मानव जिवनको सबै भन्दा बढी आवश्यक वस्तु के हो ? भन्ने प्रश्नको जवाफमा सयौं उत्तर आउने गर्छन् । मानवले प्रयोग गर्ने हरेक वस्तु औषधी देखी मोबाइलफोन, खानेकुरा, कपडा, घर सबै आवश्यक छन् । तर यसको जवाफको लागी हामीले मानव जनसंख्याको इतिहाँस हेर्नु पर्ने हुन्छ । इसापुर्व १०,००० वर्ष अगाडी विश्वको जनसंख्या करिब ४ करोड थियो र सन् १७०० मा ०.०४% को बृद्धि दरले ६० करोड, सन् १८०० मा ९९ करोड, सन् १९०० मा १ अर्ब ६५ करोड, सन् २००० मा ६ अर्ब र सन् २०२२ मा ७ अर्ब १९ करोड ३९ लाख ९२ हजार पाँच सय सतह्तर पुग्ने अनुमान छ । करिब ११९०० वर्षमा ४ करोड बाट १ अर्ब ६२ करोड पुगेको जनसंख्या पछिल्लो १२२ वर्षमा ८ अर्ब पुगेको छ । २० औं शताब्दीमा औषधी (एन्टीवायोटीक र भ्याक्सीन) र यूरीया मलको अविस्कार विश्वजनसंख्या बृद्धीको मुख्य कारण हो । औषधी र भ्याकसीनको अविस्कारले एकै झट्कामा करौडौं मान्छे मार्ने रोगहरुबाट र यूरीयामलको प्रयोगले अन्नको बढी उत्पादन भई भोकमारीबाट मानवको मृत्यु रोकेपछी मानव जनसंख्या यो अवस्थामा पुग्न सकेको प्रष्ट छ । यसरी मावन जिवनको अत्यावश्यक बस्तुमा औषधीको महत्व रहेको छ ।  नेपालमा औषधीको इतिहास नेपालमा इसाइ धर्म प्रचारकहरुको प्रवेश सँगै एलोपेथीक औषधीको प्रवेश भएको थियो र वीर अस्पतालको स्थापना पछि यसको प्रयोग बढेको हो । उत्पादनको इतिहाँस हेर्दा २०१८ सालमा पशु रोग निदान प्रयोशालाले गौगोटी ९च्ष्लमभचउभकत० को भ्याक्सीन उत्पादन गरे सँगै औषधी उत्पादनको शुरुवात भएको र २०२७ सालमा पशु तथा मावन प्रयोगको लागी रेवीज भ्याक्सीनको उत्पादन भइ रसायनीक औषधी भन्दा पहिले जैवीक औषधीबाट नेपालमा औषधी उत्पादनको शुरुवात भएको हो । रसायनीक औषधीको हकमा २०२६ सालमा केमीड्रग स्थापना, २०३० सालमा शाही औषधीको स्थापना, २०३५ सालमा औषधी ऐन र २०३६ सालमा औषधी व्यवस्था विभागको स्थापना भए पछि २०४६ सालपछि औषधी उद्योगहरुको विकास भएको हो । २०६१ सालमा पाँचवटा औषधी उद्योगलाई ध्ज्इ न्ःएप्रदान गरि औषधी उत्पादन क्षेत्रमा नयाँ युगको शुरुवात भयो । यसको लागी औषधी व्यवस्था विभागको तत्कालीन महानिर्देशकहरु स्व. डा. अशफाक शेख, स्व. भुपेन्द्र बहादुर थापा र उद्योगीहरुमा स्व. कविराज केशरी, स्व. महेन्द्र बहादुर अमात्य, तिर्थ लाल श्रेष्ठ, स्व. गिरधरलाल मानन्धरको नाम औषधी उत्पादनको इतिहासमा सुनौलो अक्षरले लेखीन्छ ।  नेपाली औषधी उद्योग नेपालमा हाल करिब ७२ वटा औषधी उद्योगहरु संचालनमा छन् । अरु करिब ३२ वटा उद्योगहरु निर्माणका क्रममा छन् । विभीन्न अन्तराष्ट्रीय मापदण्डको पालना गर्दै गुणस्तरीय औषधी सुलभ मुल्यमा उपलब्ध गराउन नेपाली औषधी उत्पादकहरु सक्षम रहेका छन् । पछिल्ला वर्षमा नेपाली औषधीहरु निर्यातको शुरुवात भएको छ । वदेशमा औषधी उत्पादनका जनशक्ती उपलब्ध छन् भने प्रविधि पनि उपलब्ध छन् । स्थापीत उद्योगहरु करिब ५०% औषधीमा आत्मनिर्भरता तर्फ ?दीपक प्रसाद दाहालसदस्यः औषधि परामर्श परिषद भन्दाकम क्षमतामा संचालीत छन् । अहिलेको अवस्थामा देशलाई आवश्यक ७५% भन्दा बढी औषधी दिन सक्षम छन् । नेपाल औषधी बजारमा भ्याक्सीन बाहेक भारतीय उत्पादन ५०% नेपाली ४५% र अन्यको ५% बजार हिस्सा रहेको छ । सरकारले सितैमा बाड्ने करिब ९०% र सम्पूर्ण औषधिको ७५% औषधी उत्पादन गर्न सक्ने अवस्था विद्यमान रहेको भएपनि सरकारी उदासिनताले बजारको ४५% हिस्सामा खुम्चिनु परेको छ । औषधी व्यवस्था विभागको सहयोग र अभिभावकत्वमा हुर्केको नेपाली औषधी उद्योगहरु, खासगरि औषधी व्यवस्था विभागको २०७२ पछिको कृयाकलापकले स्वदेशी उद्योगहरुलाई नराम्रो सँग खुम्चीन बाध्य पारीएको छ । औषधी उत्पादन र नियन्त्रणको प्रष्ट कानुन र नियमावली हुँदा हुँदै विभागले अनावश्यक कार्यविधिहरु लागु गरि औषधी उद्योगलाई नयाँ औषधीको उत्पादन अनुज्ञापत्र जस्ता आवश्यक कागजात र अनुमती लिन बर्षांै लगाइने गरिएको छ । जनशक्तीको अभावको वाहानामा हप्ता दिनमा हुने काम ६ महिना सम्म पनि नहुने गरेको छ । औषधी व्यवस्था विभागका नेतृत्वनै औषधीको गुणस्तर मुल्यको बारेमा भ्रम छर्ने, नेपाल सरकारले लागु गरेको निती विपरित काम गर्ने, कार्य सम्पादन करार सम्झौता अनुसार कार्य सम्पादन नगर्ने जस्ता कार्यले स्वदेशी औषधी उत्पादनहरु अप्थ्यारोमा परेका छन् । यस कुरालाई समाधान गर्न प्रधानमन्त्रीको सचिवालयले स्वास्थ्य मन्त्रालयलाई