Int J App Pharm, Vol 13, Issue 1, 2021, 32-35Review Article

PHARMACY PROFESSIONS IN INDIA DURING COVID-19 PANDEMIC: PRESENT STATUS, FUTURE CHALLENGES AND A WAY FORWARD

VIGNESH M.1, GANESH G. N. K.2*

1Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSSAHER, Ooty, 643001, 2Department of Pharmaceutics, JSS College of Pharmacy, JSSAHER, Ooty, 643001
Email: gnk@jssuni.edu.in

Received: 10 Sep 2020, Revised and Accepted: 22 Oct 2020

ABSTRACT

People in every country became exposed to COVID-19 pandemic and cannot able to find a right solution and strategies to overcome from it. Pharmacy is the most important, dynamic and versatile health care profession in the world, whereas its scope and importance are always being emerging at any situation. Pharmacy professionals (PPs) working proactively for the public even in this pandemic situation. Since dependency is high, the responsibility and preference also high for PPs especially in this pandemic situation. Current status in pharmacy education and emerging future challenges of PPs in all aspects, particularly in this pandemic situation were addressed based on observational studies among various pharma industries and published news of Pharmacy Council of India (PCI). While in the development phase it has crossed many barriers, not only in the economic level, but also involves regulations, duration, process controls, legal hurdles and situational defects. The purpose of this review discusses the evolution and updates in pharmacy, education, pharmacy practice, regulations, and types of challenges along with recommendations for PPs in India in light of the COVID-19 pandemic.

This review was carried out to summarize knowledge about the updates and challenges in pharmacy professions in all aspects. Sources were retrieved from relevant guidelines and published articles in Google scholar, Pubmed and Science direct of articles up to June 2020. The keywords used for gathering information were listed below.

Keywords: Pharmacy, Current status, Regulations, COVID-19, Future challenges, Recommendations

© 2021 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
DOI: http://dx.doi.org/10.22159/ijap.2021v13i1.39688. Journal homepage: https://innovareacademics.in/journals/index.php/ijap
Speedy peer review was done as the subject of the manuscript was related with pandemic.

INTRODUCTION

People in every country became exposed to COVID-19 pandemic and not able to find a right solution and strategies to overcome from it. Pharmacy is the most important, dynamic and versatile health care profession in the world, whereas its scope and importance are always being emerging at any situation [1]. Pharmacy professionals (PPs) working proactively for the public even in this pandemic situation. Since dependency is high, the responsibility and preference also high for PPs especially in this pandemic situation. The pharmacy zone is an adaptable, developing and progressively different one, which has a huge number of chances for work and administration aspects [2]. PPs are human service experts whose proficient obligations incorporate to protect the individuals by dispensing medicines with prescriptions [3]. It represents the third biggest medicinal services with active gathering in the world and in India there are more than 1,000,000 (1 Million) enrolled PPs working in different positions contributing to the wellness of the country. Pharmacy is being a significant profession, since the Indian government passed the Pharmacy Act 1948 to control the pharmacy stores by following instructions to control the manufacturing, distribution and marketing [4]. Health care in the genuine sense called as pharmacy practice which incorporates; clinical, community and hospital pharmacy. PPs shape an imperative connection between doctors, nurses and the patients in the social community group with an ultimate focus on patient welfare and safety [5]. Pharmacists cannot be only the distributors, but also they need to offer some contributions to the society, including administrations such has patient counselling, guiding and arrangement of medication data to human services, suppliers as well as patients [6]. The pharma industry performed well after the amendment of new monetary changes in India in the mid-1990s till the early 2000s, for example, before the product patent was introduced in India [7]. In educational aspects level of student’s outcome in pharmacy also have been increased from the year of 2012 to 2020 and still expected to rise due to its scope. Many of the pharmacy graduates showing potential interest in the research side for drug innovation and development [8]. It has been viewed that pharmacy as a significant job in improving social insurance as they work day and night to keep up a chain of elegant integrity on pharmaceuticals especially during a COVID-19 pandemic. PPs has many roles and responsibilities right from the perspective of regulatory authorities in performing implementation of updated guidelines based on the situation defects [9].

