quality of the care provided. A secondary objective was to characterize availability and quality of such care provided by physicians in these settings.MethodsA nationally representative sample of medicine shops was drawn, in rural settings and small urban centers in Nepal, from 25 of the 75 districts in Nepal, using multi-stage cluster methodology, with a final sample of 501 shops and 82 physician-run clinics. Face-to-face interviews were conducted.ResultsMost medicine shops outside urban areas were not registered with the Department of Drug Administration (DDA). Most functioned as de facto clinics, with credentialed paramedical workers (having 2–3 years of training) diagnosing patients and making treatment decisions. Such a role falls outside their formally sanctioned scope of practice. Quality of care problems were identified among medicine shop-based providers and physicians, including over-use of antibiotics for treating diarrhea, inaccurate weighing technique to determine antibiotic dose, and inappropriate use of injectable steroids for treating potentially severe infections in young infants.ConclusionsMedicine shop-based practitioners in Nepal represent a particular type of informal provider; although most have recognized paramedical credentials, they offer services falling outside their formal scope of practice. Nevertheless, given the large proportion of the population served by these practitioners, engagement to strengthen quality of care by these providers and referral to the formal health sector is warranted.

Herbal pharmacovigilance in Nepal: challenges and recommendations

Traditional herbal medicine is widely used globally. Despite its extensive use, there are no proper regulations on standardization and use of herbal medicinal products. Nepal has a rich biodiversity and demography comprising of different socio-ethnic groups. Herbal medicines are utilized prominently in Nepalese communities. These herbal products may cause side effects and adverse effects, such as nephrotoxicity, neurotoxicity with the heavy metal toxicity associated with their powdered dosage forms. The side effects of using herbal products have been documented, such as bleeding with use of Ginkgo biloba and increase in blood pressure with use of Ephedra. Regulation of herbal products is essential to promote their optimal and rational use. Standard tools are available for assessing adverse effects of herbal products from health authorities, like the World Health Organization. In Nepal, self-medication practice using traditional herbal medicines is common and includes the concomitant use of allopathic. There is no focal point to address the regulatory issues on herbal products currently in Nepal. The Department of Drug Administration in Nepal is nominated as a national pharmacovigilance center and there are no reports on adverse events from the use of herbal medicines so far. However, not having any reports does not ensure the absolute safety and effectiveness of herbal products, so vigilance is warranted. Herbal pharmacovigilance is needed for Nepal to ensure safe and effective use of herbal medicines as the current pharmacovigilance ecosystem does not capture those cases. In the Nepalese context, the absence of reporting mechanisms may have underreported adverse cases of herbal products. The present opinion article aims to discuss the use of herbal products in Nepal, the challenges associated with the adverse reaction due to herbal medicines, and recommendations to overcome these challenges

An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia.

In the semiregulated market, different countries have varying requirements of registration for export to such a specific country or region. The objective of the present study is to give a comparative overview of pharmaceutical registration requirements for export to Tanzania, Nepal, and Cambodia. In the African region especially, east Africa including Tanzania is an emerging market for pharmaceuticals. The Tanzania Food and Drugs Authority is the drug regulatory body in Tanzania and it follows the Common Technical Document (CTD) format for dossier submission. However, Nepal is still a developing country with respect to the pharmaceutical sector. The drug governing body in Nepal, Department of Drug Administration, has its own nation-specific guidelines for drug regulation, but the CTD format is also acceptable for dossier submission. In Cambodia, the Department of Drugs and Food is the drug regulatory authority that comes under the Ministry of Health of Cambodia. As Cambodia is included in the Association of Southeast Asian Nations (ASEAN) body, it follows the ASEAN CTD (ACTD) format for dossier submission.

Adherence of Drug Promotional Literatures Distributed by Pharmaceutical Companies to World Health Organization Ethical Criteria for Medicinal Drug Promotion.

Drug Promotional Literatures are usually relied upon for drug promotion, however studies have shown them to contain several pitfalls. World Health Organization has time and often revised the guideline to address the issue and World Health Organization Ethical Criteria for Medicinal Drug Promotion was established. Based on this guideline, several regional as well as national guidelines have been formulated. Though laws to regulate drug promotion is existent, studies have shown problems with drug promotional literatures in Nepal also. This study was carried out to analyse the drug promotional literatures distributed by pharmaceutical companies in Nepal as per World Health Organization Ethical Criteria for Medicinal Drug Promotion. A cross-sectional study over a period of one year was conducted at our department. Pharmaceutical companies registered in Department of Drug Administration, Kathmandu and consenting for the study were requested to provide ten unique drug promotional literatures of their products. Collected drug promotional literatures were analysed for inclusion of essential information as per World Health Organization Ethical Criteria for Medicinal Drug Promotion, level of biasness. Different drug promotional literatures were also classified and compared for these aspects. A total of 48 pharmaceutical companies were included in the study. Drug promotional literatures (n = 372) were analysed during the study. Adherence to criteria concerned with positive attributes of the promoted medicine was found to be higher, most of the drug promotional literatures adhered to 5-8 criteria of World Health Organization Ethical Criteria for Medicinal Drug Promotion and were categorised into grade B. Difference in adherence as well as number of biased drug promotional literatures was also seen when drug promotional literatures were compared on different basis. Adherence to World Health Organization Ethical Criteria for Medicinal Drug Promotion was found to vary when drug promotional literatures were classified as per pharmaceutical company, type of formulation being promoted, type of drug promotional literatures.