औषधी व्यवस्था विभागको पुनसंरचनाको लागी समेत लेखेर पठाएको छ । भारतिय उत्पादनहरु नेपाली औषधीहरुको मुख्य प्रतिस्पर्धी हो । भारतीय औषधी उद्योगहरु भारत सरकारको संरक्षण र अनुदानमा चल्ने गरेका छन् । भारतमा सरकारी लगानीमा दर्जनौं औषधीको अनुसन्धान तथा विकास गर्ने संस्थाहरु छन्, जसले प्रविधिको विकास गरि औषधि उद्योगलाई प्रविधि हस्तान्तरण गर्छन् । नेपालमा औषधी ऐन २०३५ ले औषधी अनुसन्धान शालाको स्थापनाको व्यवस्था गरे पनि हाल औषधी व्यवस्था विभागमा औषधी प्रयोगशालाको रुपमा खुम्च्याइएको छ । भारत सरकारले ३५ वटा शिर्षक अन्तर्गत औषधी उद्योगलाई अनुदान दिने गरेको छ भने हालै भारु १५० अर्वको अनुदान प्याकेज राजपत्रमा प्रकासीत गरी लागु गरेको छ । भारत परिमाणको आधारमा औषधि उत्पादन गर्ने विश्वको तेस्रो ठुलो मुलुक हो भने मुल्यको आधारमा चौधौं ठुलो मुलुक हो । संसारमा सबै भन्दा सस्तो मुल्यमा औषधी उत्पादन गर्ने देश हो – भारत । भारतले औषधी उत्पादनमा १% ले उत्पादकत्व बढायो भने नेपाललाई एक वर्ष पुग्ने औषधी उत्पादन हुन्छ । त्यसैले औषधीमा आत्मनिर्भर हुनको लागी सरकारले आधारभुत संरक्षण दिनु पर्दछ । सरकारको निती तथा कार्यक्रममा औषधीमा आत्मनिर्भर बन्ने कुरा आएपनि कार्यान्वयन हुन सकेको छैन । केही वर्ष अगाडी सम्म औषधीमा भारत निर्भर बंगलादेश अहिले औषधीमा आत्मनिर्भर भइ विश्वको १२० देश भन्दा बढी देशमा औषधी निर्यात गर्ने देश भएको छ । बंगलादेशले स्वदेशी दुइ वा दुइ भन्दा बढी उत्पादकले उत्पादन गर्ने औषधीको कच्चापदार्थ मात्र आयात गर्ने तयारी औषधी आयात गर्न नदिने निती लिएको कारण आज औषधीको विश्वबजारमा बंगलादेश उपस्थीत हुन सकेको छ । नेपालले पनि यस्तै निती अवलम्बन गर्नको लागी माननीय गगन थापा स्वास्थ्य मन्त्री भएको बेला २०७३ सालमा औषधी व्यवस्था विभागका महानिर्देशकको अध्यक्षतामा समिति बनाई प्रतिवेदन तयार गराइएको थियो जसले २०७४ साल आसाढ मसान्त पछि नेपालमा प्रसस्त उत्पादन हुने ३० प्रकारका औषधीको कच्चापर्दाथ मात्र आयात गर्न दिने प्रतिवेदन हाल सम्म लागु गर्न सकेको छैन । त्यस्तै औषधी व्यवस्था विभागको २०६१–९–२० को सूचनाको बुँदा अनुुसार निरिक्षण गरी दर्ता गर्ने प्रयोजनका लागी आधुनिक औषधी उद्योगको आवेदन अब नलिने र निरिक्षण गर्न पनि नजाने निर्णय विपरीत हरेक वर्ष दर्जनौं विदेशी उद्योगको निरिक्षण गरी औषधी दर्ता गरिदैं आएको छ । सरकारले २०५१ सालको औषधी नितीमा १० वर्ष भित्र अत्यावश्यक औषधीको उत्पादनमा ८०% आत्मनिर्भर हुने निती लिए अनुसार स्वदेशी उत्पादकले उत्पादन क्षमता बढाए पनि सरकारले संरक्षण नदिंदा आजसम्म लागु हुन सकेको छैन । २०७१ सालको स्वास्थ्य निती २०७५÷७६ को बजेत बक्तब्यमा औषधीमा आत्मनिर्भर बन्ने कुरा राखीए पनि कार्यान्वयन हुन सकेको छैन । त्यसो त औषधी ऐन २०३५ को परिच्छेद दुइमा औषधी परामर्श परिषद र औषधी सल्लाहकार समितिको व्यवस्था राखिएको छ । औषधी परामार्श परिषद र औषधी सल्लाहकार समिति गठन नियमावली २०३७ ले परिषदको काम, कर्तब्य र अधिकारको बुँदा १ मा औषधीमा देशलाई स्वावलम्बी बनाउने मुख्य उद्धेश्यलाई ध्यानमा राखी औषधी सम्बन्धी सैधान्तिक तथा प्रशासनिक विषयमा नेपाल सरकारलाई परामर्श दिनु परिषदको कर्तव्य हुनेछ भनिएपनि विगत ४१ वर्षमा परिषदको जम्मा १७ वटा बैठक मात्र बसेको छ र पछिल्ला बैठकका निर्णयहरु कार्यान्वयन हुन सकेको छैन ।

Covid-19 originated from Wuhan China during Dec 2019 caused havoc across the world urging WHO to declare it as Pandemic. The pandemic impacted on multisectoral fronts with multifaceted effects costing several lives and shattering hopes. Global economy was impaired. According to the Central Bureau of Statistics (March 2021) – Nepal’s economy was in negative growth -15.4%. Remittances from Nepali workers abroad defied expectations and rose to NRs 729.02 billion (USD 6.23 billion) with 16.5% increase compared to the same period last year.  