Pharmacy practice

It includes implementation, evaluation and interpretation of pharmacy orders and prescription dispensing. Pharmacists are responsible for providing patient counselling, provisions for acts and social services required to promote pharmaceutical care in all areas of patient health as a primary care [10]. They are also responsible for the segregation, labelling of drugs and medical devices, by ensuring safety on proper storage of drugs and devices along with maintenance of proper records [11].

According to Supreme Court judgment of 5thMarch 2020

Pharmacy professions in India

First pharmaceutical company in India

Bengal chemical and pharmaceuticals Ltd., was set up as an initiative by the individual, started a laboratory in 1892 by the ‘Father of Indian chemistry’ Acharya Prafulla Chandra Ray and regarded the country’s first pharma company. Bengal chemicals and pharmaceuticals Ltd. has reached profits for a year 2016-17 for the first time after more than six decades [13].

Drug regulation

India has the world's toughest legislation and laws for manufacture, distribution and sale of medicines. The law enforcement’s ability does not translate by strong legislation alone; it also involves strict regulations and accepting effective challenges. There should be one drug inspector for every 50 manufacturing units and one per 200 distribution retailers, according to the regulation set out by the Mashelkar committee [14, 15]. In most of the state’s 30-50% of the posts remain vacant and the number of posts that exists also is highly inadequate for expanding the pharmacy sector. As per the Mashelkar committee report, 1 drug inspector for 200 retailers was taken into consideration and among the data of All India Organization of Chemists and Druggists (AIOCD), around 8.5 lakh pharmacies is to be taken cognizance, so more than 4250 drug inspectors needed to manage the retail pharmacy segment [16].

Division of responsibilities between CDSCO and SDRA

Pre-manufacturing

Central Drugs Standard Control Organization (CDSCO) regulates pre-manufacturing with the help of expert committees. Their key role in dealing with the two major criteria is:

Manufacturing

State Drug Regulatory Authority (SDRA) is responsible for regulating the manufacture of drug products in the states, whereas CDSCO is responsible for union territories. CDSCO and SDRAs also conduct joint inspections in certain cases [18]. The following terms are necessary for the manufacturing of drug products.

Distribution and sale

SDRA’s are responsible for regulating the distribution and sale of drug products in the states, while CDSCO is responsible for union territories. The following terms are necessary for the distribution and sale of drug products.

Current status

The current status in pharmacy education, authority functions and future challenges of PPs in all aspects, particularly in this COVID-19 pandemic were addressed. While in the development phase, it has to cross many barriers, not only in the economic level but also involves regulations, duration, process controls, legal hurdles and situational defects [21]. The educational updates were presented in table 1.

Table 1: Statistics of pharmacy education program in India

Pharmacy program Number of institutions Annual intake
D Pharm 3022 180,770
B Pharm 1961 125,524
Pharm D 267 8010
M Pharm 792 24,465
Ph. D. in Pharmacy 31 1240

COVID-19 and the impact

The impact of the SARS-CoV2 outbreak, COVID-19 has exposed the dependence of the Indian pharma sector on china for its Active Pharmaceutical Ingredient API obtainment, since India as well as other countries had decided to stop business contract with china. Gracefully, chain circulation and exportation limitations from India came out because of manpower deficiencies in china's manufacturing plants [22]. This was brought by the isolated arrangements adjusted and embraced by various common governments in china in response to the infection. Supplies were additionally affected by the interruption of coordination, transportation frameworks, confining access and exchange of items to and from ports [23]. More over the customers who are coming for pharmacy stores may be positive for COVID-19 but remain as asymptomatic, so this will impact the pharmacist to get spread, whereas in hospital pharmacy if this same incident happens, then there is an easy chance of getting more spread among the patients who came to hospital since they may be weaker in health and being low immune [24, 25].

Indian government strategies for API stimulation-atmanirbar bharat

The government has announced about promotion of common infrastructure facilities in three ‘Bulk Drug Parks’ (BDP) with the financial investment of INR 3,000 crore in the next five years. The government will provide grant-in-aid scheme to the states with a maximum limit of INR 1,000 crore per BDP, which having general facilities such as solvent recovery plant, distillation plant, common effluent treatment plant, power and steam units [26]. It will create a Production Linked Incentive (PLI) scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSM), intermediates of drug and Active Pharmaceutical Ingredients (APIs) in the country with the financial implications of INR 6,940 crore for the next eight years [27].

