Section 4 New Technologies

#### **Chapter 8**

## Bioethics of Brain Computer Interfaces

*Akram Jassim Jawad*

#### **Abstract**

Nowadays, smart home devices have started to take a part in everything in our life, which mainly have been developed to consist from brain computer interface (BCI). In recent months, Neuralink BCI (1024-Electode) has been approved to be used by Food and Drug Administration (FDA) in the USA. That makes the ethical related studies have more attention to apply these devices and technologies in our daily life with more security. In this chapter, the ethical challenges of smart home systems that use BCI for personal monitoring, such as Neuralink Interfaces, have been reviewed, analyzed and discussed regarding the fundamental principles in 'Statement of Ethical Principles for the Engineering Profession' of the UK. Firstly, a brief introduction of Neuralink BCI technology and important applications in daily life were discussed with related ethics issues. Then, proposed solutions and recommendations for every situation have been introduced and discussed as well. The main proposed ways to address that are establishing and introducing the related laws and rules, technology development of security and safety, and educate for acceptance culture in the society.

**Keywords:** Brain Computer Interface (BCI), Engineering Ethics, Bioethics, smart home, Neuralink

#### **1. Introduction**

One of the most important and recent smart home devices for personal monitoring based on brain computer interface (BCI) is Neuralink BCI implanted that invented and produced by Elon Musk company "Neuralink" [1]. Recently, Neuralink BCI (1024-Electode) has been approved to be used by Food and Drug Administration (FDA) in the USA, which makes the ethical related studies have more attention to apply these devices and technologies in smart home applications in more security [2]. This device can help people with disabilities to communicate better and control devices by them brain thinking activity [3]. For example, this device can transmit the inner speech activity of the brain into an external speaker device for people who suffer speaking problems and illnesses such as locked-in syndrome LIS [4]. Moreover, this technology could produce a revolution in the treatment of different human brain related illnesses, for example epilepsy, schizophrenia, paralysis, and even brain injury. However, these devices could also make the society have social illness related with ethics issues such as inequalities, hackers, governments or people to manipulate and control other people, and many other social problems. The aim of this report is to discuss and write a personal reflection on the ethical challenges of smart home systems that use BCI for personal

monitoring, such as Neuralink Interfaces, regarding the fundamental principles in 'Statement of Ethical Principles for the Engineering Profession'. Therefore, a brief introduction of Neuralink BCI technology and important applications in daily life were discussed with related ethics issues, and proposed solutions for every case as well.

#### **2. Neuralink brain computer interfaces**

Generally, the main components and steps in any BCI process were shown in **Figure 1**, which includes firstly an implanted array of electrodes to read brain signals, and then transition of that signals information into a receiver machine such as a computer. That BCI has the ability to read brain signals data and apply it in the control process for a specific activity [5]. However, in the implanted process of BCI device from Neuralink Company, about 3072 electrodes per array with 32 electrodes per bundle are inserted by robot. These electrodes give the ability to read and write the brain to allow humans to communicate and control many external devices [6]. Schematics of The implanted device in human, design and an experimental model

#### **Figure 1.**

*An example illustration of a brain computer interface product that contain (1) implanted array of electrodes to read brain signals and (2) transition of that signals information into (3) a receiver machine such as computer (4) which has ability to read brain signals data (5) to apply it in control process for a specific activity, created by Microsoft office.*

#### **Figure 2.**

*(a) The BCI implanted device in human by Neuralink company. (b) BCI design with a USB-C interface. (c) Experimental of Neuralink BCI in a rat model [7], the authors have been emailed to get permission.*

in a rat model of BCI and a USB-C interface by Neuralink company were shown in **Figure 2** a, b and c, respectively [7]. Consequently, there are a number of ethical issues that have to take in account when this device used in any application, such as health care or even in entertainment systems.

### **3. Ethical issues**

One of the most related fundamental principles to Neuralink BCI technologies and devices in 'Statement of Ethical Principles for the Engineering Profession' is point two, which titled "Respect for life, law, the environment and public good". Their main points were summarized in **Table 1**, which clarify the comment on the application possibility of these limits in the targeted devices of this report. In the literature, it has been suggested that there are four different areas of ethical concern, which are privacy, agency, identity, and bias as well [8]. It has been mentioned that the governments have to establish regulations, rules, and laws depending on them public ethnicities, religious and socio-economic culture for them nations. **Figure 3** shows appications of BCI, and **Figure 4** represents a summarizing show which cover all possible ethics issues in BCI that proposed by Coin et al., (2020), which includes three main factors are physical, physiological and social actors [9]. The physical factor is just the user safety, the physiological factors are humanity and personhood, as well as autonomy. While the social factors are stigma and normality, responsibility and regulation, research ethics and informed consent, privacy and security, and justice [9].

As it has been mentioned, there are six groups of ethical challenges of BCI Neuralink's devices. The first one is the device has to be lawful and justified work, which means that the device has to be approved before its ethical issues will be considered. For example, Neurohype, which means publicity for some devices and


#### **Table 1.**

*The main factors of point 2 in fundamental principles in the UK that were written in 'Statement of Ethical Principles for the Engineering Profession', which titled "Respect for life, law, the environment and public good", with comments on possible application for BCI products.*

#### **Figure 3.**

*Applications of BCI, created by Microsoft office.*

#### **Figure 4.**

*A summarizing show which cover all possible ethical issues in BCI.*

technologies before they have been approved by scientist society, or even before they have been made, which are technologies false and exaggerated or even unsubstantiated claims [10]. The second challenge is to clarify the hazards and research ethics officially from the producer and the organizations. Where, spreading the culture and increasing the awareness regarding the BCI devices not just between the specialist scientist but also between public society, such as the EU and the UNESCO, play a significant role to solve the fair access of both technology and its ethics [11]. Therefore, the transparency of using these devices have to be highly clear to avoid the deception with or without intention, and to make and encourage equality and fairness in the society. The third issue is the physical safety. As Neuralink's devices and technology involves inserting thousands of electrodes into the brain surface, it uses by helping a robot to identify and avoid targeting neurons and blood vessels as possible [9]. However, this process may produce physical safety issues such as infections and distortions of neurons, tissues and blood vessels, or reactions of the immune system. Therefore, the developing and improving in these robot technologies are necessary to minimize the physical safety concerns.

Another point is the privacy that is related to personal information, and identity issues. As this device uses a USB interface, Wi-Fi or Bluetooth ways to transmit the data, which are likely to be hacked with or without permission, and as an implanted device that gives physical pain under some conditions as it has been mentioned before, together raising hybrid ethical concerns [10]. This could be a big issue in terms of safety considerations. As a result of that, the scientists and suppliers community should provide high safety that the access for these devices only under control of the users. For example if a person has done a crime and consequently the police wanted abscess to access to their device to do the investigation [12]. This police procedure may produce high ethical concerns of the personality data and privacy, which could be widely dangerous and harmful in non-democracy governments. Kellmeyer (2018) mentioned that the data protection of the brain have to be in the top of safety guidelines and protection regulations in BCI devices, to solve the important ethical issue in this technology that is personal data protection and mental privacy of users [5]. People should have high ability, freedom and the right to protect their private neural and mental information [8]. Also, it is clear that the data will be one of the main things that sells in what is called the black market, which needs to stablish new laws to organize and control that.

The agency, autonomy, and responsibility play a significant ethical concerns in BCI devices uses. This ethical issue could happen by sharing such a hybrid agency between these implanted devices and human body that makes limitation in the human autonomy range in different activities of life. Kellmeyer (2019) pointed out that surgically placing implanted devices inside the human brain gives permission and high ability of these systems in some cases to share the brain thinking or

#### *Bioethics of Brain Computer Interfaces DOI: http://dx.doi.org/10.5772/intechopen.97213*

processing activities and maybe making decisions [11]. That is raising a question whether a human or a machine is who would be responsible for machine errors if it happened, which leads to an unintended accident.

Additionally, the bias, justice, and normal challenges have high impact on the application of these technologies. As these devices have been manufactured and engineered by a human, to follow a specific direction of brain activity to distinguish based on for example gender, ethnicity, or color, which maybe produce interaction bias of planted brain. Consequently, these criteria could encourage more differences between society levels and its culture that places the community in a more unstable situation [13, 14]. There are different possible ways to deal with this challenge by computer and data scientists under study [15]. Also, the possible ethical concern with increasing in intelligence and memory of a specific and selected human groups with that hidden device [10]. As a result for that, the device has to be obvious, and not hidden for the society, by setting rules for that. Regarding the equality of access issues that encourage inequalities in the society, these devices have to be available to all people who need it [16–18].

#### **4. Recommendations**

There are different areas that could be used to deal with these six ethical issues, such as establishing regulations, rules, and laws depending on the public ethnicities, religious and socio-economic culture for people. Another way by enhancing and improving the technology ability, or by mixing technology and laws together depending on the conditions of a situation. For example, creating restrictive laws that prevent and minimize technologies false and exaggerated or even unsubstantiated claims, to define the lawful and justified work. Also, establishing high transparency laws of using these devices to avoid the deception with or without intention, and to make and encourage equality and fair in the society.

Additionally, developing and improving in surgery robots technologies are necessary to minimize the physical safety concerns in the inserting and establishing process of BCI devices inside the brain. Also, the scientists and suppliers community should provide safe technologies that allow access to these devices only under control of the users. Also, establishing laws that protect the personal data from being used by others, and organize data marketing and transmission that will be possible to solve the related issues with the privacy, personal information, and identity.