Loss of lives and psychosocial impact: The Covid-19 pandemic costed several lives mostly elderly and those suffering from chronic diseases specially respiratory diseases. The latest figure till 10th April 2022 total infections worldwide is 477,445,135 with fatality of 6,110,521 and in Nepal 1,118,717 and fatality of 11,951. It is also assumed that many persons lost the battle due to fear and psychosis of Covid 19. The family members of those demised also lost their lives due to shock or reeling under psychological setback. The healthcare safety measures restricted the free mobility of people keeping them apart from loved ones. Such isolation and seggregation among loved ones further added the psychological impact. HIGHLIGHTS  Health There are concerns around low rates of routine immunization, low testing rates, and lack of access to medicines, driven by a lack of low income, travel restrictions, unavailability of health workers or fear of transmission of COVID-19 while seeking services. The low number of tests and high (almost 1 in 5) rate of infection caused fear of further community transmission of COVID-19 and preventive measures were still needed to control further spread of the disease. The maternal mortality rate, complications increased due to lack of transportation and access to healthcare facilities. National Innovation Center led by Mahabir Pun immensely contributed to contain Covid-19 by producing Personal Protection Equipment – PPE for healthcare professionals, fixed the breakdown of biomedical equipment/devices like ventilators etc, rendered preventive maintenance & servicing to ensure uninterrupted services during critical period at no cost. Nevertheless, the hospitals have been well equipped and prepared to combat such pandemic or outbreak of critical and life threatening diseases. Many survivors and sufferers of Covid-19 are living with long Covid-19, which adversely affecting their daily functional activities. Some became victim of black fungus rendering loss of eye sight. Pharmaceutical industry, Oxygen plant played vital role in their part to produce and supply oxygen and medicines needed for the patients. Nepal is heavily dependent on India for medicines, the unfortunate part during Covid-19 pandemic was India imposed restrictions for export of crucial medicines like Paracetamol, Steroids, Remdesivir, Tocilizumab, Liposomal Amphotericin B etc. Paucity of supply of those crucial medicines created panic among people. At last Nepalese company National Health Care Pvt. Ltd became successful to produce and supply. Remdesivir. Some gaps in demand was fulfilled through the supply received from China and Bangladesh. The great lesson learned from Covid-19 pandemic is to encourage and enhance national industry to expnad the product portfolio, scale up technological and innovative capabilities to meet the therapeutic demand during such critical condition. Essential and critical care medicines’ manufacture and supply: National pharma industry accepting the fierce challenge to combat the Covid pandemic and save people’s life, manufactured all essential medicines incessantly by applying and following all public health safety measures during the lockdown and restrictions. The national pharma industry strived day and night to fulfill the dire need of highly needed and critical care medicines like Paracetamol, Corticosteroids, Remdecivir, Azithromycin, IV fluid, etc. Hand Sanitizer and alike.  