CHRISMED Journal of Health and Research

REVIEW ARTICLE
Year
: 2022  |  Volume : 9  |  Issue : 2  |  Page : 112--117

Strengthening of health care and local production of medicines and other health technologies to improve access and affordability


Abhijit Vinod Rao Boratne, Mageshwari Murugan, Senkadhirdasan Dakshinamurthy 
 Department of Community Medicine, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Puducherry, India

Correspondence Address:
Senkadhirdasan Dakshinamurthy
Department of Community Medicine, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Puducherry - 607 403
India

Abstract

A lot of discussion happened regarding the required World Health Organization's support to strengthen local production of drugs in this pandemic. During the COVID-19 pandemic, the world has struggled for everything starting from the availability of masks, personal protective equipment's, medicines, equipment, ventilators, and even basic oxygen. All these needs have exposed the existing condition of our health-care system that has called for improving the infrastructure and workforce at the earliest. Health-care spending and its impact on economic performance are vital to be seen leading to an increase in gross domestic product and vice versa. A recent estimate states that our country which was told as world's pharmacy is now facing a shortage of vaccines doses. A recent estimate states that our country which was told as world's pharmacy is now facing a shortage of vaccines doses creating the necessary research and development to discover or develop innovative way of strengthening the local production of medicines. The Ministry of Health and Family Welfare in India has initiated several measures to ensure the quality of drugs available in India. Lower- and middle-income countries face macroeconomic vulnerabilities, high levels of poverty and are lagging behind the universal health coverage. Hence, necessary recommendations were arrived for these issues in this article.



How to cite this article:
Boratne AV, Murugan M, Dakshinamurthy S. Strengthening of health care and local production of medicines and other health technologies to improve access and affordability.CHRISMED J Health Res 2022;9:112-117


How to cite this URL:
Boratne AV, Murugan M, Dakshinamurthy S. Strengthening of health care and local production of medicines and other health technologies to improve access and affordability. CHRISMED J Health Res [serial online] 2022 [cited 2023 Jan 30 ];9:112-117
Available from: https://www.cjhr.org/text.asp?2022/9/2/112/364537


Full Text



 Introduction



The world has already been trying to mitigate on inequality and inequity in health for decades. The resources to this are also limited to provide quality of care at a price that an individual and the country can afford. Unfortunately, this is the time when the World Health Organization (WHO) announced about COVID-19 pandemic on March 11, 2020. The different initiatives, plans, and projects in the health sector were hampered due to this which were an unimaginable for developed as well as developing countries.[1]

The COVID-19 pandemic has only served to highlight even more the urgent need for enhancing the quality manufacturing capacity in all regions of the world, including for innovative, highly effective health products such as mRNA technologies.[2]

 Prevalence of Noncommunicable Diseases and Infectious Diseases



Noncommunicable diseases (NCDs) such as cardiovascular diseases, cancer, diabetes, and chronic respiratory diseases encounter around 41 million deaths each year which accounts for about 71% of all deaths globally, and 85% of them occur in low- and middle-income countries, i.e. around 80% of all premature NCD deaths. Out of which India accounts for about 5.8 million NCD deaths each year.[3],[4] Forty-three percent accounts for the burden of communicable diseases in India.[5]

 Expenditure on Health



Health expenditure includes all expenditures such as health services, family planning activities, nutrition activities, and emergency aid designated for health excluding basic water and sanitation. Health financing is a vital component of health systems and health economics is an upcoming field in this public health.[6]

Health-care spending and its impact on economic performance are vital to be seen leading to an increase in gross domestic product (GDP) and vice versa. Welfare economics deals with the economic and social welfare. The per capita health expenditures vary between countries. According to recent estimates, some high-income countries such as the United States, Germany, France, and Japan spend 12% on GDP on health care compared to few other low-income countries such as Brazil, China, and India which spend as little as 3% only.[7] Lower- and middle-income countries face macroeconomic vulnerabilities, high levels of poverty, and lagging behind the universal health coverage.[8]

Similarly, WHO released data on “Global Spending on Health: Weathering the storm” examining the progress toward financing universal health coverage before the pandemic. Before the pandemic, the global spending on health continued to rise at a slower rate in recent years and the out-of-pocket (OOP) expenditures continue to be the major component of health spending in low- and middle-income countries.