The agency, autonomy, and responsibility issues have become a significant challenge, which could be solved by making more restrictive laws and developing these device technologies to make a clear limit between human brain and the BCI activities. It is supposed that setting rules and developing new cheap technologies are both important factors to deal with the bias, justice, and normality challenges of these devices contain BCI. For example, new technologies that are less expensive could make these devices available to all people who need them, which is making the equality of access to these devices, to sole inequalities issues in the society. The restricted laws, which apply to force people whom are using these devices to show it in a transparent way, and it has to be obvious for other people, might solve the related issues of the bias and makes it more justice.

#### **Acknowledgements**

I would like to express all my deep thanks and respect to Federica Carta (a member of Istituto Italiano di Cultura di Lima, Sardinia, Italy) for her help and cooperation in this work.

### **Conflict of interest**

The author declares that there are no conflict of interest.

### **Notes/thanks/other declarations**

I would like to express all my deep thanks and respect to University of Babylon, college of engineering of materials for them help and cooperation in this work.

### **Appendices and nomenclature**


### **Author details**

Akram Jassim Jawad1,2\*

1 Department of Polymer and Petrochemicals Industrials Engineering, College of Materials Engineering, University of Babylon, Al Hillah, Iraq

2 School of Engineering and Materials Science, Queen Mary University of London, London, UK

\*Address all correspondence to: akrammaterials4@gmail.com

© 2021 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

*Bioethics of Brain Computer Interfaces DOI: http://dx.doi.org/10.5772/intechopen.97213*

#### **References**

[1] Fourneret E. The Hybridization of the Human with Brain Implants: The Neuralink Project. Cambridge Quarterly of Healthcare Ethics. 2020 Oct;29(4):668-672.

[2] Neuralink Progress Update, Summer 2020, Neuralink, 28 August 2020, accessed 18 December 2020.

[3] Collinger JL, Wodlinger B, Downey JE, Wang W, Tyler-Kabara EC, Weber DJ, McMorland AJ, Velliste M, Boninger ML, Schwartz AB. Highperformance neuroprosthetic control by an individual with tetraplegia. The Lancet. 2013 Feb 16;381(9866):557-564.

[4] Rainey S, Maslen H, Mégevand P, Arnal L, Fourneret E, Yvert B. Neuroprosthetic speech: The ethical significance of accuracy, control and pragmatics. Cambridge Quarterly of Healthcare Ethics. 2019 Sep 2;28(S4).

[5] Kellmeyer P. Big brain data: On the responsible use of brain data from clinical and consumer-directed neurotechnological devices. Neuroethics. 2018 May 19:1-6.

[6] Steinert S, Friedrich O. Wired emotions: Ethical issues of affective brain–computer interfaces. Science and engineering ethics. 2020 Feb;26(1):351-367.

[7] Musk E. An integrated brainmachine interface platform with thousands of channels. Journal of medical Internet research. 2019;21(10):e16194.

[8] Yuste R, Goering S, Bi G, Carmena JM, Carter A, Fins JJ, Friesen P, Gallant J, Huggins JE, Illes J, Kellmeyer P. Four ethical priorities for neurotechnologies and AI. Nature News. 2017 Nov 9;551(7679):159.

[9] Coin A, Mulder M, Dubljević V. Ethical Aspects of BCI Technology: What Is the State of the Art?. Philosophies. 2020 Dec;5(4):31.

[10] Dadia T, Greenbaum D. Neuralink: The Ethical 'Rithmatic of Reading and Writing to the Brain. AJOB neuroscience. 2019 Oct 2;10(4):187-189.

[11] Kellmeyer P. 2019. Artificial intelligence in basic and clinical neuroscience: opportunities and ethical challenges. Neuroforum, 25(4), pp. 241-250.

[12] Weinberger S, Greenbaum D. Are BMI prosthetics uncontrollable Frankensteinian monsters?. Brain-Computer Interfaces. 2016 Jul 2;3(3):149-155.

[13] Knight W. Biased algorithms are everywhere, and no one seems to care. Technology Review. 2017 Jul 12.

[14] Jawad AJ. Bioethics of Medical Devices Based on Brain Computer Interfaces (BCI). J Clinic Res Bioeth. 2021; S8. 003.

[15] Courtland R. The Bias Detectives as Machine Learning Infiltrates Society, Scientists Grapple with How to Make Algorithms Fair. Nature. 2018;558(7710):357-360.

[16] Inglesant P, Hartswood M, Jirotka M. 2016. Thinking ahead to a world with quantum computers. The landscape of responsible research and innovation in quantum computing.

[17] Abdulkader SN, Atia A, Mostafa MS. Brain computer interfacing: Applications and challenges. Egyptian Informatics Journal. 2015 Jul 1;16(2):213-230.

[18] Jawad AJ. Engineering Ethics of Neuralink Brain Computer Interfaces Devices. Ann Bioethics Clin App 2021; 4(1):000160.

#### **Chapter 9**

## Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status in COVID 19

*Mrinmoy Roy*

#### **Abstract**

The pandemic of COVID-19 has highlighted the importance of emergency preparedness and response (EP and R) in India's education, training, capacity building, and infrastructure growth. Healthcare professionals, especially pharmacy professionals (PPs) in India, continued to provide drugs, supplies, and services during the pandemic. The public-private healthcare system in India is complicated and of varying quality. Patients face problems as a result of gaps in pharmacy practice education and training, as well as a lack of clarity about pharmacists' positions. Job requirements and effective placement of healthcare professionals in patient care, as well as on (EP and R) task forces or policy representation, are complicated by this lack of distinction. We have also seen malpractice and spurious distribution in the healthcare and pharmaceutical domain in terms of personal protective kits, medications, injectable, life-saving oxygen, and other items during this unprecedented pandemic situation. A few of the incidents are as follows. The central division police in Bangalore (the Global BPO & IT Hub of India) booked a case of bed-blocking at a private hospital and arrested three people, one of whom is an Arogya Mitra (primary contact for the beneficiaries at every empaneled hospital care provider), for allegedly extorting ₹1.20 lakh from the son of a COVID-19 patient who later passed away. At least 178 COVID-19 patients in India have died because of oxygen shortage in recent weeks. Another 70 deaths have been attributed to an oxygen shortage by patients' families, but this has been denied by the authorities. The Allahabad High court made a remark "Death of COVID patients due to non-supply of oxygen not less than genocide" on reports circulating on social media regarding the death of COVID-19 patients due to lack of oxygen in Lucknow and Meerut. A day ago, the Delhi police busted an industrial manufacturing unit in Uttarakhand's Kotdwar where fake Remdesivir injections were being manufactured and arrested five people. These depict the ground reality and ethical standards of good pharmacy practice in this country. There is an utmost necessity to relook and re-establish the standards of pharmacy practice in healthcare setups available in each and every corner of the country in line with guidelines provided by the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP). For that, the dependency and responsibilities are very high on healthcare professionals, particularly in this pandemic situation. The pharmacy zone is

adaptable, evolving, and increasingly diverse, offering a wide range of work and management opportunities to execute. PPs are human service professionals whose responsibilities include safeguarding individuals by dispensing medications based on prescriptions. Representing the world's third-largest medicinal services with active gathering, and in India, there are over 1,000,000 (1 million) enrolled PPs employed in various capacities and readily contributing to the country's well-being. Pharmacy practice, which includes clinical, community, and hospital pharmacy, is referred to as total healthcare in its true sense. Through adaptation and implementation of GPP in healthcare setup, PPs form an essential link between physicians, nurses, and patients in the social community group, with an ultimate emphasis on patient well-being and protection. To instill quality and raise the standard in this chaotic situation there are strict measures required in the country. The International Pharmaceutical Federation and World Health Organization define good pharmacy practice (GPP) as practices that meet the personal needs of patients or those using pharmacy services by offering appropriate evidence-based care. In developed countries, pharmaceutical assistance is defined as a pharmaceutical practice model that involves attitudes, ethical values, behaviors, skills, appointments, and coresponsibility to prevent diseases, promote and recovery health in an integrated manner as part of the healthcare process, highlighting, among other, the requirement that the institution fully adopts the GPP. There is a need for a GPP Program designed by the Indian Govt. or its stakeholders in the context of the Indian healthcare system and adopting "new normal" due to the unprecedented event of COVID 19 and also raising the standard and importance of GPP for the healthcare professionals in the current scenario.

