Skip to main content
SpringerLink
Log in

Recombinant Drug Development, Regulation, and Commercialization

An Indian Industry Perspective

  • Original Research Article
  • Published:
BioDrugs Aims and scope Submit manuscript

Abstract

Introduction

The Indian biopharmaceutical sector comprises nearly 40 companies that manufacture and/or market 14 recombinant drugs that account for nearly 50 products. Among these, 22 companies have manufacturing facilities in India.

Objective

The aim of the present study was to analyze the patenting trends, commercialization, and regulatory system for biopharmaceuticals in India.

Methods

Representatives from 19 such biopharmaceutical companies were interviewed on aspects related to regulatory compliance, manufacturing, commercialization, and innovation in order to understand the challenges faced by them in the current regulatory and patent system.

Results

The study revealed that 94% of the companies have filed patents and 52% are developing new biologic entities in areas such as diabetes mellitus, cancer, and congestive heart diseases. Forty-two percent of the companies consider delays in regulatory approval to be a major constraint for biopharmaceutical industry development. Almost all are of the opinion that uniform guidelines across countries would help to prevent delays in the commercialization of products.

Conclusion

A high proportion of representatives of the biopharmaceutical industry in India identified that elaboration of regulatory guidelines, defined submission requirements, and drug approval timelines are vital to the growth of the biopharmaceutical industry.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Fig. 1
Fig. 2
Table II
Fig. 3

Similar content being viewed by others

References

  1. Market report. Biologics pipelines: who has the next promising recombinant proteins? Decision Resources, Inc., 2008 Apr [online]. Available from URL: http://www.researchandmarkets.com/reportinfo.asp?report_id=603343 [Accessed 2010 Mar 30]

  2. Ernst and Young. Biotech: market and opportunity. A report by Ernst and Young for IBEF, 2008 [online]. Available from URL: http://www.ibef.org/download%5CBiotech_250608.pdf [Accessed 2010 Mar 30]

  3. Technology Information, Forecasting and Assessment Council (TIFAC). Recombinant DNA therapeutic products (2001), Technology Information, Forecasting and Assessment Council (TIFAC) report [online]. Available from URL: http://www.tifac.org.in/index.php?option=com_content&view=article&id=734&Itemid=205[Accessed 2010 Mar 30]

  4. BioSpectrum Asia Pacific awards 2009: BIOMAb-EGFR [online]. Available from URL: http://www.biospectrumasia.com/content/090309IND8787.asp [Accessed 2010 May 30]

  5. Sahoo N, Chowdhury K, Padmavati M. Manufacturing of biodrugs: need for harmonization in regulatory standards. Biodrugs 2009; 23: 217–29

    Article  PubMed  CAS  Google Scholar 

  6. Central Drug Standard Control Organization (CDSCO), India. Targeted timelines for approvals of complete applications by DCG (I) office (2009). New Delhi: CDSCO [online]. Available from URL: http://www.cdsco.nic.in/revised_new_timelines.pdf[Accessed 2010 Mar 30]

  7. EU directive 2001/83/EC [online]. Available from URL: http://www.edctp.org/fileadmin/documents/ethics/DIRECTIVE_200183EC_OF_THE_EUROPEAN_PARLIAMENT.pdf[Accessed 2010 Jul 11]

  8. US Food and Drug Administration (US FDA). Code of federal regulations title 21, part 314. Silver Spring (MD): US FDA [online]. Available from URL: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314[Accessed 2010 Mar 30]

  9. European Medicines Agency (EMA). EMA guidance on pre-submission meetings for initial marketing authorization application for human medicinal products in the centralised procedure [EMEA/382712/2006]. London: EMA, 2007 Jan 12 [online]. Available from URL: http://www.ema.europa.eu/htms/human/presub/38271206en.pdf[Accessed 2010 Jun 1]

  10. Central Drug Standard Control Organization (CDSCO), India. Guidance for industry [CT/71108 version 1.1]. New Delhi: CDSCO [online]. Available from URL: http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf[Accessed 2010 Mar 30]

  11. Shanpoietin® product information. Medchal: Shantha Biotechnics Pvt Ltd, 2005 Oct 28 [online]. Available from URL: http://www.shanthabiotech.com[Accessed 2010 Oct 10]

  12. Shanferon product information. Medchal: Shantha Biotechnics Pvt Ltd, 2005 Oct 28 [online]. Available from URL: http://www.shanthabiotech.com[Accessed 2010 Jul 11]

  13. Reliferon™ package insert. Navi Mumbai: Reliance life Sciences Pvt Ltd [online]. Available from URL: http://www.rellife.com/pdf/reliferoninsert.pdf [Accessed 2010 Jul 11]

  14. US Food and Drug Administration (US FDA). Guidance for industry: changes to an approved application for specified biotechnology and specified synthetic biological products. Silver Spring (MD): US FDA, 1997 Jul [online]. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM124805.pdf [Accessed 2010 May 30]

  15. European Medicines Agency (EMA). CPMP guideline on comparability of biotechnology-derived products [CPMP/BWP/1113/98]. London: EMA, 1998 Jun 24 [online]. Available from URL: http://www.ema.europa.eu/pdfs/human/bwp/111398en.pdf [Accessed 2010 July 11]

  16. European Medicines Agency (EMA). Guideline on comparability of medicinal products containing biotechnology-derived protein as active substance: nonclinical and clinical issue [EMEA/CPMP/3097/02/Final]. London: EMA, 2003 Dec 17 [online]. Available from URL: http://www.ema.europa.eu/pdfs/human/ewp/309702en.pdf [Accessed 2010 Jul 11]

  17. European Medicines Agency (EMA). Note for guidance on biotechnological/ biological products subject to changes in their manufacturing process [CPMP/ ICH/5721/03]. London: EMA, 2005 Jun [online]. Available from URL: http://www.ema.europa.eu/pdfs/human/ich/572103en.pdf[Accessed 2010 Jul 11]

  18. European Medicines Agency (EMA). Guideline on virus safety evaluation of biotechnological investigational medicinal products [EMEA/CHMP/BWP/ 398498/05]. London: EMA, 2005 Jul 24 [online]. Available from URL: http://www.ema.europa.eu/pdfs/human/bwp/39849805enfin.pdf [Accessed 2010 Mar 30]

  19. European Medicines Agency (EMA). Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials [EMEA/CHMP/BWP/534898/08]. London: EMA, 2008 Feb 18 [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/03/WC500075559.pdf[Accessed 2010 Mar 30]

Download references

Acknowledgments

Both authors contributed equally to this work. The authors have no conflicts of interest that are directly relevant to the content of this article. The authors are very grateful to the representatives of all of the companies who participated in the survey for their responses to the questionnaire and valuable insights on the research work. No funding was received to conduct this study or prepare this manuscript.

Author information

Authors and Affiliations

  1. Rajiv Gandhi School of Intellectual Property Law, Indian Institute of Technology Kharagpur, Kharagpur, 721302, West Bengal, India

    Niharika Sahoo &  Padmavati Manchikanti

Authors
  1. Niharika Sahoo
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Padmavati Manchikanti
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Padmavati Manchikanti.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Sahoo, N., Manchikanti, P. Recombinant Drug Development, Regulation, and Commercialization. BioDrugs 25, 105–113 (2011). https://doi.org/10.2165/11584670-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11584670-000000000-00000

Keywords

Search

Navigation