Nepalese Pharma industry forged ahead to supply the medicines across the country, when in fact the whole world was under lockdown, there was no eatery on the highway or any where in transit to the destination. Transportation and shipment was pretty expensive. The national pharma industry and enterpreneurs deserve great appreciation for their immense dedication without longing for profit and extra benefit.The role of pharmaceutcal traders, engaged in import and distribution of essential and critical & life saving medicines was also important in supply of essential and critical care & life saving medicines, when in fact govt. of India imposed restriction on export of such medicines. The enterpreneurs explored far & wide and made it available. Temperature controlled medicines (cold/cool chain medicines) were transported by cold chain/AC van, as the aviation was restricted. The fast action of Nepal Health Research Council and Medicine Regulatory body for facilitation is applaudible. The vehicle drivers exhibited tremendous courage and firm determination to the mission to cater medicine irrespective of uncertainties of food and shelter. Their role is equally invocable. Covid pandemic taught great lession that the dependency on import of essential commodities like medicines directly impacts people’s livelihoods and well-being. Our initiative and thrust must be to improve health and health security by “Strengthening Pharmaceutical Sustenence”.  Amidst Covid pandemic, United Nations of late has backed Medicines Patent Pool- MPP program with aim to increase access to, and facilitate the development of, life-saving medicines for low and middle income countries through an innovative approach to voluntary licensing and patent pooling. Such initiative ensure rapid access to effective treatments, health technologies in home country without relying on import. The avenue of MPP is extensive encompassing HIV, Hepatitis C and Tuberculosis including Covid-19 treatments and pandemic preparedness. As many as 16 low and middle-income countires are now included in MPP involving almost 60 manufacturing sites across the globe. Nepalese Pharmaceutical Industry must vouch for such golden opportunities offered through global organization like UN. It may not be feasible at the mere initiative of the pharma industry alone. The government and international development partners as well as stakeholders must come forward to shoulder the national industry. The nation as a whole should revamp capability and grab full advantage of MPP for “Strengthening Pharmaceutical Sustenence”.  Food Security, Livelihoods, Nutrition and Social Protection Programmes Restrictions on the movement of people and commodities have severely limited people’s ability to earn, access necessities and commodities, and enjoy food security. This has affected the most vulnerables. Continuous lockdowns restricting movement and therefore the ability to earn livelihoods and access essentials, and the limited provision and accessibility of social protection schemes are contributing factors to the food insecurity status in Nepal. Hats off to Philanthropic and Non-governmental organizations, which came forward to distribute food and medical supplies as well as hyegiene and sanitation kits to the underpriviledged. Though it was not adequate or sufficient to meet the need during entire Covid-19 period. Social organizations also contributed to provide Oxygen cylinders, Oxygen concentrators and sanitation items like hand wash system etc.  