**Keywords:** GPP in India, healthcare scams in India, scams during COVID-19, healthcare malpractices in India

#### **1. Introduction**

The COVID-19 pandemic has brought attention to the necessity of emergency preparedness and response (EP&R) in India's education, training, capacity building, and infrastructure development. During the pandemic, healthcare workers, particularly pharmacy professionals (PPs) in India, continued to deliver medication, supplies, and services. In India, the public-private healthcare system is complex and of variable quality. Gaps in pharmacy practice education and training, as well as a lack of understanding about pharmacists' roles, cause complications for patients. This lack of difference complicates job requirements and successful placement of healthcare professionals in patient care, EP&R task forces, and policy representation. During this unprecedented pandemic situation, we have also observed malpractice and bogus distribution in the healthcare and pharmaceutical arena in terms of personal protective kits, medications, injectable, life-saving oxygen, and other products. The following are a few of the incidents. The central division police in Bangalore (India's Global BPO & IT Hub) filed a complaint of bed-blocking at a private hospital and arrested three people, one of whom is an Arogya Mitra (primary contact for beneficiaries at every empaneled hospital care provider), for allegedly extorting Rs. 1.20 lakh from the son of a COVID-19 patient who later died. In the last few weeks, at least 178 COVID-19 patients in India have died due to a lack of oxygen. Another 70 deaths have been linked by patients' families to a lack of oxygen, though this has been refuted by authorities. "Death of COVID patients due to non-supply of oxygen not less than genocide," the Allahabad High Court ruled in response to reports spreading on social media regarding the

*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

death of COVID-19 patients in Lucknow and Meerut due to a shortage of oxygen [1]. Five persons were arrested after the Delhi police raided an industrial manufacturing site in Uttarakhand's Kotdwar, where duplicate Remdesivir injections were being made. This reflects the reality of Good Pharmacy Practice in this country, as well as the ethical norms that apply to it. It is critical to re-evaluate and re-establish pharmacy practice standards in healthcare settings throughout the country, in accordance with World Health Organization (WHO) and International Pharmaceutical Federation (FIP) principles. As a result, healthcare workers have a great deal of reliance and responsibility, especially in current pandemic circumstances. The pharmacy zone is adaptive, growing, and becoming more diverse, providing a comprehensive range of job and management opportunities [2]. PPs are human service professionals tasked with keeping people safe by distributing drugs according to prescriptions. In India, there are about 1,000,000 (1 million) enrolled PPs working in diverse capacities and contributing to the country's well-being, making it the world's third-largest medical service with active gathering. In its real definition, pharmacy practice, which encompasses clinical, community, and hospital pharmacy, is referred to as overall healthcare. PPs form a crucial link between physicians, nurses, and patients in the social community group through the adaptation and application of GPP in healthcare settings, with the ultimate emphasis on patient well-being and protection. In order to instill quality and elevate the standard in this chaotic scenario, the country must take stringent steps. Good pharmacy practice (GPP) is defined by the International Pharmaceutical Federation and the World Health Organization as practices that fulfill the individual requirements of patients or people who use pharmacy services by providing adequate evidencebased care. Pharmaceutical assistance is defined in developed countries as a pharmaceutical practice model that includes attitudes, ethical values, behaviors, skills, appointments, and co-responsibility to prevent diseases, promote, and recover health in an integrated manner as part of the healthcare process, highlighting, among other requirements, the institution's full adoption of the GPP. In the context of the Indian healthcare system and adopting a "new normal" due to the unprecedented event of COVID-19, there is a need for a GPP program designed by the Indian Government or its stakeholders, as well as raising the standard and importance of GPP for healthcare professionals in the current scenario.

India is a developing country in southern Asia with 29 states and seven union territories, 22 nationally recognized languages, and a population of 1.38 billion. India is a rural country with an agriculture-based economy, with rural areas accounting for over 75% of the population. In recent decades, India's average income has risen dramatically, resulting in growing urbanization, improved middleclass access to a better lifestyle, and increasing awareness of health insurance. Male and female literacy rates have climbed to 82% and 65%, respectively. According to reports, the average life expectancy is 69.9 years [3]. According to World Bank research from 2020, about 400 million Indians live on less than \$1.25 a day, and 44% of children are hungry. Even though the government has taken attempts to reduce baby and maternal death rates, they remain high. Ancient Hindus acknowledged pharmacy as a complementary healing profession, and they specialized in vegetable treatments. Vedic and Brahmanic medicine were the two periods of Hindu medicine. The Vedic period or Vedic age (c.1500–c.500 BCE), and was a rudimentary period. During the Vedic period, sin was thought to be a major source of disease. Between 800 BC and 1000 AD, the Brahmanic period was a high-quality time for Hindu medical education. The works of Charaka, Susruta, and Vagbhat, which are based on ancient Vedic themes, are the three great masterpieces of Brahmanic medicine [4]. The origins of pharmacy in India can be traced back to Ayurveda, which dates to 5000 BC. Lord Brahma initially taught Ayurveda, or "life science," which was further transmitted by Charaka and Sushruta [5]. The Charaka Samhita, early work on Ayurveda, focuses on vegetable goods as well as some animal and earth goods. The classification of medications in this book is based on how they affect different bodily parts [4]. In 900 AD, Tamilnadu established a hospital to treat piles, jaundice, bleeding, and tuberculosis [5]. Tantrism was a prominent philosophical and religious movement that emerged in India after the downfall of Buddhism; it brought the art and science of the production of metallic compounds, particularly mercury and sulfur, to the fore [4]. In 1811, Scotch M. Bathgate built the first chemist shop in Calcutta, which is regarded as the birthplace of pharmacy practice in India. In December 1860, Madras Medical School began pharmacy instruction, enrolling students with only middle school education; the pharmacy degree was 2 years long. Madras Medical College (MMC), Chennai, established the diploma course in pharmacy in 1874. The Bengal Chemists and Druggists Association was founded in 1926 after the Calcutta Chemists and Druggists Association was founded in 1920. The first issue of the official *Indian Journal of Pharmacy* was published in 1939. In 1868, the British monarchy released the first Indian pharmacopeia. In 1881, a formal provision for the education and examination of compounders was established in Bengal. In 1920 and 1940, master's degrees in pharmaceutics and applied chemistry were introduced, respectively. Gorakh Prasad Srivastava was the first postgraduate pharmacy student to complete the degree in 1943. In 1945, the first steps toward standardizing pharmacy education were taken. The first annual conference of the Indian Pharmaceutical Congress Association was held in 1948. The Pharmaceutical Association was India's first pharmaceutical society, founded in 1923 and renamed The Pharmaceutical Society of India after 2 years. In 1949, a West Bengal institute introduced a Diploma in Pharmacy, and the Pharmacy Council of India (PCI) approved the diploma as the minimal prerequisite for beginning pharmacy practice in 1953. In 1954, Prof. M.L. Schroff, known as the "Father of Pharmacy in India," was elected president of the PCI.

#### **2. Health statistics**

Many issues face India's healthcare system, including the need to lower mortality rates, enhance physical infrastructure, provide health insurance, and train healthcare experts and workers. A rise in communicable diseases, lifestyle diseases, and noncommunicable diseases has been recorded. Diseases such as poliomyelitis, leprosy, and newborn tetanus will be eradicated; nevertheless, certain previously controlled infectious diseases, such as dengue fever, viral hepatitis, tuberculosis, malaria, and pneumonia, have resurfaced or developed medication resistance.

Even though Indians are now more affluent as a result of the rise of the middle class, their eating habits have shifted dramatically to unhealthy, high-sugar, highfat diets, leading to an increase in lifestyle diseases such as hypertension, cancer, and diabetes. Furthermore, India's healthcare institutions and services would be burdened by the expanding older population.

Due to a dearth of hospital beds and skilled medical personnel such as doctors, nurses, and pharmacists, the people do not have access to their medical needs. In comparison to urban areas, healthcare services are much scarcer in rural communities. Females have an adversely skewed proportion in the healthcare workforce when compared to males. In the 11th five-year plan, total healthcare expenditure (comprising state funds, private funds, and external flows) accounted for 4.1% of GDP (GDP). The 12th five-year plan (2012–2017) intends to raise public health spending from 1.1% of GDP to 2–3% of GDP [6].

*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

#### **3. A look at the healthcare system as a whole**

The state is responsible for the healthcare system. This system is currently managed by both public and private (for profit and nonprofit) groups. Policymaking, planning, guiding, aiding, reviewing, and coordinating the activities of various provincial health authorities are all responsibilities of the federal government, as is providing financing to implement national healthcare initiatives [7]. Allopathic hospitals, hospital beds, Indian System of Medicine and Homeopathy hospitals, subcenters, Pharmacy Health Care (PHC), Community Health Center (CHC), blood banks, Eye Bank, psychiatric hospitals, and cancer hospitals are all part of India's healthcare infrastructure [7]. The Department of Ayurveda, Yoga, and Naturopathy, as well as Unani, Siddha, and Homeopathy, provide medical and healthcare services (AYUSH). The ownership of the public sector is split between the federal and state governments, municipalities, and panchayats (local governments). Dispensaries, primary health centers, subcenters, and health posts are among the facilities. Teaching hospitals, secondary-level hospitals, first-level referral hospitals (community health centers/rural hospitals), dispensaries, primary health centers, subcenters, and health posts are among the facilities. Public facilities for specific occupational groups are also included, including organized labor (Employees State Insurance Scheme), defense, government employees (Central Government Health Scheme), railways, post and telegraph, and mining, to name a few. The private sector (profit/nonprofit) is the most prevalent, with services ranging from >1000 beds to two beds. Health-related facilities are available through the federal government healthcare program in 25 cities, with 246 allopathic dispensaries [7]. Private healthcare providers are currently treating 78% of outpatients and 60% of inpatients in India. Private healthcare providers range from world-class hospitals that promote medical tourism by providing world-class treatments to international clients and Indians who can afford it to private doctors who have minimal medical expertise or formal training on the other end of the spectrum. Furthermore, the private sector controls 80% of doctors, 26% of nurses, and 49% of hospital beds, demonstrating its power.