Health-care allocation budget in 2020 is 5.7% lower than the prior pandemic era. The health-care allocation in 2020–2021 falls short of the target of spending 2.5% of GDP on health care.[9] According to the recent estimate, India is among the countries having the lowest public health-care budget in the world of 1.26% of total GDP of which 70% is allocated to primary health care.[10]

 Gross Domestic Product-Developed and Developing Country Situation



Competing the developed countries such as the US spending 16% of their GDP on health care, Japan, Canada, France, Germany, and Switzerland spend 10% of GDP on health care to the other countries such as the UK, the Netherlands, NZ, Finland, and Australia spending 9% of their total GDP on the health-care system. The developing countries such as Brazil, Bangladesh, and Pakistan also stand in the lane of contribution toward 8% and 3% of GDP on health care.[10]

 Expenditure on Medicine



Pharmaceutical sectors cover expenditures on prescribed medicines as well as self-medications often referred to as over-the-counter products.[11] The National Health Expenditure data reveal that Medicare spending on prescription drug increased by 5.7%.[12] Dichotomy on drug price control said the fixation of ceiling prices of medicines resulted in a total saving of Rs. 12,447 crores to the public which saves Rs. 4547 crores on coronary stents and Rs. 1500 crores on implants Rs. 984 crores on anticancer drugs.[13]

In generic market, India faces high competition from China since it receives 70% of all the active pharmaceutical materials from China. Hence, India's health security is under heavy dependence on China. In view of the COVID-19 pandemic situation, the government has taken important initiatives for improving the technical and financial barriers proposing an incentive package of Rs. 13.76 billion for the promotion of domestic manufacturing materials, medical devices, etc., Urgent action was initiated on supply to sanitizer, face masks, disinfectants, gloves, personal protective equipment, testing kits, inhalers, ventilators, finally vaccines, etc., Later, the government started to spent around 1.5 lakh crore to 37,000 crore finally on vaccines. SII initiated the vaccine development and now it plays a crucial part in this pandemic.[14],[15],[16]

The availability of affordable effective drugs is a visible indicator for the quality of health services. Being the leading producer of cost-effective and quality-controlled generic drugs, India supplies 20% of global pharmaceutical demands.[17] National regulatory authorities play a vital role in the health-care system by providing regulatory oversight of all medical products such as medicines, vaccines, blood products, traditional or herbal medicines, and medical devices.[18]

 High Out-of-Pocket Expenditure



According to the national health accounts, the government health expenditure per person per year is Rs. 1108 that comes to Rs. 3 per day which is in contrast to the OOP expenditure of Rs. 2394 which comes around 63% of the total health expenditure. India is spending 67.78% of total expenditure on health in India is paid as OOP when compared to 18.2% of world estimate to OOP.[19]

 Shortage of Medicines and Vaccines



Recent estimate states that our country which was told as World's Pharmacy is now facing shortage of vaccines doses would continue till July because the production is expected to increase from about 60–70 million doses a month to 100 million.[20] The annual costs of drugs made by big pharma were high as Rs. 8.8 lakh today where an Indian company named Cipla scaled up to offer medicines at $350 to $600 per patient per year.[21] Apart from remdesivir, favipiravir and Fabiflu were also running shortage.

 Reasons for Shortage of Medicines



WHO estimates 13.6% of all medicines in low- and middle-income countries may be substandard impeding patient outcomes, imposing financial burden, and contributing antimicrobial resistance.[22]

National government is facing multiple responsibilities with regard to procurement, quality control, and dissemination of pharmaceuticals. In resource-constrained developing countries, to some extent, the consequences of government policies to improve access to medicines and to promote access to needed medicines through the promotion of generic versions of branded products, still land up in conflict with policies to promote the domestic pharmaceutical industry. Furthermore, there is an asymmetry between the regulation of imported and exported medicines enforced by high-income countries with stronger regulatory capacity. Regulations for quality control on exported medicines are insufficient.[23]

Creating the necessary research and development to discover or develop innovative way of strengthening the local production of medicines. In developing countries, there is a great disparity between the demand for medicines to treat endemic diseases and the lack of purchasing power of patients. Poor-quality medicines can endanger patients, extend illness, and result in death. Low-income countries often have limited capacity and resources to carry out the range of critical regulatory functions in an effective manner where they spend a bulk of their financial resources on aspects of quality assurance that may not necessarily yield the greatest benefit to public health.

