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Article . 2026
License: CC BY
Data sources: Datacite
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
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Study Of Regulations for Generic Drug Approval in Myanmar, Malaysia, Madagascar and India

Authors: Atharva Gandhi*, Dr. G. D. Basarkar;

Study Of Regulations for Generic Drug Approval in Myanmar, Malaysia, Madagascar and India

Abstract

Regulatory procedures for generic medication approval are crucial to guaranteeing the availability of safe, effective, and inexpensive medicines while preserving strong public health safeguards. This research compares the regulatory requirements for generic drugs in Myanmar, Malaysia, Madagascar, and India, with an emphasis on approval procedures, dossier forms, and compliance expectations. The key regulatory parameters analyzed include governing authorities, legal frameworks, dossier formats, submission systems, Good Manufacturing Practice (GMP) certification, bioequivalence (BE) requirements, stability data, local representation, review timelines, and post-marketing surveillance obligations. Myanmar and Malaysia generally follow the ASEAN Common Technical Dossier (ACTD), which reflects regional regulatory harmonization attempts, whereas India uses the CDSCO SUGAM portal to submit an Abbreviated New Drug Application (ANDA) based on the Common Technical Document. Madagascar uses a national regulatory approach that is consistent with internationally recognized quality, safety, and efficacy requirements. Regardless of procedural differences across jurisdictions, all four regulatory systems priorities proof of pharmaceutical quality, therapeutic equivalency, and manufacturing conformity. The assessment reveals both convergence and variation among national regulatory regimes, as well as potential obstacles in dossier preparation and approval timescales for pharmaceutical businesses. Regulatory affairs experts must have a thorough awareness of these regulatory variances in order to optimize submission strategies, assure compliance, and allow fast market entry for generic pharmaceuticals in varied regulatory settings.

Keywords

Generic drug approval, ASEAN Common Technical Dossier (ACTD), Good Manufacturing Practice (GMP), Bioequivalence, Drug registration regulations, and Abbreviated New Drug Application (ANDA).

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
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