Education Most children were staying at home and/or schools remain closed during COVID-19 lockdowns. The ability of caregivers to support learning at home, and the accessibility of learning tools – including online, virtual, and physical – varies, most significantly affecting vulnerable rural households. The closure of educational institutions has led to the postponement of all national level examinations and formal education has largely discontinued at schools. Learning and skills development of students has been affected, impacting student assessment, drop-out rates, and advancement into upper grades without the development of the requisite skills. COVID-19 Risk Communication Majority of population have a level of knowledge of COVID-19 and are aware of preventive measures, but a gap between knowledge and practice in relation to limiting the spread of COVID-19 is evident. Digital technology: The Covid-19 pandemic provided opportunity to surge digital technology. The physically apart people remained in connection through digital tech system. The digital communication became preferred option to hold meeting remotely and digital sign obtained official recognition. Digital marketing also got ground for promotion of products and services including pharmaceuticals. Online marketing, online supplies were also practiced extensively.Digital technology and devices like Tele-health, Telemedicine, Artifical intelligence are widely used by health sector to cater healthcare services remotely. Covid pandemic impelled people to hold formal meeting, seminars, conferences as well as training etc through digital technology. Zoom, MS Team, Google meet, messenger, viber group call, skype etc are some leading remote digital meeting modality being used. The digital technology has also been extensively used remotely by psychologists, clericks, priests for psychosocial counselling, preaching and even to perform rituals and even last rituals of deceased.Aviation, Tourism and Hospitality sector:The entire sector was almost paralysed. Limited operation of aviation caused paucity of essential, life saving and critical care medicines. Hospitality, Travel and tourism sector was worst affected.Agriculture sector: Agri production had difficulty for access to market and reach out to consumer. The consumer on the other end were deprived of supply of agri products and compelled to pay high price.Manufacturing sector: Non-essential sector was worse affected, though Essential sector manufacturing was relaxed to run; however, public health safety factor for work force became the hitches. Due to closure of academic institutions the paper industry faced lack of paper demand in the market.Environmental sector: The restriction on human activity during Covid pandemic offered huge respite to the environment, the silver lining on the cloud is the polution level sank nearly to the rock bottom.Public health safety sector: The public health safety and sanitation sector leaped forward due to huge demand for public health safety and sanitation kits like hand sanitizer, face mask/cover, face shield, IR thermometer, Pulse/Oxymeter, Personal protection equipment-PPE etc. The Covid-19 pandemic preached good lesson to human folk to practice health hyegiene and sanitation in day to day life and remain healthy.Remarkable achievement in Vaccine development:The most remarkable achievement is development of vaccines for emergency use against Covid in short span of time. Accolade to the scientists for their outstanding performance. Though the big question mark is on fair and justifiable distributioin of vaccines across the globe. Massive consumption and holding of vaccine done by developed nations is not justifiable and fair. The response to the impact of COVID-19 require policy and programming options at multiple levels and by multiple stakeholders – national and local government, communities, development partners, local and international organizations. 