Development status and suggestions for e-commerce platform of traditional Chinese medicine in Henan Province

With the further implementation of the "Internet plus" and "healthy China 2030" national strategy, the development environment of the Chinese herbal medicine industry has improved. In order to accurately understand the development situation of Henan Province's e-commerce platform of traditional Chinese medicine(TCM) and promote the development of the industry of TCM, this paper investigated the planting situation of TCM, the basic situation of Chinese medicinal farmers, the demand for technical services and the use of e-commerce platform of TCM in the main planting areas of Henan Province by means of on-site visits, questionnaires and expert interviews. The results showed that the development of E-commerce of TCM in Henan Province was still in the extensive stage, and the development of E-commerce was lagged behind.Therefore, this paper put forward that Henan Province's drug administration departments should actively promulgate supporting policies to establish a standardized and modern distribution system of TCM seamlessly joined by both producers and sellers, set up public trading platform and modern logistics distribution system of TCM E-commerce, and adopt the policy of assisting agriculture by science and technology to promote the communication between farmers and technical experts.

Determination of Total Phenolic Contents and Antioxidant Activity of the Roots of Pimpinella candolleana Wight &amp; Arnott

Pimpinella candolleana Wight &amp; Arnott belonging to family Apiaceae is a valuable medicinal plant. The plant specimens were collected from Pindaya Township, Southern Shan State in July 2014. The total phenolic contents in the aqueous, ethanolic and methanolic extracts of the roots of Pimpinella candolleana Wight &amp; Arnott were determined at Food and Drug Administration Department, Mandalay by Folin-Ciocalteu colorimetric method using gallic acid as the standard. The antioxidant activity of the different concentrations (100 µg/ml, 200 µg/ml, 300 µg/ml, 400 µg/ml and 500 µg/ml) of three extracts was evaluated at Department of Medical Research (Pyin Oo Lwin Branch) by DPPH free radical scavenging method. The total phenolic contents of aqueous, ethanolic and methanolic extracts of roots were 83.63 mg GAE/g extract, 93.87 mg GAE/g extract and 118.85 mg GAE/g extract, respectively. The IC50 values of aqueous, ethanolic and methanolic extracts were 69.183 µg/ml, 63.096 µg/ml and 31.622 µg/ml, respectively. The results showed that there is a positive correlation between free radical scavenging effect and total phenolic contents. Thus, this study scientifically proved that this resource sample is rich in total phenolic contents and significantly has antioxidant activity.

An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia

In the semiregulated market, different countries have varying requirements of registration for export to such a specific country or region. The objective of the present study is to give a comparative overview of pharmaceutical registration requirements for export to Tanzania, Nepal, and Cambodia. In the African region especially, east Africa including Tanzania is an emerging market for pharmaceuticals. The Tanzania Food and Drugs Authority is the drug regulatory body in Tanzania and it follows the Common Technical Document (CTD) format for dossier submission. However, Nepal is still a developing country with respect to the pharmaceutical sector. The drug governing body in Nepal, Department of Drug Administration, has its own nation-specific guidelines for drug regulation, but the CTD format is also acceptable for dossier submission. In Cambodia, the Department of Drugs and Food is the drug regulatory authority that comes under the Ministry of Health of Cambodia. As Cambodia is included in the Association of Southeast Asian Nations (ASEAN) body, it follows the ASEAN CTD (ACTD) format for dossier submission.

Market quality surveillance and analysis of chinese medicinal materials and decoction pieces in 2017

With the rapid development of traditional Chinese medicine (TCM) in China as well as the implementation of the four most strict requirements, the quality of Chinese medicinal materials and decoction pieces had beem improved in recent years, however new problems and challenges were occurred. All the data of Chinese medicinal materials and decoction piece in special inspection,supervision test and evaluation inspection of drug administration department to were summarized and analyzed evaluate and analyze of the quality of Chinese medicinal materials and decoction pieces in 2017. On this basis, the relevant quality control strategies and suggestions were put forward for the relevant departments of China Food and Drug Administration to formulate and implement regulatory measures, furthermore to improve drug standards, and ensure the safety of medication.

History of Pharmaceutical Development in Nepal

The historical event of the development of pharmacy was started during ancient Lichchhavi ruler Amshu Berma date back to 605-620 AD when a Ayurvedic hospital was established. In 1641-1674 AD, King Pratap Malla started ayurvedic medicine production unit in the royal place. Modern allopathic medicines were introduced in Nepal in 1816 AD after Suguali Treaty and establishment of British residency in Nepal. Allopathic medicine manufacturing was started in 1969 in private sector and a government undertaking Royal Drug Limited was established in 1972. Department of Drug Administration (DDA), a drug regulating Agency of the country was established according to the Drug Act in 1979. The pharmaceutical education was started in Nepal with the commencement of the Proficiency Certificate Level, a two and half year program (Intermediate in Pharmacy that is similar to Diploma of Pharmacy) at the Institute of Medicine, Tribhuban University in 1972. Santabhavan Hospital (present patan Hospital that was established in 1956) is pioneer to start hospital Pharmacy service in Nepal followed by Tansen Mission hospital Palpa that was started operation in 1959.Journal of Manmohan Memorial Institute of Health SciencesVol. 3, No. 1, 2017, page: 86-93