Bhoomi D. Patel^1*, Shailesh P. Suthar², Arman M Mansuri², Vishvash D. Joshi²

¹Department of Pharmaceutical Chemistry & Quality Assurance, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA-382260.

²School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA-382260.

* Address    for  Correspondence:

Dr. Bhoomi Dineshkumar Patel

Associate Professor & HOD

Department of Pharmaceutical Chemistry & Quality Assurance, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA.

Email: bhoomi.patel@raiuniversity.edu

Abstract

The Abbreviated New Drug Application (ANDA) is used for the regulatory submission of generic drugs, which are pharmaceutical equivalents to brand-name drugs and distributed without patent protection. Different countries have their own regulatory requirements for the approval of generic drugs, enforced by authorities such as the CDSCO in India, EDQM in Europe, and USFDA in the United States. This review aims to compare the regulatory processes and requirements for generic drug approval in India, Europe, and the US, highlighting key differences and challenges. The involvement of regulatory authorities in the drug development process is crucial for expediting approval and addressing queries, helping to minimize delays. The Common Technical Document (CTD) format is employed across regions to harmonize submission requirements. This study underscores the differences in dossier submission for generics across the three regions, illustrating India’s position in the global generic drug approval landscape. By comparing approval requirements, this work provides insight into the hurdles India must overcome to streamline its approval process. The ANDA allows generic manufacturers to submit bioequivalence studies, using the original innovator’s safety and efficacy data. However, obtaining approval simultaneously from multiple regulatory authorities remains a challenging task. Careful review of regulatory documents by skilled personnel can reduce regulatory queries, ultimately accelerating the market launch of generic drugs. This review provides a comprehensive overview of the generic drug approval process, emphasizing the need for harmonization and improved efficiency in India’s regulatory framework.

Keywords  Generic Drug, Regulatory Approval, Abbreviated New Drug Application, Common Technical Document

PDF  A Comparative Analysis of Generic Drug Assessment and Regulatory Approval in the USA, Europe and India.pdf