During the last decade Nepal has made remarkable progress in pharmaceutical manufacturing and supports to the national pharma market which portrays cumulative growth of 12 to 15% annually. The investment in pharmaceutical infrastructure is significantly huge and almost 75 companies are already in production and market operation. The national companies are able to produce almost all generic products as well the latest drugs including anti-viral, anti-cancer, and almost all therapeutic segment products except vaccines.  Although the invisible enemy Covid-19 was well fought and contained to great extent by the global health communities. Huge applause to the efforts put by those Pharmaceuticals, which could develop emergency vaccines so quick, able to produce in large quantities and made available to most countries of the world for rapid vaccination. These great efforts have enabled us to curtail the worse ever situation the world has been facing for the past two years. Globally more than 475 Million were infected and reportedly 6.1 Million lost their lives due to this deadly menace of Covid-19. The rapid vaccination worldwide has brought some level of respite after the omicron variant. However, still, some threats could pose by a newer variant of this deadly virus. Amid the surge in global Covid-19 cases, Moderna, one of the leading vaccine developers manufacturers has cautioned about new variants that could predictably give some trouble in the future.  The efforts of large production of vaccines by many developed countries could achieve more than 11.2 billion vaccine doses distributed globally and out of 4.53 billion fully vaccinated and hence 58% of the global population is fully vaccinated now. During the pandemic we must appreciate all the Pharmaceutical companies who did their best to produce vaccines and essential drugs, maintain the supply chain of other drugs and stood as strong support in the health delivery system.  Now some relief from the Covid-19 pandemic has been achieved, but the socio-economic and several unseen impacts that are prevailing and revival could take longer to recuperate. The unexpected Russia Ukraine war is to cause unwanted and very difficult situation the world would never want to face. Due hostile situation in east Europe, economic sanction etc, the rampant price escalation of Petroleum products is worsening the current situation where the global economy is expected to face further set back. The pharmaceutical companies cannot skip away from this situation. The cost of production is severely hit by the steep rise in the price of materials, thereby impeding to manufacture. It is a very pathetic that despite knowing the genuine reason and the fact of production cost of Paracetamol tablet has shot up by three fold, the Government authorities were irresponsive and reluctant to revise and increase the price ceiling of Rs 1 which was fixed 14 years ago.  The supply chain of Pharmaceutical materials is adversely affected. The prices of Most of the APIs (Active Pharmaceutical Ingredients) and packaging materials have increased by 50% to 150%. China plays an important role in maintaining the supply chain. China is the world’s largest exporter of generic medicines and also the main source of (approximately 85%) essential intermediates and allied chemicals to global API (Active Pharmaceutical Ingredients) manufacturing companies. The present interruption of coal supply and pollution in China caused energy crises forcing insufficient production that has severely interrupted the smooth supply chain resulting into shortage and price escalation of most of the Raw Materials and allied chemicals worsening the condition.  Even, India is not fully self-sufficient in Pharmaceuticals though is the second-largest exporter of generic finished formulation. Yet India also depends on approximately 70% of the Intermediates chemicals on China; this scenario again hindered the smooth supply of requisite Intermediates and allied chemicals resulting in a shortage of the required inventory and production therefore disturbance in smooth supply. The post-Covid situation has created an unpleasant environment for businesses in Nepal, as we are fully dependent on imports for all their API and packaging materials. We import 80% of Raw materials from India and the rest from China and other countries, so we are facing a difficult situation even after the pandemic subsides. The new fiscal policy of reduction in CCD ratio by Nepal Rastra Bank, followed by massive liquidity crises in the commercial banks compounded further worse to the trade and business. The national companies are in an agonizing phase due to the unfavorable and non-supporting policy of the nation.  Nepal has enforced the price ceiling of most of the Pharmaceutical products that indigenous companies manufacture. It is a very pathetic that despite knowing the genuine reason and the fact of production cost of Paracetamol tablet has shot up by three fold, the Government authorities were irresponsive and reluctant to revise and increase the price ceiling of Rs 1 which was fixed 14 years ago. On the contrary, our neighboring country India strive to support their domestic Industry by showing their quick response to the situation, as and when the price of material increases they relax their price ceiling and allow to increase the price of the medicines, and recently they have issued a notification to increase the price of all price capped medicines by 10.76%. Strengthening Pharmaceutical Sustenance- the remedy towards Sustainability Covid-19 crises have taught good lesson to every nation that self-sustenance is the only remedy to survive and sustain in such global calamities and boost up the national economy. In the modern era of interdependence it is not possible for any country to remain isolated from the other. Hence, International cooperation and coordination for harmonization is inevitable among countries. However, every country should certainly identify their key areas of strength for self-sustainability and go forward to achieve it. Nepal need to emphasize and focus on Strengthening Pharmaceutical Sustenance. Need to promote National Industry :As we all know that Industrial growth is the back bone for economic progress of any country.We observed during the calamities and crises, only national industry stood in the fore front to tackle and overcome the problems of shortages. Even during covid pandemic shortage of paracetamol and other essential medicines were made available by the national pharma industry. It is also a well known fact that every country would always promote their national industry and it is their prime responsibility to tackle the WTO and TRIPS provisions in the larger interest of the country. So for the economic stability and progress, sustained industrial growth is essential. So conducive industrial policy and strong political and beurocratic commitment to promote and support the national industry is the call of the hour. Nepalese Pharmaceutical industry is well developed, sufficient investment has been done and huge installed capacity is already in place, thus the national industry are capable to produce more than 90% of the nation’s requirements. Now the need of the hour is how we can develop and support national industry thereby lead our Nepal to self sustenance in pharmaceuticals. Let us realize self-sustenance is our priority for every citizen, the government lets be fully committed in achieving it.

