A COMPREHENSIVE STUDY OF INDIA'S REGULATORY FRAMES FOR ADOPTION OF REPURPOSED DRUG AS COVID-19 TREATMENT

PDF

Published: 2021-12-13

Page: 11-29


K. S. DEEKSHA *

Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru – 570015, Karnataka, India.

C. S. LAKSHMEESHA

Department of Pharmaceutical Regulatory Affairs, Acharya and B M Reddy College of Pharmacy, Bengaluru-560107, Karnataka, India.

V. BALAMURALIDHARA

Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru – 570015, Karnataka, India.

VISHAKHARAJU MOTUPALLI

Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru – 570015, Karnataka, India.

*Author to whom correspondence should be addressed.


Abstract

Drug repurposing reflects an innovative approach to drug development to explore potential  therapeutic advantages in clinical trials. The strategy is employed to overcome the bottlenecks in terms of financial assistance, time and money during conventional drug development. Several data driven and creative methods for identifying repurposable drug candidates have been suggested. However significant challenges related to technology and regulatory requirements have to be overcome. The regulatory guidelines and procedures are of paramount importance for pharmaceutical companies to obtain manufacturing licence from the drug regulator. CDSCO, the Indian drug regulator as clear guidelines and procedure for obtaining any manufacturing licence of any new drug or formulation or vaccine. A repurposed drug as to undergo one of the two alternative pathways before obtaining necessary regulatory clearances. A repurposed drug as to be tested for safety and efficacy for the treatment of the intended or proposed disease. Therefore, it as to undergo necessary clinical trials followed by formulation development and technology transfer from research and development to the production department. The regulatory approvals are required to conduct clinical trials, formulation development and commercial manufacturing. Data should be submitted after clinical trials as well as formulation development work to the Indian regulator work through specific forms and procedure. The regulator will review the data and the decision to move to the next stage. This article is the result of a comprehensive study of the regulatory framework that has to be followed by pharmaceutical company to commercialize repurposed drugs. Generic products have a different procedure.

Keywords: COVID-19, CDSCO, WHO, pandemic, repurposing


How to Cite

DEEKSHA, K. S., LAKSHMEESHA, C. S., BALAMURALIDHARA, V., & MOTUPALLI, V. (2021). A COMPREHENSIVE STUDY OF INDIA’S REGULATORY FRAMES FOR ADOPTION OF REPURPOSED DRUG AS COVID-19 TREATMENT. Journal of Disease and Global Health, 14(3), 11–29. Retrieved from https://ikprress.org/index.php/JODAGH/article/view/7245

Downloads

Download data is not yet available.

References

Draft guidance on approval of clinical trial and new drugs; August 24,2011. Available:https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadAlertsFiles/Guidance_for_New_Drug_Approval-23july2.pdf

Central Drugs Standard Control Organization (Import & Registration Division) Guidance document No.IMP/REG/200711. Available:https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/import-registration/Import_guidance_doc.pdf

Espanol, Regulations and laws that may apply during a pandemic. Available:https://www.cdc.gov/flu/pandemic-resources/planning-preparedness/regulations-laws-during-pandemic.htm

Vasani B, Hasan M, Pednekar S, Himadri E. Covid-19: Officialy a pandemic March 18, 2020. Available:https://corporate.cyrilamarchandblogs.com/2020/03/covid-19-officially-a-pandemic-faqs-coronavirus/

Global health security survey report, October, 2019. Available:file:///C:/Users/abbyjamayca/Downloads/regulatory-compliance-india-covid-19.pdf

Rajkumar M, Coronavirus: A quick guide to the laws the Indian government can invoke to fight epidemics, March 24, 2020. Available:https://scroll.in/article/957029/coronavirus-a-quick-guide-to-the-laws-the-indian-government-can-invoke-to-fight-the-pandemic

Janati A, Hosseiny M, Ghaderi E. Communicable Disease Reporting System in the World: A Systematic Review Article, October 18, 2015. Available:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4703224/#idm139758723194352title