#### **4. The country's hospitals**

In contrast to India, the number of hospitals in other nations is not given. However, according to World Bank statistics, available at https://data.worldbank. org/indicator/SH.MED.BEDS.ZS India's accessible beds per 1000 population is lower than that of a lot of other countries. As a state of concern, public health and hospitals are largely responsible for the upkeep, providing health treatment to individuals, and maintaining hospital information. However, the following details are provided below:


#### **State/UT–wise number of PHCs, CHCs, SDHs, DHs, and beds in the country.**


**State/UT No. of public facilities No. of beds available in public facilities PHC CHC SDH DH Total** Tamil Nadu 1854 385 310 32 2581 72,616 Telangana 788 82 47 15 932 17,358 Tripura 114 22 12 9 157 4895 Uttar Pradesh 3277 671 174 4122 58,310 Uttarakhand 275 69 19 20 383 6660 West Bengal 1374 406 70 55 1905 51,163 **All India 29,899 5568 1255 1003 37,725 739,024** *Source: Data as uploaded by States-UTs on HMIS portal, status as of 20 July 2018.*

*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

#### **India, State/UT wise number of government hospitals and beds in rural and urban areas.**



*Source: National Health Profile 2018/Directorate General of State Health Services.*

*Notes: Government hospitals include central government, state government, and local govt. bodies. Figures are provisional.*

*\*States/UTs provided information for the year 2017 and PHCs are also included in the number of hospitals.*

#### **State-wise distribution of AYUSH hospitals and beds as on 1-4-2017.**



*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

#### **Number of hospitals and beds maintained by Ministry of Defense, State wise.**



#### **Number of hospitals and beds in railways (as on 21/03/2018).**



*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

#### **Employees State Insurance Corporation hospitals and beds (as on 31.03.2017).**



#### **5. Core pharmacy practices**

#### **5.1 Hospital pharmacy**

The hospital pharmacy is one of the most important departments in the hospital, and it is responsible for drug procurement, storage, compounding, dispensing, manufacturing, testing, packaging, and distribution. This section is also in charge of pharmaceutical science and education research, which is carried out by skilled and knowledgeable pharmacists. The hospital pharmacy has a significant impact on healthcare cost economics. In today's hospital pharmacy, medication monitoring and drug information services are combined. Purchasing, storing, handling, pricing, and dispensing pharmaceuticals are all skills that a hospital pharmacist possesses. In addition, pharmacists give drug information to all healthcare professionals and the public, as well as serve as a link between the patient and the doctor. The criteria for acquiring pharmaceuticals, chemical and biological medications, and other items are provided by hospital pharmacists. They are also in charge of manufacturing and distributing pharmaceuticals like transfusion fluids, parenteral goods, pills, capsules, ointments, stock combinations, and safe drug storage. Hospital pharmacists can sterilize and dispense parenteral drugs made in hospitals. They fill, label, and distribute all medicine packages. Hospital pharmacists oversee purchasing pharmaceuticals, ensuring correct drug storage conditions, keeping records, and distributing pharmaceuticals to the outpatient department. In addition, hospital pharmacists provide drug monitoring services for inpatients and participate in hospital research programs [8]. Due to low wages, the hospital parts of a pharmacist's job have historically been overlooked in India; also, pharmacists have never been trained for a patient-centered role. Medical practitioners have never embraced pharmacists for clinical functions, while pharmacists have been hesitant to accept their profession's clinical obligations. Many Indian hospitals have begun to assign pharmacists a clinical role, with encouraging outcomes, but India still lags behind other countries in this regard. In India, the concept of a hospital pharmacy is confined to the dispensing of medications at hospital pharmacies [9].

Hospital pharmacies require certain personnel.

The dispensing, manufacturing, quality assurance, and clinical pharmacy services are all integrated within the hospital pharmacy. Personnel requirements for an inpatient pharmacy are determined by the nature and scope of services supplied by the department. The number of hospital pharmacists required is determined by the workload and the number of beds in the hospital. Small hospitals typically require a minimum of three pharmacists; however, this varies depending on the number of

*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

beds. **Table 1** shows the number of pharmacists necessary based on the number of beds in a hospital [8].

According to 2011 data, the number of government hospital beds in rural and urban locations is shown in **Table 2**.

Personnel who work in hospital pharmacies must be knowledgeable and welltrained. The director of the pharmacy must have a postgraduate degree in hospital pharmacy, pharmacology, or pharmaceutics and serves as a liaison between pharmacy and non-pharmacy personnel. The hospital pharmacy's structure is depicted in the Flowchart below (**Figure 1**).

Even we have seen the present status, there were no significant improvements*.*

#### **5.2 Community pharmacy**

In India, the Pharmacy Act of 1948 was passed to ensure that every practicing pharmacist had a registration certificate [11–13]. On completion of the minimum diploma in pharmacy, educational institutes authorized by the PCI can grant this


#### **Table 1.**

*Pharmacist requirement in hospitals.*


*N.A., not available.*

*Source: GOI,Table 6.2.2 State/UT wise number of govt. hospitals and beds in rural and urban areas (including CHCs) in India (provisional), in "Health infrastructure" in "National Health Profile, 2011," Central Bureau of Health Intelligence, Ministry of Health and Family Welfare, 2011.*

#### **Table 2.**

*State and union territory wise number hospitals and beds in rural and urban areas in India.*

**Figure 1.**

*Organization structure of hospital pharmacy. Source: Nahata [10]*.

credential. A pharmacy diploma involves at least 2 years of education and 500 h of practical training, including three months in a community or hospital pharmacy [11]. These pharmacists with a diploma represent most of the workforce and run most community pharmacies in India today. A bachelor's degree in pharmacy is designed to meet the needs of the pharmaceutical business, with most graduates working in pharmaceutical companies or regulatory agencies. In comparison to community pharmacy, many B. Pharm graduates prefer to work in the pharmaceutical business because of the higher pay scale and other benefits.

In practice, these pharmacists with a diploma or bachelor's degree are still unheard of in half of the community pharmacies. Most patients come to community pharmacists for help on sexually transmitted diseases, minor ailments, contraceptive options, and menstruation issues [11]. The majority of community pharmacies are administered by people with minimal awareness of health issues or medical training, and pharmacists are hired on low pay rates. Most pharmacists in community pharmacies lack counseling abilities and are simply able to deliver medications. Despite the public's negative opinion of pharmacists and the idea that pharmacies are like grocery stores, community pharmacies remain the principal provider of low-cost medical treatment.

#### **5.3 Medicine promotion and marketing**

In India nowadays, the average cost of a prescription per patient who visited a private clinic is around 1000–1500 rupees, and the number of prescriptions per drug has increased. The marketing efforts of pharmaceutical companies have a significant impact on doctors' prescribing patterns. Pharmaceutical companies spend less on R&D than they do on marketing. Medical representatives are trained by pharmaceutical companies to advertise and sell pharmaceuticals utilizing printed product materials, medicine samples, and gifts. Around 80,000 medical representatives are hired by pharmaceutical companies in India, and they are paid well.

In addition to their pay, they are offered significant incentives. General practitioners have been found to prescribe new products under the influence of sales reps. Furthermore, medical representatives promote medications by stating more indications than are officially registered.

One of the main tools used by pharmaceutical firms to advertise their medication is gifts (ranging from a table-top reminder to an air conditioner), gratification, foreign excursions, pleasure excursions, and so on. From clocks to air conditioners, calendars to cars, rubber bands to refrigerators, telephone indexes to television, and office items to overseas trips, the variety of gifts includes stationery, timepieces,

#### *Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

bags, books, folders, office desks, medical supplies, and household items—from clocks to air conditioners, calendars to cars, rubber bands to refrigerators, telephone indexes to television, and office items to overseas trips. According to Chren and associates, there is an implicit relationship between doctors and the pharmaceutical industry, which leads to a responsibility to respond to gifts [14].

Advertising has a significant role in the marketing of medicine. Pharmaceutical companies spend a lot of money to advertise in medical and pharmaceutical magazines, which are read by a lot of general practitioners and clinical specialists. Medical journals in India would perish if pharmaceutical companies did not advertise in them. The advertising of pharmaceuticals is strictly monitored, and if there is any false information, harsh action is taken. Drug information should be accurate, current, and balanced, according to the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and The Association of the British Pharmaceutical Industry (ABPI) guidelines. The IFPMA code must be followed by all members of the Organization of Pharmaceutical Producers of India (OPPI). Internal codes and promotional material for the pharmaceutical producers of India must be approved by medical advisers, according to the organization. A Promotional Quality Improvement and Assurance Committee also performs a thorough study of these promotional materials. Furthermore, this committee makes recommendations for marketing enhancements.

Irrational prescription and its consequences are heavily influenced by pharmaceutical marketing and promotional activities. The Medical Council of India has issued a new code of ethics for practitioners who receive any sort of compensation from pharmaceutical companies. New legislation in Rajasthan, India, states that a doctor must only put the generic name of a medicine on a prescription [14].

#### **5.4 Pharmacy-related services and activities that are unique**

With the advent of clinical pharmacy, which provides high-quality treatment and assistance to patients, a pharmacist's job has been expanded. Pharmacists now provide drug and toxicity information, manage anticoagulation clinics, and administer smoking cessation programs, among other things.

