INTRODUCTION:

Drugs (medicine) price coverage polices that has incentivize recommended drugs for switching to affected people from the product manufacture; this aspects biosimilar studies may be a saving the patient health care. The biosimilar medicine products mainly used in the chronic diseases such as cancer, autoimmune diseases, diabetes may be provide the opportunity in business segments, pharmaceutical segments and significantly increases the public utilization of the drugs as well as the huge demand in the biotechnology sectors so on.

In the year of January, 2020 the World Health Organization (WHO) has declared the Health global emergency by the spreading of COVID-19. As well, announced that 11^th March, 2020 COVID-19 virus outbreak and the spreading virus were detected in every country. All the countries has given the severe rules and quarantine information to the infected patients. In this present scenario, Indian pharmaceutical companies have effort with market dynamics of the biosimilar drugs. The COVID-19 pandemic virus destruction, control and the outbreak as a big challenges for the people in the global world¹.

Beforehand having insight about India Pharmaceutical Market dynamics; it is imperative to know about COVID-19 pandemic outbreak devastation and challenging times faced by entire humankind.

COVID-19 Information key points were given and tabulation for treatment:

· As a record COVID-19 infection caused by the SARS-CoV-2 virus and mainly affected the modulate respiratory system and recovered without any special treatment.

· COVID-19 seriously ill the geriatric peoples, who have the cardio vascular diseases, Diabetes mellitus, respiratory disorder likes an asthma patients affected serious illness.

· The virus development to be spread mainly in the infected person nose and the mouth during the cough, sneeze, breathe and speak near the people in a short distances.

· COVID-19 transferred from the respiratory tract of the larger particles in to the smaller particles via aerosols conditions.

· The main infection spread from China to Europe and affected Italy more in the early March 2020 and had moved to the US (United State) COVID -19 infection accelerating the record.

· By the April 2021, the infection was peak in all over world particularly India, Brazil, Africa and Asia continents the infections number and death significantly increased in the record².

· In September 2021, COVID -19 developed the more delta virulent strain included the prompted countries leaders call for the more health care as well as the checkup followed that more travel restrictions were introduced.

· In early November 2021, in another virulent omicron COVID identify in 38 countries and the detected strains have 30 mutations with their spike protein³ as well as the more spreadable than COVID-19.

· In 3^rd December 2021 WHO reported 263 million patients were confirmed and death reached 5 million in all over the World.

· In the pandemic situation world economy caused by COVID-19 in around 90 trillion US dollar⁴.

In this pandemic conditions, Govt. instruction and regulatory procedures were valuable in saving the human precious life. Whereas the reputed pharmaceutical companies drugs were repurpose with their commercial aspects and the clinical evidences; the drugs approved by the Govt. The Govt. recommended drugs Remdesivir followed that Itolizumab and Tocilizumab doses and time frame were designed for infected COVID-19 patient by the COVID-19 Regulatory authorities for emergencies. However, the COVID-19 infection as well as the spreading frequently recorded simultaneously safety and examinations of the treatment still under research aspects with the National and International research laboratories.

Some variants of the coronavirus, such as Delta and Omicron, are spreading more easily between people. Alpha (B.1.1.7 and Q lineages):

· Beta (B.1.351 and descendent lineages)

· Gamma (P.1 and descendent lineages)

· Delta (B.1.617.2 and AY lineages)

· Epsilon (B.1.427 and B.1.429 lineages)

· Eta (B.1.525 lineages)

· Iota (B.1.526 lineages)

· Kappa (B.1.617.1 lineages)

· Mu (B.1.621, B.1.621.1 lineages)

· Zeta (P.2 lineages)

· Omicron (B.1.1.529, BA.1, BA.1.1, BA.2, BA.3, BA.4 and BA.5 lineages).

In addition, we know we can protect from the virus and its new variants by: i) Getting vaccinated when it’s your turn; ii) Keeping a safe distance; iii) Opening windows when possible; iv) Wearing a mask; v) Covering coughs and sneezes; vi) Keeping hands clean.