During the pandemic, the price of many key COVID medicines such as ivermectin, methylprednisolone, doxycycline, enoxaparin, paracetamol, azithromycin, meropenem, and pipratazo has scaled up approximately 200% in 1 month, i.e. March to April 2021.[24]

The main reason behind the surge in the prices is a huge demand for drugs following the anticipated shortage of raw materials owing to the suspension of China cargo services resulting in the hoarding of stocks. Indian drug makers import 70% of their total bulk drugs from China. Furthermore, in 2019, the government had informed the Lok Sabha the drug makers imported bulk drugs worth $2.4 billion from China.[25]

 Government Initiation to Overcome the Problem



The initiatives taken by the government to promote the pharmaceutical sector in India are as follows:

In March 2018, the Drug Controller General of India announced its plans to start a single-window facility to provide consents, approvals, and other information aimed at giving a push to the “Make in India” initiativeIn October 2018, the Uttar Pradesh Government announced that it will set up six pharma parks in the state and received an investment of more than Rs. 5000–6000 croreThe National Health Protection Scheme is the largest government-funded health-care program in the world, which is expected to benefit 100 million poor families in the country by providing a cover of up to Rs. 5 lakh per family per year for secondary and tertiary care hospitalization and the program was announced in Union Budget 2018–2019The Government of India planned to set up an electronic platform to regulate online pharmacies under a new policy, in view to stop misuse due to easy availabilityThe Government of India unveiled “Pharma Vision 2020” which aimed at making India a global leader in end-to-end drug manufactureThe government introduced mechanisms like the Drug Price Control OrderThe National Pharmaceutical Pricing Authority deals with the issue of affordability and availability of medicines.[26]

 Our Viewpoint/Thoughts to Overcome



Drugs are often the most vital cost driver of health-care expenditure on hospitals and ambulatory care. Drug shortages and quality problems continue to undermine the performance of health-care systems. The current pandemic has shown the need to ensure access to NCD and cancer drugs. We support policies to increase the uptake of quality-assured generics/biosimilars, capacity building for local manufacturers, and efforts to facilitate the transfer of technologies. Nearly 2 billion people still lack access to medicines that could prevent unnecessary illness and death.[27]

Local production saves foreign exchange, creates jobs, facilitates technology transfer, and stimulates exports to neighboring countries since raw materials are readily available and are cheaper than the finished products. Contributing to improved access to quality-assured, affordable, safe, and efficacious essential medicines, the local production promotes access to medicine and increases price-based (reference prices of the primary drugs linked in the Ministry of Health, Directorate of Pharmaceuticals) competition in the market, contributing to ensuring lower prices of drugs and greater affordability.

Being pandemic, with repeated changes in the testing and the treatment protocol and cargo which were being stopped in between the big counties, there is an immediate need in local production. Even with respect to the treatment of mucormycosis, nowadays, we need 5–7 vials per patient per day over 42 days which accounts for 250 vials per patient. Even with imports and domestic production, what is available is way below what is required since more cases are being added up daily.[28]

The mesh started with the shortage of hydroxychloroquine which turned the whole population to run around it, thinking it as a lifesaving drug ending up in the selfmedication of it among patients, finally leading to the havoc arising cardiac arrest in COVID patients, followed which remdesivir remains the most soughtafter medication in the scramble for drugs to treat COVID19. The explosive caseload has dried up the stocks of it prompting the government to ask companies to double its capacity. Similarly, favipiravir, tocilizumab, and multivitamins are also becoming scarce. Hence, we need a robust process mapping system of the local production of medicines, particularly in this pandemic crisis.[29]

 When Wealth Decides Health



India is the largest provider of generic drugs globally. Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US, and 25% of all medicine in the UK. Even in a pandemic crisis, India exports 6 crore vaccines to the other parts of the world in view to save the health-care workers community. Globally, India ranks 3rd in terms of pharmaceutical production by volume and 14th by value. The domestic pharmaceutical industry includes a network of 3000 drug companies and approximately 10,500 manufacturing units.[30]

