REGULATORY REQUIREMENTS ON PARENTERAL DOSAGE FORMS AS PER CDSCO IN INDIA COMPARISON WITH JAPAN

*Dr. P. Ashok Kumar, Harshitha B., Deepashree G., Kavya Galag, 5Sindhushree H. K., Karthik G. S.

ABSTRACT

Parenteral dosage forms are sterile pharmaceutical preparations administered by injection, infusion or implantation and are used when rapid onset, high bioavailability, accurate dosing or an alternative to the gastrointestinal route is required. Since these products bypass many natural barriers to infection, regulatory control focuses strongly on sterility assurance, contamination prevention, product quality and patient safety. This review summarizes the regulatory requirements applicable to parenteral dosage forms in India and compares this with the framework of Japan. This review is based primarily on the regulatory and technical material compiled within the source thesis and supplemented by the current official information of the Central Drugs Standard Control Organization (CDSCO), the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). In India, the regulatory framework consists of the Drugs and Cosmetics Act and Rules, New Drugs and Clinical Trials Rules, 2019 and Schedule M requirements for sterile manufacturing. In Japan, the regulatory oversight is shared between MHLW and PMDA under the Pharmaceuticals and Medical Devices Act framework with Japanese Pharmacopoeia and GMP requirements supporting quality assurance. Both systems focus on aseptic processing, sterilization, sterility testing, bacterial endotoxin control, particulate control, container-closure integrity, validation, documentation and post-marketing safety. The comparison suggests substantial alignment with international pharmaceutical quality principles as well as differences in regulatory structure, pharmacopoeias references, approval pathways and post-marketing systems.

Keywords: Parenteral dosage forms; CDSCO; PMDA; Sterility assurance; Schedule M; Japanese Pharmacopoeia.