COVID-19 pharmaceutical products manufacturing, product licensed and the drug products were commercialize to solve the unexpected demands⁵. In addition, major reputed companies were emphasis with clinical evidence of the respective drugs and the immune mechanism done in SARS-CoV-2 infection patents. The immunomodulatory drugs chloroquine and hydroxychloroquine, which are more potent and less toxic, have been used to treat malaria for many years. Since it has been shown that chloroquine and hydroxychloroquine have in vitro activity against SARS-CoV and SARS-CoV-2, it has been hypothesized that they may be employed as effective therapies for COVID-19. In the early stages of the disease, individuals who received IFN-β-1b in combination with lopinavir/ritonavir or atazanavir/ritonavir with hydroxychloroquine showed a greater improvement. Few of drugs were available in standard care procedure of COVID-19 that contains inhibitors of interleukin-1 and interleukin-6 and respective inhibitor act as immunomodulation potential in previous research studies⁶. Present study, we have emphasize the COVID-19 biosimilar drug products in India, reproduced drugs, Govt. approval, time frame the drugs, clinical proof, treatment procedure were optimized with the respective clinical approval.

MATERIALS AND METHODS:

The COVID-19 pharmaceutical product and regulatory accesses were selected based on the debates in India. COVID-19 biosimilar drugs were searched with the standard data bases of Google, Pubmed, Scopus, Ingenta and Agricola etc., information consider primary sources of the experiments. As well, we have collected secondary sources of the biosimilar products through the technical reports, short communication, Editorial note, mini-review, original articles from National and International reputed journals. In addition, COVID-19 recommended drugs and repurposed drugs were listed by Govt. of India, update literature proof of WHO (Geneva, Switzerland), FDA (Food and Drug Administration, United States), CDSCO (Central Drugs Standard Control Organization, India) and RCGM (Review Committee on Genetic Manipulation, India) etc. The biosimilar drugs of COVID-19 in focus on cost aspects, economic burden to purchase the respective drugs, demand of the drugs, manufacture time frame of the drug, clinical trial, sources of the drugs and the storage repurposed based on the details the biosimilar experiments were conducted in this study.

RESULTS AND DISCUSSION:

The complete results were done at early February, 2020; the COVID-19 infections cases starts in India. Govt. of India has monitoring the outbreak and simultaneous taken the action in various states of India at late February 2020. As well as, the government took unprecedented steps to control the COVID-19 in end of March 2020 such as lock down instruction, stop the social activities. Travel passenger need to get Govt. pass between the district and implements the social distances between the people. The lockdown issues were develops the inadvertently creating the global economic downturn in Government and public sector company. Govt. of India has taken surprise action the broad view of the economic and regulatory policies were adopted and retained the economic issues. At the same time, the various countries were seriously involved, often without a formal as well as the coordinated plan were described.

As the stage of Initial steps, government have adopted the monetary followed that subsidized policies were established with the stabilizing financial values and significantly ensuring the credit to flow. In the second step, governments adopted the policy type of actions on economic calculated and determine the growth through infected people quarantines as well as social distance helpful to determine COVID-19 infections. In addition, follows the quarantines regulatory issues and the sustainable economic issues were optimized in the regulatory pathways for the treatment of COVID 19 suitable drugs, oximeter devices, oxygen cylinder etc. Whereas the third step, governments significantly allotted policies to prevent COVID-19 infection, vaccine purchasing and distribute based on the state requirements. As well as the health issues and economic aspects were evolved and persevered, the phases determine by government and have less distinct. However, vaccine population efforts that have a coincided with additional economic status to sustainable to the family income, for the COVID-19 situation.

Biosimilar pharmaceutical products were reached the respective patient on the time has a big challenges to the pharma industries. In addition, the pharmaceutical product demand was significantly increased throughout countries at the same time; it makes a rapid product development and the biosimilar opportunities in another avenue to assure continuous and the consistent with respectable delivery to the patients with an unprecedented increasing demand in short time.

