Regulatory Requirements For MRNA-Based Therapeutics As Per CDSCO (India) in comparison with Swissmedic (Switzerland)
Abstract
mRNA based therapeutics have evolved emerged as a promising platform in modern medicine because they facilitate provisional production of specific protein within cells. Their applications extend beyond infectious disease vaccines to cancer immunotherapy, protein replacement, gene editing, regenerative medicine, and treating of genetic disorders. Although, the successful development of these products depends on appropriate control of RNA quality, stability, delivery system, manufacturing processes, safety, and efficacy. This research focus on reviewing the regulatory requirements for m RNA based therapeutics in India and Switzerland with particularly focus on the central drug standard control organization (CDSCO) and SWISSMEDIC. The study compares their regulatory framework, approval pathways, manufacturing requirements, quality and storage condition, development criteria. India follow its existing drug and biological product regulatory framework, while Switzerland provide a structured approach for innovative and advanced therapeutics products. The comparative assessment indicates that India has considerable potential for cost effective manufacturing and expanding mRNA research, whereas Switzerland has a highly developed pharmaceutical and research environment. Continued improvement in regulatory guidance, manufacturing capability, product characterization, delivery technologies and safety monitoring may facilitate the wider development and adoption of mRNA-based therapeutics. Keywords: mRNA therapeutics, cancer immunotherapy, CDSCO, SWISSMEDIC, regulatory framework.
