PRODUCT LIFE CYCLE MANAGEMENT OF DRUGS: A COMPARATIVE ANALYSIS OF REGULATORY APPROACHES AND HARMONIZATION STRATEGIES BETWEEN USFDA AND CDSCO

Ashok Kumar P.*, Pavan S., Dhanush D., Harsha C. N., Maruthi C., Jayanth R.

ABSTRACT

Product Life Cycle Management (PLCM) governs a pharmaceutical product from development through approval, marketing, post-approval variation, and eventual withdrawal, so that safety, efficacy, and quality are preserved throughout its commercial life. This comparative, document-based study examined and contrasted the regulatory frameworks and PLCM practices of India's Central Drugs Standard Control Organization (CDSCO) and the United States Food and Drug Administration (USFDA), using primary regulatory texts (the New Drugs and Clinical Trials Rules 2019, 21 CFR Parts 314 and 601, ICH Q12), agency guidance, and peer-reviewed literature, supported by two illustrative case analyses. USFDA was found to operate a mature, risk-tiered PLCM system — Prior Approval Supplements, CBE-30/CBE-0, and Annual Reports for major, moderate, and minor changes respectively — with extensive public guidance and defined timelines. CDSCO regulates post-approval changes mainly through case-by-case major/minor variation review, with limited formal adoption of ICH Q12 and no standalone PLCM document. A CDSCO initiative reforming review of imported-drug changes, built on reliance on stringent regulatory authority assessments, reduced review time by over 60% and cut submission deficiencies by about 40%. Formal harmonization of CDSCO's variation-management system with internationally recognized, risk-based PLCM practice is likely to improve efficiency, patient access, and India's integration into global pharmaceutical supply chains.

Keywords: Product Lifecycle Management; Post-Approval Changes; Regulatory Harmonization; CDSCO; USFDA.