IJCRT Peer-Reviewed (Refereed) Journal as Per New UGC Rules.
ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013
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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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
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
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
Regulatory Affairs, Pharmaceutical Regulations, Import and Export, Marketing Authorization, India, Rest of the World (ROW), GMP, Pharmacovigilance, Regulatory Harmonization, Market Access.
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
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
test 1233
Licence: creative commons attribution 4.0