#### **6. Education parameters of healthcare workforce**

The paramedic education system has been supply-driven, with no regard for industry demand. Allied healthcare providers are the most crucial because, if a patient has a hundred interactions at a hospital, allied healthcare workers account for 80 of those encounters. In India, healthcare is the third most important source of employment. It is broken down into three categories: Doctors make up 10–15% of the healthcare workforce, nurses make up 20–25% of the workforce, and paramedics, also known as allied healthcare professionals or healthcare technicians, make up the largest segment of the healthcare workforce. The doctor-to-allied healthcare-professional ratio in India is 1:4. The advanced countries, such as the United States and the United Kingdom, have a 1:20 ratio. India already employs over 10 million allied healthcare workers, but to meet the 1:20 ratio, we will need to increase this number to 40–50 million in the next few years. Diagnostic, curative, and rehabilitative allied healthcare professions are categorized into three groups. The diagnostic and therapeutic industries in India have been expanding. Allied healthcare professionals such as X-ray technicians and medical app technicians work in diagnostic. Technicians such as OT technicians and emergency medical technicians work in Curative. The difficulty is that in India, only about 7% of

these allied healthcare professionals are certified because there was no centralized authority to certify them until the NSTC was established. Before NSTC, each state certified them at their own level, and the biggest problem today is for quality healthcare services, allied healthcare professionals are the most important because if a patient has a hundred interactions in a hospital, 80 of those interactions are with allied healthcare professionals, and the biggest challenge in India is that there are less than a hundred allied healthcare professionals. Until 2008, there was no centralized body. One of the most significant issues is that, in general, education in India has been supply-driven, with no connection to industry needs. As a result, when compared to worldwide norms, we are one of the least prepared for the workforce. What needs to be done is for education to be driven by demand. It must be presented from the standpoint of the company and how these individuals will work in the sector. To do so, we must recognize three factors—technical training, practical training, and soft skills and grooming training, all of which must be provided so that these individuals are prepared to fully contribute to the workforce in a productive manner when they enter the workforce. Mr. Narendra Modi, Prime Minister of India, believes that ongoing training of the workforce required to combat the COVID 19 crisis is critical. He recommended officials and doctors to hold training sessions and webinars, particularly for paramedics and doctors who work in rural areas. He also requested that the officials endeavor to reduce vaccination waste in the district. Interacting with Varanasi doctors and administrators via video chat Prime Minister Narendra Modi paid a heartfelt tribute to those who died because of COVID-19. He emphasized the necessity of ongoing training for those fighting COVID, advising officials and doctors to hold training sessions and webinars, particularly for paramedics and doctors functioning in remote areas. He also requested that the officials endeavor to reduce vaccination waste in the district. "Jahan Bimar Wahan Upchar," is the new slogan in COVID management in terms of delivering therapy to the patient's doorstep that will minimize the strain on the health system. The doctors from Varanasi updated the other doctors through video conference on the measures made in the last month to restrict the spread of COVID, vaccination status, and ongoing steps and strategies to prepare the district for future difficulties. They stated that they have been vigilant in their response to the threat of mucormycosis and have already taken action and established facilities to handle the condition. Our Prime Minister also praised the microcontainment zones project and praised the home distribution of medicines, and he urged health professionals to make the campaign as widespread as possible in rural areas. He praised the physicians, nurses, technicians, ward boys, ambulance drivers, and other Kashi frontline health professionals for their efforts. He praised the medical staff in Kashi for their efforts in controlling the pandemic to a large extent, but warned against complacency, urging them to fight a lengthy battle right now by focusing on the rural districts of Banaras and Purvanchal. PM emphasized the critical role of Accredited Social Health Activists (ASHAs) and Auxiliary Nursing Midwifery (ANMs) sisters in the ongoing village campaign against COVID-19 and urged health officials to use their potential and experience. The main reason is if the frontline employees had already been vaccinated, they were able to serve the people safely during the second wave. We need to encourage everyone to get the vaccine when it is their turn, that is what has currently been done.

#### **7. International standards of good pharmacy practice**

Diverse countries and continents, including emerging, transitional, and industrialized countries, have different pharmaceutical practices. The World Health

*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

Organization (WHO)/International Pharmaceutical Federation (FIP) joint guideline of good pharmacy practice (GPP), which was updated in 2011, is meant to account for these changes in practice. The pharmacy profession is rapidly expanding, with new responsibilities being offered and announced not only by pharmacists but also by other medical professionals, national organizations, and institutions. The GPP's guideline is progressive and adaptable, and it must remain relevant when new positions develop. Standardizing many parts of pharmacies is one of the most important techniques of quality control for medications and pharmaceutical services for the public. The GPP Guide is a significant step toward bettering pharmacy services [12]. The GPP guideline is designed for use by national professional pharmaceutical associations, as well as national authorities and other relevant agencies responsible for drafting relevant documents and related laws and regulations in their countries, according to the WHO and FIP. It is not a clear national standard, but it does provide guidance on certain tasks, responsibilities, and actions that help pharmacists to fulfill their mission. Professional issues and attitudes are given specific attention throughout the guideline's content, and the patient's well-being is given priority. However, it should be noted that this is the first time that a legal, economic, and labor framework has been introduced in the context of the GPP structure, and it comes at an appropriate time given global debates on the economic aspects of medicines, access to quality medicines, access to skilled medical workers, the global workforce failure, the increased cost of medical care, and new models of healthcare [13]. The GPP is defined by the WHO and the FIP as a pharmacy practice that satisfies the needs of people who use pharmacists' services to deliver optimal medical care based on evidence-based medicine principles. To support this approach, a national framework of quality standards and guidelines is required. The goal of this project is to investigate the historical stages of development of GPP requirements, as well as to examine modern normative texts proposed by FIP for use in global pharmaceutical practice, as well as to investigate the current state of this issue around the world. The study included the generalization of information material and system analysis methods. The WHO and the FIP have been working together since the late 1980s to define pharmacist duties and functions, as well as produce guidelines for the GPP as a framework for pharmacological care. The WHO amended the medicines strategy, which was accepted by the World Health Assembly in 1986, and two meetings on the function of pharmacists were held in accordance with it. The inaugural meeting was held in Delhi, India, in 1988 [15]. The FIP produced criteria for pharmaceutical services in 1992, and the WHO Information Centers disseminated the approach of good pharmaceutical practice in March 1993. The standards of pharmacy services entitled "GPP in Public and Hospital Pharmacies" were officially issued during the convention in Tokyo, Japan [15]. Under the framework of the Tokyo declaration on quality standards of pharmaceutical services, the FIP congress accepted the FIP/GPP text. The FIP has asked pharmaceutical companies and governments to work together to implement GPP standards or to amend current national standards in countries where they currently exist, according to this paper. Then, in May 1994, the World Health Assembly adopted a resolution on the role of the pharmacist in support of the WHO's new pharmaceuticals strategy. In 1994, a version of the GPP was also presented to the WHO Expert Committee on Pharmaceutical Medicine Specifications in Geneva. In 1999, a joint document of the WHO/FIP of the GPP was published in a series of technical reports of the WHO Expert Committee on concerns of pharmaceutical medicine specification, following the recommendations of the WHO Expert Committee and the approval of the Board of the FIP in 1997. This gave the GPP more formal standing and assured that it was widely distributed around the world [16]. A Soon after, the WHO convened two more meetings on the pharmacist's role, one in 1997 in Vancouver, Canada, and the other in 1998 in The Hague, Netherlands. These gatherings reinforced the necessity for reforming pharmacy education programs and highlighted the pharmacist's role in self-help and self-healing. The European Union's (EU) pharmaceutical group prepared a paper containing the GPP for Europe in 1998, with special emphasis dedicated to EU countries—"the GPP in Europe." [17]. The "GPP in the New Independent States" was established in 2001. The Copenhagen Center for Drug Policy and Development of Pharmaceutical Practice developed "Guidelines for the creation and implementation of standards" in Denmark. The document examined the state of pharmacy practice and focused on issues such as health education and morbidity prevention, the provision of prescription drugs and their use, self-treatment, the effects of prescription and use of drugs, as well as the method of implementing proper pharmacy practices in developing countries. The WHO experts recommended that European standards for pharmacies be implemented on a par with existing national standards to regulate various aspects of pharmaceutical activity, including the quality of prescription data received by the pharmacist, the development of medical forms, the building of contacts with doctors based on individual recipes, and the evaluation of data on the use of medical products [18]. There is a strategy for establishing national GPP standards, according to FIP recommendations. To begin, fundamental pharmaceutical services must be established, for which a regulatory framework and relevant standards must be created. The secondary and higher education systems in pharmacy should be revised after that because pharmacists will require a more in-depth understanding of pharmacotherapy, pharmacopeia, and communications skills. The provision of more complex professional pharmaceutical services is the ultimate stage. The FIP highlights GPP elements that demonstrate that the pharmacy provides high-quality service and adheres to strict guidelines: The presence of a zone in the pharmacy with information about healthy lifestyles; availability of a pharmacy for people with disabilities and elderly patients; availability of a comfortable waiting area; the possibility of a private conversation between a pharmacist and a patient, including those with disabilities; and the presence of a pharmacist on call. The pharmacist's responsibility in providing successful drug therapy, according to FIP's recommendations, is as follows: Management of therapy, monitoring of treatment success, and disseminating information on the safe and effective use of medications. The pharmacist should evaluate the client's health and needs, taking into consideration his unique qualities. Professional collaboration between the pharmacist and the doctor is an important part of GPP. Each patient's medical and pharmacological information (diagnosis and laboratory data) should be in the first one. It is also crucial to keep track of whether GPP standards are being followed. It can be internal and/or external; it can also be necessary or simply for accreditation/certification purposes. This will disclose the drawbacks of meeting GPP requirements as well as ideas for how to avoid them. One of the simplest ways to ensure that a pharmacy's work is of high quality is to assess customer satisfaction with the service. In 2006, FIP and WHO collaborated to publish the handbook "Developing Pharmacy Practice—A Patient-Centered Approach." This guide introduces the new pharmacy practice paradigm and the approach to pharmaceutical assistance. The FIP has taken the initiative to explore the possibilities of providing technical assistance to its member organizations in Cambodia, Moldova, Mongolia, Paraguay, Thailand, Uruguay, and Vietnam in developing national standards of the GPP in a pilot project to improve standards and practice of medicine distribution and use with the help of the WHO/FIP setting with the GPP as the framework. The "Bangkok declaration of the GPP in public pharmacies" was adopted across Southeast Asia in 2007, and member associations pledged to improve the quality of pharmacy services and professional practice [19]. *Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

