Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

@article{210627,
        author = {Ankita Suryawanshi and Avinash Mathapati and Nasheer Shaikh and Shruti Pandge and Aakansha Dhanasure and Pranita Nade and Vasudha Pargave and Pallavi Borphale},
        title = {A Comparative Study of Regulatory Requirements for the Approval of Generic Drugs in the United States, European Union, and India},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {6},
        pages = {1648-1660},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=210627},
        abstract = {Generic medications are crucial for lowering costs and increasing access to healthcare. Regulations ensuring, they are of the highest quality and have the same therapeutic effect as the original medications are necessary for their approval. With an emphasis on legal frameworks, bioequivalency research, data protection, patent limits, and approval processes, this article examines the regulatory requirements for generic pharmaceutical clearance in the US, EU, and India. A narrative examination was conducted using published scientific literature, government instructions, and regulatory papers. While the US employs the Hatch-Waxman Act's Abbreviated New Drug Application (ANDA) system, the EU uses the generic application process under Directive 2001/83/EC. The main legislation governing generic pharmaceuticals in India are the new pharmaceuticals and Clinical Trials Rules of 2019 and the Drugs and Cosmetics Act of 1940. A crucial prerequisite for proving that generic medications function similarly to their reference items is bioequivalence research. 
While the three regions differ in terms of patent protection, data exclusivity, regulatory processes, and study criteria, they share fundamental scientific concepts. The development and approval of generic drugs may be further impacted by recent events, such as the proposed modifications to EU pharmaceutical legislation and the reported 2026 update to India's bioequivalence study regulations. The evaluation emphasizes the necessity of improved regulatory harmonization, more precise norms, and increased collaboration amongst regulatory bodies, especially with regard to complicated generic medications. Better regulatory harmonization could save development costs, streamline applications across several markets, and facilitate the prompt supply of safe, efficient, and reasonably priced generic medications.},
        keywords = {medication approval, bioequivalence, regulatory framework, ANDA, United States, European Union, India, and regulatory harmonization},
        month = {November},
        }