Abstract

REGULATORY REQUIREMENTS AND FILING PROCEDURE FOR DRUG MASTER FILES IN INDIA UNDER THE CENTRAL DRUGS STANDARD CONTROL ORGANIZATION COMPARED TO BRAZIL

Hanamant B. Sannakki, C. Madhavan Reddy*, Adarsh Utale and Trupti Hunnura

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Abstract

The regulatory requirements and filing procedures for Drug Master Files (DMF) in India and Brazil are pivotal for ensuring the safety, efficacy, and quality of pharmaceutical products. Both countries have stringent frameworks to evaluate the quality of drug substances and ensure compliance with relevant standards. In India, the Central Drugs Standard Control Organization (CDSCO) oversees the submission and review process, while Brazil has its own regulatory authorities managing DMF filings. Despite sharing similar goals in safeguarding public health, these two countries have distinct processes, making it essential for pharmaceutical companies to understand the nuances of each system to achieve timely approvals. The quality of Active Pharmaceutical Ingredients (API) is a critical element in the manufacture of safe and effective drug products, and any changes to an approved DMF must be promptly notified, as they can impact drug product applications. Although emerging markets like India and Brazil enforce more stringent API approval requirements compared to established markets, the lack of harmonized guidelines and transparency in these regions presents challenges. This study emphasizes the importance of adherence to local regulatory standards and highlights the complexities pharmaceutical companies face when navigating the DMF filing procedures in these emerging markets.

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