REGULATORY REQUIREMENTS FOR APPROVAL OF VACCINES IN INDIA IN COMPARISON WITH THE PHILIPPINES

Dr. P. Ashok Kumar*, Lavakumar J. N., Rochana B. V., Chinmayi N., Ananya G. A., Karthik P

ABSTRACT

This expanded review provides an in-depth comparative investigation into the regulatory frameworks governing vaccine evaluation, clinical trials, dossier evaluation, quality verification, and post-market oversight in India and the Philippines. Administered respectively by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare (India) and the Food and Drug Administration (FDA Philippines) under the Department of Health, both systems strive to safeguard public safety while facilitating access to life-saving biological products. This work delineates the statutory legal foundations—specifically India's Drugs and Cosmetics Act (1940) and New Drugs and Clinical Trials Rules (NDCTR, 2019) versus the Philippines' Republic Act No. 3720 as amended by RA 9711 (FDA Act of 2009). Furthermore, the review contrasts national CTD structures against the ASEAN Common Technical Dossier (ACTD/eCTD), details multi-tiered biosafety and ethical committees (RCGM, GEAC, IRB/REC), compares lot-release mechanisms (CDL Kasauli vs. international lot release validation), evaluates emergency use authorization (EUA) pathways deployed during pandemic responses, and reviews ongoing pharmacovigilance and AEFI monitoring networks.

Keywords: Vaccines; Biologicals; CDSCO; FDA Philippines; NDCTR 2019; ACTD; Emergency Use Authorization; Pharmacovigilance; AEFI.