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INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS - IJCRT (IJCRT.ORG)

International Peer Reviewed & Refereed Journals, Open Access Journal

IJCRT Peer-Reviewed (Refereed) Journal as Per New UGC Rules.

ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013

Call For Paper - Volume 14 | Issue 8 | Month- August 2026

Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 7.97 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(CrossRef DOI)

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Volume 14 | Issue 7 |

Volume 14 | Issue 7 | Month  
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Chania Chania
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  Paper Title: A Study on Regulatory Barriers Governing the Import, Export, and Marketing of Pharmaceutical Products in India and Selected ROW Countries"

  Author Name(s): Ms. Divya Nimrao Lothe, Chhagan R. Doijad

  Published Paper ID: - IJCRT21X0414

  Register Paper ID - 311000

  Publisher Journal Name: IJPUBLICATION, IJCRT

  DOI Member ID: 10.6084/m9.doi.one.IJCRT21X0414 and DOI :

  Author Country : Indian Author, India, 441209 , Gadchiroli, 441209 , | Research Area: Pharmacy All

Published Paper URL: http://ijcrt.org/viewfull.php?&p_id=IJCRT21X0414
Published Paper PDF: download.php?file=IJCRT21X0414
Published Paper PDF: http://www.ijcrt.org/papers/IJCRT21X0414.pdf

  Your Paper Publication Details:

  Title: A STUDY ON REGULATORY BARRIERS GOVERNING THE IMPORT, EXPORT, AND MARKETING OF PHARMACEUTICAL PRODUCTS IN INDIA AND SELECTED ROW COUNTRIES"

 DOI (Digital Object Identifier) :

 Pubished in Volume: 14  | Issue: 7  | Year: July 2026

 Publisher Name : IJCRT | www.ijcrt.org | ISSN : 2320-2882

 Subject Area: Pharmacy All

 Author type: Indian Author

 Pubished in Volume: 14

 Issue: 7

 Pages: x487-x577

 Year: July 2026

 Downloads: 84

  E-ISSN Number: 2320-2882

 Abstract

The pharmaceutical industry is one of the most highly regulated sectors worldwide, with regulatory frameworks playing a critical role in ensuring the safety, quality, and efficacy of medicinal products. The import, export, and marketing of pharmaceutical products are governed by diverse regulatory requirements that vary across countries, creating both opportunities and challenges for pharmaceutical companies. India, as one of the world's leading producers and exporters of generic medicines, must comply with both domestic regulations and the regulatory expectations of international markets. This study reviews the regulatory barriers governing the import, export, and marketing authorization of pharmaceutical products in India and selected Rest of the World (ROW) countries. It compares the regulatory frameworks, documentation requirements, registration procedures, quality standards, Good Manufacturing Practices (GMP), labeling, pharmacovigilance, and post-marketing surveillance requirements across different regions. The study also highlights the challenges faced by manufacturers in meeting varying regulatory expectations, including differences in technical guidelines, approval timelines, and compliance requirements.


Licence: creative commons attribution 4.0

  License

Creative Commons Attribution 4.0 and The Open Definition

 Keywords

Regulatory Affairs, Pharmaceutical Regulations, Import and Export, Marketing Authorization, India, Rest of the World (ROW), GMP, Pharmacovigilance, Regulatory Harmonization, Market Access.

  License

Creative Commons Attribution 4.0 and The Open Definition


  Paper Title: Test 123

  Author Name(s): Jatin, Hitesh

  Published Paper ID: - 111

  Register Paper ID - 311242

  Publisher Journal Name: IJPUBLICATION, IJCRT

  DOI Member ID: 10.6084/m9.doi.one.111 and DOI :

  Author Country : Indian Author, India, - , -, - , | Research Area: Biological Science

Published Paper URL: http://ijcrt.org/viewfull.php?&p_id=111
Published Paper PDF: download.php?file=111
Published Paper PDF: http://www.ijcrt.org/papers/111.pdf

  Your Paper Publication Details:

  Title: TEST 123

 DOI (Digital Object Identifier) :

 Pubished in Volume: 14  | Issue: 7  | Year: July 2026

 Publisher Name : IJCRT | www.ijcrt.org | ISSN : 2320-2882

 Subject Area: Biological Science

 Author type: Indian Author

 Pubished in Volume: 14

 Issue: 7

 Pages: 136-139

 Year: July 2026

 Downloads: 63

  E-ISSN Number: 2320-2882

 Abstract

test 1233


Licence: creative commons attribution 4.0

  License

Creative Commons Attribution 4.0 and The Open Definition



Call For Paper August 2026
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ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
ISSN
ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
ISSN
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