Drugs were comparison based on the small molecule classified drugs, biological treatment drugs significantly have the complex more and the product manufacturing process were need a lots of time and lengthy. However, selected biosimilar products were significantly characterized with support of the original drug molecules similarity meet the update regulatory feedback. In addition, biosimilar drug production fast increasing demand in a short month of time and not only fulfil the requirement of the patients and make the lot of profits the COVID -19 drug maker respectively⁷. The Govt. emphasize and facilitated with approval of the biosimilar drugs with various countries guidelines. Many of the countries were evaluated and implemented rules and guidelines have given the legal structure frame that to allow the described approval pathway helps to the public with significant permission to safe and clinically proved biological products used in COVID-19 treatment.

The board members of CDSCO was listed key initiatives under Ministry of Health and Family Welfare, Govt of India. In addition, to ensure the safety as well as the efficacy of the other treatment drugs were used in COVID-19 patients in an outstanding approach: rules and regulatory studies of R&D drugs, followed that vaccines, as well as regulatory clinical trials, and the In-Vitro Diagnostics (IVD) kits were used in COVID-19 diagnosis respectively: In addition, the CDSCO (Govt. of India) was issued two notices and video no. (X-11026/07/2020-PRO) in March 19, 2020^{8, 9}, as well as the discuss about treatment drugs/vaccines and diagnostic kits for COVID-19 and the list of vaccine approved by World Health Organization, sources of preparation, the vaccine are import or own country development, dosage recommended, time of the dose interval, Govt. approved status, vaccine age permitted, vaccine administration and vaccine recommend storage represent in Table 1.

Table 1. List of Vaccine Approved by World Health Organization

Pharmaceutical

Company

Vaccine

Source of

Vaccine

Export /import/

Date

Dose allowed

Dosing Time

Govt.

Approved

Dose

permit Age

Administration

route

Storage

recommendation

M/S Serum Institute

of India Pvt

ChAdOx1 nCoV-19

Recombinant

AdenoVector (Chimpanzee)

Export/

03.01.2021

Two

4-6 weeks

Yes

Above

18 Years

Intra muscular

injection

2-8ºC

M/S Dr. Reddy’s

Lab, India

SPURNIK-V

Component ( I & II)

Recombinant Adenovirus

vector based SARS-CoV2

liquid vaccine

Import/

12.04.2021

Two

I week

(Comp–I)

III week

(Comp–II)

Yes

Above

18 Years

Intra muscular

injection

-18ºC

M/S Bharath

Biotech, India

SARS- CoV-2 Vaccine

Whole-Virion Inactivate

SARS– CoV-2

Export/

03.01.2021

Two

I week

(Starting)

IV week

(Starting)

Yes

Above

18 Years

Intra muscular

injection

2-8ºC

M/S Cipla

Ltd. India

mRNA-1273

COVID-19 Vaccine

mRNA-1273

Moderna

Importer

Two

I week

(Comp–I)

IV week

(Comp–II)

Yes

Above

18 Years

Intra muscular

injection

25ºC to -15 ºC

M/s Panacea Biotech

Ltd, India

Recombinant Adenovirus

vector based SAR-CoV-2

liquid vaccine

Gam COVID Vac

Recombinant

Adenovirus vector

Component (I and II)

(SPUTNIK-V)

Importer

02.07.2021

Two

Day 0 (Comp 1) and

Day 21 (Comp II)

Yes

Above

18 Years

Intra muscular

injection

-18 ºC

M/s Johnson and

Johnson Pvt. Ltd, India

COVID-19 vaccine

(Ad26.COV2-S)

Recombinant) –

Janssen Vaccine

Importer

07.08.2021

Single dose

As per your

convenient

Yes

Above

18 Years

Intramuscular

-25ºC to -15 ºC and

consider in 2-8ºC

Biological E

Limited

COVID-19 Vaccine

(Ad26.COV2-S)

