REGULATORY RECURRENCE FOR APPROVAL OF ANDA (GENERIC DRUG) AS PER CDSCO IN INDIA COMPARISON WITH JAPAN

Dr. P. Ashok Kumar*, Jeevan S, Darshan V. S., Lingaraja N. P., Hemanth M., Kirankumar B. R.

ABSTRACT

Generic medicines play an important role in providing safe, effective, quality and affordable healthcare. They are developed as equivalent alternatives to brand-name medicines and must meet regulatory requirements for quality, safety, efficacy and bio equivalence. Their availability reduces healthcare expenditure, improves access to essential medicines and promotes competition in the pharmaceutical market. The Abbreviated New Drug Application (ANDA) is an important pathway for generic drug approval. It allows manufacturers to demonstrate equivalence to a Reference Listed Drug without repeating the complete development programme of the original product. Major requirements include bioequivalence studies, pharmaceutical quality, Chemistry, Manufacturing and Controls (CMC), current Good Manufacturing Practices (cGMP), stability testing and impurity control. In India, generic medicines are regulated under the Drugs and Cosmetics Act, 1940, Drugs Rules, 1945 and applicable regulatory requirements. The Central Drugs Standard Control Organization (CDSCO) performs important functions related to drug quality, safety, efficacy, clinical trials, marketing authorization, imported drugs, pharmacovigilance and bioavailability/bioequivalence requirements. In Japan, the regulatory framework involves the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). PMDA conducts scientific and technical reviews, inspections and post-marketing safety activities, while MHLW provides final regulatory authorization. This comparative study evaluates the generic drug approval systems of India and Japan, focusing on regulatory requirements, bioequivalence, quality standards, review procedures and patient safety. It highlights major similarities and differences between the two regulatory frameworks and their approaches to ensuring the availability of safe, effective and affordable generic medicines.

Keywords: Generic drugs; ANDA; CDSCO; PMDA; MHLW; Bioequivalence.