Significant advances in practice applied science and technology, and pharmaceutical policy has happened since the GPP guideline was accepted in community and hospital settings. Despite changes that have occurred since the GPP's previous guidance in pharmaceutical policy, practice, and applied science was adopted in 2007, FIP was established to investigate the problem of updating the GPP's guiding principles to reflect current standards and professional thinking peculiarities [20]. During the 68th World Congress in Basel, Switzerland, in 2008, the FIP convened expert consultations for this aim. A total of 50 people attended the meeting, including members of the working group (WG), FIP of the GPP, WHO headquarters staff, representatives from the WHO regional office for the Eastern Mediterranean countries, medicines advisers from Ghana, Nigeria, and the United Republic of Tanzania, presidents, and secretaries of six Regional Pharmaceutical Forums, FIP member organizations, and several NGOs [21]. Following these consultations, the FIP GPP working group performed a detailed examination of current national standards for GPP in at least 37 countries and developed a time zone that could allow for adequate consultations with all 120 national associations, relevant experts, and the WHO. In October 2008, a proposal for this project was given to the WHO Expert Committee on concerns of pharmaceutical medicine specification at its 43rd meeting, and an updated report was provided to the Committee of Experts at its 44th meeting in October 2009. Simultaneously, in late 2008, the Pan-American Health Organization prepared "the guide for pharmaceutical services in primary health care" with the help of a group of experts from various pharmaceutical organizations, with the goal of highlighting the role of pharmaceutical experts in Latin America's health system. Following discussion with 120 national members of the FIP in 2011 and changes in the pharmaceutical industry, the GPP recommendations were adopted and updated by the approval of a joint guideline FIP/WHO titled "the GPP: Standards of the quality of pharmacy services." This general guideline was released as new standards of pharmacy service quality in the WHO Expert Committee's 45th report. In addition, this document encourages national pharmacy professional associations to embrace these standards and propose some GPPspecific norms [22]. The GPP establishes standards that are usually higher than the requirements of a country's pharmaceutical legislation. In the modified version of the GPP, pharmacists play many roles:


Depending on the duties that each pharmacist does, these positions may differ. Only through national pharmacy professional associations may specific GPP standards be defined. This recommendation is made in the form of a set of professional goals that must consider the needs of patients and other pharmaceutical stakeholders.

In comparison to the previously authorized concept of the GPP, the present updated version reinforces the requirements for the GPP's well-known primary aspects and identifies functions in each pharmacist's position for which minimum national standards should be established. Different countries have different versions of the GPP rules. There are holistic papers in some countries that cover both

requirements for the material-technical base, infrastructure, personnel, and standards for the provision of pharmacological treatment. These rules and regulations are spelled out in numerous documents in other countries. The standards for pharmacists in France, for example, are established in several guidelines. In Austria, on the other hand, nearly all the requirements for pharmacists are encapsulated in a single piece of legislation. There is also a guideline for pharmacists' work, which includes standards for a quality management system in addition to the typical criteria for premises, equipment, and staff. The GPP standards have a recommended status in industrialized countries. As a result, the Norwegian pharmaceutical association's standards of pharmacy practice, created in partnership with other professional groups, include requirements for pharmacy activities that are utilized by pharmacy owners to conduct internal quality control of pharmacy services. The government adopts legislation acts that provide the minimum standards for the functioning of pharmacies [23]. The Pharmaceutical Society of Ireland published a guideline on pharmacy practice to help pharmacists meet legal and regulatory requirements when providing pharmaceutical services [24]. In addition, the GPP is adopted in CIS countries. Belarus has implemented a pharmacy classification system. The GPP was adopted in Kazakhstan in 2006, and the provisions of the GPP of the customs union are currently approved in the Russian Federation. It should be noted that the GPP standard and guidance on the implementation of proper pharmacy practices serve as the foundation for implementing the total quality management (TQM) concept and the international standard of ISO quality management at pharmaceutical companies, both of which have been in use for more than 30 years. The understanding of the existence of an inextricable link between the quality management system and the organization's management system, as well as the understanding that this is an essential tool for continuous improvement and increasing the pharmacy organization's competitiveness in any market, is the foundation of TQM [25]. As a result, by enhancing the requirements to assure the quality of public services, the GPP standards are a significant step toward the expansion and enhancement of pharmacy operations. Despite improvements in pharmaceutical research and practice, the development and implementation of GPP criteria into pharmacy practice is a longterm and ongoing process. The standardization of pharmacists' activity in providing people with medications and medical items receives a lot of attention in GPP guides of all years. Because national regulation of pharmacy practice differs widely among nations, the establishment of GPP standards should be handled at the level of public professional organizations. The results of the study will be used to design and apply GPP national standards around the world, according to future scientific research.

#### **8. Current pharmacy practice scenario in India**

A recent countrywide survey done by final year postgraduate diploma in management students from Indian Institute of Health Management & Research, Bangalore finds that out of 107 hospitals 66 hospitals only follow the WHO/FIP GPP 2011 or Indian Pharmacy Practice Regulations 2015 which is merely 62% of the entire sample.

Students were asked to conduct a brief analysis and report on the top five hospitals or community pharmacy dept. in their area or where they did train/observer ship whether these guidelines are followed or not and where are the loopholes in following this guideline. There were two kinds of data generated, such as


*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

The graphical representation of the quantitative survey data is illustrated as follows:

The qualitative observational/survey data is represented as follows:




Pharmacy practice, which includes clinical, community, and hospital pharmacy, is referred to as healthcare in the true sense. PPs establish a vital link between doctors, nurses, and patients in a social community group, with the goal of improving patient welfare and safety [26]. Pharmacists must provide more than only distribution; they must also provide services to society, such as patient counseling, guidance, and the organization of drug data for human services, suppliers, and patients [27]. For example, before the product patent was implemented in India in the early 2000s, the pharma industry thrived successfully after the amendment of new monetary reforms in India in the mid-1990s until the early 2000s [28]. In terms of educational outcomes, the degree of student achievement in pharmacy has improved from 2012 to 2020 and is predicted to continue to climb due to its scope. Many pharmacy graduates have expressed an interest in medication discovery and innovation through research [29]. It has been suggested that pharmacies play an important role in strengthening social security because they work around the clock to maintain a chain of elegant integrity on drugs, particularly during the COVID-19 pandemic. From the standpoint of regulatory authorities, PPs play a variety of roles and duties in the execution of new recommendations based on situational faults [30].

#### **8.1 The practice of pharmacy**

It entails the implementation, evaluation, and interpretation of pharmacy orders as well as the dispensing of prescriptions. Pharmacists are responsible for providing patient counseling, legislation, and social services to promote pharmaceutical treatment as primary care in all areas of patient health [31]. They are also in charge of segregating and labeling pharmaceuticals and medical devices, as well as guaranteeing the safety of medication and device storage and maintaining adequate records [32].

**According to a Supreme Court decision on March 5, 2020, [**IN THE SUPREME COURT OF INDIA CIVIL ORIGINAL/APPELLATE JURISDICTION TRANSFERRED CASE (CIVIL) NOS …………… ...OF 2020 [TRANSFER PETI-TIONS (CIVIL) NOS. 87-101 OF 2014] The Pharmacy Council of India. Petitioner Versus Dr. S.K. Toshniwal Educational Trusts Vidarbha Institute of Pharmacy and Ors. Etc. .. Respondents]


*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

In India, there are two types of pharmacists—those who work in hospitals and those who work in


#### **8.2 India's first pharmaceutical company**

Bengal Chemical and Pharmaceuticals Ltd. was founded in 1892 as an individual initiative by the "Father of Indian Chemistry," Acharya Prafulla Chandra Ray, and is considered the country's first pharmaceutical enterprise. For the first time in more than six decades, Bengal chemicals and medicines Ltd. made a profit in 2016–17 [34].

#### **8.3 Regulation of pharmaceuticals**

For the manufacture, distribution, and sale of medications, India has the harshest rules and regulations in the world. The ability of law enforcement is not just determined by good legislation; it also requires stringent regulations and the acceptance of successful challenges. According to the Mashelkar committee's recommendations, one drug inspector should be assigned to every 50 manufacturing units and one to every 200 distribution outlets. In most states, 30–50% of positions are vacant, and the number of positions available is insufficient to expand the pharmaceutical sector. According to the Mashelkar committee report, one drug inspector is assigned to every 200 retailers, and the data from the All-India Organization of Chemists and Druggists (AIOCD) indicates that there are approximately 8.5 lakh pharmacies to be considered, implying that more than 4250 drug inspectors are required to manage the retail pharmacy segment [35].

CDSCO and SDRA have different roles.

Pre-manufacturing is the process of preparing a product for manufacture.

Expert panels help the Central Drugs Standard Control Organization (CDSCO) to regulate premanufacturing. The following is their primary role in dealing with the two major criteria:


#### **8.4 Industrial production**

The State Drug Regulatory Authority (SDRA) oversees regulating drug product manufacturing in the states, while CDSCO oversees union territories. In some circumstances, the CDSCO and SDRAs undertake joint inspections [37]. The terms listed below are required for the manufacture of pharmaceutical products.