Recombinant) –

Janssen Vaccine

Importer

18.08.2021

Single dose

Anytime

Yes

Above

18 Years

Intramuscular

-25ºC to -15 ºC and

consider in 2-8ºC

Cadila Health Care

Limited

Multi-pharmaceutical

Company

Novel Corona

Virus - 2019

nCov vaccine

(recombinant DNA)

Importer

20.08.2021

Three doses each dose (2 mg))

First dose I week

Second dose

4th Week

Third dose

8th Week

Yes

12 Years

Intradermal

Storage

2-8 ºC

· The Govt. guidance and circular with requirements needs to enhance the R and D (Research and Development) with support of in vitro diagnostic kits, recommended drugs, and vaccines were used in COVID-19 diagnosis and prevention respectively.

· The ICMR (Indian Council of Medical Research, New Delhi, India) has provided the funding for the research experiments. In addition, Virology lab were developed in the major cities and researcher, research chemical reach the lab on time with support of Govt.

· Govt. of India make a circulars in order to enhance the research activities; the identification of COVID-19 infection done in RT-PCR through in vitro diagnostic kits methods.

· COVID diagnosis done by the drugs by various drugs/vaccine (Pharma companies manufacture, India) and some the drugs and the vaccines were imported from the R and D leading counties.

· The prevention (or) treatment of the respective COVID patients were quarantine separately with the proper direction of the Government. As well CDSCO has provided the guidance and monitoring the regulatory pathway will process any such application on high priority and CDSCO will also provide guidance for regulatory pathway on this matters.

· In emergency aspects, any of the research industries, foreign companies and pharmaceutical drug industries have the submitted application and discussion about the manufacture or imported the drug products and in vitro diagnostic kits for the COVID-19 patients. The submitted application was immediately examine by Govt. authorities and evaluation and performance may be proceeded within 7 days based on the priority and requirements.

· The Pharma industries drugs, vaccines and clinical trial application was in under the express plan with the proper review and accelerate approval for sales in India. In case of emergency, Govt has allotted the FORM 10 (import license of drugs/vaccine/kits) as well as reported FORM 41 for the without registration (emergency purpose) approval by the Govt. of India.

· Under the guidance of USFDA, UK MHRA (Europe), PMDA Japan countries were listed the approval drugs for the emergency time with permission of WHO. The approval drugs were used in bridging trials at 15^th April, 2021 on 100 patients and experiment period (7 days) in the COVID-19 vaccine in India. In addition, the further relaxation on the bridge trials on the imported vaccine at 1^st June, 2021. Received results were certified by National control laboratory, Govt. of India^{10, 11}.

Biosimilar studies and suitable drugs selection for the patients to be useful to prevent the high cost drugs purchase as well as to providers an alternative treatment of the original biologics. The record and the publications declared that the biosimilar competition will be increased three time more in 2023. It has helpful to prevent the medical expenses as well as recommend to purchase similar drugs with the same mechanism of action in the cheap cost; it has helpful reduce the burden to the patient and family in around $160 billion on the next five years¹².

The biosimilar drugs were useful in the various type of cancer studies, autoimmune diseases and other chronic diseases and has supported for to provide the business chances to the pharmaceutical industries, increasing the potential as well as the efficiency of public health, need to be concentrates on cheap drugs production and helpful production of the drugs in the large scale aspects in a short time with less price¹².

The infection of COVID-19 and blocking by the respective antibodies such as IL-1 (Serum interleukin 1) and IL-6 ((Serum interleukin 6) )receptor and blocking antibodies; these antibodies were commercialized with the other indications, such as autoimmune studies including rheumatoid arthritis (RA); it has an alternate treatment for the COVID -19 treatment with respective clinical trials with the recently infected patients. The few studies emphasis on the IL-6 targeted to the respective drugs that approved by the Govt. of US and has delivered to the Indian markets. Tocilizumab drug used in the earliest study of COVID-19 that have approval received by the FDA as well as the clinical trial Phase III started on March 26, 2020. As well as all over the World the demand has increases for tocilizumab reported by the Company Roche license holder. The company has reported that the “product working urgently as well as the accelerate production of the drugs at the maximum level and the possibilities product supply increasing globally”.