Overall, India's per capita expenditure on health amounted to over 1600 Indian rupees. However, this was an average estimate with some parts of the country focusing on health far more than others. The larger and wealthier states such as Maharashtra and Uttar Pradesh spent between 120 and 180 billion rupees on health in the fiscal year 2018, whereas northeastern states spent around three to six billion rupees on health care that year.[31]

According to the Indian Economic Survey 2021, the domestic market is expected to grow three times in the next decade. India's domestic pharmaceutical market is estimated at US$ 41 billion in 2021 and likely to reach US$ 65 billion by 2024 and further expand to reach ~ US$ 120–130 billion by 2030.

India presents major opportunities for multinational pharmaceutical companies in clinical trials, contract research, and manufacturing. The licensing opportunities for big pharmaceutical companies as well as the collaborative business model including services give access to low-cost smart intelligent base, indigenous technology, and most importantly, the large domestic market. The most important advantage which India presents is the low cost that includes the low-development costs, low-fixed asset costs, low-clinical trial costs, and low-cost workers.[32]

The Ministry of Health and Family Welfare in India has initiated several measures to ensure the quality of drugs available in India. Steps have been taken against counterfeit drugs which account for 15%–30% products in the market.

 Various Health Technologies to Improve the Access and Affordability



In context to local production, access means lower prices with great affordability, availability, local adaptation of existing products, and new innovative medicines. Starting from thermal scanners like infrared thermometers, digital thermometers, pulse-oximeters which were in the global demand during the first wave of COVID19 to the recent selftesting kits (Coviself) and oxygen concentrators which are now being the hallmark rise in the local production during the second wave of the pandemic, health technology has been improving in India.

There are many types of technology-based inventions for improving access to local production of drugs, namely Apps such as eHealth, which most people try out to improve their mental and physical health, wearables, websites, virtual reality, and video conferencing. While commenting on the stage of the level of local production, India is in the primary stage of manufacturing which implies manufacturing of active pharmaceutical ingredients, intermediaries, and excipients. When there are possibilities to manufacture the vaccines during the pandemic, i.e. local production, then local production of drugs is also definitely possible.[33]

Process analytical technology (PAT) is still not being widely deployed in the industry. There are a lot of sensors available today which give us vital information about the process. PAT tools along with continuous manufacturing technologies bring significant efficiency in pharma operations by reduced footprint, less material handling, lower storage space, and energy consumption.[34]

 Process Analytical Technology



There is a significant need to increase process knowledge and improvements in the pharmaceutical industry. PAT is primarily focused on reducing process variability. It will help the pharmaceutical industry to produce more flexibly, at a lower cost with consistently high quality. Reducing product variability subsequently reduces the risk of releasing an off-spec product into the marketplace. The push means to shift away from the “historical quality assurance approach” to a “true quality control approach” where the process is continually adjusted to maintain the product quality. PAT results in operational excellence, real-time monitoring, and control of one unit operation.

Since PAT is a key element of a paradigm change in the pharmaceutical industry, its implementation involves deep organizational changes. There is a need for intense communication, often over cultures, countries, and the involvement of different organization levels. Often, a new structure with dedicated resources is required. This is something which typically needs to grow over the years.

In terms of technology, we see the need to improve the instrumentation to simplify validation processes and the development of even more unit operation-specific solutions, based on fit-for-purpose standard instruments.

 Conclusion



Lower- and middle-income countries face macroeconomic vulnerabilities, high levels of poverty, and are lagging behind the universal health coverage. Proper resource allocation based on the disease prevalence, morbidity, and mortality patterns should be considered while the production of the drugs by the drug industries. Ensuring lower prices of drugs promoting greater affordability should be prioritized for which the validation processes must be simplified.

Recommendations

State-wise mapping of drugs and equipment industries needs to be done at priority. Licensing procedure should be made user-friendly. Accessibility and affordability should be prioritized. Tie-up and knowledge transfer procedure with foreign partners to be intensified in view of future challenges.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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