Riley E. What is a pandemic? Definition, examples, and how it compares toan epidemic Apri l1, 2020. Available:https://www.goodrx.com/blog/what-does-pandemic-mean-with-examples-vs-epidemic/

Sharma P Health ministry revises remdesivir dosage for Covid-19 patients July 04, 2020. Available:https://health.economictimes.indiatimes.com/news/diagnostics/health-ministry-revises-remdesivir-dosage-for-covid-19-patients/76783188

Jeetendra K. India’s First Pharma Company BCPL Gets Clearance for manufacturing Hydroxychloroquine, April 11, 2020. Available:https://microbiozindia.com/pharma-news/indias-first-pharma-company-bcpl-gets-clearance-for-manufacturing-hydroxychloroquine/

Q&A: Dexamethasone and Covid-19, June 25, 2020. Available:https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/q-a-dexamethasone-and-covid-19?gclid=EAIaIQobChMI5NWZ87nF6wIV23wrCh1--wD8EAAYASAAEgJzoPD_BwE

Luo P, Liu Y, Qiu L, Liu X, et al. Tocilizumab treatment in COVID-19: A single center experience, April 15, 2020. Available:https://pubmed.ncbi.nlm.nih.gov/32253759/

Rees V. Glenmark approved to supply Favipiravir as COVID-19 treatment in India, June 23, 2020. Available:https://www.europeanpharmaceuticalreview.com/news/121787/glenmark-approved-to-supply-favipiravir-as-covid-19-treatment-in-india/

Strides develops Favipiravir antiviral tablets; drug shows positive outcome in COVID-19 treatment, The Economic Times, April 29, 2020. Available:https://health.economictimes.indiatimes.com/news/pharma/strides-develops-favipiravir-antiviral-tablets-drug-shows-positive-outcome-in-covid-19-treatment/75448928

EH News Bureau, Hetero launches first generic COVIFOR in India for COVID-19 treatment, June 21, 2020. Available:https://www.expresshealthcare.in/covid19-updates/hetero-launches-first-generic-covifor-in-india-for-covid-19-treatment/422098/

Singh T. While finding a solution for COVID-19, Indian drug laws must balance safety and speed, May 05, 2020. Available:https://caravanmagazine.in/health/indian-drug-laws-must-balance-safety-and-speed-while-finding-covid-19-solution

Nurton J. Drug repurposing and the COVID-19 pandemic, WIPO magazine, June, 2020. Available:https://www.wipo.int/wipo_magazine/en/2020/02/article_0004.html

New regulatory guidance to facilitate drug and vaccine approval for COVID-19, March 27, 2020. Available:https://cliniexperts.com/covid-19-india-cdsco-drug-vaccine-19-march/

Rajgopal D. DCGI to fast-track approval for Covid-19 drug, vaccine. Theeconomictimes, March 24, 2020. Available:https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/dcgi-to-fast-track-approval-for-covid-19-drug vaccine/articleshow/74764495.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

Vishal Gupta N, Mohan Reddy C, Pradeep Reddy K, et al. Process of approval of new drug in India with emphasis on clinical trial, March-April, 2012. Available:https://www.globalresearchonline.net/journalcontents/v13-2/004.pdf

Singh & Associates India: CDSCO Issues clarification regarding issuance of NOC for issuance of Form 29 license, Febrauary 20, 2018. Available:https://www.mondaq.com/india/life-sciences-biotechnology-nanotechnology/674734/cdsco-issues-clarification-regarding-issuance-of-noc-for-issuance-of-form-29-license

Itsaruns, Checklist for applications for grant of approval of various categories of New Drug, Global Clinical trial and Bioequivalence study for export purpose, DCGI prescreening new drug applications, November 06, 2012. Available:https://www.slideshare.net/itsaruns/dcgi-prescreening-new-drug-applications?from_action=save