Fig. 1: Incentive details of the proposed scheme [29]

Initiative by the government

PLI Scheme is open for four months from June 2, 2020 will allow investors to propose the establishment of Greenfield facilities for any of the 53 key drug intermediates and bulk drugs that are hardly manufactured in India today [28]. The list includes key ingredients that go into the manufacturing of commonly prescribed medicines like paracetamol, aspirin, metformin, atorvastatin, etc. The total proposed incentive package contains Rs. 13,760 crore, that is segregated for bulk drugs and medical devices were classified below in fig. 1.

Challenges associated with PPs

COVID-19 challenges

Regulatory challenges

This segment suffers from the problem of information asymmetry across the different layers of regulatory and enforcement mechanisms. There is a large variance in the quality of drug regulation across states in the country, since each state having their own regulations [30]. Drug inspectors of India who are the key players in drug regulations should be made highly qualified and be well paid to bring about the dignity associated with the huge responsibility. There is a budget constraint with the department for implementation of advanced methods of monitoring the regulations [31].

Pharma industry-future challenges

There is a huge expectation, price pressure and carefulness in monitoring of vaccine development, especially (Covaxin) for treatment of COVID-19, which is still under the Phase I and II clinical trial in India. There may be a chance of unsatisfactory results occur in Phase III trial, whereas many countries faced the issue on Phase III trial, which resulted failure in vaccine development and outcome [32]. Nowadays there are emerging challenges in the management of process controls during a formulation of pharmaceuticals is the formation of impurities, which are in the form of genotoxic and carcinogenic that are highly toxic and harmful for the patients who were taking medication for the management of diabetes, gastric ulcer and psychosis [33]. There is also a compensation challenge for the loss of Fixed Dose Combination (FDC) drugs in India, since many of the drugs around 344 under this category were banned and withdrawn due to they are therapeutically irrational and produced toxicity to the patients for treatment of chronic diseases like tuberculosis and HIV. So there are still expectations of producing FDCs, into the market for patient beneficence with assurance in the safety and efficacy [34]. The quality of research, drug discovery and development is suboptimal if the money investment is not strengthened.

Digital education

Holon IQ global education intelligence, a provider estimates that the present education sector size of $6 trillion will reach $10 trillion by 2030. Only 3% of the global education spends is digital platform and by 2025 the digital spend will be $325 billion, which is less than 5% of the global education spend [35, 36]. The present challenges faced by the government are the seamless delivery of education in the post-covidian direction of digital education, but this will be a far cure for the education disorders in the country [37]. The UGC is in the process of developing a game-changing policy where the universities that have a high ‘NAAC’ score among the top 100 NIRF rankings will be permitted to offer online programs. This will be a game-changer as the jurisdiction of education will become global and only those universities which are equipped will survive [38].

Recommendations

Based on the unique situation faced by the every country due to COVID-19, the recommendations were executed below for the PPs:

CONCLUSION

The Indian pharmaceutical industry has experienced a wide strategy changes that is expected to affect the execution of national as well as regional level. Although the greater part of the states recovered from the serious issues and gave indications of nearly better execution from the year 2007 to 2011, but there is still an emerging challenges and lack of developments to reach the benchmark when compared to other developed countries. From the overall study, key elements are money investment, educational trainings, awareness programs and recommendations, which is highly required for PPs to expand their roles in bringing up navigation for greater development in quality of pharmaceuticals to defend any challenges, health issues and deadly disease like COVID-19, so ultimately the recognition will reach globally for PPs in India. The money investment from the government or funding agency should come forward and contribute to the researchers in bringing up the development for better quality pharmaceuticals to defend any health issues and deadly diseases like COVID-19 that affect from personally to globally.

FUNDING

Nil

AUTHORS CONTRIBUTIONS

All authors contributed equally.

CONFLICTS OF INTERESTS

None

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