#### **8.5 Sales and distribution**

The SDRAs oversee regulating the distribution and sale of drugs in the states, while the CDSCO oversees the union territories. The terms listed below are required for the distribution and sale of pharmaceutical items.


#### **8.6 Situation now**

The current state of pharmacy education, authority functions, and future difficulties of pharmacists in all aspects was discussed, particularly considering the COVID-19 epidemic. During the development phase, it must overcome numerous obstacles, including regulations, duration, process controls, legal stumbling blocks, and situational flaws [39]. **Table 3** summarized the educational updates.

#### **8.7 The government's initiative**

From June 2, 2020, the PLI Scheme will be open for 4 months, allowing investors to propose the construction of Greenfield facilities for any of the 53 important drug intermediates and bulk pharmaceuticals that are now barely made in India [40]. The list contains important chemicals found in regularly given medications such as paracetamol, aspirin, metformin, atorvastatin, and others. The whole planned incentive package is worth Rs. 13,760 Crore, which is divided between bulk medicines and medical devices as shown in **Figure 1**.

COVID-19 PPs



**Table 3.** *Statistics of pharmacy education program in India.* *Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*


#### **8.8 Regulatory hurdles**

Across the several layers of regulatory and enforcement procedures, this industry suffers from knowledge asymmetry. Because each state has its own regulations, there is a lot of variation in the quality of drug regulation across the country [41]. India's drug inspectors, who are crucial players in drug regulation, should be highly qualified and adequately compensated to reflect the dignity that comes with such a large duty. The agency has a budget limit when it comes to implementing innovative methods of regulatory monitoring [39].

#### **8.9 Future challenges for the pharmaceutical industry**

There is a great deal of anticipation, price pressure, and caution in the development of vaccines, particularly (Covaxin, Covishield, or Sputnik) for the treatment of COVID-19, which is still in Phase I and II clinical trials in India. There is a potential that poor data will emerge in a Phase III study, as several countries have done in the past, leading to vaccine development and outcome failure [42]. Nowadays, one of the most pressing issues in the management of process controls during the formulation of pharmaceuticals is the formation of impurities in the form of genotoxic and carcinogenic impurities, which are extremely toxic and harmful to patients taking medication for diabetes, gastric ulcers, and psychosis [43]. There is also a compensation challenge in India due to the loss of fixed-dose combination (FDC) drugs, as many of the 344 drugs in this category were banned and withdrawn because they were therapeutically irrational and caused toxicity in patients when used to treat chronic diseases like tuberculosis and HIV. As a result, there are still hopes of bringing FDCs to market for patient benefit with assurances of safety and efficacy [44]. If the financial expenditure is not increased, the quality of research, drug discovery, and development will suffer.

#### **8.10 Online education**

According to Holon IQ global education intelligence, the current \$6 trillion education market will grow to \$10 trillion by 2030. Digital platforms account for only 3% of worldwide education spending, and by 2025, they will account for \$325 billion, or less than 5% of total spending [45, 46]. Although this will go a long way toward solving the country's educational challenges, the government's present worries include guaranteeing smooth delivery of education on the post-Covid road of digital education [47]. The UGC is now working on a game-changing regulation that will allow universities with a high "NAAC" score in the top 100 NIRF rankings to offer online programs. This will be a game-changer since educational jurisdiction will become worldwide, and only equipped universities will survive [48].

#### **8.11 Observations and recommendations**

The following recommendations were implemented for the PPs based on the unique circumstance faced by each country because of COVID-19:


#### **9. Unethical practices in healthcare and pharmaceuticals during COVID 19 in India**

The devastating second wave of the COVID-19 outbreak has brought strangers together offline and online to assist one another in any way they can. Even terrible stories of death and loss have not deterred some people from engaging in unethical and immoral actions including black-marketing medical life-saving medicines, hoarding, and defrauding in the name of COVID-19 medical supplies, and charging exorbitant prices for ambulance service. The Delhi Police recently raided a finedining restaurant in Lodhi Colony and seized 419 oxygen concentrators. These were being sold at an astronomical price of 69,999, complete with bogus MRP labels. About 96 oxygen concentrators were seized from Khan Chacha, owner of a famous food joint in Khan Market. When Delhi-NCR is in the midst of the biggest crisis in its history, notable figures in the city urge tough punishments for anyone who engages in such unlawful and inhumane activities. In connection with a Rs 450 crore medical equipment maintenance scam, Andhra Pradesh's Crime Investigation Department (CID) has filed a complaint against Bengaluru-based TBS India Telematic & Biomedical Services Private Limited, private individuals, and health department employees. The case was filed under the sections of the Indian Penal Code dealing with cheating, criminal conspiracy, and criminal breach of trust. Price increases, inflated bills for nonexisting equipment, and increased invoices for equipment in government hospitals in AP are among the irregularities. Over 300 doses of anti-COVID vaccination were taken from a hospital in Jaipur during a spike in coronavirus illness, forcing authorities to file a criminal complaint. According to agency reports citing a Centre RTI response, Tamil Nadu recorded 12.10% vaccine wastage, followed by Haryana (9.74%), Punjab (8.12%), Manipur (7.80%), and Telangana (7.80%) (7.55%). Vaccine wastage in Tamil Nadu is up to 13% for Covaxin and 9% for Covishield, according to data from the state directorate of public health, which distributes vaccines and regulates its use. Between January 16 and April 17, 7.14 lakh doses of Covaxin and 44.80 lakh doses of Covishield were sent to drug retailers, according to state authorities. A vial must be used within 4 h of being opened and stored at a temperature between 2 and 8°C. The state has used 47.05 lakh dosages by April 17, including 40.5 lakh Covishield. Health staff was under pressure to vaccinate as many individuals as possible. Even though there were not enough individuals, they opened bottles of 20 and 10 dosages. We will now be able to expand immunizations due to an increase in cases and stock. On Friday, as a new day dawned over Delhi, a somber narrative surfaced from Sir Ganga Ram Hospital, one of the capital's most prestigious institutions. In the last 24 h, at least 25 COVID-19 patients had perished there. Physical ventilation occasional6manual compression of a gas-filled reservoir bag to drive the gas into a patient's lungs—has been used on occasion to ensure that patients on ventilator assistance survive. The burning question is how to treat patients when key supplies are not available. As per specialist doctors without oxygen, a patient who requires ventilator assistance can die in minutes. Many other hospitals were in a similar situation. The hospitals then devised a plan to have two patients share a cylinder by using connectors. But also, according to doctors, those on a ventilator can die in minutes if their oxygen supply is cut off. Doctors face a significant hurdle because of this. Despite government pledges and rules, the black market for Remdesivir, a crucial COVID-19 medicine, is thriving in Chennai, with many pharma dealers asking up to Rs 14,000 per 100-mg vial. Even though the Tamil Nadu government has promised to assist them in obtaining the drug, many private hospitals have thrown in the towel, leaving numerous COVID-19 patients in their care without treatment. A private COVID panel hospital has been charged with overbilling by the Kanpur district administration. On Monday, the complainant filed a complaint alleging that he was overcharged by Rs 3.50 lakh in the previous 7 days, and on Tuesday, the district administration issued a notice to the hospital's management after completing a preliminary investigation. The charges were confirmed to be accurate after a preliminary investigation by the extra city magistrate and a government doctor. When the hospital's management failed to respond satisfactorily, district magistrate Alok Tiwari issued an order to register an FIR against it on Tuesday. The administration has appointed static magistrates and sector magistrates to investigate overbilling issues in private panel hospitals, according to the district magistrate. Furthermore, the government has already circulated cell phone numbers for the public to use to report any overbilling complaints. Despite threats of severe consequences for overbilling, private panel hospitals are seizing every opportunity to overcharge patients. Prices of oxygen concentrators, oximeters, and nebulizers have risen by 50–100% in the last 10 days, owing to a massive demandsupply mismatch as the coronavirus epidemic enters its second wave. Even as the organized medical device sector, legal entities, and consumers pressed for enforcing pricing control over these products, e-commerce giant Amazon stated it has begun removing listings of accounts selling these products beyond MRP. Over the last 7 days, the price of oxygen concentrators, which generate oxygen from the air, has nearly doubled, while the price of oximeters has increased by Rs 1000–2000. Prices have risen in both physical businesses and online marketplaces such as Amazon and Flipkart. The government set a price cap on certain products last year, but some vendors, companies, and importers are not following it. A spokesman for Amazon India stated the business is taking urgent action to stop the surge pricing. Hundreds of tweets from customers have gone viral, claiming that they had to pay more than Rs 1 lakh for oxygen concentrators that would normally cost Rs 45,000. The device's monthly rentals have also increased from Rs 5000 to Rs 10,000–20,000. Many sellers and importers have boosted costs of COVID-essential medical supplies by two to four times in just a week, even on online markets like Amazon and Flipkart. The problem is large with imported products by opportunistic dealers who import these products at low costs and then continuously raise prices to profit from the scenario while blaming it on their suppliers.