The demand of the specific drugs at the time of fast-growing COVID-19 and has shown the demand for these drugs undergone the multiple clinical trials. This drug has recommended for the emergency purposes in worldwide at severely ill of COVID-19 patients. The concerns drug effectiveness on the shortages time of patents and uses in anti-COVID-19 drugs recommended by EUA (Emergency Use Authorization) and given the suggestion to large scale manufacturing production. In this situation many controversial and demand was in around the world. Peoples and scientists looking forwarded the biosimilar drugs with aforementioned form drugs as well as the roughly equivalent properties to the generic applicable version of biologics. We have optimized that the biosimilar drugs increasing the human needs at the time of emergency as well as to reduce the cost of drugs and frequently supplies by pharmaceutical companies^13,
14. In this connection, we are discussing many biosimilar drugs and its application during the COVID-19 spreading time.

· Tocilizumab drug - Actemra (24^th June, 2021 by USFDA; CDSCO, India)

The positive COVID-19 patients were hospitalized including adults as well as the child patient. The properly given the systemic corticosteroids (drugs), oxygen ventilation, invasive (or) non-invasive ventilation in the mechanical aspects or EMCO (Extracorporeal Membrane Oxygenation) respectively with continuous monitoring the admitted patients.

· Sotrovimab drug (26^th May, 2021 by USFDA)

The drugs recommended for the initial stage and the moderate stage Covid-19 patients (used in less than 40 Kg). In addition, this drug recommended for the SAR-CoV-2 viral infection and used in high risk progression stage of COVID-19 as well as the hospitalization stage and death state.

· Propofol‐Lipuro 1% drug (12^th March, 2021 by USFDA)

The admitted patients were restfulness via continuous infusion of the patients have a greater age 16 COVID-19 infection suspected patents or the confirmed patients after RT-PCR studies. The respective patients were fully monitoring by the hospital under ICU (Intensive Care Unit) with proper mechanical ventilation for the admitted patients.

· Bamlanivimab and Etesevimab drugs (09^th February, 2021 by USFDA; 26^th May, 2021, CDSCO, India)

Limitations and authorization drugs of Bamlanivimab and etesevimab drugs (monoclonal antibodies) are not authorize the COVID-19 mild and moderate treatment of the infection and has suspects from the SAR-CoV-2 virus (12 years old and older age less than 40 Kg). The above describe drugs not authorize the COVID-19 patients, age, oxygen therapy, respiratory issues support due to COVID-19 and oxygen therapy. The monoclonal antibodies of Bamlanivimab and etesevimab drugs associate with less clinical outcomes and hospitalized patients with require flow oxygen as well as the mechanical ventilation.

· Casirivimab and Imdevimab drugs (21^st November, 2020 by USFDA; 05^th March, 2021, CDSCO, India)

REGEN-COV® (Casirivimab and imdevimab) drugs used in adults and 12 years old under the weight 40 kg. The treatment of the mild as well as the moderate symptoms of the COVID-19. In laboratory confirmed patients with SARS-COV2 infection and severe COVID-19 and those patients does not require oxygen significantly.

· Convalescent Plasma from COVID -19 (23^th August, 2020 by USFDA; Approved by CDSCO, India)

FDA has showed the new guidelines that to health care providers and investigations on COVID-19 convalescent plasma material. The Plasma under the examination in India in the period of health emergency. The treatments were conducted in the hospitalized patient with COVID-19 infection.

· REGIOCIT (Renal replacement solution) 13^th August, 2020 by USFDA

It is solution and authorized replacement that contains citrate solution for the regional citrate of the anticoagulation (RCA) in the extracorporeal circuit. It has used for the critical care setting. It has mainly used in CRRT patients (Continuous Renal Replacement Therapy (CRRT).

