PRODUCT APPROVAL PATHWAYS IN SOUTH ASIA: INSIGHTS FROM INDIA, PAKISTAN, AND NEPAL"

Author(s)	Mr. GANESH HEBBAR
Country	India
Abstract	A regulatory process, by which an applicant gets authorization to launch a drug in the market, is known as drug approval process. Submission of INDA, conducting clinical trials, application to marketing authorization of drug and post-marketing studies are the key steps in the drug approval process. The current landscape of regulatory affairs highlights that different countries have distinct regulatory requirements for the approval of Marketing Authorization Applications (MAAs) for drug products. Each country has a designated regulatory body tasked with implementing laws, issuing guidelines, and overseeing the marketing and distribution of pharmaceutical products. In this study we compare the regulatory bodies, drug approval process of India, Nepal and Pakistan. India's regulatory system, led by the CDSCO, demonstrates a mature and structured approach, whereas Nepal and Pakistan must prioritize regulatory reform, enhance technical expertise, and foster collaboration with global health agencies to ensure the safety, efficacy, and quality of pharmaceutical products.
Keywords	CDSCO, DRAP, DDA
Field	Medical / Pharmacy
Published In	Volume 7, Issue 3, May-June 2025
Published On	2025-06-30

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International Journal For Multidisciplinary Research