National Medicines Laboratory is the National Control Laboratory of Nepal which helps to evaluate the actual quality of the medicines appropriate for consumption. NML provides the reassurance of quality attribute (identity, strength and purity) of the Pharmaceutical product and can monitor the manufacturing consistency of the products. National Medicines Laboratory (NML), was established in 1964 A.D. as “Royal Drug Research Laboratory” under Department of Plant Resources, Ministry of Forest, Soil and Conservation. In 1993 A.D., NML was kept as separate organization under Department of Drug Administration, Ministry of Health & Population. Royal Drug Research Laboratory (RDRL) was named as “National Medicines Laboratory” in 2006 A.D. headed by Director. Drug Act 1978: Chapter 3(Research and control of Drugs), Clause 6 states RDRL established by Government of Nepal shall be the principal body of Government of Nepal to perform scientific research, testing and analysis of drugs. The main activity of NML is to carry out the testing, analysis of regulatory drug, pre-marketing and post market surveillance drug and drug from other organizations (Government institutions, hospital and other organization) in order to deliver safe, effective, and quality medicines to the public as per the provisions of the Drugs Act 2035. NML also perform Lot Release Certification and Lot Verification of the vaccines and Biological Products. Besides monitoring of the quality of marketed products, NML extends its role to the audit of different independent private analytical laboratories and quality control laboratories of domestic pharmaceutical manufacturers. NML also facilitates different Pharmaceutical sciences academic institutions for observation and interaction.  For the analysis of the non pharmacopoeial drug, DDA has constituted “Analytical Method Validation Committee for Non Pharmacopoeial Product” in NML according to Drug Standard Regulation, 1986. The committee has prepared Guideline on Analytical Method Validation on Non-Pharmacopoeial Products for Regulatory Approval in order to recommend a non pharmacopoeial test method to DDA for approval from Drug Advisory Committee. The main role of committee is to strengthen the national quality assurance system regarding the non pharmacopoeial drugs.  Due to lack of availability of adequate human resource, physical infrastructure and adequate budget, the scope of NML is limited to human Allopathic drugs only. NML should expand its scope of activities to the quality assurance of Ayurveda, Veterinary & traditional medicines. Establishment of the biological testing facilities and competent human resources development should be done to monitor the marketed biological product. The hidden activities of NML according to Drug Act, 2035 i.e. Scientific Research of drugs should be emphasized to develop and validate the non pharmacopoeial methods regarding the adulteration of drugs and also the development of Nepal compedial method i.e. Nepal Pharmacopoeia. NML should also magnify its role and responsibility in the analysis of the Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products. Policy & Programme of Fiscal Year 2077/78 state the concept of Department of Drug Administration (DDA) to Food and Drug Administration (FDA). In this regard, NML should be prepared for the strengthening of the testing facilities and competent human resources for the medical devices, diagnostic products and safety issues related to food. Now the country is in the state of federalism, so it’s time to do expansion of NML in federal concept to assure the quality of medicines all over the country.  Since NML is the only National Control Laboratory of the country, its reliability and accuracy of test results has the greatest impact on the quality of local, imported and exported medicines. NML has initiated the necessary preparation for accreditation. ISO 17025:2017 accreditation is huge milestone for NML to deliver quality services to ensure quality medicines and thus to safe guard the health of the Nepalese citizen.