· Fresenius Kabi Propoven 2% (5^th August, 2020 by USFDA)

The drugs was a used in the sedation conditions through COVID-19 continuous infection patients above the age of 16 and older. The patient need to be proper ICU setting as well as the mechanical ventilation respectively².

· Itolizumab Injection (21^st September, 2020, CDSCO, India)

The injection resources was a rDNA (100 mg /vial lyophilized pow material) and COVID-19 infection patents treatment with an moderate conditions. The drug was used in the chronic psoriasis condition with systematic therapy conditions. For the country emergency COVID-19 conditions, in the treatment CRD (Cytokine Release Syndrome in initial and moderate condition the Acute Respiratory Distress Syndrome (ARDS) patients recommended in the emergency aspects.

· Pegylated Interferon-Alpha 2b (23^rd April, 2021, CDSCO, India)

It is a recombinant interferon alpha with covalent conjugations and PEG (polyethylene glycol) recommended to the anti-neoplastic and anti-viral agents. The drug used in the restricted emergency conditions for the patient infection by COVID-19 as well as the recommended for the country emergency conditions.

· 2-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose drugs (1^st May 2021, CDSCO, India)

The drugs can be used as adjunct therapy with a moderate as well as the severe infection of COVID-19 patients. The 2-Deoxy-D-Glucose bulk (2.34g) and 2-Deoxy-D-Glucose (5.85 g sachet) contains glucose molecules that inhibits the glycolysis process via to involve the moderate action by hexokinase through glycolysis process.

· Remdesivir drug (1^st May, 2020 by USFDA; 1st June, 2021, CDSCO, India)

The specialized drugs were used in all over the world particularly during the COVID-19 emergency periods¹⁵. It is provided by the licensed health care, who are the patients suspected as well as the confirmed by COVID-19 patients have taken up to recovered in different dose and the time period respectively. The patients admitted in 3.5 Kg (Pediatric patients) and 40 Kg adults were used the drugs.

· Baricitinib drug (Olumiant) (19^th Nov, 2020 by USFDA; 5^th March, 2021; CDSCO, India)

The drug baricitinib range of 2 mg and 4 mg properly combination with the remdesivir drugs helps to prevent COVID-19 patients¹⁶. Initially, Corona Virus infected patients admitted in the hospital and recovered in different doses of the above combination drugs. However, the patients were supplemental treatment with oxygen as well as the patients needs the invasive mechanical or EMCO (Extracorporeal Membrane Oxygenation) respectively.

· Favipiravir bulk and 200 mg tablet (Favipiravir film coated) 19^th June, 2020 ; CDSCO, India

The tablets and drugs were recommended for the COVID-19 mild to moderate stage patients; it is also consider the initial stage of COVID-19 emergency period in maximum countries to outbreak the COVID-19¹⁷.

At the same time to outbreak COVID-19, eight vaccines were approved by the World Health Organization and applied in the emergency period in the all over the world ¹⁸. Table 1 represents that the various vaccine approved by the World Health Organization (WHO) and sources were described.

CONCLUSION:

· The biosimilar drugs were significant achievement in the outbreak COVID-19 conditions. In this period, people has understand the scientist roles and their potential innovation importance. It has save many of the hospital admitted patient life.

· The Government policy to screen the recommended biosimilar drugs and determine the drug properties as well as the other clinical indication and remarks of the suffering patients with fierce new complication unfolded every new day.

· In addition, Govt. determined and taken the action on fiscal measurement including the economic growth and issues during quarantines and the social distance measurement.

· In this short communication, we have discussed various vaccines, recommended drugs injection timelines, repurposed drugs and the needs to people during the emergency period of the short span of time.

· At the same time, many of the pharmaceutical companies were concentrated on the biosimilar drug products with cheap, economic aspects and delivered to COVID-19 affected patients on time with support of Government.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

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Received on 13.04.2022 Modified on 17.09.2022

Research J. Pharm. and Tech 2023; 16(9):4042-4048.

DOI: 10.52711/0974-360X.2023.00663