Regulatory requirements on parenteral dosage forms as per CDSCO in India comparison with south Africa

ABSTRACT

Parenteral products are currently widely utilized in emergency situations since they provide the highest bioavailability. Parenteral product legislation is crucial as non-sterile, non-pyrogenic products can provide a serious health risk to patients, potentially leading to death. The Central Drugs Standard Control Organization (CDSCO) in India and South African health products regulatory authority (SAHPRA) in South Africa have specified different dosage formats, and this review offers a comparative examination of those requirements. This review explores critical aspects including governing legislation, clinical trial requirements, good manufacturing practices (GMP), quality control, packaging and labelling standards, import and export regulations and recent reforms. As indicated above comparative analysis of regulation and registration process for parenteral dosage from will be valuable regulatory point of view as well as business development point. With this viewpoint industry can unify dossier application in better method, which would aid in lowering time for product to go in market.

Keyword: Parenteral products, CDSCO, SAHPRA, GMP.