#### **10. Essential commodities (control of unethical practices in marketing of drugs), 2017**

Since the pharmaceutical industry's exponential rise, there has been a need to regulate the interaction between pharmaceutical firms and medical practitioners. The Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, as revised until February 1, 2016, ("MCI Regulations") were enacted with this in mind. The MCI Regulations, Regulation 6 (Unethical Acts), establishes a code of conduct for medical practitioners in their interactions with the pharmaceutical and allied healthcare industries. The MCI Regulations, on the other hand, apply only to medical practitioners. As a result, on December 12, 2014, the Department of Pharmaceuticals ("DoP") declared the Uniform Code of Pharmaceuticals Marketing Practices ("UCPMP") effective on January 1, 2015, for a 6-month period of voluntary adoption. When the DoP announced UCPMP, it stated that it was a voluntary code for the Indian pharmaceutical industry, but warned that if it is discovered that the pharma associations/companies have not implemented it successfully, the government may consider making it a statutory code. The DoP then extended UCPMP until further orders on August 30, 2016. Despite the fact that the UCPMP was the first of its kind and contained substantial regulations, the DoP

*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

attempted to replace the voluntary code with mandatory recommendations since it was optional. As a result, the DoP transmitted the draught Essential Commodities (Control of Unethical Practices in Drug Marketing) Order, 2017 ("Order") to the Law Ministry in July 2017 for final approval. The Law Ministry, on the other hand, is concerned about the Order, which is now being sought to be issued under the Essential Commodities Act, 1955. It is worth noting that the Order is beyond the scope of the Vital Commodities Act of 1955 ("Act"), whose goals are to control the manufacture, supply, and distribution of essential commodities rather than to oversee medication marketing. In 2015, the UCPMP was expanded to include the medical devices business, which is worth more than Rs 25,000 crore annually. The Order indicates that it will not apply to medical devices because the DoP is in the process of creating and releasing a separate code of marketing practices for the medical device industry (which would be voluntary for 6 months). The Order, like the UCPMP, prohibits pharmaceutical corporations from presenting cash, gifts, or sponsorship to doctors, chemists, or pharmacists, as well as giving travel facilities or paid vacations. Any pharmaceutical firm or its representatives are prohibited from giving presents, cash cards, hampers, or any other item that may produce monetary benefit or allow profits in kind to a medical practitioner, a retail chemist, or pharmacists, or their "family members" under paragraph 3 of the Order. It does, however, allow for the financing of academic conferences organized by medical groups, as well as the organization of screening camps or awareness campaigns in government-owned healthcare institutions, with the caveat that these cannot be used as surrogate advertising. A pharmaceutical business or its agent is also prohibited from providing free samples to any medical practitioner under the terms of the Order. Allowing pharmaceutical companies to distribute free samples up to a full course of medicines for a maximum of three patients has created an exemption to this norm. Three, on the other hand, is a modest amount for any medical professional to comprehend and analyze the effects of a new drug on patients. It is important to note that the term "Agent" is defined very broadly in paragraph 2(b) of the Order, and includes any person, company, society, nongovernmental organization, or other institution who has been hired or authorized by a third party to call on any healthcare facility to promote a pharmaceutical company's drugs. The Order further states that a company's MD or CEO is accountable for ensuring that the Order is followed. All complaints involving violations of the Order shall be investigated by an Ethics Compliance Officer (ECO) designated by the Government of India, who shall not be below the rank of a Joint Secretary to the Government of India, according to paragraph 5 of the Order. It should be noted that a firm or its agent who fails to comply with the terms of subparagraphs (a) (b) (c) or (d) of paragraph 3 of the Order will face a penalty under paragraph 4 of the Order. Furthermore, paragraph 5(4) of the Order lays out the mechanism for imposing a penalty by prohibiting the breaching corporation from marketing its best-selling product for the previous 12 months for a period of three to one year. The Order also states that corporations can pay a penalty ranging from Rs 5 lakh to Rs 10 lakh to have the marketing prohibition lifted. According to the Order, the DoP Secretary will be the appellate authority, and appeals from the Appellate authority's orders will be handled by the court.

#### **11. The way forward**

There is an utmost necessity to relook and re-establish the standards of pharmacy practice in healthcare setups available in each and every corner of the country in line with guidelines provided by the World Health Organization (WHO) and

International Pharmaceutical Federation (FIP). For that, the dependency and responsibilities are very high on healthcare professionals, particularly in this pandemic situation. The pharmacy zone is adaptable, evolving, and increasingly diverse, offering a wide range of work and management opportunities to execute [27]. PPs are human service professionals whose responsibilities include safeguarding individuals by dispensing medications based on prescriptions [28]. Representing the world's third-largest medicinal services with active gathering, and in India, there are over 1,000,000 (1 million) enrolled PPs employed in various capacities and readily contributing to the country's well-being [51]. Pharmacy practice, which includes clinical, community, and hospital pharmacy, is referred to as total healthcare in its true sense. Through adaptation and implementation of GPP in healthcare setup, PPs form an essential link between physicians, nurses, and patients in the social community group, with an ultimate emphasis on patient well-being and protection [30].

There should be country-wise GPP training programs are specifically aimed to gain rapid insights from World Health Organization (WHO) and International Pharmaceutical Federation (FIP) joint guidelines for advancing pharmacy practice worldwide and especially in India. In the view of current COVID-19 crisis, this initiative should be the first of its kind training program being offered in India. This training program mainly focuses on experiential training while promoting the GPP concept among healthcare professionals in India. This course will help the participants to get easy access to the guidelines, provides opportunities for peer discussions, and eventually be influential in improving pharmacy practices.

There should be a very focused approach for the same as follows


Across the globe, pharmacy is one of the most important, dynamic, and versatile segments of the healthcare industry. The pharmacy zone has become adaptable, evolving, increasingly diverse, adhering to the quality standards. However, the importance of ensuring appropriate quality to every patient has taken a center stage in this pandemic, especially in India. In such time, it is important to understand and execute the methodology and principles of quality management and set standards, for continual improvement in one's own working environment, while realizing the emerging roles of pharmacists, national pharmaceutical organizations, and healthcare systems in developing good pharmacy practice (GPP) standards in this pandemic era.

The International Pharmaceutical Federation and World Health Organization define good pharmacy practice (GPP) as practices that meet the personal needs of

#### *Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

patients or those using pharmacy services by offering appropriate evidence-based care. In developed countries, pharmaceutical assistance is defined as a pharmaceutical practice model that involves attitudes, ethical values, behaviors, skills, appointments, and co-responsibility to prevent diseases, promote and recovery health in an integrated manner as part of the healthcare process, highlighting, among other, the requirement that the institution fully adopts the GPP. The program should be designed to take care of the Indian healthcare system and its context of adoption of "new normal" due to the unprecedented event of COVID 19 and the importance of GPP for the healthcare professionals in same.

This kind of training program should be opened to


Today, the forms of care are shifting from secondary care providers to primary care providers to patients (**Figure 2**). This trend has already started in developed countries, such as the behind-the-counter drug option in European countries that was already endorsed by the FDA. The FDA showed positive signs toward boosting the numbers of nonprescription drug statuses to over-the-counter statuses. The healthcare delivery system is coming closer to the patient due to knowledge and understanding, as well as better diagnostic tools and monitoring devices [52] (**Figure 2**).

The use of simulation and related technology in healthcare education will continue to grow in the next years, and this methodology has a collective role within the pharmacy curriculum. It is expected that increasing the quantity of simulation in pharmacy curricula will have a good impact on pharmacy student education and training, resulting in favorable outcomes for patients and the healthcare team. The obvious goal of incorporating simulation techniques into the pharmacy student training curriculum is to increase pharmacist education and training with the ultimate goal of enhancing patient care and safety. Simulation experiences will never be able to replace real-world clinical experiences, but they do have the ability to

**Figure 2.** *The healthcare delivery status of 2007 and 2020. Source: PricewaterhouseCoopers.*

supplement clinical education and serve as a tool for developing the skills necessary for a successful pharmacist. Simulation approaches have been utilized in pharmacy education to address broad cognitive and social skills, particularly communication, decision-making, ethical dilemmas, prioritization, and teamwork, in addition to the development of technical skills such as procedural and clinical abilities. Simulated learning environments could provide a more systematic approach to both clinical skill training and pharmacy programs that aim to provide an opportunity for theoretical knowledge to be applied to a real clinical situation. Basic sciences, dispensing, and drug supply all benefit from simulation's constant, predictable experience. In an ideal world, simulation training would be integrated into all levels of pharmacy education and training.

Types of simulation technology used in healthcare education [53, 54].


#### **11.1 Key components should be included in hospital & community pharmacy practice: automation & technology**




#### **Author details**

Mrinmoy Roy Indian Institute of Health Management and Research, Bangalore, India

\*Address all correspondence to: mroy2612@gmail.com

© 2021 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

*Good Pharmacy Practice in India: Its Past, Present and Future with Need and Status… DOI: http://dx.doi.org/10.5772/intechopen.100635*

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### *Edited by Peter A. Clark*

This book examines the challenges in bioethics from medical, ethical, legal, and industrial perspectives. A critical exchange of ideas from professionals in interdisciplinary fields allows all people to learn and benefit from their far-reaching insights gained through personal and professional experiences in the fields of medicine and research. Examining these complex issues, ranging from brain-computer interfaces to disabilities in health care to the determination of death to safe injection sites, presents viable paradigms for all healthcare professionals who are being confronted with these issues today and in the future. The more we face these challenges directly, examine them critically, analyze them thoroughly, and debate them enthusiastically the more knowledge will be gained and hopefully more lives will be saved.

Published in London, UK © 2022 IntechOpen © Lan Zhang / iStock

Bioethical Issues in Healthcare

Bioethical Issues in Healthcare

*Edited by Peter A. Clark*