Many consider the pharmaceutical industry to have a fairly simple business model. A therapeutic product is discovered, developed, manufactured, marketed, and sold after it has been discovered or licensed from another pharmaceutical or biotechnology company. In reality, the pharmaceutical value chain is quite complex. For example, the main customer of apharmaceutical sales representative is the doctor who prescribes the drug. The drug, however, is consumed by the patient. The social, political, and economic conditions in each country further complicate the situation.  We are living in exciting times. The development of new technology and innovative ideas that can change the way we live is occurring at an unprecedented rate. In spite of the fact that the pharmaceutical industry is considered very technologically advanced, it is also quite internally focused and thus stuck in the past. Pharmaceuticals and healthcare as a whole have been relatively slow to adopt digital strategies in comparison with other industries. It is therefore very interesting to understand how technology and innovation are shaping trends in the pharmaceutical industry, and how ready the industry is for those trends.  In order to understand why a pharmaceutical company should invest in digital technologies,  we must develop a simple model of the attributes that make digital technologies attractive and useful in drug discovery and marketing. In the Internet-era there can be very rapid the exchange of personal (or one-to-one) communication – this can be very simple like the use of email or it can be extremely complex like the use of interactive web-based communication. Internet communications facilitate a broad range of transactions, from the sharing of information to the exchange of goods and services. The Internet is already widely used by pharmaceutical companies for internal and external communications, product promotion, and a variety of transactions. The Internet will nevertheless become more important to companies in the near future due to a combination of forces. In addition to unspectacular pipelines, critical media coverage, social and political pressures, patent expirations, new therapeutictechnologies, and changes in e-business models, these forces often fall outside the realm of e-business. A growing number of industry customers are dissatisfied with the cost and quality of service they receive. Cost cutting and improving service are key to improving customer satisfaction. As digital technologies become more advanced, they can be used as cost-saving tools. The Internet will begin to play a pivotal role in day-to-day business in everything from drug discovery to clinical trials to physician detailing. The Internet and digital technology are seen as the most likely enablers of this transformation, so the pharmaceutical industry is now entering the e-age. Over the medium term, however, technological advances (both digital and biotech) will change the way physicians and consumers interact, and pharmaceutical companies need to be prepared to capitalize on these developments. Biology and digital technology will cause healthcare to shift from an industry that provides largely the same service to every patient to one that provides increasingly personalized services to consumers, based on their preferences, needs, and desires. A medical approach that satisfies our needs, depending on our genetic susceptibility to disease and response to treatments, is referred to as ‘individualized medicine’. The delivery of this data-intensive personalized service will only become feasible with the adoption of digital technologies. We are on the threshold of major advances in medicine. Using remote diagnostics, artificial intelligence, and biomonitoring devices, we will be able to manage many aspects of our health without the direct intervention of a physician. This is the real digital revolution, the first tangible step towards pharmaceutical companies dealing directly with the end-consumer, the patient, and opening up a door to innovative collaboration with physicians in order to create and deliver customized therapeutic solutions. The use of disease management packages will be increasingly bundled with specific treatment regimens to lock doctors and patients into a long-term relationship with a particular drug. The physician is slowly but surely drawing into the web of digital innovation, and pharmaceutical companies, when they provide solutions that make daily practice easier, address privacy and safety concerns, and provide innovative solutions, can use the Internet to build relationships with prescribers. An effective digital technology strategy is simply not something a pharmaceutical company can ignore. The pharmaceutical industry must consider how to use the Internet to support the entire value chain and prepare for the inevitable opportunities in therapeutics and technology that will occur in the digital age. For the pharmaceutical company of the near future, digital strategy, e-business, and the Internet will play an increasingly important role. Even thoughmany applications are specific to parts of the pharmaceutical value chain, such as e-clinical trials in drug development and e-CRM in sales and marketing, the efficiency and transparency they offer will increasingly be used to save money and improve customer service, whether they are internal or external. With digital technology and financial pressures, global pharmaceutical industries will undoubtedly experience organizational transformation. Customers, whether physicians or consumers, must be interacted with in real time and on a small group or individual level which requires skills in CRM and analytics that have not previously been regarded as important for career success in pharmaceuticals. Incorporating digital technologies into the pharmaceutical value chain is well on its way to realization; the next step is maximizing their potential